bioihbjkbjnl/mcl2 huggingface dataset:
Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Hispanics With RRMS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Gilenya (fingolimod) is approved for multiple sclerosis. However, it is unclear of its
      clinical effect in the Hispanics with MS given that clinical studies had limited
      representation of this population. It is also unclear if Gilenya would be as effective in
      individuals with disease predominantly affecting the optic nerve and spinal cord (OSMS)
      commonly seen in Asian populations.

      Objectives: To compare the clinical response of Gilenya® (fingolimod) in relapsing remitting
      OSMS and MS of Hispanic descent using ancestral markers as a biomarker of treatment response
      and clinical disease state.
    

Detailed description: 
      The primary objective of this study is to determine the success of Gilenya® (fingolimod)
      treatment in patients with MS of Hispanic descent relative to their ancestral background.
      Therapeutic success will be determined by annualized relapse rate (ARR; defined as the number
      of relapses divided by the person years followed) after initiation of treatment with Gilenya®
      (fingolimod)in comparison to the relapse rate in the previous 12 months. This will be
      determined based on medical chart extraction, in-person assessment and regular clinical
      follow-up.

      A secondary objective of this study is to investigate whether the efficacy of Gilenya®
      (fingolimod) is superior or equal in HW which have higher loads of Amerindian versus
      Caucasian background with opticospinal MS (OSMS-NMO neg) versus classical MS (CMS) in the
      first 12 months using radiological and clinical parameters. The following measures will be
      obtained:

        1. Number of relapse-free patients over the investigational period

        2. Site of relapse defined as brain or spinal cord.

        3. Sustained Disability progression will be defined as a one point (1) increase from
           baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5)
           increase in patients with baseline EDSS score of 5-5.5 or above after 3 months.

        4. MRI changes as described as number of new T2 lesions and number of Gd-enhancing lesions
           after 12 months from baseline.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit 50 individuals with MS who self identify Hispanic descent and are served at
        USC clinics. Hispanic patients with clinically definite MS, defined by the newly revised
        McDonald criteria, will be offered the opportunity to participate in this study and asked
        to give informed consent.
      
Biospecimen description: 
      DNA will be extracted from isolated cells; the remaining cells will be cryopreserved for any
      duplicate analyses.
    
Keywords: Multiple Sclerosis; MS; Autoimmune
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis
Condition: Adenoviral Conjunctivitis
MeSH terms: Conjunctivitis, Inclusion; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy
      and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to
      Placebo in the Treatment of Adenoviral Conjunctivitis
    


Intervention name(s): IVIEW-1201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days; Placebo drug; QID; one drop per eye, four times per day (QID) for 7 days
Other intervention name(s): Treatment Arm; Placebo Treatment Arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IVIEW-1201; Adenoviral Conjunctivitis
Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will determine the effectiveness of cognitive behavioral therapy in preventing a
      relapse of depressive symptoms in children.
    

Detailed description: 
      Depression is a chronic and episodic condition that may have devastating effects on social
      and emotional functioning, particularly in the pediatric population. While approximately 90%
      of children eventually recover from an episode of depression, up to 40% of those children
      relapse within 1 to 2 years. Data indicate that cognitive behavioral therapy (CBT) delivered
      after depressive symptoms subside can significantly reduce depression relapses in adults.
      However, there are no comparable studies in children or adolescents. This study will
      determine whether CBT is effective in reducing a relapse of depressive episodes in children
      and adolescents with major depression.

      This study comprises two phases. In Phase 1, all participants will receive drug treatment for
      12 weeks. Participants who respond to the treatment will complete the study after 12 weeks.
      Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2. In
      Phase 2, participants will be randomly assigned to either continue drug therapy alone or to
      receive drug therapy plus CBT for 6 months. The CBT will focus on teaching participants
      skills to manage depressed moods and to identify situations which might put them at risk for
      a relapse in depressive symptoms. Self-report scales will be used to assess the depressive
      symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the
      study.
    

Intervention name(s): Cognitive behavioral therapy (CBT); Drug therapy
Intervention type(s): Behavioral; Drug
Intervention description(s): CBT sessions will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms.; All participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms).
Other intervention name(s): fluoxetine
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Child; Adolescent; CBT; Drug Therapy
Kinesio Taping in Stroke Patient
Condition: Stroke; Cardiovascular Diseases; Physical Disability
MeSH terms: Stroke; Cardiovascular Diseases
Study type: Interventional

Summary: 
      Despite being nearly independent in daily life, chronic high-functioning stroke survivors
      still experienced mild impairments in skilled hand function. Kinesio Taping (KT) has been
      used to help stroke patients improve their balance and ambulation. Few studies explored the
      effects of KT on fine motor function in stroke patients. The purpose of this study was to
      investigate the hand function performance of high-functioning stroke survivors after KT.
      Participants were divided into two groups: KT group and control group. Last two days, the KT
      group received KT intervention. After the taping was removed, baseline and post-test
      evaluation were conducted. Outcome measures included muscle strength, range of motion (ROM),
      spasticity, fine motor function, and self-reported upper limb disability. The results
      revealed that the KT group had less spasticity, increasing ROM trend, and improved fine motor
      function and disability. KT improved spasticity, active movement, and muscle flexibility,
      resulting in more skilled and delicate hand function in chronic high-functioning stroke
      survivors.
    


Intervention name(s): Kinesio taping
Intervention type(s): Other
Intervention description(s): Kinesio taping is a non-invasive physical treatment, which is breathable, hypoallergenic and elastic. Because of the mechanical properties and physiological effects, Kinesio taping has been thought to relieve pain, reduce swelling, support and relax soft tissue, promote motor performance, and correct posture or abnormal movement patterns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: kinesio tape; high-functioning stroke; hand function; stroke
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Condition: Locally Advanced Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local
      recurrence is still the major cause of failure together with distant metastasis.
      postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the
      overall survival. Adjuvant chemotherapy has also improved the survival in different studies.
      This study is performed to test the efficacy and toxicity of adding the two modalities
      together compared to each modality alone.
    


Intervention name(s): Radiation; gemcitabine and cisplatin; Radiotherapy and Drug
Intervention type(s): Radiation; Drug; Other
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: locally advanced bladder cancer; Postoperative radiotherapy; Adjuvant chemotherapy; Radical Cystectomy
Mildronate for Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic
      drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating
      acute ischemic stroke.
    

Detailed description: 
      A randomized, double-blind, multi-center clinical study was made on mildronate injection for
      treating acute cerebral infarction. 113 cases in the experimental group were given with
      mildronate injection, while 114 cases in the active-control group were given with cinepazide
      maleate injection. In addition, both groups were given aspirin as basic treatments. Modified
      Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale
      (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse
      events were evaluated.
    

Intervention name(s): mildronate injection; cinepazide maleate injection; aspirin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da; infusion of plabcebo once a day and for 14 days; infusion of aspirin (100mg) once a day for days
Intervention MeSH terms: Aspirin; Cinepazide; 3-(2,2,2-trimethylhydrazine)propionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized trial; acute ischemic stroke; mildronate
Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes
Condition: COPD
Study type: Interventional

Summary: 
      Researchers want to learn more about telehealth pulmonary rehabilitation programs that help
      people with Chronic obstructive pulmonary disease (COPD) improve physical activity and
      quality of life.
    


Intervention name(s): Telehealth Program
Intervention type(s): Behavioral
Intervention description(s): Telehealth program delivered remotely to study participants. Program developed by Cambium Technologies.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
Condition: Chronic Troublesome Sialorrhea; Cerebral Palsy; Stroke; Traumatic Brain Injury; Intellectual Disability
MeSH terms: Sialorrhea; Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Intellectual Disability; Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate the efficacy and safety of NT 201 compared with
      placebo for the treatment of chronic troublesome sialorrhea associated with neurological
      disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in
      children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.
    


Intervention name(s): NT 201 Placebo; NT 201
Intervention type(s): Drug; Drug
Intervention description(s): NT 201 placebo matching injection.; NT 201 injection.
Other intervention name(s): IncobotulinumtoxinA; Xeomin; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Blood Donation and Subjective Well-being
Condition: Blood Donation; Happiness
Study type: Interventional

Summary: 
      Studies have suggested a positive relationship between prosociality and well-being. attempt
      to analyze the relationship between blood donation and subjective well-being, and try to
      figure out the moderators and mediators. Also, the investigators would like to compare
      difference of subjective well-being between donors who are explicitly presented with
      information that the participants' blood has saved patient's life and those who are not.
    


Intervention name(s): Information
Intervention type(s): Other
Intervention description(s): A reminder to inform donors that their blood has saved patient's life in a questionnaire.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD).
    


Intervention name(s): Placebo; Vilazodone
Intervention type(s): Drug; Drug
Intervention description(s): Viibryd
Other intervention name(s): Matching 10 mg and 20 mg placebo tablets, once-daily oral administration.; Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once daily
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder, GAD
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is:

      Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate
      the efficacy
    


Intervention name(s): OPB-31121; OPB-31121 phase2
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month); Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma
Does Numerical And Pictorial Information On Risk And Benefit Affects The Uptake Of Colorectal Cancer Screening?
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      To establish whether provision of numerical data, framed as event rates and illustrated by
      pictograms, and including figures for all-cause mortality, affects subjects' attitudes to
      colorectal cancer (CRC) screening.

      Design and Intervention. Randomised questionnaire and telephone study comparing the responses
      of a control group given the standard National Health Service (NHS) CRC screening information
      with the responses of an intervention group given the same information but enhanced with
      additional numerical and pictorial information.

      Setting
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects attending GP and hospital outpatients
      
Keywords: colorectal cancer; consent; screening
Comparative Effects of Post-exercise Ingestion of a High or Low Molecular Weight Solution on Resistance Exercise Performance
Condition: Task Performance and Analysis
Study type: Interventional

Summary: 
      This study sought to examine differences in resistance exercise performance, as measured by
      the kinetic and kinematic profile during multiple sets of the back squat exercise, following
      ingestion of high or low molecular weight carbohydrate beverages.
    


Intervention name(s): Vitargo ®, Swecarb AB, Karlskrona, Sweden; DE15 maltodextrin, Matrin® M160, Grain Processing Corporation, Muscatine, IA; Placebo: Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of
      pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born
      to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal
      glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in
      how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there
      is a paucity of data guiding practitioners in the intrapartum management of blood glucose
      levels for women with GDM, particularly those treated with insulin antepartum. The goal of
      this project is to compare two protocols of intrapartum glucose management in women with GDM
      and investigate the impact on neonatal blood glucose levels.
    

Detailed description: 
      Research objective- To compare "Tight" vs. "Less Tight" intrapartum glucose management

      Hypothesis: Neonates born to mothers managed via the "Less Tight" intrapartum glucose
      management protocol will have lower mean glucose levels in the first 24 hours of life when
      compared to mean glucose levels among infants born to mothers managed via the "Tight"
      intrapartum glucose management protocol.

      Study Design: Randomized trial

      Population: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes
      in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants
      Hospital

      Once enrolled, patients will then be randomized to "Tight" or "Less Tight" intrapartum
      glucose control.

      Once admitted to the labor floor for intrapartum management the appropriate power plan for
      glucose control will be initiated. The specifics of labor management will be left to the
      discretion of the provider.
    

Intervention name(s): Standard Protocol for intrapartum glucose management; Experimental Protocol for intrapartum glucose management
Intervention type(s): Other; Other
Intervention description(s): Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60mg/dL; Less Tight: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60 mg/dL
Other intervention name(s): Tight Control; Less Tight Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Intrapartum
Work Productivity and Social Activities In Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis; Work Productivity
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to evaluate the relationship between decrease in work productivity
      and social activities in patients with Ankylosing Spondylitis (AS) with disease activity,
      depression and quality of life together with demographic data.
    

Detailed description: 
      For this study, which is planned as a cross-sectional clinical study, 100 patients who were
      diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical Therapy
      Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between April 15,
      2019, and April 15, 2020, and 100 healthy volunteers compatible with age. was included.
      Demographic data of the participants were recorded. Work productivity and activity reduction
      questionnaire: general health (WPAI: GH), social role participation questionnaire short form
      (SRPQ), short form-36 (SF-36), hospital anxiety, and depression scale (HADS), will be
      evaluated. Besides, if the patient group exists, laboratory results (CRP, erythrocyte
      sedimentation rate, HLA-B27), and bath ankylosing spondylitis functional index (BASFI), bath
      ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis metrology
      index (BASMI), visual analog scale (VAS) resting, night and activity values were recorded.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        For this study, which is planned as a cross-sectional clinical study, 100 patients who were
        diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical
        Therapy Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between
        April 15, 2019, and April 15, 2020, and 100 healthy volunteers compatible with age was
        included.
      
Keywords: Spondylitis; Ankylosing; Quality of Life; Employment