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#Study Description Brief Summary This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmona...
#Eligibility Criteria: Inclusion Criteria: * Subject is undergoing his/her first myocardial revascularization Exclusion Criteria: * Previous participation (randomisation and dosing) in this trial * Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic atta...
NCT02239146
{ "brief_title": "Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass", "conditions": [ "Acquired Bleeding Disorder", "Cardiac Surgery Requiring Cardiopulmonary Bypass" ], "interventions": [ "Drug: placebo", "Drug: catridecacog" ], ...
#Study Description Brief Summary The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RM...
#Eligibility Criteria: Inclusion Criteria: * 18 through 55 years * Patients with CIS demonstrating one unifocal neurological event AND at least 2 T2-weighted brain lesions measuring a minimum of 6mm in diameter by MRI analysis; or a definite diagnosis of RMS, as defined by the 2005 revised McDonald criteria(1, 2), and...
NCT01569451
{ "brief_title": "Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate", "conditions": [ "Multiple Sclerosis" ], "interventions": [ "Drug: Glatiramer Acetate", "Other: Placebo", "Drug: Rituximab" ], "location_countries": [ "United States" ], "nct_id": "NCT01569451...
#Study Description Brief Summary This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver. Detailed Description Subjects with non-alcoholic fatty liver (simple steatos...
#Eligibility Criteria: Inclusion Criteria: * Documented history of clinical diagnosis of NAFLD by ultrasound, MRI or biopsy within one (1) year prior to screening (V1). If the diagnostic test date is greater than one (1) year, abdominal ultrasound will be repeated at (V1) and must confirm a diagnosis of NAFLD. * Men o...
NCT02923804
{ "brief_title": "Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients", "conditions": [ "Non Alcoholic Fatty Liver" ], "interventions": [ "Dietary Supplement: Omega-3", "Dietary Supplement: Olive oil" ], "location_countries": [ "United States" ], "nct...
#Study Description Brief Summary The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy). There are two main types of techniques (open \& laparoscopic) Many studies were done comparing these two techniques show...
#Eligibility Criteria: Inclusion Criteria: * All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1 <= age <= 3, N0 <= age <= 1, M0). Exclusion Criteria: * Pregnancy. * Infiltration to the( pancreas ,liver ,colon or vital vascular structure). * Metastasis to the (...
NCT02789826
{ "brief_title": "Laparoscopic Versus Open Resection of Cancer Stomach", "conditions": [ "Gastric Cancer" ], "interventions": [ "Procedure: Open gastrectomy", "Procedure: Laparoscopic gastrectomy" ], "location_countries": [ "Egypt" ], "nct_id": "NCT02789826", "official_title": "Laparos...
#Study Description Brief Summary Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, ...
#Eligibility Criteria: Inclusion Criteria: * Patients must be able to understand the study procedures agree to participate and give written consent. * Patients with acute or sub-acute eczema. * Presence of symmetric lesions to compare on side to the other. Exclusion Criteria: * Pregnancy or risk of pregnancy. * Lact...
NCT01257061
{ "brief_title": "Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment", "conditions": [ "Eczema" ], "interventions": [ "Drug: Group 1", "Drug: Group 2" ], "location_countries": [ "Brazil" ], "nct_id": "NCT01257061", "official...
#Study Description Brief Summary This is a single-center, prospective randomized controlled trial evaluating the safety and efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous detachment. Detailed Description 52 subjects will be enrolled in the trial and randomized in a 2:1 ...
#Eligibility Criteria: Inclusion Criteria: * Symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months * Documented posterior vitreous detachment on clinical examination, OCT, and B scan * Self-rating of visual disturbance by the floaters must be at least 4 on a 0 <= ...
NCT02897583
{ "brief_title": "YAG Vitreolysis for Floaters", "conditions": [ "Weiss Ring", "Floaters", "Posterior Vitreous Detachment" ], "interventions": [ "Procedure: YAG vitreolysis" ], "location_countries": null, "nct_id": "NCT02897583", "official_title": "A Prospective Randomized Controlled Tri...
#Study Description Brief Summary This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study, aiming to investigate whether higher potency of different inhaled corticosteroid confers an improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will compare...
#Eligibility Criteria: Inclusion Criteria - Subjects must be 18 <= age <= 65 of age inclusive, at the time of signing the informed Consent. - Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit - Pre-bronchodilator FEV1 >=65% of predicted at screening; the pre-dose bas...
NCT02991859
{ "brief_title": "Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects", "conditions": [ "Asthma" ], "interventions": [ "Drug: Fluticasone propionate (FP) Dry Powder Inhaler", "Drug: Placebo (ELLIPTA or DISKUS)", ...
#Study Description Brief Summary Physical activity levels of hospitalised older inpatients is low and this results in many adverse health outcomes. Studies have shown that interventions designed to promote increased physical activity of older inpatients using paid staff have shown improvement in physical function of ...
#Eligibility Criteria: Inclusion Criteria: * deemed appropriate by the medical team and therapists to receive a physical activity intervention by trained volunteers and able to mobilise with or without a walking aid. Exclusion Criteria: * patients normally resident in a nursing home, or who were immobile prior to ad...
NCT02594527
{ "brief_title": "Southampton Mobility Volunteer Programme", "conditions": [ "Physical Activity" ], "interventions": [ "Other: Volunteer-led physical activity session" ], "location_countries": [ "United Kingdom" ], "nct_id": "NCT02594527", "official_title": "The Southampton Mobility Volunt...
#Study Description Brief Summary The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy. #Intervention - PROCEDURE : Routine Care - Routine care for patients unde...
#Eligibility Criteria: Inclusion Criteria: * voluntary participation in the study and ability to cooperate with treatment and care; * patients who were to undergo enterostomy; * age >=18 years; * consciousness (being able to complete the questionnaire alone or able to answer the questions correctly); * social impact s...
NCT05845294
{ "brief_title": "A Study of the Effect of Short-term Structured Psychological Care in Patients", "conditions": [ "Colorectal Cancer" ], "interventions": [ "Procedure: Short-term structured psychological Care", "Procedure: Routine Care" ], "location_countries": [ "China" ], "nct_id": "NC...
#Study Description Brief Summary Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, d...
#Eligibility Criteria: Inclusion Criteria: * Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003. Exclusion Criteria: * Schizophrenia * Bipolar Disorder * Obsessive Compulsive Disorder * Head Injury with Loss of Consciousness for more than 30 minutes * Active Alc...
NCT01564667
{ "brief_title": "Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)", "conditions": [ "Posttraumatic Stress Disorder" ], "interventions": [ "Behavioral: Attention Bias Modification Training Protocol" ], "location_countries": [ "United States" ], "...
#Study Description Brief Summary The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD...
#Eligibility Criteria: Inclusion Criteria: * Previously untreated stage I or II non-bulky Hodgkin lymphoma * No mediastinal mass >0.33 maximum intrathoracic diameter on chest x-ray (see Appendix B) * No adenopathy >=7.5 cm in its largest diameter * Measurable disease as assessed by 2 dimensional measurement by CT...
NCT01578967
{ "brief_title": "Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma", "conditions": [ "Hodgkin Lymphoma, Adult" ], "interventions": [ "Drug: Brentuximab vedotin", "Drug: ABVD" ], "location_countries": [ "United Stat...
#Study Description Brief Summary The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX). Detailed Description Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defin...
#Eligibility Criteria: Inclusion Criteria: * Patients must be able to understand the written Informed Consent Form (ICF) * Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and ha...
NCT00753454
{ "brief_title": "Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)", "conditions": [ "Rheumatoid Arthritis" ], "interventions": [ "Drug: Certolizumab pegol" ], "location_countries": [ "Canada", "United States" ], "nct_i...
#Study Description Brief Summary Subjects with metabolic syndrome are known to possess chronic low-level inflammation. Furthermore, such individuals are at risk of developing atherosclerosis in coronary and other vascular beds. In particular, subjects with metabolic syndrome, prediabetes and type II diabetes mellitus...
#Eligibility Criteria: Inclusion Criteria: * Male and female > 50 yearsyears * Presence of MetS as defined according to recent updated criteria (13): Presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off) depending on the recently published ethnic-based variations (14), tri...
NCT03719794
{ "brief_title": "Probiotics for Vascular Inflammation in Metabolic Syndrome", "conditions": [ "Metabolic Syndrome" ], "interventions": [ "Dietary Supplement: Probiotic supplement", "Dietary Supplement: Placebo supplement" ], "location_countries": [ "Canada" ], "nct_id": "NCT03719794", ...
#Study Description Brief Summary The aim of this study is to investigate the efficiency of an exercise program based on principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic patients. Detailed Description Epidemiological studies have shown that bad posture and poor body control o...
#Eligibility Criteria: Inclusion Criteria: * Students at Technological Educational Institute of Sterea Ellada, * Aged 18 <= age <= 26 years * Males and females * Craniocervical angle < 50 degrees (statical Forward Head Posture in standing position) Exclusion Criteria: * Injury or surgery in cervical spine * Accompan...
NCT03006497
{ "brief_title": "Exercise Program Based on Motor Learning and Forward Head Posture Correction", "conditions": [ "Musculoskeletal Abnormalities", "Deformity" ], "interventions": [ "Other: Exercise program based on motor learning principles" ], "location_countries": null, "nct_id": "NCT03006497...
#Study Description Brief Summary Comprehensive Behavioral Intervention for Tics (CBIT) is an evidence based intervention for tic disorders. A recent scientific review of research priorities completed by the Tourette Syndrome Association recommended widespread dissemination of CBIT as an important next step in service...
#Eligibility Criteria: Inclusion Criteria: * Age 7 <= age <= 17 * Presence of motor and/or vocal tics for at least 6 months * Tics are of at least moderate clinical severity as evidenced by a Clinical Global Impressions Severity (CGI-S) score of 4 or higher (tic symptoms clearly noticeable to family and occasionally t...
NCT02114905
{ "brief_title": "Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study", "conditions": [ "Tourette Disorder", "Chronic Tic Disorder" ], "interventions": [ "Behavioral: OTs Trained and Deliver CBIT" ], "location_countries": [ "...
#Study Description Brief Summary This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary dysmenorrhea. #Intervention - DRUG : Shandong Danshen-Jiang-Fu Granule - Danshen-Jiang-Fu Gra...
#Eligibility Criteria: Inclusion Criteria: * meeting the diagnostic criteria of primary dysmenorrhea in the Primary Dysmenorrhea Consensus Guideline; * meeting the diagnostic criteria of Hanning-xueyu(blood stasis due to cold accumulation) Zheng according to Gynecology of Chinese medicine; * with regular menstrual cyc...
NCT02602522
{ "brief_title": "Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea", "conditions": [ "Primary Dysmenorrhea", "Traditional Chinese Medicine" ], "interventions": [ "Drug: Sichuan Danshen-Jiang-Fu Granule", "Drug: Shandong Danshen-Jiang-Fu Granule...
#Study Description Brief Summary Protocol Summary: 1. Question Does the adjunction of a humidification system to non-invasive ventilation circuit improve sleep quality and comfort of chronic ventilated respiratory insufficient patients? Does it change the efficacy of long-term non invasive ventilation therapy and pa...
#Eligibility Criteria: Inclusion Criteria: * Type 2 chronic respiratory failure (PaCO2 > 6,5 at the time of the diagnosis) * Indication of a long term non invasive ventilation at home because of an obstructive respiratory disease, a obesity hypoventilation syndrome or a neuromuscular disease. * Over eighteen years old...
NCT03561974
{ "brief_title": "Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation", "conditions": [ "Chronic Respiratory Failure With Hypercapnia" ], "interventions": [ "Device: Humidification" ], "location_countries": [ "France" ], "nct_id": "NCT03561974", "official_title":...
#Study Description Brief Summary It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence against viral and bacterial stimuli by modulating the immune response. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether m...
#Eligibility Criteria: Inclusion Criteria: * Able to provide written informed consent. * Confirmed diagnosis of bronchiectasis by HRCT. * Aged 18 <= age <= 85 years. Exclusion Criteria: * Bronchiectasis as a result of CF or active tuberculosis or non-tuberculous mycobacterial (NTM) infection. * Allergy to macrolide ...
NCT02491723
{ "brief_title": "Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa", "conditions": [ "Bronchiectasis" ], "interventions": [ "Drug: Azithromycin" ], "location_countries": [ "China" ], "nct_id": "NCT02491723", "official_title": "Macrolide Mediates Pulmonary Infection of Pseud...
#Study Description Brief Summary Does the addition of Platelet-Rich Plasma (PRP) to release of burn contractures and skin graft on the limbs of children with retractable burn sequelae reduce the initial time of the compressive treatment and maintain or lower the graft's retraction? Detailed Description Hypothesis: ...
#Eligibility Criteria: Inclusion Criteria: * Patients with burn sequelae on their upper or lower limbs * Treated with release of burn contractures and skin graft on their upper or lower limbs * Between 5 and 21 years * Following instructions in their homes * With informed and written consent * Weight 35 Kg or more * B...
NCT00858442
{ "brief_title": "Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities", "conditions": [ "Burns" ], "interventions": [ "Procedure: With PRP" ], "location_countries": [ "Chile" ], "nct_id": "NCT00858442", "official_title": "PRP on Ch...
#Study Description Brief Summary Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood. The treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. However, approximately 70% of patients do not adhere to therapy....
#Eligibility Criteria: Inclusion Criteria: Patients experiencing treatment failure despite appropriate treatment. Patients minors aged between 3 and 15 years For children age 7 and non-autonomous children in the application of treatment, the parent at the initial consultation should be the one who treats the child. I...
NCT02193230
{ "brief_title": "Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence", "conditions": [ "Atopic Dermatitis" ], "interventions": null, "location_countries": [ "France" ], "nct_id": "NCT02193230", "official_tit...
#Study Description Brief Summary Human factors engineering literature makes clear that appropriate, well-designed and well-timed information improves decision making and can reduce mental workload. Data from a previous study showed that appropriate, well-designed and well-timed information is not present in many prim...
#Eligibility Criteria: Inclusion Criteria: * Must be greater than or equal to 65 years * Must be patients of participating physicians Exclusion Criteria: * Cannot speak English * Cannot hear well enough to respond to questions via the telephone or do not have a caregiver who can respond to questions on their behalf ...
NCT01326637
{ "brief_title": "Human Factors Intervention to Reduce Risk in Primary Care of the Elderly", "conditions": [ "Primary Health Care", "Aged", "Clinical Information" ], "interventions": [ "Other: Patient Overview Document" ], "location_countries": [ "United States" ], "nct_id": "NCT0132...
#Study Description Brief Summary The study has two arms; both experimental and control areas will receive standard interventions given under polio eradication program of PCI. Participants in the experimental arm receive additional interventions on nutrition (improve diet diversity in pregnant women and children of 6-...
#Eligibility Criteria: Inclusion Criteria: For Community * * Women aged 15 <= age <= 49 years * Willing and able to provide consent * Women in 2nd and 3rd trimester of pregnancy and / or * Women with children aged 6 <= age <= 23 months For CMC * Women aged 18+ * Currently appointed a CMC in a selected HRA...
NCT03368885
{ "brief_title": "Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI", "conditions": [ "Polio" ], "interventions": [ "Other: Maternal dietary diversity", "Other: Community mobilization", "Other: Use of existing platforms VHSND", "Other: Capacity Building", "Other: Excl...
#Study Description Brief Summary This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis. #Intervention - DRUG : GLPG1972 - Film-coated tablets of GLPG1972 for oral use. - DRUG : Placebo - F...
#Eligibility Criteria: Inclusion Criteria: * Male participants or female participants of non-childbearing potential and not breastfeeding. * Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2. * Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology. *...
NCT03595618
{ "brief_title": "A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis", "conditions": [ "Osteoarthritis" ], "interventions": [ "Drug: Placebo", "Drug: GLPG1972" ], "location_countries": [ "United States" ], "nct_id": "NCT03595618", "offici...
#Study Description Brief Summary AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects. The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent pres...
#Eligibility Criteria: Inclusion Criteria: * paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA Exclusion Criteria: * other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age...
NCT04859933
{ "brief_title": "AV Node Isolation in Atrial Fibrillation vs. Modulation by 'Pace and Ablate' Strategy", "conditions": [ "Atrial Fibrillation", "AV Node Ablation", "Escape; Rhythm" ], "interventions": [ "Procedure: AV-node ablation", "Procedure: AV-node isolation" ], "location_countries...
#Study Description Brief Summary This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion. #Intervention - DRUG : Femoston - Femoston is a C...
#Eligibility Criteria: Inclusion Criteria: * Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score>=5); * Scheduled for hysteroscopic adhesiolysis; * Agreed to have two follow-up hysteroscopy; and * Written, informed consent obtained. Exclusion Cri...
NCT02726971
{ "brief_title": "Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion", "conditions": [ "Asherman Syndrome" ], "interventions": [ "Drug: Femoston" ], "location_countries": [ "China" ], "nct_id": "NCT02726971", "official_title": "A Prospective, Randomized...
#Study Description Brief Summary This novel study supports the positive benefits of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) to older adults identified as 'at-risk' by their local senior center after participating in a prevention-focused multimodal program provided by physical therapists in t...
#Eligibility Criteria: Inclusion Criteria: * Greater than or equal to 65 years * Senior Community Center staff identified them as 'at-risk' for decline in community dwelling status due to physical, social, economic, or community-related barriers * Willingness to participate Exclusion Criteria: * Received physical th...
NCT04814459
{ "brief_title": "Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals", "conditions": [ "Fall", "Risk Reduction" ], "interventions": [ "Other: HOP-UP-PT Program" ], "location_countries": [ "United States" ], "nct_id": "NCT04814459", "official_title"...
#Study Description Brief Summary Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD), making it the most common birth defect. With recent medical advances, more children with CHD survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with CHD. Thes...
#Eligibility Criteria: Inclusion Criteria: * Open heart surgery before age 12 months of life * Ages between 7 years 0 months and 12 years 11 months * >=6 months post-cardiac surgery at enrollment * Cardiology follow-up (clinic or inpatient) at BCH or other affiliated center in the last 6 years. * English and/or Spanis...
NCT03023644
{ "brief_title": "Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study", "conditions": [ "Congenital Heart Defect", "Executive Function", "Children", "Neurodevelopmental Disorders", "Working Memory", "Infant Open Heart Surgery" ], "interv...
#Study Description Brief Summary This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or ...
#Eligibility Criteria: Inclusion Criteria: * Patients must have platinum-resistant/refractory (i.e., platinum-free interval <6 months) recurrent or persistent histologically confirmed epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Patients may have serous, endometrioid, clear cell, c...
NCT03093155
{ "brief_title": "Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab", "conditions": [ "Epithelial Ovarian Cancer", "Fallopian Tube Cancer", "Primary Peritoneal Cancer" ], "interventions": [ "Drug: Ixabepilone", "Drug: Bevacizumab" ], "location_countries": [ "Unite...
#Study Description Brief Summary A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female healthy volunteer subjects...
#Eligibility Criteria: Inclusion Criteria: * Female non-smokers aged 18 years and over * Willing and able to provide written informed consent * Generally, in good health in the opinion of the investigator * Subject must have a body mass index between 18 and 30 kg/m2, inclusive * Willing and able to comply with all stu...
NCT01184105
{ "brief_title": "A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation", "conditions": [ "Premature Ejaculation" ], "interventions": [ "Drug: Intervention A", "Drug: Intervention B" ], "location_countries": null, "nct_id": "NCT01184105", "offic...
#Study Description Brief Summary To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery. Detailed Description Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in Shuang Ho hospital. For these ...
#Eligibility Criteria: Inclusion Criteria: * Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include. * Patients who undergo fistulectomy or fistulotomy are include. Exclusion Criteria: * Emergency operation * Patients with colorectal cancer * Liver cirrhosis * Patients with coagulo...
NCT05605080
{ "brief_title": "Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery", "conditions": [ "Hemorrhoids", "Anal Fistula" ], "interventions": [ "Other: Bosmin gauze", "Device: Gelfoam" ], "location_countries": [ "Taiwan" ], "nct_id": "NCT05605080", "off...
#Study Description Brief Summary The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy. The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outc...
#Eligibility Criteria: Inclusion Criteria: * Clinical diagnosis of patellar tendinopathy * Symptoms > 3 months * Pain localized to the inferior pole of the patella * Victorian Institute of Sport Assessment (VISA) score less than 80 points * Palpation tenderness of the patellar tendon * Abnormal tendon (hypoechoic) con...
NCT03917849
{ "brief_title": "Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy", "conditions": [ "Patellar Tendinitis", "Jumper's Knee" ], "interventions": [ "Behavioral: Exercises program for patellar tendinopathy" ], "location_countries": [ "Arg...
#Study Description Brief Summary There are millions of births each year with 32% of women undergoing cesarean sections (C-sections), which results in skin scarring. Repeat C-sections increased by 178% from 1979-2010. Given the frequency of C-sections, it is important to achieve a desirable cosmetic outcome. The PICO...
#Eligibility Criteria: Inclusion Criteria: * Scheduled or non-labor repeat cesarean delivery * One or more prior cesarean section(s) with prior pfannenstiel incision scar * Gestational > 23 yearsweeks * Age 18 and older Exclusion Criteria: * Patients with malignancy in the wound bed or margins of the wound * Non-ent...
NCT05266053
{ "brief_title": "Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections", "conditions": [ "Hypertrophic Skin Condition of Anterior Abdomen" ], "interventions": [ "Other: Standard wound dressing", "Device: PICO 7 dressing" ], "location_countries": [ "United States" ], "nct_i...
#Study Description Brief Summary The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (MIST) in preterm infants. Detailed Description OBJECTIVE: To de...
#Eligibility Criteria: Inclusion Criteria: * One hundred sixty infants born at 26 <= age <= 32 weeks' gestation not endotracheally intubated in the delivery room (DR) Exclusion Criteria: * Infants with major congenital anomalies, and who required intubation in the DR and no parental consent were excluded. Sex : ALL...
NCT02287116
{ "brief_title": "Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial", "conditions": [ "Bronchopulmonary Dysplasia", "Death" ], "interventions": [ "Device: Easy Flow system and INCA® nasal cannulae set" ], "location_countries": null, "nct_id": "N...
#Study Description Brief Summary The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. Endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (HPA-axis)...
#Eligibility Criteria: Inclusion Criteria: * Inpatient treatment on the Depression ward * International Classification of Diseases (ICD)-10: F32, F33 or F31 * HDRS-17>16 Points * written informed consent Exclusion Criteria: * Any physical condition that prohibits endurance exercise * 3 or more cardiovascular risk fa...
NCT02679053
{ "brief_title": "Aerobic Exercise as add-on Treatment for Inpatients With Depression", "conditions": [ "Depression" ], "interventions": [ "Behavioral: Placebo control", "Behavioral: Aerobic exercise" ], "location_countries": [ "Switzerland" ], "nct_id": "NCT02679053", "official_title"...
#Study Description Brief Summary The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ('Study Electrode') is designed to answer basic physiological clin...
#Eligibility Criteria: Inclusion Criteria: * patients undergoing a spinal cord stimulation procedure for neuropathic pain. * have undergone a successful SCS trial and are determined eligible for a permanent SCS implant. * Patients must be fluent in English as well as mentally competent to read and answer the questionn...
NCT05459324
{ "brief_title": "Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II", "conditions": [ "Chronic Pain", "Neuropathic Pain", "Failed Back Surgery Syndrome", "Complex Regional Pain Syndromes" ], "interventions": [ "Device: HD Study Electrode" ], "location_countries":...
#Study Description Brief Summary The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal. Detailed Description Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The pu...
#Eligibility Criteria: Inclusion Criteria: * men and women between the ages of 18 <= age <= 60 * Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse * Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the ...
NCT00217971
{ "brief_title": "Dronabinol Treatment for Marijuana Addiction", "conditions": [ "Marijuana Abuse" ], "interventions": [ "Drug: Placebo", "Drug: Dronabinol" ], "location_countries": [ "United States" ], "nct_id": "NCT00217971", "official_title": "A Randomized, Double-Blind, Placebo-Con...
#Study Description Brief Summary Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly increase mortality, length of stay, and costs, however detection has proven difficult as markers like elevated creatinine and decreased urine output may take days to manifest and are late indic...
#Eligibility Criteria: Inclusion Criteria: * trauma patients with multiple injuries; * abdominal injuries; * crush injuries; * those who present in shock (systolic blood pressure <90 or mean arterial pressure <65); * require blood transfusions, vasopressors or mechanical ventilation Exclusion Criteria: * known pregn...
NCT02765464
{ "brief_title": "Acute Kidney Injury in Critically Ill Patients", "conditions": [ "Acute Renal Injury" ], "interventions": null, "location_countries": [ "United States" ], "nct_id": "NCT02765464", "official_title": "Predicting Acute Kidney Injury in Critically Ill Trauma Patients Using Metallop...
#Study Description Brief Summary Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to...
#Eligibility Criteria: Inclusion Criteria: * Smoking, apparently healthy subject as judged by the Investigator. * Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting. * Subject has smoked for at least the last 3 consecutive years. * Subje...
NCT01989156
{ "brief_title": "Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting", "conditions": [ "Smoking" ], "interventions": [ "Other: Menthol Conventional Cigarette (mCC)", "Other: THS 2.2 Menthol (mTHS 2.2)", "Other: Smoking A...
#Study Description Brief Summary This randomized clinical trial studies the preliminary efficacy of a yoga skills training (YST) compared to counseling and education (CE) for reducing treatment-related symptoms in patients with colorectal cancer who are receiving chemotherapy. The YST may reduce fatigue, other treatm...
#Eligibility Criteria: Inclusion Criteria: * Signed protocol specific informed consent * Are diagnosed with colorectal cancer * Recruited within 2 weeks of initiating chemotherapy (including reinitiating chemotherapy after a treatment holiday of greater than or equal to 4 weeks) * Able to understand written and spoken...
NCT01590147
{ "brief_title": "Supportive Intervention Programs Study", "conditions": [ "Fatigue", "Nausea and Vomiting", "Pain", "Recurrent Colon Cancer", "Recurrent Rectal Cancer", "Stage I-IVB Colon Cancer", "Stage I-IVB Rectal Cancer" ], "interventions": [ "Other: educational intervention...
#Study Description Brief Summary The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes. Detailed Description Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an...
#Eligibility Criteria: Inclusion Criteria: * Age greater than or equal to 18 years * Self-reported diagnosis of type 2 diabetes Exclusion Criteria: * Not diagnosed with type 2 diabetes * Diagnosed with type 1 diabetes * Known to be pregnant (Self Reported) * Receiving dialysis or having known renal compromise...
NCT01346033
{ "brief_title": "Evaluation of SCOUT DS in Subjects With Type 2 Diabetes", "conditions": [ "Type 2 Diabetes" ], "interventions": null, "location_countries": [ "United States" ], "nct_id": "NCT01346033", "official_title": "An Evaluation of a Non-invasive Diabetes Screening Device in Subjects Wit...
#Study Description Brief Summary The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be em...
#Eligibility Criteria: Inclusion Criteria: A patient is deemed suitable for inclusion in the study if the patient meets the following criteria: * Male or female at least 18 years * IC/BPS diagnosed by a health care provider based the following criteria: Complaint of suprapubic pain related to bladder filling, acc...
NCT01393223
{ "brief_title": "Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome", "conditions": [ "Interstitial Cystitis" ], "interventions": [ "Drug: Normal saline", "Drug: LP-08 20mg", "Drug: LP-08 80mg" ], "location_countries": [ "United States" ], ...
#Study Description Brief Summary The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines rec...
#Eligibility Criteria: Inclusion Criteria: * Screening for colorectal neoplasia * Surveillance after previous polypectomy/endoscopic mucosal resection (EMR) * Positive results on colorectal cancer (CRC) screening tests * Evaluation of clinical symptoms of non overt gastrointestinal bleeding * Indeterminate iron-defici...
NCT03000361
{ "brief_title": "Motorized Spiral Colonoscopy Trial: A First Feasibility Trial", "conditions": [ "Colonoscopy", "Safety Issues", "Adenoma" ], "interventions": [ "Procedure: Motorized Spiral Colonoscopy" ], "location_countries": [ "Germany" ], "nct_id": "NCT03000361", "official_tit...
#Study Description Brief Summary To evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. To evaluate the effects of Mild to moderate valvular diseases with Newyork Heart Association (NYHA) grade I and II . Previous studies were designed to target on Coronary artery bypass graft surger...
#Eligibility Criteria: Inclusion Criteria: * Patients awaiting heart valve surgery for repair or replacement * Both gender * Mild to moderate valvular diseases * NYHA grade I and II * Pre-frail to moderately frail patients with a CFS of 4 <= age <= 6 * Patients with an estimated 6 <= age <= 8 weeks of surgical waiting...
NCT04993963
{ "brief_title": "Prehabilitation and Heart Valve Surgery", "conditions": [ "Valvular Heart Disease" ], "interventions": [ "Other: Control Standard Group", "Other: Cycle Ergometery Training (Prehabilitation)" ], "location_countries": [ "Pakistan" ], "nct_id": "NCT04993963", "official_t...
#Study Description Brief Summary To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide. #Intervention - DRUG : Placebo - DRUG : 2% Rebamipi...
#Eligibility Criteria: Inclusion Criteria: * Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy. * Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions. 1. Definitive therapy: nasopharynx, oropharynx, hypopharynx...
NCT02085460
{ "brief_title": "A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer", "conditions": [ "Head and Neck Cancer" ], "interventions": [ "Drug: 4% Rebamipide liquid", "Drug: Placebo", "D...
#Study Description Brief Summary In patients with a chronic renal disease at the terminal stage, extrarenal epuration is essential for the control of clinico-biological complications. Two extrarenal epuration techniques are currently available: peritoneal dialysis (using the peritoneal membrane of the patient) and he...
#Eligibility Criteria: Inclusion Criteria: * All patients undergoing dialysis within the CHU Brugmann Hospital Exclusion Criteria: * Mutation of factor V * Mutation G20210A of the prothrombin gene * Protein C deficiency * Protein S deficiency * Antithrombin III deficiency Sex : ALL Ages : - Minimum Age : 18 Year...
NCT03893357
{ "brief_title": "Prevalence of Antiphospholipid Antibodies in the Hemodialysis Patients Population Within the CHU Brugmann Hospital", "conditions": [ "Antiphospholipid Syndrome" ], "interventions": [ "Other: Data extraction from medical files" ], "location_countries": [ "Belgium" ], "nct_id...
#Study Description Brief Summary Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Therapeutic exercises are widely employed in the attempt to delay or minimize disease progression, characterized by significant motor and s...
#Eligibility Criteria: Inclusion Criteria: * medical diagnosis of idiopathic Parkinson's disease present for at least 12 months, * spontaneous demand for treatment, * in clinical follow-up and pharmacological treatment by a responsible physician, * Parkinson's classification of 1.5 <= age <= 3 according to the Hoehn a...
NCT03473522
{ "brief_title": "Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.", "conditions": [ "Parkinson Disease" ], "interventions": [ "Device: tDCS", "Behavioral: Exercise Therapy" ], "location_countries": [ "Brazil" ], "nct_id": "NCT03473522", "offici...
#Study Description Brief Summary The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia accordin...
#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed (e.g., slide of tissue) breast cancer * HER2/NEU positive or negative * Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy * Received 1st and 2nd line chemother...
NCT00338286
{ "brief_title": "A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy", "conditions": [ "Breast Cancer", "Neoplasm Metastasis" ], "interventions": [ "Other: Standard supportive car...
#Study Description Brief Summary In obese patients the superficial adipose tissue works as an endocrine active tissue to express different cytokines, and multiple molecular pathways implied in the cross talking with different part of the human body, such as the cardiovascular system. To date, adipocytes and adipose t...
#Eligibility Criteria: Inclusion Criteria: * body mass index > 30; * prediabetes; * normal glycemic blood profile; * both gender; * > 18 yearsand < 65 years. Exclusion Criteria: * body mass index < 30; * diabetes; * age < 18, and > 65 years. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age...
NCT03491241
{ "brief_title": "Inflammatory Axis and Sirtuins' in Overweight Pre-diabetics Patients", "conditions": [ "Pre-diabetes", "Obesity" ], "interventions": [ "Dietary Supplement: hypocaloric diet therapy" ], "location_countries": [ "Italy" ], "nct_id": "NCT03491241", "official_title": "Effe...
#Study Description Brief Summary To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women. Detailed Description The Phase 2a study is a randomized, double-blind multiple-dose study that is expected t...
#Eligibility Criteria: Inclusion Criteria: * Be a female between 18 <= age <= 45 of age. * Have at least one well defined dimple that is at least 1 cm but not more than 2 cm along the long axis and that is evident when the subject is standing * Have a photonumeric cellulite severity scale (CSS) score between 6 and 12 ...
NCT01987986
{ "brief_title": "A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy", "conditions": [ "Edematous Fibrosclerotic Panniculopathy (EFP)" ], "interventions": [ "Biological: Collagenase Clostridium...
#Study Description Brief Summary The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients. Detailed Description The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine w...
#Eligibility Criteria: Inclusion Criteria: * Age > 18 years * Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours * Expected duration of critical care unit admission > 48 hours Exclusion Criteria: * History of chlorhexidine allergy Sex : ALL Ages : - Minimum Age : 18...
NCT01989416
{ "brief_title": "Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients", "conditions": [ "Antibiotic Resistant Infection" ], "interventions": [ "Drug: Soap", "Drug: 2% chlorhexidine wipe" ], "location_countries": [ "Thailand" ]...
#Study Description Brief Summary This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion. Detailed Description Degenerative spondylolisthesis is defined as the slip of one vertebra onto the other due to d...
#Eligibility Criteria: Inclusion Criteria: * Adults aged less than 75, * Having been informed about clinical trial objectives and risk, * Covered by health insurance system, * Suffering from degenerative spondylolisthesis (whatever the grade and intervertebral disc height) needing one-level surgical fusion due to eith...
NCT00869882
{ "brief_title": "SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis", "conditions": [ "Degenerative Spondylolisthesis" ], "interventions": [ "Procedure: Circumferential arthrodesis", "Procedure: Posterolateral fusion with instrumentation" ], "locat...
#Study Description Brief Summary Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and ...
#Eligibility Criteria: Inclusion Criteria: * Patients must provide written informed consent before any study-related procedures are performed. * Patients must be 50 years or older at Screening/Baseline. Study eye: * Active CNV lesions secondary to nAMD diagnosed < 18 months prior to Screening/Baseline that affect ...
NCT04264819
{ "brief_title": "Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration", "conditions": [ "Neovascular Age-Related Macular Degeneration" ], "interventions": [ "Drug: RTH258/Brolucizumab" ], "location_countries": [ "France" ...
#Study Description Brief Summary To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load, procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American College o...
#Eligibility Criteria: Inclusion criteria: * Patients admitted in the ICU, with an expected length of mechanical ventilation > 3 days. * Not receiving antibiotics for >24 hrs before ICU admission- An expected length of mechanical ventilation > 3 days Exclusion Criteria: * Patients <18 yrs old * Pregnancy and lactati...
NCT02078999
{ "brief_title": "Biomarkers in Patients Undergoing Mechanical Ventilation", "conditions": [ "Ventilator Associated Pneumonia" ], "interventions": null, "location_countries": [ "Spain" ], "nct_id": "NCT02078999", "official_title": "Observational Study in Patients Admitted in the Intensive Care U...
#Study Description Brief Summary Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible. Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillom...
#Eligibility Criteria: Inclusion Criteria: * older than18 years * Under invasive mechanical ventilation * Sedated with i) a Richmond Agitation Sedation Scale (RASS) : >= -4 and <1, ii) being unable to evaluate their pain by a visual numeric scale Exclusion Criteria: * Ophthalmological diseases which could modify the...
NCT05469841
{ "brief_title": "Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit.", "conditions": [ "Critical Illness" ], "interventions": [ "Other: Systemic pain assessment" ], "location_countries": [ "France" ], "nct_id": "NCT05469841", "official_title": "Pupi...
#Study Description Brief Summary The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension. #Intervention - DRUG : Olmesartan - 10 mg, 20 mg, 40 mg capsules - DRUG : Placebo - Matching placebo of LCZ696 tablet, mat...
#Eligibility Criteria: Inclusion Criteria: * Patients must give written informed consent before any assessment is performed * Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure >= 150 mmHg and < 180 mmHg * Patients must be able ...
NCT01615198
{ "brief_title": "Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension", "conditions": [ "Essential Hypertension" ], "interventions": [ "Drug: Placebo", "Drug: LCZ696", "Drug: Olmesartan" ], "location_countries": [ "Japan", "China"...
#Study Description Brief Summary This study aimed to investigate the efficacy of different physical therapy protocols in the treatment of chronic plantar fasciitis patients. Patients in this study were randomly assigned into 3 groups. Group A received ultrasound therapy protocol, group B received radial shock wave th...
#Eligibility Criteria: Inclusion Criteria: * Patients suffered plantar fasciitis of more than 3 months * Maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning Exclusion Criteria: * Bilateral plantar fasciitis * Previou...
NCT04967703
{ "brief_title": "Physiotherapy Protocols in Treating Plantar Fasciitis", "conditions": [ "Plantar Fascitis" ], "interventions": [ "Procedure: Group A", "Procedure: Group B", "Procedure: Group C" ], "location_countries": [ "Saudi Arabia" ], "nct_id": "NCT04967703", "official_title"...
#Study Description Brief Summary The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addi...
#Eligibility Criteria: Inclusion Criteria: * Patients with sickle cell disease should have one or more of the following: acute chest syndrome requiring hospitalization; nonhemorrhagic stroke or central nervous system event lasting longer than 24 hours; recurrent caso-occlusive pain or recurrent priapism; sickle neurop...
NCT00153985
{ "brief_title": "Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies", "conditions": [ "Hemoglobinopathies", "Sickle Cell Disease", "Thalassemia" ], "interventions": null, "location_countries": [ "United States" ], "nct_id": "NCT00153985", "of...
#Study Description Brief Summary Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often dif...
#Eligibility Criteria: Inclusion Criteria: * Prevalent recurrence free patients with cancers in the tongue, oral cavity, pharynx and larynx attending the oncology clinic at Herlev Hospital, Herlev, Denmark. 9 months to 5 years after end of treatment Exclusion Criteria: * Patients with recurrence of their cancers and...
NCT01803061
{ "brief_title": "Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care", "conditions": [ "Head and Neck Cancer Patients", "Late Effects" ], "interventions": [ "Behavioral: WebCan" ], "location_countries": [ "Denmark" ...
#Study Description Brief Summary The proposed project will examine a promising brief therapy for posttraumatic stress Disorder (PTSD) for use in Veterans Health Administration (VHA) Primary Care and its impact on functional outcomes. This intervention will provide an alternative point of access to effective PTSD trea...
#Eligibility Criteria: Inclusion Criteria: * Any era Veterans seeking care in VA PC for PTSD symptoms [PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) of at least 28)] and PTSD confirmed based on Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) * English speaking * Repo...
NCT03581981
{ "brief_title": "Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)", "conditions": [ "Posttraumatic Stress Disorder" ], "interventions": [ "Behavioral: Treatment as Usual", "Behavioral: Prolonged Exposure for Primary Care (PE-PC)" ], "location_countries":...
#Study Description Brief Summary The aim is to evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE) procedures. Detailed Description The use of femtosecond (FS) laser has become one of the most si...
#Eligibility Criteria: Inclusion Criteria: * minimum age of 18 years(range from 18 year to 25 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between * 2.00 diopter (D) and -6.50 D; preoperative cylindrical equivale...
NCT02540785
{ "brief_title": "Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction", "conditions": [ "Myopia", "Astigmatism" ], "interventions": [ "Procedure: lenticule extraction", "Procedure: small-incision lenticule extraction" ], "location_countries": null, "nct_id": ...
#Study Description Brief Summary The goal of this research study is to compare three harm reduction approaches for at-risk college student drinkers. One approach provides generic risk-related information after an initial interview/questionnaire assessment session. A second approach uses an established motivational in...
#Eligibility Criteria: Inclusion Criteria: * We initially screen anonymously on the telephone for the inclusion/exclusion criteria (see attached phone screen). The responses obtained from respondents are used only to determine if they meet study criteria. Their names and responses are not recorded and the information ...
NCT01757353
{ "brief_title": "Detroit Area Study of College Student Lifestyles", "conditions": [ "Excessive Alcohol Consumption" ], "interventions": [ "Behavioral: BASICS motivational interview", "Behavioral: Self-directed: Information only", "Behavioral: BASICS plus normative enhancement motivational inter...
#Study Description Brief Summary The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criter...
#Eligibility Criteria: Inclusion Criteria: * Patients must have histologically confirmed advanced breast cancer * For the dose escalation phase: Patients must be refractory to standard therapy or for which no curative standard therapy exists, to be considered. * For the phase II: Patients with histologically confirmed...
NCT00719875
{ "brief_title": "HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer", "conditions": [ "Advanced Breast Cancer" ], "interventions": [ "Drug: Vorinostat" ], "location_countries": [ "United States" ], "nct_id": "NCT00719875", ...
#Study Description Brief Summary The purpose of the study is to develop and pilot-test a home-based intervention to facilitate sate HIV testing and disclosure within pregnant couples in order to increase use of prevention-of-mother-to-child-transmission (PMTCT) and family health services in Kenya. Detailed Descripti...
#Eligibility Criteria: Inclusion Criteria: * (a) 18 years or older (b) 36 weeks of pregnancy or less (c) has been offered HIV testing at ANC, (d) is currently in a stable relationship (married or cohabiting) with a male partner of duration of at least 6 months (e) is currently living with a male partner who will be in...
NCT02403583
{ "brief_title": "Jamii Bora: A Home-Based Couples Intervention", "conditions": [ "Human Immunodeficiency Virus" ], "interventions": [ "Behavioral: Intervention- Home Visits" ], "location_countries": [ "Kenya" ], "nct_id": "NCT02403583", "official_title": "Jamii Bora: A Home-based Couples ...
#Study Description Brief Summary Endodontic therapy is to achieve the eviction of the inflamed or infected pulp and fill the canal opening with a hermetic sealing material. The analysis of the literature on intracanal therapeutic shows great variability of the results obtained, the reported success rate is 53 to 95%...
#Eligibility Criteria: Inclusion Criteria: * Patients aged at least 18 years * Patient receiving endodontic treatment for a tooth with a periapical pathology (Category IV of Baume) * Patients affiliated to a social security scheme or of such a regime, * Patients admitted to the CSERD, * Patients in good general health...
NCT02819258
{ "brief_title": "Monocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)", "conditions": [ "Dental Pulp Disorder" ], "interventions": [ "Other: Endodontic treatment" ], "location_countries": [ "France" ], "nct...
#Study Description Brief Summary The purpose of this study is to evaluate the effectiveness and safety of IONIS-FB-LRx, an antisense inhibitor of complement factor B messenger ribonucleic acid (CFB mRNA), and to evaluate the effect of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in partic...
#Eligibility Criteria: Inclusion Criteria * Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control * Biopsy-proven primary immunoglobulin A (IgA) nephropathy * Hematuria * Proteinuria Exclusion Criteria * Clinically significa...
NCT04014335
{ "brief_title": "A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy", "conditions": [ "Primary IgA Nephropathy" ], "interventions": [ "Drug: IONIS-FB-LRx" ], "location_countries": [ ...
#Study Description Brief Summary This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mo...
#Eligibility Criteria: Inclusion Criteria: * systemically healthy individuals of > 30 years with previously untreated generalized chronic periodontitis (defined by Armitage in 1999), * having minimum 15 teeth, * minimum of six teeth with at least one interproximal site with PPD between 5 <= age <= 7mm, * CAL between 5...
NCT04074915
{ "brief_title": "Effects of Herbal Mouth Rinse for Chronic Periodontitis", "conditions": [ "Chronic Periodontitis" ], "interventions": [ "Other: Placebo mouth rinse", "Drug: Test group", "Drug: Chlorhexidine mouth rinse" ], "location_countries": [ "India" ], "nct_id": "NCT04074915",...
#Study Description Brief Summary Leucine supplementation could be useful to support muscle anabolism. This study aims to investigate the effects of leucine supplementation on muscle mass and muscle strength in young subjects undergoing resistance training. #Intervention - DIETARY_SUPPLEMENT : Leucine - DIETARY_SUP...
#Eligibility Criteria: Inclusion Criteria: * training experience > 12 months * no previous use of anabolic steroids * no diagnosed diseases or injuries at the time of recruitment * one-maximum repetition strength (1-RM) in leg press >= 3.5 and <= 5.0 times the body weight Exclusion Criteria: * use of creatine or bet...
NCT02744443
{ "brief_title": "Leucine Supplementation in Young Subjects Undergoing Resistance Training", "conditions": [ "Healthy Volunteers" ], "interventions": [ "Dietary Supplement: Placebo", "Dietary Supplement: Leucine" ], "location_countries": [ "Brazil" ], "nct_id": "NCT02744443", "official...
#Study Description Brief Summary Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To impr...
#Eligibility Criteria: Inclusion Criteria: * Able to provide informed written consent. * PSA < 20. * Referred for prostate biopsy. Exclusion Criteria:: * Previously diagnosed with prostate cancer. * Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies. * Previou...
NCT03730324
{ "brief_title": "Predicting Prostate Biopsy Results With Biomarkers and mpMRI.", "conditions": [ "Prostate Cancer" ], "interventions": [ "Diagnostic Test: Urine and plasma biomarkes.", "Diagnostic Test: mpMRI" ], "location_countries": [ "Denmark" ], "nct_id": "NCT03730324", "official_...
#Study Description Brief Summary The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects. These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS). The investigators want to determine if brain functional imaging and cognit...
#Eligibility Criteria: Inclusion criteria : * Subjects males and females with more than 18 y.o, age and sex-matched with patients with Kleine-Levin Syndrome * with the same educational level and dominant hand than patients with Kleine-Levin Syndrome * without any brain disease or sleep disease (Epworth score < 11/24) ...
NCT02337023
{ "brief_title": "Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects", "conditions": [ "Healthy Subjects", "Kleine-Levin Syndrome" ], "interventions": [ "Radiation: Brain scintigraphy with injection of Neurolite® (ECD)" ], "location_countries": [ "France" ], "nct_id": "NC...
#Study Description Brief Summary The purpose of this survey is to collect the data on perceptions, behaviours and awareness related to obesity and obesity management for People with Obesity (PwO) and Health Care Professionals (HCP) treating obesity. Data will be collected via online surveys among each of the responde...
#Eligibility Criteria: Inclusion Criteria: - PEOPLE WITH OBESITY - Age at least 18 years, both males and females - On-line consent to participate in study - Lives in one of the participating countries: Italy, Spain, United Kingdom (UK), Brazil, Chile, Mexico, Australia, Israel, Saudi Arabia, United Arab Emirates (UAE),...
NCT03584191
{ "brief_title": "Awareness, Care & Treatment In Obesity Management - An International Observation", "conditions": [ "Obesity" ], "interventions": [ "Other: No treatment given" ], "location_countries": [ "Israel", "Saudi Arabia", "Mexico", "United Arab Emirates", "United Kingdom"...
#Study Description Brief Summary The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece. #Intervention - DEVICE : ReSTOR ...
#Eligibility Criteria: Inclusion Criteria: * diagnosed with bilateral cataracts * candidate for presbyopic lens Exclusion Criteria: * >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings * pre-existing conditions that could skew the results Sex : ALL Ages : - Minimum Age : 21 Years - Age Group (Chil...
NCT01166971
{ "brief_title": "A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)", "conditions": [ "Cataract" ], "interventions": [ "Device: Tecnis MF", "Device: ReSTOR +3" ], "location_countries": [ "United States" ], "nct_id": "NCT011669...
#Study Description Brief Summary The primary objective of the study is to compare the effect of PM101 I.V. administered as an immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest valu...
#Eligibility Criteria: Inclusion Criteria: * Be a healthy male or female 18 <= age <= 55 of age, inclusive. Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial and must have a negative serum pregnancy test at screening and upon check-in to the study ...
NCT00502346
{ "brief_title": "A Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers", "conditions": [ "Healthy" ], "interventions": null, "location_countries": [ "Canada" ], "nct_id": "NCT00502346", "official_title": "A Randomized, Double-blind, Do...
#Study Description Brief Summary The aim of this study is to determine the combined effect of SLP along with Physiotherapy in improving Type 2 DPN patients taking OHAs and GLP-1 analogues. Detailed Description Diabetes mellitus (DM) is a chronic metabolic disease defined by persistently increased blood glucose leve...
#Eligibility Criteria: Inclusion Criteria: * Gender includes both male and female * Patients between age group 40 <= age <= 75 years * Clinically diagnosed patients of Type 2 diabetes on OHAs and GLP-1 analogues * Diabetic patients with symptomatic peripheral neuropathy (Severity of DPN is associated with a physical e...
NCT04813146
{ "brief_title": "Role of Synchronized Lifestyle Modification Program on Diabetic Neuropathy Taking Oral Hypoglycemics", "conditions": [ "Diabetic Neuropathies" ], "interventions": [ "Other: SLP along with Physiotherapy", "Other: Physiotherapy", "Other: SLP" ], "location_countries": [ "P...
#Study Description Brief Summary Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life. The investigat...
#Eligibility Criteria: Inclusion Criteria: * The patient's surrogate was enrolled in 'ICU Rounding Summaries for Families of Critically Ill Patients' (NCT03969810) and the patient had COVID-19 * The patient has been discharged from the hospital Exclusion Criteria: * None Sex : ALL Ages : - Minimum Age : 18 Years...
NCT04501445
{ "brief_title": "Psychological Symptoms and Families of COVID-19 Patients", "conditions": [ "Family Members", "Post Intensive Care Unit Syndrome", "Post Traumatic Stress Disorder" ], "interventions": [ "Behavioral: Written Summary of Rounds" ], "location_countries": [ "United States" ...
#Study Description Brief Summary The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in patients with chronic HCV infection. Detailed Description Randomized, placebo-controlled, double-blind, parallel group, multicenter, dose response trial utilizing four doses of CTS-1027, admini...
#Eligibility Criteria: Inclusion Criteria: * Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial * A history of chronic HCV infection * Unsuccessful...
NCT00570336
{ "brief_title": "Study of CTS-1027 in Hepatitis C Patients", "conditions": [ "Chronic Hepatitis C Virus Infection" ], "interventions": [ "Other: Placebo", "Drug: CTS-1027" ], "location_countries": [ "United States" ], "nct_id": "NCT00570336", "official_title": "A Dose Response Study o...
#Study Description Brief Summary The goal of this clinical research study is to learn if a type of MRI scan called diffusion weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to learn if DWI can predict how tumors will respond to radiation therapy. Detailed Description If yo...
#Eligibility Criteria: Inclusion Criteria: * All patients who have gynecologic malignancies involving the middle third and the distal third of the vagina who will be receiving radiation therapy * Patients who have gynecologic malignancies involving the upper, middle and/or lower third of the vagina or are undergoing p...
NCT01703195
{ "brief_title": "Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina", "conditions": [ "Vaginal Cancer" ], "interventions": [ "Procedure: Diffusion Weighted Magnetic Resonance Imaging (DWMR)", "Procedure: Magnetic Resonance Imaging (MRI)" ], "location_countries": [ "...
#Study Description Brief Summary Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event....
#Eligibility Criteria: Inclusion Criteria: ( - )MI >= 6 months before assessment ( - )Age 18 <= age <= 75 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score >=20) ( - ) On optimal medical treatment ( - )Able to read and write in S...
NCT05128981
{ "brief_title": "Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction", "conditions": [ "Myocardial Infarction", "Cardiac Anxiety", "CBT", "Exposure" ], "interventions": [ "Behavioral: MI-CBT" ], "location_countries": [ "Sweden" ], "nct_id": "NCT051289...