bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
Condition: Sleep; Physical Performance; Cognitive Performance; Balance
Study type: Interventional

Summary: 
      The primary objective is to assess the impact of two nutritional interventions vs. placebo on
      objective and subjective sleep measures in athletes. Participants receive one beverage on
      each of three consecutive nights in a randomized manner. It is hypothesized the two
      nutritional interventions will result in significant improvements in sleep onset latency, and
      will not result in a negative impact on next-day cycling performance.

      The secondary objective is to assess the impact of the nutritional interventions vs. placebo
      on next-morning performance (physical, cognitive function, and balance).
    


Intervention name(s): Trypophan, Theanine and 5'AMP; Placebo
Intervention type(s): Other; Other
Intervention description(s): 250 ml beverage consumed at 21:00 hours; 250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: nutrition; sleep; polysomnography; performance; exercise
Resperine, Gabapentin, or Lamotrigine for the Treatment of Cocaine Dependence: 2 - 7
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the treatment
      of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo
      control.
    

Detailed description: 
      Considerable progress in preclinical research has provided a basis for hypothesis driven
      clinical trials in cocaine dependence. A greater mechanistic understanding of both cocaine
      and many clinically approved medications has led to the identification of many promising
      medications for the treatment of cocaine dependence.

      For this reason NIDA has developed a CREST (Clinical Rapid Evaluation Screening Trial)
      protocol to provide a needed incremental medication screening step between preclinical
      research and full blown expensive Phase III pivotal trials. While patients receive manual
      based psychotherapy, three medications are screened compared to unmatched placebo in an
      eight-week, 60-subject, four cell design trial. Other important features of the CREST
      protocol include collecting baseline measurements over a two week period and analyzing
      primary outcome measures (quantitative urine toxicology and clinical global improvement
      scales) in terms of a composite score of overall individual patient improvement.

      The three medications being evaluated in this trial include reserpine, gabapentin and
      lamotrigine. Reserpine is being screened because of its well-known preclinical ability to
      functionally antagonize cocaine (by depleting neurochemicals elevated by cocaine). Gabapentin
      and lamotrigine are hypothesized to interfere with glutamatergic cocaine
      sensitization/kindling mechanisms relevant to addiction.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: cocaine dependence
Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
Condition: Atypical Endometrial Hyperplasia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To see if megestrol acetate plus rosuvastatin will be superior to reversing the endometrial
      lesion to a normal endometrium than megestrol acetate alone in patients with atypical
      endometrial hyperplasia (AEH). Considering the large sample size in RCT, we used Simon
      two-stage design.
    

Detailed description: 
      After diagnosed of AEH by hysteroscopy, patients will be enrolled. Age, height, weight, waist
      circumstances, blood pressure, basic history of infertility and blood pressure will be
      collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), OGTT
      2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels, anti-müllerian
      hormone(AMH), creatine kinase(CK) and renal/liver function tests will be performed before
      treatment to evacuate their basic conditions. Each subject will receive body fat testing by
      Inbody 520.

      Patients are randomized to 1 of 2 treatment groups. Patients will receive MA 160 mg plus
      rosuvastatin 10mg by mouth daily for at least 6 months. Then hysteroscopy will be used to
      evaluate the endometrial condition every 3 months, and intra-operative findings will be
      recorded. Complete response (CR) is defined as the reversion of endometrial atypical
      hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as
      regression to simple or complex hyperplasia without atypic; stable disease (SD) is defined as
      the persistence of the disease; and progressive disease (PD) is defined as the appearance of
      endometrial cancer in patients. Continuous therapies will be needed in PR or NR. Patients
      with PD will be recommended for hysterectomy.

      Two months of maintenance treatment will be recommended for patients with CR, and
      participants will be followed up for 2 years.
    

Intervention name(s): Megestrol Acetate; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): At a dosage of 160 mg/day; At a dosage of 10 mg/day
Intervention MeSH terms: Megestrol; Megestrol Acetate; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: megestrol acetate; rosuvastatin; atypical endometrial hyperplasia; conservative treatment
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Condition: Bipolar Disorder; Major Depressive Episode
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to understand the efficacy of light therapy for bipolar
      depression.
    

Detailed description: 
      Bipolar Disorders (BD) are associated with chronic depression, disability, and increased
      suicide risk. Building on earlier findings, we conducted a 6-week randomized, double-blind,
      placebo-controlled trial to investigate the efficacy of midday light therapy for bipolar
      depression. The aims were to examine the change in depression levels and the proportion of
      patients who responded and remitted. We assessed predictors of response with measures of side
      effects, sleep quality, suicidality, and psychosocial functioning. We included depressed
      adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic
      medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive
      disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality.
      Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for
      45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured
      Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement
      (SIGH-ADS) and global functioning.
    

Intervention name(s): 7000lux broad-spectrum light; 50lux dim red light
Intervention type(s): Device; Device
Intervention description(s): dosage - 15-60minutes NOON-2PM daily; dosage: 15-60minutes NOON-2PM daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder Depression Midday Light Therapy; Bipolar Disorder Type I or II
Effectiveness Study of a Behavioral Teacher Program Targeting ADHD Symptoms
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The goal of this study was to investigate the effectiveness of a behavioral teacher program
      addressing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) in the classroom.
    

Detailed description: 
      Background:

      Most behavioral teacher programs involve intensive and expensive teacher trainings by health
      care specialists, which may limit successful large-scale implementation. This behavioral
      program, on the contrary, involves a self-containing manual that does not require expert
      training in order to increase the likelihood of successful implementation (if proven
      effective). The aim was to investigate the program's effects on behavioral, socio-emotional
      and school functioning in primary school children.

      Methods:

      Children with ADHD symptoms were randomly assigned at school level to the intervention
      condition (receiving the program during 18 weeks) or control group (not receiving the program
      but who were allowed to receive care as usual).

      Measures to assess program's effectiveness:

        -  Strengths and Weaknesses of ADHD-symptoms and Normal Behavior,

        -  Strengths and Difficulties Questionnaire

        -  Social Skills Rating Scale

        -  Spence Children's Anxiety Scale

        -  Classroom Observation Code

        -  Actigraphy

        -  Sociometric measures (peer nomination and peer rating)

        -  Dutch arithmetic test (Tempo-Test-Rekenen)

        -  reading test (Drie-Minuten-Toets) and writing test (PI-dictee).

      Additional measures:

        -  Wechsler Intelligence Scale for Children (Block Design and Vocabulary; used to estimate
           IQ);

        -  Sensitivity to Punishment and Sensitivity to Reward Questionnaire and several
           neuropsychological computer tasks
    

Intervention name(s): Behavioral Teacher Program
Intervention type(s): Behavioral
Intervention description(s): This program was based on the evidence-based Summer Treatment Program (MTA Cooperative Group, 1999), involving psycho-education for the teacher and universal and individual behavioral techniques that focused on classroom structure and contingency management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: symptoms of ADHD
Acetabular Shell Positioning Using Patient Specific Instruments
Condition: Osteoarthritis, Hip; Rheumatoid Arthritis; Avascular Necrosis
MeSH terms: Osteoarthritis, Hip; Necrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is a double-blinded randomized controlled trial comparing patient specific
      instruments with solely standardized instruments and pre-operative planning used for the
      placement of the acetabular cup prosthesis used in total hip arthroplasty.

      The investigators will enroll 36 patients who have consented to total hip arthroplasty for
      treatment of hip pathology. This treatment is a standard of care. Patients will receive
      standard of care pre- and post-operative care and placement of standard of care implants all
      of which are commercially available and FDA approved for general use for the clinical
      indications used in these patients. All patients will receive a pre-operative CT scan for
      surgical planning and comparison with post-operative CT scan. The difference in intervention
      between the groups will be the creation and use of patient specific instruments from the
      pre-operative planning session. These instruments will be used for placement of an indexing
      peripheral guide wire to direct acetabular preparation and placement of the shell assisting
      standard surgical instruments. Print-offs from the pre-operative plan will also be used in
      the treatment group.

      The post-operative scan will be performed within two weeks of the surgery for both the
      treatment and control groups. The investigators will analyze the difference in acetabular
      shell placement (acetabular version and abduction angle) from the pre-operatively planned CT
      scan. These differences will be compared between the control and experimental groups.
    

Detailed description: 
      No further details to report.
    

Intervention name(s): Acetabular positioning system
Intervention type(s): Procedure
Intervention description(s): Pre-operative planning through 3D software with design and fabrication of patient specific instruments for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Total Hip Arthroplasty (THA); Patient-Specific Instruments; Acetabular Cup Placement; Accuracy
Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity; Conduct Disorder; Oppositional Defiant Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant
      treatment is more effective than stimulant treatment alone in reducing aggressive behavior
      among children with attention deficit hyperactivity disorder (ADHD).
    

Detailed description: 
      ADHD is one of the most common childhood mental disorders. It often causes impaired
      functioning in multiple areas, including home, school, and peer relationships. Additionally,
      children with ADHD often develop aggressive behavior, which is not usually adequately
      suppressed by standard stimulant treatments for ADHD. In order to address this problem, many
      physicians prescribe multiple medications at once. There is no clinical evidence, however,
      proving that this method is safe and effective. This study will assess whether adding a mood
      stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant
      treatment alone in reducing aggressive behavior among children with ADHD.

      Participants in this double blind study will first receive open label stimulant treatment for
      ADHD and a comorbid disruptive behavior disorder. Participants whose aggressive behavior
      subsides with stimulant treatment alone will not proceed into the next phase of the study.
      Participants whose ADHD symptoms lessen from the treatment but whose aggressive behavior
      persists will be randomly assigned to receive either divalproex sodium or placebo in addition
      to their stimulant treatment for 8 weeks. Study visits will be held weekly for 11 to 16
      weeks. At these visits, aggression levels and medication side effects will be assessed.
      Families will also meet with the researchers to discuss the child's progress, and attend
      behavioral counseling with a therapist. Participants who did not continue into the second
      phase of the study will be asked to return to the study site for a follow-up visit 8 weeks
      following the end of the first phase.
    

Intervention name(s): Divalproex Sodium; Methylphenidate; Dextroamphetamine; Mixed Amphetamine Salts; Family Counseling; Behavior Management Training with Parents
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral; Behavioral
Intervention MeSH terms: Valproic Acid; Methylphenidate; Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADHD; ODD; Conduct Disorder; CD
Gender-specific aEEGs and Outcome in Preterms
Condition: Gender Role Disorder, Male to Female Type
Study type: Observational

Summary: 
      Background and objectives: Male sex is a risk factor for poor neurodevelopmental outcome
      following preterm birth. The investigators aimed to investigate gender-related differences in
      amplitude-integrated electroencephalography (aEEG) and to correlate these findings with
      neurodevelopmental outcome.

      Methods: Preterm infants born <30 weeks' gestational age between 2000 and 2002 were
      prospectively included. aEEGs obtained within the first two weeks of life were evaluated and
      classified according to background activity, sleep-wake cycling (SWC) and seizure activity.
      Outcome was assessed at three years.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        preterms born < 30 weeks gestational age who had aEEG measurements within the first 2 weeks
        of life who had assessment of outcome at 3 years corrected age
Value of Pulse Pressure Variations and Corrected Flow Time in Esophageal Doppler as a Predictor of Fluid Responsiveness in Prone Position During Spinal Surgery
Condition: Elective Posterior Lumbar Spinal Fusion
Study type: Interventional

Summary: 
      In patients under mechanical ventilation, Usefulness of dynamic indices based on the
      heart-lung interactions for guiding volume resuscitation has been well validated. Recently,
      validity of pulse pressure variation (PPV) has been also reported to predict fluid
      responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important
      hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated and
      used as a preload index, and has been reported to predict fluid responsiveness. Prone
      position caused physiologic and hemodynamic changes and influenced the predictability and
      cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled study,
      the investigators evaluated the validity of PPV and FTc as predictors for fluid
      responsiveness in supine and prone position in patients undergoing posterior lumbar spinal
      fusion
    


Intervention name(s): 1.Esophageal doppler monitor; 2. philips Intelivue MP70 monitors
Intervention type(s): Device; Device
Intervention description(s): 1.Esophageal doppler monitor (CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.)-inserted into the esophagus and positioned approximately 35-40 cm from the teeth. The position of OED prove was confirmed by continuously measuring blood flow velocity in the descending thoracic aorta and focused to find the optimum peak velocity and waveform signal.; 2.philips Intelivue MP70 monitors (Intellivue MP70, philips medical Systems, Suresnes, France) -a radial arterial cannula was inserted and arterial pressure waveforms were monitored through Philips Intelivue MP70 monitors. In the monitor, PPVauto was displayed in real-time. It based on automatic detection algorithms, kernel smoothing, and rank-order filters.
Other intervention name(s): 1.CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.; 2.intellivue MP70, philips medical Systems, Suresnes, France
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
GSK2239633 FTIH Study
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first time into human study is to investigate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of GSK2239633 in healthy male subjects.
    

Detailed description: 
      GSK2239633 is a human chemokine receptor 4 (CCR4) antagonist with a novel anti-inflammatory
      profile acting mainly on a subset of Th2 cells, with potential for the oral treatment of all
      severities of asthma. Inhibition of the CCR4 receptor represents a target for asthma because
      of the potential to inhibit Th2 cell chemotaxis and the subsequent effects of limiting Th2
      cell involvement in both the acute and chronic inflammatory response. Recent data in man
      suggests that the CCR4 receptor ligands (thymus and activation-regulated chemokine (TARC) and
      macrophage-derived chemokine (MDC)) may be important in asthma and in the development of
      Allergic Bronchopulmonary Aspergillosis (ABPA). This will provide a unique opportunity to
      differentiate GSK2239633 significantly from other oral non-steroidal asthma treatments. This
      study is the first administration of oral GSK2239633 in humans. Two alternating cohorts of 12
      subjects will receive 3 single, ascending doses of oral GSK2239633 or placebo. In addition,
      one cohort will receive a single dose of GSK2239633 or placebo following the standard FDA
      high fat/high calorie meal. Safety will be monitored (ECGs, telemetry, vital signs, clinical
      laboratory assessments, adverse events), and blood samples will be taken for pharmacokinetic
      and pharmacodynamic analysis.
    

Intervention name(s): GSK2239633; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug will be orally administered at the doses and time points detailed in the 'arms' section.; Placebo will be orally administered to 4 subjects in each treatment period of each cohort.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Complement 2: Blood Donations to Develop Vaccines Against Infectious Diseases
Condition: Complement Mediated Bacterial Killing in Healthy Adults
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      We need human blood to understand the immune response to infection and to test promising new
      vaccines against infectious diseases in the laboratory. One test is called the Serum
      Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing
      certain bacteria and can be an important measure of how effective a new vaccine may be.

      The samples would be used in the laboratory analysis of clinical trials of vaccines used in
      adults and children, and some samples in pre-clinical (animal) experiments testing new
      vaccines before they enter human-stage testing. Most people have some form of protection
      against most bacteria already, so not everyone is a suitable blood donor for this laboratory
      test. We therefore start by taking a small blood sample and test this one before asking for
      more blood if we found yours suitable for the work we do.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers, who are willing and able to give informed consent for
        participation in the study.
      
Biospecimen description: 
      Serum only, no DNA or other blood components are stored.
    
Keywords: Complement; Serum Bactericidal Assay