bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In 2005, there were 50,620 HIV-infected children living in Thailand. Current anti-HIV
      regimens, comprised of individual pills for each drug, frequently lead to missed doses. To
      properly control their infection, regimens that are tolerable and effective in children and
      without pill burden are necessary. The primary purpose of this study is to evaluate the
      safety and bioavailability of GPO-VIR Z30, a combination fixed dose tablet containing
      zidovudine (ZDV), lamivudine (3TC), and nevirapine (NVP), in HIV-infected children in
      Thailand.
    

Detailed description: 
      An important factor affecting the therapeutic response to ARVs is adherence. A common reason
      for poor adherence is high pill burden. A combination fixed dose drug approach appears to be
      an effective strategy to improve adherence and therapeutic response. In this study,
      investigators will compare the bioavailability and safety of GPO-VIR Z30, a combination fixed
      dose drug, with the liquid formulations of ZDV,3TC, and NVP, in children.

      This study will last approximately 8 weeks. Participants will be randomly assigned to one of
      two arms. Participants in Arm 1 will receive GPO-VIR Z30 for 2 weeks before receiving liquid
      formulations of ZDV, 3TC, and NVP for the following 2 weeks. Participants in Arm 2 will
      receive liquid formulations of ZDV, 3TC, and NVP for 2 weeks before receiving GPO-VIR Z30 for
      the following 2 weeks.

      This study will consist of 4 study visits after screening. Visits will occur at study entry
      and on Days 14, 28, and 56. Medical history and a physical exam will occur at all visits. A
      pregnancy test will occur for females at all visits. Pharmacokinetic tests, involving
      hospitalization for the 12 hour procedure, will occur on Days 14 and 28. Safety and adherence
      monitoring will occur by telephone on Days 7, 11 or 12, 13, 21, 25 or 26, 27, and 35. Home
      visits for directly observed therapy (DOT) may also occur.
    

Intervention name(s): GPO-Vir Z30 tablet; Lamivudine; Nevirapine; Zidovudine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet consisting of ZDV 30 mg/3TC 15 mg/NVP 28 mg taken orally twice daily; Oral suspension containing 10 mg 3TC in each mL. Dosage depends on weight.; Oral solution containing 10 mg NVP in each mL. Dosage depends on weight.; Oral solution containing 10 mg ZDV in each mL. Dosage depends on weight.
Other intervention name(s): 3TC; Epivir; NVP; Viramune; ZDV; Retrovir
Intervention MeSH terms: Lamivudine; Zidovudine; Nevirapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Experienced
A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)
Condition: Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled, crossover, single centre study of
      gefapixant (AF-219/MK-7264) in participants with idiopathic or treatment resistant chronic
      cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective
      cough frequency.
    


Intervention name(s): Gefapixant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets, BID; Oral tablets, BID
Other intervention name(s): AF-219; MK-7264
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Condition: Irritability Associated With Autism Spectrum Disorder (ASD)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out about the potential benefits and safety of
      brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability
      associated with autism spectrum disorder.
    


Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; take once daily; Administered orally daily for up to Week 8.
Other intervention name(s): brexpiprazole, OPC-34712 and LuAF41156
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Irritability; Autism Spectrum Disorder; ASD
Buprenorphine Maintenance Protocol - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of buprenorphine versus methadone.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: Double
Primary purpose: Treatment
Adult Double Cord Blood Transplant Study
Condition: Cord Blood Stem Cell Transplantation; Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of the study is double unit umbilical cord blood transplantation in adults
      will be associated with a one year survival rate of at least 40%.
    


Intervention name(s): Cord blood transplantation
Intervention type(s): Procedure
Intervention description(s): Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cord Blood Stem Cell Transplantation; Hematologic Malignancies; Leukemia; Myelodysplastic Syndrome
Inspiratory Muscle Training in Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The aim of this study is to investigate the potential effects of inspiratory muscle training
      on cardiovascular, respiratory, physical, and psychosocial functions in patients with heart
      failure.
    

Detailed description: 
      Heart failure is a syndrome that leads to decreased cardiac output, inflammation, increased
      catabolism, and prolonged immobilization, causing inspiratory muscle weakness. Cardiac
      rehabilitation is a well-known treatment approach in heart failure however, the participation
      rate in cardiac rehabilitation is low. Therefore, inspiratory muscle training may serve as an
      alternative approach in patients with heart failure.

      Patients will be randomly allocated into the inspiratory muscle training group and control
      group. The inspiratory muscle training (IMT) group will carry out IMT sessions three days per
      week for 8 weeks by using an inspiratory threshold loading device. Each session will consist
      of seven cycles including 2 min of breathing on an inspiratory loading device followed by 1
      min of rest and will last 21 min. IMT will be performed at the tolerable maximum load for
      each 2-min work interval and will be progressively increased over the 8 weeks. The control
      group will perform unloaded IMT by using an inspiratory threshold loading device during all
      training sessions. Data will be collected before and after the treatment by a masked outcome
      assessor.
    

Intervention name(s): Inspiratory muscle training; Sham inspiratory muscle training
Intervention type(s): Device; Device
Intervention description(s): Inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the highest tolerable load and will be gradually increased.; Sham inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the unloaded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of
      NNC9204-1177 in Subjects being Overweight or with Obesity
    


Intervention name(s): NNC9204-1177; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose administered subcutaneously ( s.c. under the skin); A single dose administered subcutaneously ( s.c. under the skin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the effects of CYP3A polymorphisms on the
      pharmacokinetics of Atorvastatin in Chinese subjects with coronary heart disease.
    

Detailed description: 
      Large variability exists in the individual response to statins. CYP3A polymorphisms likely
      contribute to variable response to those drugs primarily metabolized by CYP3A including
      atorvastatin.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): The subjects will receive atorvastatin (20 mg single dose) orally with approximately 240 ml of water. Blood samples(4 mL) will be taken prior to dosing and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24 and 48 h after drug administration.
Other intervention name(s): Lipitor; Atorvastatin Calcium Tablets
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: atorvastatin; genetic polymorphisms; coronary heart disease; pharmacokinetics; CYP3A
Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Leakage is the most common complication after laparoscopic sleeve gastrectomy which may
      amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A)
      injection into the pyloric sphincter during the operation may decrease the risk of
      postoperative gastric leakage.
    

Detailed description: 
      Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity
      comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its
      encouraging results, the pretended feasibility of the operative procedure can be associated
      with a remarkable operative morbidity. The main reason is gastric leakage from stable line
      which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of
      a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative
      will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure
      inside the gastric pouch will be decreased abolishing the formation of high pressure tube
      with subsequent leakage.
    

Intervention name(s): laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): creation of a gastric tube of 100cc using a stapler.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Varenicline Treatment for Cannabis Use Disorder
Condition: Substance Use Disorder
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Marijuana is the most commonly used illicit drug. There is high demand for effective
      interventions for cannabis use disorder, yet few specific treatments for have been developed.
      This study will evaluate the efficacy of varenicline for reducing marijuana use in people who
      use marijuana frequently.
    


Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg daily; 2 mg daily
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Marijuana use; Varenicline/Chantix; Motivational enhancement therapy
A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects
Condition: Pharmacokinetics of FG-4592; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics
      (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin
      alone and in combination with multiple doses of FG-4592, and will evaluate the effect of
      multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.
    

Detailed description: 
      The study consists of 2 periods, separated by a washout period (a minimum of 14 days after
      warfarin dosing on Day 1, Period 1). Screening takes place from Day -22 to Day -2.

      Subjects are admitted to the clinical unit on Day -1 of Period 1. On Day 1 of the first
      period, subjects receive a single oral dose of warfarin. After completion of all assessments
      on Day 8, subjects are discharged from the clinical unit on the condition that there are no
      medical reasons for a prolonged stay. They return to the clinical unit on Day -1 of the
      second period, after the washout period.

      In Period 2, the subjects receive multiple doses of FG 4592. On Day 7 of Period 2, FG 4592 is
      given concomitantly with warfarin. After completion of all assessments on Day 16 of Period 2,
      subjects are discharged from the clinic on the condition that there are no medical reasons
      for a prolonged stay. The subjects return for an End of Study Visit (ESV) 5 to 9 days after
      the last assessment of Period 2 (or after early withdrawal).

      Safety assessments are performed throughout the study. Blood and urine samples are collected
      for PK and PD assessments.
    

Intervention name(s): Warfarin; FG-4592
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Coumadin®; ASP1517,; roxadustat
Intervention MeSH terms: Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; FG-4592; Warfarin; Pharmacokinetics; Pharmacodynamics
The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP)
      versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of
      obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.
    

Detailed description: 
      Randomised, placebo-controlled trial of Provent® versus Placebo-Provent® versus continuous
      positive airway pressure therapy (CPAP) to define the effects of Provent® on the severity of
      obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk in
      patients with obstructive sleep apnea.

      Patients successfully treated with CPAP will be randomised to one of three arms for a
      duration of 2 weeks:

        1. Withdraw CPAP and use Provent®

        2. Withdraw CPAP and use Placebo-Provent®

        3. Continue treatment with CPAP
    

Intervention name(s): Provent®; Placebo-Provent®; CPAP
Intervention type(s): Device; Device; Procedure
Intervention description(s): Nightly use of Provent® versus Placebo-Provent® versus CPAP; Nightly use of Provent® versus Placebo-Provent® versus CPAP; Nightly use of Provent® versus Placebo-Provent® versus CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
Condition: Mortality Through Six Months of Age; Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency; Infant Death
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered
      to newborn infants within the first days of life, reduces six-month infant mortality by at
      least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A
      dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene
      supplementation during pregnancy through three months postpartum, gestational age and birth
      size.
    

Detailed description: 
      This is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin A
      supplementation on mortality in the first six months of life. The trial is being implemented
      in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a
      population of ~580,000 in rural northern Bangladesh (Gaibandha/Rangpur area) and is nested
      within the JiVitA-1 maternal supplementation study. Women residing in the study area are
      already under 5-weekly pregnancy surveillance conducted by village-based field staff as part
      of the maternal supplementation trial. During their third trimester of pregnancy, women are
      visited by a study supervisor who explains the purpose and procedures of the study. After
      obtaining informed consent, women are interviewed for possible risk factors in the third
      trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol
      intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal
      anthropometry (mid upper arm circumference measurement). Upon birth, household members
      contact the village-based field staff who immediately administers the vitamin A or placebo to
      the infant, according to sector assignment. After supplementation, newborns are measured for
      weight, length and mid-upper arm, head and chest circumference, and then followed weekly for
      vital status for three months, and again at six months of age. A child death initiates the
      process of death verification and cause of death determination.
    

Intervention name(s): vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)
Intervention type(s): Dietary Supplement
Intervention description(s): Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Vitamin A; Newborn health; Infant Mortality; Supplementation; Micronutrients; Bangladesh
Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors
Condition: Dental Caries; Gingivitis
MeSH terms: Gingivitis; Dental Caries
Study type: Observational

Summary: 
      This study is observational only and is intended to evaluate changes in the makeup and
      function of bacteria naturally present in the mouth during treatment with braces to
      straighten teeth.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients entering and then undergoing orthodontic treatment
      
Biospecimen description: 
      bacteria isolated from plaque and saliva; human genome
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography
Condition: Infant, Premature
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high
      risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive,
      inexpensive bedside tool and examinations can be repeated as often as necessary without major
      disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent
      acoustic windows to examine the deep midline and periventricular regions of the brain.Some
      data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial
      US is not very suitable for investigating cortical regions or structures in the posterior
      fossa. There is limited data for very preterm infants.The investigators aimed to measure
      ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge
      number of infants.
    


Intervention name(s): Cranial ultrasonography
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All NICU preterm infants under 1500 gr
Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      20 mg or 40 mg of quizartinib will be given to Chinese patients who were just diagnosed with
      AML. The study drug will be given to them along with standard therapies. The purpose is to
      find out the highest dose they can stand.
    

Detailed description: 
      This is a Phase 1, multicenter, open-label study to evaluate the safety and pharmacokinetics
      (PK) of quizartinib in combination with standard induction therapy and consolidation therapy
      in Chinese patients with newly diagnosed AML.

      The quizartinib doses will be Level 1: 20 mg and Level 2: 40 mg. No increase in the
      quizartinib dose will be made in the same subject.

      Dose-limiting toxicity associated with quizartinib occurring at each level will be assessed,
      and the maximum tolerated dose (MTD) will be decided using a 3 + 3 design.
    

Intervention name(s): Quizartinib
Intervention type(s): Drug
Intervention description(s): Quizartinib is provided as 20 mg tablets for oral administration
Other intervention name(s): Experimental product; AC220
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment