bioihbjkbjnl/mcl2 huggingface dataset:
The Sapheon Closure System Feasibility Study
Condition: Venous Insufficiency of Leg
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      This is a single center, prospective, non-randomized, feasibility study for the evaluation of
      safety, efficacy and performance of the Sapheon™ Closure System for the treatment of
      incompetent saphenous veins.
    

Detailed description: 
      Venous insufficiency of the lower extremities is a very common condition that is influenced
      by genetic and mechanical factors, and is a chronic and progressive disorder. The primary
      objectives for this clinical Study are to

        1. demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent
           saphenous veins,

        2. demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment
           of incompetent saphenous veins, and

        3. demonstrate the satisfactory performance of the Sapheon™ Closure System device
           components.
    

Intervention name(s): Sapheon™ Closure System
Intervention type(s): Device
Intervention description(s): Sapheon™ Closure System for the treatment of incompetent saphenous veins.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
Condition: Cytomegalovirus Disease
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the efficacy and safety of NPC-21 when administered
      prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney
      transplant from a CMV seropositive donor.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo-controlled study of NPC-21 for kidney
      transplant recipients at high risk of CMV infection in the United States and Japan.
      Approximately 108 eligible patients will be randomized prior to first study drug
      administration to receive low-dose NPC 21, high-dose NPC-21, or placebo. Randomization will
      be stratified by region (United States or Japan)
    

Intervention name(s): NPC-21 Low dose; NPC-21 High dose; NPC-21 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NPC-21 will be administered via an approximately 60-minute intravenous infusion; NPC-21 will be administered via an approximately 60-minute intravenous infusion; Placebo will be administered via an approximately 60-minute intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
FDA Approved Medication to Reduce Binge Eating and/or Purging
Condition: Binge Eating Disorder; Bulimia Nervosa
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa
      and binge eating disorder.
    

Detailed description: 
      Bulimia nervosa (BN) and binge eating disorder (BED) are serious mental disorders associated
      with adverse psychological and physical consequences. Treatment options to date offer limited
      success, leaving at least 50-70% of patients still symptomatic after treatment. The purpose
      of the study is to evaluate whether phentermine-topiramate (Qsymia), a medication currently
      FDA approved for the treatment of obesity, will demonstrate efficacy-compared to placebo-
      when re-purposed for patients with bulimia and binge eating.

      Participants will be randomized into one of two conditions: qsymia or Placebo. One condition
      will receive 3 months of phentermine-topiramate, a 2 week washout, then 3 months of placebo.
      The other condition will receive 3 months of Placebo, a 2 week washout, then 3 months of
      phentermine-topiramate. Participants will receive a total of 6 months of treatment and then
      have a 2 month follow-up off of medications.
    

Intervention name(s): Phentermine/Topiramate-First; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients randomly assigned to this Arm will have a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated). Then will have a 2 week washout followed by a crossover to 12 weeks of control medication/ placebo.; Patients randomly assigned to this Arm will have begin with 12 weeks of placebo followed by a 2 week washout. They will then crossover to Qsymia and receive a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated).
Other intervention name(s): Qsymia; Placebo-First
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: binge eating; bulimia nervosa; binge eating disorder; eating disorder treatment
Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a double-blinded randomized controlled trial of 24-hour blood pressure control in
      sub Saharan type 2 diabetes patients, newly diagnosed for hypertension. They were allocated
      to receive either a fixed combination of perindopril + amlodipine or perindopril + indapamide
      for 42 days.
    

Detailed description: 
      This was a double-blinded randomized controlled trial conducted at the National Obesity
      Center and the cardiology unit of the Yaoundé Central Hospital in Cameroon from October 2016
      to May 2017. Eligible patients were type 2 diabetes patients, newly diagnosed for
      hypertension (grade I or II) with confirmation on ambulatory BP monitoring (ABPM). Patients
      were either on lifestyle modification alone or on a stable anti-diabetic treatment for the
      past three months, aged 25-65 years naïve to any anti-hypertensive treatment, who provided
      their written informed consent. Participants were assigned to receive as anti-hypertensive
      treatment perindopril-amlodipine once daily or perindopril-indapamide at the same frequency.
      The two groups were followed up and monitored for sixth weeks and patients did not take any
      additional treatment with BP modifying properties.

      The primary outcome was the relative change in circadian blood pressure profile between the
      two groups after six weeks of treatment
    

Intervention name(s): Perindopril and Amlodipine; Perindopril-indapamide
Intervention type(s): Drug; Drug
Intervention description(s): Fixed combination of Perindopril 5mg and Amlodipine 5mg; Perindopril 5mg and Indapamide 1.25mg
Other intervention name(s): Coveram5/5mg; Bipreterax5/1.25
Intervention MeSH terms: Amlodipine; Perindopril; Indapamide; Indapamide, perindopril drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind head to head trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; hypertension; blacks; Africa; ACE inhibitor; Calcium channel blocker; Diuretic
PK-PD Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients
Condition: Kidney Transplant
Study type: Observational

Summary: 
      The purpose of this study is to determine how fast children, who have had a recent kidney
      transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their
      prescribed dose. The results may lead to better dosing based on individual needs.
    

Detailed description: 
      This is an open-label, inpatient-outpatient population pharmacokinetic-pharmacodynamic
      (PK-PD) study of mycophenolic acid (MPA) in pediatric subjects (age 2-17 years) who have had
      a recent kidney transplant, as well as during the stable renal transplant period when on a
      stable oral regimen of MPA. The primary objective of this study is to develop population
      pharmacokinetic-pharmacodynamic (PK-PD) models for mycophenolic acid (MPA) and mycophenolic
      acid glucuronide (MPAG) in order to improve individualized pediatric dosing. Subjects will
      have been receiving CellCept as part of their clinical standard of care. It is anticipated
      that the clinical portion of the study for each patient will be approximately six months post
      renal transplant with four study days: a screening visit pre-transplant, two 10-hour
      inpatient days at 2-3 and 6-9 days post-transplant, and one (up to 10 hour) outpatient visit
      at 3-6 months post-transplant. Pharmacokinetic and pharmacodynamic measurements will be
      conducted at various time points (up to 9 hours post dose) on study days 2, 3, and 4. Safety
      data to be collected will include physical examinations, measurement of vital signs, and
      laboratory assessments, as well as data on adverse events and clinical outcomes.
    

Intervention name(s): CellCept (mycophenolate mofetil); Dietary Monitoring; Drug Diary; Blood Sampling
Intervention type(s): Drug; Behavioral; Behavioral; Procedure
Intervention MeSH terms: Mycophenolic Acid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male subjects and non-pregnant female subjects aged 2-17 years who are about to receive a
        kidney transplant and will be on post transplant MMF containing immunosuppressive therapy,
        per clinical care.
      
Keywords: Pediatric Kidney Transplant; Kidney Transplant; CellCept; Mycophenolate mofetil; Mycophenolic Acid; MPA
Dexmedetomidine in Spinal Anesthesia
Condition: Blood Pressure; Anxiety
Study type: Interventional

Summary: 
      Patients were randomized into two groups, A group and B group. A group and B group patients
      are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy
      bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine,
      respectively.

      The investigators will compare of hemodynamics and patient's comfortability between two
      groups.
    

Detailed description: 
      A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading
      infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous
      dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before
      procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated
      patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes
      interval at operating room and post-anesthetic care units.
    

Intervention name(s): Dexmedetomidine; Dexmedetomidine with heavy bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine; Dexmedetomidine infusion after IT of heavy bupivacaine
Other intervention name(s): Precedex; Precedex; Marcaine
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Dexmedetomidine; Spinal anesthesia
Non-Specific Effects of Manual Therapy
Condition: Musculoskeletal Manipulations; Placebo Effect
Study type: Interventional

Summary: 
      The mechanism responsible for improvement following manual physical therapy techniques is
      unknown. Previous studies have indicated both biomechanical and neurophysiologic effects
      which may be responsible for clinical changes observed. Yet, other studies report clinical
      changes following sham interventions. Through a mixed-methods design, this study aims to gain
      more understanding of the social and contextual factors that may be related to the
      improvement often observed following manual therapy techniques.
    

Detailed description: 
      A convenience sample will be utilized to obtain subjects. Subjects will be given a brief
      questionnaire to identify possible contraindications for manual therapy treatment techniques
      and exclude individuals if necessary. Subjects will be randomized into one of eight groups
      (three variables, each with two conditions including: therapist gender match/mismatch, lab
      coat worn/not worn, detailed explanation/colloquial conversation about the technique) and
      participate in neurodynamic testing for the upper quarter via the Upper Limb Provocation
      Test. Subjects who are determined to be positive for one or more extremities will receive a
      sham thoracic spine manipulation technique. After application of the technique, previously
      positive limbs will be retested. Individuals who respond favorably to the sham technique upon
      reassessment will participate in an exit interview with open-ended questions in attempt to
      gain more insight into the factors which may have influenced their neurodynamic mobility
      improvement.
    

Intervention name(s): Spinal Manual Therapy
Intervention type(s): Procedure
Intervention description(s): Supine thoracic spine sham manipulation located between the levels of T4-7; identical procedure as an active treatment intervention but without the delivery of a high velocity low amplitude thrust
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patient-Therapist Interaction; Non-Specific Effects; Manual Therapy; Neurodynamics; Sham
Study With CIN-107 Following Multiple Oral Ascending Doses in Healthy Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, study to assess the safety, tolerability, PK, and PD of
      multiple oral doses of CIN-107 when administered to healthy adult subjects.
    


Intervention name(s): CIN-107; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A repeat oral dose of CIN-107 once daily for 10 days.; A repeat oral dose of matching placebo once daily for 10 days.
Other intervention name(s): baxdrostat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pharmacokinetics (PK), metabolism, baxdrostat
Xylitol for Caries Prevention in Inner-City Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purposes of this study is to determine whether xylitol use in kindergarten school
      children in addition to oral health education, provision of tooth brush and fluoride paste,
      fluoride varnish and sealant treatment will reduce decay in the first permanent molars and
      other permanent teeth.
    

Detailed description: 
      This is a two group, 30 month randomized controlled clinical trial to assess, in conjunction
      with other primary preventive modalities, the use of xylitol gummy bears as snack food during
      school hours to reduce dental caries among children attending Kindergarten at the time of
      recruitment.

      Classrooms in five elementary schools were randomized to receive xylitol gummy bears or the
      control sugar-free (fiber) gummy bears. All gummy bears were formulated to be similar in
      size, consistency, color, and sweetness. They were in six bright colors attractive to
      children, and in strawberry and cherry flavors which are popular among children. Children
      were encouraged to chew the gummy bears slowly to maximize the xylitol exposure time in the
      mouth. The children received xylitol or placebo gummy bears throughout the 9 month
      kindergarten year, 3 times/day within the supervised school environment.

      In addition to gummy bears, all participating children received oral health education, tooth
      brushing and fluoridated toothpaste, topical fluoride varnish treatment, and dental sealants
      when the first permanent molars have completely erupted. This design allows for the
      comparison between the current best recommended public heath practices and the addition of
      the new strategy, xylitol gummy bear snacks. Children were enrolled in kindergarten and
      followed until the middle of 2nd grade.
    

Intervention name(s): Xylitol gummy bears; Sugar free fiber gummy bears; Oral health education; Fluoride varnish; Dental sealant
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral; Device; Device
Intervention description(s): The children receive xylitol gummy bears 3 times/day within the supervised school environment.; The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.; Oral health education, toothbrush, and fluoride toothpaste; The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.; The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.
Other intervention name(s): Cavity Shield; UltraSeal XT plus
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dental Caries; Xylitol; Prevention
A Cross-sectional Study on IBS Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The investigators will conduct a cross-sectional study to discovery the distribution of IBS
      subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the
      investigators will also collect the serum, urine and stool samples of the participants to
      explore the host-gut microbiota metabolic interactions associated with IBS subtypes.
    

Detailed description: 
      It is a cross-sectional study to discovery the distribution of IBS subtypes who would like to
      seek CM treatment and their CM patterns.Serum, urine and stool samples of the participants
      will be collected from 400-600 IBS participants to explore the host-gut microbiota metabolic
      interactions associated with IBS subtypes. The primary outcome will be the distribution of
      IBS subtype and their CM pattern in Hong Kong population. Secondary outcomes will be the
      host-gut microbiota metabolic interactions associated with IBS subtypes, the relationship
      between CM pattern and their microbiota and metabolic profiling. The relationship between IBS
      subtype distribution and other predetermined factors will be assessed, including gender, age,
      weight, Body Mass Index (BMI), dietary habit, education, economical status, the overall and
      individual IBS Symptom Severity Scale (IBS-SSS), syndrome of Chinese medicine, QoL assessment
      and Bristol Stool Scale.For those who had fulfillment of the Structured Clinical Interview
      for DSM-5 Disorders-(SCID-5), the Hamilton Depression Rating Scale (HAMD-17), Clinical Global
      Impression-severity (CGI-S), and Self-Rating Depression Scale (SDS) will also be assessed.
      After the collection of serum, urine and stool samples, bacterial total DNA will be
      extracted, purified,concentrated,dried and stored for further fecal 16s rRNA sequencing
      analysis. A number of parameters, including serum alanine aminotransferase (ALT), aspartate
      aminotransferase (AST), alkaline phosphate (ALP) et al., will be measured in serum. Total BA
      and BA profiles in serum and feces will be tested as well.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        IBS Patients
      
Biospecimen description: 
      Serum: The participants will be instructed to meet fasting for the blood sample collection
      and 15ml whole blood will be drawn from the participants.

      Stool: Fecal samples should be naturally excreted from subjects (500ml at least) and should
      be collected without mixing with urine, sanitizer and sewage.

      Urine: Mid-stream morning urine will be collected.
Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine whether the transdermal testosterone system (TTS) is
      effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in
      postmenopausal women who are on transdermal estrogen.
    

Detailed description: 
      This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week
      study to be conducted in approximately 300 patients at approximately 14 clinical sites in the
      UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised
      1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous
      phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log
      (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal
      Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free
      and total testosterone, total estradiol, and sex hormone binding globulin) will be collected
      at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.
    

Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks; patch, placebo, patch changed every 3-4 days, 24 weeks
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment