bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory CNV in Young Patients (ALINEA).
Condition: Inflammatory Choroidal Neovascularization
MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and
      Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment
      should not be delayed.

      InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)
      therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated
      in AMD. Case reports suggest that such patients would not need as many injections as in AMD.

      ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main
      objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment
      with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage
      regimen is designed to achieve maximum efficiency. The patients are followed on a monthly
      basis until 52 weeks. The first injection is mandatory. The other ones are injected only in
      case of active InCNV.
    


Intervention name(s): Aflibercept
Intervention type(s): Drug
Intervention description(s): The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated at inclusion (mandatory injection) with reinjection every 4 weeks only in case of CNV activity (PRN regimen) until 52 weeks.Therefore, each patient receives between 1 and 13 injections in the whole study.
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aflibercept; inflammatory choroidal neovascularization; young patient
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of
      rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.

      Secondary Objective:

      -To assess the safety of sarilumab added to MTX in Japanese RA participants with an
      inadequate response to MTX.
    

Detailed description: 
      The total duration of study was expected up to 62 weeks (screening period of 4 weeks,
      treatment period of 52 weeks, and a 6-week post treatment observation).
    

Intervention name(s): Sarilumab SAR153191 (REGN88); Placebo (for sarilumab); Methotrexate; Folic acid
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Dispensed according to local practice.; Dispensed according to local practice.
Intervention MeSH terms: Folic Acid; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Urdu Version of Parkinson's Disease Questionnaire: Reliability and Validity Study
Condition: Quality of Life
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      In the study , the researchers will investigate the reliability and validity of Urdu version
      Parkinson's Disease Questionnaire in Pakistani population having Parkinsonism
    

Detailed description: 
      The study is aimed to translate and culturally adapt Parkinson's Disease Questionnaire-39
      into Urdu language and to investigate validity and reliability of Parkinson's Disease
      Questionnaire-39 in Parkinson's diseased patient among Pakistani population.The study will be
      a cross sectional survey in which non-probability purposive sampling technique will be used
      to enroll the participants into the study as per criteria.

      The results of the study will help to establish an understanding of validity and reliability
      of Urdu version of Parkinson's Disease Questionnaire-39 with quality of life of Parkinson's
      Disease patients in Pakistani population having Parkinson's Disease. Reliability of the scale
      will be checked through internal consistency and test-retest methods. Cronbach's alpha value
      will be used to analyze internal consistency and for analyzing test-retest reliability an
      intraclass correlation coefficient with 195 patients will be used
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson Disease in advanced age along tremors, rigidity and bradykinesia
        and postural abnormalities.will be recruited in this study.
      
Keywords: Parkinson's Disease Questionnaire-39; Parkinson's Disease; Reliability; Validity; Urdu Version
Promoting Sleep to Prevent Substance Use in Adolescence
Condition: Sleep; Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The goal is to adapt and refine an innovative, developmentally-appropriate universal health
      promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while
      engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness
      of the program for diverse school settings.
    

Detailed description: 
      The goal is to adapt and refine an innovative, developmentally-appropriate universal health
      promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while
      engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness
      of the program for diverse school settings.

      The investigators aim to conduct a pilot feasibility randomized controlled trial (RCT) among
      adolescents (n = 300) who will be randomized to Sleep Fitness (SF) or Sleep Education (SE) to
      obtain effect size estimates in preparation for a larger scale intervention study. This pilot
      trial is designed to obtain preliminary data for the following hypotheses:

      SF, compared to SE, will produce greater pre-post improvement in sleep after treatment and at
      6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants,
      depending on resources).

      SF, compared to SE, will produce greater pre-post reductions in substance use after treatment
      and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of
      participants, depending on resources).

      SF, compared to SE, will produce greater pre-post improvement on selected mental health
      outcomes (anxiety, depression) after treatment and at 6 month follow-up (with the possibility
      of a 12 month follow-up for a subset of participants, depending on resources).
    

Intervention name(s): Sleep Fitness Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of 5-7 sessions. Each session includes interactive and small group discussions. The intervention also includes lessons on sleep science, behavior change strategies, and one-on-one motivational interviews on behavior change motivation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sleep; Substance Use; Adolescents
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in
      Japanese participants with episodic migraine.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache
Minocycline to Treat Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to test the safety, tolerability, and effectiveness of
      minocycline compared to placebo in patients with amyotrophic lateral sclerosis (ALS).
    

Detailed description: 
      ALS is a progressive neurodegenerative disorder without cure or known treatment that
      significantly improves function. Loss of motor neurons in the brain and spinal cord of ALS
      patients causes the progressive symptoms. Laboratory studies have linked inducible nitric
      oxide synthase (iNOS) and caspase enzyme activation to motor nerve cell death in ALS.
      Minocycline-a medication currently approved by the FDA for treatment of bacterial
      infections-is a tetracycline antibiotic with high central nervous system penetration when
      taken orally. The drug inhibits the activity of iNOS and caspase enzymes.

      Minocycline has been tested and shown to protect nerve cells in many scientific experiments.
      It reduces cell death and prolongs survival in animal models of ALS, stroke, trauma,
      Huntington's disease, and Parkinson's disease. It has been shown to be beneficial in many
      different animal experiments of ALS, conducted in Europe, Canada and the United States.

      Minocycline has been tested in 2 preliminary human trials and has been shown to be safe in
      patients with ALS. It has been well tolerated in conjunction with riluzole (Rilutek), the
      only currently FDA-approved medication for ALS.

      This trial is the final important step in determining whether minocycline improves the course
      of ALS. The principle objective of this clinical trial is to determine whether minocycline
      slows disease progression and helps maintain function in patients with ALS. This multi-center
      placebo-controlled study will select patients early in the course of ALS, when a
      neuroprotective therapy may be most beneficial. The study will measure change in function (as
      detected by ALSFRS-R scores), strength, pulmonary function, survival, and quality of life.
      Participants will undergo monthly outpatient evaluations and analysis of laboratory and
      adverse events. This is a 13-month study.
    

Intervention name(s): minocycline
Intervention type(s): Drug
Intervention MeSH terms: Minocycline
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: ALS; amyotrophic lateral sclerosis; minocycline
Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
Condition: Opioid-use Disorder; Opioid Dependence; Opioid Abuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that
      applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain
      that the investigators determine to be healthier, more mature, and less traumatized.
      Investigators will compare an active and a sham treatment given twice weekly for 4-weeks.
      Investigators hope this will lead to a significant weapon in the battle against the opioid
      epidemic as well as lead to psychological and physiological insights into possible relations
      among trauma, cerebral laterality, and addiction.
    

Detailed description: 
      This project is to demonstrate that a novel treatment for opiate addiction is safe and far
      superior to a sham comparison treatment. The treatment is hoped to significantly aid in the
      battle against the opioid epidemic that is ravaging much of the country and the world. The
      treatment consists of using a 4-minute application of transcranial photobiomodulation, near
      infra-red mode, through a supra-luminous LED, to one side of the forehead over the brain
      hemisphere that we determine (through a proprietary test) to have a more positive emotional
      valence. Based on preliminary data, we anticipate that the treatment will be very effective
      in reducing drug cravings, anxiety, and depression as well as in reducing relapses. Aim I
      will offer twice-weekly treatments to two groups, active and sham, for 4-weeks and will look
      specifically for differences in opioid cravings, anxiety, depression, and opioid use. The
      investigators will evaluate participants weekly for safety and efficacy for 3-weeks
      post-treatment. In Aim II a highly-regarded product engineer will work with the company to
      design a marketable product that may have patentable elements.
    

Intervention name(s): supra-luminous LED; Sham
Intervention type(s): Device; Device
Intervention description(s): 810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.; Light-emitting diode covered with aluminium foil
Other intervention name(s): unilateral trancranial photobiomodulation, near-infrared mode
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 participants will receive twice a week active treatment for 4-weeks of a 4-minute near-infrared light treatment through the forehead to a brain hemisphere and 20 will receive a sham treatment.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
Condition: IGA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether fostamatinib is safe and effective in the
      treatment of IgA Nephropathy
    


Intervention name(s): Fostamatinib 150 mg; Fostamatinib 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks; Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks; Placebo tablet twice daily by mouth, over the course of 24 weeks
Other intervention name(s): R935788; R788; R935788; R788
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IGA Glomerulonephritis; Nephritis, IGA Type
UARK 2014-14: Phase II Prospective Evaluation of Bone Remodeling During Ixazomib Treatment
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of Ixazomib on inducing osteoblast
      activation as measured by bone markers and imaging in patients with relapsed/refractory
      myeloma.
    

Detailed description: 
      This is a phase II study designed to examine the bone anabolic effect of the next generation
      proteasome inhibitor, ixazomib, in relapsed/refractory myeloma patients. Treatment consists
      of Ixazomib 4 mg on days 1, 8, 15, 22 of a 28 day cycle, for a maximum of 6 cycles.
      Determination of relapsed/refractory disease as an entry criterion may be based on patient
      data obtained during or following the patient's most recent prior antineoplastic therapy.
      Treatment periods will be defined as 28-day cycles. Patients will be seen at regular
      intervals while they are participating in the study.
    

Intervention name(s): Ixazomib
Intervention type(s): Drug
Other intervention name(s): (MLN 9708)
Intervention MeSH terms: Ixazomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed; Refractory; Proteasome Inhibitor
Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)
Condition: Chronic Hepatitis c
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype
      4), worldwide it also poses a significant health burden. To date standard of care treatment
      (pegylated interferon and ribavirin) give modest results with a sustained virological
      response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an
      aim to improve current results. Recent reports have suggested an increased SVR with the
      addition of Nitazoxanide to standard of care. The results are preliminary and need to be
      confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to
      standard of care compared to standard of care alone.
    


Intervention name(s): Pegylated interferon alfa-2a; Nitazoxanide; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pegylated interferon 160ug once weekly 48 weeks; Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks; Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
Other intervention name(s): Reiferon retard; Xerovirin-C
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Immediate Effects of Stepping Training Using External Feedback in Spinal Cord Injury Patients
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      -  Does stepping training with or without external feedback change functional ability of
           ambulatory patients with iSCI immediately after training?

        -  Are there significant differences between the immediate effects of stepping training
           with or without external feedback in ambulatory patients with iSCI?
    

Detailed description: 
      To compare immediate effects of stepping training with or without the utility of external
      feedback on functional ability relating to walking in ambulatory patients with iSCI
      (between-group comparison).

      Secondary objective To compare immediate effects in a group of stepping training with or
      without the utility of external feedback on functional ability relating to walking in
      ambulatory patients with iSCI (within-group comparison).
    

Intervention name(s): Stepping training without feedback; Stepping training with feedback
Intervention type(s): Other; Other
Intervention description(s): Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.; Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
Other intervention name(s): Control program; Experimental program
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Neurological condition; Walking ability; Feedback; External information
Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children
Condition: Asthma; Development
Study type: Observational

Summary: 
      A molecular epidemiologic study of African American and Hispanic mothers and newborns to
      investigate the role of common urban pollutants on procarcinogenic and developmental damage.
    

Detailed description: 
      The major objective of the proposed research is to study the impact of early-life exposures
      to common urban pollutants on neurobehavioral development and asthma in a sample of children
      living in three low-income, minority communities of New York City (Central Harlem, Washington
      Heights and the South Bronx). Using a molecular epidemiologic approach with monitoring,
      biomarkers, and clinical assessments at serial time points, we will extend our study of
      African-American and Latina urban mothers and children in order to follow the cohort through
      child age 11 years to assess the longer-term impact of exposures on child health and
      developmental outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The present study enrolled 727 African American and Latino (Dominican) mothers and their
        children. The African American and Latino (Dominican) women were initially enrolled into
        the parent CCCEH study during pregnancy. Caucasian women are not included because a central
        purpose of the research is to evaluate health outcomes in a high risk, minority population.
      
Biospecimen description: 
      We collected maternal urine during the third trimester of pregnancy, maternal blood at
      delivery, umbilical cord blood, meconium, blood and urine from the child at ages 24, 36, and
      60 months.
    
Keywords: Pollutants