bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGS
Condition: Primary Focal Segmental Glomerulosclerosis
MeSH terms: Glomerulosclerosis, Focal Segmental
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Rituximab therapy is safe and effective in
      treating patients with the kidney condition, focal segmental glomerulosclerosis (FSGS), that
      is no longer responsive to traditional therapies.
    

Detailed description: 
      This is a pilot trial to assess the safety, feasibility and efficacy of Rituximab therapy in
      20 adult and pediatric patients with either steroid and/or calcineurin inhibitor resistant
      FSGS or with a significant intolerance or contraindication to the use of these agents. In
      addition to clinical criteria, elevated levels of suPAR will define inclusion. Changes in the
      baseline levels of the potential biomarkers (suPAR, as well as activation of beta-3 integrin)
      in response to treatment will be compared to clinical measures of efficacy.

      Participants will have a screening/baseline visit to confirm eligibility within 6 weeks prior
      to the first of two Rituximab infusions (at Day 1 and Day 15). Participants will then attend
      follow up visits at 1, 3, 6 and 12 months after Rituximab treatment to assess adverse events
      and collect safety blood and urine samples.
    

Intervention name(s): Rituximab
Intervention type(s): Biological
Intervention description(s): Rituximab will be infused intravenously on Day 1 and Day 15 at a dose of 375 mg/m2 up to a maximum of 1000mg per dose in children and at a dose of 1000 mg on Day 1 and Day 15 in adults.
Other intervention name(s): Rituxan®
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Resistant Idiopathic FSGS; Glomerulosclerosis; Proteinuria; Rituximab
Magnetic Resonance Imaging (MRI) of Appendicitis in Children
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Study to find out if MRI can diagnose appendicitis in children as well as or better than CT
      scan and/or ultrasound scan performed at the same time. No additional contrast material or
      sedation will be used to perform the MRI.
    


Intervention name(s): MRI of the abdomen
Intervention type(s): Device
Intervention description(s): Multiple MRI pulse sequences of the abdomen
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Appendicitis; Children; Magnetic Resonance Imaging
Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: The aim of this randomized controlled trial was to compare the efficacy and safety
      of sertraline and escitalopram in participants with moderate to severe major depressive
      disorder (MDD).

      Methods: A total of 744 participants with moderate to severe MDD were randomly assigned to
      receive either sertraline or escitalopram for 8 weeks. Drug dosages and titration schedules
      were based on the recommendations of the prescribing information for each product and
      according to the judgment of the clinicians involved in the study.

      The primary outcome measures were changes from baseline on the Montgomery-Åsberg Depression
      Rating Scale (MADRS) and the Clinical Global Impression (CGI) scale as well as frequency of
      adverse events in both groups.
    

Detailed description: 
      This is a monocentric, double-blind, parallel, randomized controlled trial conducted in Khan
      Research Laboratories (KRL) hospital, Islamabad, Pakistan for a total period of 16 weeks. By
      employing appropriate measures to ensure adequate allocation concealment, thereby minimizing
      the potential for selection bias in the assignment of participants to treatment groups, the
      investigators studied if there was any significant difference in in efficacy and tolerability
      of oral sertraline (50 - 200 mg/day) and oral escitalopram (10 mg/day) given either at night
      or during the day in the South Asian population for the treatment of moderate to severe major
      depressive disorder (MDD). 744 South Asian patients with moderate to severe MDD as per the
      Montgomery-Asberg Depression Rating Scale (MADRS) scale who had consented to participate in
      the trial and who fulfilled the inclusion criteria were included in our study. The study was
      conducted at KRL hospital.
    

Intervention name(s): Sertraline; Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): Sertraline (200 mg/day) capsule; Escitalopram (10 mg/day) capsule
Other intervention name(s): Sertraline pill; Escitalopram pill
Intervention MeSH terms: Dexetimide; Citalopram; Sertraline; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sertraline; Depressive Disorder, Major; Escitalopram; South Asian People; Humans
Wetsuit and Life Jacket Induced Effects on Spirometry and VO2 in Windsurfers
Condition: Ventilation; Exercise
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of wearing both neoprene suit and life
      jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in
      windsurfers.
    

Detailed description: 
      Windsurfers will perform resting spirometry and exercise test on cycle ergometer until
      exhaustion in two conditions: with or without equipment. The investigators will measure
      Forced Vital Capacity, FEV1 peak flow at rest and oxygen uptake, carbon dioxide consumption,
      ventilation at each step of the incremental exercise and at exhaustion.
    

Intervention name(s): resting standard spirometry; maximum exercise testing
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The subject (seated, bust straightened) should perform, after a slow and maximum inspiration, a forced and complete exhalation followed by a new inspiration to the total lung capacity.; Incremental exercise on cycle ergometer with 100W start for men (80W for women) for 4 minutes as part of the warm-up. Then, step increment of a 50W power for men (40W for women) lasting 2 minutes each.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: windsurfer; wetsuit; spirometry; cardiopulmonary exercise testing; lung function; pulmonary function; oxygen uptake
Naproxen on Tooth Sensitivity Caused by In-office Bleaching
Condition: Toothache; Tooth Bleaching
MeSH terms: Dentin Sensitivity; Toothache
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory
      Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.
    


Intervention name(s): Naproxen
Intervention type(s): Drug
Intervention description(s): The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
Condition: Congenital Heart Disease; Health Related Physical Fitness; Motor Skills; Cardiovascular Prevention
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Children with congenital heart diseases (CHD) often show reduced health related physical
      fitness as well as limitations in gross and fine motor skills/development. Intervention
      programs in childhood are still rare and often focus just on the improvement of cardiac
      outcomes or exercise capacity. Web-based interventions, as a useful alternative to training
      manuals or supervised training, are cost effective and allow a customization of training
      times. Primary purpose of this study is to improve health related physical fitness in
      children with congenital heart disease.
    


Intervention name(s): Supervised web- and home-based exercise intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention group gets access to a training platform. Every week, 3 training videos of 20 minutes each will be released on that platform with the aim to perform those during the ongoing week.
Each exercise session is arranged in a video session with child friendly instructions and executions for the different exercises. The videos serve as a virtual training partner and exercise will be performed simultaneously while watching the video
The overall training volume is 72 session calculated from 3 sessions per week over a duration of 24 weeks (6 month)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the safety, tolerability, and pharmacokinetics
      of BI 201335 NA following administration of single rising doses from 4 mg to 1200 mg. In
      addition, the food effect on the bioavailability of BI 201335 NA (480 mg) was investigated.
    


Intervention name(s): BI 201335 NA; Placebo solution
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.
Condition: Exercise, Insulin Resistance, Visceral Adipose Tissue
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and
      metabolic syndrome. However, there is controversial data from prior studies to inform the
      type of exercise training recommendations.

      Aim: The aim of this study will determine the differences of different type of exercise in
      the effects of reducing insulin resistance and visceral adipose tissue for community
      residents.

      Methods: The four-arm randomized controlled trial will conducted in adults aged 40 to 70
      years old in Tainan. A total of at least 177 patients will randomly assign to the group of
      aerobic exercise (AE), aerobic exercise combined with resistance exercise (RE), AE combined
      with medium intensity interval training, and placebo. The participants in exercise group will
      received 12 weeks, 3 times per week program, including twice a week intervention guided by
      the intervenors, and once a week exercise guided by the video at home. All the exercise keeps
      moderate-intensity by monitoring with 64%-75% of the maximum heart rate. Insulin resistance
      status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks
      (HOMA index= insulin μU/mL）× glucose（mmol/L）/22.5).

      Relevance to clinical practice: The research findings will help the clinical health works to
      know which type of exercise is the best choice in reducing insulin resistance and visceral
      adipose tissue in community residents, and can be promoted to the general public to reduce
      the prevalence of metabolic syndrome as well as prevent the root causes of ill health.
    


Intervention name(s): exercise; No exercise intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): different type of exercise; No exercise intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
Condition: Negative Symptoms in Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to evaluate the Safety, Tolerability, Pharmacodynamics,
      and Pharmacokinetics of the Co-Administration of Roluperidone and Olanzapine in Adult
      Subjects with Moderate to Severe Negative Symptoms of Schizophrenia.

      The main question this clinical trial aims to answer are the pharmacodynamic and
      pharmacokinetic effects and safety of the concomitant therapy of Roluperidone with an
      established and widely used antipsychotic, such as olanzapine in order to provide further
      guidance to clinical practitioners that may prescribe off-label use of these drugs
      concomitantly in clinical practice.

      Eligible Participants will undergo the following study phases in the clinic:

        -  Screening Phase: Between 2 and up to 28 days during which study eligibility will be
           established and subjects receiving psychotropics will be washed out. Subjects will
           remain inpatient at the clinical site at least through the end of Treatment Phase 2.

        -  Treatment Phase 1: After the Baseline Visit, Roluperidone 64 mg/day will be administered
           as a monotherapy for 7 days (Days 1-7).

        -  Treatment Phase 2: Concomitant administration of Olanzapine 10 mg/day and Roluperidone
           64 mg/day for 10 days, starting on Day 8 (Days 8-17). Subjects may be discharged from
           the clinic at least 48 hours after the last administration of the study drugs and after
           the collection of the last plasma sample; however, the inpatient period may be extended
           at the discretion of the investigator.

      End of Study (EOS): Will take place at least 14 days after the last dose of the study.
    


Intervention name(s): Roluperidone 64 mg; Olanzapine 10 MG
Intervention type(s): Drug; Drug
Intervention description(s): 64 mg/day oral; 10 mg/day oral
Other intervention name(s): MIN-101
Intervention MeSH terms: Olanzapine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EPANOVA in Crohn's Disease, Study 1
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin
      Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease
      Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months
      and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP,
      methotrexate, 5-ASA or antibiotics.

      Secondary objectives are to assess the:

      efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and
      Subject Global Ratings, employment status and use of CD related medical visits in subjects
      with CD in remission

      safety and tolerability of Epanova

      ability of Epanova to maintain the quality of life of CD patients in remission
    


Intervention name(s): Epanova
Intervention type(s): Drug
Intervention description(s): 4g/day in divided doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's Disease
Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind placebo-controlled study was intended to measure the effects of
      the GWMP with Release supplement versus GWMP with placebo supplement in a representative
      group of obese subjects with or without diabetes at one outpatient medical practice.
    


Intervention name(s): Release Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Calorie reduced diet plus Release supplement; Calorie reduced diet plus Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg
      brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy
      adults.

      Participants will be randomized to each receive one tablet of Form H and one tablet of Form
      II,14 days apart and undergo pharmacokinetic testing pre-dose and post-dose to evaluate
      safety. This is an open-label, single-dose, randomized, two-period, crossover study.
    

Detailed description: 
      Primary Objectives:

        -  To evaluate the bioequivalence (BE) of brincidofovir (BCV) hydrate (Form H) tablet and
           the Form II tablet when administered under fasting conditions in healthy adult
           participants.

        -  To characterize plasma BCV pharmacokinetics (PK) following single doses of BCV when
           administered in healthy adult participants.

      Safety Objective:

      - To evaluate the safety of BCV following administration of single dose of 100 mg BCV Form H
      and BCV Form II tablet in healthy adult participants.
    

Intervention name(s): Brincidofovir
Intervention type(s): Drug
Intervention description(s): 100 mg tablet of Form H and 100 mg tablet of Form II
Other intervention name(s): CMX001-129
Intervention MeSH terms: Brincidofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, single-dose, randomized, two-period, crossover study to evaluate BE of BCV plasma PK parameters after administration of single 100 mg doses of BCV using the Form H (test tablet) and Form II (reference tablet) under fasting conditions in normal healthy adults. The study will also evaluate the safety of BCV following administration of two 100 mg single doses of BCV.
Eligible participants will be randomized in a 1:1 ratio to one of two treatment sequences, Treatment AB or Treatment BA.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smallpox; Pharmacokinetics (PK); Bioequivalence (BE); Orthopox; CMX001-129
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
Condition: Renal Impairment; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in
      subjects with mild or moderate renal impairment compared to subjects with normal renal
      function.
    


Intervention name(s): MCI-186
Intervention type(s): Drug
Intervention description(s): 30 mg of edaravone will be administered intravenously over 60 minutes.
Other intervention name(s): Edaravone; Radicut
Intervention MeSH terms: Edaravone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of LY2835219 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to compare how much of the study drug gets into the blood stream
      when it is given as a single oral dose and as an intravenous infusion (given directly into a
      vein via a small needle).

      The study will also provide information on how well the study drug is tolerated when given as
      a capsule in combination with giving it intravenously, and information on any changes in
      heart function.

      The study will last about 10 days. Screening is required within 28 days before study drug is
      given.
    


Intervention name(s): LY2835219; ¹³C₈-LY2835219
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered IV
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis
Condition: Cystic Fibrosis; Lung Clearance Index
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Recent improvements in cystic fibrosis management have enabled an important subset of
      patients to maintain normal spirometry. Nevertheless, even in these patients with normal
      spirometry, chest computed tomography (CT) might identify structural lung abnormalities such
      as bronchiectasis, mucus plugging, bronchiolitis and air trapping.

      Lung clearance index (LCI) has been shown to correlate well with structural pulmonary
      alterations seen on CT even in CF patients with well-preserved spirometry. In cystic
      fibrosis, a high LCI is associated with a worse feeling of illness assessed by the Cystic
      Fibrosis Questionnaire-Revised (CFQ-R). School-aged CF patients with normal spirometry also
      have normal aerobic function as assessed by peak oxygen uptake (V̇O2) measured during
      symptom-limited incremental cardiopulmonary exercise test. However, the ability of LCI to
      predict ventilatory abnormalities appearing at exercise in CF patients has not been
      investigated. The investigators therefore aimed to compare physiological parameters at
      exercise between CF patients with elevated LCI (i.e., LCI above the upper limit of normal
      [ULN]) and patients with normal LCI, all with preserved spirometry.
    


Intervention name(s): data collection
Intervention type(s): Other
Intervention description(s): data collection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 10 to 17 years old with a diagnosis of cystic fibrosis
Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will explore the efficacy and tolerability of centanafadine at a dose of 400 mg
      per day of centanafadine in promoting smoking abstinence in adult smokers seeking to quit.
    

Detailed description: 
      This single-group, open-label study of 50 participants will explore the potential of
      centanafadine in promoting smoking abstinence in adult smokers seeking to quit. The efficacy
      and tolerability of centanafadine at a dose of 400 mg total daily dose (TDD) (200 mg twice a
      day (BID)) approximately 4 to 6 hours apart (during a 7-week treatment period) will be
      compared with a benchmark of abstinence based on historical data from clinical trials of
      varenicline, viewed as the most efficacious pharmacotherapy currently approved by the FDA.
    

Intervention name(s): Centanafadine
Intervention type(s): Drug
Intervention description(s): 400 mg total daily dose Centanafadine Sustained Release, oral tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment