bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the equivalence of the lyophilized formulation of
      Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of
      TDV.
    

Detailed description: 
      The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate
      (TDV). This study is designed to determine whether the lyophilized formulation provides
      equivalent safety and immunogenicity as the original liquid formulation. An exploratory
      analysis has been added for the purpose of understanding whether there is a manufacturing or
      formulation effect on the vaccine.

      The study will enroll approximately 1000 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the four study groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  Group A: TDV Liquid Formulation 1, subcutaneous (SC) injection on Day 1 and placebo
           (dummy) SC at Month 3 - this is a liquid that looks like the study drug but has no
           active ingredient

        -  Group B: TDV Liquid Formulation 1, SC injection Day 1 and Month 3

        -  Group C: TDV Liquid Formulation 2, SC injection Day 1 and Month 3

        -  Group D: TDV Lyophilized formulation SC injection Day 1 and Month 3

      In order to keep the treatment arms undisclosed to the participant and the doctor,
      participants will receive a placebo injection at any study visit where TDV is not being
      administered (Month 3). Participants will be asked to record any adverse events that may be
      related to the vaccine or the injection in a diary card for 28 days after each vaccination.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 10 months. Participants will make 9 visits to the clinic
      including a final visit 1 month after last dose of study drug for a follow-up assessment. A
      follow up phone call will be done 6 months after the last dose to assess serious adverse
      events.
    

Intervention name(s): TDV Liquid Formulation 1; TDV Liquid Formulation 2; TDV IDT Lyophilized; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TDV Liquid Formulation 1 for subcutaneous injection; TDV Liquid Formulation 2 for subcutaneous injection; TDV Lyophilized Formulation for subcutaneous injection; TDV liquid formulation placebo-matching solution for subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Drug therapy
Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly
Condition: Elderly; Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The increase in life expectancy of the world population is associated with a higher incidence
      of diseases, leading to functional incapacity and dependence in old age. Aging is usually
      accompanied by progressive loss of muscle mass, muscular strength and functional capacity,
      possibly exacerbated by inactivity and low protein and energy consumption of elderly
      individuals. However, the response to strength training, as well as the daily recommendation
      of protein and other factors related to sarcopenia in this population seem not to be well
      understood. Objective: To evaluate the effect of protein intake and resistance training on
      body composition, muscle strength and functional capacity in the elderly. METHODS: A
      randomized placebo-controlled clinical trial will be conducted with 38 elderly people, ≥ 60
      years old, sedentary, and body mass index between 22 and 30 kg / m2. All those who agree to
      participate will be randomized into two groups (intervention or placebo) and will undergo an
      initial assessment consisting of food consumption analysis through the application of the
      three-day food record, assessment of muscle thickness of the thigh and arm by muscle
      ultrasonography, evaluation of body composition by dual energy X-ray absorptiometry (DEXA),
      dynamic maximal strength (1RM) test of knee extension and elbow flexion, peak torque test of
      knee extension, functional capacity tests and quality of life questionnaire (SF-36). The
      elderly will participate in resistance training for 12 weeks, two session per week. The
      intervention group will be supplemented with whey protein isolate (2x / day - 20g for
      breakfast and 20g for dinner) and the placebo group will receive maltodextrin (2x / day - 20g
      for breakfast and 20g for dinner). All outcomes will be assessed before and after the 12-week
      resistance training period.
    


Intervention name(s): Exercise training + whey protein; Exercise training + placebo (maltodextrin)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Whey protein (2x / day - 20g for breakfast and 20g for dinner).; Maltodextrin (2x / day - 20g for breakfast and 20g for dinner).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Protein Supplementation; Body Composition; Resistance Training; Functional Capacity; Muscle Strength
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Condition: Gastric Neoplasm
MeSH terms: Carcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the role of splenectomy in potentially curative
      total gastrectomy for proximal gastric carcinoma in terms of survival benefit and
      post-operative morbidity.
    

Detailed description: 
      European clinical trials of gastrectomy showed that splenectomy is an important risk factor
      for post-operative morbidity and mortality. Retrospective comparisons suggested that
      splenectomy is associated with poor long term survival. However, Japanese studies revealed
      that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal
      metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the
      standard operation in specialized centers where splenectomy is not considered a risk factor
      for operative mortality. There have been no prospective randomized trials to evaluate the
      survival benefit of splenectomy in total gastrectomy for proximal gastric cancer.

      Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy
      without splenectomy
    

Intervention name(s): Surgery: Splenectomy; Surgery: Spleen-preservation
Intervention type(s): Procedure; Procedure
Intervention description(s): Procedure/Surgery: Surgery: Splenectomy; Procedure/Surgery: Surgery: Spleen-preservation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric neoplasm; gastrectomy; splenectomy; randomized trial; T2, T3 and T4 carcinoma in the proximal third of the stomach
A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 mg Cenobamate Administered Orally
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence,
      3-period, 3-treatment crossover study in healthy adult male and female subjects to assess:
      the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg
      tablet via NG tube of cenobamate. All treatments will be administered under fasting
      conditions.
    

Detailed description: 
      This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-
      period, 3-treatment crossover study in healthy adult male and female subjects to assess: the
      relative bioavailability of a crushed 200 mg cenobamate table in suspension administrated
      orally (Treatment B, Test 1) compared to an intact (whole) 200 mg cenobamate tablet
      administered orally (Treatment A, Reference), and the relative bioavailability of a crushed
      200 mg cenobamate tablet in suspension administered via an NG tube (Treatment C, Test 2)
      versus an intact (whole) 200 mg cenobamate tablet (Treatment A, Reference). All treatments
      will be administered under fasting conditions.
    

Intervention name(s): Cenobamate
Intervention type(s): Drug
Intervention description(s): 200 mg Cenobamate Tablet
Other intervention name(s): YKP3089C045
Intervention MeSH terms: Cenobamate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, 6-sequence, 3-period, 3-treatment crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
Condition: Scleroderma; Systemic Sclerosis; Raynaud Phenomena; Raynaud's Disease
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the safety and efficacy of the Celution
      Device in the processing of an autologous graft consisting of adipose derived regenerative
      cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
    

Detailed description: 
      The STAR Trial is a prospective, randomized, multi-center device trial intended to assess
      safety and efficacy of subcutaneous administration of Celution processed ADRCs into fingers
      of patients with hand dysfunction due to scleroderma.

      Following informed consent and screening evaluations, eligible subjects will undergo
      pre-operative testing. Subjects will then undergo fat harvest through small volume
      liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to
      isolate and concentrate ADRCs for immediate subcutaneous administration under local
      anesthesia. Subjects will be randomly assigned to receive ADRCs (40 million cells) or a
      visually-matched placebo in a 1:1 ratio. All subjects will receive subcutaneous
      administration of test substance (ADRC or placebo) into all fingers of both hands. Following
      completion of all 48 week visits and database lock, placebo treated subjects will be offered
      treatment with their ADRCs cells should they continue to qualify according to the
      inclusion/exclusion criteria and should they wish to be treated with ADRCs and agree to the
      fat harvest procedure.
    

Intervention name(s): Celution Device; Placebo
Intervention type(s): Device; Other
Intervention description(s): ADRCs prepared using the investigational Celution Device; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multicenter, parallel-group study in participants with normal renal
      function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD)
      undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug
      VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single
      oral dose of ceftibuten/VNRX-7145.
    


Intervention name(s): VNRX-7145; Ceftibuten
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose; single oral dose
Intervention MeSH terms: Ceftibuten
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will enroll approximately 32 participants assigned to groups based on renal function.
Masking: None (Open Label)
Primary purpose: Basic Science
Developing a Mobile Method to Measure THC-induced Impairment
Condition: Measuring THC-induced Cognitive Impairment Using a Mobile Application
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly
      common as states remove restrictions on use. The increased use raises new concern about the
      safety of this drug, including its ability to impair basic cognitive and psychomotor tasks,
      and whether the users are aware of their impairment. We propose to design a simple
      performance test that users can use in the field, using a cell phone, to assess their level
      of impairment relative to their own drug-free state. In this preliminary study, we will
      compare participants' simple task performance after a known dose of
      delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions.
      In our app the participants will be asked to gauge their own perceived level of impairment
      (as determined by self-ratings and judgments of impairment) as well as their actual
      impairment (as gauged by the app), providing important feedback and training about their
      ability to detect impairment.
    


Intervention name(s): Dronabinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication (Broyd et al, 2016; Hartman and Huestis, 2013).; Placebo
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Phase 1 Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of GS-5806
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, Phase 1 study to determine the mass balance of of
      GS-5806 following administration of a single, oral dose of radiolabeled [14C]-GS-5806 in
      healthy subjects.
    


Intervention name(s): GS-5806
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RSV infection
A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on
      dextromethorphan.
    


Intervention name(s): reference [dextromethorphan]; test [PF-00299804 + dextromethorphan]
Intervention type(s): Drug; Drug
Intervention description(s): single 30 mg oral dose; single 45 mg oral dose of PF-00299804 and a single 30 mg oral dose of dextromethorphan
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug interaction Study CYP2D6 inhibition Healthy Subjects
Prevention of Preterm Birth With a Pessary in Singleton Gestations
Condition: Preterm Birth; Short Cervix
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The
      incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at
      less than 37 weeks gestation annually. The rate of PTB in the United States increased to
      12.8% in 2006, and remains high compared to almost all other developed countries, despite the
      introduction of many public health and medical interventions designed to delay PTB. Weekly
      treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has
      been shown to significantly reduce the risk of PTB and is currently recommended for women who
      experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of
      spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB
      is likely to have a small effect on the overall rate of prematurity since only about 10% of
      spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality
      and morbidity in premature babies will only be achieved with increased precision in the
      identification of women at risk of spontaneous PTB and through the development of an
      effective prevention for this complication. Transvaginal ultrasound measurement of cervical
      length is a reliable screening test for prediction of PTB. Although treatment with vaginal
      progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women
      still experience premature delivery and many women find daily administration of progesterone
      to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may
      be effective in preventing PTB. If effective this approach would be particularly appealing
      because of the wide availability of pessaries, ease of use, and low cost. Unfortunately,
      existing studies are inadequate to confirm effectiveness; a well designed, properly powered,
      prospective randomized trial is warranted prior to widespread implementation in clinical
      practice. We propose such a trial to study the effectiveness of the pessary in decreasing the
      incidence of PTB in an inner city Philadelphia population.
    


Intervention name(s): Bioteque cup pessary
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preterm birth; Preterm delivery; short cervix; pessary
Complex Dynamic Systems in Mood Disorders
Condition: Bipolar Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Mood Disorders
Study type: Observational

Summary: 
      Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the
      relationship between voice samples, heart rate, respiration, movement, galvanic skin
      conductance, and sleep architecture with mood states in patients with Major Depressive
      Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear
      dynamic analyses will be able to reveal hidden patterns of complexity in each domain of
      voice, heart rate variability, movement, arousal, and sleep stage data.
    

Detailed description: 
      Aim 1: To assess multichannel physiologic measures associated with mood disorders.

      Hypothesis: The overall hypothesis is that nonlinear dynamic analyses will be able to reveal
      hidden patterns of complexity in each domain of voice, heart rate variability (RR intervals),
      movement, arousal, and sleep stage data.

      Aim 2: To assess differences in patterns and complexity of multiple physiological measures in
      patients with MDD compared to healthy controls.

      Hypothesis: MDD will be associated with decreased measures of complexity and increased
      measures of approximate entropy compared to healthy controls.

      Aim 3: To assess differences in patterns and complexity of multiple physiologic measures in
      patients with BD compared to healthy controls.

      Hypothesis: BD will be associated with decreased measures of complexity and increased
      measures of approximate entropy compared to healthy controls.

      Aim 4: To assess changes in patterns and complexity of multiple physiologic measures at
      baseline and after 2 weeks of treatment for patients with MDD and BD.

      Hypothesis: Measures of complexity will increase and measures of approximate entropy will
      decrease in the first two weeks of treatment.

      Aim 5: To assess the relationship between changes in patterns and complexity of multiple
      physiologic measures and changes in mood state.

      Hypothesis: Measures of complexity will increase and measures of approximate entropy will
      decrease, especially for those who are much or very much improved
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The sample will consist of subjects with Major Depressive Disorder(n=5), Bipolar Disorder
        (n=5), as well as healthy controls (n=5)
      
Keywords: Complex Dynamic Systems; Biomarkers; Mood Disorders
PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the effect of bismuth subsalicylate
      (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in
      healthy volunteers receiving TECFIDERA™ (dimethyl fumarate [DMF]; also known as BG00012)
      twice daily (BID) The secondary objectives of this study in this study population are: To
      characterize the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on the
      frequency, severity, and duration of GI-related events and to evaluate GI-related events that
      lead to discontinuation of DMF.
    


Intervention name(s): bismuth subsalicylate (Pepto-Bismol®); matching placebo (bismuth subsalicylate); dimethyl fumarate (DMF)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 524 mg bismuth subsalicylate twice a day (BID); placebo twice a day (BID); dimethyl fumarate (DMF) twice a day (BID)
Other intervention name(s): Pepto-Bismol®; BG00012; DMF; TECFIDERA™
Intervention MeSH terms: Dimethyl Fumarate; Bismuth; Bismuth subsalicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Experience of Adolescents With Anorexia Nervosa Towards Antidepressants
Condition: Adolescents Cared for Anorexia Nervosa at Maison de Solenn
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The purpose of this study is to explore the experience of adolescents suffering from anorexia
      nervosa confronted with the prescription of antidepressants
    

Detailed description: 
      In our adolescent psychiatric unit, antidepressant's prescription is common during the care
      pathway for adolescents with anorexia nervosa.

      The literature highlights a paradox between scientific data and clinical practice, based on
      expert consensus. There are a very few qualitative studies in this subject and none of them
      concern adolescents.

      The purpose of this qualitative study is to explore the experience and opinion of adolescents
      suffering from anorexia nervosa confronted with the prescription of antidepressants
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Oral interview and written questions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents (between 12 and 25 years) suffer from anorexia nervosa, at the Maison de
        Solenn, Cochin Hospital, Paris, France
      
Keywords: Anorexia nervosa; Adolescents; Antidepressive agents