bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, randomized, cross-sectional comparison study examining the relative
      safety and resulting blood level profiles after administration of a new boceprevir tablet
      formulation versus its current capsule formulation for treatment of chronic hepatitis C. In
      Part 1 of the study participants will receive boceprevir tablets and capsules under fed
      conditions. In Part 2 of the study a new group of participants will receive boceprevir
      tablets and capsules under fasted conditions.
    


Intervention name(s): boceprevir; boceprevir; boceprevir; boceprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.; Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.; Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.; Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
Other intervention name(s): SCH 503034; SCH 503034; SCH 503034; SCH 503034
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: boceprevir; hepatitis C; bioequivalence; SCH 503034
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric
      participants who are undergoing cancer chemotherapy.
    


Intervention name(s): LDV/SOF
Intervention type(s): Drug
Intervention description(s): Tablet(s) administered orally once daily
Other intervention name(s): Harvoni®; GS-5885/GS-7977
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV genotype 1 or 4 (GT-1 or GT-4); Direct Acting Antiviral; Combination Therapy; Hepatitis C, Chronic; Liver Diseases; Virus Diseases
A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix
Condition: Comparison of a Sheathed Versus Standard Plastic Speculum
Study type: Interventional

Summary: 
      The purpose of this study is to estimate if a novel sheathed speculum provides improved
      visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate
      if the sheathed speculum causes less discomfort during the examination.
    

Detailed description: 
      This is a randomized trial where physician investigators will perform clinically indicated
      vaginal speculum examinations using either a sheathed or a standard plastic speculum, to
      determine which speculum provides the best visualization of the cervix. As a secondary
      outcome, study participants will record their pain level on a 10-cm visual analogue scale.
    

Intervention name(s): Sheathed speculum examination; Standard speculum examination
Intervention type(s): Procedure; Procedure
Other intervention name(s): speculum; sheath; ClearSpec
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: speculum; vagina; cervix; examination
Aripiprazole in the Treatment of Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      A systematic open-label prospective pilot study to assess aripirazole for acute bipolar
      depression, with a secondary assessment of longer-term mood stabilization.
    

Detailed description: 
      Study is 6 weeks long with 7 clinical visits.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yoga for Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      To establish the safety and feasibility of having patients with epilepsy perform yoga.
    

Detailed description: 
      Subjects will keep logs of seizure frequency prior to, during, and following training in a
      yoga regimen. Instruction in the yoga regimen will occur at BIDMC, and home practice
      following classroom instruction will occur as part of the study. Side effects, changes in
      seizure frequency, and quality of life assessments will be performed.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: epilepsy, yoga
Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
Condition: Joint Function Disorder
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind intervention study of four parallel branches depending
      on the product consumed, to analyze the efficacy of an Omega-3 based product on the mobility
      and functionality of the evaluated joint.
    

Detailed description: 
      The duration of the study will be 60 days (8 weeks). Each day they will have to consume the
      product under investigation. Subjects who meet the selection criteria will be randomized into
      each of the study groups (A, B, C o D, depending on the group in which they have been
      randomized). Each day the subjects will have to fill in a diary regarding pain and
      concomitant medication.

      They will make a total of two visits to the research laboratory and will perform the tests
      pre-established in the protocol. In addition, a follow-up telephone call will be made after
      30 days of consume. Subsequently, a statistical analysis will be performed with the variables
      measured in the study to obtain the results.
    

Intervention name(s): Omega-3 and/or botanical ingredient; Control product consumption
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.; Product with identical characteristics to the experimental product. Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Omega-3
Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects
Condition: Histological Response of Tissue to Cold
Study type: Interventional

Summary: 
      This study is designed to characterize the biological response of the epidermis, dermis and
      subcutaneous tissue to treatment with the Myoscience Cryo-Touch III system.
    


Intervention name(s): Cryo-Touch III
Intervention type(s): Device
Other intervention name(s): PCP 1.0
Intervention model: Single Group Assignment
Intervention model description: Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.
Masking: None (Open Label)
Primary purpose: Treatment
Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy of cilostazol in preventing
      recurrence of cerebral infarction and the safety of long-term administration of the drug (100
      mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral
      embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg,
      once daily).
    


Intervention name(s): Cilostazol; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years; oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
Intervention MeSH terms: Aspirin; Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Randomized Trial to Assess the Efficacy and Safety of GO2KA1(Chitosan Oligosaccharide)on Blood Glucose Control
Condition: Impaired Fasting Glucose, Newly-diagnosed Type 2 Diabetes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The effects of chitosan on blood glucose levels have been contradicting. Hypoglycemic effects
      of high molecular weight chitosan are related to diabetic models with hypoinsulinemia but
      have shown little effect on the blood glucose levels in hyperinsulinemia related diabetic
      models. Based on previous reports, high molecular weight chitosan either directly or
      indirectly related to insulin secretion in pancreas but has little effect on insulin
      resistance. In the present study, the effect of GO2KA1 (low molecular weight chitosan
      oligosaccharide) on blood glucose levels in Korean pre-diabetic adults, will be evaluated.
      The changes in postprandial blood glucose levels will be investigated in subjects with
      impaired fasting glucose or glucose tolerance.
    

Detailed description: 
      In the detailed description we believe that it will be wise to discuss about the long-term
      study of the effect of GO2KA1(Chitosan oligosaccharide: oligosaccharides derived from
      chitosan) on pre-diabetic individuals (in addition to the postprandial blood glucose levels).
      In the present study, we will investigate the effects of GO2KA1 on the level of postprandial
      blood glucose in adult Koreans with impaired fasting glucose or impaired glucose tolerance.
      Postprandial blood glucose levels will be tested for 2 hours at every 30 min interval after
      75g-OGTT and the experimental group will be pre-fed with 500 mg of GO2KA1. Primary outcomes
      will be included change in HbA1c, insulin, glycemic AUC, and lipids(total cholesterol,
      triglyceride, and HDL).

      This clinical study will be conducted with 60 subjects after explanation and accommodation
      about experimental protocols and model. To test under same condition, smoking and drinking
      water will be completely prohibit from 1 hour before and during the experiment. At first day,
      control experiment will be conducted without oral take of GO2KA1 or placebo.
    

Intervention name(s): GO2KA1; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): GO2KA1(chitosan oligosaccharide)1500mg/day for 12weeks; placebo 1500mg/day for 12weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Dose Response Study of a Natural Extract for Reducing Post Prandial Blood Glucose
Condition: Blood Glucose
Study type: Interventional

Summary: 
      Randomized, balanced incomplete block design dose response study of efficacy, with 4
      different dosages of mulberry fruit powdered extract added to cooked rice compared to a
      reference treatment (cooked rice only).
    

Detailed description: 
      Dose response study with 4 dosages of mulberry fruit powdered extract (0.37, 0.75, 1.12 and
      1.5 g) added to cooked rice, compared to cooked rice only(reference) on post prandial blood
      glucose response in healthy Indian adults.

      In addition, 1.5 g of mulberry fruit powdered extract was added to instant rice porridge and
      compared to instant rice porridge only as positive control (replication of previous research.

      In total there were 7 test products in the study: 5 active treatments and 2 reference
      treatments.

      The study was a cross-over study (4 interventions per subject, 4 out of the 7 test products).
      The recovery period between treatments was at least seven days.
    

Intervention name(s): Boiled Rice; Boiled Rice+0.37 gr mulberry fruit powdered extract; Boiled Rice+0.75 gr mulberry fruit powdered extract; Boiled Rice+1.12 gr mulberry fruit powdered extract; Boiled Rice+1.50 gr mulberry fruit powdered extract; Rice Porridge; Rice porridge+1.50 gr mulberry fruit powdered extract
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, balanced incomplete block design dose response study of efficacy,
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002,
      Tysabri®) in the study population (Russian participants with relapsing remitting multiple
      sclerosis). The secondary objectives are to look at evaluation of severity of relapse,
      hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS),
      functional tests, quality of life self-assessment questionnaires including the short form
      health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29
      (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical
      activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.
    


Intervention name(s): BG00002
Intervention type(s): Biological
Intervention description(s): IV Infusion
Other intervention name(s): Tysabri®
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Second Young Adult Naturalistic Alcohol Study
Condition: Young Adult Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Observational

Summary: 
      This study involves completion of questionnaires, computer-based cognitive tasks and an
      alcohol drinking session. Participation in this study consists of an initial, in-person
      screening appointment, 4 brief daily appointments at the research office, an alcohol drinking
      session at a local bar and a follow-up appointment 1-3 days after the alcohol drinking
      session.

      Participants who are found to be eligible in the screening phase will then complete a daily
      appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on which
      they will not attend an appointment). Each appointment will last 20 minutes, on average and
      consist of a questionnaire and computer-based cognitive task. On the day of the fourth
      appointment, participants will complete an alcohol drinking session. The alcohol drinking
      session begins at 4pm and lasts until at least midnight.

      Participants in this study will be young adults between the ages of 21-25, who regularly
      drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two
      participants will complete this study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy young adults between the ages of 21-25 years of ago who regularly drink alcohol and
        are not currently seeking treatment for alcohol.
Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to compare in healthy subjects, the GI tolerability of
      bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl
      fumarate).

      Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and
      Tecfidera® when administered orally following bioequivalent dose regimens in healthy
      subjects.
    

Detailed description: 
      Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl
      fumarate) will enter a double-blind titration period where they will receive either Bafiertam
      95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period,
      they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or
      Tecfidera 240 mg BID for 4 weeks.
    

Intervention name(s): Bafiertam; Tecfidera
Intervention type(s): Drug; Drug
Intervention description(s): Over-encapsulated capsule to mask treatment; Over-encapsulated capsule to mask treatment
Other intervention name(s): monomethyl fumarate; dimethyl fumarate
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastrointestinal
Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to develop an upper extremity robotic training system for use by
      people with stroke to practice arm and hand movement in the clinic.
    

Detailed description: 
      Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute
      stroke survivors lose arm and hand movement skills. Movement impairments are typically
      treated with intensive, hands-on physical and occupational therapy for several weeks after
      the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care
      system, stroke patients are receiving less therapy and going home sooner. Our goal for this
      study is to develop an upper extremity robotic training system for both acute and chronic
      stroke population to improve movement ability with intensive and repetitive movement in the
      clinic without continuous supervision from a therapist.
    

Intervention name(s): Functional/ Multi-joints activities; Individual Joint Training
Intervention type(s): Device; Device
Intervention description(s): Subjects participated in 4 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program focusing on functional tasks such as cleaning the windows, driving a steering wheel, grocery shopping, etc.; Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements focusing on one joint at a time.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; cerebrovascular accident; robot
Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients
Condition: Bispectral Index; Transcutaneous Carbon Dioxide; PONV; Blood Pressure; Heart Rate
Study type: Observational

Summary: 
      This study is to find the fewer side effects formula of anesthesia for TVOR patients, to
      compare the BIS level during emergence and to find the correlation between BIS and
      transcutaneous carbon dioxide concentration.
    

Detailed description: 
      Transvaginal oocyte retrieval (TVOR) is a procedure often used in infertility women . During
      the procedure, sedation, analgesia or anesthesia are often required. Propofol and alfentanyl
      are used for these patients for years, but these drugs are used in intravenous form and can
      be found in follicular fluid. Although further investigation needs to be undertaken to
      investigate any potential influence on fertilization and implantation rates, we
      anesthesiologist want to lower the use of drugs in these women. Target-controlled infusion
      (TCI) pumps can estimate and calculate the target and plasma concentration of propofol. By
      using these pumps , we can estimate the stable concentration of drugs. Besides, Bispectral
      index (BIS) monitor can help us to evaluate awareness or unarousable amnesia when we turn
      lower the drug use and keep patients amnesia during the procedure. Transcutaneous carbon
      dioxide monitor (tcCO2) can mimic the level of CO2 in patients by using noninvasive method.
      During anesthesia, CO2 will retain and may induce CO2 nacrosis, so we use these noninvasive
      method to help us to detect CO2 level preventing CO2 nacrosis and to see if there are any
      relationship with BIS.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR
        procedure.
      
Keywords: target control infusion; alfentanyl; propofol; BIS
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Condition: Cystic Fibrosis; Pancreatic Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of
      Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption
      in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma
      (formerly Axcan).
    

Detailed description: 
      This is a multicenter, explorative, phase IIIb, open-label study in patients with CF and PI.
      The study consists of a screening visit (visit 1), followed by a baseline phase of 9 days
      (plus a 5-day window if necessary) during which the regular pancreatic enzyme will be
      maintained and 10 stool samples will be collected over 5 days, for baseline evaluation of
      steatorrhea. Afterward, a treatment phase of 19 days (plus a 5-day window if necessary) with
      Ultrase® MT12 will follow (the usual pancreatic enzyme will be replaced by Ultrase® MT12).
      Over the last 5 days of the treatment phase, 10 additional stool samples will be collected,
      for evaluation of steatorrhea.
    

Intervention name(s): Ultrase® MT12
Intervention type(s): Drug
Intervention description(s): Ultrase® MT12 capsules will be given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose not to exceed 10,000 lipase units/kg/day.
Intervention MeSH terms: Pancrelipase; Pancreatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Steatorrhea; Malabsorption of fat; Pancreatic enzymes; Abdominal pain; Greasy stools