bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Condition: Rhegmatogenous Macula-off Retinal Detachment
MeSH terms: Retinal Detachment
Intervention: 400 ug Brimonidine Implant; 200 ug Brimonidine Implant; Sham (no implant)
Intervention description: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.; 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.; Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200
      μg and 400 μg brimonidine tartrate) on visual function in patients with previous
      rhegmatogenous macula-off retinal detachment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous
             in etiology)

          -  The repair of the macula-off retinal detachment must have occurred at least 6 months
             before the Day 1 visit in the study eye

          -  The repair must have been deemed an anatomic success and required no more than one
             macular re-attachment procedure

          -  The visual acuity score must be between 20/50 and 20/320 in the study eye

        Exclusion Criteria:

          -  Any sight-threatening ocular condition in the study eye other than the ruptured
             retinal detachment

          -  Anticipated need for ocular surgery during the 12-month study period

          -  Any injectable, periocular, or intravitreal corticosteroid treatment to study eye
             within 6 months prior to screening (eg, triamcinolone acetonide)

          -  Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye
             within 3 months prior to screening (eg, Avastin or Lucentis)

          -  Any infectious condition in the study eye
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: PRO-148 Ophthalmic Solution; Active Comparator: SYSTANE ® Ophthalmic Solution
Intervention description: PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.; Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PRO-148; Dry eye syndrome

Summary:

      The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic
      solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms
      of mild-to-moderate dry eye syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diagnosis of mild-to-moderate drye eye syndrome.

          -  Male or female patients.

          -  Patients 18 years of age

        Exclusion Criteria:

          -  Patients with one blind eye.

          -  Visual acuity of 20/40 in any eye

          -  Patients with history of active stage of any other concomitant ocular disease.

          -  Patients taking any medication, topically or by any other route, which could interfere
             with the study's results, in the 3 days prior to trial or until a time period in which
             residual effects could be present.

          -  Contraindications or sensitivity to any component of the study treatments.

          -  Ocular surgery within the past 3 months.

          -  Contact lens users.

          -  Females of childbearing potential )may not participate in the study if any of the
             following conditions exist:

               -  They are pregnant,

               -  They are breastfeeding,

               -  They have a positive urine pregnancy test at screening,

               -  They intend to become pregnant during the study, or

               -  They do not agree to use adequate birth control methods for the duration of the
                  study.

          -  Participation in any studies of investigational drugs within 90 days previous to the
             inclusion.

        Discontinuation criteria:

          -  Patients could be discontinued before the completion of the study because of adverse
             events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ruxolitinib phosphate cream; Dovonex® calcipotriene 0.005%; Diprolene® AF betamethasone dipropionate 0.05% cream.; Placebo cream; Ruxolitinib phosphate cream; Ruxolitinib phosphate cream
Intervention description: Ruxolitinib phosphate cream 0.5%; Cream applied once or twice daily for up to 56 days.; Cream applied once or twice daily for up to 56 days; Cream applied once or twice daily for 56 days; Ruxolitinib phosphate cream 1.0%; Ruxolitinib phosphate cream 1.5%
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study is comprised of two parts. The first portion of this study will be a double-blind,
      Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to
      paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part
      2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA
      approved products in patients with active but stable plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) of 17 to 40 kg/m2

          -  Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2
             and these target lesions must be similar in size to each other, and separated by at
             least 15 cm.

        Exclusion Criteria:

          -  Subjects with lesions solely involving the palms of the hands or soles of the feet or
             intertriginous areas, the scalp or the face.

          -  Subjects with pustular psoriasis or erythroderma.

          -  Subjects currently on other topical agents or UVB therapy within 2 weeks of the first
             dose of study medication.

          -  Subjects receiving PUVA within 4 weeks of the first dose of study medication.

          -  Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral
             immunosuppressives within 3 months prior to the first dose of study medication.

          -  Subjects receiving any other biological therapy (infliximab, alefacept, abatacept,
             etc) within 3 months of the first dose of study medication.
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: RLX030 (serelaxin); Placebo
Intervention description: RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours.; Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure, CHF, Heart Failure, HF, Immunogenicity, Anti-bodies, Hypersensitivity, Serelaxin, RELAX-REPEAT

Summary:

      The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic
      heart failure.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Body weight of ≤ 160 kg.

          -  Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior
             documented history of chronic heart failure.

          -  NT-proBNP >300 pg/ml (according to central measurement) at visit 1.

          -  Subjects treated with appropriate and guideline-indicated CHF standard of care.

          -  Ability to comply with all requirements, including ability to receive at least a 48
             hour infusion plus follow-up time required for each dosing visit.

        Key Exclusion Criteria:

          -  Current acute decompensated HF

          -  Any major solid organ transplant recipient or planned anticipated organ transplant
             within 1 year.

          -  Documented history of untreated ventricular arrhythmia with syncopal episodes,
             ventricular tachycardia, or ventricular fibrillation without ICD (implantable
             cardioverter defibrillator) with significant hemodynamic consequences within the 3
             months prior to screening.

          -  Presence of hemodynamically significant mitral and /or aortic valve disease, except
             mitral regurgitation secondary to left ventricular dilatation: including significant
             left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy,
             severe aortic stenosis)

          -  Subjects with severe renal impairment defined as pre-randomization eGFR < 30
             ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or
             planned dialysis or ultrafiltration
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Olpasiran; Placebo
Intervention description: Dose 1 Dose 2 Dose 3 Dose 4; Dose 5
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Olpasiran; AMG 890; siRNA; lipoprotein (a) Lp(a); Cardiovascular; Cardiovascular disease; Atherosclerotic cardiovascular disease; Cholesterol; Apolipoprotein (B); Hyperlipidemia; Dyslipidemia

Summary:

      Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on
      percent change from baseline in lipoprotein(a) (Lp[a]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 80 years

          -  Lipoprotein (a) > 150 nmol/L

          -  Evidence of atherosclerotic cardiovascular disease

        Exclusion Criteria:

          -  Severe renal dysfunction

          -  History or clinical evidence of hepatic dysfunction

          -  Malignancy within the last 5 years

          -  Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day
             Niacin
A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Odanacatib; Placebo; Vitamin D3; Calcium
Intervention description: Odanacatib 50 mg tablets once weekly for 24 months; Placebo to odanacatib 50 mg tablets once weekly for 24 months; Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months; Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 246.0
Sex: Female
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and
      the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with
      alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once
      weekly will increase bone mineral density at the femoral neck compared to placebo at the end
      of 24 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has been postmenopausal for at least 5 years

          -  Has taken or is taking alendronate

          -  Agrees not to use medications for osteoporosis other than what is provided by the
             study

        Exclusion Criteria:

          -  Has a history or evidence of hip fracture

          -  Has a history of cancer within 5 years of screening, except certain skin or cervical
             cancers.

          -  Has active parathyroid disease

          -  Has a history of thyroid disease not adequately controlled by medication

          -  Is taking anti-seizure medication and has abnormal calcium metabolism

          -  Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or
             within 3 months of screening
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Belinostat
Intervention MeSH terms: Belinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Belinostat; Peripheral T-cell lymphoma; PXD101; PTCL; HDAC inhibitor; Histone deacetylase inhibitor

Summary:

      The purpose of this study is to assess efficacy and safety of belinostat in participants with
      relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior
      systemic therapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  A histologically confirmed diagnosis of PTCL

          -  Participants must have relapsed or refractory disease after at least one prior
             systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or
             immunotherapy administered systemically.

          -  Participants must have at least one site of disease measurable in two dimensions by
             computed tomography (CT).

          -  Age ≥ 18 years.

          -  Adequate bone marrow, liver, and renal functions.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Negative pregnancy test for women of childbearing potential.

        Exclusion criteria:

          -  Relapse within 100 days of autologous or allogeneic bone marrow transplant.

          -  Prior histone deacetylase (HDAC) inhibitor therapy.

          -  Co-existing active infection or any medical condition likely to interfere with trial
             procedures.

          -  Severe cardiovascular disease.

          -  Clinically significant central nervous system disorders with altered mental status or
             psychiatric disorders precluding understanding of the informed consent process and/or
             completion of the necessary studies.

          -  Active concurrent malignancy (except adequately treated non-melanoma skin cancer or
             carcinoma in situ of the cervix).

          -  Symptomatic or untreated central nervous system (CNS) metastases.

          -  Pregnant or breast-feeding women.

          -  Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Placebo; PF-00547659 SC Injection; PF-00547659 SC Injection; PF-00547659 SC Injection; PF-00547659 SC Injection
Intervention description: Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To determine the dose or doses of PF-00547659 that will be the most effective to improve or
      halt the disease symptoms in patients with moderate to severe ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with diagnosis of Ulcerative Colitis for 3 or more months.

          -  Ulcerative colitis must be active beyond the rectum.

          -  Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points

        Exclusion Criteria:

          -  Pregnant or breast feeding.

          -  Diagnosis of indeterminate colitis or Crohn's Disease

          -  Subjects with history of colonic or small bowel obstruction or resection.
Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: Splanchnic nerve block
Intervention description: Percutaneous splanchnic nerve block
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: heart failure, exercise, splanchnic nerve block

Summary:

      Splanchnic vasoconstriction may contribute to decompensation of chronic heart failure (HF)
      via volume redistribution from the splanchnic vascular bed to the central compartment. This
      is a sympathetically mediated reflex and can be interrupted through a splanchnic nerve block
      (SNB). We hypothesize that interruption of the efferent/afferent innervation of the
      splanchnic vasculature will decrease cardiac congestion in patients presenting with HF. Based
      on preliminary safety and efficacy data in acute and chronic heart failure patients with
      temporary (<24 h) SNB. Now we will apply a prolonged SNB in chronic heart failure patients
      using a long acting agent. We will test the effects of SNB on long term exercise capacitance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Followed at DUMC for known or suspected diagnosis of HF (NYHA stage 2-4, Class C-D),
             including patients on inotropic medication

          -  Systolic blood pressure (SBP) > 100 mmHg

          -  History of HF hospitalization or ER visit or iv diuretic use in last 12 months.

          -  Patients will be included regardless of left ventricular ejection fraction.

        Exclusion Criteria:

          -  Anticoagulation at the time the procedure or in case of recent warfarin use an INR
             >1.4. Anticoagulation includes: warfarin, or novel oral anticoagulants like
             dabigatran, rivaroxaban, apixaban, endoxaban or full dose intravenous heparin products
             or bivalirudin and fondaparinux). Antiplatelet agents besides aspirin such as
             ticagrelor, prasugrel, Plavix are also considered to be a contraindication if used at
             time point of procedure.

          -  Immunosuppressive medications for solid organ transplant

          -  Acute MI (STEMI or Type I NSTEMI) within 7 days?

          -  Evidence of progressive cardiogenic shock within 48 hours

          -  Restrictive cardiomyopathy

          -  Constrictive pericarditis

          -  Pericardial effusion with evidence of tamponade

          -  Severe valvular stenosis requiring intervention

          -  Known history of an increased bleeding risk

          -  Thrombocytopenia (< 50,000)

          -  End-stage renal disease CKD stage 5 due to primary renal pathology