bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: M1095 (Sonelokimab); Placebo; Secukinumab
Intervention description: M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.; Placebo contains no active drug.; Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type
      psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites
      in North America and Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects between 18 and 75 years of age.

          2. Moderate to severe plaque-type psoriasis for at least 6 months.

          3. Subject is a candidate for systemic biologic therapy.

          4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening
             and at baseline.

          5. Subject is able to comply with the study procedures.

          6. Subject must provide informed consent.

        Exclusion Criteria (Main):

          1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g.,
             eczema). (Psoriatic arthritis is allowed).

          2. Other medical conditions, including planned surgery or active infection / history of
             infection, as defined in the study protocol. Subjects will be screened for
             tuberculosis and hepatitis B / hepatitis C.

          3. Laboratory abnormalities at screening, as defined in the study protocol.

          4. Prior use of systemic or topical treatments for psoriasis, as defined in the study
             protocol.

          5. Prior use of any compound targeting IL-17, more than two biologic therapies,
             ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.

          6. History of suicidal thoughts within 12 months.
A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction
Condition: Acute Myocardial Infarction; Moderate Renal Impairment
MeSH terms: Renal Insufficiency; Myocardial Infarction; Infarction
Intervention: CSL_112; Placebo
Intervention description: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.; 0.9% weight/volume sodium chloride solution (ie, normal saline)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a phase 2, multicenter, double-blind, randomized, placebo controlled,
      parallel-group study to investigate the renal safety and tolerability of multiple dose
      intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate
      renal impairment (RI) and acute myocardial infarction (AMI).
    

Eligibility criteria:

        Inclusion Criteria:

        • Men or women, at least 18 years of age, with evidence of moderate renal impairment (an
        eGFR ≥ 30 and <60 mL/min/1.73 m2) and myocardial necrosis in a clinical setting consistent
        with a type I (spontaneous) acute myocardial infarction (AMI).

        Exclusion Criteria:

          -  Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of
             the index event that are consistent with a diagnosis of AMI but are likely not due to
             primary myocardial ischemia

          -  Ongoing hemodynamic instability

          -  Planned coronary artery bypass surgery

          -  Evidence of hepatobiliary disease

          -  History of acute kidney injury (AKI) after previous exposure to an intravenous
             contrast agent.

          -  History of nephrotic range proteinuria.

          -  Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency,
             antibodies to IgA , or hypersensitivity to CSL112 or any of its components.

          -  Other severe comorbid condition, concurrent medication, or other issue that renders
             the subject unsuitable for participation in the study.
Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: GW823093 15mg; GW823093 placebo capsule; GW823093 30mg
Intervention description: White opaque capsule containing 15mg of GW823093 as free base; Matching placebo of GW823093 capsule or 15mg capsule; White opaque capsule containing 15mg of GW823093 as free base
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: pharmacodynamics; Diabetes; pharmacokinetics

Summary:

      To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of
      GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes
      mellitus (T2DM) patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG)
             level <280mg/dL at the Screening visit.

          -  Concurrent T2DM therapy: Must be diet controlled - OR - not taking more than 2 oral
             anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to
             the first dosing.

        Exclusion criteria:

          -  Must not have any other major illness other than diabetes
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Condition: Cardiovascular Disease; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Intervention: angiotensin converting enzyme inhibitor; lisinopril
Intervention description: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day; 1 x 40 mg per day
Intervention MeSH terms: Lisinopril; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 60 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cardiovascular disease; angiotensin converting enzyme inhibitors; chronic kidney disease; cardiovascular disease in elderly patients with CKD

Summary:

      The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs
      primarily used to treat hypertension or congestive heart failure) to prevent or delay
      cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining
      their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 60 years

          -  BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF
             bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)

          -  CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

        Exclusion Criteria:

          -  Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New
             York Heart Association (NYHA) class III or greater).

          -  Serum potassium > 5.2 meq/L

          -  Known allergy or hypersensitivity to ACE inhibitor or ARB

          -  Female of childbearing age not practicing contraception

          -  Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or
             Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week
             washout period)

          -  History of ACE-I induced angioedema

          -  History of angioedema, hereditary or idiopathic

          -  Persons lacking consent capacity

               -  500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios
Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa
Condition: Eating Disorders
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Intervention: Olanzapine; Placebo
Intervention description: Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.; Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Anorexia Nervosa

Summary:

      This study will evaluate the effectiveness of the antipsychotic medication olanzapine in
      treating outpatients with anorexia nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria (not including amenorrhea) for AN

          -  Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2

          -  Patient (or family if the patient is a minor) refuses hospitalization

          -  Free of psychotropic medication (4 weeks medication free for fluoxetine and
             antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose
             of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry

          -  Prior treatment of AN

        Exclusion Criteria:

          -  Any medical or psychiatric problem requiring urgent attention and/or any significant
             comorbid illness not likely to benefit from proposed treatments

          -  Allergy to olanzapine

          -  Significant orthostatic high blood pressure

          -  Recent commencement of psychotherapy in the community

          -  Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting
             serum glucose greater than 140 mg/dL

          -  Known history of current or past jaundice

          -  Known history of narrow angle glaucoma

          -  Active substance abuse or dependence

          -  Schizophrenia, schizophreniform disorder, or bipolar illness

          -  Movement disorder or presence of tics

          -  History of tardive dyskinesia

          -  History of seizures

          -  Pregnant
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
Condition: Parenteral Nutrition Associated Liver Disease PNALD; Cholestasis
MeSH terms: Liver Diseases; Cholestasis
Intervention: Omegaven™
Intervention description: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: PN; parenteral nutrition; fat emulsions; omega-6 fatty acid; liver disease; fatty acid deficiency

Summary:

      The purpose of this study is to determine if established parenteral nutrition (PN) associated
      liver disease can be reversed or its progression halted by using a parenteral fat emulsion
      prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and
      bilirubin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be enrolled in the Intestinal Rehabilitation Program at the University
             of Nebraska Medical Center, AND:

          -  Be unable to meet nutritional needs solely by enteral nutrition and be expected to
             require PN for at least another 30 days

          -  Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as
             defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not
             necessary for treatment

          -  Signed patient informed consent

        Exclusion Criteria:

          -  Parent or guardian or child unwilling to provide consent or assent

          -  Inability or unwillingness on the part of parent/guardian or child to follow clinical
             recommendations of the Intestinal Rehabilitation Program

          -  Allergies or clinical conditions precluding safe use of Omegaven™
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: DCV/ASV/BMS-791325; Ribavirin; Sofosbuvir; Peginterferon α-2a
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether the combination of Daclatasvir (DCV),
      Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C
      virus.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Males and Females ≥18 years of age, inclusive

          -  Chronic HCV infection Genotype 1 only

          -  Non-cirrhotic

          -  Treatment naive subjects with no previous exposure to an Interferon formulation (ie,
             IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease,
             polymerase inhibitor, etc.)

        Exclusion Criteria:

          -  HCV Genotype other than Genotype 1

          -  Documented or suspected hepatocellular carcinoma

          -  Evidence of decompensated liver disease

          -  Contraindication(s) to Peg/RBV therapy
Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
Condition: Pain; Urinary Stone; Urinary Calculi
MeSH terms: Urinary Calculi; Urolithiasis; Calculi
Intervention: Ketorolac; normal saline
Intervention description: IM injection of either normal saline or Ketorolac; normal saline
Intervention MeSH terms: Ketorolac
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: stent removal, pain, kidney stones

Summary:

      This is a prospective randomized double-blind controlled trial assessing the benefits of
      intramuscular ketorolac before or immediately after office ureteral stent removal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral
             stent placement at Clements University Hospital and are presenting to the office for
             cystoscopy and stent removal.

        Exclusion Criteria:

          -  eGFR <50

          -  any active or history of peptic ulcer disease or GI bleeding

          -  Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic
             diathesis, or incomplete hemostasis

          -  Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or
             heparin

          -  Allergic reaction to NSAIDs

          -  Concurrent use of other NSAIDs within 24 hours

          -  Pregnancy (ketorolac contraindicated in this population)

          -  Recent myocardial infarction (MI)
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: M281; Placebo
Intervention description: M281 administered as IV infusion; Placebo administered as intravenous (IV) infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: M281; Generalized Myasthenia Gravis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281
      administered to participants with generalized myasthenia gravis (gMG) who have an
      insufficient clinical response to ongoing standard of care therapy.
    

Eligibility criteria:

        Participants must be ≥18 years of age with a documented history of Generalized Myasthenia
        Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no
        history of any neurologic disorder other than MG that might interfere with the accuracy of
        study assessments.

        Additional, more specific criteria are defined in the protocol.
Heart Rate Variability Biofeedback for Smoking Cessation
Condition: Tobacco Smoking
Intervention: Cognitive-Behavioral Smoking Cessation; Heart Rate Variability Biofeedback (HRVB); Transdermal Nicotine patch
Intervention description: Participants were provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.; All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.; All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).
Masking: None (Open Label)
Masking description: This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.
Enrollment: 10.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Heart rate variability biofeedback

Summary:

      Open trial of heart rate variability biofeedback as an adjunct to individualized smoking
      cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with
      elevated emotional distress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoking ≥5 cigarettes, daily, for at least two years

          -  expired carbon monoxide analysis of breath sample ≥8 ppm

          -  elevated affective distress

          -  motivation to quit

          -  computer proficient

        Exclusion Criteria:

          -  current use of other tobacco or nicotine products for recreation or to aid in
             cessation, use of pharmacological intervention for cessation, or current enrollment in
             a psychosocial intervention for smoking cessation

          -  endorsement of current or past psychotic or manic symptoms indicative of bipolar
             spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal
             ideation

          -  inability to provide written informed consent

          -  current evidence of another substance use disorder

          -  severe visual or hearing impairments

          -  self-reported medical condition or medication use that may be contraindicated for
             participation in a HRVB or confound autonomic parameters:

          -  self-reported medical issues of potential concern to nicotine patch users
Therapeutic Cocaine Vaccine: Human Laboratory Study
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Cocaine vaccine (TA-CD)
Intervention description: TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.
Intervention MeSH terms: Cocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cocaine; immunotherapy; vaccination; antibody; addiction; dependence

Summary:

      Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces
      selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct
      effects is unknown. The objective of this human laboratory study was to measure the
      relationship between antibody titers and the effects of smoked cocaine on ratings of
      intoxication, craving and cardiovascular effects.

      Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks
      inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and
      at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria
             for other substance abuse, but not dependence (other than nicotine).

          2. Primary route of cocaine administration is smoking.

          3. Age 21-45.

          4. Females must be surgically sterilized or post- menopausal

          5. Able to give informed consent, and comply with study procedures.

        Exclusion Criteria:

          1. Dependence on substances other than cocaine or nicotine.

          2. Judged to be noncompliant with study protocol.

          3. History of autoimmune disease, immune deficiency or hypersensitivity to other
             vaccines. An HIV test must be negative.

          4. Currently uses drugs intravenously

          5. Currently taking any psychotropic medication

          6. Laboratory tests that are clinically unacceptable to the study physician (BP > 140/90;
             BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men)

          7. Blood or blood products given in the three months prior to vaccination

          8. Other vaccines, including flu vaccine, given within 30 days of screening.

          9. Ongoing active infection

         10. Currently taking immunosuppressives -