bioihbjkbjnl/mcl2 huggingface dataset:
Blood Flow and Vascular Function in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Sildenafil (Acute-1 hour); Sildenafil (Subchronic-4 weeks); Placebo
Intervention description: Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg); Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks; Sugar pill designed to mimic the sildenafil treatment
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: arterial stiffness; flow-mediated dilation; endothelial function; pulse wave velocity; inflammation; oxidative stress; pulmonary function test; Cystic Fibrosis; Lung Disease; Nitric Oxide; Exercise Capacity; CF; Muscle Function; Sildenafil; Viagra; Revatio

Summary:

      Cystic fibrosis (CF) has many health consequences. A reduction in the ability to perform
      exercise in patients with CF is related to greater death rates, steeper decline in lung
      function, and more frequent lung infections. However, the physiological mechanisms for this
      reduced exercise capacity are unknown. The investigators laboratory recently published the
      first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is
      reasonable to suspect that the blood vessels are involved with exercise intolerance in CF.
      This study will look at how 1) blood flow and 2) artery function contribute to exercise
      capacity in CF.
    

Eligibility criteria:

        Inclusion Criteria.

          -  Diagnosis of CF and healthy controls

          -  Men and women (greater than 18 yrs. old)

          -  Resting oxygen saturation (room air) greater than 90%

          -  Forced expiratory volume (FEV1) percent predicted greater than 30%

          -  Patients with or without CF related diabetes

          -  Traditional CF-treatment medications

          -  Ability to perform reliable/reproducible pulmonary function tests (PFT)

          -  Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment
             within 2 weeks of testing or major change in medical status)

        Exclusion Criteria.

          -  Children less than 17 years old

          -  Body mass less than 20 kg

          -  A diagnosis of pulmonary arterial hypertension (PAH)

          -  FEV1 less than 30% of predicted

          -  Resting oxygen saturation (SpO2) less than 90%

          -  Self-reported to be a smoker

          -  Current use of any vaso-active medications

          -  History of migraine headaches

          -  Pregnant or nursing at the time of the investigation

          -  A clinical diagnosis of cardiovascular disease, hypertension, or CF related diabetes
Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-122 Vehicle Lotion; IDP-122 Vehicle Cream; IDP-122 Lotion; Ultravate Cream
Intervention description: Vehicle; Vehicle; Lotion; Cream
Intervention MeSH terms: Clobetasol; Halobetasol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Subject is willing to comply with study instructions and return to the clinic for
             required visits.

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently
             participating in another clinical study with an investigational drug or device.
A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo Cream; Ruxolitinib Phosphate
Intervention description: Cream with no active drug; Ruxolitinib phosphate cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study was double-blind, randomized, vehicle-controlled study with application of
      Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis
      applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups
      anticipated to have 50 participants in each.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plaque psoriasis involving up to 2 to 20% Body Surface Area

        Exclusion Criteria:

          -  Lesions solely involving intertriginous areas, the scalp or the face

          -  Systemic therapy for their psoriasis

          -  Pustular psoriasis or erythroderma

          -  Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the
             first dose of study medication

          -  Started or discontinued therapy within 2 months of Screening with agents that can
             exacerbate psoriasis

          -  Receiving systemic triazole antifungals except fluconazole
Smoking, Sex Hormones, and Pregnancy
Condition: Nicotine Dependence; Contraception
MeSH terms: Tobacco Use Disorder
Intervention: Low-dose Progesterone; High-dose Progesterone
Intervention description: The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).; The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
Intervention MeSH terms: Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators aim to (1) examine the association between levels of progesterone (Prog),
      allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related
      symptomatology during ad libitum smoking and (2) determine the association between Prog,
      Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine
      following overnight abstinence
    

Eligibility criteria:

        Inclusion Criteria:

          -  currently taking oral contraceptives

          -  English fluency

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  use of progestin only contraceptive

          -  pregnancy
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Intervention: NYX-2925 50 mg; Placebo
Intervention description: NYX-2925 administered orally; Placebo administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive either placebo or NYX-2925.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain
      associated with diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent

          -  Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities
             for ≥4 years and reports at least moderate pain over the last week

          -  Stable diabetic and protocol allowed medication during the study

          -  Agrees to use highly effective birth control during the study

          -  Has not participated in an interventional study for at least 30 days and agrees not to
             participate in another interventional study during the study

        Exclusion Criteria:

          -  Pain due to other conditions or diseases that would complicate participation in the
             study or pain reporting

          -  Current or historical serious medical conditions

          -  Prior participation in NYX-2925 clinical trial
Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-809; Placebo
Intervention description: Capsules; Placebo matched to VX-809 capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ∆F508; F508del; Cystic Fibrosis Transmembrane Conductance Regulator; CFTR; Pancreatic diseases; Lung diseases; Genetic disease, inborn; Infant, newborn, diseases

Summary:

      The primary objective of the study was to evaluate the safety and tolerability of VX-809 in
      participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF
      transmembrane conductance regulator (CFTR) gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF with ∆F508-CFTR mutation in both alleles

          -  Forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent
             (%) of predicted normal for age, gender, and height

          -  Weight >=40 kilograms (kg) and body mass index greater than or equal to 18.5 kilogram
             per square meter (kg/m^2)

          -  Screening laboratory values, tests, and physical examination within acceptable ranges

          -  Negative pregnancy test (for women of child-bearing potential)

          -  Able and willing to follow contraceptive requirements

          -  Willing to remain on a stable medication regimen for the duration of study
             participation

        Exclusion Criteria:

          -  History of any illness, or any ongoing acute illness, that could impact the safety of
             the study participant or may confound results of study

          -  Pulmonary exacerbation or changes in therapy for pulmonary disease within 14 days
             before receiving the first dose of study drug

          -  Impaired hepatic or renal function

          -  History of organ or hematological transplant
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: GDC-0853
Intervention description: Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term
      safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who
      have completed Study GA30044 (NCT02908100) up to 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to comply with the study protocol, in the investigator's judgment

          -  Completion of Study GA30044 up to 48 weeks

          -  Acceptable safety and tolerability during Study GA30044 as determined by the
             investigator

        Exclusion Criteria:

          -  Met protocol-defined treatment-stopping criteria during Study GA30044

          -  An adverse event in Study GA30044 that required permanent discontinuation of study
             drug

          -  In the opinion of the investigator, any new, significant, uncontrolled comorbidity or
             new clinical manifestation (related to SLE or not) that requires medications not
             allowed in this protocol; or could put the participant at undue risk from a safety
             perspective

          -  Any uncontrolled or clinically significant laboratory abnormality that would affect
             safety, interpretation of study data, or the participant's participation in the study
             in the opinion of the investigator in consultation with the Medical Monitor
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
Intervention description: Monthly intravitreal injections
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration
      (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical
      trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab
      (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study
      period of 12 months in 30 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration

          -  Written informed consent

        Exclusion Criteria:

          -  Time of diagnosis more than 6 months before study recruitment

          -  Ocular surgery of the study eye within 1 month before study recruitment

          -  Extensive subretinal fibrosis or retinal atrophy of the study eye

          -  Significant opacification of optical media of the study eye

          -  Uncontrolled glaucoma of the study eye

          -  Active ocular inflammation of the study eye

          -  Best-corrected visual acuity of the contralateral eye below 20/200

          -  Concurrent ocular or systemic therapy with other vascular endothelial growth factor
             (VEGF)-inhibitory drugs
Evaluation of Drug-drug Interaction Between LCZ696 and Sildenafil in Subjects With Mild to Moderate Hypertension
Condition: Mild to Moderate Hypertension
MeSH terms: Hypertension
Intervention: LCZ696; Sildenafil
Intervention description: LCZ696 400mg QD was administered alone for 4 days and in combination with sildenafil for 1 day; Sildenafil 50 mg single dose was administered alone for 1 days and in combination with LCZ696 400mg QD for 1 day
Intervention MeSH terms: Sildenafil Citrate; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: LCZ696, sildenafil, pharmacokinetics, mild to moderate hypertension

Summary:

      This study was conducted to investigate the potential for a pharmacokinetic drug-drug
      interaction in support of the co-administration of LCZ696 and sildenafil.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects with mild to moderate hypertension, either treated or not currently on
             treatment, between age 18 and 65 years of age, and otherwise in good health as
             determined by past medical history, physical examination, vital signs,
             electrocardiogram, and laboratory tests at screening.

          -  At screening: systolic blood pressure 120-140 mmHg on therapy, or 140-160 mmHg if
             untreated

          -  At screening: diastolic blood pressure, 70-95 mmHg on therapy, or 90-100 mmHg if
             untreated

          -  Baseline: BP ≥140/90;

        Exclusion Criteria:

          -  Use of non-antihypertensive prescription drugs, herbal supplements, and/or
             over-the-counter (OTC) medication, dietary supplements (vitamins included) within two
             (2) weeks prior to initial dosing

        Other protocol-defined inclusion/exclusion criteria may apply.
NICardipine Neuroprotection in AortiC Surgery (NICNACS)
Condition: Aortic Aneurysm, Thoracic
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
Intervention: Nicardipine; 0.9% saline
Intervention description: on bypass; on bypass
Intervention MeSH terms: Nicardipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aortic Arch Reconstruction Surgery

Summary:

      Objective

      The objective of this study is to discover whether an infusion of nicardipine is able to
      reduce the time taken to achieve electrocerebral silence (ECS) during cardiopulmonary bypass
      (CPB) for aortic surgery.

      Hypothesis

      By inhibiting cold-induced cerebral vasoconstriction, nicardipine will maintain cerebral
      blood flow and allow more rapid cooling of the brain during CPB. This will manifest as a
      reduction in the time taken to achieve ECS and also as a reduction in overall CPB time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult (>18 years) patients at Duke University Medical Center (DUMC) presenting for
             elective aortic surgery scheduled to include a period of deep hypothermic circulatory
             arrest.

        Exclusion Criteria:

          -  Failure to provide written informed consent

          -  Emergency operation

          -  Documented allergy to nicardipine
Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies
Condition: Hemoglobinopathies; Sickle Cell Disease; Thalassemia
MeSH terms: Anemia, Sickle Cell; Thalassemia; Hemoglobinopathies
Intervention: Busulfex; Fludarabine; Alemtuzumab; Stem Cell Transfusion
Intervention description: Given once daily for 4 days; Given intravenously once daily for 4 days; One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days.; Performed three days after the end of chemotherapy
Intervention MeSH terms: Fludarabine; Alemtuzumab; Busulfan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemoglobinopathies; Sickle cell anemia; sickle cell-hemoglobin C disease; sickle cell-B-thalassemia; transfusion-dependant thalassemia; allogeneic transplant; nonmyeloablative transplant; Stem cell transfusion; graft vs. host disease

Summary:

      The purpose of this study is to determine if treatment with reduced-dose busulfex,
      fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor
      stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating
      blood counts. In addition the incidence and severity of side effects and of graft vs. host
      disease (GVHD) will be monitored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with sickle cell disease should have one or more of the following: acute
             chest syndrome requiring hospitalization; nonhemorrhagic stroke or central nervous
             system event lasting longer than 24 hours; recurrent caso-occlusive pain or recurrent
             priapism; sickle neuropathy; bilateral proliferative retinopathy and major visual
             impairment of at least one eye; osteonecrosis of multiple joints; transfusion
             dependence; vaso-occlusive.

          -  Patients with thalassemia should have one or more of the following: transfusion
             dependence; iron overload; presence of 2 or more alloantibodies against red cell
             antigens.

        Exclusion Criteria:

          -  Pregnancy

          -  Acute hepatitis

          -  Cardiac ejection fraction < 30%

          -  Severe renal impairment

          -  Severe residual functional neurologic impairment

          -  Evidence of HIV infection