bioihbjkbjnl/mcl2 huggingface dataset:
NAD+ Precursor Supplementation in Friedreich's Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: MIB-626
Intervention description: Two (2) 500 mg Tablets, By Mouth, Daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: Open Label, 14 Days (+/- 2 Days)
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The primary objective is to test the safety and tolerability of short-term therapy with a
      nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's
      Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%.
      A key secondary objective is to test the effects of MIB-626 on cardiac and skeletal muscle
      bioenergetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Molecular diagnosis of Friedreich's Ataxia (FA).

          -  Males and females, ages 18 years to < 65 years.

        Exclusion Criteria:

          -  Known sensitivity to nicotinamide-containing compounds.

          -  Concurrent use of Vitamin B3 supplements and/or any medications likely to increase
             risk of MIB-626 toxicity.

          -  HgbA1c > (great than or equal to) 8.5% and or Diabetes Mellitus (DM) requiring insulin
             or insulin secretagogue.

          -  Kidney disease (Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73 m2) using
             serum creatinine and MDRD equation. The eGFR levels will be calculated using the
             Modified Diet in Renal Disease Study (MDRD) equation, which is the equation used by
             the Children's Hospital Of Philadelphia laboratory.

          -  Liver disease (Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) > 3 x
             Upper Limit of Normal)

          -  Severe co-existing cardiac disease (Ejection Fraction (EF) < 40%, known arrhythmia) as
             demonstrated by an echocardiogram within 12 months of screening.

          -  Any contraindication to MRI, including spinal rods (related to unknown safety
             considerations for cardiac 31-Phosphorus -MRS).

          -  Use of any investigational agent within 4 weeks of enrollment.

          -  Females: Pregnant/lactating or planning to become pregnant during their participation.

          -  Any medical condition that, in the opinion of the investigator, will interfere with
             the safe completion of the study.
A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: Placebo; Sodium Zirconium Cyclosilicate(ZS); Insulin; Glucose; Insulin; Glucose
Intervention description: Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).; Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).; Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.; Glucose 25g administered IV <15 minutes before the insulin.; Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.; Glucose 25g administered IV <15 minutes before the insulin.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      The study is designed to determine if ZS 10g administered up to three times over 10h added to
      insulin and glucose in patients presenting with hyperkalemia will prove tolerable and
      efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with
      insulin and glucose.
    

Eligibility criteria:

        Inclusion Criteria:

        ≥ 18 years of age

        Potassium ≥5.8 mmol/L

        Exclusion Criteria:

        Possible pseudohyperkalaemia

        Hyperkalaemia caused by any condition for which a therapy directed against the underlying
        cause of hyperkalaemia would be a better treatment option than treatment with insulin and
        glucose.

        Dialysis session expected within 4h after randomization

        Treated with any therapy intended to lower S-K between arriving at the hospital and
        randomization during Visit 1.
Dose Confirmation Trial of AAV5-hFIXco-Padua
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: AAV5-hFIXco-Padua (AMT-061)
Intervention description: Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label, single-dose, single-arm, multi-center trial
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemophilia,; Gene Therapy; Bleeding; Factor IX; FIX; viral vector; Padua

Summary:

      This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a
      treatment + post-treatment follow-up phase, and a long-term follow-up phase.

      The IMP AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5)
      containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic
      acid (cDNA) under the control of a liver-specific promoter. The IMP is identified as
      AAV5-hFIXco-Padua (AMT- 061). The pharmaceutical form of AMT-061 is a solution for
      intravenous infusion.

      The administered dose of AMT-061 will be 2 x 10^13 gc/kg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male

          2. Age ≥18 years

          3. Subjects with congenital hemophilia B classified as severe or moderately severe

          4. >20 previous exposure days of treatment with FIX protein

        Exclusion Criteria:

          1. History of FIX inhibitors

          2. Positive FIX inhibitor test at screening

          3. Select screening laboratory values > 2 times upper normal limit:

          4. Positive human immunodeficiency virus (HIV) at screening, not controlled with
             anti-viral therapy

          5. Active infection with Hepatitis B or C virus at screening

          6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
Condition: Overactive Bladder With Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Intervention: URO-902; Placebo
Intervention description: intradetrusor injection; intradetrusor injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: Female
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: URO-902; hMaxi-K; pVAX/hSlo; Overactive Bladder; Urge Urinary Incontinence

Summary:

      This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902
      24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with
      placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up
      to 48 weeks post-dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has symptoms of Overactive Bladder (OAB) (frequency and urgency) with Urge
             Urinary Incontinence (UUI) for a period of at least 6 months prior to screening.

          -  Participant experiences ≥ 1 episode of UUI per day.

          -  Participant has not been adequately managed with ≥ 1 oral or transdermal pharmacologic
             therapies for the treatment of their OAB symptoms.

        Exclusion Criteria:

          -  Participant has symptoms of OAB due to any known neurological reason (e.g., spinal
             cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease,
             Parkinson's disease, etc).

          -  Participant has a predominance of stress incontinence in the opinion of the
             investigator, determined by participant history.

          -  Participant currently uses or plans to use medications or therapies to treat symptoms
             of OAB, including nocturia.

          -  Participants who have previously been treated with onabotulinumtoxinA for urological
             indications within 12 months of starting the Screening Bladder Diary, or any other
             toxin for urological indications, regardless of when treated (participants treated
             with onabotulinumtoxinA or other toxins for non-urological indications are eligible,
             regardless of when treated)
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Condition: Infection Viral; Thromboses, Venous; COVID-19
MeSH terms: COVID-19; Virus Diseases; Thrombosis; Venous Thrombosis
Intervention: Enoxaparin Prefilled Syringe [Lovenox]
Intervention description: Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 0 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, dose-requirements, and exploratory
      efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in
      children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection
      (i.e., COVID-19).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Birth to <18 years of age; AND

          2. Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND

          3. Hospitalized, <72 hours post-admission; AND

          4. One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as
             follows:

               1. Cough; OR

               2. Fever (oral temperature >100.4°F/38°C); OR

               3. Chest pain; OR

               4. Shortness of breath; OR

               5. Myalgia; OR

               6. Acute unexplained loss of smell or taste; OR

               7. New/increased supplemental oxygen requirement; OR

               8. Acute respiratory failure requiring non-invasive or invasive ventilation; OR

               9. Encephalitis.

        Exclusion Criteria:

        An individual who meets any of the following criteria will be excluded from participation
        in this study:

          1. Receiving therapeutic anticoagulation for treatment of a thromboembolic event
             diagnosed within the past 12 weeks; OR

          2. Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past
             72 hours; OR

          3. Platelet count <50,000/µL within the past 24 hours; OR

          4. Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local
             reference range within the past 24 hours; OR

          5. Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of
             age-appropriate local reference range within the past 24 hours; OR

          6. Fibrinogen level <75 mg/dL; OR

          7. Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) <31
             mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR

          8. Parent or legally authorized representative unwilling to provide informed consent for
             patient participation.
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: OPC-6535(Tetomilast)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 29.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-6535; Crohn's disease

Summary:

      The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its
      optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination
      with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral
      dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with active Crohn's disease

          -  Patients who have a primary lesion in either the small intestine or the large
             intestine

          -  Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a
             fixed dose

          -  Patients who have either never received enteral nutrition or have been receiving
             enteral nutrition at a fixed intake of 1200 kcal/day or less

          -  Either inpatient or outpatient

        Exclusion Criteria:

          -  Patients who have an external fistula (including anal fistula) in which persistent
             drainage is observed (and who require treatment with antibiotics or synthetic
             antibacterial agents)

          -  Patients with short bowel syndrome (and who require intravenous nutritional support
             due to insufficient intestinal nutrient uptake)

          -  Patients with an artificial anus

          -  Patients who have a complication of serious infectious disease (intra-abdominal
             abscess, etc.)

          -  Patients who have a complication of malignant tumor

          -  Female patients who are pregnant, lactating, or possibly pregnant, or who wish to
             become pregnant during the study period
Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive
Intervention: Placebo; Dalfampridine
Intervention description: Placebo 3 hrs before sleep; Dalfampridine 10 mg extended release 3 hrs before sleep
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this protocol the investigators will test the effect of dalfampridine (a potassium channel
      blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy
      control subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy control subjects

        Exclusion Criteria:

          -  Cardiovascular disease other than well controlled hypertension

          -  History of seizures
Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
Condition: Cognitive Decline; Chemo-brain
MeSH terms: Cognitive Dysfunction
Intervention: Memantine
Intervention description: memantine dose
Week 1: 5 mg dose once daily
Week 2: 5 mg dose twice daily
Week 3: 5 mg each morning/10 mg each evening
Week 4 through the end of Chemotherapy: 10 mg dose twice daily
Total duration: 12 - 26 weeks (depending on chemotherapy regimen)
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Purpose: To conduct a one-arm phase II trial to: (1) compare changes in pre- to
      post-chemotherapy cognitive function in a cohort of patients with breast cancer receiving
      memantine to historical controls; (2) examine how depression, anxiety, fatigue, baseline
      Intelligence Quotient (IQ), and cognitive effort relate to objective and self-reported
      cognitive function; and (3) estimate the feasibility of conducting a clinical trial of
      memantine for attenuating cognitive decline in patients with breast cancer during
      chemotherapy.

      Participants: Adult patients with stage I-III breast cancer scheduled for adjuvant or
      neoadjuvant chemotherapy.

      Procedures (methods): Cognitive assessments will be performed within one week of initiating
      and four weeks after completion of chemotherapy. Patients will receive memantine 10 mg twice
      daily between the pre- and post-chemotherapy study assessments. Cognitive function will be
      assessed objectively using a computerized cognitive test (Delayed Matching to Sample (DMS)
      test) and a standard neuropsychological battery. To assess subjective cognitive function, the
      Patient Reported Outcome Measurement Information System (PROMIS) Cognitive Function measure
      will be used. Depression, anxiety, fatigue, menopausal status, and sleep will be assessed as
      covariates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  At least 18 years of age

          -  Able to speak English

          -  Diagnosed with breast cancer, Stages I-III

          -  Scheduled for adjuvant or neoadjuvant chemotherapy

        Exclusion Criteria:

          -  A history of adverse reaction to memantine

          -  Another cancer diagnosis with an estimated survival of less than five years

          -  Previous chemotherapy exposure

          -  Severe cognitive impairment, defined as Blessed Orientation Memory Concentration Test
             (BOMC) ≥ 11.

          -  Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment,
             or breastfeeding

          -  Current alcohol or drug abuse
Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
Condition: Thrombosis
MeSH terms: Thrombosis
Intervention: BMS-986141; Aspirin; Placebo
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether BMS-986141 is effective in reducing the
      recurrence of stroke in people who recently had a stroke, or a transient ischemic attack
      (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as
      aspirin or ASA) to treat the stroke or TIA.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male or female, age 18 or older

          -  Must have had a very recent stroke or transient ischemic attack ("mini stroke") that
             can be confirmed by the study doctor

          -  Able to be assigned to a study group no later than 48 hours after the stroke occurred

          -  Has an image of the brain that confirms that the stroke was not caused by hemorrhage
             or other reason that could explain symptoms

        Exclusion Criteria:

          -  A suspicion by the study doctor that the transient ischemic attack or stroke was
             caused by a blood clot that formed in the heart; examples of this include history of
             an abnormal heart rhythm known as atrial fibrillation or a ventricular aneurysm or
             defect of the heart.

          -  Any condition requiring treatment with an anticoagulant

          -  History of intracranial hemorrhage ("bleeding in the brain")

          -  Gastrointestinal ("stomach or intestinal") bleeding in the last 3 months that required
             treatment

          -  Planned or anticipated invasive surgery or procedure during the study

          -  Unable to tolerate MRI procedures.
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: Emtricitabine
Intervention description: 6 mg/kg capsule once daily, up to a maximum dose of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
Intervention MeSH terms: Emtricitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: HIV-1 infection; emtricitabine; pediatrics; pediatric patients

Summary:

      The primary objectives of this trial are to provide FTC-203 study participants in South
      Africa with continued access to the study drug, emtricitabine (FTC), following completion of
      the FTC-203 study and to collect long-term safety information in participants receiving
      emtricitabine in combination with other antiretroviral agents.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Complete or have previously completed at least through the Week 96 Visit (i.e., 96
             weeks on study) for the FTC-203 study.

          -  Complete all End-of-Study Visit procedures for the FTC-203 study.

          -  Either (a) have a plasma HIV-1 RNA viral load of ≤ 400 copies/mL at the End-of-Study
             Visit for the FTC-203 study, or (b) if the subject's plasma HIV-1 RNA viral load at
             the End-of-Study Visit for FTC-203 study is > 400 copies/mL, their viral load is < 1.0
             log10 above the nadir recorded after Week 8 of the FTC-203 study and there is reliable
             genotypic evidence showing a lack of resistance to emtricitabine.

          -  A parent or other legal guardian has provided written informed consent to the subject
             participating in the rollover protocol. As applicable, based on the subject's age and
             normal institution practice, the subject should additionally provide their written
             informed consent or assent to participate in the rollover protocol.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.