bioihbjkbjnl/mcl2 huggingface dataset:
Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization
Condition: QT/QTc
Study type: Interventional
Phase: Phase 1

Summary: 
      THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION
    

Detailed description: 
      This is a single-center, randomized, partially double-blind (open-label moxifloxacin),
      placebo- and positive-controlled, 4-way crossover study in healthy subjects. Following a 28
      day screening period, eligible subjects will enter the clinical research unit (CRU) on Day
      -1. A total of 32 subjects will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment
      sequences (8 subjects per treatment sequence). Subjects will receive the assigned study drug
      as a single oral dose in the morning on Day 1 of each treatment period (Day 1 [Period 1], Day
      8 [Period 2], Day 15 [Period 3], and Day 22 [Period 4]) after an overnight fast. Subjects
      will have serially matched blood samples (for determination of plasma concentrations) and
      12-lead ECGs collected at predose and up to 48 hours after each dose for C QTc analysis.
      Subjects will be discharged from the CRU 96 hours after the last dose of the study drug (Day
      26). A follow-up telephone call will occur 5 ±2 days after discharge (Day 31 ±2).
    

Intervention name(s): Ecopipam Hydrochloride; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablets; oral tablet; oral tablet
Intervention MeSH terms: Moxifloxacin; Ecopipam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
Condition: Intubated and Mechanically Ventilated Pediatric Subjects
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to characterize the pharmacokinetic and pharmacodynamic
      profile of dexmedetomidine administered as an intravenous loading dose followed by a
      continuous intravenous infusion in pediatric subjects ages ≥2 through <17 years old.
    

Detailed description: 
      This is a phase II, open-label, multicenter, escalating dose study evaluating the
      pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects. The study
      population consists of initially intubated and mechanically ventilated pediatric subjects,
      ages ≥2 through <17 years old, that require sedation in an intensive care setting for a
      minimum of 6 hours. Subjects will be divided into two groups based on age: Group I will
      consist of subjects ages ≥2 through <6 years old and Group II subjects age ≥6 through <17
      years old. Within each group there will be four escalating dosing levels. Both groups can
      enroll simultaneously; however within each group, the next dose level cannot begin to enroll
      until all subjects have completed the previous dose level and the Data Safety Monitoring
      Board (DSMB) has approved enrollment to the next level. The level of sedation will be
      assessed using the Ramsay Sedation Scale (RSS). Based on these scores, and clinical judgment,
      additional sedation with midazolam will be administered according to the label. Pain will be
      assessed using the Faces, Legs, Arms, Cry & Consolability (FLACC) scale. Venous blood samples
      for pharmacokinetic analysis will be obtained at designated times. The pharmacodynamic and
      safety measures that will be monitored and the pharmacodynamic impact of dexmedetomidine on
      tracheal extubation will also be explored if subject is extubated within 24 hours.
    

Intervention name(s): Dexmedetomidine, midazolam; fentanyl
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Escalating dose; Dexmedotimidine; Intubated; Mechanically ventilated; Pediatrics
A Prospective Observational Study of the Performance of Zarin in Kenya
Condition: Contraceptive Usage
Study type: Observational

Summary: 
      This will be a non-comparative prospective observational study of women using Zarin as a
      primary method of contraception in Kenya. It will be conducted in close collaboration with
      the Kenya MoH in several MoH-affiliated clinics that have experience with implants and
      sufficient expected flow of implant users per month. The investigators will enroll a total of
      600 women divided into two cohorts in this one-year prospective study:

        -  a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months
           after enrollment; and

        -  a surveillance cohort of 300 women who will report back to the clinic during 12 months
           after enrollment only if they have complications, medical problems, pregnancy, or want
           to remove the implant

      The main study outcomes are pregnancy, immediate and delayed complications associated with
      insertion or removal, adverse events, early discontinuation and reasons for discontinuation,
      and level of women's satisfaction with Zarin services.
    

Detailed description: 
      A non-comparative prospective observational study of women using Zarin as a primary method of
      contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in
      several MoH-affiliated clinics that have experience with implants and sufficient expected
      flow of implant users per month. The investigators will enroll a total of 600 women divided
      into two cohorts in this one-year prospective study:

        -  a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months
           after enrollment; and

        -  a surveillance cohort of 300 women who will report back to the clinic during 12 months
           after enrollment only if they have complications, medical problems, pregnancy, or want
           to remove the implant

      The main study outcomes are pregnancy, immediate and delayed complications associated with
      insertion or removal, adverse events, early discontinuation and reasons for discontinuation,
      and level of women's satisfaction with Zarin services.
    

Sampling method: Non-Probability Sample
Study population: 
        healthy women aged 18-44
      
Keywords: AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; IU international units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot; post-marketing monitoring; safety; efficacy; acceptability
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the combination therapy of lifestyle
      intervention and use of Metformin together will improve ovulation induction and
      hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and
      adolescent females.
    

Detailed description: 
      PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is
      also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a
      variety of non-hospital based populations have provided evidence that the incidence of
      hyperandrogenic chronic anovulation is in the range of 4-6% of the female population.
      Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or
      through pharmaceutical intervention, have consistently resulted in a marked improvement in
      the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult
      female population is to determine that combination therapy will improve ovulatory frequency.
      Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then
      single agent therapy. The primary objective of the adolescent population is to determine that
      the combination therapy will improve hyperandrogenemia. Secondary objective is to improve
      ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.
    

Intervention name(s): Metformin; Placebo; Lifestyle Intervention
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).; Placebo; A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome (PCOS); Anovulation; Elevated Testosterone
The Effect of Aged Garlic Extract Supplementation on Immune System
Condition: Improvement in Immune Cell Function in Healthy Humans
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether consuming capsules of aged garlic extract
      is effective in enhancing function of NK and/or γδ T cell resulting in fewer cold and flu
      symptoms.
    

Detailed description: 
      A non-therapeutic intervention study is described. The Aged Garlic Extract (AGE) supplement
      (and placebo) intervention occurs over a total of 90 days between mid-January to March. The
      CDC indicates that this is the cold and flu season
      (http://www.cdc.gov/flu/weekly/fluactivity.htm ). Blood is taken at baseline and at 45 days,
      2 hours after they have taken their capsule. Capsule consumption will continue for a total of
      90 days in order to continue monitoring cold and flu symptoms. Subjects will be given a diary
      to keep a record of their cold and flu symptoms. Peripheral blood mononuclear cells are
      isolated from the blood draw and used fresh, cultured in autologous serum for 24 hours or
      cultured in autologous serum for 10 days. Freshly isolated cells will be used for glutathione
      analysis, for protection against induced DNA strand breaks, and for γδ T cell and NK cell
      numbers. The supernatant of 24 hour cultures will be used for cytokine determination,
      specifically, interferon-g, tumor necrosis factor-a and IL-12. Cells cultured for 10 days
      will be used to determine the rate of proliferation. If cells have been primed by AGE, we
      expect the AGE cells to proliferate to a greater extent and have greater cytokine secretion
      compared to placebo.

      If AGE enhances the function of one or both of these cell types (NK or γδ T cell), then it is
      possible that there will be fewer cold and flu symptoms in the group consuming the
      supplement.
    

Intervention name(s): Aged garlic extract; AGE
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 aged garlic extract capsules taken twice daily; encapsulated aged garlic extract, 4 capsules per day, 2.56g/day
Other intervention name(s): AGE; Kyolic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gamma delta T cell; natural killer cell; proliferation; cytokine secretion; Improvement in immune cell function in healthy humans
Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose,
      parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation
    


Intervention name(s): YH12852 IR 0.05mg; YH12852 IR 0.1mg; YH12852 IR 0.3mg; YH12852 IR 0.5mg; YH12852 IR 1mg; YH12852 IR 2mg; YH12852 IR 3mg; YH12852 DR1 0.5mg; YH12852 DR1 1mg; YH12852 DR1 2mg; YH12852 DR1 4mg; YH12852 DR2 8mg; Prucalopride 2mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prucalopride; YH12852
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with
      autism spectrum disorder. During the study, subjects received repeated transcranial magnetic
      stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10
      days. From the beginning of intervention to the end of 4 weeks after the completion of
      intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and
      adverse events will be followed up.Our purpose is to explore whether rTMS can improve the
      clinical symptoms of children with autism spectrum disorder in China, and to explore the
      neurophysiological mechanism of rTMS for autistic children.
    

Detailed description: 
      Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10
      sessions). If feasible for the participant, all stimulation sessions will be held at the same
      time of the day. During this study，participants' clinical symptomatology, cognitive
      psychology, neuroimaging, and adverse events will be followed up for four times,
      specifically，before intervention, 5 days after intervention, immediately after the completion
      of intervention , and 4 weeks after the completion of intervention.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation（rTMS）; Continuous theta Burst Stimulation （cTBS）
Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the bioavailability of a generic product of
      methyldopa with that of a reference product when administered to healthy volunteers under
      fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917)
      manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical
      Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620).
      The plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to
      access the interchangeability of the products.
    

Detailed description: 
      It is planned to enroll 16 to 30 healthy subjects, with an aim to obtain at least 12
      evaluable subjects. The study design is a single-dose, two-treatment, two-period,
      two-sequence crossover with a washout period of one to two weeks. During each study session,
      the subjects will be administered a single oral dose of 250mg methyldopa (one BF-Methyldopa
      Tablet 250mg or one Metopa Tab 250mg) after an overnight fast of approximately 10 hours.
      Venous blood samples will be collected at pre-dose (0h) and at 0.75 (45min), 1.5, 2, 2.5, 3,
      3.5, 4, 5, 6, 8, 10, 12 and 24 hours post-dose. The plasma concentrations of methyldopa will
      be determined by a validated assay. The non-compartmental method will be used to analyze the
      plasma concentration-time data and calculate the main pharmacokinetic parameters such as
      Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. Anylasis of variance (ANOVA) will be conducted on
      logarithmically transformed Cmax, AUC0-last and AUC0-inf using the General Linear Model. The
      two one-side tests will be used to calculate the 90% confidence intervals for the mean
      difference in AUC0-last, AUC0-inf and Cmax and to assess the bioequivalence of the two
      products.
    

Intervention name(s): BF-Methyldopa 250mg Tablet; Metopa Tab 250mg
Intervention type(s): Drug; Drug
Intervention description(s): BF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited; Metopa Tab 250mg is manufactured by APT
Other intervention name(s): Methyldopa 250mg Tablet; Methyldopa 250mg Tablet
Intervention MeSH terms: Methyldopa
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, two-treatment, two-period, two-sequence crossover
Masking: None (Open Label)
Primary purpose: Other
Intramedullary Nailing of Tibia Fractures
Condition: Tibial Fractures; Malleolar Fractures
MeSH terms: Fractures, Bone; Tibial Fractures; Ankle Fractures
Study type: Observational

Summary: 
      Currently, the treatment of choice for tibial fracture is intramedullary nailing. This
      procedure has been shown to have low rates of infection, high rates of bone healing, and a
      faster return to weight bearing and activity in comparison to conservative treatment. In
      concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to
      identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the
      tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures
      prior to tibial nailing is a safe treatment in which the reduction of the malleolus is
      maintained intraoperatively, postoperatively, and remains reduced until the fracture has
      healed.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Prospectively evaluating all patients that have been treated at the University of Utah over
        the past five years for Tibial Fracture combined with medial or posterior malleloar
        fracture.
      
Keywords: Tibia Fractures; Medial Fractures; Posterior Malleolar Fractures
Effect of Folate on Colon and Blood Cells
Condition: Subjects Will Have a Pre-cancerous Colorectal Polyp; Family Member Has History of Colorectal Adenoma of Adenocarcinoma
MeSH terms: Adenoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at the effect of folate supplementation and depletion on the blood cells and
      the colorectal cells. To examine the effect of these changes, blood samples and colorectal
      biopsy samples are collected. The genetic material (RNA and DNA) is examined to see what
      changes occur during the depletion and supplementation of folate. The hypothesis is that
      folate may help prevent colon cancer
    

Detailed description: 
      Folate Depletion Arm and Supplementation Arm:

      The folate depletion study requires an 8-week run-in period. During this run-in period, all
      participants will eat an average folate diet with no high folate containing foods. There are
      two screening visits during this period where initial blood-work is done and participants
      undergo nutritional consultation. Following the 8-week run-in period, subjects in the folate
      depletion arm will be hospitalized for approximately 3 months at the Rockefeller University
      Hospital. You may leave the hospital during the day, but are required to return each evening.
      During this entire time, subjects are given a low folate diet. During the last month of the
      study, folate supplements are given to replace folate in the body. A follow-up visit is
      required approximately 1 month after the study period. Blood will be drawn every two weeks.
      Four sigmoidoscopies will be taken at approximately monthly intervals. A male is required to
      use an effective form of birth control throughout his participation in the study and for two
      months after the study ends.

      The folate supplementation study requires an 8-week run-in period. During this run-in period,
      all participants will eat an average folate diet with no high folate containing foods. There
      are two screening visits during this period where initial blood-work is done and participants
      undergo nutritional consultation. Following the 8-week run-in period, subjects in the folate
      supplementation arm will be given a folate supplement for 8 weeks. During this entire time,
      subjects will continue to eat an average folate diet with no high folate containing foods.
      Blood samples and colorectal mucosa samples obtained during a sigmoidoscopy will be taken 3
      times at 4 week intervals.
    

Intervention name(s): Folate depletion and supplementation
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Prevention