bioihbjkbjnl/mcl2 huggingface dataset:
Dyslipidemia of Obesity Intervention in Teens
Condition: Dyslipidemia; Obesity
MeSH terms: Obesity; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial of pitavastatin will determine efficacy and safety in this high risk population
      and provide evidence for clinicians to target this treatable risk factor to achieve an impact
      on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular
      disease.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled clinical trial of pitavastatin for 2 years
      comparing the effect of study drug versus placebo on vascular measures in at least 354
      adolescents with excess adiposity and CDO (defined as high non-HDL-C + high triglycerides
      (TG)/HDL-C ratio or low HDL-C). Enrollment will take place over 36 months.
    

Intervention name(s): Pitavastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Statin; Placebo
Other intervention name(s): Livalo
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dyslipidemia; obesity; pitavastatin; lipids
A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome in Females
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the effect of orally administered TU-100 (5 g three times
      daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients.
    


Intervention name(s): TU-100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15g daily, orally as 5g three times daily for 4 consecutive weeks; Matching placebo given 5g three times daily orally for 4 consecutive weeks
Other intervention name(s): Daikenchuto
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Rome III criteria; abdominal bloating; natural; herbal; Kampo; Adult ages 18 to 65; Female subjects
Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
Condition: Congestive Heart Failure; Cardiac Resynchronization Therapy
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This is a trial to examine the effects of meditation on the incidence of ventricular
      arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.

      We wish to test the following hypotheses:

        1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in
           patients with congestive heart failure.

        2. Vipassana meditation improves the psychological profile in patients with CHF. In this
           study, subjects meeting the inclusion and exclusion criteria will be recruited into the
           study after obtaining informed consent. The subjects will then be randomized into either
           an experimental group ( Meditation) or into a control group (usual care).
    

Detailed description: 
      This is a single center, investigator-initiated, randomized, controlled trial to examine the
      effects of meditation on the incidence of ventricular arrhythmias and the psychological
      profiles in patients with implanted cardiac defibrillators and cardiac resynchronization
      devices. The former are used to protect patients against cardiac fibrillation and the latter
      for synchronizing the contractions of the two ventricles.
    

Intervention name(s): Vipassana Meditation practice and instruction; Standard Medical Care
Intervention type(s): Behavioral; Other
Intervention description(s): 2-3 instructed meditation sessions per week in addition to standard medical care.; Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
Other intervention name(s): Meditation + ICD; Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meditation; Congestive Heart Failure; ICD; Cardiac Resynchronization Therapy
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to compare the safety and efficacy of the following three treatment regimens
      in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1)
      PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2)
      PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3)
      PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
    

Detailed description: 
      PegIntron Dose will be administered once weekly subcutaneously on the same day of the week:

      Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to
      Inject (mL) 0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL) 0.33; Screening 2 Weight
      76-85 kg Volume to Inject (mL) 0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL) 0.48;
      Screening 2 Weight 105-125 kg Volume to Inject (mL) 0.58 from two vials

      REBETOL Dosage (for Use With PegIntron):

      Screening 2 Weight 40-65 kg Daily Dose 800 mg; Screening 2 Weight >65-85 kg Daily Dose 1000
      mg; Screening 2 Weight >85-105 kg Daily Dose 1200 mg; Screening 2 Weight >105-125 kg Daily
      Dose 1400 mg

      The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same
      day of the week

      COPEGUS Dosage (for Use With PEGASYS):

      Screening 2 Weight <75 kg Daily Dose 1000 mg; Screening 2 Weight > or = 75 kg Daily Dose
      1200mg

      NOTE: Double Blind for PegIntron; Open Label for REBETOL, PEGASYS and COPEGUS

      NOTE: REBETOL is the Schering-Plough brand name for ribavirin. COPEGUS is the Hoffman-La
      Roche brand name for ribavirin.
    

Intervention name(s): PegIntron (peginterferon alfa-2b; SCH 54031); PegIntron (peginterferon alfa-2b; SCH 54031); REBETOL (ribavirin; SCH 18908); PEGASYS (peginterferon alfa-2a); COPEGUS (ribavirin)
Intervention type(s): Biological; Biological; Drug; Biological; Drug
Intervention description(s): 1.5 ug/kg/week subcutaneously (SC) for 48 weeks; 1.0 ug/kg/week SC for 48 weeks; weight based dose 800-1400 mg/day orally (PO) for 48 weeks; 180 ug/week SC administered for 48 weeks; 1000-1200 mg/day PO for 48 weeks
Other intervention name(s): PegIntron; PegIntron; REBETOL [the Schering-Plough brand name for ribavirin]; PEGASYS; COPEGUS [the Hoffman-La Roche brand name for ribavirin]
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Probiotics (VSL) on Portal Hypertension
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will address the hypothesis that portal hypertension is mediated in part by
      bacterial or endotoxin translocation and the production of inflammatory mediators (tumor
      necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with
      the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial
      effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and
      improving systemic and splanchnic hemodynamics.
    

Detailed description: 
      We have recently completed an open-label uncontrolled trial of the probiotic VSL#3 in 8
      patients with compensated cirrhosis and evidence of portal hypertension (VIP study) to
      determine whether this agent would have beneficial effects in portal pressure reduction
      (unpublished data Tandon, P. et al.). The open label design and the inclusion of compensated
      (Child Pugh A) cirrhotic patients in this initial study were chosen to confirm the safety and
      tolerance of VSL#3 and the safety of the portal pressure measurements at our center. No
      changes of physical status occured. There was a non-significant reduction in portal pressure
      from 19.7 to 18.1 mm Hg after 2 months of VSL#3 supplementation. Furthermore, there was a
      significant reduction in the serum aldosterone level (p=0.03). IL-8 levels were reduced in
      4/6 patients analyzed to date. These results suggest that VSL#3 results in cytokine reduction
      and an improvement in the effective circulating volume even in these well-compensated
      cirrhotic patients. The comparison of the rest of the pro-inflammatory mediators and stool
      microflora is still being analyzed.

      The data in our initial study is very promising. As our patients were compensated cirrhotics
      with normal intestinal permeability and only mild baseline perturbations in hepatic function
      parameters (INR, bilirubin, albumin) and neurohormonal markers (aldosterone, renin), it is
      not surprising that a reduction in portal pressure was not identified. Consistent with
      previous studies however, these local results confirm the safety and tolerance of both VSL#3
      as well as portal pressure measurements in cirrhotic patients (20,24,25).
    

Intervention name(s): Probiotic
Intervention type(s): Drug
Intervention description(s): Patients in this group will be given the probiotic VSL#3 2 packets BID for a total of 8 weeks.
Other intervention name(s): VSL#3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Portal Hypertension; Portal Pressure Measurement; VSL3; Cirrhosis; End Stage Liver Disease; Probiotics
Human Dopamine Transported Imaging in Cocaine Abuse: 2 - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the density of DA transporters during prolonged
      cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that
      DA transporters are altered by cocaine abuse and reestablished during withdrawal.
    


Intervention name(s): Cocaine
Intervention type(s): Drug
Intervention MeSH terms: Cocaine
Primary purpose: Treatment
Keywords: cocaine dependence
AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The purpose of this study is to identify whether changes in age-related macular degeneration
      (AMD) over time as seen with spectral domain optical coherence tomography (SDOCT) imaging,
      can be used to predict vision loss and the advancement of AMD in people at moderate to high
      risk for progression.
    

Detailed description: 
      The primary objective of this study is to identify whether SDOCT patterns such as: drusen
      size, OCT reflectivity within drusen, photoreceptor (PR)change over drusen, microfoci of
      subretinal fluid (SRF), or retinal thickening are predictive of vision loss, progression of
      drusen, progression of photoreceptor loss over drusen, development of choroidal
      neovascularization (CNV), or development of geographic atrophy (GA).

      The secondary objectives of this study are:

        1. To define the relationship between SDOCT imaging, autofluorescence (AF)imaging, and
           color photographic or other fundus imaging of AREDS 2 patients in both a cross-sectional
           study of baseline data and a longitudinal study in data collected over the 5 year AREDS
           2 study.

        2. To compare the extent of geographic atrophy on SDOCT versus color photographs and
           autofluorescence.

        3. To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2
           patients randomized to different oral supplements in the AREDS2.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The A2A SDOCT study will recruit AMD subjects from the AREDS 2 study population at 4 AREDS
        2 Study Centers. Controls will be recruited from Duke University Eye Center and Emory
        University.
      
Keywords: Spectral Domain Optical Coherence Tomography; Optical Coherence Tomography; AREDS2; AMD; Age-related macular degeneration; Drusen
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone
      or with oral antidiabetic agents will be randomly assigned to one of three treatment groups:
      insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a
      background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of
      myocardial fuel selection will take place, under fasting conditions in the morning following
      that day's treatment injection(s).
    

Detailed description: 
      The investigators will test the hypothesis that effects of liraglutide plus insulin detemir
      on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type
      2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with
      oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin
      detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). All subjects will
      undergo an initial standardization of background treatment to metformin 2000 mg per day,
      followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once
      daily each morning, tapering up according to label instructions) and/or detemir (administered
      twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose
      readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at
      the end of this treatment period, under fasting conditions in the morning following that
      day's treatment injection(s).
    

Intervention name(s): liraglutide; insulin detemir; liraglutide plus insulin detemir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.8mg subcutaneous qd for 3 months; 5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months; liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months.
Other intervention name(s): Victoza; Levemir; Vyctoza plus Levemir
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes; Myocardial metabolism
Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1)
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency
      Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong
      therapy. This study will evaluate how safe ABBV-382 is and how it is absorbed, distributed
      and eliminated from the body in adult participants with HIV-1 infection.

      ABBV-382 is an investigational drug being developed for the treatment of HIV-1 infection.
      This study takes place in 2 parts. In Part A, participants with HIV-1 and no history of
      combination antiretroviral therapy (cART) or who are off cART for more than 3 months will be
      enrolled to receive ABBV-382. In Part B, participants with no virus in their blood and on
      maintenance cART will be enrolled into one of the intravenous (IV) or subcutaneous (SC)
      groups. In the IV groups, participants will receive either placebo or ABBV-382 whereas
      participants in the SC group will receive ABBV-382. There is 1 in 3 chance that participants
      will receive placebo (no drug) in Part B IV groups. The IV group in Part B is double-blinded
      which means neither the study doctors nor the participants will know who will be given study
      drug or placebo. Around 52 adult participants with HIV-1 infection will be enrolled at
      approximately 21 sites across the United States, including Puerto Rico.

      Participants in Part A will receive an intravenous (IV) dose of ABBV-382 on Day 1.
      Participants in Part B will receive an IV or SC dose of ABBV-382 or placebo on Days 1, 29 and
      57.

      There may be a higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests, and
      presence of side effects.
    


Intervention name(s): ABBV-382; ABBV-382; Placebo for ABBV-382
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous (IV) infusion; Subcutaneous (SC) injection; Intravenous (IV) infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus; HIV; HIV-1; ABBV-382
Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy
Condition: Primary Spontaneous Pneumothorax
MeSH terms: Pneumothorax
Study type: Interventional

Summary: 
      Investigators compared the patients' subjective postoperative symptoms and complications
      between the double lumen endotracheal intubated patients under general anesthesia and
      non-intubated patients under sedation and local anesthesia including

        1. postoperative Visual scale of pain

        2. postoperative sore throat/voice change

        3. postoperative nausea/vomiting

        4. intraoperative Arterial blood gas analysis

        5. cost for anesthesia

        6. morbidity
    

Detailed description: 
      Thoracoscopic bullectomy for primary spontaneous pneumothorax is relatively simple and short
      procedure compared to other thoracic surgery. However, in the anesthetic preparation,
      complicated technique and procedures are needed including a double lumen endotracheal
      intubation, auscultation, and flexible bronchoscopic confirmation of the tube location, even
      during lateral decubitus position. The double lumen endotracheal tube has a bigger outer
      diameter. And postoperative sore throat and voice change can develop after the intubation
      procedure.

      Recently, single lumen intubation using carbon dioxide gas instillation under general
      anesthesia during thoracoscopic surgery is reported. However, if safety and efficacy are
      warranted, thoracoscopic surgery using nonintubated and self-ventilated anesthesia will be a
      best solution for above mentioned postoperative discomforts.

      Investigators designed the comparative study of nonintubated local anesthesia under sedation
      and intubated general anesthesia in thoracoscopic bullectomy through the single port.
      Investigators will investigate postoperative pain, sore throat, voice change, nausea,
      vomiting, and intraoperative arterial blood gas analysis.

      This study will be performed at Korea University Ansan Hospital. A total of 40 patients will
      be enrolled (20 patients in each arm).
    

Intervention name(s): nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration; intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas; single port thoracoscopic bullectomy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.
Intervention MeSH terms: Lidocaine; Dexmedetomidine; Ketamine; Anesthetics; Propofol; Sevoflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the absolute bioavailability of BI 1265162
      following administration of oral solution and inhaled (with and without charcoal) via
      Respimat.
    


Intervention name(s): BI 1265162 (T1); BI 1265162 (T2); BI 1265162 (R); BI 1265162 (T3)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral solution; Solution for inhalation; concentrate for i.v. solution; Solution for inhalation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms
      of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of
      symptoms of AVV (dryness and / or dyspareunia) associated with menopause.
    

Detailed description: 
      Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms
      of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of
      symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

      Open study with only one arm. The study has a total duration per patient of 3 months: initial
      visit (V1), a follow-up visit (V2) after 4 weeks of treatment and a final visit (V3) after 12
      weeks of treatment.
    

Intervention name(s): Idracare
Intervention type(s): Device
Intervention description(s): Treatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed.
Intervention model: Single Group Assignment
Intervention model description: open study, only one arm
Masking: None (Open Label)
Primary purpose: Treatment