bioihbjkbjnl/mcl2 huggingface dataset:
Consistency in Individual Differences in Energy Intake Following Acute Exercise
Condition: Obesity; Sedentary
MeSH terms: Obesity
Study type: Observational

Summary: 
      The importance of exercise for weight control is well documented; however if exercise results
      in an increase in food intake, the beneficial effect of exercise may not be seen. This study
      addresses a gap in the current literature and examines why some people eat more after
      exercise and why some people eat less and also examines whether these responses are
      consistent over time. Participants in this study will be asked to come to our center on 7
      different occasions over a 3-4 month period. The first visit will be an assessment visit
      where body weight and body composition will be measured, questionnaires will be completed,
      and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions
      with visits in each pair separated by 48-96 hours) the procedures will be nearly identical.
      Upon arrival at our center, participants will consume a meal replacement, complete a series
      of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be
      resting and 3 will be exercising). One hour following the exercise/resting session,
      individuals will be given access to a buffet of food, unaware that their food intake will be
      monitored. All food will be weighed and measured before and after the eating period and the
      amount of food consumed after each pair of exercise and resting conditions will be compared
      to one another. It is hypothesized that the difference in food intake will be consistent
      across pairs of testing sessions. Findings from this study will help us to better understand
      the relationship between exercise and food intake and may ultimately lead to future studies
      that can address the clinically significant question of why some individuals gain weight and
      others lose weight when engaging in exercise training programs. Findings from this study may
      also help to develop exercise programs that maximize the beneficial effect of exercise on
      body weight.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Relatively sedentary (exercising less than 60 minutes/week over the past 6 months)
        overweight and obese (BMI: 25.0 to <35.0 kg/m2) women between the ages of 18 and 45.
      
Keywords: obesity; exercise; energy intake; physical activity
Haploidentical (Half-matched) Related Donor Stem Cell Transplantation Using Killer Immunoglobulin-like Receptors in Addition to Normal Selection Factors to Determine the Best Donor
Condition: Hematologic Malignancy
MeSH terms: Hematologic Neoplasms
Study type: Interventional

Summary: 
      This study will test whether half matched donors with favorable KIR genes will reduce the
      risk of cancer recurring after transplant.
    


Intervention name(s): melphalan; fludarabine; thiotepa; Cyclophosphamide; Mesna; Mycophenolate Mofetil; Filgrastim; Tacrolimus
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): melphalan (140 mg/m2 IV on day -7); fludarabine (40 mg/m2/d on days -5 through -2); thiotepa (5 mg/kg IV on day -67); cyclophosphamide (50 mg/kg IV on day +3 and +4); (15 mg/kg PO/IV TID)
Other intervention name(s): Alkeran®; FLUDARA®; Cytoxan®; Mesnex®; CellCept®; Neupogen®; Prograf®
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Melphalan; Thiotepa; Fludarabine; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transplant conditioning; KIR/HLA based haploidentical donor selection; allogeneic hematopoietic cell transplantation
Core Training Protocol vs Traditional Abdomen Exercise Protocol
Condition: Functional Performance; Resistance Training; Exercise
Study type: Interventional

Summary: 
      The main objective of this study is to analyse the effectiveness of core stability exercises
      to increase motor control, function and resistance strength of the abdominal muscles,
      compared to a traditional abdominal and trunk exercise program in semi-professionals soccer
      players
    

Detailed description: 
      The 51 participants were semi-professional soccer player and were divided into two different
      groups using a computer system: the CORE-group or ABDOMINALS-group. Four weeks of training
      were developed. Outcome variables: Back extension test; Flexion endurance test; FMS;
      functional movement screen; lateral muscle test right; lateral muscle test left. Kinematic
      variables were recorded during the test using an accelerometer. A comparison intra-group and
      intergroup were developed.
    

Intervention name(s): Core training
Intervention type(s): Other
Intervention description(s): A total of 12 sessions were carried out, which lasted for 4 weeks, with a frequency of 3 sessions/ week. The duration of each session was 11 minutes 30 seconds. The working time of each exercise was 30 seconds with a 5 seconds rest between exercises, meaning that each exercise cycle lasted for 2.50 seconds. Three exercise cycles were performed with a 90 seconds rest between each one of them
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; core; accelerometer; functional
A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration
Condition: Healthy; Pharmacokinetics of ASP1941; Pharmacokinetics of Mitiglinide
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide
      calcium hydrate in healthy volunteers.
    

Detailed description: 
      This will be a randomized, open label, four group, two-way crossover design study to assess
      the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the
      pharmacokinetics of them after separate and concomitant administration to healthy non-elderly
      adult male subjects.
    

Intervention name(s): ASP1941; Mitiglinide calcium hydrate
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ipragliflozin; Glufast
Intervention MeSH terms: Ipragliflozin; Mitiglinide; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1941; ipragliflozin; Mitiglinide calcium hydrate; Drug-Drug interaction; Pharmacokinetics
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Condition: Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC)
      once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma
      exacerbation in participants with persistent moderate to severe eosinophilic asthma.

      Secondary Objectives:

        -  To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in
           participants with persistent moderate to severe eosinophilic asthma.

        -  To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in
           participants with persistent moderate to severe eosinophilic asthma.
    

Detailed description: 
      The total duration of the study period per participant was 20-22 weeks broken down as
      follows:

        -  Screening period: up to 14 days,

        -  Treatment period: 12 weeks,

        -  Follow-up period: 6-8 weeks.
    

Intervention name(s): Dupilumab; Placebo (for Dupilumab); Fluticasone/Salmeterol combination therapy; Fluticasone monotherapy; Albuterol; Levalbuterol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution for injection, one subcutaneous injection.; Solution for injection, one subcutaneous injection.; Oral inhalation twice daily.; Oral inhalation twice daily.; Oral inhalation as needed.; Oral inhalation as needed.
Other intervention name(s): SAR231893; REGN668
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effectiveness of a Nursing Intervention for Nurses Have Experienced Trauma: a Study Based on Swanson's Caring Theory
Condition: Nurses Who Have Experienced Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This study aimed to (1) develop an internet-based psychiatric nursing intervention, based on
      Swanson's theory of caring, and (2) examine its effects on functional health, resilience,
      social support, post-traumatic stress, depression, and anxiety.

      This study was a randomized clinical trial(RCT) study with repeated measures to identify the
      effectiveness of an internet-based psychiatric nursing intervention. Participants were
      evaluated at the following time points: pre-test (pre), post-test (post-test 1, immediately
      after intervention), and follow-up (post-test 2, one month after the intervention) to assess
      the sustainability of the internet-based psychiatric nursing intervention.

      Of the 112 women who enrolled in the study, 10 dropped out before post-test 1, resulting in
      102 participants who completed all interventions and surveys.
    


Intervention name(s): The trauma recovery nursing intervention program
Intervention type(s): Other
Intervention description(s): The trauma recovery nursing intervention program was for adults who had experienced trauma and consisted of eight sessions, each lasting 30 min. It included a spoken audio track that was accompanied by visual prompts to provide knowledge on traumatic stress and introduce trauma recovery methods. Its online format made it convenient and widely accessible, and allowed for a low-intensity, cost-effective educational program. The program focused on providing self-help guidelines for clients to develop their mental and physical well-being.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Metabolomic Fingerprint After Bariatric Surgery
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Background: Obesity is associated with multiple diseases. Bariatric surgery is the most
      effective therapy for severe obesity that cannot only reduce body weight but also
      obesity-associated morbidity.

      Objective: The metabolic alterations associated with obesity and respective changes after
      bariatric surgery are incompletely understood.

      Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based
      global, untargeted metabolomics strategy on human serum samples that were collected before
      and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy,
      proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also
      analyzed serum samples from normal-weight and less obesity obese subjects that were matched
      for 1-year postoperative BMI values of the surgical groups.
    


Intervention name(s): bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        severely obese patients of the Interdisciplinary Obesity Center, St. Gallen, Switzerland
      
Keywords: metabolic alterations
ET-01 in Subjects With Lateral Canthal Lines
Condition: Lateral Canthal Lines; Crow's Feet
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Detailed description: 
      This product is being tested for its ability to reduce lateral canthal lines, also known as
      Crow's Feet.
    

Intervention name(s): botulinum toxin, Type A; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): topical liniment; Vehicle Formulation
Other intervention name(s): ET-01
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: sequential, dose escalating study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on
      LY3537982 when administered as multiple doses by conducting the blood tests to measure how
      much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in
      adult healthy participants. The study will also evaluate the safety and tolerability of
      LY3537982. The study is conducted in two parts. Participants will stay in the research center
      during the study, which will last about 11 and 15 days for part 1 and part 2, respectively,
      not including screening.
    


Intervention name(s): LY3537982; Itraconazole; Carbamazepine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Itraconazole; Carbamazepine
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the relative bioavailability of Venlafaxine MR
      Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human
      subjects.
    

Detailed description: 
      An open labeL balanced, randomized, two-treatment. two-period, two-sequence, single
      dose,crossover, evaluation of relative bioavailability of Venlafaxine 150 mg (as the HCl
      salt)MR capsules of Dr. Reddy's comparing with that of Effexor XR (containing Venlafaxine 150
      mg (as the HCl salt)capsules of wyeth Laboratories, Philadelphia, PA, USA in healthy human
      subjects under fed conditions.
    

Intervention name(s): Venlafaxine
Intervention type(s): Drug
Intervention description(s): Venlafaxine MR Capsules 150 mg
Other intervention name(s): Effexor XR
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Venlafaxine; two way crossover
Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the long-term persistence of immunity to hepatitis B
      in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The
      study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these
      subjects.
    

Detailed description: 
      This MDD has been updated following the Protocol Amendment 1, dated 20 June 2013.

      The Protocol was amended because GSK replaced its in-house Enzyme-Linked ImmunoSorbent Assay
      (ELISA) that was used to measure anti-HBs (antibodies to Hepatitis B surface antigen)
      antibody concentrations with ChemiLuminescence ImmunoAssay (CLIA).

      Additionally, the threshold level of prednisone was modified to reflect the dosage normally
      prescribed to adolescents.
    

Intervention name(s): Engerix™-B Kinder
Intervention type(s): Biological
Intervention description(s): Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy; Hepatitis B; Adolescents; Engerix™-B Kinder
Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg
      of OHM Laboratories Inc., USA with ALTACE® (ramipril) capsule 10 mg manufactured by King
      Pharmaceuticals Inc., Bristol, TN 37620, USA in healthy, adult, male, human subjects under
      fasting condition.
    

Detailed description: 
      Following an overnight fast of at least 10 hour, a single oral dose of ramipril 10 mg capsule
      was administered during each period of the study, along with 240 mL of drinking water at
      ambient temperature, under low light condition and supervision of trained study personnel.

      A total of sixty-eight (68) subjects were enrolled into the study, to be administered a
      single oral dose of the test or reference formulation of ramipril 10 mg capsule according to
      a randomization schedule. Two subjects (subject numbers 01 and 06) were withdrawn from the
      study in period I and subject number 02 did not report for period II.

      Sixty-five (65) subjects completed both the periods of the study.
    

Intervention name(s): Ramipril 10mg capsules
Intervention type(s): Drug
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence ramipril fasting condition
Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies
Condition: RENAL FIBROSIS
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      Elastography is a emerging imaging technique that has demonstrated high reliability in the
      assessment of tissues stiffness and quantification of fibrosis particularly in adult's
      livers. This ultrasound exploration has no secondary effects. There is no study published in
      the pediatric population concerning the role of ultrasound elastrography in kidney. The aim
      of this study is to look for a correlation between the elastography's results and the kidney
      fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential
      diagnostic and/or prognostic role in the management of these patients which would limit
      invasive biopsy procedures.
    


Intervention name(s): Elastography
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of the fixed combination of
      valsartan/amlodipine in adult patients with mild to moderate hypertension
    


Intervention name(s): Valsartan/amlodipine 80/5 mg; Amlodipine 5 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.; 1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Intervention MeSH terms: Amlodipine; Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension, valsartan, amlodipine, high blood pressure
Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a
      cosmetic treatment for spotted hand skin; in particular it was investigated the synergic
      activity of an emulsion, with clarifying-antioxidant activity combined with an activator gel,
      with hydration and keratolytic activity.

      Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were
      included in the study.

      It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by
      the volunteers and tolerance both by investigator and volunteers.
    

Detailed description: 
      The following instrumental evaluations were performed in basal conditions (T0 - before
      product use), after 4 (T4) and 8 week-treatment (T8):

        -  Image analysis with UV flash (Wood's light)

        -  Photographic recovery

        -  Skin spots image analysis

        -  Skin colour evaluation

        -  Spectrophotometry (skin brightness)

        -  Optical colorimetry (spots colour)

      At the end of the study (T8), each volunteer filled a questionnaire regarding:

        -  the efficacy of the study product (skin brightness and hydration, spots dimensions and
           colour intensity - score: very marked; marked; medium; light; absent)

        -  the cosmetic acceptability of the study product: colour and perfume before and after
           application, consistency, spreadability, absorption, effect on the skin, greasiness and
           presence of product residues (score: negative; medium; good; excellent) the product
           tolerance (score: bad; poor; medium; good; excellent).

      At the end of the study the investigator assessed the treatment tolerance considering the
      possible appearance of related adverse events as bad, poor, medium, good, excellent.
    

Intervention name(s): Emulsion and gel
Intervention type(s): Other
Intervention description(s): A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperpigmentation; depigmenting treatment; hand