bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I, Healthy Volunteer Positron Emission Tomography Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess central receptor occupancy of PF 03654746 at
      the H3 receptor after a single oral dose of PF 03654746.
    

Detailed description: 
      Additional Study Purpose Details: To validate PET ligand which will be used to determine
      receptor occupancy and to determine receptor occupancy of PF-0367456
    

Intervention name(s): Positron Emission tomography; PET Scan with PF-03654746; PET Scan with PF-03654746; PET Scan with PF-03654746
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Positron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities.; If none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention.; If none of the data from the previous interventions are informative, then: 3) an additional 3 patients will receive 2 scans on Day 1 and 1 scan on Day 2 following three different doses of PF-0365476. Doses will be determined based upon the outcomes of the previous interventions.; Part 2 of the study will have 3 possible interventions:
1) 3 subjects in Cohort 2 will receive 2 scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746 (0.5 mg, 1.5 mg, 4 mg).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Positron Emission Tomography study in healthy volunteers for ligand qualification and receptor occupancy determination.
Exploring the Biological Basis of Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Observational

Summary: 
      To collect blood and urine samples from patients with Chronic Fatigue Syndrome (CFS), myalgic
      encephalomyelitis (ME), and SEID (Systemic Exertion Intolerance Syndrome) and controls for
      genomic, viral and metabolomic testing.
    

Detailed description: 
      To analyze gene expression (genomic) and viral analysis data from patients diagnosed with
      ME/CFS, the study will collect blood samples (finger stick) and information from up to 500
      subjects for analysis. In addition, urine will be collected for all subjects to evaluate the
      study subject's metabolomics.

      All participants will complete a single Study Collection event consisting of at least one MCD
      (2nd sample is optional) and one urine collection from home: 10% of each group (ME/CFS and
      Control) will complete a second Study Collection event approximately 1 to 2 weeks after the
      initial Study Collection. The second collection is to compare data between two collections
      from the same participants to observe any time-related changes in the results.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort 1 of this study will collect blood sample and a urine sample from up to 150 subjects
        who are either diagnosed with CFS/ME or experience symptoms of fatigue.

        Cohort 2 (Control Group) of the study will collect blood and urine samples from
        participants who have NOT been diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic
        Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) or experience symptoms of profound
        fatigue based on the cohort specific exclusion criteria.
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety
      and pharmacodynamic of MW031 and Prolia® in healthy adults.
    

Detailed description: 
      This is a phase I, single center, randomized, double-blind and parallel group clinical trial.

      The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous
      injections of MW031 and Prolia® in healthy volunteers.

      The secondary objective are to assess the Clinical safety and immunogenicity similarity of
      single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.

      At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and
      Prolia®.

      Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection.
    

Intervention name(s): MW031; Prolia®
Intervention type(s): Drug; Drug
Intervention description(s): Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment.; Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment.
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of a Breath-controlled Video Game App
Condition: Anxiety Acute
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The proposed research study will assess the impact of a newly developed, breath-controlled
      app and custom-designed tablet (equipped with a breathing sensor) on the patient and parent's
      preoperative anxiety and anesthesia induction experience.
    

Detailed description: 
      Aim 1: Determine whether induction distress differs between patients using the
      breathing-controlled app and those using standard care interventions: The investigators will
      measure patient compliance with induction using the Child Induction Behavioral Assessment
      (CIBA). The investigators predict that patients using the breathing-controlled app will
      demonstrate significantly better induction compliance. Older children (ages 6-8) are
      typically more cooperative with induction than younger children (ages 3-5 years). Both age
      groups will be studied to determine whether there are age-related differences impacting
      receptiveness to the app.

      Aim 2: Compare patient anxiety between the breath-controlled app and control group. The
      investigators will measure child preoperative anxiety (modified Yale Preoperative Anxiety
      Scale, the "mYPAS-SF"). The investigators predict there will be significantly lower anxiety
      (mYPAS-SF) during induction for children in the breath-controlled app group.

      Aim 3: Compare parent anxiety between the breath-controlled app and control group. The
      investigators will measure parental anxiety using the Visual Analog Scale for Anxiety, the
      "VAS-A". The investigators predict there will be significantly lower anxiety (mYPAS-SF)
      during induction for parents in the breath-controlled app group.

      Aim 4: Determine overall family satisfaction with the induction experience. A survey will be
      administered to assess satisfaction levels with induction behavioral interventions and
      determine whether these scores differ between the intervention and standard care group. The
      investigators predict that satisfaction scores will be higher in the intervention group than
      the control group.
    

Intervention name(s): standard care; breath-controlled app
Intervention type(s): Other; Other
Intervention description(s): standard care non-pharmacologic interventions during anesthesia induction; breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: anxiety, children
Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD).
      These deficits can significantly disrupt otherwise normal trajectories toward academic and
      vocational achievement and negatively impact psychosocial outcomes. Despite widespread
      recognition of neurocognitive deficits, there are no treatments shown to maintain or recover
      functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a
      standard intervention used to stabilize and recover functioning in individuals with
      accidental or disease-related brain injury. Recent advances in technology have led to the
      development of computerized CT programs. This study seeks to assess the feasibility and
      efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents
      with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a
      randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed).
      Feasibility will be assessed by examining participation, retention, and program completion
      rates, as well as feedback from a feasibility and acceptability questionnaire and a brief
      qualitative interview. Participants will also complete assessments of attention, working
      memory, and academic fluency at baseline and immediately following the intervention. A final
      assessment will be conducted 6 months after the conclusion of the intervention to evaluate
      the stability of treatment effects.
    


Intervention name(s): Cogmed RM
Intervention type(s): Behavioral
Intervention description(s): Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurocognitive; Working memory; Cogmed; Cognitive training
Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm
      and thrombosis by production of a variety of regulatory substances, including nitric oxide.
      In patients with atherosclerosis, these functions of the endothelium are impaired and these
      abnormalities may contribute to the development of heart attack and stroke.

      Observational studies have shown that frequent nut consumption decreases the risk of
      cardiovascular disease (CVD), but the mechanisms of benefit have not been fully defined.
      Recent studies suggest that specific fatty acids and flavonoids in nuts may have favorable
      effects on cardiovascular disease. In addition, there is growing evidence that these
      compounds may improve the function of the endothelium.

      The present study is designed to test the hypothesis that an almond-enriched diet will
      improve the function of the endothelium in patients with coronary artery disease. Subjects
      will be enrolled into a randomized, placebo-controlled, crossover study that will compare a
      National Cholesterol Education Program Step 1 diet without nuts to a Step 1 diet that has the
      same number of total calories but includes 3 ounces of almonds daily. Participants will
      consume each diet for six weeks with a four-week rest period between diets. The order of
      diets will be randomized (almonds or no almonds). Dietary assessments via food recall
      questionnaires will be employed at the study entry, end of the four week washout period, and
      end of the second intervention. If subjects are drifting from the recommendations of the STEP
      1 diet, counseling will be given to urge compliance. The primary endpoint will be
      endothelium-dependent flow- mediated dilation assessed by ultrasound. Secondary study
      outcomes will include lipid profiles, markers of inflammation and oxidative stress.
      Enrollment will continue until 40 subjects with complete data are available.

      Patients will be enrolled at Boston Medical Center and the Jean Mayer US Department of
      Agriculture Human Nutrition Research Center at Tufts Medical Center. Dietary interventions
      will be performed at Tufts Medical Center or by telephone. Ultrasound studies and blood
      collection will be performed in the principal investigator's research unit at Boston Medical
      Center.
    


Intervention name(s): NCEP Step 1 diet plus Almonds; No Almonds
Intervention type(s): Other; Other
Intervention description(s): NCEP Step 1 Diet Plus Almonds 3 oz per day for 6 weeks; NCEP Step 1 diet without almonds
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: endothelium; almonds; dietary interventions; coronary artery disease
Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      We compared the effects of 8 weeks of aerobic exercise only, resistance exercise only, or a
      combination of both on blood pressure in overweight or obese middle-aged adults with elevated
      blood pressure. Participants engaged in supervised exercise sessions 3 times per week for 60
      minutes each session. Outcomes were assessed at baseline and after the 8-week intervention.
      Extra-intervention physical activity and diet were also assessed.
    


Intervention name(s): Aerobic Exercise; Resistance Exercise; Combined aerobic and resistance exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 180 minutes of moderate-vigorous intensity aerobic exercise per week; 180 minutes of resistance exercise per week; 180 minutes of exercise per week with 90 minutes per week coming from moderate-vigorous intensity aerobic exercise and 90 minutes per week coming from resistance exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and
      exclusion criteria will be enrolled in the study. The women will be randomly assigned to one
      of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch
      once a week for 12 weeks.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Menostar (estradiol transdermal delivery system); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day); Placebo patch
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Menopause
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004
      following multiple dose administration over 14 days.
    


Intervention name(s): Placebo; BI 187004; BI 187004; BI 187004; BI 187004; BI 187004; BI 187004; BI 187004
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): placebo; BI 187004, dose 2; BI 187004, dose 4; BI 187004, dose 5; BI 187004, dose 6; BI 187004, dose 7; BI 187004, dose 1; BI 187004, dose 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Exercises on Total Body Health in Children With Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Bone Density Increased
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Osteosclerosis
Study type: Interventional

Summary: 
      In recent years, the survival of patients has increased with the success of leukemia
      treatment in children. However, according to the treatment modalities applied, complications
      such as changes in body composition such as obesity, osteoporosis and impaired bone health
      such as increased fragility are more frequent after treatment in patients.In this study,
      virtual reality exercise practices in remission of acute lymphoblastic leukemia cases will
      prevent negative effects on bone health and body composition and increase the quality of life
      of patients.
    

Detailed description: 
      Treatment and intervention options are being tried to avoid such complications that affect
      the quality of life of patients and there is still no standard treatment to convert bone
      health to healthy bone structure before the disease. There is a positive effect of improving
      the bone health of the activity and exercise programs. In this study, it was planned to
      demonstrate the positive effects of these changes on bone health through changes of
      adipokines and myokins released from fat and muscle tissue by virtual reality exercise
      method. Thus, the quality of life can be increased and cancer complications can be reduced in
      cancer cases.
    

Intervention name(s): Exercise therapy
Intervention type(s): Other
Intervention description(s): The exercise therapy group will make by physiotherapist supervision.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: acute lymphoblastic leukemia; bone density; total fat; exercise
The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood
Condition: Fetal Heart Failure (Disorder)
MeSH terms: Heart Failure
Study type: Observational [Patient Registry]

Summary: 
      Pregnant women between 32-41 weeks' gestation designated for either vaginal birth or cesarean
      section will be recruited for the study. Data regarding maternal resting heart rate and fetal
      baseline heart rate as depicted on the monitor will be collected. A blood sample will be
      acquired from the parturient and the umbilical cord as well as a sample from the placenta
      will be obtained. Levels of Acetyl Choline Esterase (AChE) will be determined from all
      aforementioned samples. Statistical correlation between fetal baseline heart rate and fetal
      and maternal AChE levels will be assessed.
    

Detailed description: 
      Pregnant women between 32-41 weeks' gestation designated for either vaginal birth or cesarean
      section will be recruited for the study. After signing an informed consent, data regarding
      maternal resting heart rate and fetal baseline heart rate as depicted on the monitor will be
      collected.

      Patients will be divided into 2 equal groups according to fetal baseline heart rate:

        1. st group-fetal heart rate between 110-130 beats per minute (bpm).

        2. nd group-fetal heart rate between 140-160 bpm. A blood sample will be acquired from the
           parturient and the umbilical cord as well as a sample from the placenta will be
           obtained. Levels of Acetyl Choline Esterase (AChE) will be determined from all
           aforementioned samples. Statistical correlation between fetal baseline heart rate and
           fetal and maternal AChE levels will be assessed.

      Data regarding demographic, medical and obstetric information of the participants will be
      obtained from the hospital's electronic records.
    

Intervention name(s): AChE levels
Intervention type(s): Diagnostic Test
Intervention description(s): AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women between 32 and 41 weeks' gestation undergoing either vaginal or cesarean
        delivery with a fetal baseline heart rate of 110-130 beats per minute and 140-160 beats per
        minute.
Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to better understand the influence of insulin resistance upon
      treatment response in hepatitis C virus treated with PEG Intron and Rebetol.
    

Detailed description: 
      The relationship between HCV and IR is an evolving one. This study will allow a more formal
      evaluation of this relationship. Four hundred patients will be treated using weight based Peg
      Intron and Rebetol. Clinical and biochemical data related to IR will be collected to
      determine if any such factors can predict who will have a sustained virological response. To
      evaluate patients for insulin resistance, the HOMA score (the product of the fasting insulin
      level and blood glucose level), waist circumference, and body mass index will be measured.
    

Intervention name(s): PEG-Intron Plus REBETOL
Intervention type(s): Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV