bioihbjkbjnl/mcl2 huggingface dataset:
BRAIN - Home Intervention Trial
Condition: Asphyxia
MeSH terms: Asphyxia
Study type: Interventional
Phase: Phase 4

Summary: 
      We plan to test a home-based parent-provided early developmental intervention (EI) both in
      infants with mild to moderate birth asphyxia and in infants without perinatal complications
      who will constitute a healthy comparison group in a randomized controlled trial. The trial
      will evaluate the effect of a resource-intensive early intervention (EI) program on the
      outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist
      of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third
      years) between parents and the parent trainer. The control group will receive enhanced health
      counseling (HC).

      The overall goal will be to implement and evaluate an EI program for infants following birth
      asphyxia, which is sustainable in developing countries. The challenge will be to adapt
      programs demonstrated to be effective in developed countries to the circumstances of the
      developing world, while reducing the demands on resources. Because there are limited data on
      normative development and EI programs in developing countries, a group of infants without
      perinatal complications will also be randomized to the same conditions in order to provide a
      comparison of what may be achieved from the intervention in healthy infants in developing
      countries. A final aim will be to address individual variation in EI effects that could be
      due to child and/or family characteristics.

      A randomized controlled experimental design will be used, in which infants who survive
      following birth asphyxia are randomly assigned to either EI or enhanced health education
      counseling (HC). The trial will randomize infants to a home-based parent-provided early
      developmental intervention (EI) with frequent home interaction between parents and parent
      trainers vs. HC. A group of infants without birth asphyxia or other major perinatal
      complications also will be randomized. Children will be examined by masked examiners at three
      time points (12, 24, and 36 month's assessments).
    


Intervention name(s): Early intervention counseling; Health education counseling
Intervention type(s): Other; Other
Intervention description(s): Bi-monthly home visits by counselor; World Health Education health education counseling program at home visits,twice per month
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: asphyxia; neurodevelopmental outcome; home counseling
Safety and Tolerability of BVS857 in Subjects With Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the safety, tolerability, drug label and effect in subjects with and
      without insulin resistance.
    


Intervention name(s): BVS857; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety; BVS857; insulin resistance
Eye Tracking as a Predictor of Methylphenidate Response in Autism With ADHD
Condition: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this research is to use neurophysiological measures to profile strengths
      and deficits for Attention Deficit Hyperactivity Disorder co-morbidity in Autism Spectrum
      Disorder to clarify diagnosis and to predict treatment response.
    

Detailed description: 
      The project "Eye Tracking as a Predictor of Methylphenidate (MPH) Response in Low Functioning
      Autism Spectrum Disorders (ASD) with comorbid ADHD" will investigate the role of a
      non-invasive neurophysiological biomarker in an underserved population to clarify diagnosis
      and guide treatment decisions. Specifically, we will modify an existing eye tracking paradigm
      that discriminates between ADHD and typical youth, for use in an ASD cohort with (ASD+) and
      without an ADHD comorbidity. A case-control design (Aim 1) will lead into a randomized
      placebo controlled trial of MPH in children with ASD with comorbid ADHD (Aim 2). We
      hypothesize that children with ASD+ will demonstrate specific abnormalities in microsaccades,
      eye blink frequency, and pupil dilatation on continuous performance testing that will predict
      MPH treatment response on standardized clinical outcomes for ADHD. As a secondary measure, we
      will also perform a brief electrophysiological measure, short interval cortical inhibition
      (SICI), as measured by paired pulse transcranial magnetic stimulation (TMS). We have
      extensively investigated this measure as a robust predictor of ADHD diagnosis and symptom
      severity in ADHD and typical youth. We anticipate this personalized medicine-based approach
      to clarify ADHD co-occurrence in ASD will result in a novel neurophysiological biomarker will
      enhance diagnostic reliability and better match appropriate pharmacotherapy in a highly
      complex neurodevelopmental disease.
    

Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose methylphenidate; 0.3mg/kg, up to 20mg, rounded to the nearest 2.5mg; Placebo pill identical in appearance to methylphenidate
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      There exist already a few studies that have measured changes of brain metabolism pre and post
      Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all
      performed in a small number of patients and used different methodologies. It is therefore not
      surprising that these investigations provided inconsistent results, as reviewed previously
      {{23 Schmidt,E.Z. 2008}}.

      In patients with treatment-refractory major depressive episodes, the investigators here
      therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur
      after treatment with ECT and (b) whether these correlate with the clinical amelioration of
      symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive
      function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at
      the end of treatment.

      Patients with a treatment refractory depression - defined as absent clinical improvement of
      depressive symptoms after at least two trials with antidepressants from different
      pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30
      Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively
      asked for participation in this study. Patients had to be between 18 and 80 years old and to
      be physically healthy.
    


Intervention name(s): Electroconvulsive therapy; 18-Fluoro-desoxy-glucose positron emission tomography
Intervention type(s): Device; Device
Intervention description(s): treatment for major depression; intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min.
It´s a neuroimaging technique.
Other intervention name(s): no other names; no other names
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; FDG-PET; Electroconvulsive therapy; glucose metabolism
Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, single-dose study to assess the absorption, metabolism, excretion and mass
      balance of [C14] CT1812
    

Detailed description: 
      Open-label, single-dose study to assess the absorption, metabolism, excretion and mass
      balance of [C14] CT1812 in 8 healthy male subjects

      Subjects will be screened 28-days prior to dosing to determine eligibility.

      Eligible subjects will be admitted to the clinical research unit (CRU) on Day -1. On Day 1,
      subjects will receive a single dose of CT1812 with a microtracer dose of [14C] CT1812. Whole
      blood, plasma, urine and fecal samples will be collection during the confinement period.
      Safety will be monitored throughout the study by repeated clinical and laboratory
      evaluations.

      Subjects will be and discharged from the CRU following completion of procedures 168 hours
      post dose (Day 8)
    

Intervention name(s): 300 mg [C14] CT1812
Intervention type(s): Drug
Intervention description(s): Single dose of 300 mg CT1812 with microtracer dose of [C14]
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-dose study
Masking: None (Open Label)
Primary purpose: Basic Science
Prevention of Acute Voiding Difficulty After Radical Proctectomy
Condition: Rectal Cancer; Urinary Retention
MeSH terms: Rectal Neoplasms; Urinary Retention
Study type: Interventional
Phase: Phase 3

Summary: 
      Various adrenergic blockers are used for acute voiding difficulty after proctectomy.
      Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit
      in reducing urinary symptom score and in reducing the rate of intermittent
      self-catheterization for patients with rectal cancer after radical proctectomy.

      This study is to evaluate the efficacy of pharmacologic prevention to ameliorate the
      incidence of postoperative urinary dysfunction.
    

Detailed description: 
      Acute voiding difficulty is caused from damage to pelvic sympathetic nerve after rectal
      surgery, and usually resolved spontaneously within several months after the surgery. However,
      acute voiding difficulty results in prolonged insertion of urinary catheter and is associated
      risk for urinary tract infection. Various adrenergic blockers are used for acute voiding
      difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has
      been reported to have benefit in reducing urinary symptom score and in reducing the rate of
      intermittent self-catheterization for patients with rectal cancer after radical proctectomy.

      This study is to evaluate the efficacy of pharmacologic prevention to ameliorate teh
      incidence of postoperative urinary dysfunction.
    

Intervention name(s): Tamsulosin
Intervention type(s): Drug
Intervention description(s): oral administration of Tamsulosin
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Identify Specific Peripheral Blood Mononuclear Cell (PBMC) MiRNA as Biomarkers for Inflammatory Bowel Disease (IBD)
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational [Patient Registry]

Summary: 
      To find high sensitivity and specificity biomarkers to better diagnose and monitor
      progression of inflammatory bowel disease (IBD). In this study, we try to find miRNAs that
      can used to diagnose or monitor progression of IBD by exploring differential expression of
      miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis
      and healthy controls. And we further validate these miRNAs in a larger population to assess
      their function as biomarkers.
    

Detailed description: 
      Incidence of inflammatory bowel disease (IBD) has been rising in the past decades. However,
      diagnosis and differential diagnosis of IBD still lack gold standard. To diagnose IBD,
      physicians need to combine clinical manifestation, lab results, image examination, endoscopy
      examination and pathology. After diagnosis, patients still need to monitor their disease
      progression. The most accurate way is to do endoscopy examination, however, endoscopy
      examination is an invasive, expensive and uncomfortable procedure. At present, C-reactive
      protein (CRP), erythrocyte sedimentation rate (ESR) and fecal calprotectin are used as main
      noninvasive biomarkers to monitor progression routinely. But their specificities are still
      unsatisfactory. So, it's urgent to find high sensitivity and specificity biomarkers to better
      diagnose and monitor progression of IBD. In this study, we try to find miRNAs that can used
      to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in
      peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and
      healthy controls. And we further validate these miRNAs in a larger population to assess their
      function as biomarkers.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 14-75 years old, diagnosed as CD or UC according to WHO criteria, are
        recruited at specialist IBD clinic. They are excluded if upper GI is the only involved
        part, had colectomy or in artificial opening status or have other autoimmune comorbidity.
Lifestyle Intervention in Obstructive Sleep Apnoea
Condition: Obstructive Sleep Apnoea; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by
      interrupted breathing while sleeping. It is associated with cardiovascular problems such as
      high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are
      overweight and have impaired quality of life. Lifestyle interventions incorporating exercise
      training, dietary advice and behaviour change have been shown to elicit favourable changes in
      quality of life, body mass/composition and cardiovascular risk in a range of patient groups.
      However, no study has investigated the impact of lifestyle modification on such health
      outcomes in patients with OSAHS. This study will address this issue by investigating the
      effects of a lifestyle intervention on quality of life, body mass/composition and
      cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and
      randomly allocated to one of the two groups. Patients in the intervention group will be
      offered a 12-week individualised lifestyle programme consisting of supervised exercise
      training, dietary advice and behaviour change counselling. Patients in the control group will
      receive an educational booklet detailing healthy eating and exercise guidelines but no
      supervised or structured intervention. The results of this study will inform the design of a
      larger, multi-centre randomised controlled trial.
    


Intervention name(s): Combined lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Exercise training, dietary advice, behaviour change counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise; diet; lifestyle; sleep apnoea; obesity
Bobath and Vojta Therapy for DS
Condition: Down Syndrome; Motor Performance; Bobath Therapy; Vojta Technique
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Different physiotherapy approaches and education programs are applied to minimize motor and
      mental impairment in children with Down syndrome (DS). The present study was conducted with
      the aim of comparing the effectiveness of two different physiotherapy approaches in babies
      with Down syndrome in the early period.

      A total of 23 babies with DS aged between 0-24 months were included in the study. Infants
      were randomly divided to two groups: Bobath therapy (BT) group included 12 infants (6 girls
      and 6 boys) and Vojta technique (VT) group included 11 infants (4 girls and 7 boys). The
      infants were applied a total of 12 sessions of physiotherapy (twice weekly during 6 weeks).
      Alberta Infant Motor Scale (AIMS) was used for comparison of motor development level before
      and after the therapy. Emotional status of the mothers was evaluated with Beck Depression
      Scale (BDS) and quality of life was evaluated with Nottigham Health Profile (NHP).
    


Intervention name(s): Bobath Therapy; Vojta technique
Intervention type(s): Other; Other
Intervention description(s): Bobath group received 45 min of sessions three times weekly for 12 weeks. An individual program was scheduled for each case following pre-assessment. It was targeted to enable normal posture, facilitation of corrective balance and protective responses and development of normal movement patterns; Vojta group received the following three times weekly for 12 weeks: 1. Reflex crawling, 2. First stage of reflex turning, 3. Second stage of reflex turning. Stimuli (pressure and stretch) for 30-60 sec were given by using the main stimulus points and auxiliary stimulus points together.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infant with Down Syndrome; Bobath therapy; Vojta technique
The Effect of Nursing Care Program on Women With Endometriosis
Condition: Endometriosis; Quality of Life; Healthy Life Style
MeSH terms: Endometriosis
Study type: Observational [Patient Registry]

Summary: 
      This study was carried out to determine the effect of the endometriosis nursing care program
      (ENCP) given to women with endometriosis in line with the Health Promotion Model, on the
      quality of life and healthy lifestyle behaviors of women.
    

Detailed description: 
      This experimental study, which was conducted in a single-blind, with control group,
      prospective, randomized type in the first test-post-test order, was carried out in the
      endometriosis polyclinic of Istanbul Zeynep Kamil Gynecology and Pediatrics Training and
      Research Hospital.

      In the preliminary evaluation, 46 women with Endometriosis Health Profile Questionnaire-5
      (EHP-5) scores of 22 and above (50 and above in the 100 system) constituted the sample of the
      study, including 23 intervention and 23 control groups. While the Nursing Care Program for
      Women with Endometriosis (NCPE) was applied to the intervention group, only routine care was
      applied to the control group. Introductory Information Form, EHP-5, Healthy Lifestyle
      Behaviors Scale II (HLBSII), and Satisfaction Questionnaire for NCPE were used as data
      collection forms in the study.
    

Intervention name(s): Nursing Care Program for Endometriosis; EHP-5 Endometriosis Health Promotion Model.; Healthy Life Style Behaviours Scale II.; The Satisfaction Questionnaire for Nursing Care Program for women with Endometriosis.
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Nursing Care Program for Endometriosis, developed in line with Health Promotion Model; EHP-5 Endometriosis Health Promotion Model. A questionnaire used to measure the quality of life of women with endometriosis; A questionnaire used to measure the Healthy Life Style Behaviours.; A questionnaire used to measure the satisfaction levels of women with endometriosis who applied the Nursing Care Program for women with endometriosis.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All women diagnosed with endometriosis who applied to the outpatient clinic.
      
Keywords: Endometriosis, Health Promotion Model, Nursing Care
Phenobarbital for Acute Alcohol Withdrawal
Condition: Alcohol Withdrawal
Study type: Interventional

Summary: 
      Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based
      alcohol withdrawal protocol will be associated with decreased need for ICU admission,
      continuous lorazepam infusion and will not be associated with increased adverse events.
    


Intervention name(s): 10 mg/kg IV phenobarbital in 100 ml saline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/kg IV phenobarbital in 100 ml saline; 100 m l saline
Intervention MeSH terms: Phenobarbital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      To determine the effectiveness of adding a physical therapy exercise program to low-level
      laser therapy on the treatment of chronic tinnitus treatment
    


Intervention name(s): Exercise Therapy program added to laser therapy
Intervention type(s): Other
Intervention description(s): a supervised physical therapy exercise program for the neck muscles in the form of manual mobilizations for sternocleidomastoid muscle and upper fibers of trapezius in addition to myofascial trigger point release
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence
      study of orally- and IV-administered rolapitant in healthy male and female subjects.
    

Detailed description: 
      To assess the bioequivalence of a single oral dose of 200 mg rolapitant and a single
      intravenous dose of 185 mg rolapitant administered as an infusion.
    

Intervention name(s): Rolapitant - Oral; Rolapitant - IV
Intervention type(s): Drug; Drug
Intervention description(s): Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight); IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight)
Other intervention name(s): Rolapitant; Rolapitant
Intervention MeSH terms: Rolapitant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention