bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)
Condition: CTEPH
Study type: Interventional
Phase: Phase 3

Summary: 
      This is phase III trial to evaluate whether edoxaban, a direct factor Xa inhibitor, is
      noninferior to warfarin in preventing worsening of chronic thromboembolic pulmonary
      hypertension (CTEPH).
    


Intervention name(s): Edoxaban; Warfarin Potassium; Warfarin Potassium placebo; Edoxaban placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): - Edoxaban 30 mg/60 mg tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications; - Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5); - Warfarin K 1 mg placebo tablets once daily; - Edoxaban 30 mg/60 mg placebo tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications
Intervention MeSH terms: Warfarin; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Edoxaban; DOAC; Wafrarin; Anticoagulation
A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo
Condition: Vertigo
MeSH terms: Vertigo; Dizziness
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120
      patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to
      evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the
      effective dosage for phase IIb clinical study, to study the safety of Levophencynonate
      Hydrochloric.
    

Detailed description: 
      This study will conduct in 15 sites to enrolled 120 patients with vertigo under 7 days
      treatment and 7 days follow-up. The study includes three arms: high dose, low dose and
      placebo control.To observe the efficacy by change of vertigo severity and duration,and safety
      by vital sign,adverse event,etc.
    

Intervention name(s): Levophencynonate Hydrochloric; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): this drug is M receptor inhibitor; No active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
Condition: Hysteroscopic Adhesiolysis
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.
    

Detailed description: 
      Intrauterine adhesions following gynaecological surgery is a major complication which may
      cause a range of severe clinical symptoms in women. IUA's can result in menstrual
      abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to
      miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and
      possibly birth defects.

      CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the
      prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or
      laparoscopy.

      This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic
      surgery.
    

Intervention name(s): CollaGUARD
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and
      Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Doxirazole; Dexilant
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule contains 60 mg Dexlansoprazole; 1 capsule contains 60 mg Dexlansoprazole
Other intervention name(s): Dexilant
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention
Condition: Obesity; Behavior, Health; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The aim of this study is to compare brain changes in individuals with overweight or obesity
      enrolled in either the Noom Healthy Weight program or a matched control. The study objectives
      (primary and secondary) are to measure brain change reported as ERP and EEG data over a
      16-week timeframe. Additionally, we will explore changes in the default mode network
      (resting-state asymmetry in EEG measurements), changes in executive functioning, quality of
      life, mood, and salivary markers as they relate to EEG data.
    


Intervention name(s): Noom Healthy Weight; mobile behavior change program for weight loss.; Matched Control
Intervention type(s): Behavioral; Other
Intervention description(s): The mobile cognitive behavior change program follows guidelines from the Obesity Society's "2013 Guidelines for the Management of Overweight and Obesity in Adults" NIH "Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults".
There are 52 weeks of curriculum with 1-3 articles to read per day. Users are requested to perform weight logging once daily and food logging after each meal. Users are assigned human coaches and are able to interact with them via in-app messaging or phone communication. Users are also assigned to support groups via in-app messaging.; Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: EEG, mhealth, weight loss, CBT, cognitive behavior therapy
Sunscreen RV 2457C in Photoinduced CLE
Condition: Cutaneous Lupus Erythematosus; Skin Lesion; Experimental Photoinduction; Protective Sunscreen
MeSH terms: Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 3

Summary: 
      Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well
      established factor in the induction and exacerbation of this disease. In all subsets of LE,
      skin lesions occur preferentially in sun-exposed areas.

      Previous studies have demonstrated that the lesions in LE patients reproduced in controlled
      experimental conditions. The initial reports suggested that the action spectrum for the LE
      was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320
      to 400 nm) can contribute to the induction of LE skin lesions.

      Antimalarial agents and topical steroids are the main treatments of chronic LE. The second
      line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid
      and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing
      and to apply sunscreen.

      The aim of this study was to assess the efficacy of a sunscreen milk with high protection
      factor against UV-B and UV-A, used exclusively, in the photoinduced LE.
    


Intervention name(s): sunscreen RV 2547C
Intervention type(s): Drug
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: cutaneous lupus erythemaosus; photoprotection; photoprovocation; Sunscreen RV 2547C
Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points
Condition: Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, single- center, randomized (1:1) clinical trial comparing the
      effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in
      the masseter muscle versus the saline injection.
    

Detailed description: 
      The proposal presents the magnesium sulphate (MgSO4) as a possible injection treatment for
      TrPs. The MgSO4 prevents the release of pre-synaptic acetylcholine from neuromuscular and
      sympathetic junctions that could explain the ability of the MgSO4 to relax the muscle and
      reduce pain Specific aim: evaluate the effectiveness of magnesium sulphate injections in
      treatment of myofascial trigger points in the masseter muscle versus the saline injection.

      Hypothesis: the injection of masseter muscle trigger points with magnesium sulphate is more
      effective than saline injection in pain relief.
    

Intervention name(s): Magnesium sulfate; Saline
Intervention type(s): Drug; Drug
Intervention description(s): each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator; each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator
Other intervention name(s): Study; Control
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: trigger point; masseter muscle; myofascial pain; magnesium sulphate
The Safety and Effectiveness of Low and High Carbohydrate Diets
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins
      diet) with a high carbohydrate diet (conventional USDA diet).
    

Detailed description: 
      Despite the considerable mass appeal of popular diet books, such diet approaches lack data to
      support their efficacy and safety. Despite its widespread use for more than 30 years, the
      Atkins diet has never been evaluated in a large, randomized, controlled trial. This study
      will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a
      high-carbohydrate diet in overweight and obese men and women.

      Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate,
      unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low-fat). The
      study will evaluate the effects of each dietary approach on changes in: 1) weight and body
      composition; 2) metabolic and organ function; and 3) exercise tolerance. Each participant
      will be enrolled in the study for 2 years.
    

Intervention name(s): Low-calorie diet; low-carbohydrate diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): low-calorie diet; low-carbohydrate diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss
Cooking Classes for Young Adults With ID
Condition: Intellectual Disability, Mild to Moderate
MeSH terms: Intellectual Disability
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility and initial efficacy of a healthy
      lifestyles intervention for the prevention of weight gain and the promotion of basic life
      skills related to improving health in transition age young adults with intellectual
      disabilities.
    

Detailed description: 
      This is a single arm, longitudinal trial. 30 young adults with intellectual disabilities will
      be recruited to participate in a 12-week, healthy lifestyles intervention, delivered in
      person to a group of individuals with ID at the Center for Children's Healthy Lifestyles and
      Nutrition. Participants will be asked to attend one 2 hr group session each week (~5-6
      participants per group). All sessions will have an education component, a hands-on
      nutrition/cooking lesson, and a group exercise session. Additionally, participants will be
      asked to attend a 20-minute monthly individual goal setting session conducted remotely over
      Zoom video conferencing. All sessions will be conducted by a trained health educator
      experienced in working with individuals with intellectual disabilities. Tablet computers and
      Fitbit wireless activity monitors will be provided to all participants, with study issued
      HIPPA compliant Zoom and Fitbit accounts. Outcome assessments will be collected at baseline
      and after the 12-week intervention.
    

Intervention name(s): Cooking Skills; Physical Activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This session will consist of a hands-on cooking demonstration in a demo kitchen. Skills addressed in this portion of the session will include proper kitchen utensil and appliance use, measuring dry and wet ingredients, following/reading a recipe, preparing ingredients, cooking a meal, etc. The participant will follow a visual recipe that provides a breakdown of each skill needed to complete each step of the recipe. Additionally, during the cooking session investigators will address nutrition topics related to food/kitchen safety, basic nutrition education (i.e., portion sizes, food groups, reading food labels, meal planning etc.) in a discussion format.; This session will consist of a group functional fitness class. Each session will include a warm-up (~5 min) moderate-to-vigorous intensity aerobic and resistance exercise (~20 min) and cool-down/stretching (~5 min). Exercises may be accompanied by music and will include walking/jogging, dancing, imitating animal movements, vertical/horizontal jumps, squats, hurdles, walking on balance beam etc. Thera-Band, kettle bells, free weights, and medicine balls will be used during strength exercises for major muscle groups. These sessions will be led by certified personal trainers with experience in adaptive physical activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily
      dosage form currently under investigation as a potential treatment for people with type 2
      diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of
      Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes
      mellitus.
    


Intervention name(s): placebo; placebo; Exenatide LAR; Exenatide LAR
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg; Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg; Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.; Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.
Other intervention name(s): Bydureon; Bydureon
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; exenatide; long acting release; Amylin; Lilly
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess in overweight to obese subjects the change in sleep energy expenditure after
      repeated subcutaneous (SC) doses of SAR425899.

      Secondary Objectives:

        -  To assess the change in resting, basal and total daily energy expenditure.

        -  To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.

        -  To assess the change in body composition and core temperature.

        -  To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid
           metabolism and glycated hemoglobin (HbA1c).

        -  To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.

        -  To assess the safety and tolerability.
    

Detailed description: 
      Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment
      period and an end-of-study visit 7 days after last dosing.
    

Intervention name(s): SAR425899; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Self-Monitoring Assessment in Real Time
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to test the effectiveness of two different methods of mobile
      dietary self-monitoring for weight loss. Both of these interventions will provide weight loss
      information through twice weekly audio podcasts. In addition to the podcasts, participants
      will be asked to track their diet using an assigned mobile applications (for their
      smartphone), which will be randomly assigned.
    

Detailed description: 
      This study will include an intensive phase for 6 weeks and a follow-up phase that will occur
      through the final 6 months of the study. Participants will attend one 1-hour orientation
      meeting at the beginning of the study and a 2-hour baseline assessment and training meeting.
      A final assessment will be conducted at the end of 6 weeks with a follow-up assessment at 6
      months. Everyone in the study will be asked to listen to 2 podcasts per week. Each of the
      podcasts will take about 15-20 minutes to listen to and so participants should expect to
      spend 30-40 minutes each week listening to podcasts. Participants also will be randomized to
      track diet with one of the two mobile dietary tracking applications that will be used in the
      study. Participants will be encouraged to monitor their exercise and body weight.
    

Intervention name(s): Photo App; Diet App; Podcasts
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Use of a mobile photo app that takes pictures of foods consumed and allows users to share these pictures with other members of the study in order to receive feedback.; Use of a mobile diet app that allows users to track all foods and beverages consumed in order to calculate the calories consumed each day.; Listen to 2 podcasts per week about healthy eating and exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diet; weight loss; tracking; mobile; calories
Cyclophosphamide for Nasopharyngeal Carcinoma
Condition: Recurrent Nasopharyngeal Undifferentiated Carcinoma; Stage IV Nasopharyngeal Undifferentiated Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      There is no standard third-line systemic treatment for inoperable locoregionally advanced
      recurrent or metastatic nasopharyngeal carcinoma (NPC). We investigated the efficacy and
      safety of metronomic oral cyclophosphamide as third-line treatment or beyond.
    

Detailed description: 
      NPC is endemic in Southern China including Hong Kong. Despite aggressive definitive
      chemoradiotherapy for locoregionally advanced disease, still about 30% develop relapse
      locoregionally or distally. Salvage or second-course radical radiotherapy with or without
      chemotherapy may achieve durable disease control for locoregionally advanced recurrent
      disease. However for those who had received 2 courses of radical radiotherapy or those with
      distant metastases, systemic chemotherapy would be the only drug of choice. Platinum-based
      doublet chemotherapy including cisplatin + 5-fluorouracil, capecitabine, gemcitabine or
      taxane is considered the standard first-line treatment. For second-line treatment, whether
      platinum-based chemotherapy was given previously is a consideration. Re-challenge with
      cisplatin and 5-fluorouracil can be considered in patients who enjoyed a good initial
      response to the same regimen with an intervening disease-free period of more than 1
      year.However so far there has been no recognized standard third-line systemic treatment.
      Metronomic oral chemotherapy may provide an ideal choice patients treated in this setting by
      shifting the targets from tumor cells to tumor vasculature so as to reduce the chance of drug
      resistance as well as offering a relatively low toxicity profile to them who have been
      significantly jeopardized by the long-term complications brought prior courses of radiation
      therapy, surgery and chemotherapy.

      In view of the above, we investigated metronomic open-label oral cyclophosphamide as
      third-line treatment or beyond in patients with inoperable locoregionally advanced recurrent
      or metastatic NPC who had failed at least 2 lines of prior systemic chemotherapy.
    

Intervention name(s): Cyclophosphamide
Intervention type(s): Drug
Intervention description(s): Patient receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progressive or unacceptable toxicity.
Other intervention name(s): Endoxan
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal undifferentiated carcinoma