bioihbjkbjnl/mcl2 huggingface dataset:
Sleep's Influence on the Treatment of Intrusive Emotional
Condition: Intrusive Memories; PTSD
Study type: Interventional

Summary: 
      Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent
      psychiatric disorders following trauma. Exposure therapy is amongst the most successful
      treatments of PTSD that is recommended by most of the current national and international
      guidelines. The current study aims to test whether sleep as adjunct to written exposure
      sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the
      therapy.
    

Detailed description: 
      Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent
      psychiatric disorders following trauma. Exposure therapy is amongst the most successful
      treatments of PTSD that is recommended by most of the current national and international
      guidelines. However, not all patients benefit equally and only about 50% show sustained
      response. There is thus room for improvement in terms of (i) better understanding who
      benefits from this type of therapy and (ii) possible ways of augmenting existing
      trauma-focused therapies. The current study aims to contribute to these endevours.
      Specifically, the study aims to test whether sleep as adjunct to written exposure sessions, a
      type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.
    

Intervention name(s): Sleep/Nap
Intervention type(s): Behavioral
Intervention description(s): Participants sleep after a maximum of three sessions of exposure therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; memory; consolidation
Fontan Udenafil Exercise Longitudinal Assessment Trial
Condition: Single Ventricle Heart Disease
MeSH terms: Heart Diseases; Univentricular Heart
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the clinical efficacy and safety of udenafil, an orally
      administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of
      adolescent subjects who have undergone the Fontan procedure.
    

Detailed description: 
      This study is a randomized, double-blinded, efficacy trial of the effects of udenafil vs.
      placebo on the background of standard therapy on maximal VO2 (ml/kg/min) from baseline to six
      months in adolescent survivors of the Fontan procedure. . The target sample size is 400
      subjects (200 per group).
    

Intervention name(s): Udenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug; Matching Placebo
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fontan; Maximal Oxygen Consumption; Vascular Function; EndoPAT; Myocardial Performance
Investigations Into ISCU Myopathy or Iron Sulfur Scaffold U Protein Myopathy
Condition: Myopathy
MeSH terms: Muscular Diseases
Study type: Observational

Summary: 
      Background:

      - A mutation in a gene known as ISCU was found to be the cause of a rare myopathy that
      affects the muscles. Researchers collected clinical samples from people with this myopathy.
      More research is being done to develop a therapy for this disease. Researchers are asking for
      permission to study the samples already collected.

      Objectives:

      - To allow researchers to use clinical samples collected to study new treatments for ISCU
      myopathy.

      Eligibility:

      - People with ISCU myopathy who have provided clinical samples for study.

      Design:

        -  Participants will allow researchers to study clinical samples already collected. Blood,
           urine, muscle, and cell samples may be used. Medical records and photographs may also be
           studied.

        -  Treatment will not be provided as part of this study.
    

Detailed description: 
      In 2008, NIH investigators collaborated to find a mutation in the human gene, ISCU, which is
      the official human gene name for a gene involved in assembly of iron sulfur clusters, and is
      abbreviated from Iron Sulfur Cluster assembly protein, U, which was identified as the cause
      of a rare myopathy that affected about 25 patients in Sweden. This protocol is intended to
      allow for the collection and analysis of clinical specimens and medical information from
      several research subjects who previously participated in studies that led to identification
      of the disease gene.
    

Observational model: Case-Only
Time perspective: Other
Keywords: Metabolism; Muscle; Mutation; ISCU Myopathy; Myopathy
Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
Condition: Heart Failure; Atrial Fibrillation
MeSH terms: Heart Failure; Atrial Fibrillation
Study type: Interventional

Summary: 
      The positive effect of physical training in patients with heart failure (HF) has been
      increasingly established. However, the presence of atrial fibrillation (AF), mainly in its
      permanent form, makes the clinical condition of the patients more compromised.
    

Detailed description: 
      The positive effect of physical training in patients with heart failure (HF) has been
      increasingly established. However, the presence of atrial fibrillation (AF), mainly in its
      permanent form, makes the clinical picture of these patients more compromised. The literature
      has not yet demonstrated studies involving indication of physical exercise therapy when AF is
      associated with HF. Thus, the hypothesis is that physical training improves functional
      capacity, cerebral oxygenation, autonomic aspects, vascular aspects, cardiac function, plasma
      markers, quality of life and cognitive function of these patients.
    

Intervention name(s): Physical Training
Intervention type(s): Behavioral
Intervention description(s): Participants will perform physical training three times a week on a stationary bicycle. The exercise intensity will be controlled between 14 and 16 by the Borg Scale for 40 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To evaluate the physical effect of physical training in patients with heart failure and permanent atrial fibrillation
Masking: None (Open Label)
Primary purpose: Other
Keywords: heart failure, atrial fibrillation and exercise training
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately
      to severely active Crohn's Disease with a history of inadequate response to or intolerance to
      Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
    


Intervention name(s): Placebo; ABT-494
Intervention type(s): Drug; Drug
Intervention description(s): Oral Dosing; Oral Dosing
Other intervention name(s): Upadacitinib
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's Disease
Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to
      develop an appropriate challenge model. To this end, this first-in-human study will examine
      the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product
      and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.
    


Intervention name(s): Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)
Intervention type(s): Biological
Intervention description(s): Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 administered as a single injection.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dengue
Network Support for Alcohol Treatment 2
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      The Network Support project is part of an ongoing effort to improve treatment for alcohol
      dependent patients. The Network Support Project is designed to help patients change their
      social network from one that reinforces drinking behavior to one that reinforces sobriety.

      160 patients will be assigned to one of two treatments. Each of the treatments will last 12
      weeks. The first is a Network Support (NS) treatment designed to help patients develop new
      acquaintances and social networks. It is expected that alcohol dependent patients will
      benefit from increasing their contact with non-drinking people. This NS condition will be
      compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number
      of skills to help people stop drinking, but does not address social networks per se.

      In order to better understand what is happening to the investigators patients, the
      investigators will be using daily computerized telephone calls to ask about people's
      experiences. This will be done both before and after treatment. Patients will also be asked
      to participate in follow-up interviews every 3 months for 2 years following the end of
      treatment.
    


Intervention name(s): Coping Skills Training
Intervention type(s): Behavioral
Intervention description(s): Patients in both treatments will be taught skills to help them keep from drinking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol dependence; Network Support; Cognitive-behavioral treatment; Relapse prevention; Consequences of drinking; Social network development
Ruxolitinib for Polycythemia Vera in Patients Resistant to or Intolerant of Hydroxyurea.
Condition: Polycythemia Vera (PV)
MeSH terms: Polycythemia Vera; Polycythemia
Study type: Observational

Summary: 
      This was an analytical and descriptive, non-interventional, retrospective cohort study of PV
      patients aged ≥ 18 years in the US using a secondary data source, Optum EHR database.
    

Detailed description: 
      The Optum EHR database was current up to 30-Jun-2020.

      Identification period: From 01-Apr-2007 to 30-Jun-2019

      Study period: From 01-Jan-2007 to 30-Jun-2020

      Index date:

      First evidence of resistance to or intolerance of HU treatment in patients with PV according
      to modified European Leukemia Net (ELN) criteria and defined as:

        1. HCT ≥ 45% with phlebotomy (last phlebotomy within last 3 months) Or

        2. Platelet count > 400 x 109/L and presence of palpable splenomegaly (palpable spleen up
           to 3 months after platelet count)

      Pre-index period:

      Patients had a minimum of 3 months pre-index data available. Pre-index data availability was
      determined using the reported 'first month active' field.

      Post-index period:

      There was no minimum post-index period required. Each patient had a 'first month active' and
      'last month active' reported within the database. As the 'last month active' was based on any
      activity in the database, including encounters such as letters and emails which occurred
      several months after the 'death_date' of the patient, using the 'last month active' can
      overestimate the follow-up for a given patient. For this reason, the end of follow-up for
      each patient was defined as the date of the last activity within the diagnosis, observations,
      prescriptions, laboratories, procedures tables or discharge date from the last visit within
      the visit table (whichever of these activities occurs latest). This underestimated the
      follow-up for some patients where they were not actively using healthcare resources.
    

Intervention name(s): Ruxolitinib
Intervention type(s): Other
Intervention description(s): PV patients who were resistant to or intolerant of HU (as defined on the index date) and switched to RUX in the post-index period.
Other intervention name(s): Jakavi
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        PV patients who were resistant to or intolerant of HU in the Optum EHR database between
        April 2007 and June 2019
      
Keywords: Polycythemia vera,; Ruxolitinib,; JAK protein inhibitor,; Hydroxyurea,; Thrombotic events
Race Adiposity Interactions Regulate Mechanisms Determining Insulin Sensitivity
Condition: Insulin Sensitivity; Fat; Liver
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Observational

Summary: 
      This research study will examine how ethnic/racial background, body composition (%body fat),
      and the location of body fat affect the ability of the hormone insulin to promote uptake of
      blood sugar in persons who are 19 to 45 years of age. When insulin is ineffective in
      promoting blood sugar uptake, this condition is termed "insulin resistance." Insulin
      resistance plays a major role in the development of chronic metabolic diseases (such as type
      2 diabetes, cardiovascular disease, and cancer), many of which differ with race. Previous
      studies suggest that insulin resistance is higher in African-Americans (AA) vs.
      European-Americans (EA). However, results from these studies remain unclear due to different
      testing measures used for insulin resistance as well as differences in body fat between
      individuals. Results from this research study may help explain why insulin resistance differs
      with genetic background and may guide development of personalized treatment strategies with
      implications for several chronic metabolic diseases (e.g., type 2 diabetes, cardiovascular
      disease, and cancer).
    

Detailed description: 
      Insulin resistance plays a major role in the etiology of chronic metabolic diseases, many of
      which differ with race/ethnicity. Previous studies using mainly indirect methods suggest that
      insulin sensitivity is lower in AA vs. EA. Our preliminary data using the reference standard
      glucose clamp indicate that in lean individuals, insulin sensitivity is lower among AA, while
      in obese individuals, insulin sensitivity is higher among AA. We hypothesize that this
      race/body mass index (BMI) interaction may be explained in part by significantly lower
      visceral and hepatic fat accumulation in AA. Conversely, based on our preliminary data, we
      hypothesize that inherently greater oxidative stress impairs insulin sensitivity even in AA,
      explaining lower insulin sensitivity in lean AA vs. EA. We propose to test these hypotheses
      by prospectively comparing skeletal muscle and hepatic insulin sensitivity in healthy lean,
      overweight, and obese AA and EA using the hyperinsulinemic isoglycemic glucose clamp.
      Analysis of ancestral genes will permit simultaneous assessment of the contribution of
      ancestry to main outcomes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        African American and Caucasian Males and Females between 19-45 years old
      
Biospecimen description: 
      DNA will be used to identify ancestry. This information is needed to understand why African
      Americans and Caucasians have different risks for developing certain diseases.
Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess if the sublingual tablet will have similar pharmacokinetics as the conventional
      tablet of alprazolam.
    


Intervention name(s): Alprazolam tablet; Alprazolam sublingual
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg single dose of alprazolam conventional tablet; 1 mg single dose of alprazolam sublingual tablet
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; sublingual; alprazolam; pharmacokinetics
Muscle Relaxation Therapy With Odorant Cue
Condition: Generalized Anxiety Disorder; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      A novel procedure for generalized anxiety disorder where an odorant cue is paired with the
      state of deep relaxation during training. It is hypothesized that by smelling the odor in an
      anxiety-provoking situation, the patient will more easily invoke a state of relaxation,
      providing greater relief from the distressing tension and worry that characterize GAD.
    

Detailed description: 
      We hypothesize that by presenting a novel odor to a patient in a state of deep relaxation,
      the odor will serve as a conditioned inhibitory stimulus, or safety signal, in
      anxiety-provoking situations. With the odor serving as a contextual cue for the state of
      relaxation.
    

Intervention name(s): Odorant Cue
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Anxiety; Mental Health
Universal Influenza A Vaccine in Healthy Adults
Condition: Human Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this Phase 1, single- center, randomized, double blind, placebo-controlled
      dose-escalation study is to evaluate the safety, tolerability and immunogenicity of UFluA
      vaccine candidate at two dose levels and two schedules in healthy adult (18-45-year-old,
      inclusive) male and non-pregnant female subjects.
    

Detailed description: 
      A total of 60 healthy adult subjects will be enrolled in the study and followed through Day
      337 (i.e., up to 48 weeks after first dose). Subjects will be enrolled into two study cohorts
      to receive either a low dose (Cohort 1; n=30 receives) or high dose (Cohort 2; n=30) of
      adjuvanted UFluA or placebo (saline), administered intramuscularly (IM) as single dose or as
      two doses (administered 21 days apart).

      UFluA is comprised of DP-UFluA (1:1 A1-ssnp and A2-ssnp antigens) and contains aluminum
      hydroxide and CpG adjuvants.

      Primary Objective:

      To evaluate safety and tolerability of UFluA IM administration in healthy adults.

      Secondary Objectives:

      To assess anti-hemagglutinin humoral immune responses in healthy adults who receive UFluA. To
      assess ferritin (Helicobacter pylori and human) immune response in healthy adults who receive
      UFluA.
    

Intervention name(s): UFluA 20 µg each antigen/dose; UFluA 60 µg each antigen/dose; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Low dose; High Dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: universal; universal influenza vaccine; phase 1; randomized; double-blind; placebo
Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury
Condition: Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Acquired brain injury can result in impaired everyday functioning as well as psychosocial
      problems, including depressive symptoms, irritability, or negative self-concept. The purpose
      of this study is to determine whether a combination of neuropsychological and cognitive
      behavioral therapy is effective in the treatment of these sequelae.
    

Detailed description: 
      Acquired brain injury (ABI) commonly results in persistent cognitive, emotional and
      motivational problems. About 50% of patients involved develop psychiatric illness, most
      likely in the first year following ABI, which is associated with reduced psychosocial
      functioning and less favorable rehabilitation outcome. Treatment of these complex conditions
      requires a combination of neuropsychological and psychotherapeutic intervention techniques.

      This study aims at evaluating a combination of neuropsychological intervention methods, which
      include developing and using compensation strategies for cognitive impairments (attention,
      memory and executive functions), and psychotherapeutic intervention focusing on emotion
      regulation, developing positive self-concepts and adjustment of life-goals. These therapeutic
      interventions are modularized and patients are assigned to intervention modules according to
      results of objective neuropsychological testing and interviews.
    

Intervention name(s): Neuropsychological Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Neuropsychological Cognitive Behavioral Therapy encompasses 2 foci: First emphasis is on neuropsychological compensatory strategies for the treatment of deficits in attention, memory, and executive functions. Secondly, cognitive behavioral intervention techniques are employed to support the patient in the process of coping with chronic illness: i.e. improve regulation of negative affect, diversify the impaired self-concept after acquired brain injury, and adjust important life-goals to changed circumstances.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain Injury; Neuropsychology; Cognitive Behavioral Therapy; Neuropsychological Rehabilitation
Impact of PAX Good Behavior Game on Elementary School Students in Estonia
Condition: Mental Health Wellness 1; Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The aim of this study is to measure the impact of the intervention (PAX GBG) in
      Estonian-language 1st grade classrooms on students' mental health and behaviour, and
      teacher's self-efficacy.
    

Detailed description: 
      2-year, matched-pair, cluster-randomized controlled trial with a intervention and wait-list
      control arm is conducted during school years 2016/17 and 2017/18. 42 volunteering schools
      were matched to pairs. One school in each pair was randomly selected to receive the PAX GBG
      or continue their normal activities without intervention. After a post-test assessment in
      spring 2018 the control group teachers are trained and supported to implement PAX GBG.
    

Intervention name(s): PAX Good Behavior Game
Intervention type(s): Behavioral
Intervention description(s): PAX GBG includes evidence-based kernels and a classroom game where students are reinforced for their mutual success in withholding inappropriate behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention