bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
Condition: Confirmed Coronavirus Disease
MeSH terms: COVID-19
Intervention: Ruconest
Intervention description: Patients will be randomized to Ruconest or Standard of Care
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC)
      in patients admitted for stage II COVID-19 infection may reduce the risk of disease
      progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster
      clinical improvement compared to SOC alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-85 years,

          -  Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19
             infection).

          -  Evidence of pulmonary involvement on CT scan or X-Ray of the chest,

          -  Symptom onset within the previous 10 days AND at least one additional risk factor for
             progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3)
             obesity (BMI>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary
             disease, 7) chronic renal disease, 6) C-reactive protein of >35mg/L, 7) oxygen
             saturation at rest in ambient air of <94%

        Exclusion Criteria:

          -  Contraindications to the class of drugs under study (C1 esterase inhibitor);

          -  History or suspicion of allergy to rabbits;

          -  Women who are of childbearing potential and not using methods of contraception during
             the entire study period;

          -  Pregnant or breastfeeding females or has a positive serum β-human chorionic
             gonadotropin (hCG) pregnancy test at screening;

          -  Chronic liver disease (any Child-Pugh score B or C);

          -  Currently admitted to an ICU or expected admission within the next 24 hours; and

          -  Currently receiving invasive or non-invasive ventilation
Mayo Acute Stroke Trial for Enhancing Recovery
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Donepezil
Intervention description: Study participants will be treated with donepezil orally at an initial dose of 5 mg daily for the first 4 weeks, then increased at their 30-day visit by 5 mg to a maximum dose of 10 mg daily, if tolerated. If the participant does not tolerate the 10 mg dose, they will remain on 5 mg through the course of the study.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ischemic stroke; treatment; recovery; donepezil; Aricept

Summary:

      This study involves treating patients that have suffered an acute ischemic stroke with the
      medication donepezil (Aricept ®). The hypothesis is that taking donepezil (FDA-approved for
      the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances
      recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definite or probable acute ischemic cerebrovascular syndrome (AICS), as defined by
             Kidwell et al (Stroke. 2003;34:2995-8).

          -  Experimental treatment started within 24 hours of onset of symptoms.

          -  Age ≥ 18 years.

          -  Ability and willingness to return for follow-up visits.

          -  Willingness of an available informant who knows the patient well to participate in
             informant-based questionnaires for the duration of the follow-up period.

          -  Living in independent or semi-independent living situation before the stroke.

          -  Fluent in English before the stroke.

          -  Provides written informed consent.

          -  Near visual acuity of at least 20/200 in at least one eye.

          -  Auditory acuity of at least having the ability to detect finger rubbing in at least
             one ear.

        Exclusion Criteria:

          -  Parkinson's disease or restless leg syndrome.

          -  Partial or generalized seizures.

          -  No acute decompensated heart failure

          -  Routinely requiring daytime supplemental oxygen before the stroke; study participants
             on continuous positive air pressure (CPAP) for obstructive sleep apnea remain
             eligible.

          -  Gastrointestinal or genitourinary surgery within 1 month of screening.

          -  Gastrointestinal bleeding.

          -  Syncope or symptomatic bradycardia.

          -  Creatinine ≥ 3.5 mg/dL or requiring dialysis.

          -  Peptic ulcer disease.

          -  Asthma.

          -  Tracheostomy or endotracheal intubation.

          -  Taking donepezil or other acetylcholinesterase inhibitor at screening.
Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GLPG0634; Placebo
Intervention description: GLPG0634 capsules.; Placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methotrexate inadequate responders

Summary:

      Participants suffering from active rheumatoid arthritis despite continued treatment with
      methotrexate were evaluated for improvement of disease activity (efficacy) when taking
      GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as
      once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks.

      •During the course of the study, patients were also examined for any side effects that could
      occur (safety and tolerability), and the amount of GLPG0634 present in the blood
      (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of
      action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects
      of different doses and dose regiments of GLPG0634 administration on participants' disability,
      fatigue, and quality of life were evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria
             of RA and ACR functional class I-III,

          -  have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint
             count) at Screening and at Baseline,

          -  Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range
             (ULN),

          -  have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of
             MTX for at least 4 weeks prior to Screening and willing to continue on their current
             regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are
             allowed when there is documented evidence of intolerance or safety issues at higher
             doses.

        Exclusion Criteria:

          -  current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than
             MTX,

          -  current or previous RA treatment with a biologic DMARD, with the exception of biologic
             DMARDs administered in a single clinical study setting more than 6 months prior to
             Screening (12 months for rituximab or other B cell depleting agents), where the
             biologic DMARD was effective, and if discontinued, this should not be due to lack of
             efficacy,

          -  previous treatment at any time with a cytotoxic agent, other than MTX, before
             Screening.
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Condition: Ocular Inflammation and Pain
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: OTX-DP (Dexamethasone punctum plug); Placebo Vehicle Punctum Plug
Intervention description: Sustained and tapered release of dexamethasone from hydrogel punctum plug; Hydrogel punctum plug without dexamethasone
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)
      depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation
      and pain in subjects who have undergone cataract extraction with intra-ocular lens
      implantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has provided written informed consent, approved by the appropriate institutional
             review board; and is able to comply with study requirements and visit schedule

          -  Is greater than or equal to 21 years of age

          -  Has a cataract and is expected to undergo clear corneal cataract surgery with
             phacoemulsification and implantation of a posterior chamber intraocular lens

        Exclusion Criteria:

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination

          -  Score greater than "0" on the Ocular Pain Assessment at Screening

          -  Compromised immune system or an autoimmune disease that in the opinion of the
             Investigator could affect the quality of the ocular surface
Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: OPDC-34712; Placebo; Stimulant Therapy
Intervention description: OPDC-34712 tablets, daily, Orally.; Matching-placebo tablets, daily, Orally.; Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Intervention MeSH terms: Brexpiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 740.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Inattention; Hyperactivity; Impulsivity; Distractibility; Procrastination; Disorganized; ADHD

Summary:

      This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in
      adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved
      stimulant medication to explore a possible impact on sleep, quality of life and cognitive
      function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients 18 to 55 years of age, inclusive, at the time of informed
             consent.

          -  Participants with a primary diagnostic and statistical manual of mental disorders,
             fourth edition, text revision (DSM-IV-TR) diagnosis of ADHD (including inattentive,
             hyperactive, and combined subtypes) as confirmed by the Conners' Adult ADHD diagnostic
             interview (CAADID). Participants may have received prior treatment for adult ADHD, may
             be currently receiving treatment for adult ADHD at screening, or may be
             treatment-naive.

          -  Participants willing to discontinue all prohibited psychotropic medication starting
             from the time of signing the informed consent and during the study period.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug.

          -  Participants with an adequate response, as determined by the investigator, to any
             stimulant taken for the treatment of adult ADHD after 18 years of age.

          -  Participants with a clinically significant current Axis II (DSM-IV-TR) diagnosis of
             borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality
             disorder.

          -  Participants who participated in a clinical trial within the last 180 days or who
             participated in more than two clinical trials within the past year.
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Condition: Leukemia; Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Rituximab; Cyclophosphamide (CTX); Doxorubicin; Vincristine; Dexamethasone; Methotrexate (MTX); Cytarabine; G-CSF; Mesna; Pegylated asparaginase; Pegfilgrastim; Solumedrol
Intervention description: 375 mg/m2 by vein; 300 mg/m2 by vein; 50 mg/m2 by vein; 2 mg by vein; 40 mg by vein or by mouth (P.O.); 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7
200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8; 100 mg intrathecal for Courses 1,3,5,7
3 gm/m2 by vein for Courses 2,4,6,8; 10 ug/kg subcutaneous injection; 600 mg/m2 a day by vein; 2000 International units/m2 by vein; 6 mg (flat dose) within 72 hrs after completion of chemotherapy; 40 mg by vein for Courses 2,4,6,8
Intervention MeSH terms: Cytarabine; Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Cyclophosphamide; Rituximab; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Pegaspargase; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Healthy volunteers: No
Keywords: Lymphoma; HYPER-CVAD; Leukemia; Acute Lymphoblastic Leukemia; ALL; Remission Duration; Chemotherapy; Asparaginase; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Leukine; Methotrexate; Rituximab; Vincristine

Summary:

      The goal of this clinical research study is to learn if intensive chemotherapy (with
      monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed
      by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic
      leukemia (ALL) or lymphoblastic lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Newly diagnosed, previously untreated Acute Lymphoblastic Leukemia (ALL) or
             lymphoblastic lymphoma, or having achieved Complete Remission (CR) with one course of
             induction chemotherapy.

          2. Failure to one induction course of chemotherapy are eligible, but these patients will
             be analyzed separately.

          3. All ages are eligible.

          4. Zubrod performance less than or equal to 3

          5. Adequate liver function (bilirubin </= 3.0 mg/dl unless considered due to tumor) and
             renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor).

          6. Adequate cardiac function as assessed by history and physical examination.

          7. No active co-existing malignancy with life expectancy less than 12 months due to that
             malignancy.

        Exclusion Criteria:

        1) N/A
iCare Stress Management e-Training for Dementia Family Caregivers
Condition: Alzheimer's Disease; Dementia
MeSH terms: Alzheimer Disease; Dementia
Intervention: CBT-based program for dementia caregivers; Educational/Resources program
Intervention description: Participants will receive a CBT-based program [Cognitive Behavioral Therapy], containing videos, workbook, and website.; Participants will receive a traditional educational/resources program, containing videos, workbook, and website.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alzheimer's Disease; Dementia; caregiving; caregiver; coping; coping with caregiving; stress

Summary:

      Photozig and Stanford University are creating a program to help cope with caregiving,
      alleviate related stress, and enhance quality of life for caregivers, with funding from the
      National Institute on Aging. This home-based program includes a free DVD, printed materials,
      and resource website. In addition, after completing the program, participants will have free
      access to final online resources for 1 year. There are no face-to-face meetings, and
      participants can live anywhere in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Care for an individual with Alzheimer's Disease or other dementia.

          -  Own a DVD player or have Internet access.

          -  Minimum age of 21 years old.

          -  Spend at least 8 hours/week caring for a person with dementia, which may include
             assisting, watching, monitoring, or being available to help (e.g. during sleep time).

        Exclusion Criteria:

          -  Severe psychological or physical illness.

          -  Inability to read and follow English instructions.

          -  High level of depressive symptoms.

          -  Unwillingness to participate in all aspects of the study.
An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: PF-02341066
Intervention description: PF-02341066, 250 mg BID, will be administered orally on a continuous schedule
Intervention MeSH terms: Crizotinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 1069.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Neoplasms ALK gene Crizotinib

Summary:

      This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients
      with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene.
      This trial will also allow patients from a Phase 3 trial who received standard of care
      chemotherapy (Study A8081007) to receive PF-02341066.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically or cytologically proven diagnosis of non-small cell lung cancer

          -  positive for the ALK fusion gene (test provided by either a central laboratory. Local
             laboratory may be used for certain cases)

          -  may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and
             discontinued treatment due to Response Evaluation Criterion in Solid Tumors
             (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been
             analyzed and the results made available, at any time without RECIST-defined
             progression.

          -  Tumors can be measurable or non measurable

        Exclusion Criteria:

          -  prior treatment with PF-02341066

          -  received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor,
             for advanced non-small cell lung cancer

          -  current enrollment in another therapeutic clinical trial
Heart Rate Variability Biofeedback for Smoking Cessation
Condition: Tobacco Smoking
Intervention: Cognitive-Behavioral Smoking Cessation; Heart Rate Variability Biofeedback (HRVB); Transdermal Nicotine patch
Intervention description: Participants were provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.; All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.; All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).
Masking: None (Open Label)
Masking description: This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.
Enrollment: 10.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Heart rate variability biofeedback

Summary:

      Open trial of heart rate variability biofeedback as an adjunct to individualized smoking
      cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with
      elevated emotional distress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoking ≥5 cigarettes, daily, for at least two years

          -  expired carbon monoxide analysis of breath sample ≥8 ppm

          -  elevated affective distress

          -  motivation to quit

          -  computer proficient

        Exclusion Criteria:

          -  current use of other tobacco or nicotine products for recreation or to aid in
             cessation, use of pharmacological intervention for cessation, or current enrollment in
             a psychosocial intervention for smoking cessation

          -  endorsement of current or past psychotic or manic symptoms indicative of bipolar
             spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal
             ideation

          -  inability to provide written informed consent

          -  current evidence of another substance use disorder

          -  severe visual or hearing impairments

          -  self-reported medical condition or medication use that may be contraindicated for
             participation in a HRVB or confound autonomic parameters:

          -  self-reported medical issues of potential concern to nicotine patch users