bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Effects of Green Tea on Gut Flora, Fat Absorption, Body Composition and Resting Energy Expenditure
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Green tea may have positive effects for weight control and on body composition via several
      approaches such as a positive effect on the gut flora, a decrease in fat absorption from the
      intestines and an increase in resting energy expenditure.
    

Detailed description: 
      Green tea may have positive effects for weight control and on body composition via several
      approaches such as a positive effect on the gut flora, a decrease in fat absorption from the
      intestines and an increase in resting energy expenditure. We would like to investigate the
      long-term effects of green tea on gut flora, fat absorption, resting energy expenditure and
      body composition.

      The study will be conducted in a randomized, placebo-controlled, double-blind parallel design
      with four groups consisting of control groups and green tea groups with normal weight
      subjects and obese subjects. At three time points (baseline, 6 weeks and 12 weeks) faeces are
      collected for analyzing the gut flora composition and fat content. Furthermore, measurements
      of resting energy expenditure and body composition will be conducted. Activity will be
      measured during three weeks (baseline, week 6 and week 12).

      a hundred healthy subjects (50 males and 50 females) with a BMI between 18.5-25 kg/m2 and ≥30
      kg/m2 and aged between 18-50 years will be included in the study. All subjects will be
      non-smoking, non tea-drinkers, weight stable, dietary unrestraint, and at most moderate
      alcohol and caffeine consumers. Subjects will be free of medication except for oral
      contraceptives use in women.

      Intervention (if applicable):

      Subjects will receive either green tea or placebo in capsule form after their baseline
      measurement, which they have to consume three times daily for a period of twelve weeks.
    

Intervention name(s): placebo; green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will receive placebo (soy oil; 757 mg/capsule, 3 capsules with each breakfast, lunch and dinner) in capsule form after their baseline measurement, which they have to consume daily for a period of twelve weeks.; Subjects will receive green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ], 3 capsules with each breakfast, lunch and dinner)in capsule form after their baseline measurement, which they have to consume daily for a period of twelve weeks.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Obesity; Body weight; Gut flora; Fat absorption
Differential Diagnosis Athlete's Heart From Cardiomyopathy
Condition: Athlete's Heart
MeSH terms: Cardiomyopathies
Study type: Observational

Summary: 
      Assess the effects of strength sport to heart structure and function by T1 mapping with
      cardiac resonance imaging.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Athletes
Effect of Enhanced Feedback to Hospitals in an Emerging Clinical Information Network
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      A cluster randomised pragmatic trial will be conducted within an emerging clinical
      information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to
      an enhanced feedback intervention delivered over a nine-month period and compared to standard
      feedback. The trial to be implemented during a phase of implementing change in guideline
      recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake
      of the revised pneumonia treatment recommendations.
    

Detailed description: 
      The international guidelines for the classification and treatment of childhood pneumonia were
      revised recently and in Kenya the national guidelines changed in February 2016. We designed
      an enhanced feedback intervention aimed at improving uptake of the revised pneumonia
      treatment policy within a clinical network of 12 Kenyan county referral hospitals.

      Hospitals were randomized to receive either enhanced feedback (n = 6 hospitals) or standard
      feedback (n = 6 hospitals) delivered over a six-month period following nationwide pneumonia
      treatment policy change. The primary outcome is the proportion of all pneumonia admissions
      (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and
      treated using new guideline recommendations. The proportion of treatment change from oral
      amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment
      failure) will be reported as a secondary outcome.
    

Intervention name(s): Enhanced feedback; Standard feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Hospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations.; Hospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: feedback; pneumonia; quality of care
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Condition: Postoperative Urinary Retention; Urinary Tract Infections; Epidural Anesthesia
MeSH terms: Urinary Tract Infections; Urinary Retention
Study type: Interventional

Summary: 
      The purpose of this study is to compare the prevalence of postoperative urinary retention
      between retained and non-retained urinary catheter in total knee arthorplasty with epidural
      anesthesia
    


Intervention name(s): Total knee arthroplasty; Urinary Catheterization
Intervention type(s): Procedure; Procedure
Intervention description(s): A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses); Urinary catheterization is a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra. Catheterization allows the patient's urine to drain freely from the bladder for collection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Umbilical Cord Blood Therapy for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized controlled study aims to evaluate the efficacy of umbilical cord blood
      therapy for children with cerebral palsy.
    

Detailed description: 
      Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion
      or injury of the immature brain. It is a leading cause of childhood onset disability.

      Many experimental animal studies have revealed that umbilical cord blood is useful to repair
      neurological injury in brain.

      On the basis of many experimental studies, umbilical cord blood is suggested as a potential
      therapy for cerebral palsy.
    

Intervention name(s): Umbilical Cord Blood Infusion; Placebo Umbilical Cord Blood; Active Rehabilitation
Intervention type(s): Biological; Other; Other
Intervention description(s): The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.; Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.; All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
Other intervention name(s): Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Umbilical Cord Blood; Rehabilitation
MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to measure how much nitroglycerin or its metabolites may be found
      in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied
      to the skin of healthy subjects.
    


Intervention name(s): Nitroglycerin
Intervention type(s): Drug
Intervention description(s): MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
Other intervention name(s): MQX-503, Nitro-Bid
Intervention MeSH terms: Nitroglycerin
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Nitroglycerin; pharmacokinetics study of nitroglycerin containing treatments
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in
      Japanese participants with primary insomnia.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study
      to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary
      insomnia. The treatment period consists of two consecutive days (two nights) as one term.
      Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo
      once daily at bedtime for each use. Participants were randomly assigned to one of 10
      prespecified treatment sequence patterns.
    

Intervention name(s): Eszopiclone 1 mg; Eszopiclone 2 mg; Eszopiclone 3 mg; Placebo; Zolpidem Tartrate 10 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.; Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.; Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.; Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.; Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Other intervention name(s): SEP-190; SEP-190; SEP-190
Intervention MeSH terms: Zolpidem; Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary insomnia
Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.
    


Intervention name(s): Low dose of BIIL 284 BS tablets; High dose of BIIL 284 BS tablets; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This open-label, dose-escalation study is designed to evaluate the safety, tolerability,
      pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult
      participants with solid tumors with known or potential kinase pathway activation for which
      standard therapy has proven to be ineffective or intolerable or for which no curative
      standard-of-care treatment options exist. The study will be conducted in two stages: a
      dose-escalation stage and an expansion stage at the recommended dose.
    


Intervention name(s): Cobimetinib
Intervention type(s): Drug
Intervention description(s): Cobimetinib tablet or suspension will be administered as per the schedule described in arm description.
Other intervention name(s): RO5514041, GDC-0973, XL-518
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders
Condition: Brain Injury; Cerebral Palsy; Amyotrophic Lateral Sclerosis; Parkinson's Disease
MeSH terms: Parkinson Disease; Brain Injuries; Cerebral Palsy; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Wounds and Injuries
Study type: Interventional

Summary: 
      This open label trial is conducted to investigate the efficacy and safety of the combination
      therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor
      (G-CSF) for patients with brain injury or neurodegenerative disorders.
    

Detailed description: 
      Current treatments for brain injury or neurodegenerative disorders are palliative rather than
      curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as
      restorative approach for such disorders.
    

Intervention name(s): Umbilical cord blood therapy; Filgrastim
Intervention type(s): Procedure; Biological
Intervention MeSH terms: Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Umbilical cord blood; Granulocyte-colony stimulating factor; Brain injury; Neurodegenerative disorder; Efficacy; Safety
Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn more about how muraglitazar lowers blood sugar in
      people with type 2 diabetes. The safety of this treatment will also be studied.
    


Intervention name(s): Muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 diabetes
Dolutegravir Expanded Access Study
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      ING114916 is an open-label, multi-center, expanded access (EAP) study
    

Detailed description: 
      ING114916 is an open-label, multi-center EAP to allow access to patients with HIV-1 infection
      who have documented raltegravir or elvitegravir resistance, have limited treatment options
      and require dolutegravir to construct a viable anti-retroviral regimen for therapy. Patients
      must not be eligible for another ongoing dolutegravir clinical trial in order to participate
      in this EAP.

      The duration of patient accrual into the study will extend until dolutegravir receives local
      (by country) regulatory approval.
    

Intervention name(s): Dolutegravir
Intervention type(s): Drug
Intervention description(s): Eligible patients will receive DTG 50 mg given orally BID
Intervention MeSH terms: Dolutegravir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment experienced patients; Integrase resistance
Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
Condition: Hip Fractures; Anesthesia, Local; Pain, Postoperative
MeSH terms: Pain, Postoperative; Hip Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective is to complete a double-blinded randomized controlled crossover trial of
      lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance
      imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy
      volunteers.

      The investigators will assess block procedure-related parameters, anatomical spread of local
      anesthetic, and motor and sensory effects.
    


Intervention name(s): Ultrasound/MR image fusion guided lumbar plexus block (Shamrock); Ultrasound guided lumbar plexus block (Shamrock); Lidocaine-epinephrine added gadoterate meglumine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Perineural injection of 20 ml 2% lidocaine with 0.0005% epinephrine added 1 ml of gadoterate meglumine (0.13 ml) and sodium chloride (NaCl, 0.87 ml). The 1 ml of gadoterate meglumine-NaCl is added to the local anesthetic prior to the perineural injection in order to enhance visualization of the local anesthetic on MRI scanning after the intervention.
Intervention MeSH terms: Lidocaine; Epinephrine; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip surgery anesthesia; Perioperative analgesia
Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
Condition: Vaginal Inflammation; Vaginal Infections
MeSH terms: Mucositis; Vaginitis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the response of vaginal and cervical tissue after exposure to three
      vaginal products: hydroxyethyl cellulose (HEC) placebo, nonoxynol-9 (N9) and imiquimod (IMQ)
      cream.
    

Detailed description: 
      Each woman in this study will be evaluated 5 separate times:

        1. Baseline in the follicular phase of the menstrual cycle;

        2. Baseline in the luteal phase of the menstrual cycle;

        3. After a 3 day (4 dose) treatment with HEC placebo;

        4. After a 3 day (4 dose) treatment of 4% N-9;

        5. After a 2 day (2 dose) treatment of IMQ.

      A subset of 5 women will have an additional baseline visit in the follicular phase.

      The order of the N-9 and IMQ treatments is randomized. The study is cross over in design. The
      per sequence of treatments is as follows: Baseline in the follicular phase of the menstrual
      cycle, next is baseline in the luteal phase of the menstrual cycle, next is after a 3 day (4
      dose) treatment with HEC placebo. At this point in the study, half of the participants are
      randomized to do the N-9 treatment and then the IMQ treatment. The remaining half of the
      participants do the IMQ treatment and then the N-9 treatment.

      All participants are sampled at the 5 timepoints described above.
    

Intervention name(s): Imiquimod; Placebo; Nonoxynol-9
Intervention type(s): Drug; Other; Drug
Intervention description(s): Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.; Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.; Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
Other intervention name(s): Aldara; Hydroxyethylcellulose; Conceptrol
Intervention MeSH terms: Imiquimod; Nonoxynol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vaginal innate immune and inflammatory responses
A Study to Evaluate Cenerimod in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the study is to investigate the rate and routes of elimination of
      cenerimod and the mass balance in urine, feces, and expired air
    


Intervention name(s): Cenerimod
Intervention type(s): Drug
Intervention description(s): Oral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other