bioihbjkbjnl/mcl2 huggingface dataset:
Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is an open-label, 2-period, single-sequence assessment of CYP3A4 inhibition by
      aramchol using the probe substrates midazolam and atorvastatin to assess CYP3A4 activity.
    

Detailed description: 
      Enrolment of 16 subjects is planned. Each subject will take part in 2 study periods.

      In Period 1, subjects will receive a single oral dose of 2 mg midazolam on Day 1 and a single
      oral dose of 40 mg atorvastatin on Day 3.

      In Period 2, subjects will receive twice-daily oral doses of 300 mg aramchol (the IMP) for 18
      days. During aramchol dosing, subjects will take a single dose of 2 mg midazolam in the
      morning on Day 10 and 40 mg atorvastatin in the morning on Day 12.

      Subjects will be screened within 21 days before their first dose of study medicine. In Period
      1, they will remain resident on the ward from Day -1 to Day 10. In Period 2, subjects will be
      admitted on Day -1 and discharged on Day 19. Subjects will attend a follow-up visit
      approximately 2 weeks later, on Day 33 (±2 days). There will be an interval of at least 1 day
      between Periods 1 and 2.
    

Intervention name(s): Aramchol; Midazolam; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aramchol 600 mg; Midazolam 2 mg; atorvastatin 40 mg
Intervention MeSH terms: Midazolam; Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Olanzapine for Acute Headaches
Condition: Headache
MeSH terms: Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is a prospective, randomized, feasibility trial with the primary aim of comparing
      how well oral rapidly dissolving olanzapine controls primary headache pain when compared to
      the current treatment strategies used in emergency departments which often require
      intravenous or intramuscular medications.
    

Detailed description: 
      Primary Question:

      Does oral rapidly dissolving olanzapine provide efficacious analgesia in patients with acute
      headache of non-organic origin (primary headache) who come to the ED for abortive therapy
      when compared to current standard of care?

      Secondary Aim:

      Additionally, the study will aim to see if oral rapidly dissolving olanzapine decreases 1)
      duration of ED length of stay and 2) need for IV access when compared to the current standard
      of care.

      This is a prospective, randomized, convenience sample, feasibility trial to test for
      non-inferiority of oral rapidly dissolving olanzapine versus current emergency department
      standard of care in providing symptomatic relief to patients presenting with primary
      headache.
    

Intervention name(s): Standard of Care as per attending physician; 5mg rapidly dissolving olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): Patients are randomized to standard of care medication (as determined by attending physician); 5mg rapidly dissolving olanzapine
Other intervention name(s): standard of care; Zydis
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.
Masking: None (Open Label)
Primary purpose: Treatment
DynamX Bioadaptor Hong Kong Registry
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, non-randomized, multicenter registry
    

Detailed description: 
      Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions
      measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX
      Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up
      via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture
      cardiovascular related hospitalizations related to the study devic
    

Intervention name(s): DynamX Novolimus Eluting Coronary Bioadaptor System
Intervention type(s): Combination Product
Intervention description(s): up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System
Other intervention name(s): Novolimus; Bioadaptor
Intervention model: Single Group Assignment
Intervention model description: Prospective, non-randomized, multicenter registry
Masking: None (Open Label)
Primary purpose: Other
Keywords: drug eluting stent; percutaneous coronary intervention
Investigating Cytokine Genes of Stem Cell Donors
Condition: Stem Cell Transplantation
Study type: Observational

Summary: 
      This study seeks to investigate the factors that may account for the differences in the way a
      stem cell recipient s immune system works after a transplant. It will focus on cytokine
      genes, which give specific instructions to the genes and which may influence immune system
      response. More specifically, the purpose of the study is to find out how gene polymorphisms
      (gene variations among the population) affect the success or failure of a stem cell
      transplant.

      Study participants will have donated blood for a stem cell transplant. They will be asked to
      give consent for NIH personnel to run special tests on these blood samples, which will have
      been placed in storage. It is hoped that blood samples will be studied from 600 stem cell
      donors.
    

Detailed description: 
      The NHLBI Stem Cell Allotransplantation Program is researching methods to improve allogeneic
      stem cell transplantation. We are particularly interested in identifying factors, which
      result in individual variability in outcomes. Cytokines are biological modulators of the
      immune system known to influence various phases of the immune response. Normal variations in
      the genetic material coding for cytokines (Cytokine Gene Polymorphisms or CGPs) are believed
      to account for some of the differences in the inflammatory response between individuals. In
      the future, we hope to tailor stem cell transplantation to take into account these
      immunological profiles. In order to characterize the effect of any such intervention, we
      first need to better understand the role CGPs play in immune responses in normal, healthy
      persons. This involves testing for the presence or absence of a polymorphism in healthy
      individuals, and comparing with a validated in vitro assay. None of these polymorphisms are
      associated with known clinical disease to be classifiable as a 'genetic defect'. Moreover, we
      will not correlate these polymorphisms with clinical studies to identify traits in the sample
      donors. We plan to utilize stored blood samples from stem cell transplant donors who have
      previously participated on a hematology branch protocol as well as consent future donors.
    

Time perspective: Other
Keywords: Tumor Necrosis Factor Alpha (TNF-Alpha); Interferon-Gamma (IFN-Gamma); Interleukin-10 (IL-10); Interleukin-6 (IL-6); Interleukin-1 (IL-1 Ra); Interleukin-1 Receptor Antagonist (IL-1 Ra); Vitamin D Receptor (VitD R)
Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to test the safety and efficacy of a drug called
      saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized
      patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c
      ≤7.0% on ≤ 2 non-insulin agents at home.
    

Detailed description: 
      The current professional organization guidelines recommend insulin as the preferred treatment
      for hospitalized patients. It is recommended that most critically ill patients should receive
      insulin infusion therapy and non-critically ill patients should receive basal bolus insulin
      therapy in the hospital.

      The study will test the hypothesis that treatment with saxagliptin is non-inferior to
      treatment with basal bolus insulin in this group of patients during their hospital stay. The
      study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in
      non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)

      The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The
      study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as
      compared to the control group
    

Intervention name(s): Saxagliptin
Intervention type(s): Drug
Intervention description(s): 2.5-5 mg daily
Other intervention name(s): Onglyza; DPP4 inhibitor
Intervention MeSH terms: Saxagliptin; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this
      study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair
      growth in men with tendencies for hair loss.
    

Detailed description: 
      This study consists of a treatment phase (6 months) and a follow-up phase (6 month ).
      Eligible subjects will be randomly assigned to receive treatment with the study medication or
      placebo. Subjects will visit the clinic at 3, 6, and 12 months after treatment start for
      safety and efficacy evaluations.

      HCap Formula or placebo tablets will be taken orally every other day during 6 months.
    

Intervention name(s): HCap Formula; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Pill should be taken every other day during the treatment phase.; Similar pills without active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male; Baldness; hair loss pattern
Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma; HIV
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the safety of rituximab plus cyclophosphamide,
      doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse large
      B-cell lymphoma (DLBCL) patients in Malawi.
    

Detailed description: 
      The study is a single-center, non-randomized phase II clinical trial of R-CHOP for
      CD20-positive DLBCL, using the Indian generic biosimilar for rituximab, Reditux™. The
      investigators will enroll 40 adult patients age 18-60 years (20 HIV-infected with CD4 count ≥
      100 cells/µL, 20 HIV-uninfected) who will receive a maximum of 6-8 cycles of R-CHOP over
      18-24 weeks. The primary goal of this study is to establish the safety of R-CHOP in the
      Malawi population.

      Secondary objectives of the study include estimates of complete response (CR) rates,
      progression-free survival (PFS), and overall survival (OS). In addition, quality of life,
      costs of care, study patient characteristics, clinical outcomes and other published data from
      the region will be collected and used to evaluate the cost-effectiveness of R-CHOP. If the
      investigators' study supports incorporating rituximab into treatment regimens in sub-Saharan
      Africa, this strategy can be examined in larger trials, and provide momentum to increase
      access to modern cancer medicines globally.
    

Intervention name(s): R-CHOP
Intervention type(s): Drug
Intervention description(s): maximum of 6-8 cycles of R-CHOP over 18-24 weeks
Other intervention name(s): Indian generic biosimilar for rituximab, Reditux™
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: single arm phase 2; safety and efficacy; R-CHOP
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the safety and the effectiveness of a new vaccine for
      the prevention of the disease, smallpox.
    

Detailed description: 
      The objective of this study is to determine the minimum dose of ACAM2000 that is calculated
      to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29
      years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are
      to:

        1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose
           of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety
           and tolerability will be determined by examination of the local cutaneous reaction,
           adverse events, physical examinations, vital signs, structured interviews, and
           laboratory analysis.

        2. Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of
           Dryvax® in healthy adults 18-29 years of age by comparing:

             1. the proportion of subjects at each dose level who develop a major cutaneous
                reaction;

             2. the proportion of subjects in each treatment group who develop neutralizing
                antibodies, including the fold-increase in antibody titer between Baseline and Day
                30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.

        3. Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous
           reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve
           to smallpox vaccine.
    

Intervention name(s): Vaccinia virus: ACAM2000 smallpox vaccine; vaccinia virus (calf lymph): Dryvax
Intervention type(s): Biological; Biological
Intervention description(s): Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml; Group 5 dose: 1.0x10-8th PFU/ml
Other intervention name(s): Dryvax®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Smallpox
Autologous Cord Blood Cells for Brain Injury in Term Newborns
Condition: Hypoxic Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to test feasibility and safety of collection, preparation and infusion
      of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby
      is born with signs of brain injury. The cord blood used is fresh (not frozen and then
      thawed).
    

Detailed description: 
      The purpose of this pilot study is to evaluate the safety and feasibility of infusions of
      autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants
      with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to
      severe encephalopathy at birth and have cord blood collected at birth can receive their own
      cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental
      outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks
      and 4-6 months old.
    

Intervention name(s): Autologous cord blood
Intervention type(s): Biological
Intervention description(s): Baby's own umbilical cord blood
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoxic ischemic encephalopathy; Autologous cord blood
Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task
Condition: Heavy Drinking
Study type: Interventional

Summary: 
      The study aims to utilise olfactory stimulation in addition to the visual stimulation in cue
      reactivity tasks to enhance precision in measuring alcohol based cues in individuals
      diagnosed with heavy drinking. The study consists of one cue reactivity task with visual
      stimuli, another cue reactivity task with matching odour/visual stimuli and lastly a monetary
      incentive delay task.
    

Detailed description: 
      The intention of the study is to enhance the measurement precision in image-based cue
      reactivity task by introducing a new level of stimuli in the form of odours. During the
      course of the functional Magnetic Resonance Imaging (fMRI) screening, participants are
      required to finish three tasks, namely; odour-based cue reactivity task (OCRT), image-based
      cue reactivity task(ICRT) and monetary incentive delay task (MID).

      Participants will be randomly divided into two groups, one group will receive tasks in the
      following order: OCRT-MID-ICRT and the other group will receive them in the following order:
      ICRT-MID-OCRT. With this, the habituation effect from receiving odours during OCRT is
      expected to be balanced.
    

Intervention name(s): Non-Alcoholic Odour; Alcoholic Odour; Non-Alcoholic Images; Alcoholic Images
Intervention type(s): Other; Other; Other; Other
Intervention description(s): A chemical used in fragrances and flavouring with a smell close to a nutty, buttery structure. Used as a 1:100 deionised water dilution.; Alcoholic beverage beer / Alcoholic beverage red wine / Alcoholic beverage brandy / The type of the Alcoholic Odour intervention will be presented in a participant-preference basis.; Images of non-alcoholic items, namely; broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent are presented in parallel with the non-alcoholic odour; Images of alcoholic items, namely, beer, wine, schnapps are presented in parallel with the alcoholic odour
Other intervention name(s): Coffee furanone; 2-Methyltetrahydrofuran-3-one; Beer; Wine; Schnapps
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two group study is constructed with the sole intention to balance the amount of participants who would undergo the same experiment with a different order. Half of the participants will receive odour based Cue Reactivity Task first, other half will complete the image based Cue Reactivity Task first.
Before the MRI screening participants would be asked about their preference between beer, wine and schnapps then during the odour based Cue Reactivity Task only their preferred beverage odour would be delivered.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cue Reactivity Task; Heavy Drinking; Olfactory Cue Reactivity Task
Trial of Vitamin D Fortified Milk
Condition: 25-hydroxyvitamin D Serum Concentrations
Study type: Interventional
Phase: Phase 3

Summary: 
      Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not
      been suspected before. The most cost-effective method for reducing population-wide VDD is
      through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification
      varies by dose, duration, and population characteristics; and it is currently unknown whether
      it could be an efficacious public health intervention to curb the VDD epidemic among children
      living in tropical areas. We propose to conduct a randomized, controlled, double blind trial
      to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D
      concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families
      with a child participating in an ongoing cohort study will be randomized to receive one liter
      per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim
      milk for a six-week period. Caregivers will be instructed to give the index child two cups of
      milk per day and to distribute the remaining milk to the rest of the family. We will measure
      serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the
      intervention period.
    


Intervention name(s): Vitamin D; No vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Milk fortification; Children; Colombia
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Condition: Lumbosacral Radicular Pain
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a research study of SP-102, an experimental medication designed to relieve pain in
      patients with a specific type of leg pain. The medication is given once by your healthcare
      professional, with a possibility of a second injection as early as about 1 month after the
      first treatment.

      The purpose of the study is to measure how well a single injection of the experimental
      medication, SP-102, relieves pain. The study will also investigate the side effects of
      SP-102.
    


Intervention name(s): SP-102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): injection; injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lumbosacral radicular pain; sciatica; leg pain
A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis
Condition: Pulmonary/Respiratory Diseases
MeSH terms: Cystic Fibrosis; Respiratory Tract Diseases; Respiration Disorders; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of inhaled AZD5634 on Mucociliary clearance (MCC) in
      patients with Cystic fibrosis (CF) after single-dose administration.
    

Detailed description: 
      The primary pharmacodynamic endpoint will be the average whole lung particle clearance
      between 0 and 60 minutes after administration of aerosolized radiolabelled particles
      (colloids) at Visits 2 and 3 (%MCC 0-60, whole).
    

Intervention name(s): Placebo; AZD5634
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a placebo in either period 1 or period 2 by inhalation.; Subjects will receive a single tentative dose of 625 μg of AZD5634 in either period 1 or period 2 by inhalation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AZD5634; Mucociliary Clearance; Safety; Tolerability; Pharmacokinetic; Cystic Fibrosis; Cross-Over Study