bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Zilucoplan (RA101495)
Intervention description: 0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The purpose of the study is to evaluate the safety and efficacy of zilucoplan (RA101495) in
      patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients
      in the study: the first group will include patients who have never received eculizumab for
      treatment of PNH. The second group will include patients who have received treatment with
      eculizumab for at least 6 months prior to the study. Patients will be treated with RA101495
      for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PNH by flow cytometry

          -  For treatment naive patients: subjects must not have received treatment with
             eculizumab prior to or during the Screening Period and must have a lactate
             dehydrogenase (LDH) level ≥2 times the upper limit of normal (xULN) during Screening

          -  For patients who previously received eculizumab: subjects must have received treatment
             with eculizumab for at least 6 months prior to Screening

        Exclusion Criteria:

          -  History of meningococcal disease

          -  Current systemic infection or suspicion of active bacterial infection
Tofacitinib Ointment For Chronic Plaque Psoriasis
Condition: Psoriasis Vulgaris; Psoriasis
MeSH terms: Psoriasis
Intervention: tofacitinib ointment 20 mg/g; tofacitinib ointment 10 mg/g; placebo ointment (vehicle); tofacitinib ointment 20 mg/g; tofacitinib ointment 10 mg/g; placebo ointment (vehicle)
Intervention description: tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks; tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks; placebo ointment (vehicle) BID (twice daily) for 12 weeks; tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks; tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks; placebo ointment (vehicle) QD (once daily) for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; vulgaris; topical treatment; skin diseases; papulosquamous; Tofacitinib; CP-690550; Xeljanz; psoriasis; moderate; severe; itch; nail psoriasis

Summary:

      The study is beng done to test if tofacitinib ointment is safe and effective for people with
      plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied
      once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment
      used for 12 weeks will be compared to the safety and effectiveness of placebo ointment
      (vehicle) used for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6
             months prior to Baseline

          -  At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA)
             on the trunk and limbs (excluding palms, soles, and nails)

          -  If received certain treatments, should be off treatment for a minimum period of time
             (washout)

        Exclusion Criteria:

          -  Currently have non-plaque forms of psoriasis or drug-induced psoriasis

          -  Require treatment with or cannot stop medication(s) prohibited during the study

          -  Have certain laboratory abnormalities at Baseline

          -  Current or history of certain infections

          -  Females who are pregnant, breastfeeding, or are of childbearing potential not using
             highly effective contraception
Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy
Condition: Adverse Effect of Radiation Therapy
MeSH terms: Macular Degeneration
Intervention: aflibercept
Intervention description: This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward.
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Radiation Retinopathy; aflibercept

Summary:

      The primary objective of the study is to assess the safety of intravitreal aflibercept
      injection in treating visually compromising radiation maculopathy secondary to treatment of
      uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25
      patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks.
      Subjects in arm 2 will undergo treatment and if improvement is documented at the following
      evaluation the next treatment will be extended by two weeks. Secondary objectives of the
      study include evaluation and analysis of visual acuity, number of injections, macular edema,
      and vascular activity between both arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A Patient must meet the following criteria to be eligible for inclusion in the study:

               1. 21 years of age and over

               2. 20/800 or better visual acuity

               3. Must have received previous treatment for radiation maculopathy within the last
                  4-26 weeks

               4. Any presence of macular edema (evaluated by SD-OCT) caused by radiation
                  retinopathy

               5. Willing and able to comply with clinic visits and study-related procedures

               6. Provide signed informed consent

        Exclusion Criteria:

          -  A patient who meets any of the following criteria will be excluded from the study:

               1. Patients less than 21 years of age.

               2. Patients with mental disability or any other condition that precludes the
                  acquisition of an sdOCT image such as (nystagmus, neck disease, etc.)

               3. Patients who have previously been treated with intravitreal triamcinolone
                  acetonide for macular edema (signs of recalcitrant disease)
A Lifestyle Change Program to Prevent Type 2 Diabetes
Condition: Prediabetes
MeSH terms: Prediabetic State
Intervention: Enhanced standard care; Lifestyle counseling
Intervention description: One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes); Enhanced standard care Six appointments with nurse practitioner (20 minutes)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: diabetes prevention, primary care

Summary:

      The purpose of this study was to evaluate the effect of a diabetes prevention program
      provided by nurse practitioners in primary care to adults at risk for diabetes.
    

Eligibility criteria:

        Inclusion Criteria

          -  age 21 or older

          -  medically stable and safe to exercise

          -  at high risk for type 2 diabetes

          -  able to speak English.

        Exclusion Criteria

          -  Type 2 diabetes

          -  Cardiovascular disease

          -  Cancer requiring treatment in the past 5 years

          -  Anemia

          -  Hepatitis

          -  Renal disease

          -  Gastrointestinal disease

          -  Recent or significant abdominal surgery

          -  Pulmonary disease with dependence on oxygen or daily use of bronchodilators

          -  Chronic infection (ie., HIV, active tuberculosis)

          -  Unable to walk 0.25 miles in 10 minutes

          -  Participation in commercial diet program

          -  Currently pregnant or within 3 months postpartum

          -  Currently nursing or within 6 weeks of having completed nursing

          -  Treatment of impaired glucose tolerance (IGT) with metformin

          -  Currently taking any glucocorticoid or beta-blocker

          -  Recently prescribed or changed dose of a statin (within 2 months)
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
Condition: Genital Herpes
MeSH terms: Herpes Genitalis
Intervention: AIC316; Valacyclovir
Intervention description: 100 mg oral administration; 500 mg oral administration
Intervention MeSH terms: Valacyclovir; Pritelivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIC316; Viral shedding

Summary:

      The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg
      once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital
      shedding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, immunocompetent men and women in good health of any ethnic group

          -  Seropositive for Herpes Simplex Virus Type 2 (HSV-2)

          -  History of recurrent episodes (>=4 to <=9) of genital herpes for at least 12 months
             and willingness to obtain 4 swabs per day.

        Exclusion Criteria:

          -  Present episode of genital herpes at time of randomization

          -  Clinically relevant acute or chronic infections (excluding HSV-2)

          -  Known intolerance to valacyclovir, acyclovir, or any component of the formulation

          -  Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir
Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
Condition: NSAID-induced Gastroduodenal Injury; Ulcers; Rheumatoid Arthritis; Osteoarthritis
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Wounds and Injuries
Intervention: Cobiprostone; Placebo; Non-steroidal anti-inflammatory drug
Intervention description: 18 mcg cobiprostone capsules for oral administration; Matching placebo capsules for oral administration; Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Intervention MeSH terms: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine the efficacy and safety of three dose
      levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20
      months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is more than 40 and less than 70 years of age.

          -  Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could
             benefit from NSAID therapy.

          -  No current gastrointestinal H. pylori infection.

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to NSAIDs, or has any other contraindicated
             condition(s) to NSAID therapy.

          -  Patient has undergone a gastrointestinal or abdominal surgical procedure within 90
             days prior to the Screening Visit, or has had a bowel resection at any time.

          -  Medical history includes prior or active GI complications and/or disorders, including
             but not limited to Barrett's esophagus, erosive esophagitis, esophageal stricture or
             ring, gastric obstruction, irritable bowel syndrome (IBS), or inflammatory bowel
             disease (IBD).

          -  Active symptomatic peptic ulcer disease or GI bleeding.

          -  Patient has received cobiprostone (SPI-8811; RU-8811) or AMITIZA (other names:
             lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.
Bortezomib in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: bortezomib
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV renal cell cancer; recurrent renal cell cancer; papillary renal cell carcinoma

Summary:

      RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with
      metastatic kidney cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)

          -  Distant metastatic disease (Tx, Nx, M1)

          -  Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein

          -  Measurable disease on imaging scan (≥ 1 cm)

          -  Brain metastases allowed provided they have been treated with surgery and/or radiation
             therapy and show no evidence of progression on cerebral CT or MRI scan 2 months
             following surgery and/or radiation therapy.

          -  Life expectancy ≥ 3 months

          -  Karnofsky performance status ≥ 60%

          -  Negative pregnancy test

          -  Fertile patients must use an acceptable method of contraception

          -  No other major illnesses likely to limit survival

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1, 000/mm^3

          -  Hemoglobin ≥ 10 g/dL (transfusion allowed)

          -  Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL

          -  ALT or AST ≤ 2.5 times upper limit of normal

          -  At least 4 weeks since prior radiotherapy and recovered

          -  More than 30 days since any other prior investigational drugs

        Exclusion Criteria:

          -  active CNS metastases

          -  pregnant or nursing

          -  myocardial infarction within the past 6 months

          -  New York Heart Association class III or IV heart failure

          -  uncontrolled angina

          -  severe uncontrolled ventricular arrhythmias

          -  electrocardiographic evidence of acute ischemia or active conduction system
             abnormalities

          -  Peripheral neuropathy ≤ grade 1

          -  hypersensitivity to bortezomib, boron, or mannitol

          -  history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of
             the skin

          -  serious medical or psychiatric illness that would preclude study participation

          -  prior cytotoxic chemotherapy for this cancer

          -  other concurrent investigational therapy

          -  concurrent chemotherapy, immunotherapy, or hormonal therapy
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Oral solution
Evaluation period (3 weeks up-titration):
For subjects ≥8 years:
~0.4 mg/kg bid for Week 1
~0.8 mg/kg bid for Week 2
~1.6 mg/kg bid for Week 3
For subjects <8 years:
~0.5 mg/kg bid for Week 1
~1.0 mg/kg bid for Week 2
~2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
~0.8 mg/kg bid for Week 4
~0.4 mg/kg bid for Week 5
For subjects <8 years:
~1.0 mg/kg bid for Week 4
~0.5 mg/kg bid for Week 5
Intervention MeSH terms: Brivaracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Epilepsy; Child; Pharmacokinetics; Adolescents

Summary:

      Initial study in children with epilepsy to evaluate the pharmacokinetics, safety,
      tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to
      develop dosing adaptations for future studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of epilepsy

          -  Subject having at least 1 seizure (any type) during the 3 weeks before first visit

          -  Stable dosing of 1-3 concomitant antiepileptic drugs

        Exclusion Criteria:

          -  Pregnant or nursing females

          -  Concomitant use of Levetiracetam

          -  Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative
             disease

          -  History of status epilepticus

          -  Clinically significant acute or chronic illness, underlying disease or medication
             condition

          -  History of suicide attempt
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
Condition: Weight Gain
MeSH terms: Weight Gain
Intervention: metformin; placebo
Intervention description: 500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks; 500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: antipsychotic; metformin; children; adolescents

Summary:

      The purpose of this pilot study is to determine whether starting metformin in conjunction
      with a second-generation antipsychotic (SGA) and providing information about healthy eating
      and activity will prevent or reduce the amount of weight gain and the metabolic changes in
      adolescent youth typically seen with second-generation antipsychotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity

          -  Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with
             a SGA- typically but not limited to psychotic, mood, pervasive developmental,
             oppositional defiant, and conduct disorders

          -  SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone

          -  Legal guardian able and willing to give written informed consent

          -  If competent, subject able and willing to assent for their own participation

        Exclusion Criteria:

          -  Previous trial of metformin

          -  Recommendation for treatment with clozapine or ziprasidone

          -  Current use of insulin or any oral hypoglycemic agent

          -  Current use of a medication known to mitigate weight gain - amantidine, histamine (H2)
             antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine,
             stimulants (dextroamphetamine, methylphenidate)

          -  Any current or past diagnosis of an eating disorder

          -  Diabetes mellitus

          -  Current active thyroid (TSH >18 microIU/ml; T4 total >18 mcg/dl), hepatic (2 LFTs >4x
             upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum
             Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease

          -  Current substance abuse/dependence within past 2 weeks; a positive urine tox screen at
             baseline in the absence of meeting criteria for abuse/dependence will not preclude
             enrollment.

          -  Pregnancy or breast feeding
Assessing Symptomatic Clinical Episodes in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: AXS-05; Bupropion
Intervention description: AXS-05 taken twice daily for 6 weeks.; Bupropion taken twice daily for 6 weeks.
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: AXS-05; Major Depressive Disorder; MDD; Axsome; Depression; Dextromethorphan; Bupropion; Sigma-1; NDMA; ASCEND

Summary:

      Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently meets DSM-5 criteria for MDD

          -  Body mass index (BMI) between 18 and 40 kg/m^2, inclusive

          -  Agree to use adequate method of contraception for the duration of the study

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Suicide risk

          -  History of treatment resistance in current depressive episode

          -  History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic
             stimulation or any experimental central nervous system treatment during the current
             episode or in the past 6 months

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

          -  Additional criteria may apply