bioihbjkbjnl/mcl2 huggingface dataset:
Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of the present study is to confirm in humans the in-vivo bioconversion of a Prodrug
      (PRX-P4-003) to (-)-fencamfamine (FCF) the active moiety when orally administered as a single
      microdose. A second component of the study will evaluate effect of food on pharmacokinetics
      of PRX-P4-003.
    

Detailed description: 
      A crossover study comparing blood concentrations after oral administration of microdoses of
      (-)-fencamfamine (FCF; 40 µg) or its prodrug form (PRX-P4-003; 100 µg)) in the fasted state
      will be carried out in 4 healthy male volunteers (Study A). This will be followed by
      determination of blood concentrations of (-)-fencamfamine in a separate cohort of 4
      volunteers following oral administration of a microdose of PRX-P4-003 (100 µg) in a fed state
      (Study B).
    

Intervention name(s): PRX-P4-003, (-)-FCF
Intervention type(s): Drug
Intervention description(s): sequential study
Other intervention name(s): Prodrug; Stimulant
Intervention MeSH terms: Central Nervous System Stimulants
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: In the first arm a fixed order crossover of a PRX-P4-003 followed by administration of the (-)-FCF after a washout period. In the second arm a separate cohort will be administered PRX-P4-003 under fed conditions.
Masking: None (Open Label)
Primary purpose: Other
Effectiveness Fluoride Varnishes in Children With Early Childhood Caries
Condition: Early Childhood Caries
Study type: Interventional

Summary: 
      The study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who
      were referred to the investigators' clinic. Patients who completed dental treatment under
      general anesthesia in a single session, were included to the study.

      Patients were divided randomly into 4 groups and after dental treatment one of the fluoride
      varnish listed below was applied to each child. The groups were as follows;

        1. Duraphat varnish containing 5% Sodium Fluoride (Colgate) (n = 22),

        2. Clinpro ™ White Varnish containing 5% of Sodium Fluoride tricalcium phosphate (3M ESPE)
           (n = 22),

        3. Embrace ™ Varnish containing 5% Sodium Fluoride with CXP ™ (Pulpdent) (n = 22),

        4. MI Varnish containing 5% Sodium Fluoride casein phosphopeptide amorphous calcium
           phosphate varnish (GC) (n = 22).

      Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva
      samples before general anaesthesia; one month after treatment and three months after
      treatment.
    

Detailed description: 
      Duraphat (Colgate), which we used as a positive control group in our study, contains only 5%
      sodium fluoride. It has been reported in studies that Duraphat is effective in
      remineralization.

      Clinpro ™ White Varnish, another topical varnish in this study,was reported to be effective
      for caries prevention in pre-school children.

      One of the varnishes we evaluate in the study, Embrace™ Varnish, contains 5% sodium fluoride
      with xylitol-coated calcium and phosphate. According to the manufacturer, the xylitol coating
      prevents the calcium and phosphate salts from reacting until they come in contact with
      saliva. Saliva dissolves the xylitol and releases the calcium and phosphate ions, which react
      with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish,
      in the fourth group containing 5% sodium fluoride with casein phosphopeptide amorphous
      calcium phosphate (CPP-ACP) had a high release of calcium and fluoride ions.
    

Intervention name(s): Sodium Fluoride; Sodium Fluoride with TCP; Sodium Fluoride with CXP; Sodium Fluoride with CPP-ACP
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Colgate Duraphat varnish; Clinpro ™ White Varnish 3M ESPE; Embrace ™ Varnish Pulpdent; MI Varnish GC
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Cod Liver Oil for Covid-19 Prevention Study
Condition: Covid-19; Respiratory Tract Infections
MeSH terms: Infections; COVID-19; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, parallel-group treatment, quadruple masked, two-arm study to assess the
      effectiveness of cod liver oil compared to placebo in the prevention of Covid-19 and airway
      infections in healthy adults.

      In this study, the investigators will investigate whether daily cod liver oil can prevent
      Covid-19 infections and reduce the severity of such infections. The investigators will also
      examine whether cod liver oil prevents other airway infections in healthy adults.
    

Detailed description: 
      Preliminary evidence from literature and an ongoing study in the investigators' lab suggests
      that cod liver oil may prevent Covid-19 and complications of Covid-19. In the present study,
      the investigators will examine whether this is actually the case by randomizing volunteers to
      take cod liver oil or placebo (corn oil) during the winter months of 2020-2021. The
      investigators also aim to explore whether cod liver oil can prevent other respiratory tract
      infections, as well as explore and confirm already known health effects and possible new
      health effects, in particular rare adverse events associated with cod liver oil use.

      Cod liver oil is a traditional source of vitamin A, D, and E and omega-3 fatty acids and the
      dose administered in the study will contain 250 ug vitamin A, 10 ug vitamin D, 10 mg vitamin
      E, and 1,2 g omega-3 fatty acids.
    

Intervention name(s): Cod liver oil; Corn oil (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 ml of cod liver oil as a source of 10 ug of vitamin D and 1.2 g of long-chained n-3 polyunsaturated fatty acids (DHA 0,6g and EPA 0,4g) per day for 6 months x 1 time/day together with the first meal of the day. 5ml of Cod liver oil also contains 250ug vitamin A and 10 mg vitamin E.; 5 ml of corn oil per day for 6 months x 1 time/day together with the first meal of the day
Other intervention name(s): 10 ug of vitamin D and 1 g n-3 LCPUFA; Tran
Intervention MeSH terms: Vitamin D; Cod Liver Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A parallel-group treatment, two-arm study where participants are randomly assigned to cod liver oil or placebo (corn oil) in a 1:1 ratio
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cod liver oil; Vitamin D; n-3 LCPUFAs; SARS-CoV virus
Safety of a Hypolipidemic Agent in Healthy Normal Volunteers
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The Purpose of this study is to determine the safety and tolerability of 1-MNA, a drug that
      is intended to be used in the treatment of elevated levels of blood fats. This study will
      determine the way that 1-MNA is handled by the body, and will also determine its effect on
      commonly measured blood fat parameters.
    

Detailed description: 
      Dyslipidemia is a major risk factor for coronary artery disease (CAD) and its management is
      important in preventing the occurrence of cardiovascular events. Dyslipidemia occurs when
      there is an imbalance in the metabolism and clearance of lipoproteins resulting in
      lipoprotein overproduction or deficiency. Lipid related risk factors for atherosclerotic
      coronary artery disease include elevated levels of total cholesterol (TC), triglyceride (TG),
      low-density lipoprotein cholesterol (LDL-C), intermediate-density lipoprotein cholesterol
      (IDL-C), very low-density lipoprotein cholesterol (VLDL-C) and reduced concentrations of
      high-density lipoprotein cholesterol (HDL-C). This lipid risk profile frequently occurs in
      association with other cardiovascular risk factors (e.g., obesity, elevated blood pressure,
      diabetes mellitus), and is associated with premature atherosclerosis (NCEP, 2002).

      The Main purpose of this study is to formally evaluate the safety and pharmacokinetics and
      pharmacodynamics of 1-MNA, a hypolipidemic agent with previous human exposure in normal
      subjects and patients with Hyperlipidemia.
    

Intervention name(s): 1-MNA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Capsule
Other intervention name(s): Placebo Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyperlipidemia
Broad Effectiveness: Study With Aripiprazole
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn if aripiprazole is effective in the treatment of a
      large number of persons diagnosed with schizophrenia or schizoaffective disorders
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Bipolar I Disorder; Bipolar II; Bipolar NOS(Not Otherwise Specified); Psychotic Disorder Not Otherwise Specified; Autism Spectrum Disorder
MeSH terms: Weight Gain; Schizophrenia; Autism Spectrum Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The study attempts to evaluate a histamine analog long used for the treatment of Meniere's
      disease, betahistine, that shows promise in reversing the antihistaminergic effects thought
      to be involved in antipsychotic induced weight gain.

      Hypothesis to be tested:

      A. Patients who have gained a developmentally inappropriate amount of weight on
      antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as
      compared to placebo augmentation.

      B. Betahistine augmentation in AP treated patients will increase levels of satiety in a
      standardized meal situation and decrease caloric intake as compared to placebo augmentation.

      C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in
      differences in waist circumference, hip circumference and waist hip ratios D. Betahistine
      augmentation in this population will lead to decrease in fasting glucose-lipid lab values
      related to the development of metabolic syndrome as compared to placebo augmentation
    

Detailed description: 
      Subjects for this study were adolescents and adults from age 12 to age 59. Subjects were
      individuals who have been psychiatrically stabilized on first or second generation
      antipsychotic medication, and have gained substantial weight during their treatment. Subjects
      were excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by
      a histamine analog) or are prescribed medications known to affect body composition or
      metabolism other than those currently being studied. Subjects were randomized to receive
      either betahistine or placebo at a 1:1 ratio.
    

Intervention name(s): Betahistine; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..
Other intervention name(s): Serc, Betaserc, Betaserk
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the excretion pathway of orally administered
      [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.
    


Intervention name(s): [14C]-BMS-986196
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): BMS-986196
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; BMS-986196; Healthy male volunteers; [14C]-BMS-986196; Total radioactivity
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the
      highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors
      such as the fragile membrane, etc. Latrunculin A serves to facilitate spindle or pronuclear
      transfer procedures helping to reduce the damage rate with no harm reported. Using
      Latrunculin A during ICSI could serve to rescue some oocytes from the degeneration allowing
      for more chances of viable zygotes,
    


Intervention name(s): Medium Supplemented with Latrunculin A
Intervention type(s): Other
Intervention description(s): A medium with in-house supplementation of Latrunculin A to decrease oocyte degeneration after ICSI and improve the survival rate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
Condition: Rubella; Mumps; Measles; Measles-Mumps-Rubella Vaccine
MeSH terms: Measles; Rubella; Mumps
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines
      (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and
      safety with a six month follow-up after first vaccination. Additionally, antibody persistence
      will be assessed one and two years after administration of MMR vaccine.

      The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
    


Intervention name(s): GSK Biological's investigational vaccine 209762; M-M-R® II (Merck and Co); Varivax®; Havrix®; Prevnar®
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Subcutaneous injection, one dose; Subcutaneous injection, one dose; Subcutaneous injection, one dose; Intramuscular injection, one dose; Intramuscular injection, one dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Measles, Mumps, Rubella, Varicella Vaccine; Children; Immunogenicity; Safety; Humans; Combined Vaccine; Vaccines
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Condition: Rosacea
MeSH terms: Rosacea
Study type: Observational

Summary: 
      The purpose of this study is to determine the cosmetic appearance of metronidazole gel
      (MetroGel®) 1% with commonly marketed facial foundations.
    

Detailed description: 
      Evaluate the relationship between treatment with MetroGel® 1% and cosmetic performance with
      the Subjects' usual cosmetic products. It is expected that the female subjects will be able
      to use their routine cosmetics after application without affecting the cosmetic product's
      performance or causing side effects.
    

Intervention name(s): Metronidazole Gel
Intervention type(s): Drug
Intervention description(s): Topical, Once daily for 2 weeks
Other intervention name(s): MetroGel® 1%
Intervention MeSH terms: Metronidazole
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Rosacea, metronidazole
Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of single doses of
      QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to
      moderate COPD.
    


Intervention name(s): QAB149
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD, indacaterol, PK
Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the absorption of two different inhalation products
      with the reference product in healthy volunteers.
    

Detailed description: 
      Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products
      and one reference inhalation product according to a three-period cross-over design. Subjects
      will use the patient instruction leaflet to understand how each inhaler is administered.
      Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.
    

Intervention name(s): tiotropium
Intervention type(s): Drug
Intervention description(s): four inhalations
Other intervention name(s): Spiriva Respimat
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inhalation; anticholinergic
Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML
Condition: Refractory Acute Myelogenous Leukemia; Relapsed Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a
      short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting
      chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia
      (AML). FATE-NK100 is a natural killer (NK) cell product that is enriched for NK cells with an
      "adaptive", or human cytomegalovirus (CMV)-induced, phenotype. The NK cell product is
      comprised of peripheral blood (PB) leukocytes sourced from a related donor
      (HLA-haploidentical or better but not fully HLA-matched) that is seropositive for
      cytomegalovirus (CMV+), and enriched for adaptive NK cells by depletion of CD3+
      (T-lymphocytes) and CD19+ (B-lymphocytes) cells followed by ex-vivo culture expansion.
    


Intervention name(s): FATE-NK100
Intervention type(s): Biological
Intervention description(s): Preparative regimen:
Fludarabine 25 mg/m2 x 5 days start Day -6
Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4
Apheresis cell collection (collected from the Donor Day - 8) will be enriched for FATE-NK100 per CMC. IL-2 at 6 million IU subcutaneously (SC) every other day (EOD) for 6 doses with Dose 1 on Day 0 (no sooner than 4 hours post NK cells) and last dose no later than Day +12.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML
Physical Activity in Fontan Patients
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine which is the most effective intervention for
      increasing lifestyle physical activity in Fontan patients: an education (stage of change)
      intervention or a physical activity (mastery experience) intervention.
    

Detailed description: 
      Over 100,000 Canadian children are living with congenital heart defects and approximately
      1.5% of them have a univentricular heart. The Fontan procedure allows children with
      functionally univentricular hearts to live relatively normal lives. However, the
      cardiopulmonary physiology remains abnormal and chronic complications, including myocardial
      dysfunction, arrhythmias, pathway abnormalities, hepatic dysfunction, obstruction of the
      ventricular outflow tract or pulmonary veins, and pulmonary arteriovenous malformations may
      significantly reduce maximal exercise capacity and quality of life. Quality of life and
      life-long heart health are, therefore, critically important for Fontan patients as their
      survival depends on the continued functioning of an already sub-normal cardiopulmonary
      physiology.
    

Intervention name(s): Physical Activity; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children in this arm of the study will be provided with specific activities to be completed on most days of the week. The selected activities will be based on the child's interests and results of the baseline measures of health-related PA, MVPA and gross motor skill. The resources and facilities available to the family and season of the year will also influence the choice of activities. The frequency and duration of the required activities will be gradually increased until the child's baseline MVPA has been increased by a minimum of 30 minutes per day, most days of the week. Once that increase is achieved, the activities will be modified to maintain and reinforce the higher PA level.; Children in this arm of the study will be provided with puzzles, stories and games to be completed each week. The selected activities will be based on the child's interests and designed to increase the child's knowledge of activity options, perceptions of activity benefits, self-confidence for activity participation and motivation for daily activity. The activities introduced will vary with the resources available to the family and the season of the year, and will include information about healthy eating, injury prevention, and healthy lifestyle options.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Fontan Procedure; Physical Activity; Physical Fitness; Congenital Heart Defects; exercise rehabilitation