bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Tolcapone for Cognition in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Tolcapone
Intervention description: Placebo: One capsule 3 times a day from Day 1 to Day 7; Tolcapone: One capsule 3 times a day from Day 1 to Day 7
Intervention MeSH terms: Tolcapone
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Catecholamines; Dopamine; Clinical Trial; fMRI; PFC; Vitamin B2; Riboflavin; Tolcapone; Placebo; Normal Volunteers; Schizophrenia; Healthy Volunteers; HV

Summary:

      This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well
      as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention
      Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the
      frontal cortex of the brain.

      ...
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Prior participation under NIH protocol number 95-M-0150, or new normal volunteers
                  or schizophrenic patients that meet criteria for NIH protocol number 95-M-0150
                  (NCT00001486).

               2. No Axis I or Axis II diagnosis in normal volunteers.

               3. Age range: 18-50 years.

        EXCLUSION CRITERIA:

          1. Normal volunteers with an Axis I or Axis II disorder obtained either from prior SCID
             interview in Protocol 95-M-0150 or through a screening interview will be excluded.

          2. Subjects with a history of cardiovascular disease, liver disease and other medical
             illnesses, and untreated or uncontrolled hypertension will be excluded. An
             electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will
             be checked on all subjects prior to participation in the study. Individuals with
             persistent tardive dyskinesia or abnormal LFTs, or individuals with significant
             history of alcoholism or liver enzyme elevation will be excluded from the study.

          3. Schizophrenic patients taking clozapine, a COMT inhibitor, any illicit drugs of abuse,
             or MAO inhibitors will be excluded.

          4. Normal control subjects taking any medications other than occasional NSAI will be
             excluded.

          5. Pregnant women. Women of childbearing potential will undergo a urine pregnancy test
             the day the study initiates and screened by history for the possibility of pregnancy.
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
Condition: Seizure Disorder; Hypogonadism; Erectile Dysfunction
MeSH terms: Epilepsy; Seizures; Erectile Dysfunction; Hypogonadism
Intervention: Anastrozole 1mg; Placebo Oral Tablet
Intervention MeSH terms: Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Seizure; Epilepsy; Testosterone; Hormone; Sexual Dysfunction; Hypogonadism; Men

Summary:

      The purpose of this study is to determine if treatment using a medication
      (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a
      tablet that does not contain any active medication, when combined with testosterone
      replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole,
      the medication that is currently under study, does not, at this time, have FDA approval for
      use for this indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be a male between the ages of 18 and 50 years.

          -  Subject must have localization-related epilepsy with complex partial and/or secondary
             generalized seizures.

          -  Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone
             levels and abnormally low scores on questionnaires of reproductive and sexual
             function).

          -  Subject will have had a normal urogenital and rectal/prostate exam during the year
             prior to entry.

          -  Subject will have had documentation of therapeutic range serum AED levels, a normal
             CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than
             twofold elevated during the 6 months prior to entry.

        Exclusion Criteria:

          -  Subject that has taken hormones, major tranquilizers or antidepressants in the three
             months prior to entry.
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Condition: Progressive Supranuclear Palsy (PSP)
MeSH terms: Supranuclear Palsy, Progressive
Intervention: ABBV-8E12; Placebo solution for IV infusion on Day 15
Intervention description: Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.; 0.9% NaCl injection/solution for infusion 500 mL; participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
Intervention MeSH terms: Tilavonemab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Tauopathy; Steele-Richardson-Olszewski Syndrome; PSP

Summary:

      The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12
      (tilavonemab) in participants with progressive supranuclear palsy (PSP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)

          -  In the opinion of the investigator, the participant was compliant during participation
             in Study M15-562 (NCT02985879)

          -  Participant has an identified, reliable, study partner (e.g., caregiver, family
             member, social worker, or friend)

        Exclusion Criteria:

          -  Participants who weigh less than 44 kg (97 lbs) at the time of study entry

          -  Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

          -  Participant has any significant change in his/her medical condition that could
             interfere with the subject's participation in the study, could place the subject at
             increased risk, or could confound interpretation of study results

          -  More than 8 weeks have elapsed since the participant received his/her last dose of
             study drug in Study M15-562 (NCT02985879)

          -  Participant is considered by the investigator, for any reason, to be an unsuitable
             candidate to receive ABBV-8E12 or the participant is considered by the investigator to
             be unable or unlikely to comply with the dosing schedule or study evaluations
Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840
Intervention description: Administered orally as tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Copper Balance; Molybdenum Balance; Wilson Disease; ALXN1840

Summary:

      This exploratory study will investigate the effects of ALXN1840 on copper balance in
      participants with Wilson disease (WD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of WD by Leipzig Criteria ≥ 4.

          2. Able to reside in the clinical research unit for intensive metabolic monitoring of
             copper and molybdenum.

          3. Participants willing to adhere to copper/molybdenum-controlled diet during the study.

          4. Willing and able to follow protocol-specified contraception requirements.

          5. Capable of giving signed informed consent.

        Exclusion Criteria:

          1. Decompensated cirrhosis or model for end stage liver disease score > 13.

          2. Modified Nazer score > 7.

          3. Clinically significant gastrointestinal bleed within past 3 months.

          4. Alanine aminotransferase > 2 × upper limit of normal.

          5. Hemoglobin less than lower limit of the reference range for age and sex.

          6. Significant medical history (current or past).

          7. Previous treatment with zinc within 30 days prior to the Screening Visit.

          8. Participants in renal failure, defined as in end-stage renal disease on dialysis
             (chronic kidney disease stage 5) or creatinine clearance < 30 milliliters/minute.
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Condition: Non-Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Intervention: SEL; SIM
Intervention description: SEL tablet administered orally once daily; Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GS-4997; Non-alcoholic fatty liver disease (NAFLD); Fibrosis; Simtuzumab (SIM); Apoptosis signal-regulating kinase 1; ASK1 inhibitor

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of GS-4997
      (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic
      steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a
      2:2:1:1:1 ratio to 1 of 5 study treatment arms.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males and non-pregnant, non-lactating females

          -  Evidence of NASH with fibrosis on biopsy

        Key Exclusion Criteria:

          -  Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)

          -  Other causes of liver disease including viral hepatitis and alcoholic liver disease

          -  Any history of decompensated liver disease, including ascites, hepatic encephalopathy
             or variceal bleeding

          -  History of liver transplantation

          -  Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1
             oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine,
             and a 1 oz/30 mL measure of 40% proof alcohol)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Spartalizumab; Capmatinib; spartalizumab placebo
Intervention description: Concentrate for solution for infusion; Film-coated tablet; dextrose 5% in water (D5W) for infusion
Intervention MeSH terms: Spartalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Run-in part: single arm, open-label.
Randomized part: two-arms parallel assignment, double-blinded, placebo control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: capmatinib; spartalizumab; MET mutation; EGFR wild-type; ALK negative mutation

Summary:

      A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and
      safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus
      capmatinib and placebo as first line treatment for locally advanced or metastatic non-small
      cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed locally advanced or metastatic NSCLC which is EGFR wild-type,
             ALK rearrangement negative and METΔex14 mutated

          -  No prior systemic therapy for advanced/metastatic disease (neo-adjuvant/adjuvant
             treatment completed > 12 months before relapse are permitted)

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          -  Measurable disease as per RECIST 1.1

          -  Known PD-L1 tumor expression status (applicable to Randomized part 2 only)

        Key Exclusion Criteria:

          -  Prior treatment with a PD-1/PD-L1 inhibitor, MET inhibitor or HGF inhibitor

          -  Presence of symptomatic CNS metastases or requiring local CNS-directed therapy
             (radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to
             study entry

          -  Impaired cardiac function or clinically significant cardiac disease

          -  Presence or history of interstitial lung disease, non-infectious pneumonitis or
             interstitial pneumonitis, including clinically significant radiation pneumonitis

          -  History of allogenic bone marrow or solid organ transplant

          -  Radiotherapy to lung fields ≤ 4 weeks or to any other anatomic site ≤ 2 weeks prior to
             start of study treatment (palliative radiotherapy for bone lesions is allowed)
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
Condition: Critically Ill; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Critical Illness; Wounds and Injuries
Intervention: Calcifediol; Calcitriol; Placebos
Intervention description: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4; Calcitriol 4mcg orally daily x 5; Placebo (medium chain triglyceride oil) orally daily x 5
Intervention MeSH terms: Calcitriol; Calcifediol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and
      calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney
      injury (AKI) in critically ill patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18

          -  Admitted to the ICU within 48h prior to enrollment

          -  Likely to remain in the ICU (alive) for ≥72h

          -  Naso/orogastric tube or ability to swallow

          -  High risk of severe AKI

        Exclusion Criteria:

          -  Serum total calcium > 9.0 mg/dl or phosphate > 6.0 mg/dL within previous 48h

          -  Currently receiving oral calcium supplementation

          -  Ingestion of vitamin D3 >1,000 IU/day or any 25-hydroxyvitamin D or
             1,25-dihydroxyvitamin D during the previous 7 days

          -  AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)

          -  History of transplantation or receiving chronic (>7days) of immunosuppressive
             medications (not including glucocorticoid steroids at a dose less than or equivalent
             to prednisone 20 mg/day)

          -  Neutropenia in the previous 48h

          -  Active primary parathyroid disease, active granulomatous disease, or symptomatic
             nephrolithiasis in the previous 3 months

          -  Receiving cytochrome P450 inhibitors

          -  Chronic Kidney Disease stage V or End Stage Renal Disease

          -  Hemoglobin < 7 g/dL

          -  GI malabsorption

          -  Prisoner

          -  Pregnancy or breast feeding
An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
Condition: Geographic Atrophy
MeSH terms: Geographic Atrophy; Atrophy
Intervention: Lampalizumab
Intervention description: Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 60 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label extension study of safety and tolerability of lampalizumab
      administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who
      have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week
      treatment in Study GX29455 (NCT02288559).
    

Eligibility criteria:

        Inclusion Criteria:

          -  For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of
             Study CFD4870g without early treatment discontinuation (lampalizumab or sham)

          -  For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study
             GX29455 without early treatment discontinuation (lampalizumab or sham)

          -  Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit
             quality fundus imaging

        Exclusion Criteria:

          -  Early treatment and/or study discontinuation prior to completion of study CFD4870g
             (GX01456) and GX29455

          -  Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related
             macular degeneration (AMD) in the study eye

          -  Subfoveal focal laser photocoagulation in the study eye

          -  Treatment with Visodyne, external-beam radiation therapy, or transpupillary
             thermotherapy in the study eye

          -  Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection,
             anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye.
             Lampalizumab in study eye and ranibizumab in either eye are permitted

          -  Any concurrent ocular or intraocular condition in the study eye that contraindicates
             the use of an investigational drug or may affect interpretation of the study results
             or may render the participant at high risk for treatment complications
Ubiquinol (Reduced COQ10) for Patients With Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: Ubiquinol; Placebo
Intervention description: Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.; Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to determine if Ubiquinol (reduced form of COQ10) will attenuate
      mitochondrial injury and decrease inflammatory response in patients suffering from sepsis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years old

          -  Suspected or confirmed infection

          -  Presence of 2 or more systemic inflammatory response syndrome (SIRS) criteria

          -  Admission to the ICU

        Exclusion Criteria:

          -  Under 18 years old

          -  Current CoQ10 supplementation

          -  Unable to receive enteral medications

          -  Would need a nasogastric or orogastric tube solely for the purposes of the study

          -  Pregnancy, incarceration, mentally disability

          -  Patient confirmed Comfort measures only, Do not resuscitate (DNR) and/or Do not
             intubate. Patients with DNR but intubated and being provided full care are eligible
Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
Condition: Alopecia Universalis (AU); Alopecia Totalis (AT)
MeSH terms: Alopecia; Alopecia Areata
Intervention: Vehicle; ATI-50002
Intervention description: Vehicle Topical Solution; ATI-50002 Topical Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and
      AT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to comprehend and willing to sign an Informed Consent Form (ICF).

          -  Male or non-pregnant, non-nursing female ≥18 years old at the time of informed
             consent.

          -  Have a clinical diagnosis of stable, clinically typical, AU or AT.

          -  Have a duration of the current episode of AU or AT for a minimum of 6 months and a
             maximum of seven years.

          -  Be willing and able to follow all study instructions and to attend all study visits.

        Exclusion Criteria:

          -  Females who are nursing, pregnant, or planning to become pregnant for the duration of
             the study including 30 days after the last application of study medication.

          -  Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of
             Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).

          -  Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a
             history of skin disease on the scalp that in the opinion of the investigator would
             interfere with the study assessments of efficacy or safety.

          -  Active scalp trauma or other condition affecting the scalp that, in the investigator's
             opinion, may affect the course of AU or AT or interfere with the study conduct or
             evaluations.

          -  The presence of a permanent or difficult to remove hairpiece or wig that will, in the
             opinion of the investigator, interfere with study assessments if not removed at each
             visit.