bioihbjkbjnl/mcl2 huggingface dataset:
PRC-063 in an ADULT Workplace Environment
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the time of onset and time course of
      efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a
      simulated adult workplace environment (AWE) setting, as measured by the PERMP (an
      individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours
      post-dose.
    

Detailed description: 
      This is a randomized, double-blind, crossover, placebo-controlled, optimized-dose, phase 3
      study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride
      controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of
      Attention-Deficit/Hyperactivity Disorder (ADHD) in adult subjects greater than or equal to 18
      years of age and less than or equal to 60 years of age. After giving written informed
      consent, subjects will be screened to ascertain their suitability for the study according to
      the inclusion and exclusion criteria. The study will have four phases: (1) Screening and
      subsequent washout, if needed; (2) baseline and open-label dose optimization during which
      subjects will be titrated from a starting dose of 25 mg up to his/her final dose (25, 35, 45,
      55, 70, 85 or 100 mg/day); (3) AWE sessions 1 and 2 in the adult analog setting following a
      practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the
      clinic up to 10 times over a 9-week period.
    

Intervention name(s): PRC-063 25 mg; Placebo; PRC-063 35 mg; PRC-063 45 mg; PRC-063 55 mg; PRC-063 70 mg; PRC-063 85 mg; PRC-063 100 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral 25 mg capsule - active; Oral placebo capsule; Oral 35 mg capsule - active; Oral 45 mg capsule - active; Oral 55 mg capsule - active; Oral 70 mg capsule - active; Oral 85 mg capsule - active; Oral 100 mg capsule - active
Other intervention name(s): 25 mg capsule; Placebo capsule; 35 mg capsule; 45 mg capsule; 55 mg capsule; 70 mg capsule; 85 mg capsule; 100 mg capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Adult
Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment
Condition: Hepatic Insufficiency
MeSH terms: Hepatitis; Hepatic Insufficiency; Liver Failure; Liver Cirrhosis, Alcoholic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives were:

        -  To determine the effects of steady state TPV co-administered with low dose RTV on steady
           state PegIFN and RBV in HIV negative subjects with mild hepatic impairment (scheme A)

        -  To determine the effects of steady state of pegylated interferon (PegIFN) and RBV on
           steady state pharmacokinetics of TPV co-administered with low dose RTV in HIV negative
           subjects with mild hepatic impairment (scheme A)

        -  To determine the pharmacokinetics of single dose and steady state TPV/r 500/200 mg in
           subjects with moderate hepatic insufficiency (scheme B)
    


Intervention name(s): Tipranavir; Ritonavir; Pegylated interferon; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Interferons; Ritonavir; Ribavirin; Tipranavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study will estimate any inhibitive or inductive effect of PF-06651600 on the
      pharmacokinetics of midazolam and efavirenz.
    


Intervention name(s): PF-06651600; midazolam; efavirenz
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days; single administration of midazolam 2 mg oral solution; single administration of efavirenz 50 mg capsule
Intervention MeSH terms: Efavirenz; Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PK; Phase 1
Vector Engineering Clinical
Condition: COPD
Study type: Interventional

Summary: 
      This study aimed to validate a novel automatic non-invasive ventilation (NIV) mode that
      continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that
      abolishes tidal expiratory flow limitation (EFL). The investigator conducted a prospective,
      non-randomized, study on stable chronic obstructive pulmonary disease (COPD) patients that
      may or may not be treated currently with NIV. Patients were studied in a sleep lab on a
      single night with the auto - titrating EPAP that adjusts to abolish tidal EFL. The primary
      endpoint was to evaluate the behavior of the EPAP during the night. Additionally, a sub-group
      of patients used the device at home for a 2 week period. EPAP behavior was assessed during
      this 2 week period.
    

Detailed description: 
      Tidal Expiratory Flow Limitation (EFLT) is the inability to increase expiratory flow despite
      increasing effort. Especially in patients with mild to severe COPD, EFL can present
      challenges when receiving mechanical ventilation. To overcome EFLT expiratory positive airway
      pressure (EPAP) is applied; however, a single level or fixed EPAP may not overcome the
      airflow obstruction. The current study was undertaken to explore the variability of EFLT
      determined using Forced Oscillation Technique (FOT) to dynamically measure lung reactance
      (∆Xrs) and to evaluate the ability of automatically adjusted EPAP (PEEPopt) to over come EFLT
      overnight and over a two week period.

      In this prospective non-randomized trial, an unreleased noninvasive ventilator set in an S/T
      mode applied continuous oscillations (5 Hz, 1 cmH2O amplitude, 2 cmH20 peak to peak).
      Response to the oscillations was analyzed to calculate ∆Xrs and EPAP was adjusted
      automatically between 4 and 20 cmH2O. A fixed pressure support of 6 cmH2O was delivered. ∆Xrs
      was measured sitting and supine. Participants with evidence of EFLT (∆Xrs > 2.8) were asked
      to undergo overnight polysomnography (PSG) and then a sub-group of patients used the
      ventilator at home for two weeks. EFLT within and between participants was analyzed. EFLT
      behavior during PSG, the response of the device to dynamically abolish EFLT, as well as the
      impact of this therapy on sleep quality was studied. Objective ventilator adherence data were
      used to determine usage after the 2-week in-home use. Additionally, experienced NIV
      participants qualitatively rated therapy comfort compared to their current treatment.
    

Intervention name(s): Auto-Titrating EPAP
Intervention type(s): Device
Intervention description(s): In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Non Invasive Ventilation; Expiratory Flow Limitation
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment
      period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged
      18-80 with melatonin deficiency.
    

Detailed description: 
      Studies throughout the world have shown that insomnia is a common complaint that occurs in
      10-50% of the population depending on age, sex and country. Among the wide variety of
      available treatments of sleep disturbances, the most commonly prescribed hypnotics are the
      benzodiazepines (BZD) and non-BZD hypnotics.

      However, these hypnotics were often associated with rebound, dependency, tolerance, higher
      risk of falls mainly in the elderly population, anterograde memory disturbances and increased
      risk for motor accidents the next day.

      In response to the unmet clinical need for a safe and efficacious alternative treatment for
      primary insomnia, that in addition to treating quantitative sleep problems, would improve
      sleep quality and daytime functioning, a clinical development program on melatonin for the
      treatment of primary insomnia was initiated.

      This study is conducted using a randomised, double-blind, placebo controlled parallel group
      design, after a single-blind placebo period. Primary insomnia patients aged 18-80 will be
      screened for entry into the study.

      After the initial 3 weeks double-blind treatment period, patients will be given the option to
      enter a six-month double-blind continuation study.

      Primary parameter is sleep latency, secondary parameter is sleep maintenance. Exploratory
      parameters are total sleep time, sleep quality, morning alertness and quality of life.
    

Intervention name(s): Circadin; placebo circadin
Intervention type(s): Drug; Drug
Intervention description(s): Prolonged release melatonin 2 mg; placebo circadin tablets
Other intervention name(s): ATC code: N05CH01
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary insomnia as defined by DSM IV criteria
PET Imaging and Bariatric Surgery
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at certain areas of the brain that are related to
      addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors'
      (DRD2/3) and other studies have shown that obese people have less of these. We propose that
      low DRD2/3 availability seen in morbidly obese subjects will change with weight loss
      associated with bariatric surgery.
    

Detailed description: 
      The purpose of this study is to look at certain areas of the brain that are related to
      addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors'
      (DRD2/3) and other studies have shown that obese people have less of these. We propose that
      low DRD2/3 availability seen in morbidly obese subjects will change with weight loss
      associated with bariatric surgery.
    

Intervention name(s): F-18 (fallypride)
Intervention type(s): Drug
Intervention description(s): Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.
Intervention MeSH terms: Fallypride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Addiction; PET imaging
Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children
Condition: Dietary Rice Bran Supplementation
Study type: Interventional

Summary: 
      The purpose is to assess feasibility of rice bran consumption in weaning children and collect
      pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal
      prevention.
    

Detailed description: 
      Rice bran is a globally accessible, underutilized food ingredient with an array of beneficial
      nutrients (e.g. phytochemicals and prebiotics) that promote health and potentially prevent
      diseases. The investigators will determine if dietary rice bran intake can modulate the
      infant gut microbiome and metabolome to promote gut immunity for the benefit of preventing
      diarrheal diseases that increase risk for malnutrition and stunting.

      The investigators hope to learn about the feasibility of dietary supplementation of
      heat-stabilized rice bran in weaning children living in regions with increased susceptibility
      to diarrhea and malnutrition, and whether or not rice bran consumption can modulate the stool
      microbiome and metabolome.
    

Intervention name(s): Observational Control; Rice bran
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Participants will be observed and not provided any dietary supplementation.; Dietary rice bran consumed daily and amounts increase throughout the 6 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 2 g/day, 9 months: 3g/day, 10 months: 4g/day, 11 months: 5g/day).
Other intervention name(s): whole food dietary intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: rice bran; infants; stool metabolome; stool microbiome; dietary intervention
Prevention of CHOP-induced Chronic Cardiotoxicity
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Cardiotoxicity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the protective effect of Valsartan on chronic
      cardiotoxicity induced by CHOP.
    

Detailed description: 
      Doxorubicin has been one of the most important key drugs in treatment for malignancies.
      However, its use is limited by dose-dependent cumulative cardiotoxicity. This multi-centers
      trial was designed to investigate the preventive effect of Valsartan, the angiotensin II type
      1 receptor blocker (ARB) on chronic cardiotoxicity due to doxorubicin based chemotherapy.
      Patients with untreated non-Hodgkin's lymphoma who are scheduled to receive at least 6
      courses of the standard CHOP (-R) will be randomized by the minimization methods to the
      treatment group with Valsartan (80mg once daily by oral during entire 6 courses of CHOP) or
      control group. Cardiac function will be evaluated in detail before and after 3 and 6 courses
      of CHOP (-R).
    

Intervention name(s): Valsartan
Intervention type(s): Drug
Intervention description(s): Patients allocated into ARB administration group take Valsartan (80mg/day) from the day of the start of 1st CHOP until the completion of all the evaluations.
Other intervention name(s): Diovan
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: untreated adult Non-Hodgkin's Lymphoma; CHOP protocol; Angiotensin II Type 1 Receptor Blockers; Cardiomyopathy
Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the therapeutic equivalence between the two arms of treatment in virological and
      immunological response after 48 weeks and to evaluate the presence of side effects during the
      follow-up period.
    

Detailed description: 
      The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in
      several clinical trials. Even so, a substantial proportion of patients do not manage to
      maintain correct viral suppression in daily clinical practice.

      Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors
      that are related to adherence such as high pill load or takes, the complexity of the
      antiretroviral system, tolerability and food restrictions may have an effect on viral
      replication.

      It has been demonstrated that simpler regimens with a scant number of tablets, without food
      restrictions and with a single take a day are safe, efficacious and that adherence improves.

      The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel
      dosage that may help increase treatment adherence.
    

Intervention name(s): Kivexa
Intervention type(s): Drug
Intervention description(s): abacavir 600mg + lamivudine 300mg in one tablet QD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Simplification therapy; Efficacy; Safety; Virological effectiveness; Immunological effectiveness; HIV
Evaluation of Three Daily Disposable Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-site, 8-visit, double-masked, cross-over study involving three marketed
      products as study lenses. Participants will be randomly assigned each lens type, which will
      be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum
      washout period of 3 days before entering the study and undergo a minimum 7 day washout period
      between dispensing each lens type.
    


Intervention name(s): Lens 1 (etafilcon A); Lens 2 (nelfilcon A); Lens 3 (nesofilcon A)
Intervention type(s): Device; Device; Device
Intervention description(s): Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).; Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Other intervention name(s): 1-Day Acuvue® Moist®; Dailies® AquaComfort Plus®; Biotrue ONEday
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on
      glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus,
      whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of
      other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric
      acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition
      including fat and muscle mass with volume status.
    

Detailed description: 
      The objectives of this study are to compare the effect of 50mg of ipragliflozin, a SGLT2
      inhibitor, on glucose-lowering effect with 100mg of sitagliptin, a DPP4 inhibitor in patients
      with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin.

      We are also going to investigate changes of other metabolic and cardiovascular risk factors
      such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers.

      Changes of body composition including fat and muscle mass with volume status will be also
      examined.
    

Intervention name(s): Ipragliflozin; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes; Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
Other intervention name(s): Suglat; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ipragliflozin; Sitagliptin
Oral Contraceptives in the Metabolic Syndrome
Condition: Metabolic Syndrome X; Insulin Resistance; Obesity; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Microvascular Angina; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Oral contraceptives (OCs) are the most widely used method of reversible birth control.
      However, the long-term cardiovascular safety of the widely used low-dose OCs
      (ethinyl-estradiol < 50 mcg) is still debated. Although cardiovascular events are rare in
      young women whether they use OCs or not, the risks of myocardial infarction and ischemic
      stroke are increased among users of OCs who have conventional cardiovascular risk factors
      such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular
      events in OC users with emerging cardiovascular risk factors (such as obesity and the
      metabolic syndrome) have not been investigated. Recently, the metabolic syndrome has been
      linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors
      in a single individual, and its underlying cause may be insulin resistance. Whether the
      metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied.
      This is a critical problem because the metabolic syndrome is prevalent in 24% of adults.
      Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC
      with the least harm would not be possible.

      The investigator's long-term goal is to understand the best way to prevent and treat
      cardiovascular disease in women. The objective of this particular project is to obtain pilot
      data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and
      cardiovascular risks in women taking OCs. The researchers hypothesize that women with
      metabolic syndrome and obese women will have worsened glucose metabolism and elevated
      cardiovascular risks associated with OC use, when compared to normal weight women without the
      metabolic syndrome. Results of this study will clarify the risk factors for cardiovascular
      events in women taking OCs, and will serve as pilot data for a National Institutes of Health
      (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians
      can make better informed decisions about contraceptive choices for their patients.
    


Intervention name(s): Ortho Tri Cyclen
Intervention type(s): Drug
Intervention description(s): Ortho Tri Cyclen, one tablet daily, for 6 cycles
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inflammatory markers, oral contraceptions, obesity, metabolic syndrome X
Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare local pain experienced after subcutaneous injection of
      three excipient buffers for delivering protein drugs.
    


Intervention name(s): Formulation buffers
Intervention type(s): Other
Intervention description(s): Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science