bioihbjkbjnl/mcl2 huggingface dataset:
A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety
      of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be
      intranasally oculated with the challenge virus and will be randomly assigned to receive a
      intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be
      randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally
      twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7
      to Day 11.
    


Intervention name(s): MHAA549A; Placebo; oseltamivir [Tamiflu]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV dose; IV dose; Orally b.i.d, 5 days
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study I)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate
      the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to
      placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined
      as add-on controller therapy on top of usual care in patients with severe persistent asthma.

      The primary objective of each trial is to evaluate the long term efficacy of tiotropium over
      placebo on top of usual care in patients with severe persistent asthma as determined by
      pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on
      asthma control and health care resource utilisation. The secondary objective of each trial is
      to compare the long term safety of tiotropium with placebo in this patient population.
    


Intervention name(s): tiotropium 5mcg/day; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intervention = randomisation: Patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo; Matching placebo
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We, the researchers at the Indiana University School of Medicine, are doing this study to
      better understand how the effects of certain medications are altered when taken
      simultaneously, or in combination with each other. We will also look at how each volunteer's
      genes (DNA) may affect the way these medications are metabolized.

      Hypothesis:

      We will test the hypothesis that the extent of drug-drug interaction caused by the
      combination of erythromycin and diltiazem is not predictable from the extent of interaction
      produced by each inhibitor alone. Specifically we will test the hypothesis that the
      combination of erythromycin and diltiazem will cause a greater decrease in midazolam
      intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.
    

Detailed description: 
      Many drugs such as diltiazem are metabolized by CYP3A4, the cytochrome P450 enzyme
      responsible for the metabolism of erythromycin and when given together, the possibility
      exists that one drug inhibits the metabolism of the other leading to an increase in plasma
      concentration. The magnitude of this interaction is not known. It is therefore important to
      define this effect because diltiazem is a drug that is used commonly to treat hypertension,
      angina and atrial fibrillation and these patients may be given erythromycin for the treatment
      of intercurrent bacterial infections.
    

Intervention name(s): Erythromycin; Diltiazem
Intervention type(s): Drug; Drug
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Diltiazem
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects
Multiple Ascending Dose Study of DS-1093 in Healthy Subjects
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled multiple ascending single study. It is
      hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week
      treatment period and will result in increases in reticulocyte count and haemoglobin
      concentrations in healthy male volunteers
    


Intervention name(s): DS-1093; placebo
Intervention type(s): Drug; Drug
Intervention description(s): DS-1093 in capsules with 2.5mg or 25mg per capsule; matching placebo capsules to DS-1093 capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri
      and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days.
      Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota
      and vaginal pH
    

Detailed description: 
      Double blind, randomized, placebo-controlled biomedical research study to determine whether
      supplementation with the vaginally isolated strains of Lactobacillus gasseri and/or
      Lactobacillus crispatus can colonize the vagina. Healthy women who meet inclusion and
      exclusion criteria will be randomized 1.5:1.5:1 to one of the following study groups: group
      one will receive L.gasseri for 18 days (1 capsule/day), group two will recieve the
      combination of L.gasseri and L.Crispatus for 18 days (1 capsule/day) and the other will
      receive placebo, starting the day after menstruation is over. Main study outcome will be
      colonization throughout the study, which will be determined by analysis of specific strains
      by qPCR. Secondary outcomes comprise comprise evaluation of tolerability, impact on vaginal
      microbiota, vaginal pH and adverse events.
    

Intervention name(s): Experimental 1; Experimental 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): L. gasseri oral capsule once a day (1 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over; L. gasseri and L. crispatus oral capsule once a day (1.5 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over; One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over
Other intervention name(s): Probiotic; Probiotic mixture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: probiotics
Stylet vs No Stylet During EBUS TBNA
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      This research study compares two ways to biopsy lymph nodes in the chest using endobronchial
      ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA
      procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted
      through the mouth into the large airways of the chest, allowing us to see (via ultrasound)
      and biopsy the lymph nodes in the chest.

      The purpose of this research study is to determine if the EBUS-TBNA procedure can be made
      simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an
      inner stylet that runs through the middle of the needle. Because many other biopsy needles
      (such as the needles used in breast biopsy and different types of lung biopsy needles) do not
      use an inner stylet, the investigators do not think the use of a stylet is necessary. If this
      step can be safely eliminated without decreasing the effectiveness of the procedure, this
      could shorten the procedure (saving time). This study is deigned to formally test the
      hypothesis that a stylet is not necessary in EBUS-TBNA.
    


Intervention name(s): EBUS without stylet
Intervention type(s): Other
Intervention description(s): the patient will receive both conventional ebus with the stylet and experimental ebus (without the stylet). The two techniques will then be compared to each other on a per lymph node basis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original
      OxyContin® (OXY) formulation (40 mg) in the fed state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (oxycodone HCl); Original OxyContin® (OXY) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 40-mg tablet x 1 dose taken with food; Original OxyContin® (OXY) 40-mg tablet x 1 dose taken with food
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid
Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether stem cell mobilization by granulocyte
      colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after
      successful mechanical reperfusion reduces infarct size.
    

Detailed description: 
      Experimental studies and early-phase clinical trials suggest that transplantation of
      blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after
      acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces
      mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem
      cells that are available cells for myocardial regeneration.
    

Intervention name(s): G-CSF Granulocyte-Colony Stimulating Factor; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.; Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.
Other intervention name(s): Neupogen (Filograstim); Granocyte (Lenograstim)
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stem Cells
Natural History Study of Patients With Mucopolysaccharidosis Type IIIB (MPS IIIB, Sanfilippo Syndrome Type B)
Condition: Sanfilippo Syndrome Type B
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis III; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the natural course of disease progression in
      Mucopolysaccharidosis Type III (MPS IIIB) patients who are untreated to identify potential
      surrogate endpoints that may be utilized in future treatment trials of MPS IIIB using
      predefined assessments including standardized clinical, biochemical, neurocognitive,
      developmental, and imaging measures.
    

Detailed description: 
      This is a multicenter longitudinal, prospective, natural history study of patients with
      MPSIIIB designed to identify potential surrogate endpoints that may be utilized in future
      Enzyme replacement therapy (ERT) trials of MPS IIIB via defined assessments including
      standardized clinical, biochemical, neurocognitive, development, and imaging measures.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a documented diagnosis of MPS IIIB and who are currently untreated with
        investigational products (drugs/device) for this disease. Patient must also be ≥ 1 year and
        < 10 years of age with an age equivalent on the Vineland Adaptive Behavior Scales (VABS) of
        ≥ 1 year.
      
Biospecimen description: 
      blood (plasma and serum), cerebrospinal fluid (CSF), urine
    
Keywords: MPS IIIB
A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome
Condition: Hyperlipidemia Combined
MeSH terms: Metabolic Syndrome; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and
      elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid
      triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in
      this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and
      ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile
      of this patient population.
    


Intervention name(s): Combination of 145 mg fenofibrate and 10 mg ezetimibe
Intervention type(s): Drug
Intervention MeSH terms: Ezetimibe; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe
Follow up Glucose Levels Among Infants of Diabetic Mothers
Condition: Newborn; Full Term; Diabetic Mother
Study type: Observational

Summary: 
      Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth.
      Glucose level follow ups are recommended to each IDM. However, there are no recommendations
      as to how long this follow up should be performed for, nor are there "safe" glucose levels
      that allow stopping glucose monitoring.

      The aim of the study is to retrospectively follow up glucose levels among IDMs in order to
      find risk factors for developing hypoglycemia and determine time and glucose levels that
      would permit monitoring cessation.
    

Detailed description: 
      A retrospective study of 250-300 IDMs, born in a single large medical center. Data will be
      collected as follows: Gestational age, birth weight, sex, delivery mode, type of maternal
      diabetes, other maternal diseases, feeding mode. Glucose levels as were recorded according to
      newborn protocol (1,2,4,6 hours after delivery, and then every 8 hours for total of 48
      hours). Data of hypoglycemia treatment, if given, will be collected.

      Later we will statistically try to determine the risk factors for developing hypoglycemia and
      the "safe" time and glucose levels to stop monitoring.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Keywords: gestational diabetes; newborn; hypoglycemia
Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)
Condition: Tuberous Sclerosis
MeSH terms: Tuberous Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess preliminary safety and efficacy of ganaxolone as adjunctive therapy for the
      treatment of primary seizure types in patients with genetically- or clinically-confirmed
      TSC-related epilepsy through the end of the 12 week treatment period.
    

Detailed description: 
      This is an OL proof of concept study of adjunctive GNX treatment in patients with a confirmed
      clinical diagnosis of TSC and/or a mutation in either the TSC1 or TSC2 gene. The trial
      consists of two parts: Part A consists of a 4-week baseline period followed by a 12-week
      treatment period (4-week titration and 8-week maintenance). For patients not continuing in
      the 24-week OLE period (Part B), a 2-week taper period followed by a 2-week safety period
      would follow. The main difference between Part A and Part B is the length of treatment, less
      frequent assessments, and the ability to alter drug doses (both GNX and other antiepileptic
      drug [AED] treatments which includes initiating and stopping other medications) based on
      investigator evaluation of the patient's clinical course during Part B. Patients with a
      seizure frequency reduction during the 12-week treatment period in Part A compared to
      baseline may continue into Part B ("OLE eligible"), to assess long-term safety, efficacy and
      tolerability in patients with TSC-related Epilepsy.
    

Intervention name(s): Ganaxolone
Intervention type(s): Drug
Intervention description(s): titration followed by maintenance and extension period
Intervention MeSH terms: Ganaxolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of 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 2

Summary: 
      To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12,
      16, 20, and 24 weeks compared to placebo.
    


Intervention name(s): LY2127399; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered via Injection; Administered via Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Relapsing; Remitting; Multiple Sclerosis; Multiple; Sclerosis; MS; LY2127399
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
Condition: Central Nervous System
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel
      oral suspension on seizure frequency in pediatric participants maintained on one to three
      stable antiepileptic drugs
    

Detailed description: 
      This is a multicenter, multiple ascending dose, open-label study (Core Study) with an
      Extension Phase. The Core Study consisted of 2 phases, the Pretreatment Phase and the
      Treatment Phase. The Pretreatment Phase lasted up to 2 weeks in duration, during which
      participants were assessed for their eligibility to participate in the study. The Treatment
      Phase consisted of 3 periods: Titration (7 weeks), Maintenance (4 weeks), and Follow-up (4
      weeks; only for those participants not rolling over into the Extension Phase after completing
      the Treatment Phase and for those participants who discontinued from the study). All subjects
      who completed all scheduled visits up to and including the final visit of the Treatment Phase
      (Core Study) were eligible to participate in the Extension Phase of the study. The Extension
      Phase consisted of 2 periods: Maintenance (41 weeks) and Follow-up (4 weeks).
    

Intervention name(s): perampanel
Intervention type(s): Drug
Intervention description(s): During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, drug levels and drug
      effects of single and multiple oral doses of BMS-986331 versus placebo in healthy
      participants and healthy Japanese participants.
    


Intervention name(s): BMS-986331; Placebo, Matching BMS-986331
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy participants