bioihbjkbjnl/mcl2 huggingface dataset:
Swiss Army Physical Fitness Training
Condition: Wounds and Injuries; Physical Activity; Mood (Psychological Function); Motivation; Motor Activity
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the new sport concept of the Swiss Armed
      Forces influences the physical and psychological fitness of the recruits.
    

Detailed description: 
      The physical and psychological demands in the Swiss Army basic military service are high.
      Injury incidences in Swiss Army training schools are higher than in armed forces of other
      countries.There is evidence that progressive loading of physical demands at the beginning of
      basic military service and specific physical training can reduce injury incidences and
      attrition rates. A new sport concept by the Swiss Army takes into account these results of
      previous studies. Therefore, the aim of this study is to investigate the influences of this
      new sport concept on the physical and psychological fitness as well as on the injury and
      attrition rates of the recruits.
    

Intervention name(s): Swiss Army Physical Fitness Training
Intervention type(s): Other
Intervention description(s): 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Army; Sport; Physical Fitness; Injuries; Psychological Tests; Attrition
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to determine the safety and tolerability of RN316 when administered
      intravenously to healthy adult subjects. This is the first time RN316 has been given to
      humans.
    


Intervention name(s): RN316
Intervention type(s): Biological
Intervention description(s): Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg.
Intervention MeSH terms: Bococizumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615
Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability and evaluate
      pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly
      Japanese male and female subjects.
    


Intervention name(s): ASP8062; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ASP8062 will be administered orally.; Placebo will be administered orally.
Intervention MeSH terms: ASP8062
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ASP8062; Pharmacokinetics; Safety
Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a validation study that will replicate a completed study designed to assess
      biomarkers of treatment response to standard antidepressant treatment. The goal of this study
      is to integrate clinical, imaging, EEG, and molecular data across 8 sites to predict
      treatment outcome for patients experiencing a major depressive episode (MDE).
    

Detailed description: 
      This is a multi-site study to replicate a previous multi-site, multi-platform study completed
      by the Canadian Biomarker Integration Network in Depression (CAN-BIND). This study aims to
      validate the integrated array of markers of response and non-response to first line
      antidepressant treatments that were previously identified in the original aforementioned
      study. This will be accomplished through collection of clinical, neurophysiological, and
      molecular measures. This is not a study to evaluate efficacy of medications; medications in
      this study have been approved by Health Canada and are widely used for the treatment of MDD.

      In this study, individuals diagnosed with MDD in a current major depressive episode (MDE)
      will be treated with open-label escitalopram for 8 weeks. At week 8, participants will be
      assessed for treatment response (defined as a ≥50% reduction in Montgomery Asberg Depression
      Rating Scale score). Responders will continue on escitalopram for 8 more weeks.
      Non-responders will be given add-on brexpiprazole treatment, in addition to escitalopram, for
      8 weeks.

      Over the 16 weeks, pariticipants will attend 7 clinical visits where they will complete
      clinical assessments (clinician administered and self-report) and cognitive tests; provide
      blood, urine, and stool samples; undergo neuroimaging procedures (MRI and EEG); and provide
      speech samples. At the end of the study, modeling methods will be used to integrate data from
      these measures to determine the features that best predict treatment outcome.
    

Intervention name(s): Escitalopram; Brexpiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants are given escitalopram for 8 weeks. At week 8, those classified as responders will continue on escitalopram until the end of study.; Participants who are classified as non-responders are given 8 weeks add-on brexpiprazole, in addition to escitalopram, for the remainder of the study.
Other intervention name(s): Cipralex; Rexulti
Intervention MeSH terms: Escitalopram; Brexpiprazole
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: major depression; major depressive disorder; MDD; escitalopram; brexpiprazole; neuroimaging; genomics; proteomics; metabolomics
Bioactive Phytochemicals From Wheat Bran
Condition: Bio-availability of Wheat Bran Phytochemicals in the Human Gut; Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation
Study type: Interventional

Summary: 
      There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran
      are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It
      is still not clear exactly why this happens, but it is likely that the compounds which enter
      our bodies when we eat such products are responsible. In this study we plan to find out what
      these compounds are and where they are found. The investigators will do this by asking
      volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood,
      urine and stool samples over the next twenty-four hours. Once the investigators know how much
      and which compounds are present, we can then find out possible reasons why they are
      protective, for example by looking to see whether they are anti-inflammatory. We also plan to
      look at whether if having a diet which contains either a lot of wheat-bran products or very
      low amounts of these foods effects how they are absorbed by the body.

      HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are
      metabolized to compounds responsible for high cellular bioactivity imparting important health
      benefits.
    


Intervention name(s): Visit A high wheat bran; Visit B normal wheat bran; Follow up normal (8days) and high (1day) bran consumption
Intervention type(s): Other; Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Wheat bran cereals, bran phytochemicals, phytochemicals bioavailability
Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch
Condition: Itch
Study type: Interventional

Summary: 
      With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal
      Medulla) induce non-histaminergic itch.
    

Detailed description: 
      With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine
      Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.

      The experimenter will also compare itch and the response to antihistamine of BAM8-22,
      histamine and cowhage.
    

Intervention name(s): BAM8-22; Histamine; Cowhage (Mucuna Pruriens); Doxepin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm
Intervention MeSH terms: Doxepin; Histamine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Visual Training and and Reaction Time in Tennis
Condition: Visuomotor Skills
Study type: Interventional

Summary: 
      Tennis is situational sport in which the result of the game is directly influenced by the
      interaction with the opponent. In fact, athletes have to respond in a short-time period to
      change the way of playing by fast analyzing speed, rotation and direction of the tennis ball.
      Therefore, it is extremely complicated to predict exactly what will happen during games and
      matches. According to literature goof visual skills, players can receive and process
      information quickly and can optimize the performance with extreme precision and dexterity.
      For this reason, visuomotor training aims to improve reaction times, but its efficiency
      during playing tennis has not yet been investigated. Therefore, the aim of this study is to
      investigate how this training method could affect the improvement of visuomotor performance
      in young people between 12 and 18 years old.
    

Detailed description: 
      Two armed, parallel group, randomized control trial.
    

Intervention name(s): Visual Training; Normal Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The visual training will be performed 3 times a week for 40 minutes, at the end of warm up and before the technique training. The subjects will be performed a progression of exercise to improve their visual ability, their velocity of interpretation and transformation. The training will be performed with specific panels approved for visual training (S.V.T.A., Torino, Italy).; Normal training routine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tennis; Reaction Time; Visual training
Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Weight Gain
Study type: Interventional

Summary: 
      The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP
      treatment for obstructive sleep apnea (OSA).
    

Detailed description: 
      Obesity and obstructive sleep apnea share a bidirectional relationship. While obesity is a
      major risk factor for OSA, OSA may contribute to weight gain. Recent evidence suggests that
      OSA treatment is associated with weight gain. The mechanisms involved in weight gain after
      OSA treatment are not known. The purpose of this study is to determine the mechanisms of
      weight gain during CPAP treatment for severe OSA leads. The investigators hypothesis is that
      CPAP leads to a decrease in energy expenditure and prevents the elimination of extracellular
      fluid that is accumulated during the day. In order to test this hypothesis, 20 patients with
      severe OSA aged between 50 and 80 years old, under regular treatment with CPAP, will be
      invited to participate. Using a cross-over design, the investigators will perform bioelectric
      impedance 5 times over 24 hours in order to assess the circadian effect of fluid accumulation
      in two different conditions: during CPAP treatment and 7 days after CPAP withdrawal. A full
      polysomnography will be performed during CPAP withdrawal to confirm severe OSA and during
      CPAP treatment to confirm adequate control of respiratory events. In addition, basal
      metabolic rate, hematocrit, serum BNP, urinary sodium, creatinine and osmolality will be
      determined in the morning during the CPAP and CPAP withdrawal periods.
    

Intervention name(s): CPAP withdrawal
Intervention type(s): Device
Intervention description(s): Patients randomized to withdrawal will stop CPAP use for one week before study evaluations. Patients will also undergo a polysomnography to confirm the presence of severe OSA.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: CPAP; Weight Gain; obstructive sleep apnea
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule; Thyroid Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Use of ethanol injection in treatment of cystic thyroid nodule
    

Detailed description: 
      Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can
      either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable
      thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence
      increases to 20-76% when USG is used for detection.

      Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and
      rarely compressive symptoms necessitating surgical removal, a procedure inherently associated
      with risks and complications Percutaneous sclerotherapy has been suggested to be an effective
      alternative, especially in patients with cystic nodules. Simple cystic (purely cystic)
      constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or
      blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.

      Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan,
      tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best
      and most studied with ethanol. However, data on outcomes of percutaneous aspiration and
      ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different
      studies (success rate: 38-85%), which may be due to different populations studied and the
      heterogeneous nature of thyroid nodules evaluated.
    

Intervention name(s): ethanol injection
Intervention type(s): Drug
Intervention description(s): inject ethanol in cystic thyroid nodule and follow up until complete recovery
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fat Grafting in Skin-grafted Deep Burn Scars
Condition: Burn Scar
MeSH terms: Cicatrix; Burns
Study type: Interventional

Summary: 
      fat grafting in human skin-grafted immature burn scars histological, clinical and
      photographic follow-up
    

Detailed description: 
      Objective: A randomised clinical trial was performed to determine the effect of autologous
      fat grafting on scar formation in early skin-grafted deep burn wounds.

      Methods: Included patients received split-thickness skin grafting procedures for deep burn
      wounds less than 3 months ago. A homogenous scar area in each patient was divided into two
      equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting,
      the adjacent part with transcutaneous saline injection as control. Results were evaluated by
      clinical assessment with scar scale questionnaires, histological examination, and objective
      scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.
    

Intervention name(s): lipofilling/ fat grafting; placebo injection
Intervention type(s): Procedure; Procedure
Intervention description(s): liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: burn; scar; fat; grafting
Transplant Navigator Dissemination
Condition: Kidney Transplant; Renal Failure Chronic Requiring Hemodialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait
      listing and number of transplants. The navigator will provide tailored information and
      assistance to help dialysis patients complete the tasks required at each step in the
      transplant process. In the control group, dialysis patients will continue to get usual care
      from their nephrologists and dialysis facility personnel.

      Hypothesis: Compared to control patients, intervention patients will be significantly more
      likely to be wait listed or receive a kidney transplant.
    


Intervention name(s): navigator
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Navigators; Kidney Transplant; Hemodialysis
Normal Values of Brain Oxygenation
Condition: Cerebral Arterial Disease
MeSH terms: Cerebral Arterial Diseases
Study type: Observational

Summary: 
      New technology allows non-invasive monitoring of brain oxygenation
      (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various
      adult age groups. We hypothesised that baseline values in patients breathing room air are
      lower in old patients than in younger subjects and that younger patients respond increase
      their brain oxygenation more in response to supplemental oxygen.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective surgery
      
Keywords: Aging
Mood Change After General Anesthesia in Children
Condition: Anesthesia, General; Psychology, Child; Child Behavior
Study type: Observational

Summary: 
      Most drugs used in general anesthesia work on various receptors in the human brain, causing
      unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system.
      After the anesthesia, baseline physiological function will be attained by administration of
      some reversal drugs or as the time goes by. In this process, various side effects may occur.

      Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia
      in children and that can cause several problems during the recovery period. Previous studies
      found that ED and postoperative behavioral problems might be connected. Preschoolers are the
      most vulnerable group in developing ED after general anesthesia, however, it is difficult to
      evaluate the psychiatric problems at this age.

      The Child Behavior Checklist (CBCL) 1.5-5 is an internationally well-known standardized tool
      for assessment of developmental psychopathology, consisted of 99 problem items. Items are
      categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic
      complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.

      In this study, the investigators would observe the behavioral and emotional changes of the
      child using the CBCL 1.5-5 between before and after the general anesthesia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged between 2 and 7 years
Long-term Effect of tDCS in Patients With Disorders of Consciousness
Condition: Disorder of Consciousness
MeSH terms: Consciousness Disorders
Study type: Interventional

Summary: 
      In this multicentric double-blind sham controlled study, the investigators plan to assess the
      effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of
      consciousness. Neurophysiological outcomes (EEG) will also be collected.

      This research will 1) determine whether long-term behavioral recovery can be promoted with
      tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome
      (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of
      active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe
      brain injury and its potential application in rehabilitation.
    


Intervention name(s): transcranial direct current stimulation - active; transcranial direct current stimulation - sham
Intervention type(s): Device; Device
Intervention description(s): transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.; transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
An Observational Study to Assess Quality of Life and Satisfaction of Young Women (Aged 18-29) Following 6 (±1) Months Using Jaydess as Their Contraceptive Method
Condition: Quality of Life
Study type: Observational

Summary: 
      This is a cross-sectional, multicenter observational study to assess quality of life in young
      Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will
      be conducted in standard clinical practice conditions at the private gynecology clinics and
      during a single study visit.

      Approximately 1,200 women who have been using the intrauterine delivery system (IUS) Jaydess®
      as their contraceptive method of choice for 6 (±1) months will be included in the study.
    


Intervention name(s): Levonorgestrel (Jaydess, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 1,200 women aged 18 to 29 will be consecutively included in this study as they
        present at private gynecology clinics. Subjects must have been using the Jaydess
        intrauterine delivery system as their contraceptive of choice for a period of 6 (±1)
        months.

        The study population may be stratified into subsets to assess and identify differences in
        the subjects' quality of life, social and demographic characteristics, contraception
        characteristics, satisfaction, perceived benefits of Jaydess and bleeding pattern features.