bioihbjkbjnl/mcl2 huggingface dataset:
Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Talarozole
Intervention description: Oral Capsule Once Daily
Intervention MeSH terms: R 115866
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or
      placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and
      efficacy of R115866 will be evaluated during the treatment period and the 8-week post
      treatment follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plaque Psoriasis with PASI greater than or equal to 10

          -  Male or a female who was NOT of childbearing potential (i.e., post- menopausal for
             greater than 12 months or had a complete hysterectomy);

        Exclusion Criteria:

          -  Spontaneously improving or rapidly deteriorating plaque psoriasis

          -  Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis

          -  Subject was under treatment for a heart disorder or had a history of cardiovascular
             disease (excluding effectively controlled hypertension)

          -  Any acute psychiatric condition, including an increased risk for suicide attempt,
             based on medical and psychiatric history

          -  Previous use of a psoriasis vaccine or had participated in an investigational study of
             a psoriasis vaccine

          -  Previous use of systemic immunomodulatory therapy known to affect psoriasis and to
             typically decrease immune cell populations

          -  Previous use of any systemic immunomodulatory therapy known to affect psoriasis and
             NOT typically to decrease immune cell populations

          -  Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic
             psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or
             cyclosporine) within the previous four weeks

          -  Pregnant or a nursing mother

          -  Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic
             pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test
             for human immunodeficiency virus (HIV), a history indicating adrenal cortex
             dysfunction
Study on the Effect of a Beta Blocker on Increased Sensitivity to Pain in Humans Caused by Opioids
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Intervention: Propranolol; Placebo to Match Propranolol; Remifentanil
Intervention description: Propranolol administered intravenously, initially set to target plasma concentration of 5 ng/mL, titrated upward in 5 ng/mL intervals until a final concentration of 15 ng/mL is achieved.; Remifentanil administered intravenously at a plasma concentration of 3 ng/mL.
Intervention MeSH terms: Propranolol; Remifentanil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This research study explores whether a beta-blocker (propranolol) can prevent a person from
      becoming more sensitive to pain after administration of an opioid (remifentanil). Beta
      blockers inhibit the sympathetic (fight or flight) response and are often used to treat
      angina and high blood pressure. In a previous study in human volunteers, the investigators
      demonstrated an increased sensitivity to pain after a 60-minute infusion of the opioid
      remifentanil. The goal of this study is to identify a possible inhibitor of this phenomenon.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy men,

          2. Age between 18 and 45 years

          3. Normal weight (according to the table provided by Metropolitan Life Insurance).

        Exclusion Criteria:

          1. Hypersensitivity to opioids or naloxone,

          2. History of addictive disease,

          3. Significant cardiac, respiratory, gastrointestinal, neurological, dermatological, and
             psychiatric diseases,

          4. Concurrent medication with an analgesic drug,

          5. Student and employees affiliated with our laboratory
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: LDV/SOF; RBV; SOF/VEL; VOX
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); 400/100 mg FDC tablet administered orally once daily; 100 mg tablet administered orally once daily with food
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the antiviral efficacy, safety, and tolerability of combination
      therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Chronic HCV infection

          -  Cirrhosis determination (liver biopsy may be required)

          -  Screening laboratory values within specified limits

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol specified method(s) of contraception

          -  Specific genotype, prior medical history, or concurrent disease as required by the
             specific study group

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Pregnant or nursing female, or male with pregnant female partner

          -  Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)

          -  Use of any prohibited concomitant medications

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy
Condition: Non-diabetic Nephropathy
MeSH terms: Kidney Diseases; Albuminuria
Intervention: Aliskiren; Placebo to Aliskiren; Hydrochlorothiazide (HCTZ); Placebo to Hydrochlorothiazide (HCTZ); Ramipril
Intervention description: Aliskiren 150 mg (Tablet); Aliskiren 150 mg Matching Placebo (Tablet); HCTZ 25mg (Capsule); HCTZ 25mg (Capsule) Matching Placebo; Ramipril 10mg (Tablet)
Intervention MeSH terms: Hydrochlorothiazide; Ramipril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed to primarily assess the effect of aliskiren on albuminuria in patients
      with non-diabetic nephropathy when treated with ramipril and volume intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, age 18 years and above

          -  Patients with chronic kidney disease of non-diabetic origin

          -  Glomerular filtration rate >30 ml/min/1.73m2

          -  Patients with a history of hypertension and msSBP (mean systolic blood pressure) of
             <160 mm Hg and msDBP (mean diastolic blood pressure) <105 mm Hg at screening and
             baseline.

          -  Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2

        Exclusion Criteria:

          -  Previously treated (within 3 months of screening) with aliskiren or a combination of
             aliskiren and ramipril.

          -  Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)

          -  Pregnant or nursing (lactating) women,

          -  A medical history of unstable coronary artery disease, myocardial infarction, coronary
             bypass surgery or cerebrovascular accident within the last six (6) months

          -  Diabetes mellitus, Heart failure

          -  High rate of renal function loss

          -  History of severe hypersensitivity or contraindications to any of the medications or
             drugs belonging to the similar therapeutic class as the study drugs and the
             excipients.

          -  History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C
             test result

          -  History of immunodeficiency diseases, including a positive HIV (ELISA and Western
             blot) test result.

        Other protocol-defined inclusion/exclusion criteria applied
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)
Condition: Proliferative Diabetic Retinopathy (PDR)
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: Ranibizumab 0.5 mg; Panretinal laser photocoagulation
Intervention description: Pre-filled syringe for intravitreal injection; PRP treatment following DRS guidelines
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: An open-label design was chosen in which the evaluation of the primary objective was performed by a reading center. The reading center that evaluated the primary and several secondary objectives was blinded to randomization and therefore assessed these objectives uninfluenced by treatment information. However, laser burns were visible on the images, and no full blinding regarding panretinal laser photocoagulation (PRP) was possible for the reading center.
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Panretinal photocoagulation; Ranibizumab

Summary:

      The purpose of this study was to assess the efficacy and safety of the anti-Vascular
      Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser
      photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic
      Retinopathy (PDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Proliferative Diabetic Retinopathy

          -  Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment
             Diabetic Retinopathy Study (ETDRS) letters (20/400)

          -  Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment

        Exclusion Criteria:

          -  Proliferative vitreoretinopathy in study eye

          -  Clinically significant macular edema (CSME) in the study eye

          -  Clinically non significant macular edema (CNSME) that is likely to develop to CSME in
             the study eye

          -  Uncontrolled glaucoma in either eye

          -  Other protocol-specified conditions
A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus
Condition: Uterine Cancer
MeSH terms: Uterine Neoplasms
Intervention: Paclitaxel and carboplatin combination
Intervention description: Paclitaxel will be administered at an appropriate dose (175 mg/m2) as a 3-hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing the Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate (GFR).
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The main purpose of this study us to determine the best treatment for patients with
      endometrial cancer who are at an elevated risk for recurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a elevated risk, surgical stage II, stage IC, grade 2 or 3
             adenocarcinoma of the endometrium.

          -  Patients must have undergone, a total abdominal hysterectomy, bilateral
             salpingo-oophorectomy, peritoneal washings, and a pelvic and para-aortic
             lymphadenectomy.

          -  Patients must have adequate organ function defined as:

               1. Platelets >/= 100,000/µ

               2. Granulocytes (ANC)>/= 1,500/µl

               3. Creatinine</= 1.6 mg/dl

               4. SGOT (AST) </= 3x upper limits of normal

               5. Bilirubin within institutional normal limits

          -  Patients must have adequate performance status (ECOG performance status 0-2 or
             Karnofsky Performance Status >40)

          -  Patients must be age 19 or greater and have signed informed consent.

        Exclusion Criteria:

          -  Patients with history of other malignancies within 5 years (except non- melanoma skin
             cancer or carcinoma-in-situ of the cervix) are ineligible.

          -  Patients with high-risk histologic subtypes of endometrial cancer such as papillary
             serous or clear cell histology are ineligible.

          -  Patients with histologic evidence of uterine sarcoma, including leiomyosarcoma,
             carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible.

          -  Patients who have received past pelvic radiotherapy are ineligible.

          -  Patients receiving any other investigational agents are ineligible.

          -  Patients with known hypersensitivity to paclitaxel and/or carboplatin are ineligible.
Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Sirolimus; Standard of Care intravitreal injections of anti-VEGF
Intervention description: intravitreal injection; intravitreal injections of anti-VEGF
Intervention MeSH terms: Sirolimus; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and
      efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular
      Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular
      AMD despite previous AntiVEGF treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  best corrected visual acuity of 5-65, inclusive, in study eye

          -  presence of choroid neovascularization secondary to AMD

          -  persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the
             past 5 months

        Exclusion Criteria:

          -  greater than 100 micron decrease in central subfield thickness on Optical Coherence
             Topography (OCT) since last standard of care visit

          -  history of major ophthalmic surgery in the study eye in the past 3 months

          -  history of significant ocular disease or condition other than exudative AMD that may
             confound results
Fatty Acid Supplementation in Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Intervention: LCPUFA Oil Supplement; Canola Oil Placebo
Intervention description: 25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days; Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple
Enrollment: 72.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine how fatty acid supplementation alters biological
      signatures in children with ASD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2-6 years old

          -  ASD diagnosis at Nationwide Children's Hospital within the prior 6 months

          -  ADOS-2 score in "autism" (severe) range

          -  English is primary language

        Exclusion Criteria:

          -  Fatty acid supplementation in the past 6 months

          -  Consumes fatty fish more than 3 times per week

          -  Still breastfeeding or formula feeding

          -  Quadriparesis

          -  Deafness

          -  Blindness

          -  Seizure disorder diagnosis

          -  Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angleman Syndromes,
             Tuberous Schlerosis

          -  Feeding problems precluding consumption of the supplement

          -  Ingredient allergy (canola, fish, or borage seed)

          -  Planned surgeries scheduled within the time frame of trial participation
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in
      Japanese participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine as defined by International Headache Society (IHS)
             International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or
             1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, and migraine onset prior to age 50.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to Galcanezumab or other antibodies to CGRP or its
             receptor.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to Galcanezumab and the excipients in the investigational product.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Condition: Acute Promyelocytic Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: All-Trans Retinoic Acid (ATRA); Arsenic Trioxide (ATO); Idarubicin; Gemtuzumab Ozogamicin
Intervention description: Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; Induction: 0.15 mg/kg daily IV beginning day 1; 12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.; Induction: 9 mg/m2 on day 1 of induction
Intervention MeSH terms: Idarubicin; Tretinoin; Arsenic Trioxide; Gemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Healthy volunteers: No
Keywords: Acute Promyelocytic Leukemia; APL; ATRA; All-Trans Retinoic Acid; Arsenic Trioxide; Theophylline; Gemtuzumab

Summary:

      The goal of this clinical research study is to learn if the combination of arsenic trioxide
      (ATO) with ATRA and possibly idarubicin is effective in treating patients with
      newly-diagnosed APL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by
             cytogenetics, PCR, or POD test.

          2. Provision of written informed consent.

          3. Patients in whom therapy for APL was initiated on an emergent basis are eligible

        Exclusion Criteria:

          1. First trimester of pregnancy (ATRA is teratogenic)

          2. Corrected QT (QTC) interval must not be greater than 480 milliseconds.
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Intervention: BMS-986259; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure

Summary:

      The purpose of the study is to assess the safety of BMS-986259 in stable participants
      hospitalized for acute decompensated heart failure.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants currently hospitalized for acute decompensated heart failure (ADHF)

          -  Participants must be hemodynamically stable, as assessed by the investigator

          -  Men must agree to follow specific methods of contraception, if applicable, while
             participating in the trial

          -  Women participants must have documented proof that they are not of childbearing
             potential

        Exclusion Criteria:

          -  Acute cardiovascular condition other than heart failure (HF) decompensation

          -  Cardiogenic shock at presentation to emergency room (ER) or at any time before
             randomization

          -  Recipient of ventricular assist devices or use of any cardiac extracorporeal devices,
             within 12 weeks of study randomization

          -  Participants with contraindications to vasodilator therapy such as restrictive or
             obstructive cardiomyopathy, severe mitral or aortic stenosis

        Other protocol-defined inclusion/exclusion criteria apply