bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of VBY-891 in Healthy Volunteers After Single or Multiple (7 Days) of Oral Dosing (VBY891P1)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Psoriasis is an inflammatory autoimmune disease that might be controlled by a cathepsin S
      inhibitor like VBY-891.
    

Detailed description: 
      Refer to Brief Summary
    

Intervention name(s): VBY-891; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cathepsin S inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Subjects; Safety; Tolerability; VBY891; Maximum; Pharmacodynamic; Pharmacokinetic
A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is investigate mycophenolic acid exposure through area under the
      curve in renal transplants recipients treated with mycophenolate mofetil and after conversion
      to mycophenolate sodium.
    

Detailed description: 
      A growing body of evidence has shown that mycophenolate acid (MPA) exposure assessment and
      dosage adjustment are necessary in patients treated with mycophenolate mofetil (MMF), but
      there is still limited information about the dose-exposure-effect relationship of the
      enteric-coated mycophenolate sodium (EC-MPS) formulation that has quite different
      physicochemical properties (TETT et al., 2011).

      Pharmacokinetically guided exposure-controlled area under the concentration-time curve (AUC)
      approaches are helpful to limit interpatient variability of MPA exposure and to improve the
      clinical outcome of organ transplant recipients (TETT et al., 2011).

      MPA area under the concentration-time curve values between 30 and 60 μg h/mL in the early
      post-transplant period reduces the risk of acute rejections and seems to be appropriate in
      renal allograft recipients taking mycophenolate sodium (MPS) and calcineurin inhibitors
      (GRINYÓ et al., 2009; SOMMERER et al., 2010).

      Among the benefits of therapeutic drug monitoring of MPA are the evaluation of interaction
      between MPA and proton pump inhibitors and association of donor-specific antibodies
      reduction.
    

Intervention name(s): Mycophenolate sodium; Mycophenolate mofetil
Intervention type(s): Drug; Drug
Intervention description(s): The conversion will be performed abruptly for all patients. Mycophenolate mofetil will be discontinued one day before the day of conversion (Day 1). Mycophenolate sodium will be introduced on day 1 with equivalent doses.; Mycophenolate mofetil dose will be maintained or adjusted to keep 30 to 60 mg*h ml-1.
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Renal transplantation; mycophenolic acid; mycophenolate mofetil; mycophenolate sodium; area under the curve
Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-part study will assess, in healthy volunteers, under both fasted and fed conditions,
      and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of
      single doses of C-10355 and C-10358 and single ascending doses of the selected compound
      compared to a single dose of Kalydeco®.
    


Intervention name(s): C-10355; C-10358; Kalydeco
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Subjects; Safety/Efficacy Study; Randomized; Open Label
A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effects of ORP-101 versus placebo on stool consistency and
      abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also
      assess the safety and tolerability of ORP-101 in patients with IBS-D.
    

Detailed description: 
      The objectives of this study are to evaluate the efficacy, safety and tolerability of ORP-101
      in patients with IBS-D. This is a randomized, double-blind, placebo-controlled, 3-arm,
      12-week, parallel proof-of-concept study with 2 active arms (50 mg and 100 mg ORP-101, QD)
      and 1 matching placebo arm, using a responsive adaptive randomization approach. After
      screening, patients who qualify will enter the baseline symptom assessment period, during
      which they will be instructed on completion of an electronic diary for daily collection of
      data related to their IBS symptoms, bowel function and loperamide rescue usage (not allowed
      during baseline).

      Patients who meet all entry criteria will be randomized to receive one of two different doses
      of ORP-101 tablets or placebo for 12 weeks. The study drug will be taken once daily,
      approximately 30 minutes prior to breakfast. Patients will return to the clinic on Days 14,
      28, 56, 84 (12 weeks) and 2 weeks after dosing has completed (Day 98) for a follow-up visit.

      Study subjects will include both male and female adults. Approximately 320 patients with
      IBS-D will be randomized to receive study drug or placebo. Randomization will be stratified
      by history of cholecystectomy/gallbladder agenesis.
    

Intervention name(s): ORP-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Other intervention name(s): dibuprenorphine-ethyl-ether
Intervention MeSH terms: Ether
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; IBS
Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
Condition: Liver Transplantation; Intestinal Perforation; Digestive System Fistula; Intestinal Fistula
MeSH terms: Intestinal Perforation; Intestinal Fistula; Digestive System Fistula; Fistula
Study type: Observational

Summary: 
      Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular
      carcinoma. However some patients develop intestinal perforations for which the prognosis is
      poor.

      The aim of the study is to evaluate the risk factors of intestinal perforations using a
      retrospective study scheme.
    

Detailed description: 
      Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular
      carcinoma. However some patients develop intestinal perforations for which the prognosis is
      poor.

      The aim of the study is to evaluate the risk factors of intestinal perforations using a
      retrospective study scheme. Previous studies have shown a possible implication of drugs or
      medical history or intraoperative complications. The investigators aim to describe the other
      possible risk factors (such as portal vein clampage) and the type of surgery done after the
      diagnosis and its impact on survival as well.
    

Intervention name(s): Liver transplantation
Intervention type(s): Procedure
Intervention description(s): Liver transplantation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients having received an orthotopic liver transplantation in the Montpellier University
        Hospital from 2014 to 2019
      
Keywords: Risk Factors; Survival
Comparison of the Efficacy of rTMS and tDCS of the Motor Cortex in Patients With Chronic Neuropathic Pain
Condition: Lumbar Radiculopathy
MeSH terms: Neuralgia; Radiculopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study aims to compare directly the efficacy of two noninvasive neurostimulation
      techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical
      current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.
    

Detailed description: 
      The present study ims to compare directly the efficacy of two noninvasive neurostimulation
      techniques : repetitive transcranial magnetic stimulation (rTMS) and transcranial direct
      electrical current (tDCS) of the motor cortex in patients with chronic lumbar radiculopathy
      on average pain intensity. This will be a sham controlled crossover design : patients will be
      randomized to receive either active rTMS or tDCS during 3 consecutive days followed by the
      alternative treatment within 3 weeks apart, or sham rTMS or tDCS during 3 consecutive dats
      followed by the alternative treatment within 3 weeks apart. The investigator will be blind to
      the treatment. Assessments will be performed before each treatment, then 1 hour after the end
      of the third day session, then 2 days and 1 week after the stimulation. Assessments will
      include pain questionnaires, quality of life, anxiety and depression, catastrophizing and
      evaluation of treatment effect on experimental pain using Quantitative sensory testing.
    

Intervention name(s): active or placebo rTMS or active or placebo tDCS
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathic pain; lumbar radiculopathy; rTMS; tDCS; placebo controlled study
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
Condition: Systemic Lupus Erythematosus
MeSH terms: Myositis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the safety and tolerability of sifalimumab in adult
      participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or
      polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or
      MI-CP179.
    

Detailed description: 
      The primary objective of this study is to evaluate the long-term safety and tolerability of
      multiple intravenous (IV) doses of sifalimumab in adult participants with active SLE or DM or
      PM who were previously treated with investigational product (sifalimumab or placebo) in one
      of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.
    

Intervention name(s): Sifalimumab
Intervention type(s): Drug
Intervention description(s): All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.
Intervention MeSH terms: Sifalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sifalimumab; MEDI-545
Effectiveness of A Telehealth Postural Awareness Program Combined With Exercise In People With Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      People with neck pain often experience pain, neck disability, and poor quality of life.
      Postural-based awareness programs are evidence-based interventions for postural problems and
      neck pain disorders. This study aims to determine the effectiveness of a telehealth
      physiotherapist-delivered postural awareness program combined with exercise in people with
      neck pain. Pain, neck disability, leisure time management, and exercise stage of change were
      evaluated.
    

Detailed description: 
      Pain with visual analog scale, neck disability with Neck Disability Index, Leisure time
      management with Leisure Time Management Scale, and exercise stage of change with exercise
      Stage of change Scale were determined. The authors aim to find out if there are any changes
      before and after the program on the pain, neck disability, and evaluation subscale of the
      leisure time management scale, and exercise stage of change of participants.
    

Intervention name(s): A postural awareness program with exercises
Intervention type(s): Behavioral
Intervention description(s): A program about postural awareness, bad posture, good posture and their effects on daily life
Intervention model: Single Group Assignment
Intervention model description: 12-week physiotherapist delivered a postural awareness program with exercises
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neck pain; neck; telehealth; awareness; posture; exercise
Effect of CV4 and Rib Raising Techniques on Autonomic Balance
Condition: Autonomic Nervous System Disease; Osteopathy
MeSH terms: Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Interventional

Summary: 
      Background. Heart rate variability (HRV) and skin conductance (SC) highlight autonomic
      activity and the balance of autonomic nervous system (ANS) which regulates involuntary
      physiological functions. The modulation of ANS tonic activity is a target of osteopathic
      manipulative treatment (OMT). The main aim of the present study was to verify whether CV4 and
      RR osteopathic techniques influence ANS activity.

      Trial design. A randomized-controlled clinical trial was performed from June 2010 to January
      2011.

      Methods. 32 healthy adults were selected. At enrollment, all healthy subjects were randomized
      in three groups: CV4 group (CV4 technique), Rib Raising group (RR technique), and Placebo
      group (PL technique). HRV and SC was recorded during the session respectively with heart rate
      monitor Polar S810i and with Onda Scanner Domiana (OSD-Microsale model). All data analysis
      was performed using SPSS statistical software and the significance level set at p≤0.05.
    


Intervention name(s): CV4 technique; RR technique; Placebo treatment
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart rate variability; autonomic nervous system; osteopathic manipulative treatment; skin conductance
An Exploratory Study Comparing Two Nicotine Inhalers
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Subjects will be screened within 28 days before the first study treatment to confirm that
      they meet the requirements to participate in the trial. They will return to the site for two
      treatment visits, at least 12 hours each, and at least one day in between visits. At each
      visit treatment N1/3-I5 or Nicotine Inhaler 10 mg will be administered every hour for 11
      hours. The investigator (or an appropriate delegate at the investigator site) will obtain
      informed consent from each subject. Blood samples will be drawn on a special schedule. The
      total predicted amount of blood sampled from each subject is 174 mL over the whole study.
      Subjects will be required to follow specific smoking and dietary restrictions and rate their
      urges to smoke, general liking of the product, and how easy the product is to use.
    

Detailed description: 
      Blood for pharmacokinetic analyses will be drawn prior to the first administration and
      immediately before administration at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 hours. Thereafter
      samples will be drawn at 5, 10, 15, 20, 25, 30, 45, and 60 minutes after the 11-hour
      administration. Easiness of use will be rated using an 8-grade ordered category scale at 10
      minutes after the start of administrations at 3, 6, and 9 hours. Overall liking will be rated
      using an 8-grade ordered category scale at 12 hours. Urges to smoke will be rated on a
      4-grade ordered category scale immediately before and at 15 minutes after the first
      administration, and as well as before and 15 minutes after the start of administrations at 3,
      6, and 9 hours, and at 12 hours. Used cartridges will be collected. Pooled samples per
      subject and treatment will be analyzed to determine the amount of remaining nicotine.
      Tolerability of the treatments will be evaluated in terms of reported and observed adverse
      events (AE).

      Since the primary objective is to compare steady-state nicotine pharmacokinetics of N1/3-I5
      with that of Nicotine Inhaler 10 mg, this study will have a multiple-dose setting. A
      crossover design has been chosen for this study in order to allow within-subject comparisons
      of treatments. Healthy habituated adults smoking at least 10 cigarettes daily for at least
      one year preceding inclusion will be included in the study, since they are expected to
      tolerate the doses of nicotine that will be administered.
    

Intervention name(s): Nicotine; Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine 5 mg Inhaler; Nicotine 10 mg Inhaler
Other intervention name(s): Not yet marketed; Not yet marketed
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics
A Smoking Cessation Treatment for Adult Women
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop and pilot test a smoking cessation counseling that
      focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and
      negative affect, loss of enjoyment).

      Aim 1: To develop the risk-based smoking cessation intervention.

      Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks
      of quitting is feasible to administer and acceptable to adult women who want to quit smoking.

      Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment
      in comparison to standard smoking counseling. It is expected that women who receive
      risk-based counseling will show better quit rates and a longer time to relapse than women who
      receive standard treatment.
    

Detailed description: 
      The purpose of this treatment development study is to design and pilot test a smoking
      cessation intervention in which counseling sessions are tailored to individual smokers'
      perceived risks of quitting. The feasibility, acceptability, and efficacy of the novel
      treatment will be examined through a pilot study in which female smokers will be randomly
      assigned to receive either the tailored treatment or a standard treatment. It is expected
      that participants receiving the tailored treatment will show higher rates of smoking
      abstinence than participants receiving the standard smoking cessation treatment at the end of
      the 8-week treatment and at one month follow-up.
    

Intervention name(s): Tailored treatment; Standard Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes tailored to the perceived risks of quitting most strongly held by each participant. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.; 8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes focused on the benefits of quitting smoking. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking; treatment; perceived risks
Drug Interaction Study Between Dolutegravir and Prednisone
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical
      development for the treatment of human immunodeficiency virus (HIV) infection. DTG is
      primarily metabolized by UDP-glucuronosyltransferase (UGT1A1) with cytochrome P450 (CYP)3A4
      pathway as a minor route. Corticosteroids have demonstrated induction effects on UGTs and
      CYP3A4. Corticosteroids are often used in HIV-infected subjects and have the potential to
      reduce DTG exposure due to enzyme induction when co-administered. The primary objective of
      this study is to determine whether concomitant prednisone administration can affect the
      pharmacokinetics (PK) of DTG.

      The study is a two part, two period, open label study. Part 1 will evaluate the effect of a
      high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the
      results from Part 1. In Part 1, approximately 12 healthy subjects will receive DTG 50mg q24h
      for 5 days in Period 1. Subjects will then be administered DTG 50mg q24h in combination with
      prednisone 60mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period 2.
      PK data of DTG will be obtained from Part 1 and used to inform decision making on the need
      for Part 2. If DTG exposure is reduced by more than 50% in Part 1, Part 2 will be carried out
      where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in Period 1
      followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed by a 5 day
      taper (total duration of 10 days) in Period 2. Safety evaluations and serial PK samples for
      DTG will be collected during each treatment period. A follow-up visit will occur 7-14 days
      after the last dose of study drug. All doses of study drugs will be taken following a
      moderate fat meal. This study will be conducted at one center in the United States, with
      healthy adult male and female subjects.
    


Intervention name(s): Dolutegravir; Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.; Prednisone is a commonly used corticosteroid used for a variety of medical condiitons
Other intervention name(s): GSK1349572
Intervention MeSH terms: Dolutegravir; Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)