bioihbjkbjnl/mcl2 huggingface dataset:
Acute Hyperbaric Oxygen Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in T2D
Condition: Type 2-diabetes
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      Diabetes mellitus type 2 (T2D) is characterized by insulin resistance of liver and skeletal
      muscle, which is at least partly due to impaired muscle mitochondrial function. Long-term HBO
      therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood
      glucose concentrations. To study the underlying mechanisms, we want to examin the short-term
      effect of HBO treatment on insulin sensitivity and mitochondrial oxidative capacity and
      production of reactive oxygen species (ROS) in a randomized, double blinded,
      placebo-controlled cross-over trial.
    

Detailed description: 
      In total 14 patients are planned. Each participant participates in both experimental parts
      (100% O2 and ambient air). They are examined immediately after each HBO/ ambient air therapy.
      The allocation is randomized treated every three weeks with 2-hour therapies using pure O2 or
      indoor air. Randomized and double-blinded in a cross-over setting, one group of patients with
      type 2 diabetes is first treated with HBO therapy and the other group is first treated with
      room air. Here, an ambient pressure of 2.4 ATM is built up and then administered for
      respiration over a total of 90 minutes of pure O2. Patients are examined on two consecutive
      days for each part of the study.On the first day serum samples are taken and a sample is
      taken from the vastus lateralis muscle. A magnetic resonance spectroscopic examination (MRS)
      is performed on the patient subsequently. In this case, phosphorus metabolites (absolute
      quantification of ATP, Pi) and the ATP synthase flow rate (fATP) are determined
      non-invasively by means of 31P MRS and TG storage (HCL) by means of 1H-MRS.

      On the next day of the trial patients are treated with HBO therapy or room air. A
      hyperinsulinemic-euglycemic clamp test (120-300 min) with administration of deuterated
      glucose (D- [6,6-2H2] glucose) (0-120 min) to measure muscular and hepatic insulin resistance
      will be performed after the end of HBO therapy or room air treatment performed. Indirect
      calorimetry determines energy consumption and substrate selection (lipid and glucose
      oxidation) in hyperinsulinaemia. After the end of the HBO therapy or room air treatment and
      30 minutes after the start of the clamp test, a sample is taken from the vastus lateralis
      muscle again.
    

Intervention name(s): 100% O2 in oxygen chamber; 21% O2 in oxygen chamber
Intervention type(s): Device; Device
Intervention description(s): Application of 100% O2 in an hyperbaric oxygen chamber; Application of ambient air (21% O2) in an hyperbaric oxygen chamber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High-intensity Interval Exercise and Chocolate Milk on Blood Glucose and Cognition
Condition: Glycemic Response; Cognitive Function
Study type: Interventional

Summary: 
      The purpose of this study is to determine the separate and combined effects of high-intensity
      interval exercise and chocolate milk on glycemic response, cognitive function, subjective
      appetite, and salivary cortisol among children aged 9-13 year old children.
    

Detailed description: 
      Twenty children 9-13 years of age will be recruited for this study. On four separate
      mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast
      (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home. Using a
      2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in
      the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20
      min, followed by a treatment drink of chocolate milk or water (control) consumption in 10
      min. During high-intensity interval exercise treatment, children will exercise on a cycle
      ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power
      output and 60-second recovery, and a 3-min cool down. Blood glucose will be measured via
      finger-prick at baseline (-20 min), 10, 30, 60, and 90 min. Cognitive functions will be
      measured using a battery of cognitive tests which assess verbal declarative memory, working
      memory, and executive functioning, and will be measured at baseline, 10. 30. 60, and 90 min.
      Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS)
      at baseline, 10, 30, 60, and 90 min. Salivary cortisol will be assessed from saliva samples
      collected using the passive drool method, and will be collected at baseline, 10 and 30 min.
    

Intervention name(s): Exercise and Chocolate Milk; Exercise and Water; Sitting and Chocolate Milk; Sitting and Water
Intervention type(s): Other; Other; Other; Other
Intervention description(s): High intensity interval exercise Chocolate Milk; High intensity interval exercise Water; Sitting Chocolate Milk; Sitting Water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Child; Exercise; Chocolate milk; Blood glucose; Cognition; Appetite; Emotions; Cortisol
Resistive/Cardiovascular Training Study
Condition: Muscular Atrophy
MeSH terms: Muscular Atrophy
Study type: Observational

Summary: 
      This is a training study in healthy volunteers to characterize gains in lower-body resistive
      strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD)
      we have developed for the National Space Biomedical Research Institute. The CCD is a single
      platform which contains interchangeable modules for cardiovascular stepping exercises and
      lower body resistive exercises including squats, heel raises, abductor and adductor exercises
      and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and
      to translate in three dimensions in order to challenge the neurovestibular system. The
      underlying goal of the project is to provide a compact and efficient exercise modality that
      will prevent deterioration of the cardiovascular and musculoskeletal systems, and the
      neurovestibular system, in long-duration spaceflights. The goal of the current study is
      simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed
      for the device will improve strength and VO2 max. Subjects are tested for lower body
      resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at
      followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows
      sufficient power to detect 95% percent confidence intervals in the changes in the strength
      and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar
      to those reported in the literature for simultaneous cardiovascular and resistive strength
      protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model
      of long-duration spaceflight.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy men and women 25-55 years of age who are not exercisers
Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This was designed as a two part study comprising sequential double-dummy, placebo controlled
      3-period randomized crossover studies. The study will evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266. Only
      Part I of the study was completed.
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; Placebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.; MK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; MK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; Placebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.
Other intervention name(s): MK-8266 1.3 mg BID; MK-8266 0.9 mg FDD; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: High blood pressure
Group Parent Training for Adolescent Eating Disorders
Condition: Adolescent Anorexia Nervosa; Subthreshold Anorexia Nervosa
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional

Summary: 
      While parents are considered essential for the effective treatment of adolescents with
      anorexia nervosa, the most effective manner to involve parents in treatment is unknown. Given
      reports of high caregiver burden among parents of this clinical group, finding treatments
      that minimize parent burden while improving the child's eating disorder symptoms is
      essential.

      This investigation will examine the preliminary effectiveness of a parent skills group and
      adolescent skills group compared to family therapy for the treatment of adolescent anorexia
      nervosa. The target of this intervention is the improvement of eating disorder symptoms in
      the child and improving self-efficacy, emotion regulation, and perceived burden in the
      parent.

      The effectiveness of this experimental treatment group (Group Parent Training for the
      parents/Adolescent Skills Training for the adolescent) will be compared to the Maudsley model
      of family therapy. The effectiveness of the group program will be examined by exploring
      changes within individuals over time as well as via comparisons across treatment conditions.
      Results from this investigation will be used to calculate treatment effect sizes in the
      design of a larger, fully powered, randomized clinical trial.
    


Intervention name(s): Group Parent Training; Maudsley Family Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Skills group for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.; Family therapy specifically adapted for the treatment of adolescent anorexia nervosa.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: anorexia nervosa; group parent training; caregiver burden; eating disorders; treatment
Behaviour After Exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application
Condition: Cryotherapy Effect
Study type: Interventional

Summary: 
      Introduction: immersion cold water is a recuperative strategy commonly used, however, are not
      yet fully understood the real effects of this technique on specific conditions. Objective: To
      analyze and to compare the effects of the immersion cold water during the intense
      post-exercise recovery, using different times and temperatures on biological, clinical and
      metabolic variables. Method: 105 male subjects were divided into five groups: one control
      group (CG) and four recoveries (G1: 5' at 9±1 degrees Celsius; G2: 5' at 14±1 degrees
      Celsius; G3: 15' at 9±1 degrees Celsius; G4: 15' at 14±1 degrees Celsius). The volunteers
      were submitted an exhaustion protocol that consisted of a program of jumps and the Wingate
      test. Immediately after the exhaustion protocol, volunteers were directed to a tank with
      water and ice, which were immersed up to the height of the anterior superior iliac spine to
      the recovery procedure, during which blood samples were collected for later analysis lactate
      and creatine kinase (CK). Variables were collected prior to the exercise, 24, 48, 72 and 96
      hours after the end of it. Furthermore, the perception of pain and recovery of the lower
      limbs were also collected at specific moments by means respectively of the Likert scale of
      perceived effort and visual analogue scale pain. Appropriate statistical analysis was used to
      compare the groups and the moments, considering the 5% level of significance.
    


Intervention name(s): immersion cold water
Intervention type(s): Other
Intervention description(s): immersion cold water at different temperatures and exposure times
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immersion; Recovery of Function; Lactate; Creatine Kinase; Musculoskeletal Pain
Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin
Condition: Myocardial Infarction; Cardiovascular Death; Atherothrombosis; Stroke
MeSH terms: Myocardial Infarction; Infarction; Death
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if a new drug called ticagrelor given twice daily in
      addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death
      from heart disease, heart attack, or stroke).
    


Intervention name(s): Ticagrelor 90 mg; Ticagrelor 60 mg; Ticagrelor Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose twice a day; Oral dose twice a day; Oral dose twice a day
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Heart attack; Heart Disease; Acute coronary syndrome; ACS; Cardiovascular Disease
CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study were to evaluate: (1) the dose response and (2) the
      pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE
      for the treatment of acute angioedema attacks in children above and below 25 kg and less than
      12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and
      tolerability following IV administration of CINRYZE in this study population.
    

Detailed description: 
      Each subject received CINRYZE for treatment of a single acute angioedema attack.
    

Intervention name(s): CINRYZE
Intervention type(s): Biological
Other intervention name(s): C1 inhibitor [human]
Intervention MeSH terms: Complement C1 Inhibitor Protein
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CINRYZE; C1 INH; HAE; C1 inhibitor; Pediatric; PK/PD
Effects of Virtual Reality in Adhesive Capsulitis on Pain, Range of Motion and Function
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      Adhesive capsulitis (AC) also known as frozen shoulder typically manifests to decrease range
      of motion (ROM) and function and increase pain in shoulder. Objective of this study is to
      find the effects of virtual reality (VR) in adhesive capsulitis on pain, range of motion and
      function to decrease pain and improve range of motion and function. The study design will be
      a quasi-experimental study that will be used to compare the effects of virtual reality with
      conventional physical therapy. Subjects with adhesive capsulitis meeting the predetermined
      inclusion &amp; exclusion criteria will be divided into two groups using lottery method. Pre
      assessment will be done using visual analogue scale (VAS), shoulder pain and disability index
      (SPADI) tool and active shoulder flexion and abduction as subjective measurements. Subjects
      in group A will be treated with virtual reality stimulation given for 30 minutes per session
      through kinetic Xbox with sensory accelerator model no.1414. Two traditional training
      activities will be used to improve shoulder Range of motion i.e. shoulders finger ladder
      training activity and single curved shoulder training activity 12 times (3 rounds in each
      practice) of the training 1 . Patients will be required to complete standard training task by
      interacting with designed VR rehabilitative training games under the supervision of physical
      therapists and subjects in group B will be treated with conventional physical therapy i.e.
      grade 1 and 2 mobilization and stretching exercise. Baseline treatment protocol hot pack will
      be applied to both groups.

      Treatment duration for both groups will be 30 minutes. Each subject will receive a total 6
      week protocol with 02 treatment sessions per week. Post treatment reading will be recorded
      after the end of 2 nd , 4th and 6th treatment weeks. Recorded values will be analyzed for any
      change using SPSS 21.
    


Intervention name(s): Conventional Physical therapy; Virtual reality group
Intervention type(s): Other; Other
Intervention description(s): Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise; group B was treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414. Two traditional training activities was used to improve shoulder Range of motion i.e. badminton and American baseball activity 12 times of the training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Virtual Reality ,Adhesive Capsulitis , Range of Motion
CHemoImmunotherapy With Early Central Nervous System (CNS) Prophylaxis
Condition: Primary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to test whether early central nervous system (CNS) prophylaxis given at the
      beginning of therapy for young high risk diffuse large B-cell lymphoma (DLBCL) patients is
      feasible and could reduce the risk of CNS relapses. Early CNS prophylaxis with two courses
      high dose methotrexate (HD-MTX) in combination with
      rituximab-cyclophosphamide-doxorubicin-vincristine-prednison (R-CHOP) is followed by four
      courses of R-CHOP14 and etoposide (E) and one course of HD-Ara-C. In addition the patients
      will receive three courses of liposomal cytarabine intrathecally. The results will be
      compared to a recent Nordic CRY-04 study. Shifting of CNS prophylaxis to the beginning of the
      therapy offers a potential to overcome the subclinical disease and thus reduce the risk of
      early clinical CNS recurrence. As flow cytometry (FCM) can improve the sensitivity for
      detecting occult leptomeningeal disease over cytology , FCM from cerebrospinal fluid will be
      incorporated into the staging procedures.
    


Intervention name(s): liposomal cytarabine
Intervention type(s): Drug
Intervention description(s): 50 mg intrathecally three times
Other intervention name(s): Depocyte
Intervention MeSH terms: Cytarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLBCL; FL grade 3B; high risk; CNS prophylaxis; chemoimmunotherapy
Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic
Condition: Biliary Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      A safe and effective transvaginal approach accessing the abdominal cavity through the vagina
      rather than the abdominal wall is today considered a routine approach for many gynecologic
      surgeries.

      First described by Dr. Ott in Germany in 1901, it is used routinely for transvaginal surgery,
      for example, transvaginal hysterectomies. This transvaginal technique has been shown to
      compare favorably to a laparoscopic abdominal approach because of less postoperative pain,
      the total elimination of abdominal wall hernias and wound infections, earlier recovery and
      better cosmesis.

      Although routinely used in gynecological surgery, the advantages of the vaginal approach have
      not been utilized for general surgery applications such as cholecystectomies. Open or
      laparoscopic cholecystectomy accessing the abdominal cavity through abdominal wall incisions
      is currently still considered the standard of care in general surgery for patients with
      symptomatic gallbladder disease.

      The investigators intend to access the abdominal cavity through the posterior vaginal fornix
      instead of the transabdominal approach that is now performed routinely. So far, this method
      of accessing the abdominal cavity through the transvaginal approach for the purpose of
      performing intraabdominal general surgery.

      The investigators' transvaginal approach has the strong potential to further decrease
      invasiveness and take minimally invasive surgery to the next level in order to benefit the
      patient even more by minimizing postoperative pain, eliminating the risk of abdominal hernias
      and wound infections, improving cosmetic appearance and enabling the patient to return to
      routine activity and work earlier. First preliminary studies show these advantages but
      further research needs to be done to confirm these early positive results.
    


Intervention name(s): transvaginal cholecystectomy; laparoscopic cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Transvaginal approach to gallbladder removal.; laparoscopic cholecystectomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cholecystectomy