bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single centre, open label, randomised, two period, crossover study to evaluate the
      bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in
      dexamethasone-suppressed healthy adult male subjects.
    

Detailed description: 
      This study was an open-label, randomised, single dose, two-period, crossover study in 25
      healthy male subjects.

      The study comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a
      post-study followup.

      Screening (Day -28 to Day -1): Screening assessments were carried out within 28 days before
      first administration of IMP. Eligible subjects were asked to return for the treatment
      periods. Continued eligibility was confirmed pre-dose during each treatment period.

      Treatment Periods (Day -1 to Day 1): Eligible subjects received a single-dose of each IMP
      over 2 treatment periods (1/period as determined by the randomisation schedule), each
      separated by 7 days washout. Each study period was approximately 2 days in duration, from the
      afternoon of Day -1 to the morning of Day 1 at 24 hours (h) post-dose. During each treatment
      period, Subjects arrived at the Clinical Unit on Day -1, IMP was administered on the morning
      of Day 0 fasted (following an overnight fast of at least 10 h) and subjects were discharged
      following the 24 h post-dose blood samples and completion of the scheduled measurements.

      Pharmacokinetic (PK) samples were collected pre-dose at ~ -2min and up to 23 h post-dose (Day
      1) (24 samples) for the measurement of cortisol. A further 3 baseline samples were taken for
      the measurement of cortisol. Safety was also evaluated throughout the study.

      Post Study: After completion of both study periods, the subjects returned 4-22 days later for
      the final followup visit.
    

Intervention name(s): Chronocort®; Cortef®
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 20mg Chronocort® administered in one treatment period; Single dose of 20mg Cortef® administered in one treatment period
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy Subjects
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine safety of single doses of GSK369796 in healthy subjects, along with
      some test to examine how quickly GSK369796 gets in your blood, and how long it takes your
      body to get rid of it.
    


Intervention name(s): GSK369796; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anti-malarial; Placebo matching GSK369796
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: pharmacokinetics,; safety; single ascending dose,; Healthy volunteers,
High-Dose Imatinib for Relapsed/Refractory c-Kit Positive Acute Myelogenous Leukemia (AML)
Condition: AML
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients
      with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600
      mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day
      imatinib is permitted for 2 additional months in the event of response failure. Response is
      assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.
    

Detailed description: 
      Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease.
      Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of
      response failure. Novartis provided supplies of imatinib for all patients included in the
      study.
    

Intervention name(s): Imatinib
Intervention type(s): Drug
Intervention description(s): Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Novartis provided supplies of imatinib for all patients included in the study.
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      The purpose of the study is to investigate whether insulin sensitivity and insulin resistance
      of the human brain is comparable in all insulin sensitive parts of the brain and whether
      correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of
      the study participants.
    


Intervention name(s): Human Insulin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 160 U of insulin; Insulin dilution medium without insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid
      with ADHD and have participated in the 810P301 or 810P302 study are invited to participate in
      this study. This is a Phase 3 open label extension (OLE) study with the objective of
      collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in
      pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After
      confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be given
      a choice to extend participation in this study every 6 months for up to 36 months.
    


Intervention name(s): SPN-810
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability Study of ARC-520 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      ARC-520 in normal, adult volunteers.
    


Intervention name(s): ARC-520; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Continuous Noninvasive Method for Estimating and Predicting Maternal and Fetal Hemodynamic Changes During Regional Anesthesia
Condition: Pregnancy; Anesthesia
Study type: Observational

Summary: 
      Machine learning techniques and algorithms originally developed for use in the field of
      robotics can be applied to continuous, noninvasive physiological waveform data to discover
      hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) predict
      cardiovascular collapse well ahead of any clinically significant changes in standard vital
      signs, 2) monitor and estimate fluid resuscitation needs, 3) estimate acute blood loss
      volume, and 4) estimate intracranial pressure. The investigators hypothesize that these same
      methods can be used to predict functional hypovolemia during regional anesthesia for labor or
      fetal intervention.
    

Detailed description: 
      Specific aims:

        1. Collect noninvasive physiological waveform data from patients undergoing regional
           anesthesia for labor or fetal intervention at the University of Colorado Hospital and
           Children's Hospital Colorado.

        2. Combine the physiological data from patient monitors with clinical and demographic data,
           including maternal problem list, medications, volume infused, use of vasopressors,
           arterial and venous pressures, fetal heart rate, fetal umbilical artery Doppler
           velocimetry, maternal uterine artery Doppler waveform, fetal and neonatal outcomes etc.
           for use in developing mathematical model for early detection of maternal functional
           hypovolemia.

        3. Develop robust, real-time, computational models for:

             -  estimating maternal volume status prior to administration of epidural anesthesia

             -  estimating effective intravascular volume loss during maternal regional anesthesia

             -  predicting an optimal, individual specific requirement for IV resuscitation and/or
                need for vasopressor agents while providing adequate analgesia using regional
                techniques and optimizing the fetal outcomes

             -  identifying mothers susceptible to epidural induced hypotension
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant females undergoing regional anesthesia for labor or fetal intervention at the
        University of Colorado Hospital and Children's Hospital Colorado.
      
Keywords: pregnancy; labor; epidural; fetal intervention
Misoprostol for NASH
Condition: NASH
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating
      patients with NASH.
    


Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Misoprostol is a prostaglandin E1 analogue; Placebo contained substance that has no therapeutic value.
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Effects of Androgenicity in Aging Men and Women
Condition: Aging; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The goal of this research study is to study the effect of testosterone or estrogen on blood
      sugar control and fat metabolism. Changes in hormone levels with age may affect risk factors
      for heart disease such as diabetes. Diabetes is a glandular condition associated with lack of
      the hormone insulin or an insensitivity to it resulting in problems with blood sugar control
      and fat metabolism. The effect of commonly used hormonal supplements such as testosterone by
      older adults on insulin and body composition is not well understood. In this study, the role
      of testosterone and estrogen on your ability to control blood sugar and your body composition
      will be assessed.

      The investigators plan to study 60 subjects. All of these subjects will be healthy older men
      between the ages of 60-85 years old who are not on testosterone therapy. Subjects that are
      screened who have any clinically significant abnormalities detected on their screening
      physical exam or laboratory testing (e.g. Prostate Specific Antigen > 4), who have a history
      of prostate cancer, polycythemia, or who cannot take testosterone will not be included.

      If a subject is eligible to participate after initial screening, that subject will take
      medications to adjust their hormone levels and have tests performed that measure insulin
      sensitivity and adiposity before and after these hormone medications. The outcomes that will
      be measured are: 1) insulin sensitivity, 2) hormone levels (total and free testosterone
      levels, sex hormone-binding globulin levels) and 3) body composition and abdominal adiposity.
    


Intervention name(s): Testosterone; Estrogen
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone gel; Estrogen patch
Intervention MeSH terms: Testosterone; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Aging; Hormones; Insulin resistance
Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Little is known about old MS patients. In a previous work, systematic search in Bordeaux,
      Strasbourg and Dijon university hospital regional MS center databases European Database for
      Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS)
      patients in the 3 databases. Data analysis showed that MS may switch off in the very old
      patients with mild progression and very few relapses. The project is to continue this
      preliminary work and extend it with a systematic study of MS in the elderly.

      The scientific aims: To add new insights into long lasting MS natural history in the growing
      population of elderly patients with MS.
    

Detailed description: 
      75 to 77 years old MS patients whose disease began at 65 years old or earlier will be
      retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP) which includes
      more than 50 000 MS patients in France. Accuracy of these patients' data from 65 to 75 years
      old will be thereafter checked and completed in 3 French MS centers: Lyon, Rennes and
      Bordeaux, participating to this database directly from the patients' clinical files. From
      these 3 MS centers around 150 MS patients from 75 to 77 years old are expected to be analysed
      on site.

      The data wich will be retrieved for these patients are: irreversible disability status scale
      progression, relapses, Magnetic Resonance Imaging (MRI) data, CSF data, Lublin classification
      of type of MS, McDonald 2005 and 2010 criteria, date and age at beginning of progression,
      characteristics and modality of relapses and clinical impairment at the beginning of the
      disease, treatments used, treatment failures and side effects, co morbidity, Barthel index,
      EuroQol-5D (EQ-5D), cognitive impairment (SDMT test), social life data and socio economic
      data. To the investigator's knowledge this will be the first systematic description of very
      old MS patients with data on long term natural history of MS and characteristics in this
      population of elderly MS patients.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        75 to 77 years old MS patients whose disease began at 65 years old or earlier will be
        retrieved from the "Observatoire français de la sclérose en plaques" which includes more
        than 50 000 MS patients in France.
      
Keywords: Geriatric population; EDMUS; OFSEP
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate the effects of 12-months
      supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on
      changes in markers of bone formation and resorption and in bone mass density (BMD) in
      apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin
      supplementation.
    

Detailed description: 
      The study will include an information visit, a randomization visit, a month 3 visit and a
      final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial
      products. Outcome parameters will be measured using blood samples obtained at the
      randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters
      will moreover be analyzed based on DXA scan obtained at the randomization visit and at the
      final visit at 12 months.
    

Intervention name(s): Maltodextrin; Calcium-carbonate; Calcium-enriched permeate; Calcium-enriched permeate with Inulin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.; Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.; Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.; Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
Other intervention name(s): Capolac; Capolac Inulin
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a gluten challenge study to characterize peripheral blood and intestinal gluten
      specific cluster of differentiation 4 glycoprotein (CD4+) thymus lymphocyte (T cell) subsets
      in participants with Celiac Disease
    

Detailed description: 
      This is a multi-site, open-label gluten challenge study to characterize peripheral blood and
      intestinal gluten specific CD4+ T cell subsets in participants with celiac disease (CeD).
      Participants will receive 8 grams (g) of gluten daily for 13 consecutive days. Blood samples
      will be taken at pre-dose, Day 6, and Day 14. Duodenal biopsy samples will also be collected
      on Day 14. Participants will also complete a symptom diary.
    

Intervention name(s): Gluten powder 4g
Intervention type(s): Dietary Supplement
Intervention description(s): Gluten powder 4g oral BID
Intervention model: Single Group Assignment
Intervention model description: Experimental study to determine blood and duodenal T cell changes following administration of an 8 g gluten challenge daily for 13 days in participants with celiac disease
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Celiac disease
A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing
      regime to allow optimal zonisamide or carbamazepine therapy for individual subjects.
      Assessment of eligibility will take place at the Screening Visit. The subjects will be
      randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1
      must occur as soon as possible (and at least within 14 days) of the Screening Visit in order
      to optimize subject care.
    


Intervention name(s): Zonisamide; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.; Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
Other intervention name(s): Zonegran
Intervention MeSH terms: Carbamazepine; Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy
Evaluate Recovery of Testosterone for Patients Using Eligard
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if testosterone will recover to 90% by year 1 after
      using Eligard.
    

Detailed description: 
      This is a Multi-center, open-label study to evaluate testosterone recovery after six months
      of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients
      with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two
      subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive
      Radiation Therapy (Month 2-4).
    

Intervention name(s): Eligard (TM)
Intervention type(s): Drug
Intervention description(s): Eligard (TM) 22.5 mg administered at baseline and Month 3
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer
Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol
Condition: Contraception; Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to further understand the elimination pathways, metabolite
      profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
    

Detailed description: 
      This will be an open-label, non-randomised, single dose study in healthy female volunteers of
      non-child bearing potential.

      Subjects will be screened for eligibility to participate in the study up to 28 days before
      dosing. The study will be executed in a single group, 6 subjects will be enrolled and dosed
      with a single oral dose of carbon 14 labelled estetrol. Subjects will be admitted to the
      clinical unit on the morning prior to study drug administration (Day -1). Dosing will take
      place on the morning of Day 1 after an overnight fast (approximately 10 h).

      Subjects will be resident in the clinic up to 240 h after dosing during which plasma, blood,
      urine and faeces samples will be collected. It is planned that subjects will be released as a
      group when all subjects have achieved a mass balance cumulative recovery of >90% or if a mean
      of <1% of the dose administered has been collected in urine and faeces within 2 separate,
      consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces)
      will be stopped and the subjects will undergo discharge assessments. If this criterion has
      not been met by all subjects on Day 11, home collections of urine and faeces may be requested
      at the discretion of the investigator for individual subjects.
    

Intervention name(s): Estetrol
Intervention type(s): Drug
Intervention description(s): 15 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C
Other intervention name(s): E4
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other