bioihbjkbjnl/mcl2 huggingface dataset:
Pregabalin for Opiate Withdrawal Syndrome
Condition: Opioid Withdrawal
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      It is a single blind randomized symptom triggered study to assess efficacy and safety of
      pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs.
      clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.
    

Detailed description: 
      Study design: Single-blind randomized symptom-regulated protocol with an active control.
      Eighty patients admitted to an inpatient addiction treatment program will be randomly
      assigned to two groups. The first group (N=40) receives up to 600 mg a day of Pregabalin for
      six days along with symptomatic therapy that is divided into basic treatment that is given to
      all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as
      determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac,
      Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine). The second group (N=
      40) receives up to 600 micrograms of Clonidine a day as the main treatment along with the
      same basic and symptomatic regimen. Opiate withdrawal severity, craving, sleep disturbance,
      anxiety and depression, as well as general clinical impressions and side effects are assessed
      daily by psychiatrists who are blind to patients' group assignment using internationally
      validated quantitative psychometric instruments.
    

Intervention name(s): Pregabalin; Clonidine; Doxylamin; Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).; Clonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
Intervention MeSH terms: Ketorolac; Phenazepam; Clonidine; Pregabalin; Metoclopramide; Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Neuropsychological Functioning Among Children With Tourret's Disorder and ADHD
Condition: Tourette Disorder; Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Tourette Syndrome; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor
      and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity
      disorder (ADHD) and other psychiatric disorders. Literature documents the comorbid condition
      with ADHD predicts an increased functional deficit among individuals with ADHD. The
      information about neuropsychological functioning among individuals with TD adn/or ADHD is
      little in Asian population. This study aims to validate the diagnoses of TD, ADHD, and TD
      comorbid ADHD by symptomatology, neuropsychological measures, and social adjustment. This is
      a case-control study with a sample of 30 subjects with TD, 60 with ADHD, 30 with TD+ADHD, and
      60 controls aged from 6 to 18. All subjects will receive comprehensive assessment including
      standard psychiatric diagnostic interviews using (K-SADS-E), behavioral assessments (SNAP-IV,
      CPRS:R-S, CTRS:R-S, CBCL, YBOCS, YGTSS), social adjustment (SAICA, GCAS), parenting (PBI,
      APGAR) and neuropsychological assessment (CPT, CANTAB, WISC-III). We anticipate that this
      study will provide the primitive data to validate the TD and ADHD using neuropsychological
      and clinical measures.
    


Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Children with ADHD, children with ADHD and Tourette's disorder, normal control
      
Keywords: Tourette disorder, ADHD, comorbidity, neuropsychological
Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one
      dose of four different formulations of the MenACWY conjugate vaccine when given to healthy
      subjects aged 15-19 years. The selection of the best formulation will be based on data
      obtained up to one month after the vaccine dose.
    

Detailed description: 
      3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind
      manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or
      of the active control (Mencevax™ ACWY) will be done in an open manner. Subjects will receive
      one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2
      blood samples taken, before and one month after vaccination.
    

Intervention name(s): Meningococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism
Condition: Prediabetes; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This study was intended to evaluate the effect of vitamin D supplementation on insulin
      sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D
      supplementation to normal levels in patients with impaired fasting glucose will result in
      improved insulin sensitivity and improved beta cell function.
    

Detailed description: 
      A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0,
      baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol
      (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then
      repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH,
      and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data
      was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod
      Millennium software.
    

Intervention name(s): Cholecalciferol (vitamin D3)
Intervention type(s): Dietary Supplement
Intervention description(s): Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.
Other intervention name(s): Cholecalciferol by BIO-TECH Pharmacal, Inc.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vitamin D; Cholecalciferol; Insulin sensitivity; MinMod Millennium; FSIGT; modified frequently sampled IV glucose tolerance test
Pain and Stress Management for People With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Self-management of rheumatoid arthritis (RA) symptoms using written emotional disclosure
      (ED), coping skills training (CST), or a combination of both may benefit people with RA. The
      purpose of this study is to determine the benefits of ED, CST, or CST and ED together in
      adults with RA. This study will be conducted at Wayne State University in Detroit, Michigan
      and Duke University Medical Center in Durham, North Carolina.
    

Detailed description: 
      Two self-management strategies hold promise for improving the health of people with RA: ED
      (writing about stress, RA, and coping options) and CST (learning six pain and stress coping
      skills). A strategy integrating ED with CST may be more effective than either intervention
      alone. This study will compare the effectiveness of ED, CST, ED in combination with CST, and
      control groups in alleviating the symptoms of RA.

      This study will last until May 2009. Participants with RA will be randomly assigned to 1 of 4
      treatment groups. Each participant will receive 3 writing sessions and 8 training sessions.
      Group 1 will receive ED writing followed by CST; Group 2 will receive ED writing followed by
      arthritis education; Group 3 will receive health behavior writing followed by CST; and Group
      4 will receive health behavior writing followed by arthritis education.

      Participants will be evaluated at baseline and at Months 1, 4, and 12 for pain, physical
      disability, psychological impairment, and disease activity. In addition, participants will
      record daily diaries for 30 days regarding their pain, symptoms, coping, stress, and mood
      prior to each of the evaluations. Changes in health status over time will be compared among
      groups.
    

Intervention name(s): Coping skills training; Written emotional disclosure; Arthritis education; Health behavior writing
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 8 sessions of pain and stress coping skills training; 4 sessions of writing about stress; 8 sessions of learning about rheumatoid arthritis; 4 sessions of writing about various health behaviors
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Stress; Coping; Expressive Writing; Self-Efficacy; Disclosure
Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human
      interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure
      with the aim to quench the acute inflammatory response, as measured by the
      area-under-the-curve for C reactive protein over 14 days.
    


Intervention name(s): Anakinra (high dose); Anakinra (standard dose); Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Anakinra 100 mg daily twice daily for days 1, 2, and 3; Anakinra 100 mg daily for days 4-14; Placebo twice daily for days 1, 2, and 3; Placebo daily for days 4-14
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Exposure to Biomass-burning Air Pollution on Lung Function, Heart Rate Variability and Inflammatory Markers in Sugarcane Workers
Condition: Lung Function; Heart Rate Variability; Oxidative Stress; Systemic Inflammatory Response
MeSH terms: Burns
Study type: Observational

Summary: 
      Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and
      prevalent professional activity of agribusiness segment of the Brazilian economy, exposes
      workers and people of neighboring towns to high concentrations of pollutants and, therefore,
      potentially several risks to health hazards.

      Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers
      and volunteers from a nearby town in non-harvest and harvest periods.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population from the city of Mendonça, São Paulo-Brazil, divided into the following groups:
        sugarcane workers (those who work in sugarcane plantations) and controls (healthy
        volunteers from the same city)
      
Biospecimen description: 
      Whole blood.
Caffeinol Hypothermia Protocol
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Hypothermia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2
      glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two
      hour while being cooled to 34.5 C.
    


Intervention name(s): Caffeinol; hypothermia
Intervention type(s): Drug; Procedure
Intervention description(s): Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.; External or internal cooling for 24 hours and rewarming over 12 hours.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Nonhemorrhagic; hypothermia
What Makes People Better at Retrieving Proper Names?
Condition: Healthy Aging
Study type: Interventional

Summary: 
      This study is being conducted to learn more about how various personal and situational
      characteristics are related to the ability to produce names of pictured people. Participants
      will perform a brief mental exercise, then see 83 celebrity photographs to produce the names
      of. Participants will also complete other surveys and measures. Collected data will give
      researchers a better understanding of how different variables relate to proper name
      production.
    

Detailed description: 
      This study is being conducted to learn more about how various personal and situational
      characteristics are related to the ability to produce names of pictured people. Adult
      participants ages 18-35 and 60-80 will participant in videoconference calls during which they
      will perform a brief mental exercise, then see 83 celebrity photographs with instructions to
      name each pictured person. The naming task will be video recorded for later scoring.
      Participants will also complete other surveys and measures, including some about demographics
      and other personal characteristics. Participation will take approximately 60-75 minutes.
      Collected will be de-identified and the aggregate data will give researchers a better
      understanding about how individual's personality and cognitive traits and the mental exercise
      performed before the study relate to people's proper name production.
    

Intervention name(s): Mental Exercise
Intervention type(s): Behavioral
Intervention description(s): Participant perform a 10-minute mental exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to one of two mental exercises before performing a proper name production task and completing other measures.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: cognitive aging; name retrieval
Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
Condition: Dengue Fever; Fever
MeSH terms: Dengue; Fever; Hyperthermia
Study type: Observational

Summary: 
      The purpose of this study is to detect acute febrile episodes and dengue infection in five
      Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure
      at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent
      dengue infection.

      The primary objectives are:

        -  To identify acute febrile episodes among the cohort in order to detect the presence of
           dengue infection.

        -  To develop operational infrastructure for potential Phase III dengue efficacy trial
           sites.

        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of the
           study.
    

Detailed description: 
      All participants will make two visits to a study site, an enrollment visit and a termination
      visit. Additional visits will be made if febrile episodes occur: an acute visit and a
      convalescent visit. Participants or their parents/guardians will be contacted weekly to
      monitor the occurrence of febrile episodes and ensure appropriate assessment and care.

      No vaccine will be provided or administered in this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants aged 2 to 14 years in 5 countries in Asia: Malaysia, Indonesia, Thailand, the
        Philippines and Viet Nam.
      
Keywords: Dengue Fever Fever Dengue Infection
Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)
Condition: Sleep-Disordered Breathing; Pulmonary Disease, Chronic Obstructive; Heart Failure
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleep Apnea Syndromes; Heart Failure
Study type: Observational

Summary: 
      The aim of the study is to test the hypothesis that treatment of sleep disordered breathing
      (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart
      failure (HF) with positive airway pressure (PAP) is associated with reduced risk for
      hospitalizations and death, lower health care utilization, and greater cost-effectiveness.
    

Detailed description: 
      In this retrospective analysis the health care utilization in patients with COPD and HF will
      be quantified. Data of patients who additionally underwent a polysomnography or polygraphy
      between 2012 and 2015 are taken into consideration. The data (risk for hospitalization and
      death, comorbidities, diagnosis and therapy of SDB, costs of health care utilization) will be
      collected 12 months before and 12 months after diagnosis of SDB.

      The patients' medical records will also be reviewed for compliance to treatment for SDB, and
      the patients will be classified as treated or untreated. The treated group will be divided
      into two subgroups: those with "good adherence" to PAP therapy (≥ 4 hours PAP use per night)
      and those with "poor adherence" to PAP therapy (< 4 hours PAP use per night). Healthcare
      Utilizations, HF or COPD exacerbations and mortality will be identified by reviewing medical
      records, National database when available, or self-reported by patient or patient's family
      through phone interview or questionnaire.
    

Intervention name(s): polygraphy or polysomnography
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patient from primary care clinics and sleep medicine centers
Emotion Regulation and Binge Eating in Youth With Obesity
Condition: Obesity; Binge-Eating Disorder
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Observational

Summary: 
      This study will investigate neural activation patterns in emotion- and cognition-related
      brain regions during an emotion regulation task involving cognitive reappraisal, and their
      associations with age and pubertal status, among overweight children and adolescents with
      loss of control eating as compared to overweight and normal-weight controls.
    

Detailed description: 
      Loss of control (LOC) while eating (i.e., the sense that one cannot control what or how much
      one is eating) is prevalent among children and adolescents. LOC eating is associated with a
      range of physical and psychosocial health impairments, including obesity and the development
      of partial- and full-syndrome eating disorders. Early identification is thus critical for
      preventing or minimizing these adverse health outcomes. However, little is known about the
      development of LOC eating in children and, consequently, there is a paucity of effective
      interventions. Impairments in emotion regulation appear to be involved in the onset and
      maintenance of eating pathology in obese samples. To date, emotion regulation in youth with
      LOC eating problems is poorly understood, and research on underlying neurodevelopmental
      substrates is virtually nonexistent. The proposed research aims to characterize
      neurocircuitry involved in emotion regulation among 30 overweight children with LOC eating as
      compared to 30 overweight and 15 normal-weight controls without LOC. Participants will
      complete a cognitive reappraisal task whilst situated in an MRI scanner, the purpose of which
      is to characterize neural activity involved in reappraisal versus an emotion maintenance
      control condition. The proposed research aims to advance the field's understanding of the
      nature and correlates of LOC eating in overweight children so as to inform intervention
      development.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        75 right-handed age- and gender-matched youth, aged 10-17 years
First Episode Psychosis and Pathway to Care in Nordland
Condition: First Episode Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      First episode psychosis patients often experiences treatment delay. This reduces their
      prospects for recovery and makes unnecessary burdens for them and their carers. A better
      understanding of help seeking intentions is required, and has not been explored in a county
      like Nordland, Norway, with long distances and challenging access to health services. The
      purpose of this study is to explore the process of help seeking, including how patients and
      their careers discover and understand the psychotic symptoms. Research exploring the impact
      on families mainly focuses on parents' experiences, and there are less studies focusing on
      experiences and needs of siblings. This study will therefore explore siblings' experiences
      separate from their parents. Methods will be qualitative interviews with patients, their
      carers and siblings. Analysis will be influenced by Grounded theory.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients experiencing first and multiple episode psychosis carers siblings