bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of TAK-831 when
      administered as multiple oral doses at escalating dose levels in healthy participants.
    

Detailed description: 
      This study is a randomized, investigator and participant blinded, sponsor unblinded,
      placebo-controlled, study of the safety, tolerability and pharmacokinetics of TAK-831 in up
      to 48 healthy volunteers, with 8 subjects in each of the 6 cohorts.

      In each cohort, participants will be randomized in a 3:1 ratio to receive TAK-831 or placebo.
      Two formulations, oral suspension and tablet will be tested in this study. Both blood and
      cerebrospinal fluid (CSF) samples will be collected from selected cohorts (CSF cohorts); for
      the rest of the cohorts, only blood samples will be collected (non-CSF cohorts).

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is 58 days. Participants will make multiple visits to the clinic,
      and 30 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-831 Tablet T2; Placebo; TAK-831 Suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tak-831 tablets.; TAK-831 placebo-matching suspension.; TAK-831 Suspension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug therapy
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and
      well tolerated in Adults with Mild to Moderate Alzheimer's disease.
    


Intervention name(s): PF-04360365; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Monoclonal antibody; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to

        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg
           tablets of MercK & Co. Inc, USA in healthy subjects under fasting conditions

        -  monitor adverse events and to ensure the safety of subjects.
    

Detailed description: 
      A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence
      study of Simvastatin 80mg tablets of Dr. Reddy's Laboratories Limited to be compared with
      Zocor® 80 mg tablets of Merck & Co. Inc., USA in healthy, adult, human subjects under fasting
      conditions.
    

Intervention name(s): Simvastatin
Intervention type(s): Drug
Intervention description(s): Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
Other intervention name(s): Zocor® 80 mg tabletsof Merck & Co. Inc., USA
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Simvastatin
Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to
      protect the brain from inflammation and how it may enhance repair through remyelination.
    

Detailed description: 
      To identify specific changes in T cell subsets and functions in Relapsing Remitting Multiple
      Sclerosis.
    

Intervention name(s): Alemtuzumab
Intervention type(s): Drug
Intervention description(s): 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
Other intervention name(s): CamPath; MabPath
Intervention MeSH terms: Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions
Condition: Seizure
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750
      mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.
    


Intervention name(s): Levetiracetam Tablets, 750 mg (Sandoz Inc.); Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anticonvulsant
Effect of Resistance Training on Jump Landing Mechanics in Young Female Athletes
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine if jump landing mechanics in young female athletes
      can be improved with a resistance training intervention.
    

Detailed description: 
      After initial baseline testing, athletes were randomly selected to receive upper body
      (control group) or lower body (intervention group) resistance training. Athletes attended
      supervised training sessions twice per week for 12 weeks, after which they were re-tested.
    

Intervention name(s): Leg training; Arm training
Intervention type(s): Other; Other
Intervention description(s): Lower body resistance training twice per week for one hour each time.; Upper body resistance training twice per week for one hour each time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: resistance training
Sleep and Behavior in Children With Cleft Palate
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Observational

Summary: 
      The purpose of this study is to determine whether cleft palate repair increases the risk for
      obstructive sleep apnea in children and whether sleep apnea could explain learning and
      behavior difficulties that are often observed.
    


Intervention name(s): Polysomnography
Intervention type(s): Procedure
Intervention description(s): Overnight sleep studies will be performed on all children.
Other intervention name(s): PSG; Overnight polysomnography
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children will be recruited from cleft palate clinics
      
Keywords: Cleft Palate; Cleft Lip; Obstructive Sleep Apnea; Sleep-Disordered Breathing; Behavior; Learning
Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      Achieving results from RCTs with high internal and external validity is a major challenge
      within psychiatry due to the nature of psychiatric illnesses. The Investigators will conduct
      a "real world" naturalistic nation-wide population-based longitudinal register linkage study
      comparing long-term responses to all kinds of antidepressants in patients with major
      depressive disorder emulating a randomized trial.
    


Intervention name(s): Antidepressant
Intervention type(s): Drug
Intervention description(s): Treatment with an antidepressant according to Danish register data.
Other intervention name(s): sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
Intervention MeSH terms: Duloxetine Hydrochloride; Amitriptyline; Vortioxetine; Mirtazapine; Agomelatine; Citalopram; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Antidepressive Agents; Reboxetine; Imipramine; Escitalopram
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995
        to 2018 with a first main index diagnosis of a single depressive episode or recurrent
        depressive disorder (ICD-10 code: F32-F33.9) with an outpatient purchase of an
        antidepressant after the depression diagnosis (N=73.336).
Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of
      infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based
      infant formulas are typically recommended. These formulas are expensive and not palatable.
      For older patients with CM allergy, the standard of care is avoidance of all CM products. The
      investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed
      whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or
      amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF.
      Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The
      investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF
      and assess the degree to which taking pHWF accelerates CM tolerance.
    

Detailed description: 
      Specifically, subjects who have CM allergy will be enrolled. The investigators will perform
      an oral food challenge (OFC) to pHWF in each subject. Subjects who pass the challenge will be
      placed on pHWF for 2 years. Subjects who do not pass the challenge will receive routine care.
      The investigators will perform allergy skin testing, specific IgE measurement, other
      serologic assays, and longitudinal OFCs to profile subject characteristics in the two groups
      at baseline and over time.
    

Intervention name(s): Partially Hydrolyzed Whey formula
Intervention type(s): Other
Intervention description(s): Patients who tolerate partially hydrolyzed whey formula will be continued on this formula for two years. Patients who do not tolerate the formula will be continued on their prior diet of cows milk avoidance.
Other intervention name(s): Gerber Good Start Formula
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Food Allergy; Cows Milk Allergy
To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive
Condition: Denture Retention
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the use of a denture adhesive and its ability to
      demonstrate the improvement in overall gum-health and to improve the oral health related
      quality of life (OHrQoL) in participants who wear full dentures.
    

Detailed description: 
      This study will be a single center, controlled, single-blind, randomized, two-treatment,
      parallel design in healthy participants with a full conventional, acrylic denture in either
      or both dental arches, with a treatment period of 12 weeks. The study will assess the
      effectiveness of an experimental denture adhesive in the improvement of denture-bearing
      tissue irritation related measures, and the participant's oral health related quality of
      life. Participants will be randomized to one of the 2 treatment groups i.e. experimental
      denture arm group and control arm group and will undergo an oral soft tissue (OST)
      examination. Participants with satisfactory dentures, adequate retention and stability and
      who qualify all the inclusion and exclusion criteria will continue in the study. Participants
      will complete the Gum Comfort, OHIP-Edent questionnaires and GOHAI questionnaire. The
      assessments will be made at Baseline, and after 1, 4, 8 and 12 weeks treatment.
    

Intervention name(s): Experimental Denture Adhesive
Intervention type(s): Drug
Intervention description(s): In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Denture, Adhesive, Gum-Health, Lifestyle
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
Condition: Maculopathy; High Myopia; Surgery
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was
      evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it
      may improve visual outcome.
    

Detailed description: 
      Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was
      evaluated in each stage of macular retinischisis, foveal detachment, or macular hole.
      Efficacy of internal limiting membrane was also evaluated whether it may improve visual
      outcome.
    

Intervention name(s): vitrectomy
Intervention type(s): Procedure
Intervention description(s): Surgery
Other intervention name(s): Myopic traction maculopathy in highly myopic eyes
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Myopic traction maculopathy; vitrectomy; internal limiting membrane; Retrospective, case control study
Efficacy Of Bacterial Lysate In Asthmatic Children
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluate the efficacy of Mechanical Bacterial Lysate (PMBL - Ismigen®) to improve
      the asthma control level (ACT score) as add-on treatment to routine asthma treatment in
      children aged 6 to 16 with uncontrolled or partly controlled asthma. Half of the 150
      participants will receive Ismigen® and their current asthma therapy while the other half will
      receive Placebo and their current asthma treatment.
    

Detailed description: 
      Acute and recurrent respiratory infections of the upper and middle respiratory tracts in the
      paediatric population of asthmatic patients represent a leading clinical burden, particularly
      during the winter. Respiratory tract infections, mainly viral infection are important factors
      that exacerbate asthma course in children. Currently no clinical data demonstrated the
      benefit of oral or sublingual bacterial lysates on asthma clinical course in children apart
      from one trial with OM-85 BV (Bronchovaxom®) suggesting reduced number and duration of
      infection-related wheezing attacks in children with asthma wheezing.

      Therefore it was hypothesized that PMBL (Ismigen®) used in asthmatic children should
      significantly improve asthma course and control. A seasonal approach of active prevention,
      based on full-fledged antibacterial oral vaccination would be useful to show the potential
      benefit of this type of products.

      The Primary objective was to assess the benefit of Ismigen® versus Placebo on the mean ACT
      score after administration of a Polyvalent Mechanical Bacterial Lysate (PMBL - Ismigen®) as
      add-on to routine asthma treatment.

      Secondary objectives investigated:

        -  the potential reduction (vs Placebo) of number of asthma exacerbations, time to first
           event with Ismigen®;

        -  the potential decrease in number of respiratory tract infections during the observation
           period (3-month treatment and 6-month follow-up) after treatment;

        -  the specific changes occurring in a panel of immunological markers as the result of
           Ismigen® effect (subset of 48 patients).
    

Intervention name(s): ISMIGEN; PLACEBO
Intervention type(s): Biological; Biological
Intervention description(s): Tablets of 30 billion organisms/mg - Sublingual use 1 tablet per day over 10 days for 3 successive months.; Matched tablets without any active substance.
Other intervention name(s): Polyvalent Mechanical Bacterial Lysate - PMBL
Intervention MeSH terms: Broncho-Vaxom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: IgE-dependent asthma
Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      Life style intervention including diet and exercise is the recommended strategy for
      prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2
      diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of
      developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an
      increased risk of developing diabetes.

      Long-term endurance exercise training has been shown to increase insulin sensitivity in
      sedentary young and elderly individuals, first degree relatives of patients with Type 2
      diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients,
      non-diabetic individuals with IGT and sedentary adults after exercise training of different
      intensity, different duration and different frequency an increase of insulin sensitivity was
      found.

      However, despite the vast knowledge concerning beneficial effects physical activity for the
      prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging
      strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health
      status the lack of time is the primary reason for the failure to exercise on a regular basis
      (or is stated as primary reason). Therefore the investigators aimed at investigating whether
      a controlled endurance/resistance training twice a week over 6 month might be beneficial for
      healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure
      parameters associated with the prevention of T2DM like insulin sensitivity, flux through
      fATPase and fCK, intramyocellular and hepatocellular lipids.
    


Intervention name(s): exercise training, endurance training
Intervention type(s): Behavioral
Intervention description(s): The endurance training group exercised on a cycle ergometer (90% of power output determined at the respiratory compensation point = RCP). The duration of each training unit was increased with time. The resistance group trained on 8 weight machines where the workload gradually increased every 2-3 weeks. At week 13 an additional physical examination, OGTT and spiro-ergometry for adjusting the training were performed.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 2 diabetes; exercise training; ATP-synthesis; intramyocellular lipids; hepatocellular lipids; first degree relatives of T2DM patients
Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Condition: Cardiogenic Shock
MeSH terms: Myocardial Infarction; Shock, Cardiogenic; Infarction; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus
      standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
    

Detailed description: 
      Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal
      treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving
      patients mostly suffer from severe heart failure due to an impaired cardiac function.

      This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus
      standard treatment alone in patients with cardiogenic shock due to myocardial infarction.

      The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac
      function (left ventricular ejection fraction) in patients with cardiogenic shock complicating
      acute myocardial infarction.
    

Intervention name(s): Extra-Corporal Life Support (ECLS)
Intervention type(s): Device
Intervention description(s): Extra-Corporal Life Support (ECLS) (from Sorin)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
Masking: None (Open Label)
Primary purpose: Treatment
CPR Decision Aid For Patients With Advanced Gynecologic Malignancies
Condition: Advance Care Planning
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR)
      decision aid video on CPR knowledge and end-of-life preferences in women with advanced
      gynecologic malignancy. We will assess the baseline CPR knowledge in our research population,
      gauge the improvement after viewing a decision aid video, and evaluate its effects on patient
      preferences regarding CPR.
    


Intervention name(s): video; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): informational video; usual physician counseling on end of life care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ovarian cancer; cardiopulmonary resuscitation; end of life care; endometrial cancer; cervical cancer
GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple ascending
      oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and
      to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple
      oral administrations.
    


Intervention name(s): GLPG0778; placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules containing 50 or 100 mg of GLPG0778; multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics