bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Exercise on Energy Intake-Prescription of Resistance Exercise
Condition: Eating Behavior; Food Reward
Study type: Interventional

Summary: 
      Healthy young males will complete five trials in a randomized crossover counter-balanced
      order, including three different inter-set rest of resistance exercise in equal training
      volume, one repeated until failure and sedentary control. During each trial, blood samples
      will be collected.

      The investigators hypothesized that different inter-set rest and training volume would affect
      subjective appetite and energy intake.
    


Intervention name(s): short inter-set rest resistance exercise; medium inter-set rest; long inter-set rest; medium inter-set rest with failure
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Subjects in short inter-set rest trial performed 3 sets per exercise, 7 repetitions with load of 70%-1RM with 60 sec of rest between sets.; Subjects in medium inter-set rest trial performed 3 sets per exercise, 7 repetitions with load of 70%-1RM with 120 sec of rest between sets.; Subjects in long inter-set rest trial performed 3 sets per exercise, 7 repetitions with load of 70%-1RM with 180 sec of rest between sets.; Subjects in long inter-set rest trial performed 3 sets per exercise, repeated to failure with load of 70%-1RM with 120 sec of rest between sets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chicago Urban Resiliency Building (CURB)
Condition: Major Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether a culturally tailored, low-cost, primary
      care/internet based depression prevention intervention (CURB) is superior to wait-list
      control for African American and Hispanic youth in terms of depression-related outcomes. It
      is hypothesized that compared to teens in the wait-list control condition, teens in the CURB
      program will exhibit lower levels of depressed mood and/or more rapid changes in mood during
      the follow-up time.
    

Detailed description: 
      Additional aims and hypotheses are provided here:

      Aim 2: To determine whether or not participants in the CURB primary care/Internet based
      depression prevention intervention will have a significantly lower cumulative incidence of
      any depressive episode at 3 months compared to adolescents in the usual care wait-list group.

      Hypothesis 2: Compared to youth in the wait-list control condition, youth in the CURB program
      will have a lower incidence of depressive episodes at 6 month follow-up.

      Aim 3: To determine whether CURB is sustainable in primary care from the perspective of
      health care professionals and primary care physicians in urban primary care settings.

      Hypothesis 3: We hypothesize that providers will rate the intervention (by component)
      feasibility, acceptability, willingness to perform intervention and sustainability > 7 on a
      1-10 scale (1, not feasible, 10 very feasible).
    

Intervention name(s): CURB
Intervention type(s): Behavioral
Intervention description(s): The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adolescent; Randomized Trial; Internet; Depressive Disorder; Primary Care; Prevention
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and the efficacy of vaginally administered
      probiotic lactobacilli in combination with antibiotic therapy (metronidazole) in women with
      microbiologically defined bacterial vaginosis.
    


Intervention name(s): Probiotic lactobacilli; Placebo
Intervention type(s): Other; Other
Intervention description(s): Probiotic lactobacilli in combination with antibiotic therapy; Placebo in combination with antibiotic therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Functional Neuroimaging of Postural Reconstruction
Condition: Healthy
Study type: Interventional

Summary: 
      To study in two cross-sections of healthy volunteers, with single photon emission computed
      tomography (SPECT), the possible changes generated in the mid-term by two rehabilitation
      techniques: the postural reconstruction and the muscular stretching. The changes in the
      cortical activation patterns will be estimated during a non-specific position of the ankle,
      held static.

      The influence of each technique will be estimated though the evidence of a change in the
      functional mapping of the areas activated during the defined motor task on healthy
      volunteers.
    

Detailed description: 
      This is a monocentre, randomized study.
    

Intervention name(s): SPECT : ECD-Tc99m - Neurolite, Bristol-Myers Squibb Medical Imaging
Intervention type(s): Radiation
Intervention MeSH terms: Technetium Tc 99m bicisate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Volunteers; healthy subjects
Effects Of Different Anesthesia Applications On Mood, Depression, And Anxiety Levels In Burn Patients
Condition: Burn Unspecified Degree; Deep Sedation
MeSH terms: Burns; Depression
Study type: Observational [Patient Registry]

Summary: 
      Adequate and effective pain management and prevention of depression are essential in burn
      patients. This study aims to investigate the effects of ketamine sedation in burn patients in
      terms of mood disorders, depression, anxiety, and suicidal tendency during intensive care
      follow-up in the postoperative period.
    

Detailed description: 
      Aim: Adequate and effective pain management and prevention of depression are essential in
      burn patients. This study aims to investigate the effects of ketamine sedation in burn
      patients in terms of mood disorders, depression, anxiety, and suicidal tendency during
      intensive care follow-up in the postoperative period.

      Methods: The study was conducted with 67 patients between 18 and 65 years of age, who were
      ASA I-II class, had basic communication skills, no previous diagnosis of psychiatric illness,
      and no history of neuropsychiatric or cognitive disease or related treatment. After
      preoxygenation, anesthesia induction was performed with 2 mg/kg IV propofol and 1 mcg/kg IV
      fentanyl in the general anesthesia group. Anesthesia was continued with a mixture of 0.3-0.5
      mcg/kg/min remifentanil, 2% sevoflurane, 50% air, 50% oxygen. In the sedation group, 1 mcg/kg
      IV fentanyl and 1 mg/kg IV ketamine were administered at induction; anesthesia was maintained
      by adding 30-50 mg IV propofol if necessary. The Montgomery-Asberg Depression Rating Scale
      (MADRS), the Hamilton Anxiety Rating Scale (HAM-A), and the Beck Scale for Suicide Ideation
      (BSSI) were administered preoperatively and on postoperative day one by the psychiatrist.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of both sexes aged 18 to 65 years will be included in the study.
      
Keywords: Burn patient; Depression; Ketamine; Suicidal tendencies
CoolSculpting Treatment in the Upper Arms
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum
      applicators for non-invasive subcutaneous fat reduction of the upper arms.
    

Detailed description: 
      Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done
      concurrently, such that a subject will have an applicator placed on each arm simultaneously.
    

Intervention name(s): The ZELTIQ CoolSculpting System
Intervention type(s): Device
Intervention description(s): The CoolSculpting device will be used to perform treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
Condition: Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be
      evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will
      be evaluated in terms of immunogenicity, safety and reactogenicity.
    


Intervention name(s): Boostrix-Polio
Intervention type(s): Biological
Intervention description(s): A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; vaccine; DTP; Poliomyelitis; Pertussis; Booster; Tetanus
Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy
Condition: Nausea and Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      RATIONALE: Using acupressure wrist bands to press and stimulate nerves at an acupressure
      point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy.

      PURPOSE: This randomized clinical trial is studying how well acupressure works in preventing
      nausea and vomiting in young cancer patients receiving chemotherapy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of implementing an acupressure therapy for the prevention of
           chemotherapy-associated nausea in children with cancer.

        -  Test the hypothesis that acupressure bands will prevent chemotherapy-associated nausea
           and vomiting in children, when compared to placebo acupressure (wrist bands without
           acupressure).

        -  Develop a competitive grant application for a large, multi-institutional randomized
           controlled trial of the efficacy of acupressure in preventing chemotherapy-associated
           nausea in children.

      OUTLINE: This is a prospective, randomized, placebo-controlled, crossover, pilot study.
      Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients wear Sea-Band elastic acupressure wristbands on each wrist beginning
           approximately 1 hour before beginning their first inpatient chemotherapy session and
           continuing for at least 24 hours after completing chemotherapy. Patients do not wear
           wristbands for their second chemotherapy session. Patients wear placebo wristbands on
           each wrist beginning approximately 1 hour before their third chemotherapy session and
           continuing for at least 24 hours after completing chemotherapy.

        -  Arm II: Patients wear placebo wristbands on each wrist beginning approximately 1 hour
           before their first chemotherapy session and continuing for at least 24 hours after
           completing chemotherapy. Patients do not wear wristbands for their second chemotherapy
           session. Patients wear Sea-Band acupressure wristbands on each wrist beginning
           approximately 1 hour before their third chemotherapy session and continuing for at least
           24 hours after completing chemotherapy.

      All patients also receive standard antiemetic therapy.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): acupressure therapy; sham intervention
Intervention type(s): Procedure; Procedure
Intervention description(s): Acupressure wristband; Sham wristband
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: nausea and vomiting; unspecified childhood solid tumor, protocol specific
Effects of MCDG Oil on Postprandial Lipid Metabolism
Condition: Hyperlipidemias; Triglycerides High
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have
      effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and
      DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism
      compared to long-chain triglycerides (TGs).
    

Detailed description: 
      A randomized, double-blinded, controlled, cross-over trial was conducted to verify the
      effects of MCDGs. Twenty-eight healthy male and female subjects aged 21-29 years with normal
      body weight [18.5 kg/m^2 ≤ body mass index (BMI) < 25 kg/m^2] were recruited. The subjects
      visited the research site twice over with a seven-day interval after an overnight fast at
      least 12 hr. On the first visit, the participants were randomly assigned to consume a test or
      placebo product [test product: muffins containing MCDG oil (MCDG muffin); placebo product:
      muffins containing LCT oil (LCT muffin)] and ingested the assigned product. On the second
      visit, the participants consumed the other product that they did not eat on the first visit.
      On both visit day, the 6-hr meal tolerance test was conducted and started at 8:00 in the
      morning; venous blood samples were collected before (0 hr) and after ingestion (2, 3, 4, and
      6 hr) of the products.
    

Intervention name(s): LCT oil; MCDG oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): LCT muffin was provided to the study participants. The LCT muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was LCT.; MCDG muffin was provided to the study participants. The MCDG muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was MCDG.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Postprandial lipid metabolism; Medium-chain triglycerides; Diacylglycerols; Serum triglycerides; Chylomicron triglycerides
Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain
      has proven its short-term effectiveness. Exercise therapy plays a major role in such a
      combination of treatments. There is a considerable need to develop theory-based exercise
      interventions which foster a long-term adherence to physical activity. Furthermore, an
      integration of behavioral elements such as coping competencies regarding back pain is needed.
      It is not yet clear, which specific part of multidisciplinary rehabilitation causes its
      effects. The role of exercise therapy has yet to be investigated. Aim of this study is the
      implementation of a standardized behavioral exercise therapy into an existing
      behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is
      that the participation in the behavioral exercise therapy leads to greater short- and
      long-term improvements in functional capacity compared to the usual care.
    


Intervention name(s): Behavioral Medical Rehabilitation plus behavioral exercise therapy; Usual Behavioral Medical Rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An "Behavioral Exercise Therapy" (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity.; The Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more "traditional" concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to investigate the effect of an investigational drug in adults with
      schizophrenia by using Electrocardiogram (Picture of the electrical action of the heart).
      This study is accepting male and female participants between 18 years old -65 years old who
      have been diagnosed with schizophrenia. This study will be conducted in approximately 7
      locations in the US. The study will last approximately 7 weeks.
    

Detailed description: 
      This is a Phase 1, randomized, single-dose, active and placebo controlled, 3-period crossover
      study of the effect of SEP-363856 150 mg on electrocardiogram (ECG) intervals in subjects
      with schizophrenia. SEP-363856 and matching placebo will be utilized in a double-blind
      fashion. Moxifloxacin will be utilized as an active control in an open-label fashion.

      The primary analysis will be based on concentration-QTc modeling of the relationship between
      plasma concentrations of SEP-363856 or its metabolite SEP-363854 and change-from baseline
      QTc.
    

Intervention name(s): SEP363856 150 mg; Placebo; moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP363856 tablet 150 mg; Placebo tablet; moxifloxacin tablet 400 mg
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized using a double Williams design in equal ratio to six possible sequences of receiving the three treatments being studied:
SEP-363856 150mg, Matched Placebo, moxifloxacin 400mg.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia
Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis
Condition: Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations
      for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and
      Australia.
    

Detailed description: 
      Patients with RMS receiving Ocrelizumab or Ofatumumab will be recruited to measure the time
      spend for Healthcare Providers (HCP) (neurologist, nurse and hospital pharmacist) on
      preparing, administering the medication and following up with the patient.
    

Intervention name(s): Ocrelizumab; Ofatumumab
Intervention type(s): Drug; Drug
Intervention description(s): There is no treatment allocation. Patients administered Ocrelizumab by prescription that have started before inclusion of the patient into the study will be enrolled.; There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Intervention MeSH terms: Ofatumumab; Ocrelizumab
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult patients diagnosed of RMS will be recruited if they have been prescribed either
        Ocrelizumab of Ofatumumab. The person accompanying the patient will be invited to
        participate as a caregiver.
      
Keywords: Relapsing forms of Multiple Sclerosis; RMS; Ocrelizumab; Ofatumumab; TIMIOS