bioihbjkbjnl/mcl2 huggingface dataset:
Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Intervention: Tanezumab; Placebo
Intervention description: single administration of tanezumab 20 mg sub-cutaneously; single administration of placebo to match tanezumab, sub-cutaneously
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Tanezumab is effective in reducing the pain associated with chronic pancreatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female

          -  Written informed consent

          -  Diagnosis of chronic pancreatitis based on imaging studies

          -  Persistent abdominal pain due to chronic pancreatitis

          -  Qualifying pain score during the pre-treatment period

          -  Willing to comply with study visit schedule and study requirements including for women
             of child-bearing potential or male patients with female partners of child-bearing
             potential, the use of 2 forms of birth control

        Exclusion Criteria:

          -  Pregnant women, lactating mothers, women suspected of being pregnant and women who
             wish to become pregnant during the course of the study

          -  Chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct
             obstruction

          -  Pancreatic surgery, lithotripsy or endoscopist decompression within 3 months

          -  History of alcoholism (within 1 year of screening) or concurrent alcohol abuse

          -  History of cancer in the past years

          -  Significant cardiac disease within 6 months

          -  History, diagnosis or signs and symptoms of significant neurologic disease

          -  Disqualifying laboratory values including Hepatitis B or C, HIV and drug test

          -  Other medical condition that may interfere with study endpoints or safety of the
             patient as determined by the Investigator

          -  Known history of rheumatoid arthritis

          -  Avascular necrosis of the bone

          -  History of trauma to a major joint Evidence of osteoarthritis
Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Intervention: Propranolol
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Recipients

Summary:

      This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic
      antagonist propranolol is effective in decreasing gene expression of stress-mediated
      beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic
      stem cell transplant (HCT) for multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with multiple myeloma receiving an autologous HCT are eligible when the following
        criteria are met:

          1. 18-75 years of age

          2. ≤ 1 year since initiation of systemic anti-myeloma therapy

          3. Patient is scheduled for autologous hematopoietic stem cell transplant as the upfront
             therapy for their multiple myeloma

          4. Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the
             study

          5. All men and women must agree to practice effective contraception during the study
             period if not otherwise documented to be infertile.

        Exclusion Criteria:

          1. Prior autologous HCT

          2. Non secretory multiple myeloma

          3. Concurrent beta-blocker therapy at or within 3 weeks of study entry.

          4. Previous intolerance to beta-blocker therapy

          5. Any medical contraindications to beta-blocker therapy including, but not limited to,
             symptomatic hypotension; drug hypersensitivity; sinus bradycardia, sick sinus
             syndrome, or 2nd or 3rd degree atrioventricular block without a pacemaker;
             uncompensated heart failure; or uncontrolled asthma

          6. Active, untreated depression screened for by the HCT physician (Patients who screen
             positive will be offered a referral to the Medical College of Wisconsin
             Psycho-Oncology program for further evaluation and treatment)

          7. Concurrent use of medications as specified in the protocol throughout the study or
             within one week of study entry.

          8. Pregnant or lactating women
A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: JNJ-39588146 5 ng/kg/min; JNJ-39588146 15 ng/kg/min; JNJ-39588146 30 ng/kg/min; Placebo; JNJ-39588146 5, 15, or 30 ng/kg/min
Intervention description: 1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1; 1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1; 1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1; 1-hour infusion of matching placebo on Day 1; 18-hour infusion of JNJ-39588146 or matching placebo on Day 1 immediately folllowing the 3-hour infusion at a dose equal to the maximum dose tolerated by that patient during the 3-hour infusion in Part 1 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 86 Years
Healthy volunteers: No
Keywords: Heart Failure; Cardiac Failure

Summary:

      The purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how
      the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the
      body, how it is distributed within the body and removed from the body over time) of an
      intravenous administration of JNJ-39588146 or placebo over a 3-hour period in patients with
      heart failure. The highest tolerated dose received during the first 3 hours of the study will
      be administered to some patients for an additional 18 hours. There will be up to 3 doses
      given throughout the administration period over a total of up to 21 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have been diagnosed with heart failure

          -  Women must be either postmenopausal or have been surgically sterilized at least 6
             months ago

          -  Males must be willing to use an acceptable birth control method for 3 months after the
             last dose of study medication.

        Exclusion Criteria:

          -  Patients must not have had an heart-assist device or heart transplant or be in
             imminent need of one

          -  Patients must not have had an ischemic attack within the last 6 months or a heart
             attack within the last month

          -  Patients must not have lung disease or congenital heart failure.
Efficacy of Antidepressants in Chronic Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Intervention: cognitive behavioral therapy; desipramine hydrochloride; cognitive behavioral therapy; benztropine mesylate 0.125 mg daily; desipramine hydrochloride
Intervention description: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life; desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml; cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life; benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride; desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Intervention MeSH terms: Benztropine; Desipramine; Clomipramine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic pain; back pain; antidepressants

Summary:

      This 12 week placebo controlled clinical trial tests the individual and combined effects of
      an antidepressant medication and cognitive behavioral therapy for chronic back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic back pain (daily pain for > 6 months)

        Exclusion Criteria:

          -  Major medical conditions which might contraindicate antidepressant treatment
Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in Obese Adolescents
Condition: Obesity
MeSH terms: Obesity; Insulin Resistance
Intervention: Vitamin D3
Intervention description: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin D; Obesity; Insulin sensitivity; Adolescent Obesity

Summary:

      The prevalence of obesity has reached epidemic proportions nationally as well as
      internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a
      risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to
      vitamin D insufficient. In adults, low vitamin D status appears to be associated with the
      development of type 2 diabetes and metabolic syndrome. There is little information on the
      prevalence of vitamin D insufficiency and its implications in obese adolescents.
      Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might
      result in improvement in insulin resistance, lipids and cardiovascular risk markers.

      We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and
      cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin
      resistance and cardiovascular risk factors in this population. The purpose of the study is to
      determine the impact of vitamin D3 supplementation on various parameters of insulin
      secretion, insulin action, lipids and C-reactive protein in obese adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age between 12-18 years

          2. BMI is at or greater than the 95th percentile for age and gender

        Exclusion Criteria:

          1. Subjects with 25 (OH)- D levels >100 ng/mL

          2. Serum calcium >10.8 mg/dL

          3. Current cancer

          4. Those taking a multivitamin supplementation

          5. Hepatic or renal disorders

          6. Type 1 or type 2 diabetes mellitus.

          7. Those receiving insulin, metformin or oral hypoglycemic medications

               -  Use of glucocorticoids and anti-seizure medications in the previous 6 months

               -  Malabsorption syndromes such as celiac disease
A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: tildrakizumab; Placebo
Intervention description: SC administration of tildrakizumab at assigned dose; SC administration of Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 355.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a response-driven study of tildrakuzumab for the treatment of moderate to severe
      chronic plaque psoriasis. The primary study hypothesis is that one or more doses of
      tildrakizumab will be superior to placebo for the treatment of psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic
             plaque psoriasis (defined by ≥10% body surface area [BSA] involvement, "moderate" or
             greater score on the Physician's Global Assessment [PGA] scale, and PASI score ≥12 at
             Baseline)

          -  Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as
             determined by interview and confirmation of diagnosis through physical examination by
             investigator) and be considered candidates for phototherapy or systemic therapy.
             Participants with psoriatic arthritis may be included in the study

        Exclusion Criteria:

          -  Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly
             pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new
             onset guttate psoriasis

          -  Participants who will require oral or injectable corticosteroids during the trial

          -  Presence of any infection requiring treatment with systemic antibiotics within 2 weeks
             prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint
             infections) requiring hospitalization or treatment with intravenous antibiotics within
             8 weeks prior to Screening

          -  Participants with evidence of active or untreated latent tuberculosis (TB) according
             to Screening criteria specified in the protocol. (Prophylactic treatment for latent TB
             as per local guidelines must be initiated at least 4 weeks prior to treatment with
             study medication)

          -  Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23
             (IL-23)

          -  Participants with prior exposure to two or more tumor necrosis factor (TNF)
             antagonists with discontinuation due to lack of efficacy.
Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis
Condition: Multiple Sclerosis; Cognitive Ability, General
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ginkgo biloba; Placebo
Intervention description: 120 mg orally twice a day for 12 weeks; One capsule orally twice a day for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ginkgo biloba; Multiple Sclerosis; Cognition; Neuropsychological Tests; Neurobehavioral Manifestations; Quality of life; Randomized Controlled Trials; Placebos; Double-Blind Method

Summary:

      The purpose of this study is to see if treatment with Ginkgo improves cognitive function in
      people with multiple sclerosis who have cognitive problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of multiple sclerosis by McDonald's criteria

          -  Age 18 to 65 years, inclusive

          -  A score minus one standard deviation below the mean on one or more of the following
             tests: PASAT, COWAT, CVLT-II, Stroop

          -  EDSS 0 - 7.5, inclusive

          -  No Ginkgo biloba in preceding 30 days

          -  Native English speaker

        Exclusion Criteria:

          -  Current substance abuse disorder, psychosis, or significant depression (score on the
             Beck Depression Inventory II (BDI -II) greater than 28

          -  Any significant uncontrolled medical problem including diabetes requiring insulin

          -  Relapse of multiple sclerosis within the 30 days before screening

          -  Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents

          -  Elective surgery planned for the study period or the following four weeks

          -  Epilepsy or history of seizures

          -  Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase
             inhibitors

          -  Pregnancy or women not using a reliable form of contraception

          -  Corrected binocular visual acuity worse than 20/50 or more than one error on binocular
             color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia
             on primary gaze

          -  Inability to complete the neuropsychological test battery at the screening visit

          -  History of alcohol abuse or illicit drug use in the prior six months
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex 25 mg; Proellex 50 mg; Lupron Depot
Intervention description: Proellex 25 mg, 1 capsule daily for 4 months; Proellex 50 mg, 2 capsules daily for 4 months; Lupron 3.75 mg monthly intramuscular injections for 4 months
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Uterine fibroids; Fibroids

Summary:

      PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects between the ages of 18 and 45 years with body mass index (BMI) between
             18 and 35 mg/kg2 inclusive

          -  Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or
             uterine arterial embolization) must not be planned or anticipated during the study

          -  Subject must have the following uterine fibroid-associated symptom: history of
             excessive menstrual bleeding

          -  Regular or steady menstrual cycle lasting from 24 to 36 days

          -  Willing to comply with all study procedures including the endometrial biopsies and PK
             blood draws for all visits including follow-up visits

          -  Subject must agree to use a medically acceptable and effective non-hormonal, double
             barrier birth control method throughout the study and for 30 days following the end of
             the study or discontinuation of study drug

        Exclusion Criteria:

          -  Documented endometriosis or active pelvic inflammatory disease

          -  History of alcohol and/or drug abuse

          -  Any history or diagnosis of gynecological cancer or cervical dysplasia

          -  Use of an IUD

          -  Use of prohibited concomitant medications:

               -  Use of Depo-Provera must cease 10 months prior to first dose of study drug

               -  Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of
                  study drug and Lupton® Depot 8 months prior to the first visit

          -  Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
Condition: Cardiorenal Syndrome
MeSH terms: Cardio-Renal Syndrome; Syndrome
Intervention: Furosemide intravenous solution; Chlortalidone; Spironolactone
Intervention description: Administrated as an 80 mg intravenous bolus every 24 hours in both arms and then as a continuous infusion dosed according to the experimental arm.; One 50 mg pill administrated every 24 hours in group B; One 50 mg pill administrated every 24 hours in group B
Intervention MeSH terms: Chlorthalidone; Furosemide; Spironolactone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Its a randomized, controlled, phase II, 2-arm, double-blind clinical trial
Masking: Double (Participant, Investigator)
Masking description: Double-blind clinical trial
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In double-blind clinical trial, determine renal recovery with two different furosemide
      strategies in patients with type 1 cardiorenal syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Comply with both clinical diagnosis of acute kidney injury by serum creatinine
             according to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines and
             acute decompensate heart failure as clinical assessed by the clinical team in charge.

          -  Have agreed and signed informed consent

        Exclusion Criteria:

          -  Patient in chronic dialysis either peritoneal dialysis or hemodialysis.

          -  History of being a renal transplant recipient

          -  History of acute kidney injury according to the KDIGO 2012 guidelines and / or renal
             replacement therapy in the last 3 months

          -  Pregnancy

          -  Impossibility to administer medication by the oral route