bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effect of ASP1941 on Cardiac Repolarization in Healthy Subjects
Condition: Healthy Subjects; Cardiac Repolarization
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on
      electrocardiogram (ECG) measurements.
    

Detailed description: 
      Subjects will be randomized in four treatment sequences of twenty subjects each. Subjects in
      each treatment sequence will participate in a total of four treatment periods (A, B, C, and
      D) separated by washout periods of at least 7 days from completion of the prior period (Day
      8) through clinical check-in (Day -1) of the next study period.

      For Period 1, subjects will be admitted to the clinical research unit on Day -2. For each
      subsequent study period, subjects will be admitted to the clinical research unit on Day -1.
      Subjects will be discharged from the unit after completing procedures on Day 8 of each
      period. Subjects will receive a follow-up telephone call 7-10 days after their last clinic
      day (Period 4\Early Discontinuation [ED]).
    

Intervention name(s): Placebo; ASP1941; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Other intervention name(s): Avelox
Intervention MeSH terms: Ipragliflozin; Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Thorough QT (TQT); ASP1941
Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The aim of this study is to compare two postoperative recovery pathways namely, enhanced
      recovery after surgery (ERAS) pathway and conventional recovery pathway after laparoscopic
      sleeve gastrectomy with respect to outcomes including hospital stay, postoperative pain and
      other postoperative outcomes.
    

Detailed description: 
      The Enhanced recovery after surgery (ERAS) pathway, initially introduced for colorectal
      surgery, is an evidence based perioperative pathway which has resulted in earlier recovery,
      less pain, and lower complication rates. Bariatric surgical patients, without severe
      co-morbidities, are good candidates for ERAS pathway, but the application of ERAS concepts
      has been limited in this field, specially, in Asia.

      Although the current literature shows that 2 randomized clinical trials (RCT) have been
      performed for application of ERAS in bariatric surgery, data is still scarce as per outcomes
      with respect to postoperative pain and analgesic usage. One of the RCTs has compared with
      historical controls and both the RCTs have not clearly defined their conventional standard
      pathways. In this study, the investigators have clearly defined both ERAS pathway and
      standard pathway leaving no ambiguity.

      This study is a prospective, randomized, parallel group trial comparing ERAS pathway and
      standard pathway after laparoscopic sleeve gastrectomy in relation to the hospital stay,
      postoperative pain, complications and other perioperative parameters.

      This is a single institute based trial, being conducted at GEM hospital and research centre,
      Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.

      In this trial, the investigators are planning to enroll participants with morbid obesity
      planned to undergo laparoscopic sleeve gastrectomy. After full assessment, informed consent,
      these participants will be randomised using computer generated random numbers either into
      ERAS pathway group or into Standard pathway group.

      All the intraoperative and perioperative details with respect to anaesthetic drugs usage,
      intravenous fluid requirement, time to ambulation, time to oral liquids, postoperative pain
      score, analgesic requirement and hospital stay will be recorded in the proforma.
    

Intervention name(s): ERAS pathway; Standard pathway
Intervention type(s): Other; Other
Intervention description(s): ERAS pathway after laparoscopic sleeve gastrectomy; Standard pathway after laparoscopic sleeve gastrectomy
Other intervention name(s): Fast track pathway; Coventional pathway
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERAS; Enhanced recovery after sugery in bariatric surgery; sleeve gastrectomy
FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable
      behaviors in autism spectrum disorders. All participants will receive active study
      medication. Participants will also receive diagnostic and cognitive evaluations at no cost.
      Participants will be required to undergo two fMRI (functional magnetic resonance imaging
      scans) where we will take pictures of your brain while performing simple tasks.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; asperger's; repetitive; restricted; compulsions
The Effects of GLA (5 mcg) on Human Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and
      tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF
      administered subcutaneously. The second focus will be to detail the global immune response by
      measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be
      to investigate the effects of GLA on the peripheral blood immune cells including monocytes
      and dendritic cells. The results of this trial will generate supportive human data to use GLA
      as an adjuvant in a dendritic cell-targeted vaccine strategy.
    


Intervention name(s): GLA-AF; GLA-SE; EM060G (SE)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).; Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).; The same stable oil-in-water emulsion (SE), but without GLA.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
    


Intervention name(s): isavuconazole; Oral Contraceptive (ethinyl estradiol / norethindrone)
Intervention type(s): Drug; Drug
Intervention description(s): oral; contraceptive pill consisting of ethinyl estradiol and norethindrone
Other intervention name(s): BAL8557; BAL4815; Ortho-Novum
Intervention MeSH terms: Isavuconazole; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norinyl; Contraceptive Agents; Contraceptives, Oral; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: isavuconazole; ethinyl estradiol; norethindrone; contraceptive; Healthy Volunteers; BAL8557; BAL4815
Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility
Condition: Obesity; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The study will evaluate the utility of hypoxic exercise training to improve cardiovascular
      and metabolic health among obese breast cancer survivors. While participants exercise, a
      lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach
      removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which
      is believed to support exercise tolerance. Participants are randomized to either the
      treatment (walking+simulated-altitude) or control (walking under normoxic conditions).
    

Detailed description: 
      Cancer survivors have a two-fold greater risk of having one or more functional limitations
      compared to those without a history of cancer. Though exercise interventions in breast cancer
      survivors exist, a large portion of women (61%) exhibit some form of lower-body dysfunction
      that severely restricts participation in physical activity and exercise. Both physical and
      emotional well-being are negatively affected by the combination of increased adiposity,
      orthopedic problems and muscle weakness, thus reinforcing a cycle of physical inactivity.

      For these reasons, obese breast cancer survivors with walking limitations are faced with a
      barrier that greatly increases the difficulty of meeting prescribed exercise guidelines (≥150
      weekly minutes of moderate-to-vigorous intensity exercise). Though previous investigations
      have demonstrated the safety and benefits of exercise+simulated altitude to improve body fat,
      physical endurance and insulin sensitivity, results have been limited to non-cancer
      participants only. Given the comorbidities common to breast cancer survivors, specifically,
      heart disease risk, lower body joint problems, low aerobic capacity, and fatigue, further
      research is needed.
    

Intervention name(s): Walking+simulated-altitude; Walking (control)
Intervention type(s): Other; Behavioral
Intervention description(s): Participants will walk on a treadmill for up to 50 minutes at a 16% oxygen level (administered via exercise mask), which is similar in altitude to Flagstaff, AZ. The progression of exercise training will be based on a varying percents of heart rate reserve.; Participants will walk on a treadmill for up to 50 minutes.The progression of exercise training will be based on a varying percents of heart rate reserve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Cancer; Obesity
Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic
      characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when
      administered alone to healthy volunteers.
    

Detailed description: 
      Healthy volunteers are administrated single-dose over the period I and II (Crossover) of
      CKD-4101 1000mg and Mycophenolate mofetil capsule 1000mg.

      Every time before and after each medication, PK parameters and safety of CKD-4101 tablet and
      Mycophenolate mofetil capsule is performed using a blood sample and conducting some tests
      respectively.
    

Intervention name(s): CKD-4101 tablet; Mycophenolate Mofetil capsule
Intervention type(s): Drug; Drug
Intervention description(s): CKD-4101 tablet 1000 mg
500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover); Mycophenolate Mofetil capsule 1000 mg
250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Healthy volunteers; Mycophenolate Mofetil
Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner
Condition: Obesity; Diabetes; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Obesity and its complications have a significant effect on morbidity and mortality in these
      subjects. Especially at risk are subjects with extremely increased BMI (above 99th percentile
      for age and gender in adolescents). In these subjects classical treatment with diet and
      cognitive therapy has a limited effect. Bariatric procedures, at the moment, are the only
      feasible therapeutic possibility.

      Bariatric procedures are based on several principles; restrictive, malabsorptive and
      combined. They can be surgical or endoscopic. The later are used in subjects that do not
      qualify for surgical procedures that decline them or are used before a planed definite
      bariatric procedure.

      Duodena-jejunal liner (DJL) is an endoscopic tool, that is efficiently and safely used to
      decrease body weight and ameliorated obesity complications, especially those associated with
      diabetic state.

      Aims of the study are:

        -  To determine (short and long-term) efficacy of DJL in decreasing body weight in
           adolescents.

        -  To determine (short and long-term) efficacy of DJL in ameliorating complications of
           morbid obesity - abnormal glucose metabolism, dislipidemia, altered adipokine secretion
           pattern, altered secretion pattern of gastrointestinal hormones in adolescents.

        -  To visualize functional alternations in the selected central nervous system regions
           associated with appetite regulation upon insertion of DJL.

        -  To evaluate psychological outcomes; change in emotional and behaviour problems, in body
           image, in eating disorder symptoms.
    


Intervention name(s): Duodena-jejunal liner
Intervention type(s): Device
Other intervention name(s): Endobarrier
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Diabetes; Metabolic syndrome; Gut hormones; Adipokines; Appetite; Adolescent
Post Trial Analysis of a Primary Prevention Study in Asian Indians
Condition: Diabetes
Study type: Observational

Summary: 
      An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this
      study we estimate the incidence of type 2 diabetes among participants enrolled in the
      diabetes prevention programme. This will provide comparison of the progression to diabetes
      among group motivated through text messages and the group educated only during enrollment. A
      total of 537 participants were enrolled in the primary study and are invited to participate
      in a follow-up visit 3 years post active trial period.
    


Intervention name(s): Text Messaging via Short Message Service
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants randomized (n=537) in the primary study NCT00819455.
      
Biospecimen description: 
      Serum and blood cells are stored.
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
Condition: Dyspepsia; Helicobacter Pylori Infection
MeSH terms: Infections; Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is
      rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a
      new triple therapy to treat H. pylori infection in dyspeptic patients.
    

Detailed description: 
      This is a, randomized, double-blind, placebo-controlled study of RHB-105 in adult subjects
      complaining of epigastric discomfort that have been screened and found to be positive for H.
      pylori infection via 13C Urea Breath Test (UBT) and either fecal antigen test or CLO test.

      Eligible subjects will be randomized in a ratio of 1:2 between placebo arm (n=30) and the
      active arm (RHB-105) (n=60). Subjects will receive study drug for 14 consecutive days.
      Eradication of H. pylori infection will be determined based on 13C UBT conducted between 28
      to 56 days after completion of study drug therapy.

      Subjects will be unblinded upon 13C UBT analysis. This will provide timely active therapy to
      all subjects enrolled in this study. Subjects in the placebo arm will be entitled to receive
      standard-of-care as prescribed by the treating physician following un-blinding.

      Eradication failures (13C UBT-positive) in the active study drug arm will undergo upper
      endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin,
      clarithromycin, and metronidazole). Culture and sensitivity directed therapy as prescribed by
      the treating physician will be offered to these subjects.
    

Intervention name(s): RHB-105; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:
Rifabutin 150 mg
Amoxicillin 3000 mg
Omeprazole 120 mg
Subjects will take study drug every 8 hours with food for 14 consecutive days.; Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Helicobacter pylori; H. pylori; Dyspepsia
Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The general aim of the present study is to investigate the impact of 4 weeks treatment with
      linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the
      current trial this effect of linagliptin treatment on endothelial function will be compared
      against both the sulfonylurea glimepiride and against placebo, which has not been tested in a
      trial before; as also is the case for other DPP-4 inhibitors.

      Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second
      most used oral antidiabetic drug class.
    


Intervention name(s): Placebo; Linagliptin; Placebo; Placebo; Placebo; Glimepiride
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo matching Glimepiride; given once daily for 28 days; Placebo matching Linagliptin; Placebo matching Linagliptin; Placebo matching Glimepiride; 1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)
Intervention MeSH terms: Glimepiride; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults
Condition: Tuberculosis (TB)
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in
      healthy European volunteers who are PPD-positive either via previous vaccination with BCG
      and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis.
    

Detailed description: 
      The BCG vaccine has been widely available for several decades. It is easy and cheap to
      produce, and when given to neonates or young children it is effective in preventing severe
      manifestations of disease such as meningeal tuberculosis and miliary tuberculosis. However,
      in terms of the capacity of the vaccine to protect adult humans it shows a wide range of
      efficacy, including zero levels of protection. Due to the general realization that BCG is
      losing its protective effect, particularly in terms of preventing adult-onset tuberculosis, a
      major effort has been made to try to develop new alternative vaccines. One such candidate,
      Mtb72F/AS02A, is a polyprotein derived from two known M. tuberculosis antigens adjuvanted
      with AS02A. Mtb72F/AS02A is a candidate TB vaccine under development for two indications:
      prevention of primary TB infection in young children in highly endemic areas and as an
      adjunct to treatment for TB in adolescents and adults.
    

Intervention name(s): Mtb72F/AS02A
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 3

Summary: 
      It is a randomized, double-blind, multi-center, two-arm study intended to assess the safety
      and efficacy of three different doses/dose regimens of paromomycin administered
      intramuscularly as follows: 11 mg/kg/day for 14 days and 11 mg/kg/day for 21 days for the
      treatment of visceral leishmaniasis (VL) in India.
    

Detailed description: 
      Paromomycin administered at a dose of 11 mg/kg/day IM for 21 days was previously demonstrated
      by iOWH and WHO to be as effective as amphotericin B administered IV at a dose of 1
      mg/kg/every other day for a total for a total of 15 doses over 30 days in the treatment of VL
      in Bihar, India (protocol VLPM01) in a recently completed study (94.6% vs. 98.8% of subjects
      were disease free at 6 months, respectively). This new study is being conducted to determine
      whether similar or better efficacy and safety of IM paromomycin can be achieved with a
      shorter duration of treatment (14 days rather than 21 days) administered for a shorter
      duration (14 days rather than 21 days) than the regimen studied in the previous trial.

      This shorter duration study will compare the initial and final cure (response to treatment)
      rates in subjects with VL receiving paromomycin at the following doses and dose regimens:

        -  Group A: paromomycin 11 mg/kg/day IM for 14 days

        -  Group B: paromomycin 11 mg/kg/day IM for 21 days

      Because compliance generally improves with shorter duration of therapy, and better treatment
      compliance decreases the probability of the emergence of drug-resistant disease,
      administration of higher daily doses of paromomycin for a shorter time may improve efficacy
      without producing unacceptable toxicity. In addition, a treatment regimen of shorter duration
      would cost less and be easier to administer.

      The current study is designed to explore different doses and dose regimens of IM paromomycin
      to determine the dose and dose regimen that should be recommended for first-line therapy for
      treatment of VL, while maintaining the efficacy and safety.
    

Intervention name(s): Paromomycin; Paromomycin
Intervention type(s): Drug; Drug
Intervention description(s): 11 mg/kg for 14 days; Paromomycin for 21 days @ 11mg/kg by intramuscular injections
Intervention MeSH terms: Paromomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visceral leishmaniasis; Paromomycin