bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of WP200 With the Unified Probe (WP200U)
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Observational

Summary: 
      The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most
      of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea
      Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep
      and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in
      addition to the previous episodes also respiratory effort related arousal episodes. The high
      cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led
      to the development of a variety of ambulatory sleep study systems.

      The primary objective of the study is to evaluate the newly developed WP200 with the unified
      probe (WP200U) compared to the currently used configuration of WP200 that uses an
      incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects, adults and children, with suspected sleep disorders who are referred to a sleep
        study and are willing to participate in this clinical study.

        Additional non selective volunteers who are willing to participate in this clinical study
        and consent to undergo an overnight sleep study at their home.
      
Keywords: sleep disorders; sleep apnea; ambulatory device; WatchPAT
Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics
      of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both
      treatment-naïve patients and patients previously treated with peginterferon and ribavirin
      were included. In addition, the effect of study medication was examined in a group of
      patients with liver cirrhosis.
    


Intervention name(s): BI 207127 NA; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of JNJ-53718678 on QT interval corrected
      for heart rate (QTc) changes using exposure response analysis in healthy adult participants
      (Part 2).
    


Intervention name(s): JNJ-53718678, 2000 mg; JNJ-53718678, 3000 mg; JNJ-53718678, 4500 mg or Dose to be decided; JNJ-53718678 500 mg; JNJ-53718678 Placebo; Moxifloxacin 400 mg; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will be administered JNJ-53718678, 2000 mg as oral suspension in Part 1 (Panel 1).; Participants will be administered JNJ- 53718678, 3000 mg as oral suspension in Part 1 (Panel 2).; Participants will be administered JNJ-53718678, 4500 mg as oral suspension in Part 1 (Panel 3). If this dose is considered safe and tolerable and if pharmacokinetic data require further dose escalation, then participants will receive JNJ-53718678 (Dose to be decided) in Part 1 (Panel 4). This dose (either from Panel 3 or Panel 4 ) will be used in Part 2 (Dose may be lower/higher based on review of safety, tolerability, and PK data obtained in Part 1).; Participants will be administered JNJ-53718678, 500 mg as oral suspension in Part 2.; Participants will be administered JNJ-53718678 matching placebo in Part 1 and 2.; Participants will be administered moxifloxacin 400 mg as capsule in Part 2.; Participants will be administered moxifloxacin matching placebo in Part 2.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of HYR-PB21 in Healthy Volunteers
Condition: Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first time into human study (FTIH) for HYR-PB21 for injection. The study
      will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending
      and single subcutaneous dose of HYR-PB21 for injection in healthy adult volunteers.The
      results of this study are intended to be used to identify appropriate and well tolerated
      doses of HYR-PB21 for injection to be used in further studies. A comparison of PK/PD
      characteristics between HYR-PB21 for injection and EXPAREL will also be included in this
      study.
    


Intervention name(s): HYR-PB21; Liposomal bupivacaine; Normal Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): HYR-PB21 for injection 100mg, 200mg,or 400mg by single subcutaneous injection on the abdomen; Liposome Bupivacaine Suspension for injection 200mg by single subcutaneous injection on the abdomen; Normal Saline 30ml, or 40mL by single subcutaneous injection on the abdomen
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; postoperative; local anesthesia; long-action
A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and acceptability and efficacy of a
      two month technology-based weight loss program for overweight and obese college students.
    

Detailed description: 
      A randomized controlled trial design will be employed to investigate the effectiveness,
      feasibility, and acceptability of a technology-based weight loss pilot intervention for the
      reduction of overweight and obesity in college students. Participants will be randomly
      assigned to one of two conditions: (1) 8-week intervention group, or (2) 8-week attention
      control group. Both conditions include 8 weekly lessons over 8 weeks. Undergraduate students
      (n=100) age 18-22 years who are overweight or obese (BMI ≥ 25 kg/m2) will be recruited from
      the University of Tennessee Knoxville. Measurements will be taken at baseline and 8 weeks.
      Since the study is a technology-based intervention, research staff will collect height and
      weight measures for BMI through a novel approach, utilizing Skype video conferencing.
    

Intervention name(s): Intervention group; attention control condition
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obesity; Technology; College Students
Bioequivalence Study of Cyclosporine 100mg Capsule Under Fed Condition
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules
      Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference
      Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis
      Pharmaceuticals Corporation, New Jersey, in 78 healthy adult male subjects under fed
      condition.
    

Detailed description: 
      Total 78 normal healthy adult male subjects will be enrolled in the study. Subjects will be
      administered either the Test or the Reference Product with 240 mL of water in each period as
      per the randomization schedule. Subjects will fast for at least 10 hours prior to High Fat
      Breakfast half an hour before administration of the study drug and for four (4) additional
      hours each, post dose during each study period. Standardized meals will be provided in each
      study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post
      dose in each period. A total of 24 blood samples will be withdrawn for pharmacokinetic
      profiling. The whole blood concentrations of Cyclosporine will be measured by a validated
      LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log
      transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on
      log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence
      interval will be constructed for the ratio of geometric least square mean of the Test and
      Reference products, obtained from the log-transformed data. Bioequivalence will be concluded
      if the ratio estimate as well as its 90% confidence interval, both falls within the
      acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
    

Intervention name(s): Cyclosporine Capsules USP (Modified) 100 mg
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule
Other intervention name(s): Cyclosporine Capsule; Gengraf Capsule; Sandimmune Capsule
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
Trial to Assess the Shedding,Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age
Condition: Influenza
Study type: Interventional
Phase: Phase 4

Summary: 
      -  To describe the proportion of individuals 5-49 years of age who shed vaccine strain
           viruses.

        -  To describe the duration of shedding of vaccine viruses in individuals 5-49 years of
           age.

        -  To describe the genotypic and phenotypic stability of shed vaccine viruses.

        -  To describe the immune responses of FluMist in individuals 5-49 years of age.

        -  To describe the safety of FluMist in individuals 5-49 years of age in relation to
           shedding and the immune response
    

Detailed description: 
      The purpose of this study is to evaluate the viral shedding, immunogenicity and safety of
      FluMist when administered to healthy individuals between 5-49 years of age.
    

Intervention name(s): FluMist
Intervention type(s): Biological
Intervention description(s): A single intranasal dose of FluMist will be administered to approx. 300 subjects.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity,
      PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects
      with primary insomnia
    


Intervention name(s): SB-649868; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active compound at doses of 10mg, 30mg and 60mg; Placebo to match SB-649868
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: primary insomnia; PSG sleep recordings; daytime cognitive function; Insomnia; SB-649868
A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
Condition: Type 2 Diabetes
Study type: Observational

Summary: 
      The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier
      Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.

      The primary efficacy endpoint is an assessment of glycemic control at week 24 or last
      assessment measured via HbA1c.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with Type 2 Diabetes
Mesenchymal Stem Cells: Alterations in Genome
Condition: Pened Chest Surgery for Programmes Coronary Bypass
Study type: Interventional

Summary: 
      The aim is to study small genetic alterations induced by cell culture in human mesenchymal
      stem cells in GMP condition.
    


Intervention name(s): harvest of a small bone marrow sample
Intervention type(s): Procedure
Intervention description(s): harvest of a small bone marrow sample during open chest surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: celle therapy; cell culture; mesenchymal stem cells
Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the impact of antihypertensive therapy with the selective mineralocorticoid
      receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect
      of equivalent blood pressure control achieved with a b-blocker, atenolol.
    


Intervention name(s): Eplerenone
Intervention type(s): Drug
Intervention MeSH terms: Eplerenone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
Condition: Safety; Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain,
      coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. Due
      to limited data availability, the goal of this clinical trial is to learn about safety,
      pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to
      the body) of Kratom in adult recreational polydrug users with opioid experience.
    

Detailed description: 
      This is a phase I, single-dose, randomized, adaptive, double-blind, placebo-controlled,
      single ascending dose (SAD), sequential group study in adult recreational polydrug users with
      opioid experience performed at a single study center.

      This study will consist of five cohorts.

      Forty subjects are planned to participate. Eight subjects will participate in each cohort.

      Within each cohort, 6 subjects will be randomized to receive Kratom and 2 subjects will be
      randomized to receive placebo. Each subject will be involved in the study for up to
      approximately 37 days (including screening).
    

Intervention name(s): Kratom; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single administration thirty minutes after the start of a high-fat breakfast; Single administration thirty minutes after the start of a high-fat breakfast
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Kratom; Mitragynine; Botanical substance; Single Ascending Dose
Which Physical Activity Influences Achilles Tendon Blood Flow the Most?
Condition: Physical Activity
Study type: Interventional

Summary: 
      Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of
      Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as
      to the most solid warming-up of the AT. Therefore, knowledge about activities which increase
      blood flow in the AT could be useful in the development of a solid warming-up programme for
      the AT. The aim of this investigation was to define the influence of different kinds of
      physical activity on the vascularisation of the AT in a healthy asymptomatic population.
      Subjects performed five activities in randomized order: running, static stretch, dynamic
      stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was
      measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before,
      immediately after, five and ten minutes after activity to investigate the duration of the
      vascular response to activity.
    


Intervention name(s): physical activity
Intervention type(s): Other
Intervention description(s): Subjects performed five activities: running, static stretch, dynamic stretch, cycling and rope skipping
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Achilles tendon; Warming-up; Vascularisation; Physical activity; Oxygen-to-See (O2C)
Treatment for First-Episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and
      risperidone (Risperdal®) can help patients with first-episode schizophrenia.
    

Detailed description: 
      The goal of the study is to prevent morbidity in first-episode schizophrenia using
      second-generation antipsychotic drugs: olanzapine, risperidone.

      Long-term studies of first-episode schizophrenia patients have clearly indicated excellent
      initial responsiveness of positive psychotic symptoms to treatment with conventional
      antipsychotic medications. However, in the years immediately following this initial good
      response, morbidity increases. Relapses, often multiple ones, are the rule and are usually
      precipitated by medication noncompliance. There is some evidence that the second-generation
      antipsychotic drugs may have superior efficacy in terms of these outcome domains. However,
      these newer agents have been studied primarily in chronic and/or treatment-resistant patient
      samples and there are virtually no long-term studies or studies comparing the new drugs with
      one another.

      First episode patients are randomly assigned to treatment with olanzapine or risperidone for
      3 years. Outcome measures for the initial episode include psychopathology (positive,
      negative, and affective symptoms), side effects, neurocognition (executive function, memory,
      and attention), social and occupational function and service utilization. The effects on
      long-term course are measured in terms of frequency and timing of relapses, level of recovery
      from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive
      function, social/vocational function, and service utilization.

      For information on a related study, please follow this link:

      http://clinicaltrials.gov/show/NCT00320671
    

Intervention name(s): Olanzapine; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): The dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects.; The dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects.
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescence; Adult; Antipsychotic Agents; Female; Human; Male; olanzapine; Risperidone; Schizophrenia; Antipsychotic Agents -- *therapeutic use; olanzapine -- *therapeutic use; Risperidone -- *therapeutic use; Schizophrenia -- *drug therapy
Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Study E2730-A001-001 is a first-in-human, sequential ascending single dose,
      placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a
      single oral dose of E2730 in healthy participants.
    


Intervention name(s): E2730; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules; capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy participants; E2730; Pharmacokinetics
Study to Evaluate the Drug Interaction Between Dolutegravir (DTG) and Daclatasvir (DCV) in Healthy Adult Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to estimate the two-way drug interaction between DCV and DTG as a drug
      interaction between DTG and DCV is expected to be low and this study is to be performed as
      confirmation. This will be a single-center, open-label, three-period, crossover study in
      healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV
      pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h
      and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the
      safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV
      60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h
    


Intervention name(s): DTG; DCV
Intervention type(s): Drug; Drug
Intervention description(s): DTG is provided as 9 millimetre white, film-coated, round tablets debossed with SV 572 on one side and 50 on the other side; DCV is provided as a plain, green, biconvex, pentagonal film-coated tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dolutegravir; healthy volunteer; pharmacokinetics; daclatasvir; drug interaction