bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess how safe risankizumab is and how risankizumab moves through the body
      of adult healthy participants. Adverse Events will be assessed.

      Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease.
      Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult
      healthy volunteers will be enrolled in at least 4 sites across the world.

      All participants will receive risankizumab as subcutaneous injections in one of the 2
      different formulations.

      There may be higher burden for participants in this trial. Participants will be confined for
      10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
    


Intervention name(s): Risankizumab Dose A; Risankizumab Dose B
Intervention type(s): Drug; Drug
Intervention description(s): Prefilled Syringe; Prefilled Syringe
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Risankizumab
Umbilical Cord Blood Therapy for Global Developmental Delay
Condition: Global Developmental Delay
Study type: Interventional

Summary: 
      This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic
      umbilical cord blood therapy for children with global developmental delay.
    

Detailed description: 
      Global developmental delay is defined as significant delay in two or more of the following
      developmental domains: gross/fine motor, speech/language, cognition, social/personal, and
      activities of daily living.

      Umbilical cord blood has been used for inherited metabolic diseases that feature global
      developmental delay and many experimental animal studies have revealed umbilical cord blood
      is useful to repair neurological impairments in brain.
    

Intervention name(s): Umbilical cord blood transplantation
Intervention type(s): Procedure
Other intervention name(s): Autologous or Allogeneic Umbilical Cord Blood
Intervention model: Single Group Assignment
Intervention model description: allogeneic cord blood transplantation for children with developmental delay
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Global developmental delay; Umbilical cord blood; Rehabilitation
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of
      formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of
      inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild
      asthma
    


Intervention name(s): formoterol; budesonide/formoterol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; allergen challenge; airway responsiveness; airway inflammation; Symbicort®
Mipolixin® Compared to Poliprotect® in Moderate Functional Dyspepsia and Heartburn.
Condition: Dyspepsia; Heartburn
MeSH terms: Dyspepsia; Heartburn
Study type: Interventional

Summary: 
      Evaluation of the clinical efficacy of two medical devices, Mipolixin® and Poliprotect®, in
      improving the overall symptom severity of functional dyspesia and/or heartburn
    


Intervention name(s): Mipolixin®; Poliprotect®
Intervention type(s): Device; Device
Intervention description(s): 1.55g chewable tablet 5 times a day for 2 weeks; 1.55 g chewable tablet 5 times a day for 2 weeks
Other intervention name(s): Advanced Natural Antacid; Neobianacid
Intervention MeSH terms: Antacids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose
      response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and
      cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro)
      inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by
      single and multiple dose administration.
    


Intervention name(s): JNJ-54175446; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.; Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Bacillus Coagulans in Adults With With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults
      with with functional constipation for 12 weeks.
    

Detailed description: 
      A previous study has indicated that Bacillus coagulans provided control of abdominal pain,
      less discomfort during defecation, and a more normalized defecation style, especially in
      adults with with functional constipation. Therefore, the investigators conduct a randomized,
      double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans
      various symptoms and fecal microbial diversity in adults with with functional constipation
      for 8 weeks; the safety of the compound are also evaluated. The Investigators examine
      constipation visual analogue scale, Bristol Stool Form Scale type 3 & 4 ratio, visual
      analogue scale for irritable bowel syndrome (VAS-IBS) questionnaire score, IBS-symptom
      severity scale, IBS quality-of-life questionnaire score, fecal microbial diversity at
      baseline, as well as after 8 weeks of intervention. Eighty adults were administered either
      400 mg of Bacillus coagulans or a placebo each day for 8 weeks.
    

Intervention name(s): Bacillus coagulans group; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Bacillus coagulans 400 mg/day for 12 weeks; Placebo 400 mg/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Diurnal Variations of Brain Metabolite Concentrations in 1H-MRS
Condition: Diurnal Variations of Cerebral Metabolite
Study type: Interventional

Summary: 
      Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI)
      technique. It allows the quantification of cerebral metabolite concentrations. Currently,
      MRS-1H is used regardless of the examination schedule. However, it is not possible to say if
      the brain metabolite concentrations are stable over 24 hours. Thus, the main objective was to
      study the diurnal variation of cerebral metabolite concentrations in 1H-MRS in healthy
      subjects.

      Moreover, the investigators also want to investigate the association between choline
      concentrations (Cho, parameter reflecting membrane metabolism) in 1H-MRS and fractional
      anisotropy (AF) values, obtained with the diffusion tensor imaging sequence (DTI), in the
      white matter of the centrum ovale. The results obtained from this objective will allow to
      obtain reference values of an estimate of the association between Cho concentrations and AF
      values in healthy subjects. These data are intended to improve the diagnostic and therapeutic
      management of patients with neurological pathologies.
    

Detailed description: 
      Currently, it is not possible to say if the brain metabolite concentrations are stable over
      24 hours in 1H-MRS. Few studies, with small samples (< 10 subjects), have investigated this
      point. Their conclusions remain inconsistent. Without an available study with sufficient
      statistical power, it is not currently possible to state that concentrations of brain
      metabolites are stable over 24 hours. Therefore, it is not possible to formally conclude on
      differences in concentrations of metabolites between a healthy subject and a patient.

      It is known that the human circadian rhythm leads to changes on many parameters such as
      hormonal secretions (TSH, cortisol, melatonin, growth hormone, and carbohydrate metabolism)
      and body temperature. It therefore seemed relevant to choose 3 of the most critical periods
      of the human circadian rhythm (7:30, 13:30 and 18:00) to assess the diurnal variations of
      cerebral metabolite in 1H-MRS. The DTI sequence will only be performed once.

      The study will take place at the University Hospital of Poitiers, in the department of
      Medical Imaging. 3 appointments are planned: the pre-inclusion one D0, the inclusion one D1
      including the signature of the consent, and the D3 one for the realization of the 3 MRIs at
      7:30 am, 1:30 pm and 6 pm. Each MRI scan lasts an average of 20 minutes.
    

Intervention name(s): magnetic resonance spectroscopy (MRI)
Intervention type(s): Other
Intervention description(s): Each healthy subject will get 3 MRI examinations at 7:30, 13:30 and 18:00. Each MRI scan lasts an average of 20 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Proton Magnetic Resonance Spectroscopy
Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to assess the pharmacokinetic profile in patients with active
      ulcerative colitis and compare it to the experience in healthy volunteers.
    


Intervention name(s): LYC-30937
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to
      Days 1 and 2, assessed by PSG.
    

Detailed description: 
      This study consists of the following phases: screening phase; double-blind treatment phase;
      safety follow-up phase. Safety is monitored throughout the study.
    

Intervention name(s): ACT-541468 5 mg; ACT-541468 10 mg; ACT-541468 25 mg; Zolpidem; Placebo 1; Placebo 2
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule for oral administration containing ACT-541468 at a strength of 5 mg; Capsule for oral administration containing ACT-541468 at a strength of 10 mg; Capsule for oral administration containing ACT-541468 at a strength of 25 mg; Over-encapsulated zolpidem tablet at a strength of 10 mg; Placebo capsules matching ACT-541468 capsules; Placebo capsules matching over-encapsulated zolpidem
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Polysomnography
Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is an open-label, fixed-sequence, cross-over study conducted at a single Clinical
      Unit to assess the pharmacokinetics (PK) of midazolam in healthy male and female
      (non-childbearing potential) subjects when administered alone and in combination with AZD4831
      after multiple doses (once daily) of AZD4831 for 10 consecutive days.
    

Detailed description: 
      The study will consist of 2 treatment periods and will comprise:

        -  A Screening period of maximum 28 days;

        -  Treatment Period 1 and Treatment Period 2:

      Treatment Period 1: Midazolam only (Day 1). Treatment Period 2: AZD4831 only (Days 2 to 10,
      once daily dosing) and AZD4831 plus midazolam (Day 11).

      - A final Follow-up Visit after the last administration of investigational medicinal product
      (IMP) (Day 20 [± 1 day]).

      Each subject will be involved in the study for approximately 7 weeks.
    

Intervention name(s): AZD4831; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive oral doses once daily from Days 2-11.; Subjects will receive oral single doses on Day 1 and Day 11.
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Disease; Drug-drug interaction; Pharmacokinetics; Myeloperoxidase inhibitor; Fixed-sequence
Iodine Supplementation in Obesity
Condition: Iodine Deficiency; Subclinical Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Interventional

Summary: 
      The study hypothesis is that iodine supplementation will lower serum TSH and leptin
      concentrations and thereby improve the lipid and glucose profile.
    

Detailed description: 
      The study will be a double blind, placebo controlled intervention study in obese women living
      in the Atlas foot mountains in Morocco, an iodine deficient area. Eligible subjects will be
      randomized into intervention and control group and will receive the respective supplement for
      6 months. At baseline, midpoint and endpoint anthropometric as well as metabolic profile will
      be assessed. A health questionnaire will further be administered monthly when the tablets for
      the following month are distributed. Urine samples to determine iodine status will also be
      collected monthly.
    

Intervention name(s): Iodine tablet; Placebo tablet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Iodine tablets containing 200 ug iodine as potassium iodate; Placebo tablet without iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: iodine; thyroid hormones; obesity; TSH; dyslipidemia; insulin resistance
Effect of HFCWO Vests on Spirometry Measurements
Condition: Cystic Fibrosis; Bronchiectasis
MeSH terms: Cystic Fibrosis; Bronchiectasis
Study type: Interventional

Summary: 
      The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced
      Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and
      Tidal Volume is investigated during use of several products and comparing to baseline values
    

Detailed description: 
      The study will be broken into one (1) arm:

      • AffloVest® & Monarch™

      Within the arm, the order of products will be randomized.

      Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak
      Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be
      taken at the beginning, middle and end of each series of measurements with each subject,
      without any device on the subject. A product (AffloVest or Monarch) will be placed onto
      subject and turned ON to the highest frequency and intensity settings. Then the subject will
      be given a certain period of time to adjust and spirometry measurements will then be
      repeated, then the product will be removed and the subject will be allowed a recovery period,
      then the other product will be placed on the subject, turned ON and spirometry measurements
      will repeated.
    

Intervention name(s): International Biophysics AffloVest; Hill-Rom Monarch
Intervention type(s): Device; Device
Intervention description(s): High-frequency chest wall oscillation vest; High-frequency chest wall oscillation vest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      There is substantial evidence from animal model and healthy control data, that oxytocin is
      involved in the modulation of social cognition. In addition, recent genetics and plasma level
      studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum
      Disorders (ASD). As a large number of children with ASD are transitioning into adulthood and
      will likely require treatment, the lack of data to make meaningful treatment recommendations
      to facilitate adult living is an urgent issue. This study will examine the effect of
      intranasal oxytocin (IN-OXT) on social function in adults with ASD. It is hypothesized that
      IN-OXT will be superior to placebo in improving social function by the end of study
      treatment.
    


Intervention name(s): Intranasal Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 24 IU taken twice daily (BID), in the morning and at noon/early afternoon; 24 IU taken twice daily (BID), in the morning and at noon/early afternoon
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorders; Oxytocin; Adults
NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR)
      were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This
      study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy
      of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2)
      DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The
      investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive
      function in patients with AD.
    


Intervention name(s): DAOI-A group; DAOI-B group; DAOI-C group; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): DAOI with A dose; DAOI with B dose; DAOI with C dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol
Condition: Healthy Volunteers; Pharmacokinetics/Dynamics Study
Study type: Interventional
Phase: Phase 2

Summary: 
      Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that
      of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their
      metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by
      monitoring vital signs, ECG and adverse events.
    

Detailed description: 
      16 healthy volunteers of both sexes, age 18 to 45 years, will be enrolled. The mean dose
      necessary to suppress the Dobutamine induced heart rate increase of at least 30 bpm above
      baseline rate (maximum heart rate app. 110 bpm) by at least 20 bpm will be calculated for
      AOP200704 and Esmolol and the dose/efficacy relation of both agents to each other will be
      calculated for the steady state condition. For both drugs the time to reach a decrease of 10
      bpm, 20 bpm and the maximum effect will be calculated. In addition the mean time to increase
      in 10 and 20 bpm and the time to reach maximum heart rate (increase of 30 bpm above baseline
      or more) after termination of infusion will also be assessed for both drugs. Blood pressure
      values will be compared for all above mentioned time points where heart rate is assessed for
      pharmacodynamics.The study will consist of a screening, cross-over 1, cross-over 2 and
      end-of-study visit.
    

Intervention name(s): AOP200704; Esmolol hydrochloride, infusion
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of AOP200704 with Esmolol; Comparison of AOP200704 with Esmolol
Intervention MeSH terms: Esmolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AOP200704, Esmolol, Pharmacokinetics, Pharmacodynamics
Exercise in Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of aerobic exercise to usual care in
      women treated with chemotherapy and radiation therapy for non-metastatic breast cancer
    

Detailed description: 
      In this study, we will compare the effects of exercise between women previously treated with
      breast cancer to women with no history of any cancers. Therefore, in addition to a randomized
      controlled trial in women with previous breast cancer (i.e., an exerciser group and a control
      group), we also include a reference group comprising age-matched women with no history of any
      cancer diagnosis. Women in the reference group will undergo a similar exercise intervention
      and the exercise group. This study recruits through invitation only.

      The primary endpoint in this study is the change in cardiorespiratory fitness, measured as
      VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and
      cardiometabolic health, endpoints derived from the cardiopulmonary exercise test and lung
      function assessments, cellular muscle endpoints derived from muscle biopsies obtained from m.
      vastus lateralis, also patient-reported outcomes.
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Behavioral
Intervention description(s): Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention