bioihbjkbjnl/mcl2 huggingface dataset:
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
Condition: Stroke; Cerebrovascular Accident; Hemiparesis
MeSH terms: Stroke; Paresis
Intervention: Armodafinil; Placebo
Intervention description: inactive pill manufactured to mimic Armodafinil 150 mg tablet
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stroke; CVA; cerebrovascular accident; hemiparesis; impairment; motor recovery; neuroplasticity; nuvigil; armodafinil

Summary:

      Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a
      relatively safe agent with interesting neurochemical effects on the catecholamine system,
      producing an improvement in cognitive function, particularly working memory in humans. When
      combined with intensive task-related training, armodafinil may accelerate motor recovery in
      chronic stroke patients.

      The primary aim of this study is to determine whether administration of armodafinil during
      subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor
      recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by
      armodafinil and, therefore, will induce an improvement in motor function and better
      performances on measures of motor control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First clinical stroke, either cerebral infarction or intracerebral hemorrhage

          -  Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25

          -  Screening Motricity Index score of 0-83

          -  Date of stroke onset between 7 to 21 days prior to study inclusion

        Exclusion Criteria:

          -  Age less than 18

          -  Previous clinical stroke

          -  Pregnant and/or nursing patients

          -  Major psychiatric history, including psychosis and history of substance abuse

          -  Dementia

          -  Known CNS pathology such as brain tumor

          -  Significant language dysfunction or severe neglect that hinders comprehension,
             participation, and barrier to testing

          -  Seizures

          -  Left ventricular hypertrophy (LVH)

          -  Mitral valve prolapse (MVP)

          -  Severe chronic renal failure or severe hepatic failure

          -  History or current use of anti-epileptic medications, psychostimulants, or
             neuroleptics

          -  Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal
             contraceptives, cyclosporine, or theophylline
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Condition: Lupus Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Intervention: Filgotinib; Lanraplenib; Filgotinib placebo; Lanraplenib placebo
Intervention description: 200 mg tablet administered orally once daily; 30 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib
      (previously GS-9876) in adults with lupus membranous nephropathy (LMN).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Kidney biopsy within the 36 months prior to screening with a histologic diagnosis of
             LMN (International Society of Nephrology [ISN] and the Renal Pathology Society [RPS]
             2003 classification of lupus nephritis), either Class V alone, or Class V in
             combination with Class II.

          -  Urine protein excretion ≥ 1.5 grams per day

          -  Estimated glomerular filtration rate (eGFR) ≥ 40 mg/min/1.73m^2 based on the
             modification of diet in renal disease (MDRD) formulation at screening

          -  No evidence of active or latent tuberculosis (TB) as assessed during screening

        Key Exclusion Criteria:

          -  Prior treatments as follows:

               -  Previous treatment with a janus kinase (JAK) inhibitor within 3 months of Day 1

               -  Use of rituximab or other selective B lymphocyte depleting agents (including
                  experimental agents) within 6 months of Day 1. Enrollment is permitted if the
                  last dose was given > 6 months and CD19-positive B cells are detectable at
                  Screening.

          -  Use of any concomitant prohibited medications as described in the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: GLPG2222 50 mg; GLPG2222 100 mg; Placebo; GLPG2222 200 mg; GLPG2222 400 mg
Intervention description: Oral tablet(s) containing GLPG2222; Oral tablet(s) containing GLPG2222; Matching oral tablet(s) containing placebo; Oral tablet(s) containing GLPG2222; Oral tablet(s) containing GLPG2222
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to
      adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic
      Fibrosis Transmembrane conductance Regulator (CFTR) mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent
             Form (ICF).

          2. A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation

          3. Weight ≥ 40 kg.

          4. Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline

          5. Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender
             and height at screening

        Exclusion Criteria:

          1. History of clinically meaningful unstable or uncontrolled chronic disease that makes
             the subject unsuitable for inclusion in the study in the opinion of the investigator.

          2. Unstable pulmonary status or respiratory tract infection requiring a change in therapy
             within 4 weeks of baseline.

          3. Need for supplemental oxygen during the day, and >2 liters per minute (LPM) while
             sleeping.

          4. Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to
             the first study drug administration.

          5. History of hepatic cirrhosis with portal hypertension.

          6. Abnormal liver function test at screening; defined as aspartate aminotransferase (AST)
             and/or alanine aminotransferase (ALT) and/ or alkaline phosphatase and/or
             gamma-glutamyl transferase (GGT) ≥ 3x the upper limit of normal (ULN); and/or total
             bilirubin (>1.5 times ULN)

          7. Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula at
             screening.
A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Donidalorsen; Placebo
Intervention description: Donidalorsen administered SC; Placebo matching solution administered SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Part A was randomized, double-blind; Part B was open-label.
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IONIS PKK-LRx; Donidalorsen

Summary:

      The purpose of this study was to evaluate the clinical efficacy, safety, and tolerability of
      donidalorsen in participants with hereditary angioedema (HAE) type 1 (HAE-1), HAE type 2
      (HAE-2), or HAE with normal C1-inhibitor (C1-INH) and to evaluate the effect of donidalorsen
      on plasma prekallikrein (PKK) and other relevant biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of HAE-1/HAE-2 (for inclusion in Part A) or HAE-nC1-INH (for
             inclusion in Part B)

          -  Participants must have experienced a minimum of 2 HAE attacks (assessed by the
             Angioedema Activity Score [AAS] and confirmed by the investigator) during the
             screening period

          -  Access to, and the ability to use, ≥ 1 acute medication(s) to treat angioedema attacks

        Exclusion Criteria:

          -  Anticipated use of short-term prophylaxis for angioedema attacks for a pre-planned
             procedure during the screening or study periods

          -  Concurrent diagnosis of any other type of recurrent angioedema, including acquired or
             idiopathic angioedema

          -  Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C,
             or chronic hepatitis B

          -  Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or
             carcinoma in situ of the cervix that has been successfully treated

          -  Treatment with another investigational drug or biological agent within 1 month or 5
             half-lives, whichever is longer, of screening

          -  Exposure to any of the following medications:

               -  Angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing
                  medications with systemic absorption (such as oral contraceptive or hormonal
                  replacement therapy) within 4 weeks prior to screening

               -  Chronic prophylaxis with Lanadelumab within 10 weeks prior to screening

               -  Oligonucleotides (including small interfering ribonucleic acid [RNA]) within 4
                  months of screening (if single dose received) or within 12 months of screening
                  (if multiple doses received)
Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome
Condition: Velo-cardio-facial Syndrome; Psychosis
MeSH terms: DiGeorge Syndrome; Syndrome; Psychotic Disorders; Mental Disorders
Intervention: Metyrosine; Placebo
Intervention description: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).; Placebo capsules were identically matched to Metyrosine.
Intervention MeSH terms: alpha-Methyltyrosine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Patients with velocardiofacial syndrome and psychosis

Summary:

      This is an exploratory clinical investigation. The objectives of this study are to evaluate
      the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the
      treatment of psychosis in patients with velocardiofacial syndrome (VCFS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Females of childbearing potential cannot be at risk of pregnancy during the study.

          2. Genetically confirmed diagnosis of VCFS at the time of screening.

          3. Must have one of the following Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition Text Revision (DSM-IV TR) diagnoses (applicable based upon clinical
             assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise
             specified (NOS), bipolar disorder, or mood disorder with psychotic features.

          4. A total PANSS composite score >65.

          5. Willing to discontinue psychotropic medications. -

        Key Exclusion Criteria:

          1. Evidence of acute suicidality.

          2. Known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or
             gastrointestinal disorders; other clinically significant psychiatric/neurological and
             sleep disorders by DSM-IV-TR criteria; endocrine, or hematological or metabolic
             diseases.

          3. Full scale IQ of less than 50.

          4. Pregnancy.

          5. Not using a reliable means of contraception.

          6. Systolic blood pressure of ≤110 mm/Hg or ≥160 mm/Hg, diastolic blood pressure ≤60
             mm/Hg or ≥90 mm/Hg, or has clinically symptomatic orthostatic changes.

          7. QTcF > 450 msec, or PR > 250 msec, or QRS > 110 msec on ECG.

          8. History of seizure disorder. -
Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
Condition: Pancreatic Neuroendocrine Tumors (pNET)
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Intervention: BEZ235; Everolimus
Intervention description: BEZ235 400 mg bid p.o. (by mouth, twice daily); Everolimus 10 mg qd p.o. (by mouth, daily)
Intervention MeSH terms: Everolimus; Dactolisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic; Neuroendocrine tumors; PNET; BEZ235; Everolimus

Summary:

      This was a multicenter, open label, randomized phase II study to evaluate the efficacy and
      safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate
      grade pancreatic neuroendocrine tumor (pNET).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor

          -  Progressive disease within the last 12 months

          -  Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT

        Exclusion Criteria:

          -  Prior treatment with mTOR or PI3K inhibitors

          -  Patients with more than 2 prior systemic treatment regimens

          -  Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4
             weeks

        Other protocol-defined inclusion/exclusion criteria may apply
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Intervention: APD334
Intervention description: APD334 active treatment for 24 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this open-label, pilot, proof of concept study is to evaluate the safety,
      tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary
      cholangitis (PBC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females aged 18 to 80 years (inclusive) at the time of screening, with
             confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3
             criteria:

               -  Anti-mitochondrial antibodies (AMA) titer >1:40 on immunofluorescence or M2
                  positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific
                  antinuclear antibodies (anti-GP210 and/or anti-SP100)

               -  Alkaline phosphatase (ALP) >1.5 x upper limit of normal (ULN) for at least 6
                  months

               -  Liver biopsy findings consistent with PBC

          -  Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable
             dose for at least 3 months immediately prior to screening)

          -  Participants must have ALP >1.5 x ULN but <10 x ULN, alanine aminotransferase (ALT)
             and aspartate aminotransferase (AST) <5 x ULN, and total bilirubin <ULN, at all
             screening visits

          -  AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are
             within 20% of each other

        Key Exclusion Criteria:

          -  Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied
             with primary Sjögren's syndrome (pSS) are eligible to be enrolled.

          -  History or evidence of clinically significant hepatic decompensation

          -  Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)

          -  Clinically significant infections within 6 weeks prior to treatment start, or
             infection with hepatitis C virus anytime in the past

          -  Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to
             treatment start

          -  Treatment with obeticholic acid (OCA) within 30 days prior to Day 1

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
Condition: Type II Refractory Celiac Disease (RCD-II); In-situ Small Bowel T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Celiac Disease
Intervention: AMG 714; Placebo
Intervention description: Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.; Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the
      treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small
      bowel T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of refractory celiac disease Type II (RCD-II)

          -  Greater than 20% aberrant intraepithelial lymphocytes (IEL) as assessed by flow
             cytometry

          -  On a gluten-free diet for at least 6 months

          -  Avoid pregnancy

        Exclusion Criteria:

          -  Enteropathy-Associated T cell Lymphoma (EATL)

          -  Infections

          -  Immune suppression

          -  Clinically significant co-morbidities
Caring Light Project for Family Caregivers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Caring Response App; Traditional Educational/Resources Program
Intervention description: Participants will receive the Caring Light mobile app containing the coping skills training.; Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Caring Light is designed to help caregivers of someone with Alzheimer's Disease and related
      dementia to cope with the difficulties related to caregiving, reduce stress, and improve
      quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Care for an individual with Alzheimer's Disease or other dementia.

          -  Own a smartphone or tablet and have Internet access.

          -  Minimum age of 18 years old.

          -  Spend at least 8 hours/week caring for a person with dementia.

        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.
Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: oral delivery mucosal stain
Intervention description: 200mg methylene blue MMX tablet taken prior to colonoscopy
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of the intraepithelial neoplasia detection rate in patients with long standing
      ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to
      colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  endoscopically verified UC signed written informed consent

        Exclusion Criteria:

          -  Known or suspected GI obstruction or perforation Liver or renal impairment,
             malignancy, pregnancy or lactation, suppressed PT.