bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult Childhood Cancer Survivors
Condition: Childhood Cancer Survivors
Study type: Interventional

Summary: 
      The goal of this project is to evaluate the feasibility of the "Managing Your Health" online
      self-management skills+peer mentoring intervention that focuses on overcoming survivor
      barriers to self-management of their survivorship care. We will conduct a pilot randomized
      controlled trial (RCT) of the intervention versus usual care with adolescent and young adult
      survivors of childhood cancer ages 18-25 years. Participants will complete survey measures at
      baseline, Time 2 (about 2 months after baseline), Time 3 (about 5 months after baseline), and
      Time 4 (about 12 months after baseline).
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate the feasibility of the online self-management+peer mentoring program in a pilot
      RCT.

      II. Assess preliminary efficacy of the intervention.
    

Intervention name(s): Managing Your Health: Self-Management + Peer Mentoring
Intervention type(s): Behavioral
Intervention description(s): The online educational component consists of 5 self-management educational modules:
(1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy.
Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation
Condition: Non-small Cell Lung Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Adjuvant therapy has been proved effective in treating earlier stage or less advanced
      non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as
      adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The
      primary endpoint is disease-free survival.
    


Intervention name(s): Icotinib
Intervention type(s): Drug
Intervention description(s): Icotinib is administered 125 mg three times per day.
Other intervention name(s): Commana; BPI-2009
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study of Hetrombopag Olamine in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of
      increasing platelet count in animal and human. This study is designed in dose escalation
      fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.
    

Detailed description: 
      1. To evaluate safety and tolerability of Hetrombopag Olamine.

        2. To investigate pharmacokinetics of Hetrombopag Olamine Under fasting conditions.

        3. To obtain pharmacodynamics information of Hetrombopag Olamine on platelet count
           elevation in healthy volunteers.

        4. To determine preliminary regimen for phase II study.
    

Intervention name(s): Hetrombopag Olamine Tablets; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis
Condition: Bilateral Primary Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this study is to develop regenerative cell therapy for use in patients
      with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study
      that assesses the safety and feasibility of using concentrated bone marrow aspirate
      containing MSC to treat patients with painful knee OA.
    

Detailed description: 
      Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates
      for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee
      pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from
      the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one
      knee will be injected with the bone marrow concentrate. The contralateral knee will be
      injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be
      at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12
      months and MRI imaging will be performed at 6 months after injection, with repeat radiographs
      at 12 months
    

Intervention name(s): Autologous Bone Marrow Aspirate Concentrate; Sterile saline
Intervention type(s): Drug; Drug
Intervention description(s): Autologous Bone marrow aspirate will be concentrated using Magellan Cell Separator and stem cell kit according to the Standard Operating Procedures is to be injected in the treatment knee. 5ml of treatment cells will be combined with 10 ml of previously separated platelet poor bone marrow plasma and used for injection under ultrasound guidance into one of the subject's painful knees.; Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: osteoarthritis
Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Macular Hole
Condition: Macular Hole
MeSH terms: Retinal Perforations
Study type: Observational

Summary: 
      To evaluate the correlations between anatomical and functional changes studied with
      microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of
      idiopathic macular hole (MH).
    


Intervention name(s): Microperimetry
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent successful surgery for MH defined as closure of the hole, at least 1
        year before.
Ventricular and Pulmonary Vascular Reserve After the Fontan Operation
Condition: Heart Failure; Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic
      dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise
      testing.

      Aim #2: Determine the role of rest-exercise echocardiography for the assessment hemodynamics
      in Fontan physiology.

      Aim #3: Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic
      dysfunction.
    

Detailed description: 
      Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction
      as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing.
      Subjects with Fontan palliation will undergo cardiac catheterization during exercise. The
      investigators hypothesize that invasive hemodynamic assessment during supine exercise will
      enable identification of early stage pulmonary vascular disease and diastolic dysfunction
      that is not apparent from invasive studies performed at rest.

      Determine the role of rest-exercise echocardiography for the assessment hemodynamics in
      Fontan physiology. Transthoracic echocardiography will be performed at rest and during
      exercise simultaneously with catheterization in the subjects participating in Aim #1 to
      determine correlations between invasive and noninvasive hemodynamics and identify noninvasive
      alternatives to assess functional reserve.

      Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic
      dysfunction. Multi-organ function and patient reported outcomes will be evaluated at
      baseline, 12 months (optional), and 24 months (optional) in subjects participating in Aims #1
      and #2. The investigators hypothesize that subjects with poorer ventricular-vascular reserve
      will display more clinical and end-organ deterioration in longitudinal follow up.
    

Intervention name(s): rest-exercise echocardiography
Intervention type(s): Diagnostic Test
Intervention description(s): an echocardiogram performed during rest and exercise
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fontan palliation
Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The aim of this project is to follow cohort of patients with aMCI in order to establish
      whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory
      profiles and profiles of mesiotemporal atrophy and metabolic change
    

Detailed description: 
      The syndrome of "amnestic Mild Cognitive Impairment" (aMCI) has been introduced for patients
      with intact activities of daily living, with a memory complaint and objective memory decline
      on neuropathological assessment, without significative change in other domains of cognition.
      Follow-up in these patients shows that the memory impairment may remain stable or improve,
      while it worsens or extends to other cognitive domains in others, indicating prodromal AD.
    

Intervention name(s): Neurological and neuropsychological consultation, MRI; Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
Intervention type(s): Other; Other
Intervention description(s): Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36; Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Major Depressive Disorder With Mixed Features - Extension
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with
      mixed features.This clinical study is designed to test how well Lurasidone works to treat
      major depressive disorder with mixed features over time.
    


Intervention name(s): Lurasidone
Intervention type(s): Drug
Intervention description(s): Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Lurasidone; Latuda
Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Condition: ADHD; Substance Abuse
MeSH terms: Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of osmotic-release methylphenidate
      (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.
    

Detailed description: 
      Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in
      adolescents with substance abuse disorders and indicates that they have poorer substance use
      treatment outcomes and poorer prognosis and risk of persistence and progression of drug use
      and behavior problems into adulthood. Although research indicates that the majority are not
      treated for ADHD while in substance treatment, we do not know whether concurrent
      pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN)
      study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to
      placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with
      ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11
      sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment
      period, during which all participants will receive individual cognitive-behavioral therapy as
      a standardized treatment for substance abuse.
    

Intervention name(s): Methylphenidate (OROS-MPH); Methylphenidate (OROS-MPH) - Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.; Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
Condition: Condylomata Acuminata
MeSH terms: Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus
      [qHPV] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital
      lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or
      anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human
      Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received
      randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study
      follow-up continued through Month 36. In Extension 1 (EXT1), participants who received
      placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine.
      Participants were followed in EXT1 for 7 months. In Extension 2 [LTFU (EXT2)], long-term
      effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years
      following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base
      Study or EXT1 were eligible to enroll in LTFU (EXT2).
    


Intervention name(s): (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; Comparator: placebo (unspecified)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study; 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study
Other intervention name(s): qHPV; V501
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: anogenital warts
Perineural Injection Therapy for Ulnar Neuropathy at Elbow
Condition: Ulnar Neuropathy at Elbow
MeSH terms: Peripheral Nervous System Diseases; Ulnar Neuropathies
Study type: Interventional

Summary: 
      Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy.
      Although many conservative managements of UNE, the effectiveness of these methods are
      unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural
      injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment
      for entrapment neuropathy. However, current studies have not proved the effects of PIT on
      peripheral neuropathy because these studies enrolled small number of patients and lacked
      controlled design. We design a randomized, double-blind, controlled trail to assess the
      effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.
    

Detailed description: 
      After obtaining written informed consent, 40 patients, clinically diagnosed with mild or
      moderate UNE were randomized into intervention or control group. Participants in intervention
      group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and
      control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc)
      ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and
      Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area
      (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of
      palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the
      1st, 3rd and 6th month after the treatment.
    

Intervention name(s): 5% dextrose; 2cc 0.9% normal saline+3cc Triamcinolone (30mg); Ultrasound
Intervention type(s): Drug; Drug; Device
Intervention description(s): Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve; Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve; The ultrasound was used for injection guidance
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ulnar neuropathy at elbow; Dextrose; perineural injection
A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm, open-label, multicenter, phase II study to evaluate the anti-tumor
      activity, PK and immunogenicity of AK104 in patients with metastatic nasopharyngeal carcinoma
      who have progressed after at least 2 prior lines of systemic chemotherapy (of which one of
      them must be platinum-based chemotherapy).
    


Intervention name(s): AK104
Intervention type(s): Biological
Intervention description(s): Subjects will receive AK104 by intravenous administration
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immuno-oncology; PD-1/CTLA-4 Bispecific
Two Monitors for Measuring the Activated Clotting Time: A Comparison
Condition: Cardiopulmonary Bypass; Blood Coagulation; Point-of-Care Testing
Study type: Observational

Summary: 
      In this observational study a comparison is made between two different monitors for
      measurement of the activated clotting time (ACT): mechanical versus biochemical techniques
    

Detailed description: 
      The ACT is a functional test influenced by multiple factors, such as platelet function,
      coagulation factors, temperature and contact activation inhibitors. Results produced by
      different monitors are also prone to vary influenced by the specific method employed to
      perform the test.

      The present clinical study aims to compare two types of ACT monitors: the Hemostatic
      Management System Plus (Medtronic) and i-STAT (Abbott) in 20 cardiac surgical patients by
      performing five intraoperative consecutive measurements using anti factor Xa as a reference
      for the actual heparin concentration.

      Inclusion criteria comprised patients aged 20-80 years, scheduled for coronary bypass
      surgery.

      Measurements: 1) before induction of anaesthesia 2 ) after heparin bolus 3) rewarming of the
      patient 4) weaning from cardiopulmonary bypass 5) after protamine administration.

      The Hemostatic System Plus ACT monitor served as reference for dosing of heparin in all
      patients. The study protocol did not intervene with the standard protocol used for
      anticoagulation. No patient interventions were made.

      It is hypothesised that the i-STAT ACT monitor has a better correlation with the actual
      heparin concentration than the Hemostatic Management System Plus
    

Intervention name(s): Point-of-Care ACT
Intervention type(s): Diagnostic Test
Intervention description(s): Comparison between two point-of-care devices for measurement of the activated clotting time
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted for routine coronary bypass surgery with the use of cardiopulmonary
        bypass
      
Keywords: Cardiopulmonary Bypass; Blood Coagulation Testing; Point-of-Care Testing
Insulin, Neurogenetics and Memory in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines the use of insulin-sensitizing compounds, as therapeutic agents for
      cognitive impairment in Alzheimer's disease.
    


Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Energy Drinks and Vascular Function
Condition: Vascular Function
Study type: Interventional

Summary: 
      The purpose of this study will be to examine the acute effect of commercially available
      energy products on endothelial function, arterial stiffness and thrombosis in healthy young
      males.
    

Detailed description: 
      The use of energy products has significantly increased in the last few years and is
      especially high among young men. The present study will compare the acute effect of a
      commercially available energy drink, energy gum, coffee and control beverage on endothelial
      function, arterial stiffness and circulating markers of thrombosis, inflammation and
      oxidative stress.
    

Intervention name(s): energy drink; caffeinated drink; Energy gum; placebo gum; Control drink; Total sleep deprivation
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): 16 oz cold commercially-available energy drink; 16oz cold commercially-available caffeinated drink; 2 pieces of commercially-available energy gum; 2 pieces of commercially-available placebo gum; 16oz cold control drink; 24-hour total sleep deprivation prior to consumption of energy drink and placebo gum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Energy drink consumption