bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Genes: Genomic Association With Exercise Reinforcement
Condition: Overweight; Obesity; Physical Activity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study tests whether different physical activity patterns are linked an individual's
      genes.
    

Detailed description: 
      The investigators propose that an individual's genetics are one factor that may be associated
      with the motivating aspect or attractiveness of exercise and therefore the choice to exercise
      rather than be sedentary. They propose to study the association of the genomic signatures
      with the reinforcing (motivating) value of different types of exercise. This has never been
      investigated and may uncover underlying mechanisms that would help to understand individual
      differences in exercise motivation. The ultimate impact of this work is a greater number of
      Americans being physically active, meeting the United States Department of Agriculture (USDA)
      dietary guidelines for physical activity, and maintaining a healthy body weight. This study
      will be funded and undertaken at the Grand Forks Human Nutrition Research Center (GFHNRC).
      The purpose will be to assess genetic underpinnings of the motivating value of resistance and
      aerobic exercise, and to determine whether the motivating value of aerobic and resistance
      exercise are associated with usual participation in these modes of exercise.
    

Intervention name(s): Aerobic Exercise; Resistance Exercise; Sedentary Option
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will sample and rate their liking of three cardiovascular machines (treadmill, cycle ergometer, elliptical step ergometer) to determine which one will be used during the test.; Subjects will sample and rate their liking of three different resistance training circuits (upper body, lower body, core) to determine which one will be used during the test.; Subjects will rate their liking of three sedentary activities (reading magazines, playing puzzles, completing word games) as an alternative to exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: active; not active; normal body weight
Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to evaluate the effect of concomitant administration of GBT440 on
      caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a
      CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.
    


Intervention name(s): GBT440
Intervention type(s): Drug
Intervention description(s): GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anemia, sickle cell
A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of
      Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in fasted subjects.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study
      of Bupropion XL Tablets Formulation in Fasted, Normal, Healthy Subjects.

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Abrika Bupropion 150 mg XL Tablet, single dose; Wellbutrin XL® 150 mg Tablet, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Abrika formulated products under fasting conditions; B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
Other intervention name(s): Bupropion; Bupropion
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Bupropion; Healthy subjects
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
Condition: Healthy Volunteers; Patients; Pharmacokinetics; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the absorption and distribution of a single oral dose
      of TC-5214 in subjects with renal impairment and with subjects with normal renal function.
    


Intervention name(s): TC-5214
Intervention type(s): Drug
Intervention description(s): Oral tablets, single dose
Allocation: Non-Randomized
Masking: None (Open Label)
Keywords: Phase 1; healthy volunteers; volunteers with renal impairment; pharmacokinetics; TC-5214
School-Based Intervention to Increase Physical Activity Among Adolescent Females
Condition: Cardiovascular Diseases; Obesity
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Physical inactivity is a major public health problem in the United States. Research has shown
      that physical activity levels decline during adolescence, and the decline is greater in
      females than males. The purpose of this study is to evaluate a life-skills oriented physical
      activity intervention at increasing activity levels and decreasing cardiovascular risk
      factors in adolescent females.
    

Detailed description: 
      Physical activity levels decline dramatically during adolescence, particularly among females,
      with the decline most apparent among African Americans. The health benefits of regular
      physical activity are well-known; individuals who are active have lower rates of obesity and
      less incidence of cardiovascular disease. Because physical activity behaviors often develop
      during childhood, it is important to develop programs specifically for adolescents to
      encourage them to adopt and maintain a physically active lifestyle. Unfortunately, few
      programs have been developed that specifically focus on adolescents, and the long-term
      effectiveness of these programs is unknown. This study will evaluate the effectiveness of a
      life-skills oriented Comprehensive Physical Activity Program (CAP) at increasing activity
      levels in adolescents. Participants in the CAP program will develop new behavioral skills,
      which will assist them to continue a physically active lifestyle once the program ends. The
      purpose of this study is to compare CAP versus a standard physical education (PE) class at
      increasing physical activity levels and decreasing cardiovascular risk factors in adolescent
      African American and Caucasian females.

      This study will enroll 9th grade female students who attend a high school in Baltimore,
      Maryland. They will be randomly assigned to participate in either a standard PE class or CAP.
      Participants in the CAP program will also receive support from a family member to ensure that
      they receive encouragement for engaging in exercise. Baseline assessments will include
      physical activity level; cardiorespiratory fitness; cardiovascular risk factors, including
      blood pressure, lipoproteins, and body mass index (BMI); and psychosocial factors.
      Participants will attend follow-up visits at the end of each school year in the 9th, 10th,
      and 11th grades.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical Inactivity
Comparison of Medical Therapies in Marfan Syndrome.
Condition: Marfan Syndrome
MeSH terms: Marfan Syndrome; Arachnodactyly; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are looking at the different impacts of atenolol, verapamil and perindopril
      on large artery and lv function in marfan syndrome. It is a double-blind, randomised
      cross-over trial.
    

Detailed description: 
      The investigators recruited 21 patients with confirmed diagnosis of Marfan syndrome from two
      centres. The investigators performed radial artery applanation tonometry and pulse wave
      analysis to derive central aortic pressure and haemodynamic indexes pre-and post
      administering Atenolol 75mg, Perindopril 4mg and Verapamil 240mgs each for four weeks with a
      two week wash-out between medications. All patients underwent detailed functional and
      anatomical echocardiographic assessments at each visit.

      Inclusion criteria were ages 16-60 years with no treatment or β-blocker or other monotherapy
      only for Marfan syndrome. Patients with previous aortic dissection or aortic surgery, severe
      valvular regurgitation, aortic diameter at the sinotubular junction ≥ 5.0cm,
      contraindications to specific drug treatment, e.g. asthma and β-blocker, or those who were
      pregnant or at risk of pregnancy were excluded.
    

Intervention name(s): Atenolol; VERAPAMIL; Perindopril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 240 MG SR; 4 MG
Intervention MeSH terms: Atenolol; Verapamil; Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Marfan Syndrome; Large arterial function; LV function; atenolol; perindopril; verapamil; central arterial pressure
Creatine for the Treatment of Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Creatine is a naturally occurring chemical involved in the production of energy in muscle.
      Abnormalities in creatine have been linked to the progression of degenerative neuromuscular
      diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). This study
      will test whether taking creatine can improve the symptoms of ALS.
    

Detailed description: 
      Amyotrophic lateral sclerosis is a progressive neurodegenerative disorder selectively
      affecting motor neurons, resulting in progressive weakness. Currently there is no known cure
      and a specific cause has not been identified. Creatine is a nutritional supplement that
      improves mitochondrial function and has been shown to protect motor neurons in animal models
      of ALS. Preliminary research indicates that creatine may also improve strength in patients
      with ALS. This study will determine the effect of creatine treatment on short-term muscle
      strength and long-term muscle deterioration in patients with ALS.

      Participants in this study will be randomly assigned to receive either creatine or placebo.
      Participants will be enrolled in the study for 9 months. Quantitative muscle testing will be
      done weekly for the first 3 weeks; participants will then be followed monthly for the next 4
      months and bimonthly for the remainder of the 9-month study. The study will also monitor
      purposeful exercise to determine if this enhances the benefit of creatine usage on muscle
      strength. Pulmonary function testing will accompany the muscle testing to determine if
      creatine strengthens respiratory muscles, thereby enhancing pulmonary function.
    

Intervention name(s): creatine monohydrate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ALS; Creatine
Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the relative bioavailability of a capsule formulation of PF-04958242,
      relative to a oral solution formulation of PF-04958242 in healthy adult subjects.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242 capsule; PF-04958242 oral solution
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of PF-04958242 0.35 mg oral capsule; Single dose of PF-04958242 0.35 mg oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-04958242; bioequivalence; pharmacokinetics; Schizophrenia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Condition: Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as
      add-on therapy to stable daily statin therapy with or without other lipid modifying therapy
      in comparison with placebo after 24 weeks of treatment in heterozygous familial
      hypercholesterolemia (HeFH) or high cardiovascular risk participants with
      hypercholesterolemia.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks
           of treatment.

        -  To evaluate the effect of alirocumab on other lipid parameters.

        -  To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after
           52 weeks of treatment.

        -  To evaluate the safety and tolerability of alirocumab.

        -  To evaluate the development of anti-alirocumab antibodies.

        -  To evaluate the pharmacokinetics of alirocumab.
    

Detailed description: 
      Total duration per participant of approximately 63 weeks (14 months) (screening: 3 weeks,
      double-blind treatment period: 52 weeks, and follow-up period: 8 weeks).
    

Intervention name(s): Placebo (for alirocumab); Alirocumab; Lipid-Modifying Therapy (LMT)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.; Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.
Other intervention name(s): SAR236553; REGN727; Praluent
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Placebo Effect of Paracetamol in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Paracetamol is one of the most commonly used drugs in the world, indicated for the
      symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug
      used to relieve pain and reduce fever. The objective of this study is to analyze whether a
      placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of
      paracetamol is partly due to the simple fact of taking a drug.

      Moreover, during the study you propose to do a saliva sample, optional, for biological
      research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your
      body..
    

Detailed description: 
      Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open
      / hidden.
    

Intervention name(s): Paracetamol
Intervention type(s): Drug
Intervention description(s): Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Healthy volunteers; Open / hidden; Placebo effect
Amflow-device Can Help Proper Ambu-bag Ventilation
Condition: Ventilation Therapy; Complications
Study type: Interventional

Summary: 
      This is a simulation study with a prospective randomized cross-over design. The aim of this
      study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume
      compare to ordinary ambu-bag
    

Detailed description: 
      Ambu-bag ventilation is an essential skill to the patients who needed ventilatory support.
      However, the delivery of appropriate amount of tidal volume by ordinary manual bag
      ventilation may be difficult. In addition, it require adequate training to rescurer.

      We hypothesised that an Amflow assist ambu bag may be helpful to delivery accurate tidal
      volumes to the patients.

      Participants performed bag-valve ventilation to manikin by ordinary technique and Amflow
      assist technique in our simulation centre. We measured each ventilation rate and ventilation
      volume in simulated scenario and we compare those between two technique.
    

Intervention name(s): Amflow; Ambu bag
Intervention type(s): Device; Device
Intervention description(s): Amflow deviced was developed for monitoring ventiation rate and ventilation volume. Participants ventilated the simulated patients by Amflow-device assist ambu bag; Participants ventilated the simulated patients by ambu bag
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ambu bag, ventilation, tidal volume
Vascular Healing of DES at 3 Months
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to compare vascular healing of the stented segment after
      deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting
      stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
    

Detailed description: 
      Objective: The aim of the trial is to compare vascular healing and vasodilation at 3 months
      after deployment of PRO-Kinetic drug-eluting stent and Endeavor Resolute zotarolimus-eluting
      stent in patients with acute coronary syndrome.

      Design: A prospective, randomized and controlled study comparing coronary flow reserve and
      coverage of the PRO-Kinetic DES and Endeavor Resolute DES implanted in acute coronary
      syndrome. OCT and CFR measurement at 3 months. Clinical follow up is scheduled at 3, 6 and 12
      months.

      Primary endpoint: Uncovered stent struts and CFR at 3 months after stent implantation.

      Secondary clinical endpoints: MACE and stent thrombosis.

      Enrollment: 40 patients (20 receiving PRO-Kinetic DES and 20 receiving Endeavor Resolute
      DES).
    

Intervention name(s): OCT; Transthoracic echocardiography CFR measurement
Intervention type(s): Device; Device
Intervention description(s): Optical coherence tomography; CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute coronary syndrome treated with PRO-Kinetic DES or Endeavor Resolute DES
        during index PCI.
      
Biospecimen description: 
      Serum, plasma
Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single
      dose pivotal study. The purpose of this study is to assess the bioequivalence between Test
      Product and the corresponding Reference Product under fed condition in normal, healthy,
      adult, human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India and the
      corresponding Reference Product: Seroquel® (Quetiapine fumarate) Tablets 25 mg of M/s
      AstraZeneca Pharmaceuticals LP, USA, under fed condition in normal, healthy, adult, human
      subjects in a randomized crossover study.

      The study was conducted with 54 healthy adult subjects. In each study period, a single 25 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Quetiapine Fumarate Tablets 25 mg; Quetiapine Fumarate
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg tablet once a day; 25 mg tablet once a day
Other intervention name(s): Test Product; Seroquel®
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of WVE-210201 in Patients With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double-blind, placebo-controlled, single ascending dose cohort study to
      evaluate the safety, tolerability, and plasma concentrations of WVE-210201 in ambulatory and
      non-ambulatory male pediatric patients with DMD amenable to exon 51 skipping intervention.
    


Intervention name(s): WVE-210201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): WVE-210201 is a stereopure antisense oligonucleotide (ASO); Sodium Chloride
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
Condition: Brain Concussion; Cerebral Concussion; Concussion, Intermediate; Concussion, Mild; Concussion, Severe; Trauma, Nervous System; Craniocerebral Trauma; Brain Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to determine the sensitivity and specificity of an aid in
      assessment of concussion based on eye-tracking, in comparison to a clinical reference
      standard appropriate for the Emergency Department (ED) or concussion clinic.
    


Intervention name(s): EyeBox CNS
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will include all patients evaluated for potential traumatic brain injury
        presenting to the Emergency Department or concussion clinic.
      
Keywords: Eye Tracking; Concussion; Outcome Measures