bioihbjkbjnl/mcl2 huggingface dataset:
Implementation of Truma-Focused Cognitive Behavioral Therapy (TF-CBT) in Norway
Condition: PTSD
Study type: Observational

Summary: 
      Trauma-focused cognitive behavioral therapy (TF-CBT) is an evidence-based treatment method
      for children and adolescents who have been exposed to traumatic experiences and who are
      experiencing posttraumatic stress symptoms. TF-CBT has been implemented in Norwegian child
      and adolescent mental health clinics since 2012. The Ministry of Health is funding the
      implementation project, and the Norwegian Center for Violence and Traumatic Stress Studies
      (NKVTS) is responsible for the implementation, including training of therapists, quality
      monitoring, and research.
    

Detailed description: 
      All participating child and adolescent mental health clinics received training by TF-CBT
      senior trainers at NKVTS in screening for trauma exposure and posttraumatic stress. A
      sub-sample of the therapists received training in TF-CBT. Data are collected on treatment
      outcomes for quality assurance.
    

Intervention name(s): Trauma-focused cognitive behavioral therapy (TF-CBT)
Intervention type(s): Other
Intervention description(s): TF-CBT is an evidence-based treatment method for children and adolescents who have been exposed to trauma and experience posttraumatic stress symptoms. The treatment model has a family and caregiver focus, and non-offending caregivers are included in the treatment. TF-CBT is normally provided through 8-12 treatment sessions.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents aged 6-18 referred to Norwegian child and adolescent mental health
        clinics.
      
Keywords: PTSD; Trauma treatment; Implementation
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to
      assess the safety, efficacy, tolerability and steady-state plasma trough concentration of
      flexible-dosed aripiprazole once-daily administration in children and adolescents with
      Tourette's syndrome. A total of around 120 subjects will be randomized to aripiprazole (2~20
      mg) or placebo in a 1:1 ratio (approximately 60 subjects in each group), for treatment of 8
      weeks.
    

Detailed description: 
      Screening phase: It can last up to 42 days, including the screening visit (V1), a washout
      period when applicable, additional screening visit (V1a) and baseline visit (V2). The
      screening phase will serve the following purposes: 1) To allow for appropriate washout of
      prohibited medications; 2) To review the screening data; 3) To establish a pretreatment
      baseline of critical outcome measures.

      Treatment phase: It lasts 8 weeks; the purpose of the treatment phase is to assess the
      efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole
      in the treatment of children and adolescents with Tourette's syndrome.

      Safety follow-up phase: All subjects will be followed up for safety (adverse events) at Day
      16 after the final medication via telephone
    

Intervention name(s): Aripiprazole Oral Solution; Placebo Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole 2-20 mg/day (2-20 mL/day); Placebo 2-20 mg/day (2-20 mL/day)
Other intervention name(s): Aripiprazole OS; Abilify; Placebo
Intervention MeSH terms: Aripiprazole; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette; Aripiprazole Oral Solution
Yoga for the Management of HIV-Metabolic Syndromes
Condition: HIV Infections; HIV Metabolic Cardiovascular Syndrome; HIV Lipodystrophy; HIV Metabolic Syndromes; Hypertension
MeSH terms: Hypertension; Lipodystrophy; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      We are testing the safety and efficacy of a 16-wk yoga lifestyle intervention on oral glucose
      tolerance, fasting lipid/lipoprotein levels, body composition, cardiovascular function,
      quality of life, CD4+ T-cell counts and viral load in HIV-infected men and women with
      components of The Metabolic Syndrome. We hypothesize that a yoga lifestyle intervention will
      improve metabolic, anthropometric, cardiovascular disease parameters, and quality of life
      domains without adversely affecting immune or virologic status in people living with HIV.
    

Detailed description: 
      Very few safe, effective, and novel treatments for metabolic syndromes that develop in
      HIV-infected people exist. These metabolic syndromes may increase cardiovascular disease risk
      in HIV-infected people and may reduce their quantity and quality of life. Practicing a yoga
      lifestyle intervention may provide a safe, effective and novel therapy for HIV metabolic
      syndromes, but this alternative form of therapy has not been tested in HIV-infected people
      with metabolic syndromes. In men and women with HIV-related metabolic syndromes, we will
      determine:

        1. The safety of practicing a yoga lifestyle in HIV-infected people treated with HAART who
           are experiencing metabolic and anthropometric syndromes.

        2. To quantify the effects of practicing a yoga lifestyle on metabolic and anthropomorphic
           syndromes in HIV-infected people treated with HAART who are experiencing these
           syndromes.

        3. To quantify the effects of practicing a yoga lifestyle on cardiovascular disease (CVD)
           risk in HIV-infected people treated with HAART who are at increased CVD risk because of
           existing metabolic and anthropomorphic syndromes.
    

Intervention name(s): Yoga lifestyle intervention; Standard of care
Intervention type(s): Behavioral; Other
Intervention description(s): Sixteen weeks of 2-3 yoga sessions per week, 1.5 hrs per session administered by a certified yoga instructor. Sessions include breathing exercises and yoga postures/positions.; Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary.
Other intervention name(s): Hatha yoga; Ashtanga yoga; Observation control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; AIDS; insulin resistance; diabetes; dyslipidemia; visceral adiposity; subcutaneous adipose wasting; cardiovascular disease; hypertension; endothelial function; quality of life; Complementary Therapies
Simvastatin and Diastolic Dysfunction
Condition: Diastolic Dysfunction; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals
      whose treatment remains unclear. Its presence is related to higher morbidity and mortality
      independent of blood pressure levels. The aim of this study is to investigate the additive
      effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol
      levels.

      For this aim, hypertensive patients with DD and LDL-cholesterol <160 mg/dL will undergo a
      run-in phase to achieve a systolic blood pressure (SBP) <135 mmHg and diastolic blood
      pressure (DBP) <85 mmHg with enalapril. Hydrochlorothiazide could be added when need to
      achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen
      patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks.
      Echocardiograms will be performed before and after treatment with measurement of left atrial
      volume, conventional and tissue Doppler velocities in early diastole and late diastole. The
      evaluation of these will allow to identify changes of DD severity after treatment.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg once a day; 1 pill once a day
Other intervention name(s): Zocor
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diastolic dysfunction; hypertension; Statins; ACE inhibitor; Echocardiography
Dexmedetomidine in Children Having Transthoracic Echocardiography
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Sedation Techniques for children undergoing transthoracic echocardiography (TTE).
    

Detailed description: 
      The goal in this study is to determine if there is a significant difference in the quality of
      sedation between two standard sedation techniques and between two doses of dexmedetomidine
      for children undergoing (TTE).
    

Intervention name(s): Chloral Hydrate; Dexmedetomidine; Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 70mg/kg chloral hydrate; 2mcg/kg; 3mcg/kg; Flavored placebo syrup
Intervention MeSH terms: Dexmedetomidine; Chloral Hydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transthoracic echocardiography; echo; TTE
Postpartum Pelvic Floor Workshop
Condition: Pelvic Floor Disorders; Pelvic Floor; Incompetency; Pelvic Floor Muscle Weakness; Perineum; Injury
MeSH terms: Muscle Weakness; Pelvic Floor Disorders
Study type: Interventional

Summary: 
      After having a baby, there are some expected changes in pelvic floor function. However,
      tearing of the pelvic floor, having a large baby and needing a vacuum or forceps to deliver
      the baby put women at risk for having pelvic floor disorders. Our study aims to see if, in
      women who had a high risk for pelvic floor disorders, a pelvic floor education workshop four
      weeks after delivery can improve pelvic floor disorders compared to those that did not have a
      workshop.
    

Detailed description: 
      There is compelling evidence for the need for perineal education and care, especially in
      women who have recognized risk factors. For example, 30-50% of women who have a clinically
      recognized risk factor report anal incontinence, fecal urgency, dyspareunia and perineal
      pain. Despite this, a study found that less than 50% of women with anal incontinence voice
      those symptoms unless directly asked about them.

      Some authors discuss how women may not share these symptoms with their care providers out of
      the belief that it is a "normal" effect of childbirth. A review of the literature shows that
      antenatal educational workshops can be an effective means to provide pregnant women with
      information regarding pelvic floor health, including how modes of delivery impact pelvic
      floor function. Similarly, antenatal pelvic floor workshops have been found to improve
      patients' knowledge on pelvic floor health, their practice of pelvic floor muscle exercises
      and their confidence with these exercises.

      To our knowledge, there is no literature exploring the role of a postpartum pelvic floor
      workshop, on managing perineal and pelvic floor symptoms in women who are identified as being
      at higher risk of developing pelvic floor dysfunction. Our goal is to develop and assess such
      a workshop.
    

Intervention name(s): Pelvic floor workshop
Intervention type(s): Behavioral
Intervention description(s): Physiotherapist-led workshop on managing pelvic floor symptoms
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to the intervention or control group. The intervention group will receive the perineal education workshop. The control group will receive standard care. Both groups will receive surveys at baseline, 3, 6 and 12 months postpartum to assess pelvic floor distress.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postpartum perineal education
Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug
Condition: Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, randomized, multi-centre, superiority study to assess that, in patients who
      respond to zonisamide added as third drug after failure of a two-drug combination therapy,
      the triple therapy is superior to the conversion to a double therapy including zonisamide.
    


Intervention name(s): Adjunctive Zonisamide; Replacement with Zonisamide
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events.; Patients will continue to receive zonisamide as third drug
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy
Condition: Acute Lymphocytic Leukemia; Diffuse Large Cell Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Large B-Cell, Diffuse; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to evaluate humanized CD19 redirected autologous T cells (or huCART19
      cells) in patients with relapsed or refractory CD19+ leukemia and lymphoma that was
      previously treated with cell therapy. This study is targeting pediatric patients aged 1-24
      years with CD19+ B cell malignancies with no available curative treatment options (such as
      autologous or allogeneic stem cell transplantation) who have a limited prognosis with
      currently available therapies and were previously treated with a B cell directed engineered
      cell therapy product.
    


Intervention name(s): huCART19
Intervention type(s): Biological
Other intervention name(s): huCTL019
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brief Behavioral Weight Loss Treatment vs. Weight Watchers
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of Weight Watchers, brief
      behavioral treatment, and a combination treatment. We hypothesize that a combination
      treatment will achieve greater weight losses than Weight Watchers alone.
    

Detailed description: 
      Weight Watchers is a popular nonmedical commercial weight loss program. Recent studies
      suggest that people enrolled in Weight Watchers lose approximately 3-5 kg in 6 months of
      treatment. These outcomes are substantially lower than average weight losses achieved in 6
      months if university/hospital-based standard behavioral treatment (approximately 10 kg).
      However, standard behavioral weight loss programs are expensive and have limited
      accessibility to most people seeking weight loss. Therefore, the purpose of the current study
      is to investigate whether enhancing Weight Watchers by adding an 8-week group-based
      behavioral weight loss program prior to participation in Weight Watchers will improve weight
      loss outcomes at 6 months.

      Comparison: 6 months of Weight Watchers vs. combination treatment (2 months of standard
      behavioral weight loss treatment followed by 4 months of Weight Watchers) vs. 2 months of
      standard behavioral treatment.
    

Intervention name(s): Weight Watchers; brief behavioral weight loss treatment; brief behavioral + Weight Watchers combined treatment
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: behavioral weight loss treatment; brief behavioral treatment; commercial weight loss programs; Weight Watchers
Structure and Function of the Gastro-esophageal Junction
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Aims of research project:

      To identify key features of the gastro-esophageal junction (structure and function) that
      protects the esophagus from gastro-esophageal reflux investigated by combined high resolution
      manometry and magnetic resonance imaging.

      Hypothesis:

        1. Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric
           distension determine whether or not TLESR occurs; however

        2. Structural factors including separation of GEJ anatomy, intra-gastric distribution of
           the meal and secretions determine whether TLESR is accompanied by no reflux event, gas
           reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').

        3. Initial findings by descriptive studies in healthy volunteers (study #1) and patients
           with mild to moderate gastro-esophageal reflux disease (study #2) will be further
           interrogated by a randomized, double-blind control trial of baclofen in patients with
           GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .
    


Intervention name(s): Baclofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement); Placebo single 'dose' 90 minutes prior to study
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry
Safety Study of Live Attenuated Influenza Vaccine, CodaVax
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to assess the safety, tolerability, and immunogenicity of the
      CodaVax-H1N1 influenza vaccine as compared to active and placebo controls when administered
      to healthy adults.
    

Detailed description: 
      This randomized, double-blind, placebo and active controlled Phase I study is intended to
      study the effects of a live-attenuated vaccine against influenza A H1N1. Part 1 of this study
      will enroll 75 participants at a single site. Participants will be randomized in a 2:2:1
      ratio to receive one dose each of either CodaVax-H1N1, FluZone quadrivalent, or placebo. This
      study is conducted during the influenza "off season" in Australia. Part 2 of the study will
      enroll an 50 additional participants randomized to receive either CodaVax-H1N1 at a higher
      dose or placebo (40:10).
    

Intervention name(s): CodaVax-H1N1; Fluzone quadrivalent
Intervention type(s): Biological; Biological
Intervention description(s): Live-attenuated vaccine against influenza A H1N1, A/California/07/2009; Fluzone® (QuadriFlu - TIV), inactivated, quadrivalent influenza vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: vaccines; live-attenuated vaccine; influenza vaccine
Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess the relative systemic bioavailability of
      diclofenac in the presence and absence of capsaicin by comparing the systemic bioavailability
      of diclofenac from a combination product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) with
      two diclofenac only products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel,
      following topical administration.

      In order to examine potential racial differences in pharmacokinetics (PK), the study
      population will be stratified 50:50, Caucasian versus Black people. With respect to the main
      objective, additionally a supportive analysis will be performed to investigate the influence
      of race on the intra-individual bioavailability ratios.
    


Intervention name(s): Diclofenac Sodium; Diclofenac & Capsaicin; Diclofenac Sodium Topical Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): twice daily; twice daily; twice daily
Intervention MeSH terms: Diclofenac; Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment