bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 study designed to evaluate the safety and tolerability of two titration
      schedules for ALKS 5461.
    


Intervention name(s): ALKS 5461
Intervention type(s): Drug
Intervention description(s): Sublingual tablet taken once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; major depressive disorder; Alkermes; ALKS 5461; samidorphan; buprenorphine
Brain Mechanisms of Human Motivation
Condition: Major Depressive Disorder; Bipolar Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      This study aims to investigate reward learning across the mood disorder spectrum and to
      investigate the predictive validity of reward learning for subsequent symptom severity.
    

Detailed description: 
      The study involves five sessions. In the first session, participants will play a computer
      task. In the second session, participants will go through a clinical interview and will have
      an EEG recording while playing another computer task. In the third session, participants will
      undergo an fMRI scan while playing another computer task. All tasks assess reward learning.
      At three and six months after the final session, participants will come back for a follow-up
      interview session during which a clinician will assess symptom severity. There will be no
      intervention in this study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We are studying a population with depressive and/or manic or hypomanic symptoms, as well as
        healthy controls.
      
Keywords: Depression; Major Depressive Disorder; Bipolar Disorder; Mania; Hypomania; EEG; MRI; Reward
Obesity Prevention After Smoking Cessation in Menopause
Condition: Obesity; Menopause
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study addresses the high risk of weight gain associated with smoking cessation in women.
      The obesity prevention pilot study is designed for the primary prevention of weight gain that
      can lead to overweight in normal-weight women, that can progress to obesity in women who are
      already overweight, and for the prevention of additional weight gain in obese women with BMI
      greater than or equal to 30.0. Fat and other macronutrient intake, specifically, sugar,
      complex carbohydrates, and protein, are analyzed as a target for individually tailored,
      weight control intervention following smoking cessation in Caucasian and African American
      women.
    

Detailed description: 
      Middle-aged women, especially African Americans, who quit smoking are at high risk for weight
      gain, overweight, and obesity. Postcessation weight gain has been attributed to increased
      food intake, which in turn, has been ascribed to a selective increase in high-sugar and other
      high-carbohydrate foods with a high-fat content. This study compares the relative
      effectiveness, for postmenopausal Caucasian and African American women, of following an
      empirically validated smoking cessation program with either 1) a group cessation maintenance
      program with standard exercise advice and food pyramid instructions for healthy eating or 2)
      an individually tailored, dietary-control, exercise, weight-management and
      cessation-maintenance program. Effectiveness is assessed by weight change from baseline to
      postcessation months 6, 12, and 20.

      The second aim is to assess overall fat and other specific macronutrient intake (sugar,
      complex carbohydrates, and protein) and total caloric intake with the use of a novel
      macronutrient self-selection paradigm in Caucasian and African-American postmenopausal women
      at baseline prior to smoking cessation, after being abstinent for one week, and again at 6,
      12, and 20 months postcessation.

      The third aim is to assess whether there is differential responsiveness on the above measures
      in postmenopausal Caucasian vs. African-American women.
    

Intervention name(s): Individualized dietary-control and exercise program; Weight-management and smoking cessation maintenance; Smoking Cessation program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Smoking Cessation
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e.,
      airweave®) on sleep and sleep-related symptoms.

      The study will compare effects of use of high rebound mattress toppers versus use of low
      rebound mattress toppers on sleep and sleep related symptoms and core body temperature during
      diagnostic sleep studies.
    


Intervention name(s): Low rebound mattress toppers; High rebound mattress toppers
Intervention type(s): Device; Device
Intervention description(s): Patients will sleep on this mattress topper during their diagnostic sleep study.; Patients will sleep on this mattress topper during their diagnostic sleep study.
Other intervention name(s): TEMPUR-Topper Supreme; airweave® mattress topper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Sleep Apnea; Insomnia; sleep disorders; sleep environment; core body temperature
Retinal Vessel Diameter in Branch Retinal Vein Occlusion
Condition: Branch Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Observational

Summary: 
      The authors investigated the consecutive change of retinal vessel's diameter in affected eye
      and fellow eye of Branch Retinal Vein Occlusion.
    

Detailed description: 
      Twenty five consecutive patients who had undergone intravitreal bevacizumab injection for
      Branch Retinal Vein Occlusion with macular edema were included in this study. All subjects
      were enrolled between April, 2012 and April, 2013 in the Department of Ophthalmology,
      Kyungpook National University Hospital.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 25 patients will be included. All subjects with branch retinal vein occlusion
        scheduled for intravitreal bevacizumab injection.
Combination of Cryosurgery and NK Immunotherapy for Advanced Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      advanced NSCLC.
    

Detailed description: 
      By enrolling patients with NSCLC adapted to enrolled criteria, this study will document for
      the first time the safety and the short and long term efficacy of the combined therapy using
      cryosurgery and nature killer (NK) cells for NSCLC.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK Immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance); Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-small cell lung cancer; Cryosurgery; NK Immunotherapy
The Neural Basis of Oxytocin's Effects on Empathy
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The main focus of this study is to examine oxytocin effects on behavioral and neural indices
      of empathy processing.
    

Detailed description: 
      The neuropeptide oxytocin (OXT) has been demonstrated to modulate empathy in previous
      behavioural studies. The present study aims at replicating previous findings on OXT on
      empathy as well as to determine the neural basis of these effects.

      In a between-subject, randomized double-blind design, subjects will be either administered
      intranasal OXT or placebo nasal spray (40 IU). 45 minutes after administration subjects will
      undergo (fMRI) tasks of empathic processing.

      During the tasks subjects will be shown empathy inducing stimuli, and the behavioral and
      neural response in terms of cognitive, emotional and indirect emotional empathy will be
      assessed.

      Before the administration of treatment, validated questionnaires assessing potential
      confounding variables, such as depression (Becks Depression Inventory (BDI)) or mood
      (Positive And Negative Affect Scale (PANAS)) will be administered to the subjects.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 international units; 40 international units
Other intervention name(s): Oxytocin Treatment; Placebo treatment
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; fMRI; empathy
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
Condition: Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A prospective, multicenter, randomized study to assess the safety and effectiveness of
      FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of
      persistent and paroxysmal atrial fibrillation.
    

Detailed description: 
      The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided
      procedures will eliminate the source of clinical arrhythmias in subjects with clinical
      indications for repeat AF ablation procedures.

      This study is a prospective, multicenter, randomized, controlled study to assess the safety
      and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation
      versus a standard conventional procedure including pulmonary vein isolation for the
      redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous
      pulmonary vein isolation.
    

Intervention name(s): Standard PVI; FIRM-Guided Procedure and PVI
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard PVI procedure without FIRMap.
Other intervention name(s): Pulmonary vein isolation; Ablation; Arrhythmia; Atrial fibrillation Mapping; Pulmonary vein isolation; Atrial fibrillation Mapping; FIRMap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: FIRMap, Rotor, FIRM-guided procedure
Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different surgical approaches for total knee
      replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle
      (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the
      knee components. Both will have the same skin incision.
    


Intervention name(s): Total knee arthroplasty
Intervention type(s): Procedure
Intervention description(s): staged bilateral total knee arthroplasty (not more than 7 days between surgeries)
Other intervention name(s): Stryker Triathlon posterior stabilized components
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total knee arthroplasty
Research in Severe Asthma (RISA) Trial
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Alair System for the
      treatment of severe refractory asthma.

      This will be a multicenter, randomized controlled study comparing the effects of treatment
      with the Alair System to standard drug therapy in patients with severe asthma refractory to
      standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group
      (Medical management + Alair Treatment) OR the Control Group (Medical management only).
    

Detailed description: 
      Multicenter, randomized, clinical trial conducted at 8 Investigational Sites in 3 countries.

      Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy
      sessions, while subjects in the Control group will complete 3 "Control Visits" to the
      Physicians office, timed to coincide with the 3 treatment bronchoscopy sessions. Following
      completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks
      and 12 weeks. All subjects to remain on their maintenance asthma medications until they are
      evaluated again at 22 weeks after the last procedure or Control Visit. This phase from the
      last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is
      termed the Steroid Stable Phase.

      Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks (termed the Steroid Wean
      Phase) during which an attempt will be made to wean them off either their maintenance inhaled
      corticosteroids (ICS) or, if taking maintenance oral corticosteroids (OCS), their oral
      steroids. If a subject cannot tolerate the steroid reduction at a particular level (as
      evidenced by loss of asthma control), they will be stabilized on their last tolerable dose of
      steroid.

      All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean
      Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks (termed the
      Reduced Steroid Phase). All subjects will be exited from the study following completion of
      the 52 week evaluations.
    

Intervention name(s): Bronchial Thermoplasty with the Alair System; Control
Intervention type(s): Procedure; Drug
Intervention description(s): Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day.; Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.
Other intervention name(s): Alair System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Bronchial Thermoplasty
Sapropterin as a Treatment for Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to provide a definitive test of the hypothesis that elevating
      sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in
      the CNS will result in measurable improvements in core symptoms of autism in young
      individuals, under age 6 years. The study will entail a double-blind, placebo-controlled
      16-week intervention.
    

Detailed description: 
      Over the past 20 years, several studies have suggested that sapropterin (tetrahydrobiopterin)
      might ameliorate core symptoms of autism at least in young (under age 6) subjects. However,
      those studies had somewhat questionable methodologies, a major one being that the doses of
      sapropterin used were roughly one tenth that thought to be needed to provide physiologically
      meaningful increases of sapropterin in the central nervous system (CNS). This study will look
      at the impact of a sustained exposure to this higher dose in well-diagnosed young children
      with autism.
    

Intervention name(s): sapropterin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks; Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks.
Other intervention name(s): Kuvan; tetrahydrobiopterin; sugar pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism
Feasibility Trial of the Early Psychological Support for the Critically Ill
Condition: PICS
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      This is a pilot study designed to test feasibility of a psychotherapeutic intervention for
      the critically ill patients in intensive care units. Intervention is named Early
      Psychological Support for the Critically Ill (EPSCI)
    


Intervention name(s): Early Psychological Support for the Critically Ill (EPSCI)
Intervention type(s): Behavioral
Intervention description(s): early psychological support based on positive therapeutic suggestion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Condition: Arterial Dysfunction; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether nutritional (cholecalciferol) or active
      vitamin D (calcitriol) supplementation improves vascular endothelial function in patients
      with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The
      investigators hypothesize that the use of calcitriol supplementation will result in improved
      vascular endothelial function as compared to cholecalciferol supplementation.
    


Intervention name(s): Cholecalciferol; Calcitriol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D; Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic kidney disease; vitamin D deficiency
Global Post-market Registry for the Treovance Stent-graft.
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Observational [Patient Registry]

Summary: 
      Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR)
      with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years;
      infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or
      thrombus formation; infrarenal or distal iliac landing neck size requirements specified in
      the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA
      endovascular or surgical repair. The primary endpoints were standard EVAR criteria.
    

Detailed description: 
      The goal of the registry was to collect clinical data of TREOVANCE® device in subjects with
      infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology is treated
      with an acceptable technical success rate, an acceptable complication rate and that the
      device performs as expected.

      The following endovascular measures/parameters were assessed for preliminary performance at
      the follow-up intervals: delivery/deployment, stent-graft migration, stent-graft patency,
      stent-graft integrity, endoleak, aneurysm sac size changes, limb ischemia, and vascular
      access complications.

      This registry was a prospective, multi-center, post-market non-randomized study. The goal was
      to gather safety and performance data on the device. Subjects diagnosed with infrarenal
      aortic aneurysms enrolled into the registry were treated with the TREOVANCE® Stent-Graft with
      Navitel® Delivery System. Pre-procedure baseline data was gathered as well as post-procedure
      assessments prior to hospital discharge and 1, 6, and 12 months post-implantation.
    

Intervention name(s): TREOVANCE® Stent-Graft with Navitel® Delivery System
Intervention type(s): Device
Intervention description(s): Endovascular repair of abdominal aortic aneurysms.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects diagnosed with infrarenal aortic aneurysms requiring endovascular repair.
Pilot HPV Vaccination in Chinese American Community
Condition: HPV
Study type: Interventional

Summary: 
      This study provides a pioneer model in increasing knowledge of HPV vaccination among Chinese
      American families through culturally tailored interventions, and eventually increase the HPV
      vaccine uptake among Chinese American adolescents.
    


Intervention name(s): Interventional HPV vaccination video modules; General Vaccination Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The study team provide participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. The educational videos were aiming to reinforcement and improvement the awareness, knowledge, attitude, intention and actual uptake of HPV vaccination shots among Chinese parents.; Education session conducted using only handouts of vaccinations including HPV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effects of Urinary pH Changes on an Investigational Compound in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to explore the effect of increased and decreased urinary pH on the
      single pharmacokinetic (PK) dose of LY2140023 and its active metabolite LY404039. All
      participants will receive the three treatments in a randomized order.
    


Intervention name(s): LY2140023; Ammonium chloride; Sodium bicarbonate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science