bioihbjkbjnl/mcl2 huggingface dataset:
School-Home Program for Mexican Children With Attention and Behavioral Concerns
Condition: ADHD
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      A school-based behavioral intervention for Mexican youth with attention/behavior concerns
      (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas
      para el Éxito [CLS-FUERTE]:) will be pilot-tested in a mixed-method investigation with four
      Mexican elementary schools.
    

Detailed description: 
      A school-based behavioral intervention for Mexican youth with attention/behavior concerns
      (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas
      para el Éxito [CLS-FUERTE]:) will be pilot-tested in a mixed-method investigation with four
      Mexican elementary schools.

      Participants will include 24-32 students (n = 6-8 per 4 schools) in participating schools.
      School personnel will help identify students with and at-risk for
      Attention-Deficit/Hyperactivity Disorder (ADHD) with at least one caretaker and teacher able
      to participate in the intervention. Students must be in 1st-6th grade at a participating
      school and must demonstrate clinically significant attention/behavioral concerns and related
      impairment as rated by caretakers and teachers. Caretakers and teachers must be able to
      attend program sessions held at the child's school over an approximately 6-week period.
      Through a school-clustered random assignment design, two schools will be selected to receive
      CLS-FUERTE during the fall of the 2016-2017 school year and two schools will be selected to
      receive school services as usual while waiting to receive CLS-FUERTE the spring of the
      2016-2017 school year. Caregivers and teachers of students will complete questionnaires about
      child behavior and family functioning and caregivers will participate in focus groups at 4
      time points regardless of treatment assignment: Pre (prior to random assignment), Post 1
      (following CLS-FUERTE in the fall cohort), Post 2 (following CLS-FUERTE for in spring
      cohort), and Follow-up (at the end of the school year).

      Feasibility and acceptability of CLS-FUERTE will be examined via participation enrollment,
      attendance, and engagement ratings and focus group feedback. Improvement in satisfaction with
      school services and youth outcomes will be examined and estimates of effect sizes will be
      used to support future scaled-up investigation.
    

Intervention name(s): CLS-FUERTE
Intervention type(s): Behavioral
Intervention description(s): The CLS-FUERTE program is an approximately 6-week program and includes school (behavioral consultation with teachers), caretaker (caretaker skills groups), and student (skills groups) components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel
      direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in
      immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.
    

Detailed description: 
      This will be an open-label pilot study in which IgAN patients with persistent proteinuria
      despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the
      optional addition of other anti-hypertensive agents to achieve an optimal target blood
      pressure of <130/80 mmHg.
    

Intervention name(s): Aliskiren
Intervention type(s): Drug
Intervention description(s): Titrate from 150 mg daily to 300 mg daily
Other intervention name(s): Rasilez
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proteinuria
Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
Condition: Fever
MeSH terms: Virus Diseases
Study type: Observational

Summary: 
      This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay
      (ImmunoXpert™).

      The study will involve reviewing the medical charts of about 4500 pediatric patients that
      were tested using ImmunoXpert™ as part of the routine workup for acute febrile illness.

      ImmunoXpert™ uses a computer algorithm to combine immunoassay measurements of three host
      immune proteins (TRAIL, IP-10, and CRP) present in human blood. The test is intended for use
      in conjunction with clinical assessments and other laboratory findings as an aid to
      differentiate bacterial from viral infection.

      Statistical analysis will be performed to compare the diagnostic accuracy of ImmunoXpert™
      with that of current practice lab testing e.g., WBC, CRP, and PCT (whichever were taken as
      part of routine care) and clinical suspicion at time of requisition.
    


Intervention name(s): ImmunoXpert
Intervention type(s): Diagnostic Test
Intervention description(s): Host based immune response test distinguishing viral versus bacterial infection
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        1. Patients with an acute bacterial infection

          2. Patients with an acute viral infection

          3. Patients with an acute co-infection (bacterial and viral)

          4. Patients with an undetermined disease etiology
      
Biospecimen description: 
      Serum and plasma samples
Infiltration Analgesia After Caesarean Section
Condition: Pain, Postoperative; Caesarean Section
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Infiltration of a local anesthetic into the surgical wound is a simple method to strive to
      control postoperative pain after surgery. In the investigators institution, this method is
      used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover,
      the cost of the single use elastomeric pump used with this procedure is clearly higher than
      the costs of other routinely used analgesic methods.

      According to the investigators observations, infiltration of a local anesthetic into the
      surgical wound after caesarean section seems to reduce the need for rescue analgesics.
      However, the scientific evidence of the efficacy of this technique is weak. The investigators
      decided to conduct a prospective, controlled, randomised, double blind trial on this topic.

      The hypothesis is that wound infiltration with local anesthetic will reduce postoperative
      pain and opioid consumption after caesarean section without major adverse effects.
    


Intervention name(s): Ropivacaine 0,75%; NaCl 0,9%
Intervention type(s): Drug; Drug
Intervention description(s): Postoperative wound infusion 2 ml/ h/ 48h; Postoperative wound infusion 2 ml/h/48h
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative pain; infiltration analgesia; ropivacaine; Caesarean Section
Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects
Condition: Cicatrix; Lipodystrophy; Plaque
MeSH terms: Lipodystrophy; Cicatrix
Study type: Interventional

Summary: 
      The Research Question of the present study is the following: in a population of men and women
      presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects)
      will cross-linked hyaluronic acid (Janesse®) significantly decrease and / or improve the
      appearance of these defects, results observed after 4, 8 and 12 weeks?
    

Detailed description: 
      Janesse® action is to increase the volume of dermal-epidermal tissue, based on the natural
      ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times
      greater than their weight. This allows to fill the intradermal spaces and integrate the
      intercellular matrix, conferring turgidity to the tissues. The cross-linking of the
      hyaluronic acid contained in the product has the effect of more stable and durable filling
      over time. These characteristics allow Janesse® to be used as a temporary filler for
      subcutaneous areas to correct small defects in the dermal tissue due to lipodystrophies or
      the presence of fibrotic tissues as scars, caused by pathologies or trauma.
    

Intervention name(s): Janesse
Intervention type(s): Device
Intervention description(s): Device: Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
The subjects will receive at baseline the first investigational medical device by the Investigator in accordance with the clinical investigation plan.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, open-label, non-randomized clinical investigation
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of an Intranasal Testosterone Product
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial will compare the pharmacokinetic profile of testosterone after repeated
      intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
    


Intervention name(s): 10.0 mg of Testosterone, 4.0% TID; 13.5 mg of Testosterone, 4.5% B.I.D; 11.25 mg of Testosterone, 4.5% T.I.D
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): 10.0 mg of TBS-1, 4.0% TID; 13.5 mg of TBS-1, 4.5% B.I.D; 11.25 mg of TBS-1, 4.5% T.I.D
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
Condition: Colonoscopy Preparation Outcome
Study type: Interventional

Summary: 
      The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate
      magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different
      doses and administration times. The primary outcome is number of bowel motions produced.
      Secondary outcomes include the quality of bowel cleansing and patient tolerability.
    

Detailed description: 
      We will compare different doses and administration times in patients booked for morning
      colonoscopy. The primary outcome is number of bowel motions produced in total by the
      sennosides. Secondary outcomes include the quality of bowel cleansing and patient
      tolerability.
    

Intervention name(s): Sennosides
Intervention type(s): Drug
Intervention description(s): Each group will be assigned different doses of sennosides and varying times of administration
Other intervention name(s): Senokot
Intervention MeSH terms: Sennosides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer
Condition: Pain; Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

Summary: 
      RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer.
      It is not yet known whether reflexology is more effective than aromatherapy massage in
      relieving symptoms in patients with cancer.

      PURPOSE: This randomized clinical trial is studying reflexology to see how well it works
      compared with aromatherapy massage in relieving symptoms in patients with cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine whether reflexology is as effective as aromatherapy massage for alleviation
           of self-selected symptoms in patients with cancer in an outpatient setting.

      Secondary

        -  To determine the difference between the two therapies with respect to Visual Analogue
           Scale (VAS) relaxation scores before and after each treatment.

      OUTLINE: Patients are stratified according to gender (male vs female), treatment
      (chemotherapy vs other) and their first concern choice (pain vs other). Patients are
      randomized to 1 of 2 intervention arms.

        -  Arm I (Reflexology): Patients undergo 45-60 minutes of reflexology for 4 sessions.

        -  Arm II (Aromatherapy massage): Patients undergo 45-60 minutes of of aromatherapy massage
           for 4 sessions.

      Patients complete questionnaires (Measure Yourself Concerns and Well-being [MYCAW]
      questionnaire and Visual Analogue Scale [VAS]) at baseline, before and after each session,
      and after completion of all four sessions.
    

Intervention name(s): questionnaire administration; aromatherapy and essential oils; management of therapy complications; massage therapy; psychosocial assessment and care; reflexology procedure
Intervention type(s): Other; Procedure; Procedure; Procedure; Procedure; Procedure
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: psychosocial effects of cancer and its treatment; pain; unspecified adult solid tumor, protocol specific
Enhancing Slow Wave Sleep With Sodium Oxybate
Condition: Sleep
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if there the impact of sleep deprivation upon
      sleepiness, attention, memory, and mood is reduced by pharmacologically enhancing slow wave
      sleep (SWS) with sodium oxybate.
    

Detailed description: 
      SWS has been hypothesized to be a time of relatively high neural recuperation from
      wakefulness. That hypothesis has been prompted by a number of observations, including: 1)
      enhanced SWS following sleep deprivation in proportion to the duration of prior wakefulness,
      2) reduced amounts of SWS during nocturnal sleep following afternoon/evening naps, 3) a
      gradual decline in SWS across a night of sleep, and 4) increased SWS following nights of
      fragmented sleep. Within the two-process model of sleep regulation, heightened SWS has been
      viewed as reflecting Process S, the homeostatic component. Many authors have proposed that
      increased SWS represents ongoing cortical recovery from prior wakefulness activities and is a
      time of relatively heightened neurophysiologic restoration or recuperation. In a prior study
      which we conducted (Walsh et al., 1994) there was a suggestion, from post hoc analyses, that
      SWS may prevent adverse effects of sleep loss. Additionally, we recently published the
      results of an investigation of pharmacologically-enhanced SWS (with tiagabine) during sleep
      restriction which demonstrated preserved neurobehavioral performance despite sleep
      restriction (Walsh et al, 2006). In the proposed research we will examine whether
      pharmacological enhancement of SWS with sodium oxybate reduces the impact of sleep
      deprivation upon sleepiness, attention, performance, mood, and autonomic nervous system
      activity.
    

Intervention name(s): sodium oxybate
Intervention type(s): Drug
Intervention description(s): 3.5 g of sodium oxybate or placebo on two of the five overnights.
Other intervention name(s): xyrem
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: sleep; normal sleepers
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin
      D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency
    


Intervention name(s): Vitamin D3 B.O.N. Injection
Intervention type(s): Drug
Intervention description(s): cholecalciferol 200,000IU
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
Condition: Post-Operative Pain; Third Molar Extraction
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study involves approximately 200 patients designed to evaluate the efficacy and safety
      of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate
      release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain
      following third molar extraction.
    

Detailed description: 
      Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or
      more third molars (2 of which were required to be mandibular and both must be bony impacted
      third molars).
    

Intervention name(s): Intranasal Placebo; Intranasal Morphine 15 mg; Immediate Release Oral Morphine 60 mg; Intravenous morphine; Intranasal morphine 7.5 mg; Oral placebo; Intravenous placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intranasal placebo; Intranasal Morphine 15 mg; Immediate Release Oral Morphine 60 mg; Intravenous morphine 7.5 mg; Intranasal morphine 7.5 mg; Oral placebo; Intravenous placebo
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post operative pain; Third molar extraction; Dental surgery; Morphine
Clinical Study to Evaluate the Antihypertensive Efficacy and Changes of Neurohormonal Markers of Fimasartan and Atenolol With Exaggerated Blood Pressure Response During Exercise in Essential Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the antihypertensive efficacy and changes of
      neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response
      during exercise in essential hypertensive patients.
    

Detailed description: 
      After subjects have signed informed consent voluntarily, when they are taking hypertension
      medication, they go through screening period for 7 days including wash-out period.

      After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days),
      and evaluate their suitability to Inclusion and Exclusion criteria.

      Patients, who evaluated the proper subject for this clinical trial, are allocated to
      experimental group (Fimasartan 60mg) or Control group (Atenolol 50mg) randomly at a ratio 1:1
      and their investigational drugs will be administered daily for the study period (8 weeks).
      Subjects visit their investigators twice during treatment period, when they take their
      investigational drugs for 4 weeks, and 8 weeks.

      The placebo period will be single-blinded and the treatment allocation in this study will be
      double-blinded.
    

Intervention name(s): Fimasartan; Atenolol
Intervention type(s): Drug; Drug
Intervention description(s): Fimasartan 60mg; Atenolol 50mg
Other intervention name(s): Kanarb; Tenolmin
Intervention MeSH terms: Atenolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Antihypertensive efficacy; Neurohormonal markers; Blood Pressure Response; Exercise
Physical Training and the Incretin Effect
Condition: Healthy
Study type: Observational

Summary: 
      It is well known that continuous physical exercise leads to a number of changes in the body.
      Maximal oxygen uptake; the heart's pumping ability and muscle mass and strength increases.
      Also the metabolism adapts: The ability to oxidize fat increase and the insulin sensitivity
      in primarily in muscle, but also in the liver increase.

      Also endocrine glands adapts according to the level of physical activity. It is known that in
      healthy, younger people the insulin secretion from the pancreas after administration of sugar
      consumed orally or given directly into a vein, is significantly lower in trained individuals
      compared with untrained. This change does, however, not only apply to glucose, as also
      stimulation by the amino acid arginine, shows the same pattern.

      It seems plausible that the endocrine glands/cells adapts to the level of physical training,
      but this has not yet been investigated.

      The gastrointestinal tract is the birthplace of a variety of hormones. One group of these is
      called incretin hormones. They stimulate the glucose dependant insulin secretion in the
      pancreas and affect hunger/satiety. Whether the incretin production and thus their
      concentration in the blood is regulated by physical training is unknown.

      Obese and patients with type 2 diabetes, has, in contrast to well-trained, decreased insulin
      sensitivity. As a consequence their (type 2 diabetics, at least early in their disease
      course) meal stimulated insulin release is greater than in healthy, normal weight
      individuals. This in spite of the fact that the incretin effect is reduced in obese people
      and patients with type 2 diabetes compared to healthy, normal weight.

      Whether physical training affects both the secretion of incretins and the incretin effect has
      not yet been studied.

      The purpose of this study is to investigate whether incretin hormones in physical
      well-trained young men have a changed effect on insulin secretion from the pancreas compared
      to untrained young men. A difference may indicate that the body's endocrine glands adapts to
      training mode.

      The investigators hypothesis is that incretin hormones have a decreased effect on the glucose
      dependant insulin release in physically trained persons and thus results in a lower insulin
      release at any given plasma glucose level.
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Danish University Students from University of Copenhagen,
      
Biospecimen description: 
      Human plasma samples.
    
Keywords: Incretin; Training; Glucagon like peptide; glucose dependent insulinotropic peptide; Gut; Exercise; Insulin; Focus:; Gut hormone; adaptations