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{ "NCT_ID" : "NCT03136588", "Brief_Title" : "Information and Communication Technology (ICT) Based Centralized Clinical Trial Monitoring System for Drug Adherence", "Official_title" : "The Efficacy and Stability of Information and Communication Technology Based Centralized Clinical Trial Monitoring System of Adherence to Immunosuppressive Medication in Kidney Transplant Recipients", "Conditions" : ["Kidney Transplantation"], "Interventions" : ["Device: Feedback using ICT based monitoring system"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-08-23", "Study_Completion_Date(Actual)" : "2018-12-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-04-20", "First_Posted(Estimated)" : 2017-05-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-04-27", "Last_Update_Posted(Estimated)" : 2020-09-07", "Last_Verified" : 2020-09" } }}

#Study Description Brief Summary Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare cost. Aggressive preemptive effort by healthcare professionals geared to ensure adherence to immunosuppressants in KTRs is significant and imperative. This study was designed as a prospective, randomized, controlled, and multicenter study aimed at evaluating efficacy and stability of the information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. This study is based upon work supported by the Ministry of Trade, Industry \& Energy (MOTIE, Korea) under Industrial Technology Innovation Program ( No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization'). Detailed Description This study has a multi-center, open-label, prospective, and randomized clinical trial design. One hundred KTRs who fill out the informed consent form are registered and randomized 1:1 into the ICT-based centralized clinical trial monitoring group (n=50) or the ambulatory follow-up group (n=50). The planned follow-up duration is 6 months. The ICT-based centralized clinical trial monitoring group is given a smart pill box equipped with personal identification system. Fingerprint registration is required in advance, so that it would be used for authentication before each use of the smart pill box later. The adherence-related information obtained from the pill box is saved, monitored, and sent out via a home-monitoring system. In the ICT-based centralized clinical trial monitoring group, feedback is sent to both patients and medical staff in the form of texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Both groups are to make 6 office visits after randomization at 4, 8, 12, 16, 20, and 24 weeks. Each visit requires measurement of blood drug level, creatinine level, and estimated glomerular filtration rate. Serum BK virus is assessed at 12 weeks, and panel reactive antibody at 24 weeks. Both groups keep a drug administration diary that specifies date, a dose taken or not, dosing time, and dosage. At each visit, subjects go over the diary with investigators and fill out a questionnaire using the Modified Morisky Scale. The ICT-based centralized clinical trial monitoring group completes a patient satisfaction questionnaire developed by the ICT clinical trial support center at 4 and 12 weeks. The objective of this study is 1. to evaluate the effectiveness of ICT based centralized clinical trial monitoring system on adherence of immunosuppressive agents 2. to study the influence of ICT based centralized monitoring on immunosuppressive and clinical outcomes including therapeutic trough level 3. to evaluate patient's satisfaction about ICT based clinical trial monitoring system #Intervention - DEVICE : Feedback using ICT based monitoring system - In case of a missed immunosuppressant dose, the first violation does not generate a feedback while the second one does within one hour at the break of the ±3 hour range from the fixed dosing time. Up to two additional alarms/texts are sent at an interval of 30 minutes if the dose is still not taken after the feedback. For any discrepancy between the dosage taken and the dosage prescribed, a feedback is sent within 1 hour from the moment of recognition. Again, the first violation goes without response, while any violation after that generates feedbacks. Similarly, if a dose is taken outside of the allowed ±3 hour dosing time range, a feedback is sent within 1 hour of recognition, starting with the second violation.

#Eligibility Criteria: Inclusion Criteria: * Men and women aged 19 and over * At least 1 month lapsing from kidney transplantation * Stable renal function maintained after kidney transplantation(eGFR >= 30 mL/min/1.73m2) * History of kidney transplantation only and no other organs * Use of tacrolimus, mycophenolic acid, and steroids for post-transplant immunosuppression * Patients, with capability and willingness to give consent to trial participation, who have signed the informed consent form in compliance with due process and are capable of making office visits and taking part in the trial as required by the protocol. Exclusion Criteria: * Patients' refusal of the ICT-based centralized home monitoring * History of treatment for acute rejection within the past 3 months * Active infectious disease * Uncorrected ischemic heart disease * Visual or auditory defects that could affect use of the smart pill box * Fingerprint authentication of personal identity deemed impossible (ex: adermatoglyphia) * Other reasons determined by investigators that make participation in the clinical trial inappropriate Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03136588

{ "NCT_ID" : "NCT04273230", "Brief_Title" : "Kidney Affection in Non Alcaholic Fatty Liver Diseases", "Official_title" : "Early Detection of Kidney Affection in Non Alcaholic Fatty Liver Diseases(NAFLD)", "Conditions" : ["Renal Impairment"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-03-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-01", "Study_Completion_Date(Actual)" : "2021-06-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-02-14", "First_Posted(Estimated)" : 2020-02-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-02-14", "Last_Update_Posted(Estimated)" : 2022-02-23", "Last_Verified" : 2020-02" } }}

#Study Description Brief Summary Early detection of renal affection in patients with non alcaholic fatty liver diseases using microalbuminuria. Detailed Description With the increasing prevalence of obesity, diabetes mellitus and the metabolic syndrome in the general population, non-alcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease. NAFLD refers to a wide spectrum of liver damage, ranging from simple steatosis to non-alcoholic steatohepatitis, advanced fibrosis and cirrhosis as well hepatocellular carcinoma. Several large cross-sectional population and hospital-based studies involving both diabetic patients and patients without diabetes have consistently shown that the prevalence of CKD is increased in people with NAFLD . NAFLD and CKD share some common features, including visceral obesity,T2DM, hypertension and metabolic syndrome . The possible link between NAFLD and CKD has recently attracted considerable scientific interest. Establishing a link between liver and kidney injury would enhance the earlier identification of kidney disease and allow for the selection of treatments targeting both liver and kidney disease with potentially relevant preventive and therapeutic implications . The ultimate goal of identifying patients with established but also with early kidney damage is to prevent disease progression and minimize complications, to promote quality of life and improve survival . Many recent studies, including the meta-analysis from Musso et al. suggest that individuals with NAFLD should be screened for CKD by estimation of GFR and urinalysis even in the absence of classical risk factors for CKD, particularly if NASH and/or advanced fibrosis are suspected . Early recognition of impaired kidney function in patients with NAFLD, may also allow drug dosage adjustment, thus preventing drug accumulation especially in those being treated for obesity associated co-morbidities. Chronic kidney disease (CKD) is defined by the presence of reduced glomerular filtration rate (GFR \<60 mL/min/1.73 m2)and/or evidence of kidney damage (usually indicated by albuminuria or proteinuria) for 3 or more months . On the other hand kidney failure is defined as a GFR of less than 15 mL/min per 1.73 m2,or the need for treatment with dialysis or transplantation . In clinical practice the most common tests for CKD diagnosis include eGFR estimated from the serum creatinine concentration and albuminuria from the urinary albumin-to-creatinine ratio (ACR). The importance of eGFR and albuminuria as diagnostic tools becomes obvious by their use in classification of CKD patients in stages .On the basis of GFR the disease is classified into five stages:more than 90 mL/min per 1.73 m2(stage 1), 60-89 mL/min per1.73 m2(stage 2), 30-59 mL/min per 1.73 m2(stage 3), more specific 45-59 mL/min per 1.73 m2(stage 3a) and 30-44 mL/min per1.73 m2(stage 3b), 15-29 mL/min per 1.73 m2(stage 4) and less than 15 mL/min per 1.73 m2(stage 5) . Albuminuria as a marker of kidney damage is characterized by increased glomerular permeability and urine ACR \> 30 mg/g. The normal urinary ACR in young adults is \<10 mg/g. Urine ACR categories 10-29, 30-300and \>300 mg are high normal, high, and very high, respectively.Urine ACR \>2000 mg/g is accompanied by signs and symptoms of nephrotic syndrome (low serum albumin, edema, and high serum cholesterol) #Intervention - OTHER : Microalbuminuria detection - Detection of microalbumin in urine

#Eligibility Criteria: Inclusion Criteria: * All patients with fatty liver disease diagnosed by abdominal ultrasonogarphy . * All patients with fatty liver disease diagnosed by lab investigations. Exclusion Criteria: * Diabetic patients * Hypertensive patients * patients with chronic kidney disesase * patient with systemic diseases or chronic liver diseases affecting kidneys. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04273230

{ "NCT_ID" : "NCT01591005", "Brief_Title" : "SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy", "Official_title" : "Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy and Carotid Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring", "Conditions" : ["Internal Carotid Artery Stenosis"], "Interventions" : ["Procedure: sonolysis", "Procedure: endarterectomy", "Procedure: carotid stenting"], "Location_Countries" : ["Czech Republic"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-07", "Study_Completion_Date(Actual)" : "2015-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-04-23", "First_Submitted_that_Met_QC_Criteria" : 2016-07-24", "First_Posted(Estimated)" : 2012-05-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-05-02", "Last_Update_Posted(Estimated)" : 2016-09-08", "Last_Verified" : 2016-07" } }}

#Study Description Brief Summary The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MegaHertz (MHz) diagnostic probe on the reduction of risk of brain infarctions due to the activation of endogenous fibrinolytic system during carotid endarterectomy (CEA) and carotid stenting (CS). 240 patients indicated for CEA (120 patients) and CS (120 patients) will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 60minute non-diagnostic transcranial Doppler (TCD) monitoring during CEA or CS, subgroup 2 will undergo interventions without TCD monitoring. The second aim is to compare number of brain infarctions detected using MRI between CEA and CS patients. Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA or CS can be treated using these methods in the future. In the Substudy 'Risk of brain infarction after carotid endarterectomy and stenting' the the risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as well as morbidity and mortality at 30 days between patients with symptomatic and asymptomatic severe internal carotid artery (ICA) stenoses undergoing elective CEA and CAS will be compared. The sample size of the Substudy was based on an expected 80% difference of new ischemic lesions on DWI-MRI between CEA (estimated prevalence, 30%) and CAS (54%). Pre-study calculations showed that a minimum of 73 patients in each group was needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 15% of subjects would be lost to follow-up or refuse to participate in the study. Detailed Description AIM OF THE PROJECT AND HYPOTHESIS The aim of the project is to demonstrate an effect of continual TCD monitoring using 2 MHz diagnostic probe with maximal diagnostic energy on the reduction of risk of brain microinfarctions due to the activation of endogenous fibrinolytic system during CEA and CS. The second aim of the study is to compare the risk of brain infarction between CEA and CS. 240 patients indicated for CEA (120 patients) and CS (120 patients) will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of statistical significance. Patients will be randomized into 2 subgroups. Subgroup 1 will undergo a 60minute non-diagnostic TCD monitoring during CEA or CS. Subgroup 2 will undergo CEA or CS without TCD monitoring. The second aim is to compare number and volume of brain infarctions detected using MRI between CEA and CS patients. Substudy 'Risk of brain infarction after carotid endarterectomy and stenting' The aim of the prospective, randomized study was to compare the risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as well as morbidity and mortality at 30 days between patients with symptomatic and asymptomatic severe ICA stenoses undergoing elective CEA and CS. PATIENTS AND METHODS 240 patients with ICA stenosis indicated for CEA or CS according to the criteria of the American Heart Association will be enrolled into the study during a 4-year period. Altogether 120 patients indicated for CEA and 120 patients indicated for CS will be randomized for standard CEA / CS and TCD monitored CEA / CS. Randomization: Randomization using computer generated random allocation will be used, separately for CEA and CS patients. Substudy 'Risk of brain infarction after carotid endarterectomy and stenting' Minimally146 patients with ICA stenosis \>70% (symptomatic or asymptomatic) detected by duplex sonography and confirmed using computed tomography angiography (CTA); indication for carotid intervention (CEA or CAS) according to criteria set by the American Heart Association5; age 40-80 years; (iv) functionally independent (modified Rankin score 0-2 points); no contraindication to magnetic resonance imaging (MRI), computer tomography angiography (CTA) or digital angiography (DSA) will be enrolled to the Substudy. Randomization: Randomization using computer generated random allocation to CEA or CS will be used. Sonothrombolysis: In patients randomized into sonothrombolysis subgroup, middle cerebral artery (MCA) segment in depth 55 mm will be monitored for 40 minutes using a diagnostic 2 MHz probe with maximal diagnostic energy. Non-diagnostic TCD monitoring will be performed without detection of microembolic signals or detection of changes in blood flow. The second (control) subgroup will undergo a standard CEA or CS without sonothrombolysis. MRI protocol will consists of 4 sequences: 1. Localizer; 2. T2-weighted images (T2TSE); 3. fluid-attenuated inversion recovery (FLAIR); 4. diffusion-weighted imaging (DWI). Sequences 1-3 will be applied in the same level, they will have the same slice thickness and the same cut number. The slice thickness comprises its own cut thickness (5 mm) + distant factor (30%). Standard number of slices is 19. Standard slice level is considered to be a modified level of skull base due to the minimalization of distant artifacts echo planar imaging (EPI) sequence. Sequence called 'trace' with three types of magnetic resonance pictures in every slice: (a) T2\*EPI b=0; (b) DWI b=500; (c) DWI b=1000. The fourth type of images automatically created an apparent diffusion coefficient (ADC) map (in-line postprocessing). DWI show a middle (average) diffusivity of every point of examined brain tissue when b value is 500 and 1000. This sequence is applied in order to assess hemorrhage (T2\*EPI) and monitor sites of reduced diffusion (DWI, b=500 and 1000). New infarctions will be evaluated only in the territory of treated ICA. Adverse effects: All adverse effects during 1 month after ultrasound monitoring will be registered, especially all causes for new admissions to the hospital, worsening of neurological symptoms (\>4 points in NIH stroke scale), brain edema, symptomatic and asymptomatic intracranial bleeding detected in control brain MRI. Statistic evaluation: All statistical tests will be performed at the Department of Biophysics, Informatics and Biometry, Palacký University Medical School, Olomouc. Statistical evaluation in 5% level of significance of differences in the number and volume of brain infarctions detected using MRI between patients with TCD monitoring and without TCD monitoring during CEA or CS will be performed using Student T-test, χ2-test, Mann-Whitney U-test, ANOVA and multivariate analysis. Differences in the number and volume of brain infarctions between patients after CEA and CS will be evaluated as secondary end-points. Influence of other factors, e.g. age, gender, symptoms in the territory of treated artery, number of infarctions before CEA or CS, results of cognitive tests will be evaluated. Statistic evaluation for Substudy: The normality of distribution of all data will be checked using the Shapiro-Wilk test. Categorical variables in the two arms will be compared by Fisher's exact test. Continuous variables will be compared by the Student's t-test for normally distributed values and by Mann-Whitney U test for other values. Multiple logistic regression analyses were used to determine the possible predictors of a new brain infarction. All tests were carried out at an alpha level of significance of 0.05. Study protocol has been approved by the Ethics Committees in accordance with the principles and guidelines of the Declaration of Helsinki, 1975. #Intervention - PROCEDURE : sonolysis - continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes - Other Names : - sonothrombolysis, sonothrombotripsy - PROCEDURE : endarterectomy - carotid endarterectomy - Other Names : - carotid endarterectomy - PROCEDURE : carotid stenting - percutaneous transluminal angioplasty and stenting - Other Names : - percutaneous transluminal angioplasty and stenting

#Eligibility Criteria: Inclusion Criteria: * stenosis of internal carotid artery * indication to endarterectomy or stenting * age 40 <= age <= 80 years * sufficient temporal bone window for TCD with detectable blood flow in MCA * independent patient (modified Rankin score 0 <= age <= 2) * informed consent signed by the patient. Exclusion Criteria: * contraindication to MRI examination (pace-maker, implanted metal material, claustrophobia) Sex : ALL Ages : - Minimum Age : 40 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01591005

{ "NCT_ID" : "NCT01290341", "Brief_Title" : "Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis", "Official_title" : "A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis", "Conditions" : ["Tinea Pedis"], "Interventions" : ["Drug: NAFT-600 (naftin 2 % gel)", "Drug: Placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-11", "Study_Completion_Date(Actual)" : "2011-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-01-28", "First_Submitted_that_Met_QC_Criteria" : 2013-07-26", "First_Posted(Estimated)" : 2011-02-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-02-03", "Last_Update_Posted(Estimated)" : 2013-09-26", "Last_Verified" : 2013-07" } }}

#Study Description Brief Summary This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis. Detailed Description This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment. #Intervention - DRUG : NAFT-600 (naftin 2 % gel) - Topical; applied once daily for two weeks - Other Names : - Naftin® - DRUG : Placebo - Topical; applied once daily for two weeks.

#Eligibility Criteria: Inclusion Criteria: * Males or non-pregnant females, >=12 years, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test. * For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate). * Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s). Exclusion Criteria: * Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months. * Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results. * Subjects with a known hypersensitivity to study drugs or their components. * Subjects who have a recent history or who are currently known to abuse alcohol or drugs. * Uncontrolled diabetes mellitus. * Hemodialysis or chronic ambulatory peritoneal dialysis therapy. * Current diagnosis of immunocompromising conditions. * Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis. * Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection. * Extremely severe tinea pedis (incapacitating). * Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study. Sex : ALL Ages : - Minimum Age : 12 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01290341

{ "NCT_ID" : "NCT00360334", "Brief_Title" : "A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients", "Official_title" : "An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone", "Conditions" : ["Type 2 Diabetes"], "Interventions" : ["Drug: exenatide", "Drug: insulin glargine"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2006-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-04", "Study_Completion_Date(Actual)" : "2008-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2006-08-02", "First_Submitted_that_Met_QC_Criteria" : 2009-04-14", "First_Posted(Estimated)" : 2006-08-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2006-08-02", "Last_Update_Posted(Estimated)" : 2015-04-07", "Last_Verified" : 2015-03" } }}

#Study Description Brief Summary This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs. #Intervention - DRUG : exenatide - subcutaneous injection, 5mcg or 10mcg, twice a day - Other Names : - Byetta - DRUG : insulin glargine - subcutaneous injection, titrated to target blood glucose level, once a day - Other Names : - Lantus

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with type 2 diabetes * Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months. * HbA1c between 7.5% and 10.0%. * BMI >27. Exclusion Criteria: * Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study. * Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study. * Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months. * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. Sex : ALL Ages : - Minimum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00360334

{ "NCT_ID" : "NCT06318611", "Brief_Title" : "Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes", "Official_title" : "Sleep Patterns and Chronotype Among Children and Adolescents With Type 1 Diabetes Compared to Case-control Peers Without Diabetes", "Conditions" : ["Type1diabetes", "Sleep", "Chronotype"], "Interventions" : ["Other: sleep, chronotype"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-05-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-05-01", "Study_Completion_Date(Actual)" : "2023-05-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2024-02-19", "First_Posted(Estimated)" : 2024-03-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2024-03-15", "Last_Update_Posted(Estimated)" : 2024-03-19", "Last_Verified" : 2024-02" } }}

#Study Description Brief Summary Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism. This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D. The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168. The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters. Detailed Description Type 1 diabetes (T1D) is one of the most common chronic diseases in childhood. The prevalence of T1D in Turkey is reported to be 0.75%. Recent studies draw attention to the close relationship between type 1 diabetes and sleep problems. It has been suggested that sleep duration is insufficient and sleep quality is impaired in patients with T1D. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Conditions such as nocturnal glycemic variability and fear of hypoglycemia specific to patients with T1D, alarms from devices such as continuous glucose monitors and pumps used in diabetes management, anxiety, stress and depressive symptoms associated with diabetes, and treatment that may sometimes last throughout the night are possible factors that adversely affect the sleep health of people with diabetes. Studies show that children with T1D sleep significantly less than their peers without diabetes and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism. The American Diabetes Association (ADA) has emphasized that sleep health should be included in the routine assessment of people with diabetes by 2022. This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D. The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168. The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. This composite evaluates various dimensions of sleep, including regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is assigned a code of '1' for 'good' and '0' for 'poor.' The sleep health composite is designed so that a higher score indicates better overall sleep health. Sleep disturbances were assessed using the DSM-5 Level 2-Sleep Disturbance Scale Short Form. The DSM-5 Level 2-Sleep Disorders Scale short form was used to evaluate sleep disturbances. It is an 8-item scale that specifically evaluates sleep disorders in children and adolescents, within the past 7 days. Each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often, and 5=always). The total score ranges from 8 to 40 points, with higher scores indicating more severe sleep disturbances. Sleep/wake patterns were also assessed using sleep diaries. The Childhood Chronotype Questionnaire was used to evaluate the chronotype in children. This 27-item questionnaire was developed for Turkish children in the light of the Munich Chronotype Questionnaire and the Mornings-Evenings Questionnaire. The chronotypes were classified as morning, intermediate and evening types, corresponding scores of ≤23, 24-32 and ≥33. The child form of the Childhood Chronotype Questionnaire was completed by the parent and the adolescent form was completed by the adolescent. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters. Glycemic variability was evaluated using the J index to assess the effectiveness of glycemic control (calculated as 0.001 × (mean + SD)), the low blood glucose index (LBGI) to evaluate the risk of hypoglycemia, the high blood glucose index (HBGI) to determine the likelihood of hyperglycemia, and the Coefficient of Variation (CV). The Coefficient of Variation expresses the percentage variation in blood glucose levels, with a CV ≤36% indicating a stable glucose profile and a CV \>36% indicating an unstable glucose profile. For 24-hour continuous glucose monitoring, the targeted percentages of time were \>70% at 70-180 mg/dl for glycemic control, \<4% at \<70 mg/dl for hypoglycemia, \<1% at \<54 mg/dl for severe hypoglycemia, \<25% at \>180 mg/dl for hyperglycemia and \<5% at \>250 mg/dl for severe hyperglycemia. The hemoglobin A1c level is also used for glycemic control. #Intervention - OTHER : sleep, chronotype - Our objectives were to compare sleep health composite dimensions, and chronotype in children and adolescents with and without T1D, and to explore relationship between sleep and glycemic variability in T1D.

#Eligibility Criteria: Inclusion Criteria: * Aged between 6 <= age <= 18 * Use of continuous glucose monitor system Exclusion Criteria: * Acute medical condition that can impact sleep (diabetic ketoacidosis, cold, influenza) * Diagnosed neurodevelopmental or behavioral conditions like autism spectrum disorder or Attention Deficit/Hyperactivity Disorder * Diagnosed sleep disorder (Obstructive Sleep Apnea) * Current use of medications that can impact sleep (diphenhydramine) Sex : ALL Ages : - Minimum Age : 6 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT06318611

{ "NCT_ID" : "NCT04079413", "Brief_Title" : "Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients", "Official_title" : "An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO 'GEROPHARM', Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients", "Conditions" : ["Diabetes", "Diabetes Mellitus, Type 1"], "Interventions" : ["Drug: GP40071", "Drug: NovoRapid® Penfill®"], "Location_Countries" : ["Russian Federation"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-06-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-21", "Study_Completion_Date(Actual)" : "2020-01-21}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-09-03", "First_Posted(Estimated)" : 2019-09-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-09-03", "Last_Update_Posted(Estimated)" : 2020-07-23", "Last_Verified" : 2019-09" } }}

#Study Description Brief Summary This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®. #Intervention - DRUG : GP40071 - GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. - Other Names : - Insulin aspart - DRUG : NovoRapid® Penfill® - NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. - Other Names : - Insulin aspart

#Eligibility Criteria: Inclusion Criteria: * Signed written consent * Diabetes mellitus type 1 for at least 12 months prior to screening * History of basis-bolus (multiple dose injection (MDI)) therapy in stable doses at least 30 days * Glycated hemoglobin (HbA1c) level of 7.1 to 12.0 % at screening (both values inclusive) * Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive) * Subject is able and willing to comply with the requirements of the study protocol Exclusion Criteria: * Contraindication to the use of insulin aspart * Insulin resistance over 1.5 U/kg insulin pro day * Change INN of insulin for 6 months prior to randomisation * History of treatment any biosimilar insulin for 6 months prior to randomisation (excl. GEROPHARM's insulins) * History of treatment any experimental drugs or medical devices for 3 months prior to randomisation * History of treatment insulin pump for 180 days prior to signed written consent or indication for use insulin pump * Presence of severe diabetes complications * History of severe hypoglycemia for 6 months prior to screening * History of 15 or more episodes mild hypoglycemia for 1 month prior to screening * History or presence of uncontrolled diabetes mellitus for 6 months prior to screening * History of administration of glucocorticoids (14 days or more) for 1 year prior to screening * Administration of any immunosuppressive drugs (Cyclosporine, Methotrexate, Rituximab, etc.) * History of vaccination for 6 months prior to randomisation * History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1 <= age <= 3, except adrenal insufficiency * History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year prior to screening * History of stroke or TIA for 6 months prior to screening * History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions * Pregnant and breast-feeding women * Acute inflammation disease for 3 weeks prior to screening * Deviation of the laboratory results conducted during the screening: Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value * History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.) * Serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.) * Incomplete recovery after surgery procedure * History of drug, alcohol abuse for 3 years prior to screening * Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at screening * History of oncological disease during 5 years prior to screening * History of transplantation, except 3 months after corneal transplant * History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study * Inability follow to protocol Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04079413

{ "NCT_ID" : "NCT02280291", "Brief_Title" : "Single Shot Versus OnQ Pump in Extremity Fractures", "Official_title" : "Comparison Between Single Shot Peripheral Nerve Block and Continuous Infusion Via a On-Q Pump in Extremity Fracture Operations: a Randomized Prospective Control Trial", "Conditions" : ["Pain", "Fracture"], "Interventions" : ["Drug: Ankle SSB", "Drug: Ankle OnQ", "Drug: DR OnQ", "Drug: DR SSB"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-13", "Study_Completion_Date(Actual)" : "2018-12-13}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-10-15", "First_Submitted_that_Met_QC_Criteria" : 2020-03-17", "First_Posted(Estimated)" : 2014-10-31" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-10-30", "Last_Update_Posted(Estimated)" : 2020-03-30", "Last_Verified" : 2020-03" } }}

#Study Description Brief Summary Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a 'rebound pain'--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection. Detailed Description Purpose The purpose of this randomized prospective study will be to compare post-operative pain control after extremity fracture fixation surgery between patients who receive single shot versus continuous peripheral nerve blocks. Scientific or Scholarly Rationale Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery 1-4. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. Airway manipulations are avoided, post-operative nausea and vomiting are diminished, post-anesthesia care unit stay are shortened, and fewer nursing interventions in the post-anesthesia care unit are required5-6. Patients who have operative fixation of extremity fractures (ankle, wrist, forearm) are typically ambulatory patients. However, many become hospitalized overnight secondary to inadequate pain control, increasing hospital costs. Goldstein et al. showed that patients who underwent popliteal blocks after ankle fracture fixation demonstrated significantly better pain control immediately postoperatively7. The need for overnight hospitalization secondary to pain is decreased, as are nonsurgical operating room times. Despite the success of regional anesthesia, a phenomenon known as 'rebound pain' has been shown to occur as the original block wears off7-9. Patients with blocks will experience significantly increased pain compared to those without blocks approximately 12-24 hours after surgery. This can be controlled with early narcotic administration but can be a source of significant discomfort to a patient if not recognized and treated in time. A few studies have shown that continuous infusions of various numbing agents are efficacious in prolonged pain control, even in the ambulatory setting10-12. Nevertheless, no studies have thus performed a randomized prospective control trial studying the efficacy of continuous infusion therapy on pain control following extremity fracture surgery. Aims 1. To determine the effectiveness of continuously infused regional anesthetic for pain control in extremity fracture surgery 2. To determine the effect of rebound pain on patient satisfaction of surgery Description of study and study procedure Consent All patients being treated with open reduction internal fixation for foot, ankle, tibia, elbow, forearm and wrist fractures at New York University Medical Center, NYU-Hospital for Joint Diseases will be asked to participate in this study. At the patients preoperative office visit, they will be asked to participate in the study and provided a copy of the consent form at that time which they can take home with them. All questions will be answered and they will be asked verbally if they will consent to being a part of the study. Patients will then have the opportunity to either sign the written consent forms or wait till the surgical date to think about the study and any additional questions they may have. At the time of surgery, patients will be consented for surgery. If the patient did not give written consent at the preoperative visit, they will be asked if they have any questions about the study. All questions will again be answered. They will then be asked verbally if they are willing to participate in the study, if they respond yes, then written consent will be obtained at that time. Randomization Patients will then be randomized (using an online randomizer, similar to a flip of a coin) to one of two anesthetic protocols: regional block with single dose of anesthetic versus regional block with continuous infusion using an OnQ pump. If for some reason, the anesthesiologist feels that a patient would benefit from one type of anesthesia over another, the patient will be removed from the study and given that type of anesthesia. Intervention Patients will be randomized to one of two anesthetic protocols: general anesthesia/sedation with a single shot, peripheral nerve block versus general anesthesia/sedation with a continuous, peripheral nerve block. All anesthesia will be provided by an attending anesthesiologist with or without an anesthesiology resident/CRNA. Patients will have standard ASA monitors placed (pulse oximeter, blood pressure, EKG) and an intravenous line started. Sedation will be given using a combination of midazolam (1-4 mg) and fentanyl (25-100 mcg). Patients in both groups will receive an ultrasound-guided peripheral nerve block. The block will be either an infraclavicular brachial plexus block or a popliteal nerve block, depending on the location of the fracture. The appropriate region will be prepped with a chlorohexidine solution on the appropriate surgical side and the appropriate site will be visualized under ultrasound. For the group receiving a single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc. For those receiving a continuous infusion, a 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5cc. Once the injection is complete, an indwelling catheter will be placed with its tip location confirmed and then secured at the skin. After placement of the regional block, general anesthesia/sedation will be administered and maintained at the discretion of the anesthesiologist. Induction of anesthesia will involve IV propofol (2mg/kg) and fentanyl (1-2mcg/kg). Neuromuscular blockade will be used at the discretion of the anesthesiologist and will be reversed appropriately. Anesthetic maintenance will involve inhalational agents, IV agents, air, and oxygen. Fentanyl will be the only intraoperative analgesic used and will be dosed as determined by the anesthesiologist. After completion of the surgery, patients will be taken to the PACU where those with continuous catheters will have an OnQ pump attached to it. The patient will begin receiving a continuous infusion of 0.2% ropivacaine through the catheter at a rate of 8 cc/hr. The patient will be discharged home with the catheter for 48 hours. The study participant will self-discontinue the catheter in 2 days. This involves removing the tegaderm dressing and gently pulling the catheter out from under the skin. A bandage may then be applied. Germaine Cuff, the investigators anesthesiology RN, will be available via phone to answer any questions study participants may have regarding discontinuation of the catheter. Breakthrough pain while in the PACU will be treated with IV fentanyl and PO Percocet as needed. Postoperatively, all patients will be discharged home with a prescription for Percocet 5/325 with instructions to take 1-2 tabs every 4-6hrs as needed for pain. Data collection Location and type of surgical procedure, duration of procedure, and duration of intravenous sedation will also be recorded. Total time in the operating room will also be noted. Time admitted to PACU, time clinically ready for discharge, time actually discharge, PACU medications for nausea/vomiting and PACU meds for pain will all be recorded prior to discharge. Post-operative pain will be assessed using the Visual Analogue Scale (0-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken in the PACU will be recorded. Patients will be contacted 8 hours, 12 hours, 24 hours, 48 hours and 72hrs after surgery by the operative surgeon or research coordinator to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits at two, six, twelve, twenty-four, and fifty-two weeks. At these times, patients will be assessed for pain, residual neurological symptoms, and signs of infection. Patients will also be asked if they were satisfied with their postoperative pain control. Total duration of study will be fifty-two weeks. Data collection documents will be distributed to the patients at time of surgery to assist in patient understanding. #Intervention - DRUG : Ankle SSB - general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc. - DRUG : Ankle OnQ - versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc. - DRUG : DR SSB - general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc. - DRUG : DR OnQ - versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.

#Eligibility Criteria: Inclusion Criteria: * Patients at least 18 years. * Male or Female * All racial and ethnic groups * Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand * Patients who opt for surgical treatment of their fractures. * Patients who consent to be randomized. * Patients who are willing to follow-up for a minimum of 52 weeks. Exclusion Criteria: * Patients younger than 18 years. * Patients who are on chronic opioids * Patients who abuse opioids * Patients who are unwilling to follow-up for a minimum of 52 weeks. * Neurologic condition that could interfere with pain sensation Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02280291

{ "NCT_ID" : "NCT01940614", "Brief_Title" : "Use of Copeptin in Diabetes Insipidus", "Official_title" : "Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study", "Conditions" : ["Diabetes Insipidus", "Primary Polydipsia"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-06", "Study_Completion_Date(Actual)" : "2017-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-09-09", "First_Posted(Estimated)" : 2013-09-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-09-11", "Last_Update_Posted(Estimated)" : 2018-04-17", "Last_Verified" : 2018-04" } }}

#Study Description Brief Summary Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods. Detailed Description Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogenic) and primary polydipsia: a) classical water deprivation test alone, b) classical water deprivation test plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin measurement. The investigators hypothesize that firstly b) and c) is better as a). Secondly the investigators hypothesize that c) is non-inferior to b). #Intervention - OTHER : Water deprivation test - Classical water deprivation test alone - OTHER : Water deprivation test - classical water deprivation test plus plasma copeptin cut-off levels - OTHER : Hypertonic saline infusion - hypertonic saline infusion test plus plasma copeptin measurement

#Eligibility Criteria: Inclusion Criteria: * Polyuria or/and Polydipsia or/and therapy with synthetic adenovirus proteinase (AVP) derivate * Urine osmolality <800mOsm/kgH20 Exclusion Criteria: * Polyuria due to diabetes mellitus * Hypokalemia * Hyperkalemia (>5mmol/l) * Hypercalcemia * Kidney disease (min.: glomerular filtration rate (GFR) 60ml/min/1.73m2) * Pregnancy * Hyponatremia >135mmol/L * Hypernatremia >145mmol/L * Hypo- or hypervolemia * uncorrected adrenal or thyroidal deficiency * Cardia failure * Epilepsia * Uncontrolled hypertension Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01940614

{ "NCT_ID" : "NCT04025723", "Brief_Title" : "Differences in Rate of Recovery Between Young and Middle-aged Men After Downhill Running", "Official_title" : "Differences in Rate of Recovery Between Young and Middle-aged Men After Downhill Running", "Conditions" : ["Exercise"], "Interventions" : ["Other: Downhill running"], "Location_Countries" : ["Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-02-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-16", "Study_Completion_Date(Actual)" : "2021-01-16}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-07-09", "First_Posted(Estimated)" : 2019-07-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-07-16", "Last_Update_Posted(Estimated)" : 2021-03-25", "Last_Verified" : 2021-03" } }}

#Study Description Brief Summary The aim of this study is to evaluate differences in rate of recovery between young and middle-aged men after prolonged (downhill) running. Thirty healthy young (n=15, 18-30 y) and middle-aged (n=15, 35-50y) men will be recruited for this study. Participants will perform 60 minutes of downhill run at 65% of their maximal oxygen consumption (VO2max). Recovery parameters will be evaluated during 48 hours following the downhill protocol, and will include changes in performance tests, inflammatory markers, muscle integrity and heart-rate variability. Questioners will be used to evaluate muscle soreness and fatigue. We hypothesized that middle-aged males will have longer rate of recovery following the downhill running protocol, as compared to younger age males. #Intervention - OTHER : Downhill running - 60 minutes downhill running in 10% grade, in an effort of 65% of VO2max.

#Eligibility Criteria: Inclusion Criteria: * Active man which perform a minimum of 150 minutes/week of exercise * Able to complete 60 min run. Exclusion Criteria: * Injuries in lower body * cardio-respiratory disease * supplementing with performance enhancing supplements Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04025723

{ "NCT_ID" : "NCT01862523", "Brief_Title" : "Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls", "Official_title" : "Unraveling the Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls by Measuring Mucosal Potentials in the Nose.", "Conditions" : ["Rhinitis"], "Interventions" : ["Biological: diluent", "Biological: Capsaicin"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12", "Study_Completion_Date(Actual)" : "2014-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-09-05", "First_Posted(Estimated)" : 2013-05-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-05-21", "Last_Update_Posted(Estimated)" : 2014-12-05", "Last_Verified" : 2014-12" } }}

#Study Description Brief Summary Capsaicin nasal spray is used in daily practice against IR without knowledge about the exact mechanisms involved in this treatment. Therefore, this study aims to address this issue by studying the functional (electrophysiologic) changes after specific stimulations in IR patients and healthy controls before and after capsaicin/placebo treatment. Detailed Description As an essential step towards the improvement of the treatment of IR we will investigate the neural mechanisms underlying the therapeutic action of capsaicin. In particular, we plan to evaluate the effects of capsaicin on the functional properties of the innervation of nasal mucosa by monitoring the trigeminal nerve activity using measurements of negative mucosa potentials (NMP). NMPs, will be evoked by chemical and thermal stimuli in IR patients and healthy controls. Considering the evidence suggesting a role of sensory C-fibers in the pathophysiology of IR, we will employ low concentrations of irritants that specifically activate receptors expressed in those fibers, i.e., capsaicin for TRPV1 and cinnamaldehyde and allyl-isothiocyanate (mustard oil) for TRPA1. The same stimulations will be performed immediately after capsaicin treatment, and after 4 weeks, 3 months and 6 months. This will allow for an objective assessment of the functionality of the C-fiber innervation before the treatment, during the phase of therapeutic response and during the period of recurrence of the IR symptoms. The results of the NMP measurements will be contrasted with the therapeutic response and with evaluations of nasal congestion, nasal sensitivity and the presence of neuro-mediators found in nasal biopsies. Importantly, the independent assessment of the NMP responses mediated by either TRPV1 or TRPA1 will allow determining the specific role of these nociceptors in the pathophysiology of IR, which, in turn, may help to design more specific and effective therapies. #Intervention - BIOLOGICAL : Capsaicin - Thirty-three\* well-characterized IR patients will be recruited and screened for participation in this study with nasal capsaicin spray (0,1 mmol/l ) using the treatment regimen described by van Rijswijk et al. (1 x 5 applications in one day, with 1 hour between each application) - BIOLOGICAL : diluent - diluent

#Eligibility Criteria: Inclusion Criteria: * Patients with persistent (> 52w) rhinological symptoms: nasal discharge, sneezing, congestion for an average of at least 1 h per day for at least 5 days during a period of 14 days, negative skin prick test or negative RAST, and without structural abnormalities explaining nasal obstruction will be proposed to participate in the trial. * Age > 18 and < 60 years * Written informed consent * Willingness to adhere to visit schedules * Adequate contraceptive precautions in female patients with childbearing potential * Unresponsiveness to nasal steroid spray (4 weeks of use) Exclusion Criteria: * Age < 18 and > 60 years * Patients with AR, demonstrated by either positive skin prick test or RAST * Asthma * Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall. * Systemic steroid treatment less than 4 weeks before the inclusion in the study. * Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion. * Inability of the patient to stop taking medication affecting nasal function. * Evidence of infectious rhinitis/rhinosinusitis. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01862523

{ "NCT_ID" : "NCT06267287", "Brief_Title" : "Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period", "Official_title" : "Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period", "Conditions" : ["Joint Infection", "Periprosthetic Left Knee Joint Infection"], "Interventions" : ["Diagnostic Test: Microbiological examination of the patient's biological material and determination of antibiotic resistance"], "Location_Countries" : ["Russian Federation"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-31", "Study_Completion_Date(Actual)" : "2022-12-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2024-01-24", "First_Posted(Estimated)" : 2024-02-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2024-02-19", "Last_Update_Posted(Estimated)" : 2024-02-20", "Last_Verified" : 2024-01" } }}

#Study Description Brief Summary Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods. Detailed Description A continuous comparative retrospective study of cases of PJI of the joints of the extremities with positive microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods was carried out on the data basis from the medical information system (MIS) of the Federal Center for Traumatology, Orthopedics and Arthroplasty of Ministry of Health of Russia (Cheboksary, Russia), hereinafter referred to as the Center. Verification of the diagnosis of deep PJI was carried out according to the diagnostic criteria of the Society for Musculoskeletal Infections. The sample included cases of deep and superficial infection after arthroplasty of the knee, hip, shoulder and wrist joints, regardless of the location of the primary operation. Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment). The infection was classified as polymicrobial or monomicrobial. The role of the leading pathogen was determined in the structure of monomicrobial infection. Polymicrobial infection is represented by cases of simultaneous isolation of two or more pathogens in one patient. The antibiotic resistance profile included all isolated pathogens of mono- and polymicrobial PJI. At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed endoprosthesis components) were taken from patients for examination. The aspirate from the joint was placed into FA plus, FN plus bottles of the Bact/Alert 3D analyzer (Bio Merieux, France). If the sample volume was insufficient (less than 1 ml), it was inoculated into a vial with Schedler's broth and, when turbid, subcultured onto solid media. The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory. In the laboratory, saline solution was added to the container and processed in an ultrasonic machine according to the author's method. After ultrasonication, 0.5 ml of the resulting liquid was applied to solid media. Homogenized tissue samples were placed in broth with thioglycollate medium. The cultures were incubated at 37°C for up to 14 days, subcultured on solid nutrient media: on the 1st day - on Columbia, Chocolate and Schedler agars; on the 5th day - on Chocolate and Schedler agar and on the 10th day - only on Schedler agar. For aerobic, anaerobic and capnophilic microorganisms, incubation conditions were created using gas-generating packages. Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer (Vitec2 compact; Bio Merieux, France) and a semi-automatic analyzer (Multiscan FC; Thermo Fisher, USA) using kits (Erba Lachema, Czech Republic), test systems ('Diagnostic systems', Russia). Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST 2018 (studies in 2018-2019), EUCAST 2021 (studies in 2021-2022). #Intervention - DIAGNOSTIC_TEST : Microbiological examination of the patient's biological material and determination of antibiotic resistance - Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment). At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed endoprosthesis components) were taken from patients for examination. The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory. In the laboratory, saline solution was added to the container and processed in an ultrasonic machine according to the author's method. Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer and a semi-automatic analyzer using kits, test systems. Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST. - Other Names : - Identification of the infectious agent and determination of antibiotic resistance

#Eligibility Criteria: Inclusion Criteria: * Clinically confirmed periprosthetic infection Exclusion Criteria: * No signs of periprosthetic infection Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT06267287

{ "NCT_ID" : "NCT03201432", "Brief_Title" : "Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis", "Official_title" : "A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents", "Conditions" : ["Ischemic Stroke", "Vertebral Artery Stenosis"], "Interventions" : ["Device: Drug eluting stent (DES)", "Device: Bare metal stent (BES)"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-01", "Study_Completion_Date(Actual)" : "2017-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-03-04", "First_Posted(Estimated)" : 2017-06-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-06-25", "Last_Update_Posted(Estimated)" : 2017-06-28", "Last_Verified" : 2017-06" } }}

#Study Description Brief Summary Stroke is one of the important causes of disability and death in the world, in which more than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral basilar artery system, especially when in the presence of extracranial proximal vertebral artery stenosis. Vertebral artery stenting is a minimally invasive method for the reconstruction of vertebral artery stenosis and the early clinical studies showed that it was feasible, safe and effective, but the high rate of restenosis has become a bottleneck restricting its development. Previous systematic review had suggested that the drug eluting stent might reduce the incidence of restenosis of vertebral artery. However, prospective randomized controlled trials comparing the efficacy of bare metal stents and drug eluting stents on the prevention of restenosis remains absent. Detailed Description 60 patients were randomly assigned into DES and BES group to compare the safety and efficacy in the treatment of symptomatic extracranial vertebral artery stenosis with drug eluting stents (YINYI) and bare metal stents (Express SD), especially the stent restenosis rate after 6 months. #Intervention - DEVICE : Drug eluting stent (DES) - Polymer-free paclitaxel eluting stents - Other Names : - YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.) - DEVICE : Bare metal stent (BES) - Bare metal stent - Other Names : - Express SD (Bosten Scientific)

#Eligibility Criteria: Inclusion Criteria: * Symptomatic posterior circulation ischemia（Vertebral basilar artery system TIA or non-disabling ischemic stroke）result from the stenosis in the extracranial proximal vertebral artery stenosis. * Atherosclerotic extracranial proximal vertebral artery stenosis demonstrated by angiography(any of the following): 1) bilateral vertebral artery stenosis >=70%, or vertebral artery stenosis >=70% concomitant occlusion of contralateral vertebral artery; 2) superior lateral vertebral artery stenosis >=70%; 3) non-superior lateral vertebral artery stenosis >=50%, but the vertebral artery was directly extended to the posterior inferior cerebellar artery on this side and symptoms were related to insufficiency of the ipsilateral posterior inferior cerebellar artery. Exclusion Criteria: * 1) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy; * 2) vertebral artery stenosis caused by non atherosclerosis disease: Takayasu arteritis or other diseases; * 3) severe stroke within 3 months; * 4) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history; * 5) malignant tumor; * 6) with Alzheimer's disease or mental illness previously or currently ; * 7) patients or family members refuse the operation. Sex : ALL Ages : - Minimum Age : 40 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03201432

{ "NCT_ID" : "NCT04930198", "Brief_Title" : "PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria", "Official_title" : "PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria", "Conditions" : ["HIV/AIDS"], "Interventions" : ["Behavioral: PeerNaija"], "Location_Countries" : ["Nigeria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-08-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-03-13", "Study_Completion_Date(Actual)" : "2024-03-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-05-25", "First_Posted(Estimated)" : 2021-06-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-06-16", "Last_Update_Posted(Estimated)" : 2024-05-10", "Last_Verified" : 2024-05" } }}

#Study Description Brief Summary The PEERNaija application will feature routine medication reminders, along with individual adherence monitoring with adherence scores, anonymized peer adherence scores (from peers attending the same clinic; social incentive), and a monthly lottery-based prize for youth with the highest adherence scores (financial incentive). The Investigators will recruit a cohort of 50 HIV-infected adolescents and young adults (AYA) to pilot the app and assess feasibility, acceptability, adoption, and preliminary efficacy of important clinical measures (including adherence and virologic suppression). The proposed study will provide important preliminary data for the role of mobile health (mHealth) platforms to harness and deliver social and financial incentives to promote adherence efforts, especially for vulnerable youth, and for a larger intervention trial evaluating this app among HIV-infected AYA in Nigeria. Detailed Description The use of digital health solutions, especially medication reminders delivered via mHealth platforms, have shown promise as adherence support tools in sub-Saharan Africa (SSA). Importantly, the proliferation of mobile phones in resource-limited settings and the early adoption of communication technologies by young people make mHealth technologies an ideal platform for this age group. The Investigators propose to pilot a novel, mHealth peer-based intervention for AYA living with HIV in Nigeria that will utilize social and financial incentives to promote medication adherence. In addition to medication reminders and peer support, the proposed intervention will innovate within the mHealth arena to leverage the currency of social incentives through daily adherence monitoring with the provision of adherence scores for individual users in relation to their peers, and financial incentives through a monthly lottery for youth with the highest adherence scores with the prize delivered through the mHealth application itself. This proposal builds on the Investigator's successful research collaborations in Nigeria with APIN Public Health Initiatives, (APIN, a multi-site non-governmental organization with solid President's Emergency Plan For AIDS Relief-funded HIV infrastructure), the investigators expertise in building capacity for implementation research, and proficiency in developing and deploying mHealth-based interventions in SSA. This will be accomplished through the following specific aim: To establish the feasibility, acceptability, and preliminary efficacy of PEERNaija, an mHealth intervention designed to harness peer influence as an incentive to promote medication adherence among a pilot cohort of 50 AYA living with HIV in Nigeria. Hypothesis: PEERNaija will be feasible, acceptable, and show preliminary efficacy in improving antiretroviral (ART) adherence. #Intervention - BEHAVIORAL : PeerNaija - All participants (N=50) will receive daily medication reminders and access to the virtual support group on the PEERNaija app. Participants will be randomized to receive a social incentive (n=25) or a social plus financial incentive (n=25), PEER+, and be followed for 24 weeks.

#Eligibility Criteria: Inclusion Criteria: * Own a smartphone (on which they are willing to download PEERNaija), * 16 <= age <= 27 years, * on ART, and * demonstrate the ability read simple text language in English. Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 27 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT04930198

{ "NCT_ID" : "NCT05832866", "Brief_Title" : "Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA", "Official_title" : "Effect of Clinic-based and Tele-monitored Home-based Intervention on Pain Intensity, Function and Quality of Life in Patients With Knee Osteoarthritis", "Conditions" : ["Knee Osteoarthritis"], "Interventions" : ["Other: Clinical Based Isometric contraction strengthening Exercises using Thera band", "Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band"], "Location_Countries" : ["Nigeria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-02-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-14", "Study_Completion_Date(Actual)" : "2021-10-23}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-04-16", "First_Posted(Estimated)" : 2023-04-27" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-04-16", "Last_Update_Posted(Estimated)" : 2023-05-03", "Last_Verified" : 2023-04" } }}

#Study Description Brief Summary This study assessed and compared the effects of clinic-based and telemonitored home-based interventions on pain intensity, function and quality of life in patients with knee osteoarthritis (KOA). This was with a view to providing evidence for the validation of the effectiveness of home-based intervention on knee osteoarthritis Detailed Description This study was a quasi-experiment involving forty two patients with KOA. They were randomly allocated into two groups equally; clinic-based group (CBG) and telemonitored home-based group (THG). The CBG received exercises to strengthen the quadriceps and hamstring muscles using thera band while THG received same treatment regimen but at home and were monitored on phone by the researcher. The subjects performed four sets of eight repetitions for each of the exercises three days in a week for eight weeks. Pain intensity was assessed with Quadruple Visual Analog Scale, function was assessed with the Western Ontario and McMaster University Osteoarthritis Index and quality of life was assessed with WHO Quality of Life-BREF at pretreatment, 3rd week, 6th week and 8th week of intervention. Data was analysed with descriptive and inferential statistics. Repeated measure ANOVA was used to compare the mean value of variables within the group and between the groups. Alpha level was set at 0.05. #Intervention - OTHER : Clinical Based Isometric contraction strengthening Exercises using Thera band - Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone - Other Names : - Clinical Based intervention - OTHER : Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band - Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks - Other Names : - Telemonitores Home based Intervention

#Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with osteoarthritis of the knee of not less than six weeks. * Patients that have means of communication via mobile telephone. * Patients who understands English or Yoruba Language. Exclusion Criteria: Participants that have any other knee joint diseases. * Participants with history of knee joint trauma. * Participants with history of knee surgery or arthroplasty Sex : ALL Ages : - Minimum Age : 40 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05832866

{ "NCT_ID" : "NCT03015610", "Brief_Title" : "Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma", "Official_title" : "Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma", "Conditions" : ["Asthma", "Gastroesophageal Reflux"], "Interventions" : ["Drug: commercially available lansoprazole", "Drug: matched placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-10-31", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-01-18", "Study_Completion_Date(Actual)" : "2024-01-18}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-12-13", "First_Posted(Estimated)" : 2017-01-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-01-07", "Last_Update_Posted(Estimated)" : 2024-06-07", "Last_Verified" : 2024-06" } }}

#Study Description Brief Summary This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma control. Detailed Description BACKGROUND: Poorly controlled asthma especially in children remains a major public health problem. Many children with poor asthma control experience gastroesophageal reflux (GERD). The effect of mild GERD on asthma remains controversial despite studies involving proton-pump inhibitors (PPIs) assessing their effect on asthma. Past inconsistent findings regarding the effect of PPIs on asthma control may have resulted from ineffective dosing strategies of proton-pump inhibitors employed in these studies. Drug levels and efficacy vary widely in the population and depend on genetics. Dosing in children which adjusts for the gene CYP2C19 may improve efficacy and reduce side-effects leading to improved asthma control. HYPOTHESIS: #1: The investigators hypothesize that genotype-tailored lansoprazole dosing will reduce asthma symptoms in children with mild symptoms of GERD compared to placebo. #2: CYP2C19 and ABCB1 genetic variants influence the pharmacokinetics (drug levels) of lansoprazole as determined by population pharmacokinetic modeling. METHODS: The investigators will conduct a 6-month randomized controlled trial comparing genotype-tailored lansoprazole dosing versus matched placebo in the control of asthma symptoms in 6-17 year olds with asthma and mild reflux. All participants will have baseline pharmacokinetics analysis following a single genotype-tailored dose to assess the effects of CYP2C19 and ABCB1. IMPACT: These results would be a major advance in the science of safe dosing of proton-pump inhibitors in children and for the management of the millions of children struggling with reflux and asthma. #Intervention - DRUG : commercially available lansoprazole - these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily lansoprazole for 24 weeks - Other Names : - once daily - DRUG : matched placebo - these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily placebo for 24 weeks - Other Names : - once daily

#Eligibility Criteria: Inclusion Criteria: * Age: 6 <= age <= 17 year olds with documented clinician-diagnosed asthma * Evidence of recent uncontrolled asthma (must meet at least one of the following). This convention for defining poorly-controlled asthma has been successfully used in a large pediatric trial. * ACQ > 1.2 * Use of short-acting beta-agonist for asthma symptoms twice/week or more on average over the past month * Nocturnal awakenings with asthma symptoms more than once per week on average over the last month * Two or more emergency department visits, unscheduled provider visits, prednisone courses or hospitalizations for asthma in the past 12 months * Currently on stable dose of daily inhaled corticosteroid medication (ICS) for asthma control equivalent to 88mcg of fluticasone or greater for at least 6 weeks from the time of enrollment. Participant must be on National Asthma Education and Prevention Program (NAEPP) controller step 2, 3 or 4. * Currently with mild GERD symptoms reported at V1 defined by a score on the Pediatric GERD Symptom Assessment Score greater than 15 and less than 80. GSAS ranges from 0 to >440. Exclusion Criteria: * Taking daily CYP2C19 substrates, inducers or inhibitors medication * Past or current history of moderate-severe GERD or related disorders (erosive esophagitis, peptic ulcer disease, eosinophilic esophagitis) which in the opinion of the pediatric gastroenterology safety specialist/study physician requires treatment with acid-blocking agents; * Daily use of a PPI for more than 4 consecutive weeks in the past 6 months; * previous intubation for asthma, * admission to intensive care unit for more than 24 hours for asthma in the past year, * Previous surgery involving the esophagus or stomach (anti-reflux surgery, peptic ulcer surgery, trachea-esophageal fistula repair); * Forced expiratory volume in 1 second (FEV1) < 60% of predicted at enrollment; * Any major chronic illness that would interfere with participation in the intervention or completion of the study procedures; * History of phenylketonuria (PKU); * Medication use: treatment of GERD symptoms with over-the-counter antacids 4 days/week or more on average over past month; * Theophylline preparations, azoles, anti-coagulants, insulin for Type 1 diabetes, digitalis, oral iron supplements when administered for iron deficiency within 1 month; * Any investigational drugs within the past 2 months; * Drug Allergies: previous allergic reaction from lansoprazole or other proton pump inhibitor medication or adverse reaction to aspartame; * Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or site PI; * Less than 75% completion of daily diary for asthma symptoms, SABA use and ICS medication adherence during the run-in period; * Plan for family to move from study location within the next 6 months. Sex : ALL Ages : - Minimum Age : 6 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT03015610

{ "NCT_ID" : "NCT05892887", "Brief_Title" : "Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation", "Official_title" : "Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial", "Conditions" : ["Analgesia"], "Interventions" : ["Drug: Bupivacaine 0.25% Injectable Solution"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-06-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-09-20", "Study_Completion_Date(Actual)" : "2023-09-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-05-10", "First_Posted(Estimated)" : 2023-06-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-05-28", "Last_Update_Posted(Estimated)" : 2023-10-10", "Last_Verified" : 2023-10" } }}

#Study Description Brief Summary The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation Detailed Description The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations . #Intervention - DRUG : Bupivacaine 0.25% Injectable Solution - Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%

#Eligibility Criteria: Inclusion Criteria: * Aged 18 <= age <= 65 years. * Both genders. * American Society of Anesthesiologists' (ASA) physical status I or II. * Undergoing single level lumbar spine fixation. Exclusion Criteria: * Patient refusal. * Pregnant females. * Renal, lung, heart, or liver disorders. * Communication difficulties which might prevent a reliable postoperative assessment. * Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics). * BMI more than 30 kg/m2. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05892887

{ "NCT_ID" : "NCT05640037", "Brief_Title" : "Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis", "Official_title" : "Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis", "Conditions" : ["Sepsis"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-03-23", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-03-20", "Study_Completion_Date(Actual)" : "2024-03-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-11-25", "First_Posted(Estimated)" : 2022-12-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-11-25", "Last_Update_Posted(Estimated)" : 2024-05-08", "Last_Verified" : 2023-12" } }}

#Study Description Brief Summary This study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis. Detailed Description Sepsis patients admitted in the Department of Critical Care Medicine, Zhongnan Hospital will be included. There are three groups of patients in this study: control group, sepsis group and septic shock group. The interleukin-37 (IL-37) concentration in urine was analyzed in the day 1, 2, 4, 6. Additionally, IL-37 concentration between blood stream infection groups and non-infection groups were analyzed. IL-37 concentration between survivors and non-survivors were also compared. IL-37 concentration were followed from day 1, 2, 4, 6.The correlation between the concentration of IL-37, IL-1β, IL-6、IL-10 and TNF-α were analyzed. Furthermore, the investigators will determine the correlation between the concentration of IL-37, sepsis associated organ dysfunction, 28-day mortality. Lastly, the predictive value of IL-37 to sepsis associated organ dysfunction and prognosis were explored.

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Expected length of stay>24 hours in intensive care unit (ICU) * Sequential organ failure assessment (SOFA) score >= 2 on ICU admission with a suspicion of infection Exclusion Criteria: * anuria * ICU readmission in 28 days Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT05640037

{ "NCT_ID" : "NCT02833090", "Brief_Title" : "The Plasma Serotonin and Aortic Stenosis: a Pilot Study.", "Official_title" : "The Plasma Serotonin and Aortic Stenosis: a Pilot Study.", "Conditions" : ["Aortic Stenosis"], "Interventions" : ["Procedure: biomarkers"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-09", "Study_Completion_Date(Actual)" : "2012-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-07-11", "First_Posted(Estimated)" : 2016-07-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-07-11", "Last_Update_Posted(Estimated)" : 2017-05-12", "Last_Verified" : 2017-05" } }}

#Study Description Brief Summary The goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine (5-HT) in patient with increased severity of aortic stenosis and increased weight cardiac muscle. Detailed Description Calcific aortic stenosis is the most frequent valve disease in adults. Without therapeutic strategy, this disease leads to heart failure and death. Surgical aortic valve replacement is now a well tolerated cardiac surgery leading to excellent outcomes. Until recently, calcific aortic stenosis was considered to be histopathologically degenerative or passive in origin. It is now recognized, however, as a complex cellular process with features of atherosclerosis. It has been observed that drugs may slow dawn the progression of aortic stenosis in observational studies. It has been suggested that serotonin, a monoamine neurotransmitter and a peripheral signal mediator, may be involved in the progression of aortic stenosis and also in its consequences on myocardium hypertrophy. In the blood, serotonin in mainly stored in platelets, which release serotonin involved in post-injury vasoconstriction, thrombus formation, fibrosis and atherogenesis. This study hypothesized those patients with aortic stenosis exhibit higher circulating serotonin levels than their counterparts without heart disease. In addition to circulating serotonin, its metabolite 5-HIAA will be systematically measured on all patients. This study would allow to determine the potential of plasma serotonin as a prognosis marker and perhaps suggest the discovery of new targets for treatment of aortic stenosis. #Intervention - PROCEDURE : biomarkers - transthoracic echocardiography, radial, and aortic arterial blood sampling

#Eligibility Criteria: Inclusion Criteria: * Group 1 : non aortic stenosis * Goup 2, 3 and 4 : aortic stenosis Exclusion Criteria: * Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02833090

{ "NCT_ID" : "NCT01900691", "Brief_Title" : "Removal of the Evolution® Esophageal Stent - Fully Covered", "Official_title" : "Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered", "Conditions" : ["Esophageal Fistula", "Esophageal Neoplasms", "Esophageal Perforation", "Esophageal Stenosis", "Stents"], "Interventions" : ["Device: Evolution® Esophageal Stent - Fully Covered"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-10", "Study_Completion_Date(Actual)" : "2018-12-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-07-01", "First_Submitted_that_Met_QC_Criteria" : 2022-01-31", "First_Posted(Estimated)" : 2013-07-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-07-12", "Last_Update_Posted(Estimated)" : 2022-09-13", "Last_Verified" : 2022-08" } }}

#Study Description Brief Summary The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications. #Intervention - DEVICE : Evolution® Esophageal Stent - Fully Covered - Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

#Eligibility Criteria: Inclusion Criteria: * Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak * Physician plans to remove the stent within the duration of study follow-up Exclusion Criteria: * Patient is < 18 years * Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule * Patient is pregnant, lactating, or planning on being pregnant within the next 6 months * Patient is simultaneously participating in another investigational drug or device study * Patient that is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement * Patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01900691

{ "NCT_ID" : "NCT01257009", "Brief_Title" : "Atorvastatin and Sympathetic Activity in Chronic Kidney Disease", "Official_title" : "Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease", "Conditions" : ["Stable Chronic Kidney Disease", "Hypertension"], "Interventions" : ["Drug: Atorvastatin"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-07", "Study_Completion_Date(Actual)" : "2010-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-12-08", "First_Posted(Estimated)" : 2010-12-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-12-08", "Last_Update_Posted(Estimated)" : 2010-12-09", "Last_Verified" : 2010-11" } }}

#Study Description Brief Summary Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. Experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is standard treatment for CKD, is known to lower sympathetic activity. The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further lower sympathetic activity in hypertensive stage 2-4 CKD patients. Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis blockers, blood pressure and sympathetic activity (quantified by assessment of muscle sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin 20mg/day added. Ten other CKD patients will serve as time control and will be studied twice with an interval of 6 weeks without any change in medication, to quantify within subject reproducibility. Detailed Description see above #Intervention - DRUG : Atorvastatin - 6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity - Other Names : - Lipitor

#Eligibility Criteria: Inclusion Criteria: * stable chronic kidney disease * Hypertension Exclusion Criteria: * renal replacement therapy * pregnancy * diabetes mellitus Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01257009

{ "NCT_ID" : "NCT01357109", "Brief_Title" : "Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes", "Official_title" : "Effect of Bosentan on Macro- and Microvascular Function in Patients With Type 2 Diabetes", "Conditions" : ["Type 2 Diabetes Mellitus"], "Interventions" : ["Drug: Bosentan", "Drug: Placebo"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-04", "Study_Completion_Date(Actual)" : "2011-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-05-18", "First_Posted(Estimated)" : 2011-05-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-05-18", "Last_Update_Posted(Estimated)" : 2011-05-20", "Last_Verified" : 2007-10" } }}

#Study Description Brief Summary The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy. #Intervention - DRUG : Bosentan - 62.5 mg bid for two weeks and 125 mg bid for two weeks - DRUG : Placebo - Matched placebo bid

#Eligibility Criteria: Inclusion Criteria: * Diabetes mellitus type 2 of >2 years duration * Albuminuria Exclusion Criteria: * Age >80 years * Myocardial infarction/unstable angina within three months prior to randomisation * Decompensated congestive heart failure or functional class 3 and 4. * Changes in dosage of any vasodilator drugs during the preceding six weeks * Women of fertile age. * Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT) * Ongoing treatment with glibenclamide, cyclosporin or warfarin * Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol * Participant in an ongoing study * Unwillingness to participate following oral and written information Sex : ALL Ages : - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01357109

{ "NCT_ID" : "NCT00211926", "Brief_Title" : "StaphVAX Immunogenicity in Orthopedic Implant Patients", "Official_title" : "A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant", "Conditions" : ["Staphylococcal Infections", "Joint Prosthesis"], "Interventions" : ["Biological: placebo", "Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2004-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-06", "Study_Completion_Date(Actual)" : "2006-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2005-09-13", "First_Posted(Estimated)" : 2005-09-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2005-09-13", "Last_Update_Posted(Estimated)" : 2008-01-04", "Last_Verified" : 2007-12" } }}

#Study Description Brief Summary S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty. #Intervention - BIOLOGICAL : S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate - single dose of vaccine containing 100 mcg of each serotype conjugate - BIOLOGICAL : placebo - single dose of placebo

#Eligibility Criteria: Inclusion Criteria: * age >= 18 years * candidate for knee or hip replacement * expectation of protocol compliance * negative pregnancy test, where appropriate Exclusion Criteria: * known S. aureus infection in the prior 3 months * infection in the prior 2 weeks * Known HIV infection * immunomodulatory drugs * Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer) * Hypersensitivity to components of StaphVAX Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT00211926

{ "NCT_ID" : "NCT04503720", "Brief_Title" : "CLoWI Versus PCA Morphine for Pain Control After Major Abdominal Surgery", "Official_title" : "Continuous Local Anaesthetic Wound Infusion (CLoWI) Versus PCA Morphine for Pain Control After Major Abdominal Surgery:A Double Blinded, Randomized, Controlled, Non Inferiority Trial (CLoWI Trial)", "Conditions" : ["Surgical Wound", "Post-Op Complication", "Opioid Use"], "Interventions" : ["Device: PCA", "Device: CLoWI"], "Location_Countries" : ["Singapore"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-12-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-06-30", "Study_Completion_Date(Actual)" : "2022-06-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-02-26", "First_Posted(Estimated)" : 2020-08-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-08-05", "Last_Update_Posted(Estimated)" : 2024-07-12", "Last_Verified" : 2024-07" } }}

#Study Description Brief Summary Major abdominal surgery is associated with significant complications which may lead to morbidity and mortality. Pain experienced after surgery affects the recovery from surgery. Our study aims to evaluate the current gold standard of PCA morphine infusion against a continuous wound infusion (CLoWI). The use of CLoWI negates the side-effects of opioids, and will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine). Detailed Description Major intra-abdominal surgery represents one of the commonest groups of surgical procedures performed both worldwide and within Singapore. Common general surgical conditions requiring major intra-abdominal surgery include intestinal pathologies such as cancer, ischaemia, infection, haemorrhage and perforation. Major surgery within the abdominal cavity is associated with significant complications which may be life threatening with an associated hospital mortality rate of as high as 20% for emergency surgery. Importantly, the recovery from this type of major surgery often entails significant pain and discomfort for the patient during healing of the abdominal wound and internal organs from tissue trauma associated with these surgical procedures. Recent developments in major intra-abdominal surgery have demonstrated the importance of the early surgical recovery period where common postoperative complications including pain, chest infection, intestinal ileus and delerium are not only associated with prolonged hospital stay but are harbingers of poor long term surgical outcomes. Current recommendations for perioperative management of patients undergoing major intra-abdominal surgery stress the importance of high quality perioperative care to minimise these sequelae. Key features of these recommendations are to provide a pain free postoperative surgical recovery with minimal nausea and vomiting to facilitate early mobilisation and functional recovery from surgery. Patient controlled analgesia (PCA) with opioids is the first line analgesia therapy currently used in the immediate post-operative period following major abdominal surgery. PCA with opioids has some inherent disadvantages that include side-effects of opioids such as nausea, vomiting, prolonged ileus, dizziness, hallucination and respiratory depression with the need for supplementary oxygen. This is most pertinent in elderly patients who are more prone to these side-effects in addition to being more likely to have difficulties in understanding how to use the PCA and so are more vulnerable to inadequate pain control. Consequently, there may be a delay in resuming mobility and discharge from hospital. Continuous local wound infusion (CLoWI) with Ropivacaine that is delivered into the extraperitoneal plane via an ON-Q® (Halyard) infusion pump has been shown to be an effective analgesia post-operatively. The use of CLoWI negates the side-effects of opioids and furthermore, the small portable pump allows early ambulation with no requirement for supplementary oxygen. Previous published research has demonstrated the benefits of continuous local wound infusion with local anaesthesia in terms of postoperative analgesia and surgical recovery However, there are no randomized controlled trials comparing PCA versus continuous local wound infusion alone; this study will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine). The local anaesthetic drug to be used for the wound infiltration system is Ropivacaine. Its mechanism of action involves inhibiting sodium influx through sodium-specific ion channels in the peripheral nerve axonal cell membrane, in particular, the voltage gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and the conduction of a pain signal is inhibited. The local anaesthetic will be administered via 2 catheters that will be placed under direct vision by the surgeon at the time of wound closure. Ropivacaine 0.5% will be infused at a rate of 4mls/hour (2mls/hour in each catheter) for a total of 4 days. It is currently in clinical use within our hospital as a routine method of providing postoperative analgesia following major abdominal surgery. #Intervention - DEVICE : CLoWI - Patients will receive a continuous wound infusion with ropivacaine and normal saline in the PCA pump. - DEVICE : PCA - Patients will receive a continuous wound infusion with normal saline and morphine in the PCA pump.

#Eligibility Criteria: Inclusion Criteria: * Planned for elective or urgent# open abdominal surgery Abdominal Surgery may include the following procedures: A) Urgent laparotomy for perforated viscus, intestinal obstruction. B) Elective abdominal surgery for upper and lower gastrointestinal surgery * Ability to provide informed consent. A signed and dated written informed consent prior to study participation. * Age 21 <= age <= 80 for both males and females Exclusion Criteria: * Female subject who is pregnant * Inability to comply with PCA instructions due to physical disabilities. For example, visual or hearing impairment, arthritis, peripheral neuropathy. * Known allergy to local anaesthetic or opioid drugs (Morphine). * Current or recent on opioid therapy. For example due to chronic pain illness, opioid (or other) drug abuse or recent surgery. * Severe comorbid diseases including liver cirrhosis, renal failure requiring dialysis, Grade 4 NYHA (New Yoke Heart Association) heart failure, respiratory illness requiring NIV (Non-Invasive Ventilation), etc. * Severe associated acute illness American Society of Anesthesiologists (ASA) Grade 4 or 5 where survival following surgery is not expected Sex : ALL Ages : - Minimum Age : 21 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04503720

{ "NCT_ID" : "NCT05440058", "Brief_Title" : "BIS Monitoring in Relation to Muscle Relaxant Administration", "Official_title" : "Effect of Timing of Commencement of Bispectral Index Monitoring in Relation to Muscle Relaxant Administration", "Conditions" : ["Cardiovascular Surgery", "Bispectral Index", "Anesthesia"], "Interventions" : ["Device: Bispectral Index (BIS) monitoring system"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-08-26", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-09-20", "Study_Completion_Date(Actual)" : "2022-09-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-06-27", "First_Posted(Estimated)" : 2022-06-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-06-27", "Last_Update_Posted(Estimated)" : 2023-10-13", "Last_Verified" : 2023-10" } }}

#Study Description Brief Summary The purpose of this study is to determine the overall optimal timing of when the Bispectral Index (BIS) monitor should be started: before or after the muscle relaxant is given. #Intervention - DEVICE : Bispectral Index (BIS) monitoring system - Left and right sensors to record EEG activity and muscle reaction to anesthesia utilized in the operating room by anesthesia providers to assess the depth of sedation in patients with anesthesia.

#Eligibility Criteria: Inclusion Criteria: * Undergoing elective cardiac surgery * Muscle relaxation administration by rocuronium Exclusion Criteria: * Patient refusal * Pediatric patients * Emergency procedure * Patients with known or suspected carotid or cerebrovascular disease * Patients with prior stroke * Skin condition or anatomy preventing proper sensor placement * Patients who receive ketamine during the study timeframe Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05440058

{ "NCT_ID" : "NCT05112627", "Brief_Title" : "Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy", "Official_title" : "Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy", "Conditions" : ["Metastatic Renal Cell Carcinoma", "Stage IV Renal Cell Cancer AJCC v8"], "Interventions" : ["Procedure: Biospecimen Collection"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-01-24", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-15", "Study_Completion_Date(Actual)" : "2024-05-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-10-22", "First_Posted(Estimated)" : 2021-11-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-11-03", "Last_Update_Posted(Estimated)" : 2024-08-09", "Last_Verified" : 2024-08" } }}

#Study Description Brief Summary This early phase I trial evaluates blood samples to see if patients undergoing standard of care treatment with either stereotactic body radiation therapy or percutaneous ablation (using radio waves to create heat to destroy the tumor), have an increase in serum immune markers in kidney cancer. Information gained from this study may help doctors make treatment decisions for patients with kidney cancer. Detailed Description PRIMARY OBJECTIVES: I. Compare pre- and post-treatment immune markers and peripheral blood mononuclear cell (PBMC) characteristics in metastatic renal cell carcinoma (RCC) patients overall. II. Compare pre- and post-treatment immune markers and PBMC characteristics between patients being treated with stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and are also undergoing immunotherapy. III. Compare pre- and post-treatment immune markers and PBMC characteristics in patients being treated with either SBRT or PCA and not undergoing immunotherapy. IV. Assess the impact of post-treatment immune markers and PBMC characteristics on distant disease progression in metastatic RCC patients overall. OUTLINE: Patients undergo blood sample collection at baseline prior to SBRT or PCA, then at 14 days, 3 and 6 months after SBRT or PCA. #Intervention - PROCEDURE : Biospecimen Collection - Undergo blood collection - Other Names : - Biological Sample Collection, Biospecimen Collected, Specimen Collection

#Eligibility Criteria: Inclusion Criteria: * Histological diagnosis of primary RCC * Histological or radiographic diagnosis of metastatic RCC * Age >= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 3 * Feasible vascular access as determined by study staff * Undergoing standard of care SBRT or PCA to RCC metastatic lesion(s) * Provide written informed consent * Willing to consent to research blood draws * Willing to return to enrolling institution for follow-up Exclusion Criteria: * Prior local treatment of the index metastatic lesion * Pregnant or nursing women * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry * Patients receiving prophylactic steroids, defined as initiation of steroids within 1 week prior to local ablative therapy start, including the first day of local ablative therapy. * NOTE: Patients initiating steroids after the first day of local ablative therapy and within 14 days after local ablative therapy completion, will be allowed into the study and the use of steroids will be recorded. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05112627

{ "NCT_ID" : "NCT01747421", "Brief_Title" : "Validation of a High-risk Versus Low-risk Referral Model in Suspected Acute Coronary Syndrome", "Conditions" : ["Acute Myocardial Infarction"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-09", "Study_Completion_Date(Actual)" : "2010-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-12-07", "First_Posted(Estimated)" : 2012-12-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-12-07", "Last_Update_Posted(Estimated)" : 2012-12-11", "Last_Verified" : 2012-12" } }}

#Study Description Brief Summary In Emergency Departments patients admitted with chest pain may suffer from non-significant to lifethreatening conditions. The aim of the present study is to develop and validate a referral model in chest pain patients which divide the patients with non- significant ECG changes into high risk and low risk groups for acute coronary syndrome.

#Eligibility Criteria: Inclusion Criteria: * more than 15 years Exclusion Criteria: * Patients with ST-elevations in ECG Sex : ALL Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01747421

{ "NCT_ID" : "NCT04046081", "Brief_Title" : "A Clinical Trial to Evaluate Dichloroacetate (DCA) as a Treatment for Endometriosis-associated Pain", "Official_title" : "A Single-arm Open Label Exploratory Clinical Trial to Evaluate Dichloroacetate (DCA) as a Possible Treatment for Endometriosis-associated Pain", "Conditions" : ["Endometriosis"], "Interventions" : ["Drug: Dichloroacetate"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-11-19", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-30", "Study_Completion_Date(Actual)" : "2021-09-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-07-31", "First_Posted(Estimated)" : 2019-08-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-08-02", "Last_Update_Posted(Estimated)" : 2024-06-13", "Last_Verified" : 2024-06" } }}

#Study Description Brief Summary This is a single-arm open label exploratory clinical trial to evaluate dichloroacetate (DCA) as a possible treatment for treatment of endometriosis-associated pain Detailed Description Endometriosis is a chronic condition usually affecting women throughout their reproductive lives. It is defined as a growth of endometrial-like tissue (womb lining) outside the uterus (womb) and is associated with chronic pelvic pain that can be frequent and severe, resulting in tiredness, lower quality of life and difficulties in getting pregnant. Current treatments are unsatisfactory and there is an unmet need for new medical treatment for endometriosis. Research findings from our laboratory have shown that women with endometriosis have more lactate in their pelvis. In laboratory models of endometriosis, we have tested dichloroacetate (DCA), a compound used to treat metabolic disorders in children. Our results showed that DCA could stop the growth and survival of endometriosis cells and reduce lactate production. In our study we plan to investigate if we can we can recruit and retain women into a trial using this treatment. We will recruit 30 women aged 18 or over, with pelvic pain and a diagnosis of endometriosis within the last three years. Participants will complete informed consent, be willing to comply with the treatment and use contraception throughout the trial. We will recruit patients over six months at Royal Infirmary of Edinburgh. Women who consent will take a daily dose of DCA capsules for 12 weeks. #Intervention - DRUG : Dichloroacetate - 6.25 mg/kg BD for 6 weeks increasing to 12.5 mg/kg BD for 6 weeks - Other Names : - DCA

#Eligibility Criteria: Inclusion Criteria: * Women aged 18 or over * Weight between 50 and 100kg * Pre-menopausal * Superficial peritoneal endometriosis (ASRM Stage I or II) at laparoscopy, performed within the last three years (and >2 weeks from surgery) * Pelvic pain for longer than six months * Average pain score of >= 4 over the four weeks prior to treatment * Willing to comply with the treatment * Willing to use contraception throughout the trial * Willing and able to complete informed consent Exclusion Criteria: * Evidence of ovarian endometrioma or deep endometriosis (based upon current surgical staging or most recent imaging) * Women who are pregnant or actively trying to get pregnant * Known allergy or hypersensitivity to any excipient of DCA * Breastfeeding * Clinical evidence of pre-existing neuropathy * Diabetes * History of liver disease * History of kidney disease * Taking part in a CTIMP or other interventional non-CTIMP studies * Patient on combination antiretroviral therapy * History of malabsorption syndrome or substantial amount of small bowels or stomach removed Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04046081

{ "NCT_ID" : "NCT00419315", "Brief_Title" : "A Randomized Clinical Trial of Alcohol Care Management", "Official_title" : "Primary Care Based Disease Management for Alcohol Dependence", "Conditions" : ["Alcohol Dependence"], "Interventions" : ["Behavioral: Usual Care", "Behavioral: Alcohol Care Management"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-03", "Study_Completion_Date(Actual)" : "2011-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-01-04", "First_Submitted_that_Met_QC_Criteria" : 2014-11-03", "First_Posted(Estimated)" : 2007-01-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-01-05", "Last_Update_Posted(Estimated)" : 2015-05-12", "Last_Verified" : 2015-04" } }}

#Study Description Brief Summary A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings. Detailed Description Background: Alcohol dependence is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments less than 20% of individuals with alcohol dependence are actively engaged in treatment. Within the VA system systematic screening was implemented to increase the identification of patients with both abuse and dependence. However, there continues to be a marked discrepancy in the care offered or accessed among those identified with alcohol dependence. Existing treatment guidelines suggest that all persons with dependence receive care in specialty addiction treatment. Data from our center indicate that among those individuals screened in primary care who have AUDIT - C scores of \>7, only 30% are formally evaluated with 50% receiving only brief advice and 20% having no evidence of assessment or referral. Of those assessed and referred to specialty care only 60% attend an initial visit and only 33% meet the EPRP performance measure of 2 visits per month for 90 days. This disparity in treatment access exists even though Veterans self report a desire to cut down and readiness to change drinking behaviors. (VA ACQUIP) and a willingness to consider pharmacotherapy. Aims: Available evidence suggests that primary care may be a key component in the identification of alcohol dependent patients, delivery of initial interventions, and to the success of addiction treatment. Indeed, the vast majority of screening and new case identification occurs within primary care. The primary aims of this proposal are to test the effectiveness of a primary care based Alcohol Care Management (ACM) program and to evaluate the barriers and facilitators to accessing and engaging individuals into treatment. The ACM program uses a Behavioral Health Specialist to deliver care focused on the use of pharmacotherapy in combination with psychosocial support (Medication Management). This model may overcome barriers to care such as frequent intensive visit schedules often required in specialty settings, stigma associated with specialty care or group therapy approaches, access to specialty care in remote areas, and the current focus on a 12 step model of treatment. Secondary aims are to establish the acceptability of primary care based treatments and defining treatment modifiers such as age, barriers, co-occurring depression, and pharmacogenetic response. #Intervention - BEHAVIORAL : Alcohol Care Management - Care management for alcohol dependence with a focus on pharmacotherapy - BEHAVIORAL : Usual Care - Usual care included a referral to a specialty addiction treatment program.

#Eligibility Criteria: Inclusion Criteria: * be men and women = 18 years; * meet criteria for alcohol dependence; * drink more than an average of 2 drinks per day prior to study entry (over the last 60 days); * have adequate hearing to participate in assessment Exclusion Criteria: * show no evidence of current abuse or dependence of illicit substances other than marijuana; * no current hallucinations; * no current symptoms of mania; * be relatively cognitively intact * not actively participate in specialized addition or behavioral health treatment within the prior 12 months Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00419315

{ "NCT_ID" : "NCT03238807", "Brief_Title" : "Effect of Intrauterine Injection of Hcg Before ET on Clinical Outcomes in IVF/ICSI Cycles", "Official_title" : "Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Clinical Outcomes in In-vitro Fertilization/Intracytoplasmic Sperm Injection Cycles: a Randomized Controlled Trial", "Conditions" : ["Infertility", "ART"], "Interventions" : ["Drug: Human Chorionic Gonadotropin"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-07-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-04", "Study_Completion_Date(Actual)" : "2020-10-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-08-01", "First_Posted(Estimated)" : 2017-08-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-08-01", "Last_Update_Posted(Estimated)" : 2022-09-28", "Last_Verified" : 2022-09" } }}

#Study Description Brief Summary Subfertility is the inability to conceive after 12 months of regular unprotected sexual intercourse. Around 15% of couples suffer from subfertility. As a treatment for subfertility, Assisted Reproductive Techniques (ART) have been a choice for subfertile couples. In Egypt in 2010, Pregnancy Rate was calculated to be 36.2%, Live Birth Rate to be 25.7%. Implantation is the process by which the embryo adheres to the wall of the uterus. Endometrial receptivity plays the most important role for successful implantation after embryo quality. It is estimated that up to 70% of early pregnancy losses are due to failure of implantation. Despite extensive research, the embryo-maternal dialogue that orchestrates the implantation process is still not fully understood. Much effort has been done in the last decades to detect factors affecting Implantation and improve endometrial receptivity. Human Chorionic Gonadotropin (hCG) is a placental glycoprotein hormone that required to maintain pregnancy. Recent research data demonstrates that hCG is secreted very early by the embryo before implantation to facilitate it. hCG has been proved to cause attraction of inflammatory cells, promote angiogenesis, regulate chemical mediators at the endometrium. These effects proceed the classical role of hCG during pregnancy and could be a directly involved in and facilitating the implantation process. Studies have been conducted to study the effect of injection of different concentrations of hCG inside the uterine cavity before Embryo Transfer (ET) to improve endometrial receptivity and outcomes of In-Vitro Fertilization (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI) cycles. A recent systematic review was conducted on 12 studies performing intrauterine injection of different doses of hCG before ET. Results of this study showed that there is increased pregnancy outcome after injection of intrauterine 500 IU of hCG. The study recommended a definitive large clinical trial with live birth as the primary outcome. There was no evidence that miscarriage was influenced by intrauterine hCG administration, irrespective of embryo stage at transfer or dose of intrauterine hCG. Aim of the study: To detect whether intrauterine injection of hCG before ET improves clinical outcomes in IVF/ICSI cycles. Detailed Description This study is a Randomized Controlled Trial (RCT) to be done at ART center of Women's Health Hospital, Assiut university, Egypt. All steps for IVF/ICSI procedure, from the beginning of the induction for controlled ovarian stimulation until just before the procedure of ET, will be done for all enrolled patients as routinely decided according to the local protocol of the ART center in Women Health Hospital, Assiut University. In the day of ET, number and quality of Embryos will be decided according to the routine practice guided by the local protocol. The intervention preparation will be prepared by adding one vial of hCG containing 5000 IU to 1mL of tissue culture medium (Continuous Single Culture, IrvineScientific). To obtain 500 IU of hCG, 0.1 milliLiter (mL) of the preparation will be injected inside the uterus before ET in the study group. For the control group, 0.1 mL of the tissue culture medium without hCG will be injected inside the uterus before the ET. For both groups we will use Intra-Uterine Insemination (IUI) catheter (Sperm Trans, Sperm Processor) to inject the solution inside the uterine cavity 4 minutes before ET. We will standardize the procedure of ET for all women apart from the intervention versus control step. All women participating in the study will be put in lithotomy position. Cusco's speculum will be introduced to visualize the cervix. Guided by transabdominal ultrasound with a full bladder, the ET catheter (Cook Sydney IVF Catheter) will be introduced through the cervical os into the uterine cavity. After introduction of the catheter into the uterine cavity loaded embryos will be injected inside the cavity 0.5 cm from the fundus. Biochemical pregnancy test will be done 14 days after ET by measuring hCG in the woman's serum. If the test result is positive (according to the standard values that is used in the laboratory), a transvaginal ultrasound will be done 3 weeks following the positive biochemical test, to document the visualization of gestational sac, fetal pole and cardiac pulsation. Pregnancy rate (PR) is calculated by the number of women with positive biochemical pregnancy test to the number of women enrolled in each group. The clinical pregnancy was defined as a viable pregnancy when there is evidence of a gestational sac, embryo and fetal heart rate at the time of ultrasound evaluation. Clinical Pregnancy Rate (cPR) is calculated by the percentage of detected clinical pregnancies using ultrasound to the IVF/ICSI cycles in each group. Implantation rate (IR) is calculated by the number of visualized embryos by transvaginal ultrasound to the number of transferred embryos. While Live Birth Rate (LBR) is calculated by the number of live births to the number of transferred embryos. Miscarriage rate (MR) is calculated by the ratio of miscarriages to the number of confirmed pregnancies. #Intervention - DRUG : Human Chorionic Gonadotropin - 500 IU of human Chorionic Gonadotropin - Other Names : - Epifasi

#Eligibility Criteria: Inclusion Criteria: * infertility, male or female factor * Women undergoing ICSI/IVF Exclusion Criteria: * functional azoospermia * submucous uterine myomas or previous myomectomy * endometriosis * hydrosalpinges without prior excision or occlusion of the tubal ostia Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 43 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT03238807

{ "NCT_ID" : "NCT00301600", "Brief_Title" : "Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy", "Official_title" : "Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy", "Conditions" : ["IGA Nephropathy"], "Interventions" : ["Drug: Mycophenolate mofetil"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2003-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-05", "Study_Completion_Date(Actual)" : "2006-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2006-03-10", "First_Posted(Estimated)" : 2006-03-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2006-03-10", "Last_Update_Posted(Estimated)" : 2010-05-27", "Last_Verified" : 2008-07" } }}

#Study Description Brief Summary A single-center random parallel study to compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy Detailed Description IgA nephropathy is an immune-complex glomerulopathy that can result in capillary necrosis or extracapillary proliferation (crescents). Several studies have documented a higher incidence of hypertension and nephritic-range proteinuria in patients with the crescentic form of IgA nephropathy, suggesting that patients with this variant of the disease may have a worse prognosis. Some studies have shown that treatment with steroids and cyclophosphamide had efficacy on reducing proteinuria and preserving renal function by healing vasculitic lesions, therefore preventing the progression of glomerular sclerosis. Recent studies have also shown that mycophenolate mofetil is effective in the treatment of lupus nephritis with vasculitic lesion and small vasculitis with renal involvement. We will conduct a single-center prospective open-labeled clinical trial of 40 patients with crescentic IgA nephropathy and treat them randomly with pulse intravenous cyclophosphamide or oral mycophenolate mofetil. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of mycophenolate mofetil compared with cyclophosphamide in the treatment of crescentic IgA nephropathy. #Intervention - DRUG : Mycophenolate mofetil - MMF,1.0g/d - Other Names : - MMF,cellcept

#Eligibility Criteria: Inclusion Criteria: Patient with a diagnosis of IgAN without deposition of C4 and C1q, age 10 <= age <= 70y, sex free * Gross hematuria or an active urine sediment * Segmental necrotizing lesion of the capillary wall * Cellular or fibrocellular crescents >= 10% * Fibrinoid degeneration of small vessels * Fibrin positive Three or more items, with provision of criteria informed consent Exclusion Criteria: * More than four-week treatment with cytotoxic drug, such as CTX, CsA and MMF, prior to enrollment * Immune deficiency * Serum creatinine >= 5.0mg/dl * Previous malignancy * Pregnancy * Hepatitis * Diabetic mellitus or obesity * Severe infection or CVS complications * Henoch-Schonlein purpura nephritis, systemic vasculitis, SLE Sex : ALL Ages : - Minimum Age : 12 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT00301600

{ "NCT_ID" : "NCT02694107", "Brief_Title" : "Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy", "Official_title" : "A Randomized Controlled Trial of Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy", "Conditions" : ["Disturbance", "Balance", "Pregnancy"], "Interventions" : ["Other: Control", "Other: Proprioceptive exercises"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09", "Study_Completion_Date(Actual)" : "2015-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-02-01", "First_Posted(Estimated)" : 2016-02-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-02-23", "Last_Update_Posted(Estimated)" : 2016-02-29", "Last_Verified" : 2016-02" } }}

#Study Description Brief Summary The purpose of the present study was to measure the effect of proprioceptive training, short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up. Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which would perform proprioceptive exercise, or the control group(n=19, no intervention) . Detailed Description Improvement in the postural balance of pregnant women may be the improvement in joint mechanoreceptor activation present in the joint capsules, medial ligament, posterior cruciate ligament, and meniscus, which result in improved articular stabilization and, consequently, a possible increase in the musculature's ability to provide co-contraction. Improved their postural control after the intervention may have been due to central and peripheral nervous system balance control circuits and strength gains, which showed improvements extending from the second to the third trimester . The maintenance of postural balance requires the integration of the visual, vestibular, and somatosensory systems. At the spinal level, first level of motor control, nervous reflex movement patterns are received from higher levels of the nervous system. This provides for reflex splinting during conditions of abnormal stress about the joint and has significant implications for rehabilitation.The muscle spindles play a major role in the control of muscular movement by adjusting activity in the lower motor neurons. The second level of motor control is the brain stem, where the joint afferent is relayed to maintain the posture and balance of the body. Information delivered to the brain stem emanates from the joint proprioceptors, the vestibular centers in the ears, and the eyes.The final aspect of motor control includes the highest level of CNS function (motor cortex, basal ganglia, and cerebellum)and is mediated by cognitive awareness of body position and movement. Movements that are repeated can be stored as central commands, and can be performed without continuous reference to consciousness. This better joint afferent between the peripheral and central nervous system control may be reflected in the improvement of balance during pregnancy, as observed in this study as a result of proprioceptive training delivered to pregnant women. #Intervention - OTHER : Proprioceptive exercises - OTHER : Control

#Eligibility Criteria: Inclusion Criteria: * Maternal age between 25 and 30 years, * Gestational age was 20 weeks gestation, * Body mass index not exceeding 30 kg/m2, * Low risk pregnancy, * Single fetus, * Healthy sensory motor function in the lower limbs. Exclusion Criteria: * Gestational diabetes, * Pre-eclampsia, * Toxemia, * Gestational hypertension, * Previous abortion, * High-risk pregnancy, * Type I or Type II diabetes , * Any condition that could affect sensation, * A leg or foot fracture or ankle or knee sprain within the last year, * Current back or knee pain, * Cardiovascular, neurologic, neuromuscular, or pulmonary disease, * Vertigo, balance or any visual problems,or psychological illness. * Current smokers, * Currently taking any medication that would affect their ability to balance. Sex : FEMALE Ages : - Minimum Age : 25 Years - Maximum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02694107

{ "NCT_ID" : "NCT01581125", "Brief_Title" : "Sleep Duration Required to Restore Performance During Chronic Sleep Restriction", "Official_title" : "Sleep Duration Required to Restore Performance During Chronic Sleep Restriction", "Conditions" : ["Sleep", "Sleep Deprivation", "Insufficient Sleep Syndrome"], "Interventions" : ["Behavioral: Sleep:wake 1", "Behavioral: Sleep:wake 2"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06", "Study_Completion_Date(Actual)" : "2016-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-03-22", "First_Posted(Estimated)" : 2012-04-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-04-18", "Last_Update_Posted(Estimated)" : 2016-07-18", "Last_Verified" : 2016-07" } }}

#Study Description Brief Summary The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Detailed Description The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers. #Intervention - BEHAVIORAL : Sleep:wake 1 - Sleep and Wake durations for arm 1 - BEHAVIORAL : Sleep:wake 2 - Sleep and Wake durations for arm2

#Eligibility Criteria: Inclusion Criteria: * Healthy Exclusion Criteria: * Prescription medications Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 35 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01581125

{ "NCT_ID" : "NCT03303482", "Brief_Title" : "A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators", "Official_title" : "A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators", "Conditions" : ["Burnout, Professional"], "Interventions" : ["Behavioral: Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-09-19", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-05-21", "Study_Completion_Date(Actual)" : "2018-05-21}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-09-18", "First_Posted(Estimated)" : 2017-10-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-10-02", "Last_Update_Posted(Estimated)" : 2018-11-20", "Last_Verified" : 2018-11" } }}

#Study Description Brief Summary Background. To increase school readiness, Pre-K programs for low-income children must be responsive to the role of trauma in the lives of children, families, and staff. In 2017-2018, the School District of Philadelphia's (SDP) Office of Early Childhood Education will help Pre-K teachers support children's social-emotional and behavioral health, which is essential for early learning, by offering teachers a professional development course called Enhancing Trauma Awareness (ETA). Purpose. To determine whether teachers who take ETA will have: 1) better work functioning; 2) more trusting work relationships; and 3) better health. Population. Pre-K classroom teachers (n=128) working in centers under SDP auspice that serve exclusively low-income (≤300 % of poverty) children. Intervention. A 12-week professional development course-Enhancing Trauma Awareness-will delivered by Lakeside Global Institute in 6 group sessions, with 16 teachers per group and each session lasting 2.5 hours. Design. Consenting teachers will be randomly assigned by classroom (lead teacher and/or assistant teacher) to receive the ETA course in either fall 2017 (intervention groups) or spring 2018 (wait-list control groups). Data collection and analysis. An external evaluation team (Temple University) will administer a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter 2017 (after fall course), and spring 2018 (after spring course). Teacher-children relationship quality will be the a priori primary outcome, and secondary outcomes will be assessed across the domains of work functioning, trust, and health. #Intervention - BEHAVIORAL : Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute) - The trauma awareness professional development course is delivered in a small group (up to 16 participants; 2.5 hours every other week over 12 weeks). The course provides an environment for professionals to explore in depth the complex nature of trauma, while also recognizing and emphasizing the highly sensitive nature of trauma that is essential to becoming trauma-informed. The course facilitates a heightened awareness and appreciation for trauma-related behaviors and consequences that influence relationships and systems and that persist across generations.

#Eligibility Criteria: Inclusion Criteria:Preschool classroom teacher who works in a center that is under the auspice of the School District of Philadelphia and serves exclusively low-income (<=300 % of poverty) children. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03303482

{ "NCT_ID" : "NCT02526394", "Brief_Title" : "Pertussis and Meningitis C Concomitant Vaccination in Adolescents", "Official_title" : "A Phase III/IV Randomised Open-label Study and Comparison of the Immunogenicity and Safety of a Single Adolescent Booster Dose of a Meningococcal Group C Conjugate-containing Booster Vaccine (Meningitec™, OR NeisVac-C™ , OR Menitorix™), When Given Concurrently With an Acellular Pertussis-containing Booster Vaccine (Repevax™ or IPV-Boostrix™)", "Conditions" : ["Pertussis", "Meningitis", "Preventive Immunization; Meningitis", "Immunization"], "Interventions" : ["Drug: Pertussis containing vaccine", "Biological: Meningococcal vaccine"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03-31", "Study_Completion_Date(Actual)" : "2017-03-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-08-11", "First_Posted(Estimated)" : 2015-08-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-08-14", "Last_Update_Posted(Estimated)" : 2019-03-22", "Last_Verified" : 2018-04" } }}

#Study Description Brief Summary The trial includes groups receiving various combinations of meningitis C and pertussis containing vaccines, to be administered concomitantly in adolescents due their school leaving booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age). Immunogenicity and reactogenicity will be assessed. Detailed Description Recent numbers of cases of infection with meningococcal C and pertussis (whooping cough), and the characteristics of the people who are these cases, makes it clear that UK adolescents will require booster doses of vaccination for both in the near future. These are increasingly important priorities for the national immunisation policy advisers to the Department of Health, the Joint Committee on Vaccination and Immunisation (JCVI). There are good indications that the likely target agegroup for these booster vaccinations will be at 14-17 years. Therefore this study seeks primarily to measure antibody responses to the meningitis C and whooping cough vaccines when given at the same time in this agegroup, and see how well the vaccines are tolerated. Up to 800 adolescents will be recruited across eight study groups. The eight groups arise as a result of combinations of four meningococcal and two whooping cough vaccines each participant will receive a single dose of each of the two types of vaccine (i.e. two injections). Two blood samples will be collected of 10ml each, one prior to vaccination and the second at 35 weeks later. These samples will allow assessment of how the immune system responds to the vaccinations in terms of the antibodies that are present in the blood. The study will also be assessing how well the vaccines are tolerated in this age group when given together, as described above. Each participant will therefor be asked to complete a health diary for the week following vaccination. This will record any redness/ swelling/ pain at the injection site as well as any illnesses or visits to a GP or hospital. #Intervention - BIOLOGICAL : Meningococcal vaccine - Meningococcal vaccination - Other Names : - Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix - DRUG : Pertussis containing vaccine - Pertussis containing vaccination - Other Names : - Boostrix, Repevax

#Eligibility Criteria: Inclusion Criteria: * Participant is willing and able to give written informed consent for participation. If aged below 16 years, parent/legal guardian gives consent while the participant gives written assent for participation in the study. * Male or female aged 13 years and 6 months (+0 day) to 17 years (+364 days) on the day of consent. * Completed childhood meningococcal serogroup C and pertussis vaccination according to the UK (catch-up and/or routine) schedule appropriate for the participant's age Exclusion Criteria: * The participant may not enter the study if ANY of the following apply: * Any contraindication to vaccination as specified in the 'Green Book'- Immunisation against Infectious Disease. * Significant illness including progressive neurological disease or seizure disorder; confirmed or suspected immunosuppressive or immunodeficient conditions; major congenital defects; or known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time). * Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * History of invasive meningococcal disease or pertussis. * Significant contact (household or intimate exposure) to an individual with culture proven Neisseria meningitis disease or pertussis in the previous 60 days. * Received the routine teenage booster dose of tetanus/diphtheria/polio * Pregnancy Temporary Exclusion Criteria * Fever (sublingual temperature >= 38°C) * Received systemic antibiotic(s) (either oral or parenteral) within the past 7 days. For all visits, if allowed by the study visit window, receipt of systemic antibiotics (either oral or parenteral) will delay venepuncture until at least 7 days after cessation of antibiotics. * Received any blood or blood products within the past 12 weeks. * Received another investigational agent within 90 days - or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial to the end of this study. * Possibility of pregnancy Sex : ALL Ages : - Minimum Age : 13 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

NCT02526394

{ "NCT_ID" : "NCT03013829", "Brief_Title" : "Kidney Paired Donation Video-Based Education Trial", "Official_title" : "Kidney Paired Donation: A Randomized Trial to Increase Knowledge and Informed Decision-Making", "Conditions" : ["Kidney Paired Donation"], "Interventions" : ["Behavioral: KPD Educational Video"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-06-26", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-08", "Study_Completion_Date(Actual)" : "2021-01-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-12-29", "First_Posted(Estimated)" : 2017-01-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-01-05", "Last_Update_Posted(Estimated)" : 2023-07-05", "Last_Verified" : 2023-07" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the effectiveness of a targeted educational approach designed to increase knowledge about the risks and benefits of living donation generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision-making about KPD among potential live kidney donor and kidney transplant patients. Detailed Description The investigators will conduct a randomized controlled trial (RCT) to examine the effectiveness of a video-based KPD education intervention to improve knowledge, self-efficacy, concerns, and informed decision-making about KPD among potential live kidney donor and kidney transplant patients. There will be equal allocation of LKDs and intended recipients to both KPD education conditions: (1) Usual Care (UC) group and (2) UC plus video-based KPD education group. All enrolled LKDs and intended recipients will complete a baseline survey and another survey 2 weeks post-intervention. Additionally, follow-up data will be gathered on KPD decision-making, participation, and reasons for non-participation at 3 months post-intervention. Settings and target population: The study will be conducted at three kidney transplant programs in the United States: Beth Israel Deaconess Medical Center (BIDMC; Boston, MA), the Medical University of South Carolina (MUSC; Charleston, SC), and Erie County Medical Center (ECMC; Buffalo, NY). BIDMC will act as the coordinating center for this study and will be responsible for study design, oversite, reporting, updates, and final data analysis. MUSC and ECMC will rely on the CCI at BIDMC for review. This study will target potential LKDs and their intended recipients. Randomization: Random assignment to the usual education or usual education plus video intervention group will occur within the 48 hours following completion of the baseline survey. The BIDMC study coordinator will oversee randomization after receiving an automated notification of baseline completion by participants from all study sites. Randomization will be done with the LKD, with the randomized group matched to the intended recipient. We have decided to ensure that the randomized group is the same for any LKD-recipient pairs to reduce the risk of contamination, which is a critical threat to internal validity in this type of study. For instance, if a LKD was assigned to the KPD video-based education group and their intended recipient was assigned to the UC group, there is the real possibility that there would be some diffusion of treatments in which the LKD discusses some elements of the intervention with the recipient and this, in turn, may influence the recipient's living donation and KPD knowledge, concerns, and decision-making processes. A simple unrestricted random allocation sequence will be used. We will use REDCap to generate the randomization sequence, which will be accessible to the site coordinators and transplant educators. The PI and Co-Investigators will be blinded to the subjects' allocation assignment. Interventions: Usual Care (UC) Living Donation and KPD Education: Potential LKDs and recipients will receive living donation and KPD-specific education as they usually do at their respective kidney transplant programs. Typically, potential LKDs are informed of their incompatibility during a phone call with the donor nurse coordinator. At this time, the KPD option is described and the potential LKD is provided with kidney paired donation information. This information is available in English and Spanish. For those who do not have internet access, the written educational materials are mailed. The potential LKD is advised to call the donor nurse coordinator with any questions about KPD and/or to initiate the full donation evaluation. An identical KPD educational process occurs for the intended recipient, although this is done with their own transplant nurse coordinator and only if their potential donor decides to initiate the full donation evaluation. For study purposes, we will approach waitlisted recipients and any potential donors who complete an online health screening. LKDs and recipients assigned to the UC group will be sent an email after randomization, which will include a reminder to visit the usual educational websites and link to the usual care brochures. Participants will only be shown the materials provided as standard of care at their respective institutions. Video-Based KPD Education: LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch the embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences. Assessment Time-points: Study data will be collected from participants at three different time points. Baseline. Participants will complete a 30-minute online assessment via REDCap following email consent but prior to randomization. The questionnaire assessment will gather sociodemographic information, assess primary and secondary outcomes, and measure important covariates. Post-Intervention. Two weeks after randomization, participants will complete a 20-minute REDCap assessment of the primary and secondary outcomes, uptake of the written and video educational elements, any discussions they have had with others about living donation or KPD, educational intervention process and evaluation, and any steps they have taken to pursue further donation evaluation. The rationale for the timing of this assessment is to re-assess the primary and secondary outcomes in close proximity to the delivery of living donation and KPD-specific education yet that provides sufficient time for the participant to assimilate and consider the information acquired. Follow-up. Three months following the living donation and KPD-specific education, participants will complete a final REDCap assessment on living donation and KPD knowledge, as well as a brief assessment to learn of their final decision regarding living donation and the factors that contributed to it. The rationale for the timing of this follow-up assessment is that the vast majority of incompatible potential LKDs and recipients who have been offered KPD have achieved a final disposition within this time period. #Intervention - BEHAVIORAL : KPD Educational Video - LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch an embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.

#Eligibility Criteria: Inclusion Criteria: LKDs * Speaks English or Spanish * Completed the initial living donation health screening Transplant Candidates * Speaks English or Spanish * On that transplant waitlist (active or inactive) Exclusion Criteria: LKD's * Non-directed (i.e., anonymous) potential LKDs * Previously undergone donor evaluation * Participation in another study to increase knowledge about living donation/LDK Transplant Candidates * Had a prior LDKT * Previously enrolled in a KPD program * Previous or current participation in another study to increase knowledge about living donation/LDKT * Listed for a liver Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03013829

{ "NCT_ID" : "NCT01886677", "Brief_Title" : "Improving Energy Balance in Men With Prostate Cancer", "Official_title" : "Exploring the Impact of Negative Energy Balance in Men With Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Behavioral: Immediate diet and exercise intervention", "Behavioral: Delayed diet and exercise intervention"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12", "Study_Completion_Date(Actual)" : "2015-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-06-19", "First_Posted(Estimated)" : 2013-06-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-06-21", "Last_Update_Posted(Estimated)" : 2017-03-03", "Last_Verified" : 2014-12" } }}

#Study Description Brief Summary RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression. PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer. Detailed Description This is a 2-arm randomized controlled feasibility trial among 40 overweight or obese men newly diagnosed with prostate cancer who are scheduled for prostatectomy. This study will use the presurgical period to explore the potential impact of weight loss via a healthy energy-restricted diet and increased physical activity on circulating hormones, cytokines, and growth factors, as well as effects on tumor biology and other clinical outcomes. Consenting patients will be block randomized to 1-of-2 study arms: 1) a healthful diet + exercise intervention to promote a weight loss of up to 2 pounds/week; or 2) a wait-list control who will receive the intervention once the study period is complete. Both groups will receive nutritional counseling during the study period to correct nutritional deficiencies with food sources. This study will explore and contrast changes in body mass index (BMI) observed over the study period (minimum of 3.5 weeks) in the intervention vs. wait-list control arms, and also monitor changes in body composition, energy intake and physical activity; these changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor immunohistochemical markers of insulin receptor, vascular endothelial growth factor (VEGF), AKT, and nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB); and d) functional and health-related outcomes, i.e., side-effects and medical outcomes, quality of life (QoL), and functional status. #Intervention - BEHAVIORAL : Immediate diet and exercise intervention - Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed). - BEHAVIORAL : Delayed diet and exercise intervention - Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).

#Eligibility Criteria: Inclusion Criteria: * Histopathologically confirmed prostate cancer * Elects prostatectomy as first line treatment (i.e., no androgen ablation, radiation therapy, etc) * Has at least 3.5 weeks lag-time until scheduled prostatectomy (must be able to participate in the diet and exercise program a full 3.5 weeks). * Body mass index (BMI) 25 - 49.9 * Mentally competent * Able to speak and write English * Has telephone access * Agrees to be randomized to either study arm (immediate or delayed diet and exercise program) Exclusion Criteria: * Another active malignancy (not including non-melanoma skin cancer) * Medical conditions that affect weight (e.g., untreated thyroid disturbances * Currently on a weight loss regimen * Preexisting medical condition(s) that preclude adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-mths, etc. Sex : MALE Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01886677

{ "NCT_ID" : "NCT01144663", "Brief_Title" : "Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines", "Official_title" : "Immunogenicity and Safety of GSK Biologicals' Meningococcal Vaccine (GSK 134612) When Co-administered With a Pneumococcal Conjugate Vaccine and Infanrix Hexa™ in Healthy Infants", "Conditions" : ["Infections, Meningococcal", "Meningococcal Vaccines"], "Interventions" : ["Biological: Menjugate®", "Biological: Nimenrix™", "Biological: NeisVac-CTM", "Biological: Infanrix™ hexa", "Biological: Synflorix™"], "Location_Countries" : ["Germany", "Spain", "Estonia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-07-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-06-22", "Study_Completion_Date(Actual)" : "2013-09-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-06-03", "First_Submitted_that_Met_QC_Criteria" : 2018-08-29", "First_Posted(Estimated)" : 2010-06-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-06-14", "Last_Update_Posted(Estimated)" : 2020-12-31", "Last_Verified" : 2020-12" } }}

#Study Description Brief Summary The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered. Detailed Description The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2. #Intervention - BIOLOGICAL : Nimenrix™ - 4- or 3-dose intramuscular injection - BIOLOGICAL : Menjugate® - 3-dose intramuscular injection - BIOLOGICAL : NeisVac-CTM - 3-dose intramuscular injection - BIOLOGICAL : Infanrix™ hexa - 4-dose intramuscular injection - Other Names : - Infanrix hexa™ - BIOLOGICAL : Synflorix™ - 4-dose intramuscular injection

#Eligibility Criteria: Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit). * A male or female between, and including, 6 and 12 weeks (42 <= age <= 90 days) of age at the time of the first vaccination. * Written informed consent obtained from the parent(s) or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Born after a gestation period of at least 36 weeks. Exclusion Criteria: * Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example hepatitis B and BCG). * History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures (history of a single, simple febrile seizure is permitted). * Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature >= 37.5°C (99.5°F) on oral, axillary or tympanic setting, or >= 38.0°C (100.4°F) on rectal setting). (Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator). * Administration of immunoglobulins and/ or any blood products since birth or planned administration during the study period. Sex : ALL Ages : - Minimum Age : 6 Weeks - Maximum Age : 12 Weeks - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

NCT01144663

{ "NCT_ID" : "NCT01237717", "Brief_Title" : "Relationship of Urine Sodium Excretion to Central Blood Pressure and Aortic Pulse Wave Velocity", "Official_title" : "Relationship of Urine Sodium Excretion to Central Blood Pressure and Aortic Pulse Wave Velocity", "Conditions" : ["Hypertension"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-12", "Study_Completion_Date(Actual)" : "2011-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-11-09", "First_Posted(Estimated)" : 2010-11-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-11-09", "Last_Update_Posted(Estimated)" : 2013-01-23", "Last_Verified" : 2013-01" } }}

#Study Description Brief Summary One interesting area is the relationship of high salt intake and central aortic blood pressure. High salt intake is associated development of hypertension and cardiovascular mortality. Central aortic pressure is better correlated with cardiovascular events and mortality. With recent advances in technology, it is possible to measure central aortic pressure noninvasively and easily. Until now there is no study to evaluate the relationship of high salt intake and aortic blood pressure. The purpose of the present study is to evaluate the relationship of high salt intake and aortic blood pressure and aortic stiffness. Subjects with or without hypertension will be enrolled for investigation. Subjects with hypertension should be never treated with antihypertensive medications. Subjects with secondary hypertension, diabetes, heart failure, high grade kidney disease, ischemic heart disease, and major arrhythmia will be excluded. Sodium intake is measured by 24 hour urinary sodium excretion, with the measurement of peripheral and central aortic blood pressure, and aortic pulse wave velocity. Salt sensitive hypertension related single nucleotide polymorphism will be analyzed to define the relationship with high salt intake and aortic pressure and pulse wave velocity. Detailed Description Measurements: should be performed for 2 days 1. 24 hour urine Na, K and Creatinine, 24 hour urine amount 1. Calculation of urine completeness index : Cr/(21 x Bwt) 2. Definition of complete urine collection: complete index ≥ 0.7 and loss not more than one time and 100 mL 2. Peripheral blood pressure (pBP) 1. Microlife WatchBP Office 2. Sitting position 3. After 5 minutes resting 4. Peripheral systolic BP (pSBP), Peripheral diastolic BP (pDBP), 3. Central aortic blood pressure 1. SphygmoCor (AtCor Medical, Australia) 2. Central systolic blood pressure 3. Difference between peripheral SBP and central SBP (SBPp-c) 4. Pulse wave velocity 1. VP2000 (Colin, Japan) 2. Central pulse wave velocity: carotid-femoral Pulse Wave Velocity 3. Measure by tape 4. distance from suprasternal notch to carotid artery 5. distance from suprasternal notch to femoral artery 6. Silent environment 5. Blood chemistry and complete blood count 1. Measure at the morning of second day after overnight fasting 2. complete blood count, blood urea nitrogen/Creatinine, fasting blood glucose, Total cholesterol, Triglyceride, High density lipoprotein cholesterol 6. 24 hour ambulatory blood pressure measurement Measurement protocol 1. 1st day 1. Visit hospital before 9:00 AM after overnight fasting 2. start 24 hour urine collection from 9:00 AM (with education for complete collection) 3. start 24 hour ambulatory blood pressure monitoring, in parallel with 24 hour urine collection 2. 2nd day 1. Measure central aortic blood pressure 2. Measure blood Lab 3. Measure Pulse Wave Velocity Analysis of Salt sensitive gene polymorphism 1. Single Base Extension technology(SBE) 2. single nucleotide polymorphism rs2398162 and other salt sensitive hypertension related single nucleotide polymorphism

#Eligibility Criteria: Inclusion Criteria: * subjects without hypertension: n=100 * subjects with hypertension, not treated at least within 6months: n=100 Exclusion Criteria: * secondary hypertension * known diabetes (HbA1C >7.5%) * night worker * stage 3 hypertension * renal artery stenosis * primary aldosteronism * elevated GOT and/or glutamate-pyruvate transaminase > 2 fold of normal range * heart failure, significant arrhythmia, angina, myocardial infarction, stroke, carotid stenosis * pregnancy * autoimmune disease, debilitating disease * significant liver disease; active hepatitis, liver cirrhosis * alcoholics * Renal disease: Cr > 1.2 and/or proteinuria * Medication affecting blood pressure and/or vascular stiffness, including lipid lowering agents Sex : ALL Ages : - Minimum Age : 35 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01237717

{ "NCT_ID" : "NCT02295124", "Brief_Title" : "Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery", "Official_title" : "Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery", "Conditions" : ["Nausea"], "Interventions" : ["Drug: Hydromorphone", "Drug: Oxycodone"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-01", "Study_Completion_Date(Actual)" : "2016-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-02-11", "First_Posted(Estimated)" : 2014-11-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-11-19", "Last_Update_Posted(Estimated)" : 2017-11-27", "Last_Verified" : 2017-11" } }}

#Study Description Brief Summary The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone. Detailed Description Nausea and vomiting in the post-operative period is considered strongly undesirable by patients and has adverse effects on recovery from outpatient procedures, contributing significantly to delays in discharge from recovery. A know major contributor to the occurrence of post-operative nausea and vomiting is the use of opiate medications which are the cornerstone of post-operative pain management. The investigators hypothesize that the occurrence of this side-effect is different between patients prescribed oxycodone and those receiving hydromorphone for acute pain management after total hip replacement surgery. This investigation is a randomized, double-blind, head-to-head comparison to equipotent administration of oxycodone vs. hydromorphone to determine whether such a difference exists. #Intervention - DRUG : Oxycodone - Patients will receive oxycodone 10mg (5mg if \> 65) every 2 hours based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation. - Other Names : - Supeudol - DRUG : Hydromorphone - Patients will receive an initial dose of hydromorphone 2mg (1mg if \> 65) every 2 hours as needed based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation. - Other Names : - Palladone, Dilaudid

#Eligibility Criteria: Inclusion Criteria: * American Society of Anesthesiologists Physical Status Classification System 1 <= age <= 3 * Age 18 <= age <= 85 years * Patients undergoing hip replacement surgery under spinal anesthesia Exclusion Criteria: * patient refusal * contraindication or refusal of spinal anesthesia * inability to provide informed consent * history of dementia * intolerance or allergy to oxycodone or hydromorphone * chronic opioid use or chronic pain disorder * pregnancy * history of drug addiction * history of major psychiatric illness Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02295124

{ "NCT_ID" : "NCT04659395", "Brief_Title" : "How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block", "Official_title" : "How to Develop a Training Program for Nurses in Ultrasound Guided Femoral - a Methodology Study", "Conditions" : ["Hip Fractures", "Ultrasound Therapy; Complications", "Pain, Acute"], "Interventions" : ["Other: Emergency nurses"], "Location_Countries" : ["Norway"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-09-19", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-30", "Study_Completion_Date(Actual)" : "2020-11-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-11-12", "First_Posted(Estimated)" : 2020-12-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-12-02", "Last_Update_Posted(Estimated)" : 2020-12-09", "Last_Verified" : 2020-12" } }}

#Study Description Brief Summary In this study the intervention consists of a one-day-training program for nurses and three supervised ultrasound guided femoral nerve block (UGFNB) per registered nurse. The training consists of an instruction movie, one-day on-site-simulation and practical examination. The nurses are watching an instruction video and review current local guidelines for UGFNB in advance. The one-day training is situated in a simulation center and consists of theoretical and practical training divided into; infection prevention, anatomy, use of ultrasound and prevention and treatment of complications. A ultrasound model (Gen II Femoral Vascular Access and Regional Anesthesia Ultrasound Training Model) and a living human model is used to examine the femoral nerve and the neighboring structures using ultrasound. At the end of the one-day course, the nurses attends a practical examination with the researchers and anesthesiologists observing, to assure that they could perform the UGFNB procedure correctly. To pass the exam and be able to move on to the supervised blocks in real patients, there has to be a consensus between the researchers and anesthesiologist that they had sufficient knowledge and practical skills. 1) Sterile procedure 2) Management of the ultrasound machine and oral description of the anatomic surroundings in the groin area 3) Preparation of the local anesthetics and performance of an UGFNB. They also have to do an oral presentation in how they would perform a cardiopulmonary resuscitation procedure and how to manage complications / toxic reactions. Approved exam required at least seven points. This study will explore if a one-day course as described above is adequate, sufficient and maintains the safety framework of performing UGFNB in nurses Detailed Description Acute pain is a common reason for patients admitted to Emergency Departments (ED) . Globally over 1 million hip fractures occur yearly , a trauma that is close related with acute distinct pain in the proximal part of the affected extremity. Experiencing severe pain is associated with increased length of stay, higher risk of delirium, movement restriction, difficulties with mobilization and reduced health related quality of life. There is considerable research regarding patients' satisfaction with their ED experiences. These studies indicate that patient dissatisfaction with the stay at ED has been an international challenge over several years . Disapproval such as; pain management , but also limited information on potential latency before further treatment and poor explanation about the causes and treatment of the condition is prominent. Pain control can be difficult , and often requires advanced nursing and physician care due to co-morbidity . Inadequate analgesia appear to be risk factors for delirium in frail older adults, and research indicates that total avoiding opioids or using very low or high doses of opioids may increase the risk of delirium. Therefore, optimizing acute pain management is important. Ultrasound Guided Femoral Nerve block (UGFNB) performed in hip fracture patients is a valuable alternative to systemic analgesic, as it provides analgesia to the fractured area, thereby facilitating reduction in opioid administration. Traditionally, an UGFNB is performed by an anesthesiologist. Recently, several examples of task shifting from physicians to nurses are described with no significant difference in successful treatment results with equal patients satisfaction and safety as physician performed procedures. Task shifting approach is endorsed by the World Health Organization (WHO) in order to make more efficient use of the available human resource of health. A recent report from the European Union (EU) states that implementation of task shifting has been rarely evaluated and limited documented. Therefore, we need studies to examine the methodology in how we can train nurses in the ED to take more responsibility for assessing and treating patients. In the study we aime to; 1. describe a methodology for a training course for nurse led UGFNB. 2. evaluate if the training process resulted in a safe and successful UGFNB. Data which will be collected are 1. ASA classification (ASA Physical Status Classification System ) 2. Length of stay 3. Morbidity * Hospital acquired pneumonia * Acute myocardial infarction (AMI) * Acute renal failure * Respiratory failure 4. Complication rate, number of; * intravasal injection - visually + circulatory and neurological symptoms * hematoma - defined as a new tumor \> 2 cm in the groin / injection site measured by ultrasound * Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge. * Allergic reaction 5. Number of total morphine equivalents, mg (iv/po) administered prehospital and during Emergency Department stay 6. Patients physical characteristic (physical examination; gender, age, height, weight, , blood pressure, heart rate, SpO2 (oxygen saturation) and use of oxygen will be noted together with current disease A short, but personal interview with the patients having received an UGFNB by a study nurse can describe both the service received and the patient's experience with it. The interviews will be performed after the patient has been relieved of pain. The PhD (Philosophiae Doctor)-candidate, not the study nurse having performed the nerve block, will conduct the interviews. The patients will be asked whether the nerve block relieved them of pain, how they experienced the procedure and the fact that it was performed by a nurse had any relevance. Also, the PhD-candidate will interview the patient at a later point during the hospital stay for a second time to compare the answers The study nurses and the anesthesiologists that has supervised the nurses will be presented with a questionnaire after each UGFNB conducted. The PhD-candidate will hand out the questionnaire immediately after the FNB is conducted by a study nurse. The items in the questionnaire include feasibility and success of the procedure and are identical for nurses and anesthesiologists. Finally, each study nurse will do three UGFNB with supervision by an anesthesiologist before we start inclusion in a later randomized controlled trial. Five study nurses will be included and fifteen patients. The inclusion criteria for patients will be: * Patients arriving at the ED diagnosed with a hip fracture (radiological confirmed) * ASA- classification 1-4 * Written and verbal informed consent by patient Exclusion criteria for patients will be: * Patients with; dementia, without ability to give informed consent and other cognitively challenges needed to participate in this study (at the discretion of the study nurse) * Known allergies to local anesthetic (Ropivacaine) used in UGFNB * Use of anticoagulants or platelet inhibitors. Acetylsalicylic acid and dipyridamole is allowed. If a recent (last 2 hours) INR( international normalized ratio) is below \<1.5 the patient can be included. * Pregnant * Age \<18 years * Severe head injury which leads to significant loss of consciousness (GCS \<12) * \>10 mg or more morphine administrated pre-hospital * Skin lesions/infection at presumed block site * Patients admitted with other suspected or verified fractures, except small fractures in hands and foots. Verbal and written informed consent The study nurses will inform the patients by oral and written information and inclusion and intervention of the patient will start after written consent. #Intervention - OTHER : Emergency nurses - Emergency nurses who are trained for one-day in ultrasound-guided femoral nerve block

#Eligibility Criteria: Inclusion Criteria: * Registered nurses or registered nurses with continuing education in acute nursing or geriatrics * The nurses need to be aware that it will increase the workload in beginning of the project. * Registered nurse has to be senior staff experienced i.e. worked in the ED * Motivated to take on a new task in the ED * Certificated in advanced CPR * Familiar with routines in the ED and the relevant patient group * They must be willing to be a part of this project for approximately 12 months. * Working at least 75%. Exclusion Criteria: * Refuse to participate Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT04659395

{ "NCT_ID" : "NCT05878899", "Brief_Title" : "Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial", "Official_title" : "Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial", "Conditions" : ["Venous Thromboembolism"], "Interventions" : ["Drug: Enoxaparin"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-05-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-13", "Study_Completion_Date(Actual)" : "2023-03-13}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-03-06", "First_Posted(Estimated)" : 2023-05-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-05-24", "Last_Update_Posted(Estimated)" : 2023-05-26", "Last_Verified" : 2023-05" } }}

#Study Description Brief Summary In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals #Intervention - DRUG : Enoxaparin - Prophylactic dose of enoxaparin once daily for 10 days after delivery.

#Eligibility Criteria: Inclusion Criteria: adult women within 48h of delivery, with: * >=2 of the following risk factors Age >=35 years Pre-pregnancy BMI 30.0 <= age <= 34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility * and/or >=1 of the following risk factors: Emergency cesarean section Pre-pregnancy BMI >=35kg/m2 Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) Pre-eclampsia Pre-term delivery (<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight <5th percentile) Exclusion Criteria: * any indication for therapeutic anticoagulation * a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia) * an increased bleeding risk * a contra-indication to the use of heparin Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05878899

{ "NCT_ID" : "NCT01499550", "Brief_Title" : "Nocturnal Transnasal Insufflation (nTNI)", "Official_title" : "Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia", "Conditions" : ["COPD", "Hypercapnia"], "Interventions" : ["Device: humidified transnasal insufflation (TNI20oxy)", "Other: overnight oxygen treatment with individual flow rate"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-07", "Study_Completion_Date(Actual)" : "2012-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-11-03", "First_Posted(Estimated)" : 2011-12-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-12-22", "Last_Update_Posted(Estimated)" : 2012-09-25", "Last_Verified" : 2012-09" } }}

#Study Description Brief Summary On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation. Several prospective randomized studies have shown a reduction of acute mortality as result. But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. On the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. The aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night. Thirty hypercapnic COPD GOLD IV patients (PCO2 \> 50 mmHg) will be included. The two night Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At begin and end of each measurement night a capillary blood gas analysis is made. #Intervention - DEVICE : humidified transnasal insufflation (TNI20oxy) - The alternative breathing support with TNI supplies COPD patients with 20L/min of warm humidified air. This method may be applicable to wash out the dead space between glottis and nasal opening. Pre-investigations have shown that 45 minutes of TNI during daytime reduced PCO2 and respiratory rate compared to application of oxygen alone.Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night. - Other Names : - TNI20oxy - OTHER : overnight oxygen treatment with individual flow rate - The patient is treated with his individual oxygene flow rate. Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.

#Eligibility Criteria: Inclusion Criteria: * Hypercapnia in Routine Blood Gas Analysis with > 50 mmHg PCO2 * Clinically stable respiratory situation * Treatment on normal ward possible Exclusion Criteria: * Before known obstructive sleep apnea syndrome (OSA) * A found OSA during study means no exclusion * Any other severe or acute physical illness which requires intensive medical care * Acute hypercapnic decompensation with pH < 7.30 in capillary Blood Gas Analysis Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01499550

{ "NCT_ID" : "NCT01661725", "Brief_Title" : "Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001", "Official_title" : "Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine", "Conditions" : ["Meningitis"], "Interventions" : ["Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2006-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-04", "Study_Completion_Date(Actual)" : "2006-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-08-02", "First_Posted(Estimated)" : 2012-08-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-08-06", "Last_Update_Posted(Estimated)" : 2012-08-09", "Last_Verified" : 2012-08" } }}

#Study Description Brief Summary The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older. Detailed Description Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction. #Intervention - BIOLOGICAL : Group ACYW135 Meningococcal Polysaccharide Vaccine - 60 subjects were divided into three groups (20 subjects each group), adult (16\~30 years of age), early youth (7\~15 years of age) and children (2\~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime - Other Names : - Hualan Bio

#Eligibility Criteria: Inclusion Criteria: * Healthy permanent residence 2 years and older, the subjects (or their guardians) are able to understand and sign the informed consent; * Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product; * Be able to comply with the requirements of clinical trial protocol and immunogenicity examination; * Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks; * Axillary temperature <=37.0℃. Exclusion Criteria: * Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.; * Allergic to vaccines or drugs (history of allergy to any vaccine in the past); * History of neurologic symptom or signs; * Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.; * History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months; * History of receiving other vaccines or immunoglobulin injection or any research drugs; * Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week; * History of fever within the past 3 days (axillary temperature >=38.0℃); * Participating in another clinical trial; * History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease; * Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection; * Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome); * Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.; * Pregnancy; * Any condition that, in the judgment of investigator, may affect trial assessment. Sex : ALL Ages : - Minimum Age : 2 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT01661725

{ "NCT_ID" : "NCT06587516", "Brief_Title" : "Neuromuscular Warm-Up Program for Badminton Players", "Official_title" : "Developing a Novel Neuromuscular Warm-Up Program for Recreational Badminton Players: An Experimental Study", "Conditions" : ["Balance; Distorted", "Ankle Injury"], "Interventions" : ["Behavioral: Neuromuscular Warmup Program", "Behavioral: Traditional Warmup Program"], "Location_Countries" : ["Malaysia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2024-10-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-10-18", "Study_Completion_Date(Actual)" : "2024-10-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2024-09-04", "First_Posted(Estimated)" : 2024-09-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2024-09-04", "Last_Update_Posted(Estimated)" : 2024-12-20", "Last_Verified" : 2024-12" } }}

#Study Description Brief Summary This study aims to develop and evaluate a new warm-up program specifically designed for recreational badminton players. The program focuses on exercises that enhance balance and reduce the risk of ankle injury. Participants will be asked to follow this warm-up routine, and their performance will be assessed before and after to see if the exercises improve their balance and overall movement. The goal is to create a practical, effective warm-up routine that can be easily incorporated into badminton practice. Detailed Description This study investigates the effectiveness of a novel neuromuscular warm-up program tailored for recreational badminton players. The program is designed to improve balance, enhance movement efficiency and reduce the risk of injuries commonly associated with badminton. Participants will be recruited from recreational badminton clubs and will undergo baseline assessments of balance performance and lunge movement using motion capture (Mocap), EMG. and inertia measurement unit (IMU). The warm-up program includes a series of targeted exercises selected based on expert consensus from a previous Delphi study. These exercises focus on key areas such as dynamic stability, and proprioception. Participants perform pre and post test with Star Excursion Balance Test (SEBT) and forward lunge movement with (IMU, MOcap and MEG) attached on the lower limb. The intervention will be: 1) novel neuromuscular warmup and 2) traditional warmup. Participants will perform both the warmup but on different days with one day rest in between the interventions. The study\&#39;s findings aim to inform best practices for warm-up routines in badminton, potentially offering a standardized program that can be widely adopted by recreational players to enhance their performance and safety on the court. #Intervention - BEHAVIORAL : Neuromuscular Warmup Program - This intervention consists of a structured warm-up routine specifically designed to enhance neuromuscular function and balance. The program includes exercises such as two way forward lunge, single-leg balance, multidirectional lunges, single-leg hops forward and backward, and single-leg calf raises. Each exercise is aimed at improving proprioception, dynamic stability, and lower limb strength. - BEHAVIORAL : Traditional Warmup Program - This intervention involves a conventional warm-up program. It includes general stretching exercises and light jogging intended to prepare the body for physical activity.

#Eligibility Criteria: Inclusion Criteria: * Injury free for &gt;1 year, plays badminton minimum of once a week, have experience of playing at least 3 years Exclusion Criteria: * Badminton players that participate in competition in any level (novice, intermediate or elite tier), involve in any regimented training, participants with any joint disorder, non-communicable diseases (NCD), neurologically unstable, consumption of any medication that can interfere with performance. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 49 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT06587516

{ "NCT_ID" : "NCT02766309", "Brief_Title" : "The Correlation Between Health Status and Self-Assessment of Health Condition, and the Relation to Health Services Utilization", "Official_title" : "The Correlation Between Health Status and Self-Assessment of Health Condition, and the Relation to Health Services Utilization", "Conditions" : ["Sf12-v2 Questionaire"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-10", "Study_Completion_Date(Actual)" : "2015-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-05-02", "First_Posted(Estimated)" : 2016-05-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-05-05", "Last_Update_Posted(Estimated)" : 2016-05-09", "Last_Verified" : 2016-05" } }}

#Study Description Brief Summary This study aims to examine the relation between health status and self-assessment of health condition, their relation to healthcare services utilization, and also to identify the profile of those who assess their health condition as mediocre to poor in general population and according to nationality. Detailed Description Background: The World Health Organization defines 'health' as a state of physical, mental and social well-being of an individual, and not just the absence of disease or illness. Health self-assessment is almost never present in medical and clinical models, which define 'health' as the absence of physical disease. On the one hand, some say that there is a correlation between these definitions, and others argue that self-assessment of health is not always consistent with the clinical health status evaluation. Few studies have examined the relationship between self-assessment and health status among residents of the State of Israel in general and among the population residing in the Galilee and Western Galilee area in particular. The studies presented contradictory findings about the health perception among Jewish and Arab population. There are about 600,000 residents in Western Galilee from various population sectors, including Jews, Arabs, Druze and others. This composition of population pretty much reflects the general composition of population in the Galilee area. Study objective: This study aims to examine the relation between health status and self-assessment of health condition, their relation to healthcare services utilization, and also to identify the profile of those who assess their health condition as mediocre to poor in general population and according to nationality. Methods: A cross-sectional study was conducted among 250 visitors aged 18 and above of outpatient clinics in the Galilee Medical Center (former Western Galilee Hospital): opthalmology, dental, otolaryngology (ENT) and orthopedic. The target population group for this study is adult residents of the Western Galilee area. The sampling is random. For the aims of the survey five sampling days were selected in each of the four outpatient clinics. On each of the sampling days all visitors of different outpatient clinics were offered to complete a self-administered structured questionnaire adapted specifically for the study. #Intervention - OTHER : Sf12-v2 - structured questioner Sf-12v2, developed by Ware.et al (Ware, Kosinski, Turner-Bowker \& Gandeck, 2002).

#Eligibility Criteria: Inclusion Criteria: * Adult residents of the Western Galilee area Exclusion Criteria: * Non literate visitors Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT02766309

{ "NCT_ID" : "NCT04787445", "Brief_Title" : "Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension", "Official_title" : "Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension: An Exercise Hemodynamic Study (TAPH Study)", "Conditions" : ["Pulmonary Arterial Hypertension"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-03-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-11-21", "Study_Completion_Date(Actual)" : "2023-11-21}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-02-15", "First_Posted(Estimated)" : 2021-03-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-03-05", "Last_Update_Posted(Estimated)" : 2024-03-21", "Last_Verified" : 2024-03" } }}

#Study Description Brief Summary The purpose of this study is to characterize the clinical and hemodynamic response of Pulmonary Arterial Hypertension (PAH) therapy in patients with atypical PAH and risk factors for left heart disease. Detailed Description This is an observational prospective study to better understand the clinical impact of Pulmonary Arterial Hypertension (PAH) specific therapy in patients with atypical PAH among those with risk factors for left heart disease The study involves detailed baseline clinical evaluation prior to initiation of PAH therapy, followed by repeat clinical assessment after 6 months of medical therapy

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Pulmonary hypertension with mean PA pressure >20 mmHg and a planned initiation of pulmonary arterial hypertension therapy * No active treatment for precapillary pulmonary hypertension * Ambulatory (not wheelchair/scooter dependent) * Presence of any risk factor for left heart disease will qualify for inclusion (either atrial fibrillation, body mass index>30 kg/m2, arterial hypertension, diabetes, coronary artery disease or age>60 years) Exclusion Criteria: * Significant chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator * Ischemia thought to contribute to dyspnea in the opinion of the investigator * Obstructive hypertrophic cardiomyopathy * Known infiltrative cardiomyopathy (amyloid) * Constrictive pericarditis or tamponade * Active myocarditis * Complex congenital heart disease * More than mild aortic or mitral stenosis * Intrinsic (prolapse, rheumatic) valve disease with more than moderate mitral, tricuspid or aortic regurgitation * Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment * Terminal illness (other than HF) with expected survival of less than 1 year * Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months. * Inability to comply with planned study procedures * Pregnancy or breastfeeding mothers Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04787445

{ "NCT_ID" : "NCT06278025", "Brief_Title" : "Dysphagia and Deep Cervical Flexor Muscles", "Official_title" : "Comparison of Deep Cervical Flexor Muscle Strength and Endurance in Patients With and Without Neurogenic Dysphagia", "Conditions" : ["Dysphagia", "Neurological Disorder"], "Interventions" : ["Diagnostic Test: assessment"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-09-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-02-01", "Study_Completion_Date(Actual)" : "2024-02-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2024-02-19", "First_Posted(Estimated)" : 2024-02-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2024-02-19", "Last_Update_Posted(Estimated)" : 2024-03-18", "Last_Verified" : 2024-03" } }}

#Study Description Brief Summary Cervical posture is vital for normal swallowing function. Changes in cervical posture during swallowing alter the bolus flow and swallowing kinematics through changes in gravity and oropharyngeal space. The hyoid bone does not articulate with any bone, so it requires adequate tension of the hyolaryngeal complex and proper cervical postural alignment to maintain its stabilization and position. Changes in cervical posture and stabilization can cause changes in hyoid bone position and kinematics through muscles and ligaments which may lead to decrease in hyoid elevation, loss of optimal strength of the suprahyoid and infrahyoid muscles due to disrupted length-tension relationship, and an increased risk of aspiration due to insufficient laryngeal elevation. Further, deterioration in cervical posture and decreased stabilization resulting from cervical muscle weakness or/both endurance could affect the control and strength of masticatory muscles, tongue muscles and suprahyoid - infrahyoid muscles, which are involved in swallowing function. Whereby DCF weakness gives rise to inadequate cervical stabilization, change in hyoid bone stabilization, alterations in suprahyoid and infrahyoid muscle function, and decreased laryngeal elevation may adversely affect the normal function of the swallowing related muscles. Thus, decreased cervical stabilization, which is often seen in neurological diseases, may be related to neurogenic dysphagia. Given the known changes in cervical stabilization as a consequence of neurologic injury, the additional impact on swallowing or a potentially already neurologically-disordered swallow is considered. Thus, loss of cervical stabilization may be one of the factors affecting dysphagia in patients with neurological diseases providing more information on all potential factors contributing to swallow impairment, potentially leading to more targeted and effective swallowing interventions. However, there is no study investigating the role of the DCF muscles in dysphagia. Therefore, the aim of the present study was to comparison of deep cervical flexor muscle strength and endurance in patients with and without neurogenic dysphagia. #Intervention - DIAGNOSTIC_TEST : assessment - DCF Muscle Strength Evaluation DCF muscle strength was determined using the 5-step Craniocervical Flexion Test (CCFT) performed with a Chattanooga Stabilizer ™ Pressure Biofeedback Unit which was developed by Jull et al. \[33, 34\]. The CCFT is based on the craniocervical flexion movement, which is provided by DCF muscle contraction. The CCFT includes 5 pressure increments starting with 20mmHg.Activation score ranges from 0 to 10. The performance index is determined by both the highest pressure level and the number of repetitions. Evaluation of the DCF Endurance The DCF endurance test, which is a valid and reliable method, was used to measure DCF muscle endurance \[36\]. Conducted in supine, endurance is measured by calculating the time (in seconds) an individual can raise their head at minimal flexion angle.

#Eligibility Criteria: Inclusion Criteria: * diagnosis of neurological disease, age range inclusive of 18 <= age <= 65 years , independent sit-to-stand, prior consultation for dysphagia, and underwent a Modified Barium Swallowing Study (MBSS). Exclusion Criteria: * neck pain complaints in the previous 30 days history of cervical surgery and head and neck cancer, cervical pathology involving the neck region such as cervical disc herniation or radiculopathy presence of cervical osteophytes and/or cervical kyphosis detected in the MBSS, history of rheumatic diseases. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT06278025

{ "NCT_ID" : "NCT02609035", "Brief_Title" : "Immunization Services Model for Adult Rate Improvement", "Official_title" : "Immunization Services Model for Adult Rate Improvement", "Conditions" : ["Pharmacy", "Immunization", "Vaccines"], "Interventions" : ["Behavioral: Telephonic prompt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-03-31", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03-31", "Study_Completion_Date(Actual)" : "2017-03-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-11-17", "First_Posted(Estimated)" : 2015-11-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-11-17", "Last_Update_Posted(Estimated)" : 2017-04-27", "Last_Verified" : 2017-04" } }}

#Study Description Brief Summary ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to improve adult vaccination rates for pneumococcal and herpes zoster vaccines. Detailed Description This study will investigate immunization rate improvement among adult patients in 250 northeastern US community pharmacies as a result of telephonic prompts during regular automated outbound communiqués. There will be three projects assessing different forms of these appended prompts-appointment-based medication synchronization automated prompts, refill ready automated prompts, and refill reminder automated prompts. Each intervention will occur in one of three pharmacy chains, each with approximately 10,000 patients randomized to control or intervention (receive prompt or no). Prior to the outbound automated call to the patient, a third-party technology vendor (Scientific Technologies Corporation) will perform an automated immunization status assessment of the patient by submitting a query the state immunization registry to compare the adult patient's existing immunization record to the CDC Recommended Adult Immunization Schedule. Gaps in immunizations that fall within pharmacy scope of practice will be identified. During the automated call (performed by VoicePort, a pharmacy telephonic support vendor) to the patient, they will be prompted to receive identified immunization gap vaccines upon their next pharmacy visit, with priority on pneumococcal, influenza, and herpes zoster vaccinations. If the patient accepts, the vaccination will be delivered when next the patient comes to visit the pharmacy. After 6 months of running the trial, statistical modeling will be employed to assess vaccination rate differences between control and intervention patients. #Intervention - BEHAVIORAL : Telephonic prompt - Other Names : - Appended message

#Eligibility Criteria: Inclusion Criteria: * Patient at least 19 years at date of enrollment * Patient not in long-term care, hospice or otherwise identified as unable to come to pharmacy for receipt of vaccine * Patient currently missing a record of receipt of at least one of three vaccinations: flu, pneumonia, or shingles * Patient enrolled in telephonic pharmacy reminder service Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02609035

{ "NCT_ID" : "NCT01514786", "Brief_Title" : "Decision Aid to Technologically Enhance Shared Decision Making", "Official_title" : "Decision Aid to Technologically Enhance Shared Decision Making", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Behavioral: Colorectal Web"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-09", "Study_Completion_Date(Actual)" : "2015-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-01-17", "First_Submitted_that_Met_QC_Criteria" : 2017-09-10", "First_Posted(Estimated)" : 2012-01-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-01-20", "Last_Update_Posted(Estimated)" : 2017-09-15", "Last_Verified" : 2017-09" } }}

#Study Description Brief Summary Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence. Detailed Description This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS. #Intervention - BEHAVIORAL : Colorectal Web - The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS

#Eligibility Criteria: Inclusion Criteria: * 50 <= age <= 75 years * not current with colorectal cancer screening * scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician * able to read English * current contact information Exclusion Criteria: * history of colon cancer or adenomatous polyps * history of dementia or psychosis * contraindication to CRCS Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01514786

{ "NCT_ID" : "NCT02241915", "Brief_Title" : "Use of a Microbial Sealant to Reduce Surgical Site Infections.", "Official_title" : "Microbial Sealants Do Not Decrease Surgical Site Infection for Clean Contaminated Colorectal Procedures.", "Conditions" : ["Surgical Site Infection", "SCIP"], "Interventions" : ["Procedure: Laparoscopic Surgery", "Procedure: Open Colorectal Surgery"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-05", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-09-13", "First_Posted(Estimated)" : 2014-09-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-09-13", "Last_Update_Posted(Estimated)" : 2014-09-16", "Last_Verified" : 2014-09" } }}

#Study Description Brief Summary Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we hypothesized that a microbial sealant could reduce the rate of SSI by half for clean contaminated colorectal procedures (Class 2). #Intervention - PROCEDURE : Open Colorectal Surgery - PROCEDURE : Laparoscopic Surgery

#Eligibility Criteria: Inclusion Criteria: * Nonemergent colon and/or rectal abdominal surgical procedures * Women of child-bearing potential must have a negative serum HCG assay prior to surgery * Ages >=18 years. Exclusion Criteria: * Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products. * Undergoing emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done. * Undergoing a significant concomitant surgical procedure (e.g., Whipple & organ transplant surgery). The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection), cystectomy. * History of prior laparotomy within the last 60 days of this planned procedure. * Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure. * Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criteria).6, 7 * Preoperative severe neutropenia defined as total neutrophil count <=500 × 106/L. * Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason. * Receiving antibiotic therapy within the 1 week prior to the date of surgery. * Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin. * Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis. * History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer. * History of major organ transplantation, including bone marrow transplantation. * Taking systemic steroids >10 mg prednisone daily or remicade within 2 weeks prior to surgery or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count < 200. * Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1). * Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT02241915

{ "NCT_ID" : "NCT01516931", "Brief_Title" : "Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Depression", "Official_title" : "A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Depression.", "Conditions" : ["Depression"], "Interventions" : ["Behavioral: counseling", "Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12-30", "Study_Completion_Date(Actual)" : "2017-02-25}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-12-29", "First_Posted(Estimated)" : 2012-01-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-01-19", "Last_Update_Posted(Estimated)" : 2020-01-13", "Last_Verified" : 2020-01" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale. Detailed Description Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of depression.Depression is a chronic illness and generally requires life-long treatment. However, up to current days there have been no studies evaluating the effects of rTMS in the maintenance treatment of depression. This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of rTMS, as monotherapy, relative to placebo in delaying the time to relapse in patients with depression. Patients with acute symptoms of depression will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. The study will consist of 4 phases: a screening/tolerability phase of up to 7 days; an open-label, flexible-dose lead-in phase of 8 weeks; an open-label, fixed-dose stabilization phase of 6 weeks; and a single-blind relapse prevention phase of 12 months. During the open-label phase, all patients will be treated with venlafaxine. Remitterswith Hamilton Rating Scale for Depression \[HAM-D17\] score ≤ 7will be eligible to enter the single-blind phase and will be randomly assigned to one of three groups: group 1 on active rTMS and venlafaxine; group 2 on sham rTMS and venlafaxine; group 3 on venlafaxine alone. Efficacy will be evaluated during the study using relapse assessment (time between subject randomization to treatment and the first occurrence of relapse). Secondary outcome measures will include: symptom changes, measured by the Hamilton Rating Scale for Depression \[HAM-D17\]; illness severity changes, measured by the Clinical Global Impression of Severity for Depression (CGI-S-DEP); and changes in subject functioning, assessed with the Personal and Social Performance Scale. Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiography, and measurements of vital signs (temperature, pulse and blood pressure) and weight. Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study. #Intervention - PROCEDURE : repetitive Transcranial Magnetic Stimulation (rTMS) - 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks - BEHAVIORAL : counseling - Placebo monthly by general counseling for 12 months.

#Eligibility Criteria: Inclusion Criteria: * DSM-IV diagnosis of depression * Experiencing an acute exacerbation of depression symptoms * Baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items * Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements Exclusion Criteria: * Comprised ferromagnetic metallic implants * Pacemakers * Previous neurosurgery * History of seizures * Major head trauma * Alcoholism * Drug addiction * Any psychiatric or neurological disorder other than depression and anxiety * Psychotic depression * Suicidal propensities Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT01516931

{ "NCT_ID" : "NCT03616119", "Brief_Title" : "Gastroesophageal Reflux Disease in Azerbaijan", "Official_title" : "The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan", "Conditions" : ["Gastroesophageal Reflux Disease"], "Location_Countries" : ["Azerbaijan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-08-01", "Study_Completion_Date(Actual)" : "2019-09-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-07-29", "First_Posted(Estimated)" : 2018-08-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-08-02", "Last_Update_Posted(Estimated)" : 2022-12-13", "Last_Verified" : 2022-12" } }}

#Study Description Brief Summary To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location. Detailed Description It is an observational, nationwide study. The GERD questionnaire (1994) requested from Mayo clinic, was received and validated. The questionnaire was translated by 3 individuals from english to azeri and back trasnlated by 3 native english speakers. Power analysis was performed. The research was presented for the approval to Ethical Committee of Azerbaijan Medical University. Prior to the actual study, a pilot study with smaller number of participants was performed and the results were evaluated. Cluster sampling methodology was provided by the statistical department of Azerbaijan Medical University. 110 employees were hired for using a survey in different regions of Azerbaijan. Written consent was obtained from every person evaluated. Statistical ananlysis was performed.

#Eligibility Criteria: Inclusion Criteria: * Age: 18 <= age <= 80 * Both genders * Hearburn * Belching * Regurgitation Exclusion Criteria: * protom pomp inhibitor use * antibiotic use in the last 4 weeks * upper GI surgery Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03616119

{ "NCT_ID" : "NCT04453514", "Brief_Title" : "Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic", "Official_title" : "Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga", "Conditions" : ["Anxiety"], "Interventions" : ["Behavioral: Trauma-informed yoga video recording"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-07-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-06-19", "Study_Completion_Date(Actual)" : "2021-06-19}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-06-30", "First_Posted(Estimated)" : 2020-07-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-06-30", "Last_Update_Posted(Estimated)" : 2021-07-21", "Last_Verified" : 2021-07" } }}

#Study Description Brief Summary This study will help the investigators understand whether it is feasible and acceptable for people to practice trauma-informed yoga using a pre-recorded video. This study will also explore the immediate effects of trauma-informed yoga on anxiety, mindfulness, and body awareness. The results of this study will inform future research on remote delivery of trauma-informed yoga for supporting psychological wellbeing. Detailed Description Emerging data shows a high prevalence of anxiety during the first several months of the COVID-19 pandemic in the United States. Accordingly, there have been calls for supportive interventions for psychological health during the pandemic. Due to physical distancing requirements, supportive interventions for psychological health will be most accessible if they can be administered remotely. Trauma-informed yoga may support psychological health during the COVID-19 pandemic, but research on remote delivery of trauma-informed yoga is needed. The present study will evaluate the feasibility and acceptability of trauma-informed yoga delivered remotely. In this study, the investigators will create an online delivery platform within REDCap, a secure web application for research, that 1) hosts a 45-minute video of a trauma-informed yoga practice, and 2) collects data on participants' present moment experience of anxiety, mindfulness, and body awareness immediately before and after the yoga practice. Feasibility and acceptability data will allow the investigators to evaluate recruitment methods and refine the delivery method of trauma-informed yoga in a way that aligns with participant preferences. The investigators will also evaluate the short-term effects of trauma-informed yoga on state anxiety, state mindfulness, and body awareness. This study will allow the investigators to pilot the remote delivery of trauma-informed yoga during the ongoing, highly stressful COVID-19 pandemic and further develop trauma-informed yoga as a supportive intervention for psychological health. #Intervention - BEHAVIORAL : Trauma-informed yoga video recording - Pre-recorded video of a 45-minute trauma-informed yoga practice. The yoga practice can be done standing or sitting in a chair. The yoga practice is comprised of slow, gentle movements combined with paying attention to the body and the breath. The practice uses invitational language and encourages participants to make choices and customize the movements according to their individual needs.

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * Has an internet connection * Willing to try a gentle yoga practice Exclusion Criteria: * Cannot read or understand English Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT04453514

{ "NCT_ID" : "NCT01070017", "Brief_Title" : "Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru", "Official_title" : "Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru", "Conditions" : ["HIV", "AIDS", "HIV Infections"], "Interventions" : ["Other: DOT-HAART"], "Location_Countries" : ["Peru"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-07-31", "Study_Completion_Date(Actual)" : "2014-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-02-16", "First_Posted(Estimated)" : 2010-02-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-02-16", "Last_Update_Posted(Estimated)" : 2017-10-25", "Last_Verified" : 2017-10" } }}

#Study Description Brief Summary Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru. Detailed Description Community-based accompaniment with directly observed antiretroviral therapy (DOT-HAART) may improve adherence and clinical outcomes among impoverished individuals starting HAART in resource-poor settings. Furthermore, the utilization of community health workers may build social capital. This is cluster-randomized trial, with randomization at the level of health centers. Individuals in both intervention and control clusters will receive community-based adherence support (monthly adherence visits) and standard care. In addition, individuals residing in intervention clusters will receive 12 months of community-based DOT-HAART. We will enroll patients as well as community members (health providers, treatment supporters, and community health workers) to assess individual and community-level outcomes. #Intervention - OTHER : DOT-HAART - For 8 months, DOT-HAART of all doses in the participant's home or alternate location. DOT worker ensures that HIV medications are taken as indicated and witnesses ingestion of all medications including other medications prescribed by physician. The worker will be trained to identify, triage and notify providers of any psychosocial and medical problems/complications. Transition to self-administration begins in months 9-12 when DOT will be tapered and greater participation of treatment supporter to prepare patients for self-administration.

#Eligibility Criteria: Inclusion Criteria for Patient Cohort: * Age greater than or equal to 18; * Diagnosis if HIV and meeting criteria for HAART; * Lives in poverty; * EITHER: 1) HAART naïve or 2) starting salvage therapy due to virologic failure; * Documentation of baseline CD4 cell count and HIV load; * Residence and receipt of HIV healthcare within the study catchment area Exclusion Criteria for Patient Cohort: * Imprisoned or cannot give informed consent. Inclusion Criteria for Community Cohort: * Working in a health establishments in study region; * If health personnel, contracted employee caring for people living with HIV/AIDS. Exclusion Criteria for Community Cohort: * Cannot give informed consent Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01070017

{ "NCT_ID" : "NCT01279421", "Brief_Title" : "High Risk Crack Use Settings and HIV in El Salvador", "Official_title" : "High Risk Crack Use Settings and HIV in El Salvador", "Conditions" : ["HIV", "Sexually Transmitted Diseases"], "Interventions" : ["Behavioral: Peer Network Intervention", "Behavioral: Social Network HIV Testing"], "Location_Countries" : ["El Salvador"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06", "Study_Completion_Date(Actual)" : "2020-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-01-17", "First_Posted(Estimated)" : 2011-01-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-01-18", "Last_Update_Posted(Estimated)" : 2021-05-14", "Last_Verified" : 2021-05" } }}

#Study Description Brief Summary This project will first increase the accessibility and acceptability of rapid HIV testing in health clinics located in or near four low-income communities in San Salvador, El Salvador. The investigators will use crack users' social networks and small incentives, as recommended by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network Intervention among 400 crack users to change norms supporting HIV protective behaviors. The intervention will include monthly meetings open to crack using and non-crack using community residents to reinforce HIV risk reduction skills, and discussion of other topics related to HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness events. Our hypothesis is that these two intervention features will singly, and in combination, reduce HIV risk behaviors among Salvadoran crack users. #Intervention - BEHAVIORAL : Social Network HIV Testing - Crack users will be recruited for HIV testing and receive 3 coupons to recruit other crack users for HIV testing. - BEHAVIORAL : Peer Network Intervention - Peer leaders will recruit small networks of crack users and facilitate a three-day prevention intervention.

#Eligibility Criteria: Inclusion Criteria: * >= 18 years * used crack cocaine in the last 2 weeks Exclusion Criteria: * not giving informed consent * under 18 years * considered by research staff to be unfit or unable to give informed consent * engages in continued disruptive behavior while participating in the project * not using crack or cocaine in the last month Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01279421

{ "NCT_ID" : "NCT00723684", "Brief_Title" : "Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy", "Official_title" : "ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.", "Conditions" : ["ADHD"], "Interventions" : ["Other: EEG-Neurofeedback", "Other: Placebo EEG Neurofeedback"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2008-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-07", "Study_Completion_Date(Actual)" : "2013-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-07-28", "First_Posted(Estimated)" : 2008-07-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-07-28", "Last_Update_Posted(Estimated)" : 2013-03-08", "Last_Verified" : 2013-03" } }}

#Study Description Brief Summary Background: Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes. It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects in ADHD. This study is designed to examine the efficacy and safety of EEG-neurofeedback in a scientific rigorously way and to study the underlying neurobiological mechanisms of EEG-neurofeedback. Objectives: 1. To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of ADHD. 2. To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning. 3. To investigate whether EEG-neurofeedback is able to improve neural functioning. Study design: Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30 sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback. Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator. Hypothesis: The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD. #Intervention - OTHER : Placebo EEG Neurofeedback - The placebo EEG-neurofeedback group will get an identical procedure as the real EEG-Neurofeedback, but with feedback on a EEG signal simulation. The placebo group will not be rewarded on their real-time EEG but on a random, simulated EEG; known to be effective for this purpose (Utrecht University, study in progress). In the protocol selection the electrode position and rewarding versus inhibition of the treatment frequency band or bands will be individually created. The first 30 seconds of the treatment will start on a predetermined fixed threshold value for all treatment subjects. - OTHER : EEG-Neurofeedback - The EEG-neurofeedback group will receive feedback on their real-time EEG-signal (brain activity). The treatment group will be rewarded, by brightening (i.e. not being blackened of) the feedback screen. Rewards will be given to the subjects when their digitally filtered frequency EEG activity meets the criteria in the 'percentage time over threshold' parameter. The 'percentage time over threshold' parameter will be auto-adjusted on the digitally filtered real-time EEG every 30 seconds, and the percentage parameter will be kept as a constant over all participants during the entire study (i.e. not adjusted during treatment based on individual capabilities).

#Eligibility Criteria: Inclusion Criteria: * Diagnosis ADHD, classified by the (Diagnostic and Statistical Manual of Mental Disorders, 2000) * Age between 8 and 15 * A full scale IQ of more than 80 * Psychopharmaca- naïve or -free, or using a stable dosage of psychostimulants or atomoxetine but still with room for improvement (defined by an average score of more than 1 on ADHD-DSM-IV rating scale). * Deviant EEG of more than 1.5 standard deviation compared to the database Exclusion criteria: * Currently intensive (i.e. weekly) individual or group psychotherapy * Regular use of medication other than psychostimulants or atomoxetine * Diagnosis of one or more of the following comorbid psychiatric disorders: * Major depression * Bipolar disorder * Psychotic disorder * Chronically motor tic disorder or Gilles de la Tourette * Conduct disorder * Autism spectrum disorders * Eating disorders * Neurological disorders (e.g. epilepsy) currently or in the past * Cardiovascular disease currently or in the past * Participation in another clinical trial simultaneously * EEG-neurofeedback training in the past * Use of alcohol or drugs Sex : ALL Ages : - Minimum Age : 8 Years - Maximum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT00723684

{ "NCT_ID" : "NCT03046069", "Brief_Title" : "FF/UMEC/VI Inhaler: Qualitative Analysis and Subject Preference Survey", "Official_title" : "FF/UMEC/VI: Qualitative Interviews and Discrete Choice Experiment(s) Evaluating the Perceived Benefits of the Features of FF/UMEC/VI (Single Inhaler Triple Therapy) Treatment in the UK, US and Germany", "Conditions" : ["Pulmonary Disease, Chronic Obstructive"], "Interventions" : ["Other: Modified DCE", "Other: Online DCE survey", "Other: Telephone interviews", "Other: DCE surveys- cognitive interviews", "Other: In-person focus groups"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-02-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-02-23", "Study_Completion_Date(Actual)" : "2018-02-23}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-02-06", "First_Posted(Estimated)" : 2017-02-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-02-06", "Last_Update_Posted(Estimated)" : 2020-03-09", "Last_Verified" : 2020-03" } }}

#Study Description Brief Summary Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting), long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled corticosteroids (ICS). For subjects at higher risk of exacerbation, treatment with all these three classes of medication is recommended. This study aims to explore the potential utility of a device called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) inhaler containing all three groups of compound. This is a mixed methods study with a qualitative phase and a quantitative Discrete Choice Experiment (DCE) phase and will be conducted in four stages: qualitative concept elicitation, DCE development, DCE piloting and testing, and conduct of the DCE. The study will conducted in the United Kingdom (UK), United States (US) and Germany and approximately 573 subjects with COPD will be included. #Intervention - OTHER : Telephone interviews - Qualitative concept elicitation telephone interviews will be conducted in subjects with COPD to explore treatment effectiveness, symptoms, quality of life, and features of treatment that are considered to be most important to them when making treatment choices. - OTHER : In-person focus groups - Qualitative concept elicitation in-person focus groups will be conducted in subjects with COPD to explore treatment effectiveness, symptoms, quality of life, and features of treatment that are considered to be most important to them when making treatment choices. - OTHER : DCE surveys- cognitive interviews - Draft version of the DCE surveys will be tested with subjects in cognitive interviews to explore the saliency of the attribute choices and assess whether the attributes are understandable, meaningful and comprehensive. - OTHER : Modified DCE - The modified DCEs will be piloted with subjects with COPD in each country to refine the underlying design and ensure that information is collected in an efficient way to enable the statistical analysis to be as precise as possible. - OTHER : Online DCE survey - An online DCE survey questionnaire will be given to the subjects to identify subject preferences, priorities and treatment goals.

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of COPD, self-reported. * Age: More than or equal to 40 years. * Moderate to severe COPD, indicated by a COPD Assessment Test (CAT) score of greater than or equal to 10 or Modified Medical Research Council (MMRC) score of greater than or equal to 2. * Currently prescribed and receiving one of the following treatment types: ICS/LABA; LABA/LAMA; ICS/LABA/LAMA (triple therapy); LAMA. * Currently resident in the UK, US or Germany. * Adequate written and oral fluency in language of country of residence. * Willing and able to understand the study and provide informed consent. * Has access to the internet (Cognitive interviews and DCE survey only). Exclusion Criteria: * Has taken part in any other stage of this study. * Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). * Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone of face-to-face interview. Sex : ALL Ages : - Minimum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03046069

{ "NCT_ID" : "NCT02135900", "Brief_Title" : "The Use of Heliox in Obstructive Sleep Apnea Syndrome", "Official_title" : "The Use of Heliox in Obstructive Sleep Apnea Syndrome.", "Conditions" : ["Obstructive Sleep Apnea Syndrome"], "Interventions" : ["Drug: Heliox"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-04", "Study_Completion_Date(Actual)" : "2011-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-07-04", "First_Submitted_that_Met_QC_Criteria" : 2015-05-15", "First_Posted(Estimated)" : 2014-05-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-05-09", "Last_Update_Posted(Estimated)" : 2015-06-01", "Last_Verified" : 2015-05" } }}

#Study Description Brief Summary The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS). Detailed Description Obstructive sleep apnea syndrome (OSAS) is a common condition affecting up to 2-4 % of the general population. The pathophysiologic consequences of OSA include: excessive daytime sleepiness leading to increased car and work related accidents; and increased incidence of hypertension (HTN), stroke and possibly coronary artery events. In addition, patients with severe and untreated obstructive sleep apnea (OSA) have increased mortality compared to patients with treated severe OSA.The main stay of treatment of OSAS is the application of continuous positive airway pressure (CPAP) during sleep. The main problem with CPAP therapy is compliance. Heliox, a mixture of oxygen and helium has been used for many years in the treatment of upper airway obstruction. In this study, the investigators will evaluate the effectiveness of Heliox in the treatment of OSAS. Adult subjects with the diagnosis of obstructive sleep apnea syndrome who are referred for repeat sleep study for CPAP titration will be evaluated. #Intervention - DRUG : Heliox - From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines. - Other Names : - Helium/Oxygen

#Eligibility Criteria: Inclusion Criteria: * Adults >= 18 years with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration. Exclusion Criteria: * Professional singers. * Television or Radio hosts. * Disk Jockeys. * Subjects requiring oxygen therapy. * Subjects younger than 18 year old. * Pregnant women. * Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%. * History of anatomic upper airway obstruction. * Uncontrolled asthma. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02135900

{ "NCT_ID" : "NCT02865239", "Brief_Title" : "Feasibility Study of Breast MRI in Decubitus Position", "Conditions" : ["Breast Cancer"], "Interventions" : ["Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-06-25", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08-20", "Study_Completion_Date(Actual)" : "2015-08-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-07-05", "First_Posted(Estimated)" : 2016-08-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-08-09", "Last_Update_Posted(Estimated)" : 2018-08-08", "Last_Verified" : 2018-08" } }}

#Study Description Brief Summary Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position. Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position. #Intervention - PROCEDURE : Position for the 3.0 Tesla in Magnetic Resonance Imaging - Eligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position. This examination is then extended by 10 minutes without additional injection of contrast medium

#Eligibility Criteria: Inclusion Criteria: * Patient to benefit a MRI in the assessment for a breast carcinoma or a suspicious of breast carcinoma * Assessment on 3.0 Tesla in Magnetic Resonance Imaging * Age >18 years * ECOG performance status <= 3 * Ability to provide written informed consent form Exclusion Criteria: * Age < 18 years * Claustrophobia * Contraindication to the injection of contrast medium Gadoline * Contraindication to MRI * Persons deprived of liberty or under supervision Sex : FEMALE Ages : - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT02865239

{ "NCT_ID" : "NCT05044793", "Brief_Title" : "A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System", "Official_title" : "A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)", "Conditions" : ["Glaucoma, Open-Angle"], "Interventions" : ["Device: OMNI® Surgical System"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-09-30", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-08-21", "Study_Completion_Date(Actual)" : "2023-08-21}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-09-09", "First_Posted(Estimated)" : 2021-09-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-09-09", "Last_Update_Posted(Estimated)" : 2024-01-17", "Last_Verified" : 2024-01" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213 #Intervention - DEVICE : OMNI® Surgical System - The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

#Eligibility Criteria: Inclusion Criteria: * Participated in, received treatment, and completed Protocol #06213 Exclusion Criteria: * Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits * Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits) Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT05044793

{ "NCT_ID" : "NCT01287988", "Brief_Title" : "Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies", "Official_title" : "Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies.", "Conditions" : ["Symptomatic Vitreomacular Adhesion"], "Interventions" : ["Drug: placebo", "Drug: ocriplasmin"], "Location_Countries" : ["Belgium", "United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-10", "Study_Completion_Date(Actual)" : "2011-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-01-24", "First_Posted(Estimated)" : 2011-02-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-02-01", "Last_Update_Posted(Estimated)" : 2017-01-13", "Last_Verified" : 2014-04" } }}

#Study Description Brief Summary The primary objective of this study is to assess visual function in up to 44 patients who have previously participated in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007). Detailed Description Non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function #Intervention - DRUG : ocriplasmin - Subjects were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study TG-MV-006 or TG-MV-007 - DRUG : placebo - Subjects were exposed to a single intravitreal injection of placebo in a previous phase III study TG-MV-006 or TG-MV-007

#Eligibility Criteria: Inclusion Criteria: * Written informed consent obtained from the patient prior to inclusion in the follow-up study * Previous participation in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007) Exclusion Criteria: * N/A Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01287988

{ "NCT_ID" : "NCT02777970", "Brief_Title" : "Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar", "Official_title" : "Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar (Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study)", "Conditions" : ["Acute Pain"], "Interventions" : ["Drug: Tramadol Hydrochloride/Paracetamol", "Drug: Placebo", "Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol"], "Location_Countries" : ["Poland", "Spain", "Hungary", "Italy", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-02-14", "Study_Completion_Date(Actual)" : "2017-02-14}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-05-13", "First_Submitted_that_Met_QC_Criteria" : 2021-03-01", "First_Posted(Estimated)" : 2016-05-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-05-17", "Last_Update_Posted(Estimated)" : 2021-03-24", "Last_Verified" : 2021-03" } }}

#Study Description Brief Summary The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain. Detailed Description The present phase IV study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar. In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio: * TRAM.HCL/DKP.TRIS * Paracetamol/TRAM.HCL * Placebo. #Intervention - DRUG : Tramadol Hydrochloride/Dexketoprofen Trometamol - DRUG : Tramadol Hydrochloride/Paracetamol - DRUG : Placebo

#Eligibility Criteria: Inclusion Criteria: * Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate. * Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation. * Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score >= 4). Exclusion Criteria: * History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid. * History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings. * History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study. * Patients using and not suitable for withdrawing the prohibited medications specified in the protocol. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02777970

{ "NCT_ID" : "NCT00758914", "Brief_Title" : "Vitamin E and Infection in the Elderly", "Official_title" : "Vitamin E and Infection in the Elderly", "Conditions" : ["Respiratory Infection", "Elderly"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "1997-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2001-08", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-09-22", "First_Posted(Estimated)" : 2008-09-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-09-23", "Last_Update_Posted(Estimated)" : 2008-09-25", "Last_Verified" : 2008-09" } }}

#Study Description Brief Summary Aging is associated with a variety of changes in the immune system. These changes result in a less effective immune response, which places the elderly at a greater risk for infection and disease. Respiratory infections cause a great number of morbidity and mortality in the elderly population. Vitamin E has been known to improve the immune response of the elderly and has been suggested for use in preventative strategies for this population. The purpose of this study is to examine the effect of one year vitamin supplementation on respiratory infection in the elderly population residing in nursing homes. This study was conducted using a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities in the greater Boston area. A total of 617 subjects over the age of 65 were enrolled in the study, with 451 completers. The participants were supplemented wit either 200 IU of vitamin E per day or placebo. The primary outcomes consisted of respiratory tract infection, number of sick days, and antibiotic use. The study involved use of questionnaires, standard anthropometrics measurements, non-invasive body composition, blood and urine sample collection, and delayed type test (DTH) using the Mantoux method. This study has been closed since August 2000 and is in the stage of data analysis only. #Intervention - DIETARY_SUPPLEMENT : Vitamin E - 200 IU alpha-tocopherol or placebo for 1 year.

#Eligibility Criteria: Inclusion Criteria: * aged >= 65 years; * life expectancy greater than 6 months; * no anticipated discharge within 3 months; * not room-bound for the past 3 months; * absence of active neoplastic disease; * no tube feeding, no kidney dialysis; * no intravenous or urethral catheters for the last 30 days; * no tracheostomy or chronic ventilator; * antibiotic-free for more than 2 weeks; * no long-term steroid treatment greater than 10 mg/d, no use of immunosuppressive drugs, or greater than the recommended daily allowance (RDA) level of supplements of vitamins E, C, or B6, selenium, zinc, beta-carotene, or fish oil; * body mass index of at least 18; * serum albumin at least 3.0 g/dL; able to swallow pills; * willing to receive influenza vaccine; * willing to provide informed consent (for patients with dementia, family members provided informed consent) Exclusion Criteria: Sex : ALL Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT00758914

{ "NCT_ID" : "NCT03795116", "Brief_Title" : "Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention", "Official_title" : "Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention", "Conditions" : ["Fibrosis", "Skin Scarring", "Skin Wound", "Hypertrophic Scar", "Scar", "Keloid"], "Interventions" : ["Device: Mock irradiation", "Device: LED-RL phototherapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-03-18", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-26", "Study_Completion_Date(Actual)" : "2020-10-26}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-12-20", "First_Submitted_that_Met_QC_Criteria" : 2022-05-31", "First_Posted(Estimated)" : 2019-01-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-01-02", "Last_Update_Posted(Estimated)" : 2022-06-01", "Last_Verified" : 2022-05" } }}

#Study Description Brief Summary Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically. Detailed Description Skin fibrosis is a significant global health problem that has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis. In vitro data show that LED-RL can modulate key cellular and molecular processes involved in skin fibrosis. Two phase I clinical trials (STARS 1 and STARS 2) demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars. #Intervention - DEVICE : LED-RL phototherapy - The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface. - Other Names : - Omnilux handheld LED system (GlobalMed Technologies, Glen Ellen, CA) - DEVICE : Mock irradiation - The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.

#Eligibility Criteria: Inclusion Criteria: * Provision of written informed consent for all study procedures * Stated willingness to comply with all study procedures and availability for the duration of the study * Suitable candidate for elective mini-facelift surgery * Pass a screening photosensitivity test Exclusion Criteria: * Current use of any photosensitizing medications * Light-sensitive conditions * Diabetes mellitus * Systemic lupus erythematosus * Current tobacco use * History of bleeding or coagulation disorder * Lax skin associated with genetic disorders * Open wounds on the face or neck * Fibrotic skin disease, pre-existing scar(s), or other skin conditions affecting the periauricular skin * History of surgery or procedure involving or affecting the periauricular skin within the past 6 months (e.g., prior facelift, fillers, laser therapy) * Tattoos that cover the proposed treatment sites on the periauricular skin * Any other medical condition(s) that could be compromised by exposure to the proposed treatment Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT03795116

{ "NCT_ID" : "NCT05712226", "Brief_Title" : "Sleepiz One+ Versus Capnography and Electrocardiography", "Official_title" : "Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard", "Conditions" : ["COPD", "Hypertension", "Sleep Apnea", "Asthma", "Heart Diseases", "Respiratory Disease"], "Interventions" : ["Device: Sleepiz One+"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-02-22", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-04-06", "Study_Completion_Date(Actual)" : "2023-04-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-01-25", "First_Posted(Estimated)" : 2023-02-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-01-25", "Last_Update_Posted(Estimated)" : 2023-05-08", "Last_Verified" : 2023-05" } }}

#Study Description Brief Summary EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the patient's mouth or nose and a monitor that displays the concentration of carbon dioxide in the respiratory gases in real-time. EtCO2 capnography is generally considered a reliable and accurate method for monitoring respiration and is often used as a gold standard for comparing the performance of other methods for measuring respiration. Therefore, the primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ and EtCO2 Capnography for measuring respiration rate, in healthy adults and patients suffering from chronic conditions (e.g. hypertension, COPD, asthma, diabetes), at rest in a clinical setting. Additionally, the performance of heart rate estimation will be evaluated against ECG. #Intervention - DEVICE : Sleepiz One+ - In this study Sleepiz One+ will measure heart rate and respiration rate of a participant sitting or lying in different positions (right and left side, back, abdomen) on a bed. The recording will take around 35 minutes.

#Eligibility Criteria: Inclusion Criteria: Patients: * Age >=18years * Informed Consent as documented by signature * One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.) Healthy volunteers * Age >=18years * Informed Consent as documented by signature * No diagnosed chronic medical condition Exclusion Criteria: Patients * Previous enrolment into the current study, * Cardiac pacemaker or another implanted electrical device * Women who are pregnant or breastfeeding * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant Healthy volunteers: * Previous enrolment into the current study, * Cardiac pacemaker or another implanted electrical device * Women who are pregnant or breastfeeding * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant * Presence of diagnosed chronic medical condition Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT05712226

{ "NCT_ID" : "NCT03909672", "Brief_Title" : "Cupping Therapy in Nonspecific Chronic Low Back Pain", "Official_title" : "Cupping Therapy in the Treatment of Individuals With Nonspecific Chronic Low Back Pain", "Conditions" : ["Low Back Pain"], "Interventions" : ["Other: Cupping Therapy"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-06-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-10", "Study_Completion_Date(Actual)" : "2020-02-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-04-06", "First_Posted(Estimated)" : 2019-04-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-04-08", "Last_Update_Posted(Estimated)" : 2020-02-21", "Last_Verified" : 2020-02" } }}

#Study Description Brief Summary Introduction: Low back pain is a very prevalent condition in the population and windsurf therapy has been presented as a non-pharmacological treatment currently used in this population. However, there is a lack of studies that evaluate such effects, besides a standardization of application of the technique in this condition. This protocol describes a placebo-controlled, randomized, double-blind study that aims to assess the effectiveness of windsurf therapy in improving pain and other symptoms of individuals with chronic non-specific back pain. Methods: Ninety individuals with chronic nonspecific and localized chronic low back pain from 18 to 59 years, will be recruited according to the inclusion criteria. Afterwards they will be randomized to one of the 2 groups: intervention group (GI) where it will be submitted applied to the windspiration with 2 suctions; and placebo group (GP) with simulated application. Both applications will occur in parallel to the vertebrae from L1 to L5 bilaterally. The application will be performed once a week for eight weeks. The volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), 4 weeks after treatment (T4) and 8 weeks after treatment (T8). The primary endpoint will be pain, and the secondary ones will be kinesiophobia, physical function, lumbar range of motion, sleep quality, patient expectation, quality of life, and psychological factors. Discussion: This is the first protocol that proposes to evaluate the effect of windsotherapy on lumbar ROM, sleep quality, kinesiophobia and psychological problems. Few studies have been done on windsurfing individuals with low back pain, requiring further studies with good methodological quality. Because there is no consensus on the use of windsurf therapy in individuals with nonspecific chronic low back pain, our protocol will be the basis for the use of the technique by health professionals and for new studies to be performed. Detailed Description This study will involve 4 researchers; 1 researcher responsible for evaluations; 1 researcher responsible for interventions; 1 researcher responsible for the interview, initial screening and randomization of participants, and 1 researcher who will perform the statistical analysis. #Intervention - OTHER : Cupping Therapy - application of cupping therapy with two acrylic type 1 cups (4.5 cm internal diameter, Dong Yang ® brand) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally

#Eligibility Criteria: Inclusion Criteria: * female and male individuals aged between 18 and 59 years, normal BMI, presenting localized and non-specific lower back pain for more than 3 months; * have not used cupping therapy before; * report pain between 3 and 8 by NRS; * individuals who are not under physiotherapeutic treatment during the intervention; * individuals without neurological, vestibular, visual or auditory deficits that make evaluations impossible. Exclusion Criteria: * Individuals with cutaneous lesions in the region where they will be applied to cupping therapy, * Individuals with uncontrolled diabetes and hypertension; * Irradiated and sacral lumbar pain; * Individuals with contraindication to windsurf therapy, are: cancer, renal failure, hepatic and cardiac insufficiency, pacemaker, pregnancy; * Individuals with severe spinal pathology (including fractures, inflammatory diseases and tumors); * Travel planning in the next 2 months Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 59 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT03909672

{ "NCT_ID" : "NCT05926388", "Brief_Title" : "Video-Assisted Instruction in Type 2 Diabetes Patients", "Official_title" : "The Effect of Video-Assisted Instruction in Type 2 Diabetes Patients' Insulin Self-Management and Insulin Administration Skills", "Conditions" : ["Education, Patient"], "Interventions" : ["Other: Video-assisted training"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-01-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-10", "Study_Completion_Date(Actual)" : "2023-08-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-06-02", "First_Posted(Estimated)" : 2023-07-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-06-21", "Last_Update_Posted(Estimated)" : 2023-12-18", "Last_Verified" : 2023-12" } }}

#Study Description Brief Summary The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training. Detailed Description The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training. #Intervention - OTHER : Video-assisted training - Patients will be given training on insulin therapy and management using lecture, question-answer, video and demonstration methods.

#Eligibility Criteria: Inclusion Criteria * 18 <= age <= 65 years * No hearing or communication problems * Self-injecting insulin Exclusion Criteria * Health care professionals * Chronic complications * Pregnant Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05926388

{ "NCT_ID" : "NCT00658983", "Brief_Title" : "Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers", "Official_title" : "Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers", "Conditions" : ["Chronic Lower Leg Ulcer"], "Interventions" : ["Other: Autologous Platelet Enriched Gel", "Other: Metalloproteinase Inhibitor"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2008-04-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-08-20", "Study_Completion_Date(Actual)" : "2010-08-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-04-07", "First_Posted(Estimated)" : 2008-04-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-04-14", "Last_Update_Posted(Estimated)" : 2023-01-05", "Last_Verified" : 2023-01" } }}

#Study Description Brief Summary Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers. #Intervention - OTHER : Autologous Platelet Enriched Gel - Treatment with Autologous Platelet Enriched Gel - OTHER : Metalloproteinase Inhibitor - Treatment with Metalloproteinase Inhibitor (Promogran)

#Eligibility Criteria: Inclusion Criteria: * >= 18 years * A non-healing chronic lower leg ulcer * Platelet ranges of 150000 per ml circulating blood Exclusion Criteria: * Presence of a tumor or metastatic disease * Hypersensitive to collagen regenerated cellulose * Hemodynamic unstable patient * Hypercoagulability * Heart decompensation or angina pectoris Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00658983

{ "NCT_ID" : "NCT05280665", "Brief_Title" : "Specialization in Gastric Cancer Surgery", "Official_title" : "The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery", "Conditions" : ["Stomach Neoplasms", "Gastric Cancer"], "Interventions" : ["Other: Specialization"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-02-14", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-09-15", "Study_Completion_Date(Actual)" : "2023-03-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-02-22", "First_Posted(Estimated)" : 2022-03-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-03-10", "Last_Update_Posted(Estimated)" : 2023-03-21", "Last_Verified" : 2023-03" } }}

#Study Description Brief Summary Specialization is having competent and effective knowledge on a subject, and the tendency towards specialization is increasing due to the fact that it increases the success in the follow-up and treatment process of diseases. It has been observed that specialization in cancer surgery provides significant improvement in clinical outcomes in recent years. In this study, the effect of specialization in gastric cancer surgery on clinical outcomes is being investigated. Detailed Description Specialization is having sufficient and effective knowledge on a subject. Today, in the medical world, specialization is defined as having competent knowledge on a disease, and in recent years, the benefit of specialization has begun to be emphasized. Initially, it was defined as a branching and over the years, internal and surgical departments were divided into sub-areas. In surgical sciences, these fields are determined as traumatology, breast-endocrine surgery and gastrointestinal system surgery. This branching has brought a different perspective and approach to diseases and has made it possible to be more effective in the management of diseases. In recent years, a specialization approach on diseases and organ systems has developed within these branches. In surgery, surgeons specialized on many organs such as pancreatic surgery, colorectal surgery, gastric surgery, breast surgery, ovarian surgery have increased the efficiency in the management of diseases and the survival and disease-free survival rates of the patients have increased, and the postoperative morbidity and mortality rates have decreased. Gastric cancer is one of the most common malignant cancers. It is the fifth most common cause of cancer-related death worldwide. Despite advances in diagnosis and treatment methods, patients may still be diagnosed late, and patients still have a poor prognosis due to the biology of gastric cancer. Even in properly treated patients, five-year survival rates are around 20-30%. With the development of surgical techniques and disease management, clinical outcomes of the disease have improved and mortality has been reduced. In the studies, the definition of gastric surgeon was created and it was determined that the mortality decreased proportionally with the increase in the patient volume of the surgeon. In gastric cancer surgery, there are mostly studies on the number of surgeon patients and the number of hospital patients. Post-hoc analysis of hospital volume on patients included in the CRITICS study showed a 13.1% increase in survival in high-volume hospitals compared to low-volume hospitals. The number of annual resections ≥21 was determined as the definition of high-volume hospital. In addition, it was determined that there was a decrease in mortality as the number of annual cases increased in high-volume hospitals. In another study, it was seen that there was an improvement in the mortality of medium and high volume hospitals compared to low volume hospitals. The majority of studies in gastric cancer surgery have focused on hospital volume and surgeon volume. There are no data on the specialization of the surgeon other than a study based in Japan. In this study, it was aimed to evaluate the effect of specialization in gastric cancer surgery on short- and long-term clinical outcomes. #Intervention - OTHER : Specialization - * Who had undergone professional training in gastric cancer surgery in specialized gastric cancer centers (in Japan or Korea), * Who identified themselves as primarily gastric surgeons during the study period * Whose annual gastric cancer surgery volume is more than 21 - Other Names : - Gastric cancer surgery

#Eligibility Criteria: Inclusion Criteria: * cStage I/II/III gastric cancer * Histologically proven gastric adenocarcinoma * Underwent surgery with curative intent Exclusion Criteria: * Under 18 years * Patients with non-adenocarcinoma diagnosis * Emergency surgeries * The need for a thoracic approach * Patients with a history of non-gastric cancer Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05280665

{ "NCT_ID" : "NCT05834985", "Brief_Title" : "Endoscopic Management Of Controlled Colo-cutaneous Fistula As A Complication of Acute Sigmoid Diverticulitis: A Randomized Controlled Trial", "Official_title" : "Endoscopic Management Of Controlled Colo-cutaneous Fistula As A Complication of Acute Sigmoid Diverticulitis: A Randomized Controlled Trial", "Conditions" : ["Fistula; Sigmoid"], "Interventions" : ["Procedure: endoscopic management of fistula due to sigmoid diverticulitis by clip or endostitches"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-12-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-01", "Study_Completion_Date(Actual)" : "2023-04-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-04-17", "First_Posted(Estimated)" : 2023-04-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-04-27", "Last_Update_Posted(Estimated)" : 2023-04-28", "Last_Verified" : 2023-04" } }}

#Study Description Brief Summary Diverticular disease is a common condition in western countries with relatively uncommon complications\[1\]. Fistulae complicating diverticulitis are the result of a localized perforation into adjacent viscera, and occur in 4-23% of patients hospitalized for diverticular disease\[2\]. The types of fistulae include colovesical, colovaginal, colotubal, coloenteric, and colocutaneous fistulae\[3\]. Colocutaneous fistulae occur very rarely, accounting for 1-4% of the total number of fistulae complicating colonic diverticular disease\[4\]. Herein we describe a case of a fistula connecting the sigmoid colon with the left flank-lower lumbar area, due to diverticulitis of the sigmoid colon\[5\]. A new over-the-scope clip system, called OTSC (Ovesco Endoscopy, Tübingen, Germany), appeared on the market about 3 years ago\[6\]. The system consists of a nitinol clip loaded at the tip of the endoscope that can capture a large amount of tissue and compress the lesion until healed\[7\]. Results from animal models and initial clinical use support the efficacy of OTSC closure in the treatment of gastrointestinal bleeding; its role in the management of iatrogenic perforations in humans is less defined, and reports on its use in treating colorectal postsurgical leaks and fistulas are anecdotal \[8\]. Here we report on the use of OTSC in the endoscopic treatment of colo-cutaneous fistula as acomplication of acute diverticultis . Detailed Description Diverticular disease is a common condition in western countries with relatively uncommon complications\[1\]. Fistulae complicating diverticulitis are the result of a localized perforation into adjacent viscera, and occur in 4-23% of patients hospitalized for diverticular disease\[2\]. The types of fistulae include colovesical, colovaginal, colotubal, coloenteric, and colocutaneous fistulae\[3\]. Colocutaneous fistulae occur very rarely, accounting for 1-4% of the total number of fistulae complicating colonic diverticular disease\[4\]. Herein we describe a case of a fistula connecting the sigmoid colon with the left flank-lower lumbar area, due to diverticulitis of the sigmoid colon\[5\]. A new over-the-scope clip system, called OTSC (Ovesco Endoscopy, Tübingen, Germany), appeared on the market about 3 years ago\[6\]. The system consists of a nitinol clip loaded at the tip of the endoscope that can capture a large amount of tissue and compress the lesion until healed\[7\]. Results from animal models and initial clinical use support the efficacy of OTSC closure in the treatment of gastrointestinal bleeding; its role in the management of iatrogenic perforations in humans is less defined, and reports on its use in treating colorectal postsurgical leaks and fistulas are anecdotal \[8\]. Here we report on the use of OTSC in the endoscopic treatment of colo-cutaneous fistula as acomplication of acute diverticultis . Rationale: As endoscopy is less invasive maneuver and can be done without general anathesia , so we will try to close the fistula due to acute diverticulitis with OVASCO clip , to avoid major surgery with also high incidence of recurrence again . there is only one clinical trial for this resons , so we will try to achieve result to concolude the use of endoscopy in management GIT fistulas. Research question: Is Endoscopic Management Of Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis Effective? Hypothesis: Yes The Endoscopic Management Of Low Output Recurrent Colonic Fistula After Anterior Resection For Rectal Cancer Is Effective . Aim of the work Management Of Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis \& reducing the morbidity \& mortality Endoscoplically. Objectives 1. To evaluate the advantages and safety of Endoscopic Management Of Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis. 2. To evaluate the effect of Endoscopic Management Of Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis in reducing morbidity and postoperative hospital stay. Subjects and Methods Technical design: A- Site of the study: The investigators included all patients who were presented to General Surgery Department with Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis at Zagazig University hospital between (December 2020 to August 2023). B- Sample size: The sample size was calculated by using open Epi program depending on the following data ; confidence interval 95% , power of the test 80% , ratio of unexposed/ exposed 1 , the success rate of surgical repair versus endoscopic repair was 89 % versus 71 % respectively. Odd ratio 3.3 , and risk ratio 1.3 , so the calculated sample size equal 66 patients divided into two equal groups. c- Sample selection: Included patients were randomized at a 1:1 ratio to 'Endoscopic Group, EG' or 'Surgical Group , SG' via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample). D- Subjects: Patients will be divided into 2 groups in accordance type of preoperative Therapy : Group 1: 'Endoscopic Group, EG' included 33 patients. Group 2: 'Surgical Group , SG' included 33 patients. Inclusion criteria: Patients with Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis , recurrent fistula , failued conservative meaures .patient with good general condition (ASA I\&II). Exclusion criteria: We excluded patients who bad general condition (ASAIII\&IV\&V), patients with high output fistula , respond to conservative measures. E- Data collection (tools): All patients will subjected to the followings: patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed radio-logically by abdominal x- ray , abdominal ultrasound, pelvic and abdominal CT. Study design (operational study): A. Type of the study : A randomized Controlled Trial. B. Steps of performance: 1. Complete history taking. 2. Clinical and laboratory results. 3. Radiological results. 4. Endoscopic management of Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis. 5. Analysis of the results. 6. Preparing conclusion and recommendation. C-Study techniques (procedure): For patients in EG, we began with assessment of the site \& size of fistula . In this study, OTSC was used in 9 patients .We started deploying the clips perpendicular to the long axis of the defect. If needed, more than one clip was sequentially deployed, starting at edge of the defect towards the center. Standard clips were passed through-the-scope to achieve superficial tissue apposition engaging the mucosa and submucosa (with 1.2-mm-wide and 6-mm-long arms capable of an approximately 12-mm grasp) and were used in conjunction with thermal ablation or mechanical scraping of the tissue around the edges of the defect to achieve a more resilient seal. Concurrently, the interventional radiology team subcutaneously drained the intraperitoneal free fluid using 2 intra-peritoneal tubes that were placed under US guidance in the sub-hepatic region and in the pelvis. D-Outcomes: Primary and secondary outcomes were incidence of postoperative hospital stay and complications in each group during the 3-months follow-up period, respectively. #Intervention - PROCEDURE : endoscopic management of fistula due to sigmoid diverticulitis by clip or endostitches - endoscopic management of fistula due to sigmoid diverticulitis by clip or endostitches

#Eligibility Criteria: Inclusion Criteria: * Patients with Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis , recurrent fistula. * failued conservative meaures . * patient with good general condition (ASA I&II). Exclusion Criteria: * We excluded patients who bad general condition (ASAIII&IV&V), * patients with high output fistula , * respond to conservative measures. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT05834985

{ "NCT_ID" : "NCT02405104", "Brief_Title" : "Chlorzoxazone in Hip and Knee Arthroplasty", "Official_title" : "Analgetic Effects of Chlorzoxazone in Total Hip and Knee Arthroplasty", "Conditions" : ["Osteoarthritis of Hip", "Osteoarthritis, Knee"], "Interventions" : ["Drug: chlorzoxazone", "Drug: Placebo", "Procedure: TKA", "Procedure: THA"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-09-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-12-31", "Study_Completion_Date(Actual)" : "2019-07-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-03-27", "First_Posted(Estimated)" : 2015-04-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-03-31", "Last_Update_Posted(Estimated)" : 2019-09-09", "Last_Verified" : 2019-09" } }}

#Study Description Brief Summary The purpose of this study is to elucidate whether patients operated with THA and TKA can benefit from treatment with chlorzoxazone. Detailed Description Introduction and rationale Background Modern treatment of pain following surgery based on multimodal analgesic strategy where the pain system different points of attack struck with different types analgesics. This also tries to reduce the consumption of opioids associated with frequent side effects like nausea, vomiting, constipation, difficulty urinating, weather stretch problems and Lethargy. But in spite of intense research over the last decades, is pain after arthroplastic surgery in hip (total hip arthroplasty (THA)) or knee (total knee replacement (TKA)) continue a significant clinical problem. It is a current clinical assumption that patients with pain in the hip or knee region immediately after TKA or THA have tense muscles, which reinforces pain behavior. The mechanism for such muscle tension is not fully understood. For many years the investigators have been on Danish orthopedic departments dealt with these patients with postoperative pain after major joint prosthesis operations with the muscle relaxant chlorzoxazone. On some sections included in the standard chlorzoxazone prescriptions for pain after hip and knee replacement. chlorzoxazone has for many years been marketed for the treatment of pain in skeletal muscle by inhibition of mono- and polysynaptic reflexes in the CNS. The muscle relaxing effect is mediated by inhibitory effects on spinal polysynaptic reflexes. In placebo-designed clinical studies of chlorzoxazone's beneficial effect on heterogeneous groups of patients with spasticity, motor neuron syndromes, as well as muscle pain and spasm of peripheral musculoskeletal diseases have not been able to demonstrate no significant analgesic effect; chlorzoxazone have also failed to show pain-relieving effect in the treatment of back pain It is remarkable that in spite of the widespread use of chlorzoxazone not can be found only one study of chlorzoxazone used as adjuvant pain relieving treatment after hip or knee surgery (or other orthopaedic treatment). The current clinical practice is therefore made on purely empirical basis. The effect must be considered as uncertain, but may in some cases be indicated, most often as an adjunct to other therapy, for example analgesics, anti-inflammatory agents, physiotherapy or even training. In such cases, regarded chlorzoxazone be an alternative to benzodiazepines. There is therefore a need for a prospective, randomized, double-blind, placebo-controlled study evaluating the potential analgesic effect of chlorzoxazone. In this intervention study is the selected dosage of chlorzoxazone set at based on the recommendation of the Danish Medicines Information A / S 7 (http://pro.medicin.dk/Medicine / Preparations / 638) and Takeda Pharma A / S. The latter produces chlorzoxazone. The recommendation is based on our current knowledge of chlorzoxazones pharmacodynamic and pharmacokinetic properties. chlorzoxazone given in this study as tablet chlorzoxazone, 250 mg, 3 times daily for the first seven postoperative days. Adverse reactions to chlorzoxazone are well known. They are relatively few, mostly mild and transient. The most frequent adverse events related to chlorzoxazone, fatigue and dizziness (about 1-10% of patients) Adverse reactions are to some extent overlapping with the side effects that are related to the perioperative opioid treatment. It is therefore possible that the frequency of adverse events overall is reduced if chlorzoxazone found to be analgesic (and opioid-sparing). Patients will be hospitalized for a minimum of two nights after surgery and thus be close observation in the period in which the risk of side effects is greatest. At the same time, all patients undergo standardized adverse event registration. If, contrary to expectations unexpected or unacceptable side effects medication will promptly be interrupted. The study involves a group of patients (THA and TKA), which is an important clinical pain problem. All of these patients receive a well-implemented and evidence-based treatment. Thus, anesthesia, analgesia and surgical procedure standardized for all patients receiving concomitant consequences usual principles of early mobilization 8; 9th The planned randomized, double-blind, placebo-controlled design in which all patients receive the same and standardized interventions, enabling the best possible evaluation of modality under study intervention with chlorzoxazone vs. placebo). The level of pain after surgery as the primary endpoint, recorded by means of a well-tested and validated tool (visual analog scale (VAS)) 48 hours after operation. The current study could contribute to a clarification of the postoperative analgesic effect of chlorzoxazone immediately after THA and TKA. As secondary endpoints, the patients functional level be determined Oxford Hip / Knee Score 7 days after surgery. Furthermore, a number of tertiary parameters related to pain, function and side effect profile be determined as shown in Table 1. Evidence in this area will be of immediate benefit to patients operated with THA and TKA - and maybe for other surgical patients. #Intervention - DRUG : chlorzoxazone - ATC-code: M03BB03 - Other Names : - ATC-code M03BB03 - DRUG : Placebo - Placebo - PROCEDURE : THA - Surgical treatment of osteoarthrosis in the hip, by replacement. - Other Names : - Total Hip Arthroplasty - PROCEDURE : TKA - Surgical treatment of osteoarthrosis in the knee, by replacement. - Other Names : - Total Knee Arthroplasty

#Eligibility Criteria: Inclusion Criteria: * Planned primary unilateral THA or TKA * Patients (male/female) >= 18 år * Patients giving written informed consent and authority. * Patients receiving spinal anaesthesia Exclusion Criteria: * Patients with intolerance to trial medications * Rejection of or contraindicated spinal anaesthesia * Patients with rheumatoid arthritis. * Patients with Body Mass Index (BMI) >= 35 * Patients that do not read or write Danish Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02405104

{ "NCT_ID" : "NCT01151306", "Brief_Title" : "The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)", "Official_title" : "The Cardiovascular and Inflammatory Effects of Statin Therapy in Patients With COPD", "Conditions" : ["Chronic Obstructive Pulmonary Disease"], "Interventions" : ["Drug: Lactose tablet", "Drug: Simvastatin"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-04", "Study_Completion_Date(Actual)" : "2013-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-06-21", "First_Posted(Estimated)" : 2010-06-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-06-25", "Last_Update_Posted(Estimated)" : 2014-03-24", "Last_Verified" : 2014-03" } }}

#Study Description Brief Summary Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and these patients are at increased risk of heart disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the blood but may also reduce inflammation and lower the risk of heart disease. This study will explore whether simvastatin reduces one of the risk factors in patients with COPD in a short term proof of principle study. The key purpose is to determine whether simvastatin improves the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or blood inflammation and change in breathing ability #Intervention - DRUG : Simvastatin - Simvastatin 20mg once daily (in the evening) for 6 weeks - DRUG : Lactose tablet - One tablet taken each evening for 6 weeks

#Eligibility Criteria: Inclusion Criteria: * Male or female patients aged 45 <= age <= 80 years; * Confirmed COPD: FEV1 30 <= age <= 80% predicted, FEV1/FVC<0.7, salbutamol reversibility <12%, supportive smoking history * If female of childbearing potential, have a negative serum pregnancy test at screening and use a medically acceptable form of contraception starting at screening and continuing throughout the study (defined as an oral contraceptive, or barrier method combined with a spermicide) * Able to attend for regular clinic appointments * In opinion of investigator, the patient will be able to comply with the requirements of the protocol * Provide written informed consent. Exclusion Criteria: * Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate * Clinically significant liver function abnormality; alcohol excess * Hypercholesterolaemia > or equal to 6.5mmol/L * Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. * Any condition judged by investigator that would cause the study to be detrimental to patient. * Conditions: rheumatoid disease/other collagen vascular disease requiring therapy; diabetes mellitus; untreated hypothyroidism; inflammatory bowel disease; other respiratory disease; known alpha 1 antitrypsin deficiency; malignancy; documented history of ischaemic heart disease (IHD); cor pulmonale or known congestive heart failure; patients planning to undergo elective surgery during the study period. * Exacerbation in the last 4 weeks. * Significant hypoxia (PaO2 <7.3kPa) * Known lactose intolerance. * Therapies: oral prednisolone for more than 1 week in the last 6 months; disease modifying drugs (Gold/ sulphasalazine etc); weight losing drugs; concomitant use of warfarin, cyclosporine; concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone). Use of any investigational drug within four weeks of the baseline visit. Sex : ALL Ages : - Minimum Age : 45 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01151306

{ "NCT_ID" : "NCT04922775", "Brief_Title" : "The Application of Traditional Chinese Medicine Functional Reduction in Muscle Fatigue", "Official_title" : "The Application of Traditional Chinese Medicine Functional Reduction in Muscle Fatigue", "Conditions" : ["Muscle Fatigue"], "Interventions" : ["Procedure: Chinese medicine technique taping", "Procedure: conventional taping"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-08-18", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-26", "Study_Completion_Date(Actual)" : "2020-12-26}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-06-01", "First_Posted(Estimated)" : 2021-06-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-06-04", "Last_Update_Posted(Estimated)" : 2021-06-11", "Last_Verified" : 2021-06" } }}

#Study Description Brief Summary In this study, 45 healthy participants between 20 and 40 of age will be included. After obtaining the consent, the participants will be categorized into two(A\&B) groups randomly for cross-over study. Each of group will accept either conventional taping or Chinese medicine technique taping before muscle fatigue exercise. To compare the preventive effect, Myoton PRO, pulse analysis equipment, etc will be applied for evaluation. The application of Chinese medicine technique (ie. Chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement. Detailed Description Nowadays, the importance of exercise is highly valued. The prevalence of sports injury is also increasing and may be associated with muscle fatigue. Therefore, the study focused on the prevention of common muscle fatigue in legs during exercise. With the modern sport medicine knowledge and kinesio taping, the investigators tried to figure out whether muscle fatigue can be diminished through the concept of Chinese medicine channel sinews techniques in advance. In this study, 45 healthy participants between 20 and 40 of age will be included. The exclusion criteria are as follows: i.pregnancy ii.current health problem iii.injuries of legs within a month. After obtaining the consent, the participants will be categorized into two(A\&B) groups randomly for cross-over study. Each of group will accept either conventional taping or Chinese medicine technique taping before muscle fatigue exercise. To compare the preventive effect, Myoton PRO, pulse analysis equipment, etc will be applied for evaluation. The application of Chinese medicine technique (ie. Chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement. Our goal is to enhance the coordination of the entire body structure, not merely the partial body structure improvement. In this way, it will benefit the prevention of exercise injuries and therapeutic effect. #Intervention - PROCEDURE : conventional taping - Participants will accept conventional taping before muscle fatigue exercise. - PROCEDURE : Chinese medicine technique taping - Participants will accept Chinese medicine technique taping before muscle fatigue exercise.

#Eligibility Criteria: Inclusion Criteria: * participants between 20 and 40 of age Exclusion Criteria: * i.pregnancy ii.current health problem iii.injuries of legs within a month Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04922775

{ "NCT_ID" : "NCT01295892", "Brief_Title" : "Chronic Effects of Estrogen in Microcirculation", "Official_title" : "Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women", "Conditions" : ["Postmenopausal Symptoms"], "Interventions" : ["Drug: Estrogen"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-03", "Study_Completion_Date(Actual)" : "2013-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-02-14", "First_Posted(Estimated)" : 2011-02-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-02-14", "Last_Update_Posted(Estimated)" : 2013-04-18", "Last_Verified" : 2013-04" } }}

#Study Description Brief Summary This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention. Detailed Description Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation. The study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects. #Intervention - DRUG : Estrogen - transdermal 17-β-estradiol 1mg/day during three months

#Eligibility Criteria: Inclusion Criteria: * History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH > 35 IU/L * BMI between 27 to 34.9 kg/m² * Non-smokers * Not on use of any hormones or supplements for a minimum of 6 months prior to the study * No absolute contraindications to the use of physiological replacement doses of estrogen Exclusion Criteria: * Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases * Diabetes mellitus, glucose intolerance or altered fasting glucose Sex : FEMALE Ages : - Minimum Age : 48 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT01295892

{ "NCT_ID" : "NCT06198283", "Brief_Title" : "Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children", "Official_title" : "Effects of Pressure Garments With and Without Low Level Laser Therapy on Hypertrophic Hand Scar in Children With Burn", "Conditions" : ["Burns Laser"], "Interventions" : ["Other: Low Level LASER Therapy without Pressure Garment", "Other: Low Level LASER Therapy with Pressure Garment"], "Location_Countries" : ["Pakistan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-11-28", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-12-31", "Study_Completion_Date(Actual)" : "2024-01-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-12-26", "First_Posted(Estimated)" : 2024-01-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-12-26", "Last_Update_Posted(Estimated)" : 2024-01-30", "Last_Verified" : 2024-01" } }}

#Study Description Brief Summary Burns are type of injury that affect the skin or other tissues and are typically caused by acute trauma, including thermal sources, electricity, chemicals, friction, or radiation. Thermal burns are frequently caused by exposure to high temperature solids or liquids, as well as flames. The epidermis is the only layer of skin affected by superficial burns (sometimes known as 'first degree' burns). Blistering is a common symptom of partial thickness (second degree) burns, which damage both the epidermis and dermis. Detailed Description This study will include patients with age 2-10 \& having burns on hands and develop scars will be recruited through Randomized Controlled trial in which convenience sampling technique will be used. Two groups will be formed in which participants will be divided by lottery method. Group A which will be treated by low level laser therapy with pressure garment (8-10hrs a day) and group B which will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session). Vancouver Scar Scale and PSOAS tool will be used. The result after statistical analysis will either show both treatments equally effective or not. Data will be calculated before and after treatment with the help of outcome measure tools. Results will be analyzed on SPSS. #Intervention - OTHER : Low Level LASER Therapy with Pressure Garment - This group will be treated by low level laser therapy with pressure garment (8-10hrs a day) by Laplace' s Law method because it is more accurate since the range of pressures that can be delivered to a particular range of body circumferences varies depending on the fabric used and its particular tension- extension profile, the method is difficult to utilize manually and till present there is no available design tool to aid in its application. Pressure garments generate an increase in subdermal pressures in the range 9- 90 mmHg depending on the anatomical site. Garments over soft tissues generate pressures ranging from 9 to 33 mmHg. Over bony prominences the pressures range from 47 to 90 mmHg. 25mmHg pressure will be provided by garments and garments will be replaced in every 2 months - OTHER : Low Level LASER Therapy without Pressure Garment - This group will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session).

#Eligibility Criteria: Inclusion Criteria: * Age 2 <= age <= 10 years * Patient with 2nd degree of burns on hands and develop scar * Patients after 3 months of burn on hand * Only patients that were diagnosed with hypertrophic scars secondary to burn injuries were included * Patients those with second degree burns or more or those with HS from burns * Scar type (hypertrophic, flat or atrophic) and scar dyschromia (i.e. erythema) are the main factors that drive laser device selection Exclusion Criteria: * Participants who have certain medical problems that may impair scar healing or response to therapy interventions (such as uncontrolled diabetes, autoimmune disorders, or immunocompromised states). * Those who have suffered burns recently (within the past few weeks) or who have had their scars for a long time (five years or more) * Wounds that have open area and risk of bleeding occurs. * Any spinal cord injuries. * Patients with any other skin disease like skin cancer, inflammation,Allergic conditions etc * Patients with under treatment like radiations etc Sex : ALL Ages : - Minimum Age : 2 Years - Maximum Age : 10 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT06198283

{ "NCT_ID" : "NCT02773043", "Brief_Title" : "Evaluation of Myocardial Perfusion Reserve", "Conditions" : ["Coronary Artery Disease"], "Interventions" : ["Device: CZT SPECT camera"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07", "Study_Completion_Date(Actual)" : "2019-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-04-25", "First_Posted(Estimated)" : 2016-05-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-05-11", "Last_Update_Posted(Estimated)" : 2020-01-02", "Last_Verified" : 2017-10" } }}

#Study Description Brief Summary The proposed study is to validate a non-invasive imaging technique to evaluate the myocardial perfusion reserve in comparison with a validated invasive technique, the measure of coronary flow reserve (CRF) with thermodilution. Detailed Description Coronary artery disease is a public health problem. The measurement of myocardial perfusion reserve is a prognostic factor supplemental. Its measure should influence the treatment and the follow up of the patients. The measurement of CRF by by one pressure-temperature sensor-tipped guide wire is a validated technique to evaluate the myocardial perfusion reserve but it is an invasive technique. In this study, the investigators will compare this method with a non-invasive method: completely automated analysis and quantification of myocardial blood flow from DICOM files corresponding to stress and rest images was developed with a new camera CZT SPECT. #Intervention - DEVICE : CZT SPECT camera

#Eligibility Criteria: Inclusion Criteria: * Myocardial scintigraphy with pharmacologic stress and abnormal results * Coronarography indicated * Informed consent Exclusion Criteria: * Pregnant woman * Patient with terminal illness * Terminal renal failure * Allergy to iodine * Informed consent impossible * Patient under legal protection * History of coronary artery bypass surgery * Contraindications for adenosine: asthmatic patients, second or third-degree AV block without pacemaker or sick sinus syndrome. Systolic blood pressure less than 90 mmHg. Recent use of dipyramidole or dipyramidole-containing medications. Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test. Known hypersensitivity to adenosine. Unstable acute myocardial infarction or acute coronary syndrome. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02773043

{ "NCT_ID" : "NCT03316521", "Brief_Title" : "First-In-Human Clinical Study of the C3 Complement Inhibitor AMY- 101 in Healthy Male Volunteers", "Official_title" : "Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) and a Multiple Dose (MD) of the Complement Inhibitor AMY-101. A Prospective, Single-center, Open-label, First-In-Human (FIH) Clinical Study in Healthy Male Volunteers", "Conditions" : ["Complement Mediated Diseases"], "Interventions" : ["Drug: AMY-101"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "SEQUENTIAL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-04-24", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-11-30", "Study_Completion_Date(Actual)" : "2017-11-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-08-11", "First_Posted(Estimated)" : 2017-10-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-10-17", "Last_Update_Posted(Estimated)" : 2018-01-16", "Last_Verified" : 2018-01" } }}

#Study Description Brief Summary Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a Single Ascending Dose (SAD) and a Multiple Dose (MD) of the complement inhibitor AMY-101. A prospective, single-center, open-label, First-In-Human (FIH) clinical study in healthy male volunteers. Detailed Description AMYNDAS is developing a novel peptidic complement inhibitor AMY-101, based on the third-generation compstatin analogue Cp40. AMY-101 is a selective inhibitor of complement activation in humans and in NHP. It binds to the complement component C3, the central 'functional hub' that controls the upstream activation/amplification and downstream effector functions of complement. By binding to C3, AMY-101 inhibits the cleavage of native C3 to its active fragments C3a and C3b. As a consequence, the deposition of C3b, amplification via the alternative pathway and all downstream complement responses are prevented. AMY-101 is being developed to treat complement-mediated diseases, which are largely driven by aberrant C3 activation. This first-in-human study of the C3-targeting complement inhibitor AMY-101 investigates the safety and PK/PD profile of AMY-101 in healthy male volunteers after Single Ascending Dose (SAD) and Multiple Doses (MD) using subcutaneous (SQ) or intravenous (IV) administration. The study is a prospective, single-center, open-label evaluation in healthy male volunteers. #Intervention - DRUG : AMY-101 - AMY-101 is a selective inhibitor of complement activation, which binds to the complement component C3.

#Eligibility Criteria: Inclusion Criteria: * Willing and able to give written informed consent for participation in the study. * Healthy male subject aged 18 <= age <= 60 years, inclusive at the time of signing the informed consent. * Body Mass Index (BMI) >= 18 and <= 30 kg/m2 and weight at least 50 kg. * Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. * Willing to use condom and contraceptive methods with a failure rate of < 1% to prevent pregnancy and drug exposure of a partner and to refrain from donating sperm from the date of dosing until three (3) months after dosing of the IMP. * Willing and able to complete all procedures according to the Protocol. Exclusion Criteria: * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. * History of any Neisseria meningitidis infection * History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within the last 60 days prior to dosing. * History of latent or active tuberculosis, as assessed by the investigator based on chest X-ray and positive Quantiferon-TB Gold test. * History of complement deficiency. * History of any type of malignancy. However, completely resolved minor malignancies, at the discretion of the Investigator, may not be an exclusion criterion (for example: Non-Melanoma Skin Cancer). * Diagnosis of autoimmune, immunologic or rheumatologic disease (eg, systemic lupus erythematosus, rheumatoid arthritis). * Any clinically significant illness, medical/surgical procedure or trauma within four (4) weeks of the administration of IMP. * High CRP at screening (> 0.5 mg/dL). * Current evidence or history of bacterial, viral or fungal infection within 14 days prior to (first) dosing or longer according to the judgment of the investigator for e.g. viral infections including herpes simplex or herpes zoster. * Any current condition or risk, which, in the opinion of the Investigator, may interfere with the subject's participation in the study, poses an added risk for the subject, or confounds the assessment of the subject or outcome of the study * Any clinically significant abnormality in clinical chemistry, hematology, or urinalysis results at the time of screening, as judged by the Investigator. * Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and/or Human Immunodeficiency Virus (HIV). * After 10 minutes supine rest abnormal vital signs defined as any of the following: * Systolic BP > 140 mm Hg * Diastolic BP > 95 mm Hg * HR < 40 or > 90 beats per minute * Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormality in the resting ECG, as judged by the Investigator. * Any history of any allergy/hypersensitivity or anaphylactic reaction or on-going allergy/hypersensitivity. History of hypersensitivity to antibiotics or drugs with a similar chemical structure or class to AMY-101. * Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within two (2) weeks prior to the administration of IMP, except the occasional intake of paracetamol/acetominophen (maximum 2000 mg/day; and not exceeding 3000 mg/week) or nasal decongestant without cortisone or antihistamine, at the discretion of the Investigator. * Administration of another new chemical entity (defined as a compound that has not been approved for marketing) or having participated in any other clinical study that included drug treatment within 30 day or 5 half lives of the last administration of the other IMP. Subjects consented and screened but not dosed in previous phase I studies are not excluded. * Immunization with a live-attenuated vaccine one (1) month prior to the first administration of IMP. * Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three (3) times per week is allowed before screening visit. * History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator. * Positive screen for drugs of abuse at screening or on admission to the unit or positive screen for alcohol at screening or on admission to the unit prior to administration of the IMP. * Use of anabolic steroids. * Plasma donation within one (1) month of screening or any blood donation/blood loss > 450 mL during the three (3) months prior to screening. * Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03316521

{ "NCT_ID" : "NCT03451461", "Brief_Title" : "Asynchronies During Mechanical Ventilation", "Official_title" : "Asynchronies During Mechanical Ventilation: Factors Related", "Conditions" : ["Mechanical Ventilation Complication"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03", "Study_Completion_Date(Actual)" : "2019-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-02-01", "First_Posted(Estimated)" : 2018-03-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-02-23", "Last_Update_Posted(Estimated)" : 2020-06-18", "Last_Verified" : 2020-06" } }}

#Study Description Brief Summary Invasive mechanical ventilation (IMV) is a life support treatment for patients with acute respiratory failure. The IMV can generate adverse effects that may cause alterations in other organs besides the lung, creating an important problem during ICU stay, hospital stay and years after discharge. These consequences on morbidity and mortality have significant economic and social weight. In the United States the IMV represents 2.7 episodes per 1000 habitants, with an estimated cost of $27,000 million, representing 12% of all hospital expenses. The overall mortality in patients with IMV is 30-35%, increasing with age. Therefore, patients receiving IMV are a high-risk population and with higher costs. A poor interaction between patient and ventilator during IMV can develop asynchronies. The asynchronies may present in 25% of patients. The majority of studies in ICU patients are limited to a evaluation of short periods of time. Asynchronies identification needs the application of respiratory physiology knowledge and the interpretation of respiratory signals from the ventilator waves. This allows identifying in an easy way different situations of 'fight', but it also difficult the identification of situation where asynchronies are less obvious, doing that them remain underdiagnosed. Moreover, asynchronies can be only evaluated during a brief period of time, and it's difficult to know their incidence during all the IMV period and to make adjustments to improve them. In our centre, it has been developed a continuous monitoring system during IMV which integrates, in real-time, all the information derived from digital monitors and ventilators. It allows a continuous and automatic detection of different events (through an intelligent alarm system) and quantification of asynchronies. It was demonstrated that asynchronies are frequent, that it can be present from the beginning of IMV, that it increase in severe patients under deep sedation and it can increase ICU and hospital mortality. The investigators can study different factors that can influence over asynchronies development or can improve them. Detailed Description The aim of this study is to analyze the real incidence of asynchronies of patients undergoing mechanical ventilation and to analyze what factors may have an association with their appearance. This factors includes factors related with the pulmonary mechanics of each patient and other factors such as the treatment administered, especially drugs with sedative and analgesic effect will be taken into account. This can help to implement strategies for the improvement of asynchronies. #Intervention - OTHER : No intervention - Observational study. Clinical data recorded

#Eligibility Criteria: Inclusion Criteria: * Mechanical ventilation more than 48 hours. * Included during the first 24 hours of mechanical ventilation. Exclusion Criteria: * Less than 18 years * Pregnant patients * Do-not-resuscitate orders * Admitted for organ donation * Chest tubes with suspected bronchopleural fistula. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03451461

{ "NCT_ID" : "NCT01971034", "Brief_Title" : "Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.", "Official_title" : "A Prospective Study to Evaluate the Combination of Metformin With Paclitaxel in the Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.", "Conditions" : ["Pancreatic Adenocarcinoma Advanced or Metastatic"], "Interventions" : ["Drug: Paclitaxel", "Drug: Metformin"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-06", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-09-06", "First_Posted(Estimated)" : 2013-10-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-10-22", "Last_Update_Posted(Estimated)" : 2014-05-16", "Last_Verified" : 2014-05" } }}

#Study Description Brief Summary In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation. #Intervention - DRUG : Paclitaxel - 80 mg/m2, IV, Day 1, Day 8 and Day 15. - DRUG : Metformin - 850mg, PO, every 8 hours, daily.

#Eligibility Criteria: Inclusion Criteria: * Pancreatic advanced or metastatic adenocarcinoma histologically confirmed. * Previously treatment with gemcitabine as adjuvant or metastatic disease. * Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion. * Patient with intolerance to gemcitabine, even without disease progression, are also eligible. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * At least 10 weeks of life expectation. * Adequate organ function defined as: * Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)<= 2.5 × ULN (upper normal limit) * Total Bilirubin <= 2,0 x ULN * Absolute neutrophil count >= 1,500/ mm3 * Platelets >=100.000/ mm3 * Hemoglobin >= 8,0 g/dl * Serum Creatinine <= 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) >= 50 ml/min * Signed written informed consent. Exclusion Criteria: * Major surgical procedure within 4 weeks of the beginning of the treatment. * History of serious clinical or psychiatric disease. * Symptomatic hypoglycemia at the screening visit. * Target lesion radiotherapy within 4 weeks of the beginning of the treatment. * Treatment with any anti-cancer investigational drug. * Treatment with any IGF-I or IGFR-I * Treatment with metformin within 12 months prior to commencing study treatment * For female patients, current pregnancy and/or lactation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01971034

{ "NCT_ID" : "NCT01479439", "Brief_Title" : "Losartan to Reverse Sickle Nephropathy", "Official_title" : "A Phase II Trial of Losartan to Reverse Sickle Nephropathy", "Conditions" : ["Nephropathy", "Sickle Cell Anemia"], "Interventions" : ["Drug: Losartan"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-11", "Study_Completion_Date(Actual)" : "2015-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-11-16", "First_Submitted_that_Met_QC_Criteria" : 2020-09-28", "First_Posted(Estimated)" : 2011-11-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-11-22", "Last_Update_Posted(Estimated)" : 2020-09-29", "Last_Verified" : 2020-09" } }}

#Study Description Brief Summary Sickle cell disease causes kidney damage with increasing age, leading to chronic kidney disease and renal failure in nearly one third of patients with sickle cell disease. Currently, there is no treatment for sickle cell related kidney disease. Detailed Description The purpose of this research study is to see if losartan can help reduce or reverse damage done to the kidneys of children and adults with Sickle Cell Anemia (SCA) and Sickle Beta-zero (HbSβ0) Thalassemia. #Intervention - DRUG : Losartan - Form: suspension, tablet. Dosage \& frequency: age 6-16 = 0.7mg/kg once daily; age \>16 = 50mg once daily. Duration: 6 months

#Eligibility Criteria: Inclusion Criteria: * Age >=6 years; for no albuminuria (NoA) group age is >= 6 years and <21 years * Diagnosis of hemoglobin SS disease or Sβ0 thalassemia by hemoglobin electrophoresis and/or β-globin gene mapping. * Urine osmolality <700 mOsm (milliosmoles) on first morning urine * Written informed consent (and assent, where applicable) * Documented urine albumin to creatinine ratio (UACR) showing either * NoA: UACR <30mg/g creatinine on a first morning urine * MiA: UACR 30 <= age <= 300 mg/g creatinine on a first morning urine or * MaA: UACR >300 mg/g creatinine on a first morning urine sample * A documented negative serum pregnancy test for females with child bearing potential or greater than 10 years within (prior to) 7 days of starting the study medication. * Subjects with child-bearing potential must be willing to use a medically accepted form of contraception throughout the study. * Patients on hydroxyurea (HU) who are on a stable (not changing) dose of HU for three months prior to study entry. Exclusion Criteria: * Patients with Hb SC, SD, Sβ+thal, SE and other sickle hemoglobinopathies, and sickle trait (AS). * Pregnant or lactating females, or females of child-bearing potential that are unable to use a medically accepted form of contraception throughout the study. * Urine creatinine clearance (Clcr) <60 mL/minute/1.73 m2 * Gross (not microscopic) hematuria. If hematuria has resolved for 2 weeks or more, patients will be eligible. * Hyperkalemia (K>=5.5) at baseline despite a low potassium diet * Concurrent condition that predisposes to nephropathy, such as lupus, diabetes, and hypertension, not controlled with medications.. * On a renin-angiotensin pathway inhibitor (e.g., captopril, lisinopril, Losartan, valsartan, etc) for the last two weeks prior to enrollment. * Hypersensitivity to Angiotensin II receptor blockers such as losartan, valsartan, telmisartan. * Patients on red cell apheresis or ongoing aggressive chronic transfusions (one or more a month with a goal of HbS < 30%). Patients receiving a simple transfusion for symptoms during acute event will be eligible, but if they receive a partial or full exchange transfusion during an acute event, then they will only be eligible after 90 days. * Hepatic dysfunction defined as ALT (alanine aminotransferase) or direct bilirubin > 3-times upper limit of normal (ULN). * Chronic therapy with NSAIDS or Cox2 inhibitors * On another interventional trial. May be eligible two weeks after completion of another interventional study. * Any condition that interferes with the ability of the patient to understand or comply with the treatment plan and follow up. * A serious mental or physical illness or a major disease (cardiac, renal, hepatic, neurological, endocrine, metabolic, pulmonary function or psychiatric), which in the opinion of the investigator would compromise participation in the study. * Unable to take oral medications. * HIV confirmed positive. * Chronic therapy with steroids. May be eligible after three weeks of completing steroid therapy. * Patients on lithium will be excluded Sex : ALL Ages : - Minimum Age : 6 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01479439

{ "NCT_ID" : "NCT01076257", "Brief_Title" : "Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage", "Official_title" : "Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study", "Conditions" : ["Brain Damage", "Cerebral Palsy", "Traumatic Brain Damage"], "Interventions" : ["Behavioral: Modified Constraint-induced Movement Therapy"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-07", "Study_Completion_Date(Actual)" : "2010-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-01-04", "First_Posted(Estimated)" : 2010-02-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-02-24", "Last_Update_Posted(Estimated)" : 2012-07-31", "Last_Verified" : 2010-05" } }}

#Study Description Brief Summary This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between 'Modified Constraint-Induced Movement Therapy' (mCIMT) group and control group at different age. Detailed Description "Modified Constraint-Induced Movement Therapy' is one of the most recent treatments for children with Brain damage. This well-designed and follow-up RCT study compared home-based CIT with a control intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical evaluation, which is possible to examine whether functional improvement is accompanied by a change in motor control. We hypothesized that home-based CIT would induce better motor control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV)) for greater functional gains than TR. Furthermore, the beneficial effects would be maintained at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the underlying motor control changes for functional improvement after home-based CIT. #Intervention - BEHAVIORAL : Modified Constraint-induced Movement Therapy - Home based CIT 1. Restriction of the less affected limb 2. Intensive practice using affected limb 3. Positive experience 4. Functional task (task) - Other Names : - Constraint-Induced Therapy, Forced-use Therapy, Immobilization Therapy

#Eligibility Criteria: Inclusion Criteria: * Development learned-nonuse * Age range 4y/o-15y/o * Wrist ext 10˚, MP j't ext 10˚ in affected U/E * Can fallow up the simple instruction * Modified Ashworth Scale ≦2 * Pediatric Motor Activity Log ≦2.5 (average) Exclusion Criteria: * Related muscle skeleton surgery * Selective dorsal rhizotomy * Botulinum toxin in 6 months * Visual perception impaired * Hearing perception impaired * Balance ability impaired (in constrained) Sex : ALL Ages : - Minimum Age : 4 Years - Maximum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT01076257

{ "NCT_ID" : "NCT02241577", "Brief_Title" : "Surgical and Non-surgical Treatment of Peri-implantitis", "Official_title" : "Surgical and Non-surgical Treatment of Peri-implantitis: Multi-center Randomised Controlled Trial of 12-months Follow-up", "Conditions" : ["Peri-implantitis"], "Interventions" : ["Procedure: Surgical treatment", "Procedure: Non-surgical treatment"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-08", "Study_Completion_Date(Actual)" : "2019-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-09-12", "First_Posted(Estimated)" : 2014-09-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-09-15", "Last_Update_Posted(Estimated)" : 2019-10-01", "Last_Verified" : 2019-09" } }}

#Study Description Brief Summary This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients presenting with these characteristics will be included at random to one of the treatment groups. Those allocated to the non-surgical group will received implant cleansing after local anesthesia using adequate instruments. In the surgical group, patients will be submitted to a surgical procedure around the implant for visualization and cleansing also after local anesthesia. All patients will be followed over a 12-month period. The hypothesis is that surgical treatment is better than non-surgical treatment regarding clinical, radiographic, microbiological, and immunological.characteristics. #Intervention - PROCEDURE : Surgical treatment - Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia - PROCEDURE : Non-surgical treatment - Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia

#Eligibility Criteria: Inclusion Criteria: * Individuals with at least one dental implant with peri-implantitits * Individuals with good general health conditions; * Individuals presenting at least 10 natural teeth; * Individuals with no signs of active periodontitis Exclusion Criteria: * Individuals who received periodontal treatment in the last three months * Pregnant * Systemic condition that interferes with treatment such as diabetes * Individuals who are taking or have taken antibiotics or anti-inflammatory medication Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT02241577

{ "NCT_ID" : "NCT04483596", "Brief_Title" : "Melatonin to Decrease the Incidence of Postoperative Delirium in Geriatric Patients", "Official_title" : "Efficacy of Prophylactic Melatonin to Decrease the Incidence of Postoperative Delirium in Geriatric Patients Undergoing Surgeries Under General Anesthesia. A Randomized Controlled Trial.", "Conditions" : ["Postoperative Delirium"], "Interventions" : ["Drug: melatonin effect on the Abbreviated Mental Test"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-07-30", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-01", "Study_Completion_Date(Actual)" : "2020-12-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-07-20", "First_Posted(Estimated)" : 2020-07-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-07-20", "Last_Update_Posted(Estimated)" : 2020-12-22", "Last_Verified" : 2020-12" } }}

#Study Description Brief Summary POD has been reported to be associated with a large number of risk factors: age as POD occurs in 10% to 61% of those aged 65 or older, dementia, impaired left ventricular function, electrolyte disorder, alcoholism, smoking, high perioperative transfusion requirements, intraoperative pressure fluctuation, and use of benzodiazepine POD occurs mostly in some types of surgery, such as orthopedic surgeries, major gastrointestinal surgery, and major cardiovascular surgeries, surgery under general anesthesia, prolonged surgery, emergency surgery Previous studies done before to prove the efficacy of melatonin to decrease the incidence of postoperative delirium in patients with multiple risk factors for POD as traumatic geriatric patients were concerned only with the type of surgery as hip replacement or with spinal anesthesia but no study was done before to assess the prophylactic effect of melatonin to decrease the incidence of postoperative delirium in geriatric patients under general anesthesia ,which represents an independent risk factor for POD. So,this double blinded RCT will try to fill this gap in literature. Detailed Description POD has been reported to be associated with a large number of risk factors: age as POD occurs in 10% to 61% of those aged 65 or older, dementia, impaired left ventricular function, electrolyte disorder, alcoholism, smoking, high perioperative transfusion requirements, intraoperative pressure fluctuation, and use of benzodiazepine POD occurs mostly in some types of surgery, such as orthopedic surgeries, major gastrointestinal surgery, and major cardiovascular surgeries, surgery under general anesthesia, prolonged surgery, emergency surgery Previous studies done before to prove the efficacy of melatonin to decrease the incidence of postoperative delirium in patients with multiple risk factors for POD as traumatic geriatric patients were concerned only with the type of surgery as hip replacement or with spinal anesthesia but no study was done before to assess the prophylactic effect of melatonin to decrease the incidence of postoperative delirium in geriatric patients under general anesthesia ,which represents an independent risk factor for POD. So,this double blinded RCT will try to fill this gap in literature. Aim of the study: To prove the efficacy of melatonin to decrease the incidence of postoperative delirium after surgeries under general anesthesia in geriatric patients. Methodology After approval of the Research Ethics Committee and written informed consent from all patients, A randomized, prospective, controlled, double blind study of the prophylactic effect of melatonin on postoperative delirium in geriatric patients undergoing surgeries under general anesthesia will be conducted on 100 patients allocated into 2 equal groups. The study will be conducted at Cairo University Hospitals, in all surgical units. Randomization: Patients who meet all the inclusion criteria will be randomized to either Group M (Melatonin group) or Group C (Control group) by using computer generated random numbers with closed sealed envelope. All patients will fast according to standard rules and will be assessed by an anesthesiologist at the night before the surgery. All patients will be screened at that time by Abbreviated Mental Test (AMT) ,where patients having scores \< 6 will be considered to have postoperative delirium.This test has been recommended for routine assessment of cognitive function in the elderly by the Royal College of Physicians and the British Geriatric Society. Questionnare (score) Each scores one point 1. Age 2. Time (to nearest hour) 3. Address for recall at end of test (Ask patient to repeat the address to ensure it has been heard correctly) 4. Year 5. Name of hospital 6. Recognition of two persons (e.g. doctor, nurse) 7. Date of birth 8. Year of any famous event e.g: the last Egyptian revolution 9. Name of the present monarch 10. Count backwards from 20 to 1 Group M (Melatonin group): will receive 5 mg melatonin orally at 9 p.m. the night before surgery and another 5 mg melatonin with 15 ml of plain water 30 min before operation and 5 mg melatonin at 9 p.m. in the day of operation and for the first three postoperative days. Group C (Control group): received a placebo in the form of one tablet of 500 mg paracetamol that packaged the same way as melatonin at the same times. The anesthesia residents who will administer the drug and assess Abbreviated Mental Test(AMT) score postoperatively will be blinded to the allocation regimen. On arrival to the preparation room, wide bore IV cannula will be inserted in the nondominant hand, sedation will be assessed by Ramsay sedation scale,with grades from 1 to 6 where:1-Patient awake, anxious, agitated, or restless ,2- Patient awake, cooperative, orientated, and tranquil ,3- Patient drowsy, with response to commands ,4- Patient asleep, brisk response to glabella tap or loud auditory stimulus ,5- Patient asleep, sluggish response to stimulus ,6- Patient has no response to firm nail-bed pressure or other noxious stimuli. patients with score \> 4 will be excluded from the study. All Patients will be monitored with five lead ECG, noninvasive blood pressure, oxygen saturation, capnography and baseline HR,SBP,DBP,MAP,oxygen saturation,ETCO2 , and urine output will be recorded then every 10 minutes until 30 minutes postextubation. Induction of anesthesia will be done with fentanyl (2 mic/kg), propofol (1-2 mg/kg), atracurium (0.5 mg/kg). Intubation will be done with oral cuffed endotracheal tube size 6.5-7 mm ID for females and 7.5-8 mm ID for males and then a urinary catheter will be inserted. Anesthesia will be maintained with isoflurane (0.75- 1.15%), incremental doses of atracurium every 20 minutes and 1 mic/kg fentanyl IV if HR and/or BP increased 20% or more from baseline in response to surgical stimulation. After surgery, patients will be transferred to PACU. Abbreviated Mental Test (AMT) scores will be reported after recovery from anesthesia (PACU AMT) and in the same day 6 hours after operation (Day-0) and in the following three postoperative days (Day-1, Day-2 and Day-3) at the same hour of assessment in day 0. Patients having scores \< 6 will be considered to have postoperative delirium, and will be assessed by a psychiatrist for further management. Postoperative pain will be managed by IV 1g paracetamol every 6 hours and 50 mg diclofenac sodium oral every 12 hours with rescue analgesia of IV nalbuphine with 0.25 mg/kg not exceeding 0.5 mg/kg every 6 hours when the numerical rating score (NRS) or advanced dementia scale (PAINAD)(if the patient developed delirium) \>4.NRS or PAINAD will be evaluated according to at times 0-30 minutes 2, 4,8, 12, 18 and 24 hours. The 'zero' point of time will be the moment the patient recovered from general anesthesia #Intervention - DRUG : melatonin effect on the Abbreviated Mental Test - Questionnare 1. Age 2. Time (to nearest hour) 3. Address for recall at end of test (Ask patient to repeat the address to ensure it has been heard correctly) 4. Year 5. Name of hospital 6. Recognition of two persons (e.g. doctor, nurse) 7. Date of birth 8. Year of any famous event e.g: the last Egyptian revolution 9. Name of the present monarch 10. Count backwards from 20 to 1

#Eligibility Criteria: Inclusion Criteria: * ASA physical status I-II Exclusion Criteria: * ASA physical status >= III. * Allergy to the study drugs or one of their ingredients * Patients with Abbreviated Mental Test (AMT) score of< 6 , * illiterate people, * preoperative sedation score >4, * History of alcohol abuse, * Sensory impairment (blindness, deafness), * Severe anemia (hematocrit<27%), * Intracranial events (stroke, bleeding, infection), * Fluid or electrolyte disturbances including dehydration, hyponatremia, hypernatremia, * Acute cardiac events: myocardial infarction, congestive heart failure exacerbation, arrhythmia, * Acute pulmonary events: asthma or chronic obstructive pulmonary disease exacerbation, pulmonary embolism, hypoxemia, hypercarbia -,Medications Anticonvulsants, Antidepressants, Antihistamines, Antiparkinsonian agents, Antipsychotics. And history of chronic sedative hypnotic use >3 times/week during a month prior to surgery Sex : ALL Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT04483596

{ "NCT_ID" : "NCT01336751", "Brief_Title" : "Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment", "Official_title" : "Lantus® (Insulin Glargine[rDNA Origin] Injection) vs Humalog® Mix 75/25 (75% Insulin Lispro Protamine Suspension and 25% Insulin Lispro Injection) as add-on Therapy in Type 2 Diabetes Patients Failing Sulfonylurea and Glucophage (Metformin) Combination Treatment: a Randomized, Open, Parallel Study", "Conditions" : ["Diabetes Mellitus, Type 2"], "Interventions" : ["Drug: 75% insulin lispro protamine suspension and 25 % insulin lispro injection", "Drug: Insulin glargine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2001-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2002-12", "Study_Completion_Date(Actual)" : "2002-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-04-14", "First_Posted(Estimated)" : 2011-04-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-04-15", "Last_Update_Posted(Estimated)" : 2011-04-18", "Last_Verified" : 2011-04" } }}

#Study Description Brief Summary Study Primary Objectives: To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. Study Secondary Objectives : To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro: * Incidence of hypoglycemia * Change in weight * Change in serum lipid profile * Percentage of subjects achieving A1C levels ≤7% Detailed Description The planned duration of enrollment is 6 months. The study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks. #Intervention - DRUG : Insulin glargine - solution for subcutaneous injection - Other Names : - Lantus - DRUG : 75% insulin lispro protamine suspension and 25 % insulin lispro injection - suspension for subcutaneous injection - Other Names : - Humalog

#Eligibility Criteria: Inclusion Criteria: * Patients must have given their signed informed consent. * Males or females between 18 and 79 years. * Diagnosis of type 2 diabetes mellitus for at least one year. * Patients must have had continuous oral hypoglycemic treatment for at least three months using dosing of: at least half maximally labeled dose of sulfonylurea + at least 1000 mg metformin daily. * HBA1C >= 8 % and <=11 %, inclusive, as measured at screening (visit 1). * Patients must have BMI of > 25 kg/m2 at baseline * Willingness to accept, and demonstrate ability to inject insulin glargine or 75% insulin lispro protamine suspension and 25% insulin lispro injection therapy. * Ability and willingness to perform SMBG profiles using a plasma glucose meter at least twice a day. * Patients must be able to understand and willing to adhere to and be compliant with the study protocol Exclusion Criteria: * Patients, who have had stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months. * Patients with congestive heart failure requiring pharmacological treatment. * Patients on non-selective beta blockers (including ocular). * Patients with impaired renal function, as shown by but not limited to serum creatinine >= 1.5 mg/dl (133μmol/L) for males, or >= 1.4 mg/dl (124 μmol/L) for females. * Patients with acute infections. * Patients with diagnosis of dementia. * Treatment with systemic steroids or large doses of inhaled steroids. * Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis. * Patients with planned radiological examinations requiring administration of contrasting agents. * Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range. * Patients with history of hypoglycemia unawareness. * Pregnant or lactating females. * Failure to use adequate contraception (women of current reproductive potential only). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01336751

{ "NCT_ID" : "NCT05963906", "Brief_Title" : "Food Survey, Curbside, Remote APPs SCFI", "Official_title" : "An Innovative, Accessible, and Flexible Approach for Household Food Waste Measurement - SCFI", "Conditions" : ["Nutrition Sciences", "Climate", "Recycling", "Waste Management"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-10-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-11-19", "Study_Completion_Date(Actual)" : "2024-11-19}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-07-14", "First_Posted(Estimated)" : 2023-07-27" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-07-19", "Last_Update_Posted(Estimated)" : 2024-12-10", "Last_Verified" : 2024-12" } }}

#Study Description Brief Summary The proposed research will create accurate and standardized household food waste measurement technologies that foster serial and longitudinal assessments as well as confident and convenient one-time measurement. The investigators propose the SCFI field study where participants simultaneously deploy 3 measurement approaches (1) retrospective surveys (2) curbside audits, and (3) the FoodImage smartphone app.

#Eligibility Criteria: Inclusion Criteria: * Male or Female, age 18 <= age <= 64 years * Willing and able to store household food waste for curbside pickup by a third-party waste pickup company * Internet or Wi-Fi availability to complete online surveys * Ownership of an IPhone 9s or later, operable Apple ID, password, and email address that they are willing and able to use to collect data during the study. Subject acknowledges data usage and associated charges are a result of study * Willing to complete all study procedures and adhere to study visit timelines Exclusion Criteria: * Not willing to adhere to study procedures and study visit timelines * Any condition or circumstance that in the judgement of the PI could interfere with study participation Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT05963906

{ "NCT_ID" : "NCT03089242", "Brief_Title" : "MicroRNAs in Acute Kidney Injury", "Official_title" : "MicroRNAs in Acute Kidney Injury (MIRAKI) - a Pilotstudy -", "Conditions" : ["Kidney Injury in Cardiac Surgery - Expression of microRNAs"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-09-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-06-30", "Study_Completion_Date(Actual)" : "2018-12-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-03-20", "First_Posted(Estimated)" : 2017-03-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-03-20", "Last_Update_Posted(Estimated)" : 2020-05-07", "Last_Verified" : 2020-05" } }}

#Study Description Brief Summary Profiling of microRNAs and long noncoding RNAs (lncRNAs) in patients undergoing cardiac surgery. Analysis: Prediction of acute kidney injury by plasma expression profile of microRNAs? Detailed Description In this pilot study we will include 150 patients undergoing cardiac surgery in a German university hospital. We will profile microRNA expression in plasma and urine before and at several timepoints after surgery. We will use a preselected panel of microRNAs and lncRNAs for analysis. Goal is to identify microRNAs/lncRNAs that are able to predict the occurence of AKI in these patients. #Intervention - OTHER : observation of microRNA expression - no intervention

#Eligibility Criteria: Inclusion Criteria: * cardiac surgery Exclusion Criteria: * preexisting chronic kidney injury * inclusion in another study * pregnancy * Kidney transplantation in history * GFR < 30 ml/min (glomerular filtration rate) * ECLS therapy (extracorporal life support) Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03089242

{ "NCT_ID" : "NCT03963908", "Brief_Title" : "Evidence-based Pain Intervention for Veterans: AtEase for Chronic Pain", "Official_title" : "Evidence-based Pain Intervention for Veterans: Leveraging Mobile & Social Media: A Randomized 262-subject Controlled Trial of AtEase, a Pain Self-management App in the Treatment of Chronic Pain in Veterans", "Conditions" : ["Chronic Pain"], "Interventions" : ["Behavioral: Chronic Pain Education", "Behavioral: AtEase"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-09-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-12", "Study_Completion_Date(Actual)" : "2021-04-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-05-23", "First_Posted(Estimated)" : 2019-05-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-05-23", "Last_Update_Posted(Estimated)" : 2022-03-02", "Last_Verified" : 2022-02" } }}

#Study Description Brief Summary This study is a randomized controlled trial to test the efficacy AtEase, a pain self-management app in a sample of Veterans with chronic musculoskeletal pain. The primary outcome is changes in PEG scores from baseline to final follow-up (12 months). Detailed Description The primary objectives of this project are to develop and examine the effectiveness of a mobile app (AtEase) that is designed to provide tailored behavior change guidance to promote pain self-management, healthy sleep habits, and effective stress management in a randomized clinical trial including 262 Veterans with chronic pain. Veterans will be recruited from VA Connecticut Healthcare, as well as from numerous diverse community recruitment channels (including employers, community groups that provide services for Veterans, Student Veterans of America, and social media). Eligible Veterans will be randomized to receive access to AtEase or the comparison intervention (a mobile-optimized adaptation of Chronic Pain Education for Veterans) for a total of 6 months. AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies. Chronic Pain Education for Veterans is a free VA-endorsed publicly available pain management online educational curriculum that provides cognitive-behavioral therapy-based pain self-management materials. Between the baseline assessment and the 6-month follow up assessment, participants will have unlimited access AtEase or the Chronic Pain Education for Veterans program. All participants will complete follow-up assessments at 6 months and 12-months post-baseline. The primary outcome will be a comparison of PEG scores at 12 months follow-up. Secondary outcomes will include pain,Global Impression of Change; readiness to self-manage pain, manage stress, and engage in healthy sleep habits; well-being; and Post Traumatic Stress Disorder Checklist scores. #Intervention - BEHAVIORAL : AtEase - AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies. - BEHAVIORAL : Chronic Pain Education - CBT-based Education on Pain Self-Management for Veterans

#Eligibility Criteria: Inclusion Criteria: * Male or female Veteran * Chronic musculoskeletal pain defined as (numeric rating scale of >4) (10 point scale) for > 3 months.43 * Internet connectivity via tablet or mobile phone. Exclusion Criteria: * Life-threatening condition or acute medical conditions that precludes participation * Psychiatric conditions that could impair participation * Suicidal ideation or intent * Inability to read or speak English * Unwilling or unable to provide informed consent Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03963908

{ "NCT_ID" : "NCT00286624", "Brief_Title" : "Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet Transplantation", "Official_title" : "A One-Year, Single-Center, Prospective, Open-Label Study of the Safety, Tolerability, and Preliminary Efficacy of Anti-Thymocyte Globulin, Cyclosporine, and RAD in Type 1 Diabetic Islet Transplant Recipients", "Conditions" : ["Type 1 Diabetes Mellitus", "Hypoglycemia"], "Interventions" : ["Drug: Everolimus", "Drug: anti-thymocyte globulin", "Drug: Cyclosporine", "Biological: Allogeneic Islets of Langerhans"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2003-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-08", "Study_Completion_Date(Actual)" : "2006-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2006-02-02", "First_Posted(Estimated)" : 2006-02-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2006-02-02", "Last_Update_Posted(Estimated)" : 2008-05-08", "Last_Verified" : 2008-05" } }}

#Study Description Brief Summary This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet transplants in type 1 diabetic patients with hypoglycemia unawareness. 6 subjects were transplanted under this protocol using anti-thymocyte globulin induction immunosuppression and everolimus with cyclosporine maintenance immunosuppression. Detailed Description This is a Phase I/II study designed to assess the safety and efficacy of sequential islet allotransplantation for the reestablishment of stable glycemic control in type 1 diabetic recipients. A total of 6 patients with type 1 diabetes have received up to three transplants of islets from different donor pancreases. Potential candidates for islet allotransplantation included patients age 18 and older with type 1 diabetes. Induction immunotherapy for the first transplant consisted of anti-thymocyte globulin; basiliximab was used for any subsequent transplants. Peritransplant anti-inflammatory treatment with etanercept was given for each islet transplant. Maintenance immunosuppression is with cyclosporine and RAD. It is felt that those patients in whom metabolic lability/instability, reduced awareness of hypoglycemia, poor glycemic control, and progressive secondary complications persist despite continued and intensive efforts made in close cooperation with their diabetes care team are particularly likely to have a favorable benefit/risk ratio. Adverse events, irrespective of their presumed relationship to the transplantation of allogeneic islets and/or protocol-regulated treatment products (concomitant therapy), are being monitored and recorded throughout the first year after the final islet transplant. The proportion of single and sequential donor islet allograft recipients with full (insulin independence and HbA1c \<7%) and partial (insulin dependence, basal or arginine-stimulated C-peptide levels of greater or equal to 0.5 ng/mL and HbA1c \<7%) islet graft function at one year after the final islet transplant will be assessed. The impact of islet transplantation on quality of life will also be assessed. The predictive value for posttransplant insulin independence of factors such as insulin resistance before and at intervals after pancreatectomy, cellular composition of the transplant, number of beta cells transplanted; and viability and insulin secretory response of isolated islets are being assessed. #Intervention - BIOLOGICAL : Allogeneic Islets of Langerhans - Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. First infusion to contain at least 5,000 islet equivalents/kg body weight. Subsequent infusions to contain at least 3,000 islet equivalents/kg body weight. - Other Names : - Islets - DRUG : Everolimus - Loading dose of 3 mg PO on day -2 relative to transplant, followed at least 12 hours later by dose of 1.5 mg PO BID. The daily dose will be adjusted according to the whole blood 12-hr trough to target 3-15 ng/ml for the first 3 months and 3-12 ng/ml thereafter. - Other Names : - RAD - DRUG : anti-thymocyte globulin - A total of 6 mg/kg IV over 12 hours on days -2, -1, 0, +1, and +2. The dose will be 0.5 mg/kg on day -2, 1.0 mg/kg on day -1, and 1.5 mg/kg on days 0, +1, and +2. - Other Names : - ATG, Thymogloblin - DRUG : Cyclosporine - Cyclosporine started on day +1 relative to the first islet transplant. Initial dose of 3 mg/kg/day administered in 2 divided doses; then adjusted to maintain target levels of 400 (350-500) ng/mL for the first three months following islet transplant and 300 (200-350) ng/mL thereafter. - Other Names : - Neoral

#Eligibility Criteria: Inclusion Criteria: * Primary islet allotransplant * Patients with type 1 diabetes mellitus under intensive insulin management * Age >= 18 years * Ability to give written informed consent Exclusion Criteria: * Age less than 18 years. * BMI >26 kg/m2. * Insulin requirement of > 50 IU per day. * Positive C-peptide response to intravenous arginine stimulation. * Untreated proliferative retinopathy. * Creatinine clearance < 60 ml/min/1.73 m2 for females and 70 ml/min/1.73 m2 for males. * Serum creatinine >1.3 mg/dl for females, >1.5 mg/dl for males. * Previous pancreas or islet transplant. * Presence of history of panel-reactive anti-HLA antibodies >10%. * Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures. * Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB). * Negative screen for Epstein-Barr Virus (EBV). * Invasive aspergillus infection within year prior to study entry. * History of malignancy. * Active alcohol or substance abuse * History of non-adherence to prescribed regimens. * Psychiatric disorder making the subject not a suitable candidate for transplantation. * Inability to provide informed consent. * Baseline Hgb < 11.7 g/dl in females, or < 13 g/dl in males; lymphopenia (<1,000/microL), or leukopenia (<3,000 total leukocytes/microL), or an absolute CD4+ count <500/microL., or platelets <150,000/microL * History of coagulopathy or medical condition requiring long-term anticoagulant therapy after transplantation or patient with INR >1.5. * Severe co-existing cardiac disease. * Baseline liver function tests outside of normal range or history of significant liver disease. * Active peptic ulcer disease. * Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications. * Presence of severe allergy requiring acute or chronic treatment, or hypersensitivity to drugs similar to RAD (e.g., macrolides). * Known hypersensitivity to rabbit proteins. * Hyperlipidemia (fasting LDL cholesterol > 130 mg/dl, treated or untreated; and/or fasting triglycerides > 200 mg/dl). * Addison's disease. * Under treatment requiring chronic use of systemic steroids. * Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00286624

{ "NCT_ID" : "NCT01588769", "Brief_Title" : "A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients", "Official_title" : "A Phase I Study to Investigate Tolerability and Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-cells (ALECSAT) Administered to Patients With Glioblastoma Multiforme (GBM)", "Conditions" : ["Glioblastoma Multiforme"], "Interventions" : ["Biological: ALECSAT cell based immunotherapy"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-11", "Study_Completion_Date(Actual)" : "2013-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-04-27", "First_Posted(Estimated)" : 2012-05-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-04-30", "Last_Update_Posted(Estimated)" : 2016-06-06", "Last_Verified" : 2016-06" } }}

#Study Description Brief Summary It is the primary objective of this study to show safety and tolerability for administration of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a secondary objective to establish if any indications of positive therapeutic or palliative effects may be observed. Detailed Description The primary objective for this study is to establish if any side effects or toxicity issues occur, that will prevent further clinical development of the autologous cell based immunotherapy ALECSAT in Glioblastoma (GBM) or to establish if there are side effects or toxicity issues, that will suggest that the further clinical development planned, has to change course significantly. It is a primary objective to show safety and tolerability for administration of ALECSAT, thus not meeting this endpoint, may stop further clinical development of ALECSAT. The secondary objective for this study is to establish if any indications of a positive therapeutic or palliative effect may be observed. As this is a secondary objective, no observed significant positive clinical effect, will not prevent further clinical development or in itself, trigger changes in the further clinical development planned. The overall endpoint of the study is to develop a new therapeutic approach that may slow down or stop disease progression in late stage GBM patients. ALECSAT is an autologous cell based immunotherapy based on the patient's own Natural Killer cells and CytoToxic T cells. The cells are isolated from the patient's own blood - activated and expanded in number before re administering i. v. #Intervention - BIOLOGICAL : ALECSAT cell based immunotherapy - I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.

#Eligibility Criteria: Inclusion Criteria: * Recurrence of GBM tumour documented by MRI and PET in patients having received all available standard treatment. * Be over the age of 18 and capable of understanding the information and giving informed consent. * Adequate performance status > 50% (see below*). * Performance is monitored according to the Karnofsky Performance Score (KPS) * 100% - normal, no complaints, no signs of disease * 90% - capable of normal activity, few symptoms or signs of disease * 80% - normal activity with some difficulty, some symptoms or signs * 70% - caring for self, not capable of normal activity or work * 60% - requiring some help, can take care of most personal requirements * 50% - requires help often, requires frequent medical care * 40% - disabled, requires special care and help * 30% - severely disabled, hospital admission indicated but no risk of death * 20% - very ill, urgently requiring admission, requires supportive measures or treatment * 10% - moribund, rapidly progressive fatal disease processes * 0% - death. Exclusion Criteria: * A low blood count (haemoglobin < 6.0 mmol/l). * Lymphocyte counts below 0.8 x 109/l. * Positive tests for anti-HIV-1/2; * Positive tests for HBsAg, * Positive tests for anti-HBc and Anti-HCV. * Syphilis i.e. being positive in a Treponema Pallidum test. * Uncontrolled serious bacterial, viral, fungal or parasitic infection. * Clinically significant autoimmune disorders or conditions of immune suppression. * Treatment with chemotherapy three weeks prior to inclusion in the clinical trial. * Pregnant women cannot be included in the trial. Fertile women can only be included with a negative pregnancy test and must use contraceptives during the study. * Blood transfusions within 48 hours prior to donation of blood for ALECSAT production. * Inclusion in other clinical trials 6 weeks prior to inclusion in the trial. * The patient's medical condition is evaluated to be so poor that there is a significant risk for the patient to be part of the trial and to evaluate any effects of the treatment. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01588769

{ "NCT_ID" : "NCT02722993", "Brief_Title" : "Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders", "Conditions" : ["Antibiotic-associated Diarrhea"], "Interventions" : ["Dietary Supplement: Placebo", "Dietary Supplement: Probiotics"], "Location_Countries" : ["Poland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-02-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-05-08", "Study_Completion_Date(Actual)" : "2017-05-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-03-16", "First_Posted(Estimated)" : 2016-03-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-03-23", "Last_Update_Posted(Estimated)" : 2018-09-26", "Last_Verified" : 2018-09" } }}

#Study Description Brief Summary To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children. #Intervention - DIETARY_SUPPLEMENT : Probiotics - DIETARY_SUPPLEMENT : Placebo

#Eligibility Criteria: Inclusion Criteria: * Children at the age of 1 <= age <= 11 years that have been prescribed antibiotic treatment. * Problems with loose stools during earlier antibiotic treatments. * Children whose parents or legal caregivers have signed the informed consent to participate in the study. Exclusion Criteria: * Chronic intestinal disease, immunodeficiency or immunosuppressive treatment. * Chronic or acute diarrheal disease. * Use of laxatives the week before inclusion in the study. * Antibiotic treatment for the last four weeks before inclusion in the study. * Intake of probiotic products for the last two weeks before inclusion in the study. * Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (potato starch ± bacterial culture that may contain traces of soy). * Patient requiring hospitalisation. Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 11 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT02722993

{ "NCT_ID" : "NCT03993795", "Brief_Title" : "CSD190103: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products", "Official_title" : "CSD190103: An Unblinded, Randomized, Multi-site, Two-way Crossover Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products A19010-W and B19010-F in Healthy Adult Snus Consumers.", "Conditions" : ["Tobacco Use"], "Interventions" : ["Other: A19010-W", "Other: B19010-F"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-07-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-09-20", "Study_Completion_Date(Actual)" : "2019-09-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-06-19", "First_Posted(Estimated)" : 2019-06-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-06-19", "Last_Update_Posted(Estimated)" : 2019-10-25", "Last_Verified" : 2019-10" } }}

#Study Description Brief Summary The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-W and B19010-F). Detailed Description This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine pharmacokinetic parameters after use of two smokeless tobacco products A19010-W and B19010-F in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days and randomized to one of two investigational product (IP) (A: A19010-W and B: B19010-F) use sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, and then subjects will use the other product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. #Intervention - OTHER : A19010-W - A snus product - OTHER : B19010-F - A snus product

#Eligibility Criteria: Inclusion Criteria: * Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires; * Generally healthy male or female, 21 <= age <= 60 of age, inclusive, at the time of signing the ICF; * Positive urine cotinine test at the Screening Visit and Day 1; * Childbearing females must be willing to use a form of contraception acceptable to the Principal Investigator (PI) from the time of signing the ICF until study discharge; acceptable methods include: a. Female subjects who are heterosexually active and of childbearing potential (e.g., neither surgically sterile postmenopausal) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study: * Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to Check-in * Double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to Check-in * Intrauterine device for at least 4 months prior to Check-in * Exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to Check-in * Female subjects of childbearing potential who are not currently engaging * In heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study. * Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check in: * Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization procedures); * Bilateral tubal ligation or bilateral salpingectomy * Hysterectomy * Bilateral oophorectomy * Subjects' primary tobacco product must be a non-mint flavor of snus. Poly use of other (non-snus) forms of tobacco- and/or nicotine-containing products will be allowed if frequency of use of other products is less than or equal to four days per week (e.g., vaping) OR less than or equal to 15 cigarettes per week. * Self-reports currently using at least one container of their usual brand (UB) snus per week for at least 3 months prior to randomization; * Agrees to exclusively use the IP and not use any other tobacco- or nicotine-containing product during the study; * Willing to comply with the requirements of the study; * Able to safely perform the required study procedures, as determined by the PI. Exclusion Criteria: * Presence of clinically significant uncontrolled cardiovascular, chronic pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study; * History, presence of, or clinical laboratory test results indicating diabetes; * Hemoglobin level < 11.0 g/dL for females and < 12.0 g/dL for males at the Screening Visit; * History or presence of bleeding or clotting disorders; * Daily use of aspirin (> 325mg/day) or anticoagulants; * Whole blood donation within 8 weeks (<= 56 days) prior to the signing the ICF; * Plasma donation within (<=) 7 days of signing the ICF; * Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for 5 minutes; * Weight of <= 110 pounds; * Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV); * Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed; * Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to signing the ICF; * Participation in another clinical trial within (<=) 30 days of signing the ICF (the 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study); * Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the study; * A positive urine drug screen without evidence of prescribed corresponding acceptable concomitant medication(s) at the Screening Visit or at check-in on Day 1; * Postponing a decision to quit using tobacco- or nicotine-containing products to participate in this study or a previous quit attempt within (<=) 30 days prior to signing the ICF; * Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol breathalyzer result at the Screening Visit and check-in on Day 1; * Employed by a tobacco- or other nicotine-product manufacturing company, or the study site, or handles tobacco- or nicotine-containing products as part of their job; * Presence of gum bleeding and/or abscess, open mouth sores or oral ulcers at Screening, Check-in, or prior to Day 5 product use (just prior to switching IP); * Full dentures or braces (with the exception of night guard/retainer, and dental implants which may be allowed; if subjects is missing all lower teeth and does not use dentures will also be allowed); * Determined by the PI to be inappropriate for the study. Sex : ALL Ages : - Minimum Age : 21 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03993795

{ "NCT_ID" : "NCT03142516", "Brief_Title" : "FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status", "Official_title" : "A Phase II Trial to Evaluate the Efficacy and Safety of FOLFIRI + Panitumumab as First-line Treatment in Elderly Patients With RAS/BRAF Wild-type Unresectable Metastatic Colorectal Cancer and Good Performance Status", "Conditions" : ["Colorectal Neoplasms", "Colorectal Carcinoma", "Colorectal Cancer Metastatic", "Neoplasm Metastasis"], "Interventions" : ["Drug: Irinotecan", "Drug: Panitumumab", "Drug: Folinic acid", "Drug: 5-FU"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-10-31", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-21", "Study_Completion_Date(Actual)" : "2021-01-21}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-05-02", "First_Posted(Estimated)" : 2017-05-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-05-03", "Last_Update_Posted(Estimated)" : 2021-06-21", "Last_Verified" : 2021-06" } }}

#Study Description Brief Summary To estimate progression-free survival at one year in elderly patients with RAS/BRAF wild-type unresectable mCRC and good performance status treated with FOLFIRI + panitumumab as first-line therapy. The clinical hypothesis of this study is that the combination of panitumumab and FOLFIRI is a good treatment option in elderly patients with good performance status and RAS/BRAF wild-type unresectable mCRC. Another purpose of this clinical trial is to determine the RAS/BRAF mutation status in liquid biopsies at baseline and at the time of disease progression. Detailed Description Phase II, multicentre, single-arm trial. Elderly patients with good performance status and RAS/BRAF wild-type unresectable mCRC will be evaluated before being included in this trial. Eligible patients will receive panitumumab plus FOLFIRI for disease control until disease progression, unacceptable toxicity, investigator decision or the patient's withdrawal of consent. Tumour response will be evaluated by investigators using RECIST criteria (Response Evaluation Criteria in Solid Tumours) version 1.1. Tumour response will be evaluated every 8 weeks until disease progression is documented. Disease response will be confirmed no less than 28 days after the criteria for response are first met. Radiographic progression of subjects with symptoms indicating disease progression will be evaluated at the time of symptom onset. Following disease progression, information will be collected on the subsequent lines of treatment chosen by the investigator and survival at follow-up visits held every 12 weeks (± 4 weeks) until completion of the trial (approximately 24 months after inclusion of the last patient in the trial). A blood sample will be taken at baseline and at the time of disease progression in order to determine the RAS/BRAF mutation status. #Intervention - DRUG : Panitumumab - Panitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy - Other Names : - Vectibix - DRUG : Irinotecan - Irinotecan 150 mg/m2 will be administered as IV infusion over 90 min on day 1of first treatment cycle. If tolerance of this first dose is good, it will be scaled to a full dose of 180 mg/m2 starting from the second treatment cycle - Other Names : - Any marketed - DRUG : Folinic acid - Folinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1 - Other Names : - Leucovorin, Any marketed - DRUG : 5-FU - 5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2 - Other Names : - 5-fluorouracil, Any marketed

#Eligibility Criteria: Inclusion Criteria: * Males or females >= 70 years, * Able to understand, sign and date an informed consent form approved by the IEC, * Histologically confirmed colorectal carcinoma with metastatic disease, * RAS/BRAF wild-type status in solid biopsy confirmed prior to inclusion of the study, * No previous treatment for metastatic disease, * Patients starting therapy with FOLFIRI + panitumumab with a treatment aim other than achieving potential resectability of the disease, * Independence in activities of daily living (ADL) based on the Katz Index and in instrumental activities of daily living (IAL) based on the Lawton Index, * Having no or only one comorbidity according to the Charlson Comorbidity Index. The following ones are not considered comorbidities as long as it is provided they are adequately controlled with medication: gastroduodenal ulcer, diabetes without target organs' damage, chronic respiratory disease and connective tissue disease. * Presence of at least one unidimensional measurable lesion >= 10 mm according to RECIST criteria (version 1.1), * ECOG (Eastern Cooperative Oncology Group) performance status of 0 <= age <= 1, * Adequate bone marrow function: neutrophils >= 1.5 x 10^9/l; platelets >= 100 x 10^9/l; haemoglobin >= 9 g/dl, * Hepatic, renal and metabolic function as follows: 1. Total bilirubin count <= 1.5 x ULN; ALT and AST < 5 x ULN; 2. Renal function, calculated creatinine clearance or 24-hour creatinine clearance >= 50 ml/min; 3. Magnesium > LLN Exclusion Criteria: * Diagnosed or suspected central nervous system (CNS) metastasis, * Patients with initially resectable metastases at the time of diagnosis of metastatic disease. * History or presence of another malignancy, with the exception of curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer or any curatively treated solid tumour, with no active disease or administration of treatment within 5 years prior to inclusion in the study, * Prior treatment with irinotecan, * Prior adjuvant chemotherapy for colorectal cancer terminated less than 6 months before metastatic disease was diagnosed, * Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, cetuximab), anti- vascular endothelial growth factor (VEGF) or treatment with small molecule EGFR inhibitors (eg, erlotinib), * Unresolved toxicities from prior systemic treatment that, in the investigator's opinion, make the patient unsuitable for inclusion, * Hormone therapy, immunotherapy with experimental or approved antibodies/proteins (e.g. bevacizumab) <= 30 days prior to inclusion, * Evidence of previous acute hypersensitivity reaction of any grade to any of the components of the treatment, * History of interstitial lung disease or pulmonary fibrosis or signs of interstitial lung disease or pulmonary fibrosis on baseline CT, * Presence of geriatric syndromes, defined as dementia, repeated falls, fecal incontinence or urinary incontinence, * Acute or subacute bowel obstruction and/or active bowel disease or another bowel disease causing chronic diarrhoea (defined as diarrhoea of grade >= 2 according to the NCI (National Cancer Institute) Common Terminology Criteria for Adverse Events (CTCAE version 4.03), * Significant cardiovascular disease, including unstable angina pectoris or myocardial infarction within 12 months prior to inclusion in the study, * History of Gilbert's syndrome or dihydropyrimidine dehydrogenase deficiency, * Positive test result for human immunodeficiency virus, hepatitis C virus, chronic active hepatitis B infection, * Treatment for systemic infection within 14 days prior to the start of the study treatment, * Clinically significant sensory peripheral neuropathy, * Any concurrent disease that may increase the risk associated with study participation or may interfere with the interpretation of study results, * Any investigational product within 30 days prior to inclusion, * Surgery (not including diagnostic biopsy or the placement of a central line) and/or radiotherapy within 28 days prior to inclusion in the study, * Males whose partner is of child-bearing age and who does not agree to use adequate contraceptive precautions, i.e. double-barrier methods (e.g. diaphragm plus condom) or abstinence for the duration of the study and for 1 month after the last administration of the study drug, * Subjects who do not agree or are unable to meet the study requirements, * Psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and the follow-up schedule. Such conditions should be discussed with the patient before enrolment in the clinical trial Sex : ALL Ages : - Minimum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT03142516

{ "NCT_ID" : "NCT03456713", "Brief_Title" : "A Study of LY3074828 in Healthy Participants", "Official_title" : "A Safety, Tolerability, and Pharmacokinetic Study of 1- and 2-mL Injections of LY3074828 Solution Using Investigational Pre-filled Syringes and Investigational Autoinjectors in Healthy Subjects", "Conditions" : ["Healthy"], "Interventions" : ["Biological: LY3074828"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-03-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-08-13", "Study_Completion_Date(Actual)" : "2018-08-13}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-03-05", "First_Submitted_that_Met_QC_Criteria" : 2024-02-16", "First_Posted(Estimated)" : 2018-03-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-03-05", "Last_Update_Posted(Estimated)" : 2024-02-20", "Last_Verified" : 2024-02" } }}

#Study Description Brief Summary The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828, when given as a solution formulation in different devices. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 13 weeks, not including screening. #Intervention - BIOLOGICAL : LY3074828 - Administered SC

#Eligibility Criteria: Inclusion Criteria: * Must be healthy male or female Exclusion Criteria: * Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females) * Must not show evidence of active or latent tuberculosis (TB) * Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study * Must not have been treated with steroids within 1 month of screening, or intend to during the study * Must not be immunocompromised * Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1 * Must not have significant allergies to humanised monoclonal antibodies * Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever post treatment hypersensitivity reactions * Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Must not have had breast cancer within the past 10 years Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03456713

{ "NCT_ID" : "NCT03814954", "Brief_Title" : "Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children", "Official_title" : "Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months", "Conditions" : ["Respiratory Distress Score"], "Interventions" : ["Drug: Salbutamol", "Drug: Epinephrine"], "Location_Countries" : ["Lebanon"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-08-31", "Study_Completion_Date(Actual)" : "2021-08-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-01-21", "First_Posted(Estimated)" : 2019-01-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-01-21", "Last_Update_Posted(Estimated)" : 2022-08-30", "Last_Verified" : 2022-08" } }}

#Study Description Brief Summary Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol. Detailed Description The objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included in the study. Children who meet the inclusion criteria will be alternately distributed in two groups: Group 1: Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer. Group 2: Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation. Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged. #Intervention - DRUG : Salbutamol - At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status - DRUG : Epinephrine - At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status

#Eligibility Criteria: Inclusion Criteria: * Children diagnosed with acute bronchiolitis. Exclusion Criteria: * Children with congenital heart disease or * chronic lung diseases Sex : ALL Ages : - Minimum Age : 1 Month - Maximum Age : 24 Months - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT03814954

{ "NCT_ID" : "NCT04939363", "Brief_Title" : "A Study to Evaluate Efficacy & Safety of Obinutuzumab, Ibrutinib, and Venetoclax in Richter's Syndrome;", "Official_title" : "A Prospective, Phase-II Study to Evaluate the Efficacy and Safety of Obinutuzumab, Ibrutinib, and Venetoclax in Patients With Richter's Syndrome. GIVeRS Protocol: On Behalf of the Israeli CLL Study Group", "Conditions" : ["Richter's Syndrome"], "Interventions" : ["Combination Product: Obinutuzumab with Ibrutinib and Venetoclax"], "Location_Countries" : ["Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-08-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-10-09", "Study_Completion_Date(Actual)" : "2024-12-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-06-06", "First_Posted(Estimated)" : 2021-06-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-06-24", "Last_Update_Posted(Estimated)" : 2024-12-10", "Last_Verified" : 2024-11" } }}

#Study Description Brief Summary Richter's syndrome (RS) is a life-threatening complication of chronic lymphocytic leukemia (CLL). It is associated with a switch in histopathology and biology, generally with a transformation of the original CLL clone to diffuse large B-cell lymphoma (DLBCL). The development of RS is accompanied by the onset of B symptoms, rapid growth of lymphadenopathy, extra-nodal disease, significant elevations of lactate dehydrogenase (LDH), and associated multi-organ dysfunction from invasive or obstructive processes RS occurs in 2-10% of CLL patients with an incidence rate of 0.5% per year. The molecular pathogenesis of RS involves inactivation of the tumor protein p53 (TP53) tumor suppressor gene in 50-60% of cases and activating aberrations of NOTCH1 and myelocytomatosis oncogene (MYC) in about 30% of cases. . These distinct molecular footprints of RS are chemoresistance leading to an aggressive clinical course with low response rates and poor outcomes.Taking into consideration that in addition to the underlying aggressive disease, most RS patients are often at an advanced age and suffer from numerous other comorbidities. Additionally, intensive chemotherapy regimens are highly toxic to this population group and lead to excessive treatment-related morbidity. Enrolling DLBCL-RS patients in clinical trials is therefore justifiable, particularly those with RS that is clonally related to the predisposed underlining CLL disease. Due to the poor activity of immunochemotherapy, the possibility of using novel agents in the treatment of RS is of great interest. The toxicity and the efficacy of the combination of cluster of anti differentiation antigen 20 (anti-CD20) antibody (e.g. Obinutuzumab or Rituximab) with Ibrutinib and/or Venetoclax have been already reported in both relapsed and naïve patients with CLL. The use of these three agents in combination is highly active in CLL and has manageable side effects. In addition, recent reports showed that treatment with Ibrutinib or Venetoclax as a single drug are active in RS. Herein the investigators propose a phase 2, open-label, non-randomized, single arm, multi-center study aiming to assess the safety and efficacy with the combination of Ibrutinib, Venetoclax and Obinutuzumab in patients with RS . Detailed Description Richter's syndrome (RS) is a life-threatening complication of chronic lymphocytic leukemia (CLL). It is associated with a switch in histopathology and biology, generally with a transformation of the original CLL clone to diffuse large B-cell lymphoma (DLBCL). The development of RS is accompanied by the onset of B symptoms, rapid growth of lymphadenopathy, extra-nodal disease, significant elevations of LDH, and associated multi-organ dysfunction from invasive or obstructive processes. Previous research has increased general knowledge on the distinct evolutionary patterns of RS and provided a deeper understanding of the risk factors and molecular events predisposing to transformation. However, currently there're main few targetable aberrations and treatment is largely ineffective with a dismal prognosis leaving these patients with a high unmet medical need for better treatment strategies. RS occurs in 2-10% of CLL patients with an incidence rate of 0.5% per year. The molecular pathogenesis of RS involves inactivation of the TP53 tumor suppressor gene in 50-60% of cases and activating aberrations of NOTCH1 and MYC in about 30% of cases. These distinct molecular footprints of RS are chemoresistance leading to an aggressive clinical course with low response rates and poor outcomes. Patients with RS are usually excluded from clinical trials and there is no established standard of care in the treatment of RS today. A number of chemotherapy regimens have been evaluated in the treatment of DLBCL-RS resulting in overall responses ranging between 40%-60% which are short lived with disappointing Progression Free Survival (PFS) and Overall Survival (OS) ranging between 3 - 10 and 6 - 21 months, respectively. In Israel the current treatment strategy used for newly diagnosed DLBCL-RS is an anthracycline-based regimen, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). This treatment regimen has shown poor efficacy in a cohort study of 15 DLBCL-RS patients prospectively evaluated by a German CLL study group trial. The ORR was 67% with only 7% Complete Response (CR). The median PFS and median OS were 10 and 21 months, respectively in these patients. In terms of the safety profile of R-CHOP for patients with DLBCL-RS or CLL patients, 15 of the 60 (25%) patients enrolled in this study had therapy discontinued earlier than planned because of the treatment-related toxicity. Taking into consideration that in addition to the underlying aggressive disease, most RS patients are often at an advanced age and suffer from numerous other comorbidities, therefore only 10%-15% of patient scan undergo the potentially curative allogeneic Hematopoietic Stem Cell Transplantation (HSCT). Additionally, intensive chemotherapy regimens are highly toxic to this population group and lead to excessive treatment-related morbidity. Enrolling DLBCL-RS patients in clinical trials is therefore justifiable, particularly those with RS that is clonally related to the predisposed underlining CLL disease. Due to the poor activity of immunochemotherapy, the possibility of using novel agents in the treatment of RS is of great interest. The toxicity and the efficacy of the combination of anti-CD20 antibody (e.g. Obinutuzumab or Rituximab) with Ibrutinib and/or Venetoclax have been already reported in both relapsed and naïve patients with CLL. The use of these three agents in combination is highly active in CLL and has manageable side effects. In addition, recent reports showed that treatment with Ibrutinib or Venetoclax as a single drug are active in RS. Herein the investigators propose a phase 2, open-label, non-randomized, single arm, multi-center study aiming to assess the safety and efficacy with the combination of Ibrutinib, Venetoclax and Obinutuzumab in patients with RS. #Intervention - COMBINATION_PRODUCT : Obinutuzumab with Ibrutinib and Venetoclax - 1. Obinutuzumab intravenous infusion: 2. Ibrutinib PO 560mg daily starting on cycle 1 day 1 for 12 cycles. 3. Venetoclax with an accelerated ramp-up and close inpatient Tumor Lysis Syndromes (TLS) monitoring starts on cycle 1 day 15 to the target dose of 400mg daily for a total of 12 cycles:

#Eligibility Criteria: Inclusion Criteria: * Subject must be 18 years or older. * Patients with histopathological confirmation of Richter's transformation into diffuse large B-cell lymphoma (DLBCL). * Subjects must have at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma. The site of disease must be greater than 1.5 cm in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions. * Eastern Cooperative Oncology Group (ECOG) status 0 to 2; ECOG 3 is only permitted if related to RS. * Adequate renal function, as indicated by an estimated creatinine clearance higher than 30 ml/min, adequate platelet count > 25 x 109/L, adequate liver function as indicated by total bilirubin < x 2 and Alanine transaminase (ALT) < x 2.5 of the institutional upper normal levels, unless directly attributable to the RS or to Gilbert's Syndrome. * Negative serological testing for hepatitis B (anti-hepatitis Bc negative, patients positive for anti-hepatitis Bc may be included if Polymerase chain reaction (PCR) for HBV DNA is negative) and negative HIV test performed within 6 weeks prior to enrollment. * Ability and agreement to provide written informed consent and to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Diagnosed or treated for malignancy other than DLBCL-RS or CLL/Small Lymphocytic Lymphoma (SLL) , except: 1. Malignancy treated with curative intent and with no known active disease present at enrollment. 2. Adequately treated non-melanoma skin cancer or lentigo maligna melanoma without evidence of disease. 3. Adequately treated carcinoma in situ without evidence of disease. * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of enrollment, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. * Requires anticoagulation with coumadin or equivalent vitamin K antagonists (e.g., phenprocoumon). * Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/inducers. * Documented resistance to Ibrutinib and/or Venetoclax. * Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment; further pregnancy testing will be performed regularly). * Fertile men or women of childbearing potential unless: 1. surgically sterile or >= 2 years after the onset of menopause 2. Willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 18 months after the end of study treatment. * Positive serological test for human immunodeficiency virus (HIV) or active Hepatitis C Virus (HCV; RNA polymerase chain reaction [PCR]-positive) or active Hepatitis B Virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection. Subjects with PCR-negative HBV and HCV are permitted in the study. * Legal incapacity. * Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk. * Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04939363

{ "NCT_ID" : "NCT03515837", "Brief_Title" : "Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)", "Official_title" : "A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)", "Conditions" : ["Non-small Cell Lung Cancer"], "Interventions" : ["Drug: saline solution", "Drug: cisplatin", "Biological: pembrolizumab", "Drug: pemetrexed", "Drug: carboplatin"], "Location_Countries" : ["France", "Japan", "Israel", "Mexico", "China", "United States", "Germany", "Sweden", "Taiwan", "United Kingdom", "Canada", "Spain", "Australia", "Brazil", "Hong Kong", "Italy", "Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-06-29", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-01-17", "Study_Completion_Date(Actual)" : "2023-10-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-04-23", "First_Submitted_that_Met_QC_Criteria" : 2023-12-21", "First_Posted(Estimated)" : 2018-05-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-04-23", "Last_Update_Posted(Estimated)" : 2024-11-22", "Last_Verified" : 2024-11" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib \[TAGRISSO®\] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available. #Intervention - BIOLOGICAL : pembrolizumab - IV infusion - Other Names : - MK-3475 - DRUG : pemetrexed - IV infusion - DRUG : carboplatin - IV infusion - DRUG : cisplatin - IV infusion - DRUG : saline solution - IV infusion - Other Names : - Normal saline solution

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC. * Documentation of tumor activating EGFR mutation, specifically either DEL19 or L858R. * Investigator-determined radiographic disease progression per RECIST 1.1 after treatment with an EGFR TKI therapy: a) Participants previously treated with 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation; b) Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment; c) Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status. Note: TKI washout period for all participants is 1 week or 2 half-lives after last treatment dose, whichever is longer. TKI washout should be completed prior to first dose of study treatment. * Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. * Provided archival tumor tissue sample or newly obtained (no anti-neoplastic therapy since biopsy) core or excisional biopsy of a tumor lesion not previously irradiated. * Life expectancy of at least 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment but before randomization. * Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents. * Female participants must not be pregnant, not breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents. * Adequate organ function. Exclusion Criteria: * Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. * Symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. * Received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137). * Received prior systemic cytotoxic chemotherapy or investigational agent(s), excluding EGFR TKIs, for metastatic NSCLC. [Notes: 1) Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC. 2) If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. 3) Prior exposure to traditional medicine(s) is allowed as long as therapy was discontinued at least 4 weeks prior to the first dose of study treatment.] * Received prior radiotherapy within 2 weeks of start of study treatment or has received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<=2 weeks of radiotherapy) to non-central nervous system (CNS) disease. * Received a live vaccine within 30 days prior to the first dose of study treatment. * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.) * Known active untreated CNS metastases and/or carcinomatous meningitis. * Severe hypersensitivity (>= Grade 3) to pembrolizumab and/or any of its excipients. * Known sensitivity to any component of cisplatin, carboplatin, or pemetrexed. * Active autoimmune disease that has required systemic treatment in past 2 years. * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Active infection requiring systemic therapy. * Known history of human immunodeficiency virus (HIV) infection. * Known history of Hepatitis B or known active Hepatitis C virus. * Known history of active tuberculosis (TB; Bacillus tuberculosis) * Pregnant, breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03515837

{ "NCT_ID" : "NCT01226576", "Brief_Title" : "Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study", "Official_title" : "Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study", "Conditions" : ["Localized Low-Intermediate Risk Prostate Cancer"], "Interventions" : ["Device: MRgFUS Treatment"], "Location_Countries" : ["Israel", "Singapore", "Canada", "Italy", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12", "Study_Completion_Date(Actual)" : "2018-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-10-21", "First_Posted(Estimated)" : 2010-10-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-10-21", "Last_Update_Posted(Estimated)" : 2019-03-13", "Last_Verified" : 2019-03" } }}

#Study Description Brief Summary The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the potential to be a safe and effective non-invasive treatment for low to intermediate risk, organ-confined prostate cancer involving low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above. Based on the result of this study, InSightec will initiate a larger study in an effort to approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS device. Detailed Description Objective of this feasibility trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of low to intermediate risk, localized (organ confined) prostate cancer tumors. ExAblate treatment will be implemented as a focal tumor-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, (identified as cancerous by mapping biopsy with or without multi-parametric MRI), rather than a whole gland or hemi-ablation treatment. Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of low risk organ confined prostate cancer. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study. Effectiveness: determine the tumor control effect of ExAblate's MRgFUS focal treatment of low risk organ-confined prostate cancer (confirmed by TRUS-guided Transperineal Mapping Biopsy results). #Intervention - DEVICE : MRgFUS Treatment - Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy - Other Names : - ExAblate 2100 Prostate system

#Eligibility Criteria: Inclusion Criteria: * Patient of age between 50 <= age <= 75, inclusive. * Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to scheduled treatment. * Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0, M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy. * Patient with PSA less than or equal to 10 ng/mL * Gleason score 6 or 7 (no 5 grades), based on TRUS guided Transperineal Mapping Biopsy, as defined in the protocol. * Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not more than 10 mm in maximal linear dimension; each tumor should comply with the maximal 7 Gleason score requirement. * Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four (4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in prostates with volume <20 cc) * Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial images. * No definite evidence of extracapsular extension or seminal invasion by MRI * Patient eligible for epidural anesthesia, and general anesthesia (in case of complication, requiring intervention). * Patient is willing and able to give consent and attend all study visits as defined in the protocol * Prostate gland volume should be no greater than 70 cc, volumetrically measured. Exclusion Criteria: * ASA status > 2 * Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials or foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent * Severely abnormal coagulation (INR>1.5) * Patient with unstable cardiac status including: 4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4. Unstable arrhythmia status, already on anti-arrhythmic drugs * Severe hypertension (diastolic BP > 100 on medication) * Severe cerebrovascular disease (multiple CVA or CVA within 6 months) * History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy. * Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors) * Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.) * Any rectal pathology, anomaly or previous treatment, which can change acoustic properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis, fibrosis). * Any spinal pathology which can prevent safe administration of epidural anesthesia * Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm) and interfering with the acoustic beam path. * Lower limb musculo-skeletal fixed deformities. * Prostate with multiple cystic lesions. * Evidence for seminal vesicle/lymph node involvement of cancer. * Subjects with distance of the less than 2mm margin between the tumor and the prostate capsule * Bladder cancer * Patient that had TURP procedure before * Urethral stricture/bladder neck contracture * Patient with baseline symptoms of incontinence defined as urine leak in any of the following circumstances: 20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3. While being asleep 20.4. While being physically active/exercising 20.5. After finishing urinating and being dressed 20.6. Leaking for no obvious reason * Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire * Active UTI * Prostatitis NIH categories I, II and III * Implant near (<1 cm) the prostate * Interest in future fertility * Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment Sex : MALE Ages : - Minimum Age : 50 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01226576

{ "NCT_ID" : "NCT01594892", "Brief_Title" : "Fractionated Radiosurgery for Painful Spinal Metastases", "Official_title" : "Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)", "Conditions" : ["Neoplasm Metastasis", "Neoplastic Processes", "Neoplasm Recurrence, Local", "Neoplasm, Residual", "Pain"], "Interventions" : ["Radiation: Radiosurgery"], "Location_Countries" : ["Germany", "Switzerland", "Netherlands", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07", "Study_Completion_Date(Actual)" : "2017-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-05-07", "First_Posted(Estimated)" : 2012-05-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-05-07", "Last_Update_Posted(Estimated)" : 2019-09-04", "Last_Verified" : 2019-08" } }}

#Study Description Brief Summary It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this II trial. Detailed Description The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study. 1. A prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety. 2. Fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. Fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment. 3. Dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept. #Intervention - RADIATION : Radiosurgery - Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery

#Eligibility Criteria: Inclusion Criteria: * Established histological diagnosis of a malignant tumour (primary or metastatic) * Vertebral metastasis confirmed via biopsy or radiology * Pain in the involved spinal region or free of pain under pain medication * Fully consenting patients, >18 years * Karnofsky Performance Index >=60% * Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score <= 9) * Patient must be able to tolerate fixation systems and 30 minutes treatment time * Discussed in interdisciplinary tumour board * The following types of spinal tumours are eligible: * Recurrent / residual tumours after surgery * Tumours in medically inoperable patients or patients deemed inoperable due to limited life expectancy / tumour load * Lesions associated with significant surgical risk Exclusion Criteria: * Short life expectancy according to the modified Mizumoto Sore * 'Radiosensitive' histologies (i.e. lymphoma, SCLC, multiple myeloma) * Non-ambulatory status * Progressive neurological symptoms/deficit * > 3 involved vertebral levels * > 2 treatment sites * Spine instability * Previous radiotherapy at the involved levels Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01594892

{ "NCT_ID" : "NCT04936139", "Brief_Title" : "Art Therapy Effectiveness in the Level of Anxiety and Depression of Cancer Patients", "Official_title" : "Effectiveness of Art Therapy in the Level of Anxiety and Depression of Cancer Patients. Multicentric Random Clinical Trial (ATANDEC)", "Conditions" : ["Cancer"], "Interventions" : ["Behavioral: Art Therapy"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-02-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-11-03", "Study_Completion_Date(Actual)" : "2023-11-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-06-14", "First_Posted(Estimated)" : 2021-06-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-06-14", "Last_Update_Posted(Estimated)" : 2024-02-05", "Last_Verified" : 2024-02" } }}

#Study Description Brief Summary Having a diagnosis of cancer leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve the emotional well-being is considered. Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease. Detailed Description Introduction: The passage of a cancer through a person leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve your emotional well-being is considered. Research Project Hypothesis: Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease. Objectives: To evaluate the effectiveness of art therapy in reducing the levels of anxiety and depression in cancer patients, as well as in improving the quality of life and coping strategies. Methodology: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial. Eight centers will participate in the study with an N of 423 patients. Patients older than 18 years of age who are diagnosed with cancer at any stage of treatment with the intention of radical treatment or palliative treatment with a life expectancy of more than 12 months will be included. If it is carried out in an online format, the person must have access to the internet. Patients who suffer from a current or previous serious psychological / psychiatric illness or those who have participated in an art therapy program structured in the context of oncological process will be excluded. Patients will be assigned to the control group (they will receive the usual follow-up from the center) or to the intervention group (art therapy program). Patients assigned to the intervention group will participate in an art therapy workshop once a week for 12 weeks, which will be done in person / online depending on the epidemiological situation of covid-19 and the needs of each center, The group will maintain the format (online / face-to-face) with which it has started throughout all the sessions. Art therapy is a discipline that offers a space to meet with oneself, where one can dialogue with different artistic languages, with the aim of promoting emotional integration and looking for new ways to integrate difficult experiences through creative language. Assessing anxiety and depression with the HAD scale, coping strategies with the Mini-MAC scale, and WHOQOL-BREF for quality of life will be used. Statistical analysis will be for treatment purposes. IBM SPSS Statistics v.24 and STATA v.14 will be used. #Intervention - BEHAVIORAL : Art Therapy - During the 12 planned sessions, different artistic disciplines will be used: visual arts, music, play, narrative, dramatization, movement and body expression. Each session is structured in 3 phases: i. A first part of encounter and contextualization, to make contact with oneself, with the art therapist and with the group through a relaxation or meditation activity (35 minutes). ii. A second part, where the session continues with the work of artistic elaboration and production with the different materials and the different artistic languages (50 minutes). iii. A third part where the participants will be invited to make a closing, a moment to welcome and share whoever wishes, the experiences that have been experienced. A dialogue is created between Work-Patient-Art Therapist (35 minutes).

#Eligibility Criteria: Inclusion Criteria: * Over 18 years * Intention for radical treatment or palliative treatment with a life expectancy of more than 12 months * Have internet access in case the intervention is done online * Agree to participate and sign informed consent Exclusion Criteria: * Patient with active diagnosis or personal history of severe psychological / psychiatric illness * Patient who has participated in an art therapy program structured in the context of the oncological process Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04936139