bioihbjkbjnl/mcl2 huggingface dataset:
(+) Epicatechin to Treat Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: (+)-Epicatechin
Intervention description: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 10 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This 24-week study will test the safety and effectiveness of synthetically produced (+)
      Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Friedreich's Ataxia (FA) by Frataxin genetic testing and/or
             Frataxin enzyme analysis

          -  Between age 10 and 50 years of age, inclusive

          -  Body weight of 25 kilograms or higher

          -  Minimum of one affected organ (cardiac or neurological) system, as evidenced by
             clinical signs/symptoms

          -  Disease duration ≤7 years, based on onset date of FA symptoms

          -  Has no known contraindication to gadolinium contrast such as severe allergy or
             Glomerular Filtration Rate <30 ml/min/m^2.

          -  Has no known contraindication to non-contrast Magnetic Resonance Imaging (MRI)
             evaluation such as pacemaker or magnetically active metal fragments.

          -  Women of childbearing age must:

               -  Have a negative pregnancy human chorionic gonadotropin test prior to receiving
                  study drug.

               -  Agree to use contraception for the duration of the study drug dosing, plus 1
                  month after completion of the study.

        Exclusion Criteria:

          -  Advanced cardiac failure, New York Heart Association (NYHA) Classification Scale-Class
             IV (advanced stage heart failure)

          -  Clinically significant comorbidities that may also lead to cardiomyopathy, for example
             long standing hypertension, familial cardiomyopathy.

          -  Clinically significant comorbidities that would, in the opinion of the investigators,
             compromise the interpretation of test results.

          -  Pregnant, breast-feeding or planning to become pregnant during study timeframe.

          -  Patients with contraindications to regadenoson, i. e. second- or third-degree
             atrioventricular (AV) block or sinus node dysfunction. Has received an investigational
             drug within thirty (30) days of baseline visit.

          -  Thrombocytopenia (<125 x 10^9/Liter) or prolonged Prothrombin Time/Partial
             Thromboplastin Time (PT/PTT) at baseline.

          -  Clinically significant hypotension (systolic blood pressure <90) due to heart failure
             or other conditions.
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
Condition: Cardiomyopathy, Hypertrophic; Cardiomyopathy, Hypertrophic, Familial
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Hypertrophic, Familial; Hypertrophy
Intervention: Perhexiline; Use of bioanalytical assay to monitor plasma levels of perhexiline
Intervention description: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline; The bioanalytical assay is the device under investigation. It will be used to monitor plasma levels of perhexiline. The data obtained from this analysis will be used to guide dose adjustments of perhexiline.
Intervention MeSH terms: Perhexiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, 2 period, dose escalation study of perhexiline in symptomatic patients with hypertrophic cardiomyopathy
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertrophic cardiomyopathy; heart failure; cardiopulmonary exercise testing; 6 minute walk test; perhexiline; carnitine palmitoyltransferase; mixed ion channel effects; late sodium current inhibitor; calcium channel inhibition

Summary:

      The purpose of this study is to evaluate the effect of perhexiline on exercise performance
      (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe
      heart failure following dosing for 16 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Hypertrophic cardiomyopathy with symptoms of moderate-to-severe heart failure

          -  Left ventricular hypertrophy with maximum LV wall thickness ≥ 15 mm

          -  Left ventricular ejection fraction ≥ 50%

          -  Able to perform exercise testing but unable to exceed 75% of the predicted
             age-adjusted maximum level

        Key Exclusion Criteria:

          -  CYP2D6 Poor Metabolizer (PM) status

          -  History of a known chronic liver disease

          -  ALT, AST, alkaline phosphatase, or LDH > 1.5 x upper limit of normal

          -  Total Bilirubin > 2.0 x upper limit of normal

          -  Severe LV outflow obstruction

          -  Asymptomatic patients or cardiomyopathy-related criteria as per protocol

          -  QT interval related criteria as per protocol
A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
Condition: Diastolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: Sitexsentin sodium; Placebo
Intervention description: sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months; placebo identical to the study drug in description, dose and duration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study was to determine whether long-term (≥ 6 months at the target dose)
      blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with
      chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 or older with chronic heart failure and evidence of diastolic dysfunction on
             echocardiogram, heart imaging, and a minimum exercise tolerance average time of 120
             seconds on two treadmill tests within 2 weeks of enrollment

        Exclusion Criteria:

          -  unstable cardiovascular disease within 4 weeks of screening, history of heart attack,
             cardiac by-pass surgery or percutaneous intervention, stent placement, within 3 months
             of screening or amyloidosis, hypertrophic obstructive or restrictive cardiomyopathy,
             or constrictive pericarditis
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Intervention: Imsidolimab; Placebo
Intervention description: Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PPP

Summary:

      A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple
      doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed diagnosis of PPP

          -  Disease duration of at least 6 months prior to screening

          -  Present with active pustules on palms or/and soles at screening

        Exclusion Criteria:

          -  Any other ongoing inflammatory disease that interfere with the investigator's ability
             to evaluate the subject's response to therapy

          -  History of recurrent or active/serious infection

          -  Ongoing use of psoriasis prohibited medication

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cyclophosphamide; Fludarabine; Rituximab
Intervention description: Cyclophosphamide will be administered IV at 250 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.; Fludarabine will be administered IV at 25 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.; Rituximab will be administered IV at 375 mg/m^2 on Day 1 of Cycle 1 and then at 500 mg/m^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of rituximab in combination with
      chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants greater than or equal to (≥) 18 years of age

          -  B-cell CLL

          -  No previous treatment for leukemia

        Exclusion Criteria:

          -  History of other malignancies within 2 years before study entry, except for adequately
             treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate
             cancer, or breast cancer

          -  Comorbid condition requiring long-term (greater than [>] 1 month) systemic
             corticosteroids during study treatment

          -  Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)
Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis (MARINA)
Condition: Microvascular Angina
MeSH terms: Atherosclerosis; Microvascular Angina
Intervention: Ranolazine; Placebo
Intervention description: Ranolazine 1,000 mg twice daily; Placebo
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: microvascular angina; coronary microvascular disease; coronary physiology; ranolazine

Summary:

      The purpose of this study is to look at the effects of the drug Ranolazine compared to
      Placebo on symptoms of chest pain or chest tightness (known as angina), exercise endurance
      and ability, and changes in blood flow to the very small arteries of the heart (known as
      coronary microvascular function) in patients who do not have significant blockages in their
      major heart arteries. Ranolazine is a drug that is already approved by the FDA for angina,
      but it may be particularly effective in people with disease in their tiny heart vessels
      (known as coronary microvascular disease).

      This trial aims to enroll 50 patients with angina who undergo baseline bicycle exercise
      testing with monitoring of the heart's electrical activity and oxygen consumption (known as
      cardiopulmonary exercise test) and coronary angiogram (taking pictures of the heart arteries
      through small hollow tubes placed through the wrist or groin). If severe blockages in the
      main arteries are not found then testing for coronary microvascular function will be
      performed. Subsequently, participants will then be randomized 50/50 to either Ranolazine or
      Placebo. After taking the study drug for 12 weeks, they will then repeat the cardiopulmonary
      exercise test and the coronary angiogram with testing for microvascular function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of typical angina or effort-induced anginal symptoms and are currently
             experiencing angina at least once per week

          -  Abnormal stress ECG, exercise stress imaging, or pharmacological stress imaging

          -  Non-obstructive coronary artery disease as defined by lesion stenosis ≤ 50% in any
             artery as visualized by diagnostic angiography

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  Active Myocardial Infarction

          -  History of coronary artery bypass grafting

          -  Diagnosis of other specific cardiac disease such as severe valvular heart disease,
             cardiomyopathy, or variant angina

          -  Left Ventricular Ejection Fraction (LVEF) < 30%

          -  Known renal insufficiency (CrCl < 30 mL/min) or on dialysis

          -  Contraindications to the use of Ranolazine
The Street Smart Group: A Feasibility Trial of a Group Intervention Targeting Anxiety Processes in Paranoia
Condition: Paranoia; Schizophrenia-spectrum Diagnosis
MeSH terms: Schizophrenia; Paranoid Disorders
Intervention: Anxiety intervention
Intervention description: The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate a novel group psychological intervention targeting anxiety
      triggered by urban environments for people with paranoia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self reported worries about being harmed or at risk from others

          -  Non-affective psychosis(ICD10,F20-F29)

          -  Age 18-65

          -  Symptoms stable no major relapse or crisis in last 3 months prior to consent

          -  Sufficient command of English to provide informed consent, complete the measures and
             participate in the brief interventions

          -  Score above the cutoff for clinically significant levels of paranoia on the Green
             Paranoid Thoughts Scale (Green et al, 2008)

          -  Paranoia is triggered by being outside

        Exclusion Criteria:

          -  Lack of capacity to provide informed consent

          -  Primary diagnosis of drug or alcohol use with secondary psychosis

          -  Primary diagnosis of mood disorder or bipolar affective disorder

          -  Primary diagnosis of learning difficulty

          -  Unstable residential arrangements (making a move away during the course of
             participation in the research likely)
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Eye Diseases
Intervention: OC-01 (varenicline) nasal spray; Placebo (vehicle control) nasal spray
Intervention description: OC-01 (varenicline) nasal spray; Placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray
      as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult
      subjects with DED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to use an artificial tear substitute for dry eye symptoms
             within 6 months prior to visit 1.

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery (e.g.
             laser-assisted in-situ keratomileusis, laser epithelial keratomileusis,
             photorefractive keratectomy or corneal implant) within twelve months of Visit 1

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with DED are
             allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Inflammation
Intervention: Ranibizumab 0.3 mg; Aflibercept 2.0 mg
Intervention description: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg; Patient will receive intravitreal injection of Aflibercept 2.0 mg
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to compare the post injection inflammation and pain seen after
      intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.

      The investigators will be evaluating patients (1-7 days) post injections for:

      1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as
      measured on a standardized pain scale).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be eligible if the following criteria are met:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 21 years

          -  Exam and OCT confirming Diabetic Macular Edema

          -  Visual Acuity of 20/400 or better

          -  No history of post injection pain or inflammation in the past

        Exclusion Criteria:

          -  Subjects who meet any of the following criteria will be excluded from this study

          -  History of Endophthalmitis in either eye

          -  Current inflammation in either eye

          -  Uncontrolled or symptomatic Dry Eye Syndrome

          -  Intravitreal injection less than 3 months ago

          -  History of Anterior or Posterior Uveitis

          -  History of post injection pain with prior treatments

          -  Recent thromboembolic event (<3 months)

          -  Pregnancy (positive pregnancy test) or lactation

          -  Premenopausal women not using adequate contraception.