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
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: IFX-1; Placebo
Intervention description: Single IV infusions of IFX-1 diluted in sodium chloride.; Placebo
Intervention MeSH terms: Vilobelimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hidradenitis suppurativa; monoclonal antibody; complement factor C5a; IFX-1; hidradenitis Suppurativa Clinical Response; Inflammation; skin diseases

Summary:

      The purpose of this study is to determine whether IFX-1 is safe and effective in the
      treatment of moderate to severe hidradenitis suppurativa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ≥ 18 years of age

          -  Written informed consent obtained from subject

          -  Diagnosis of HS for at least 1 year

          -  Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of
             which must be at least Hurley Stage II or Stage III

          -  Inadequate response to at least 3 months of oral antibiotics, or intolerance to
             antibiotics

          -  Total abscess and inflammatory nodule (AN) count of ≥ 3

        Exclusion Criteria:

          -  Prior treatment with adalimumab or another biologic product during the 24 weeks before
             Screening

          -  Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline
             only) who have not been on a stable dose during the 28 days before Screening

          -  Subject received systemic non-biologic therapy for HS with potential therapeutic
             impact for HS during the 28 days before Screening (other than permitted oral
             antibiotics)

          -  Prior treatment with any of the following medications during the 28 days before
             Screening:

               -  Any other systemic therapy for HS

               -  Any iv anti-infective therapy

               -  Phototherapy (ultraviolet B or psoralen and ultraviolet A)

          -  History of heart disease or malignancy
A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection
Condition: COVID 19; Coronavirus
MeSH terms: COVID-19
Intervention: Fluvoxamine; Placebo
Intervention description: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.; Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
Intervention MeSH terms: Fluvoxamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID 19; fluvoxamine

Summary:

      The purpose of this research study is to determine if a drug called fluvoxamine can be used
      early in the course of the COVID-19 infection to prevent more serious complications like
      shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the
      treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of
      COVID-19 is considered investigational, which means the US Food and Drug Administration has
      not approved it for this use.

      This study is fully-remote, which means that there is no face-to-face contact; study
      materials including study drug will be shipped to participants' houses. Only residents of
      Missouri and Illinois may participate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and woman age 18 and older;

          2. Not hospitalized;

          3. Has recently tested SARS-CoV-2 (COVID-19 virus) positive.

          4. Currently symptomatic with one or more of one or more of the following symptoms:
             fever, cough, myalgia, mild dyspnea, diarrhea, vomiting, anosmia (inability to smell),
             ageusia (inability to taste), sore throat.

          5. Able to provide informed consent.

        Exclusion Criteria:

          1. Illness severe enough to require hospitalization or already meeting study's primary
             endpoint for clinical worsening.

          2. Unstable medical comorbidities including, but not limited to: Severe underlying lung
             disease (COPD on home oxygen, interstitial lung disease, pulmonary hypertension),
             decompensated cirrhosis, Congestive heart failure (stage 3 or 4 per patient report
             and/or medical records).

          3. Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose
             steroids (>20mg prednisone per day)

          4. Unable to provide informed consent (eg moderate-severe dementia diagnosis)

          5. Unable to perform the study procedures
Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: bepotastine besilate ophthalmic solution; placebo comparator ophthalmic solution
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Bepotastine besilate; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 245.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the safety and efficacy of bepotastine besilate
      ophthalmic solution in allergic conjunctivitis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

        Exclusion Criteria:

          -  No active ocular or nasal infection
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Condition: Cancer; Hepatic Injury
MeSH terms: Wounds and Injuries
Intervention: Omegaven
Intervention description: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to make Omegaven® available to cancer patients with liver
      disease and to determine if Omegaven® can improve or prevent further liver disease. The study
      will also look at the effects Omegaven® has on immune function.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female; ages 18 to 80 years old

          2. Receiving treatment at Cancer Treatment Centers of America

          3. Receiving PN (either in the infusion center or at home)

          4. Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one
             or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST),
             or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary
             obstruction

          5. Able to provide informed written consent

        Exclusion Criteria:

          1. Hypertriglyceridemia (triglycerides [TG] > 400)

          2. Allergy to fish or egg protein

          3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin

          4. Hemodynamically unstable

          5. Bilirubin > 5 mg/dL

          6. Documented liver metastases

          7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening

          8. Recent cardiac infarction (within 6 months) and taking plavix

          9. Severe hemorrhagic disorders

         10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism

         11. Active sepsis

         12. Undefined coma status

         13. In patients with abnormal kidney function, renal insufficiency with calculated
             creatinine clearance < 30 mL/min

         14. Pregnancy or lactation
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: Gemcitabine; Epirubicin; Docetaxel
Intervention description: Gemcitabine; Epirubicin; Docetaxel
Intervention MeSH terms: Gemcitabine; Docetaxel; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Treatment strategies that include induction chemotherapy have several potential advantages:
      early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging
      of both the primary tumor and regional lymphatic metastases, making breast conservation an
      option for many. The aim of the present study is to determine the efficacy and toxicity of
      induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel,
      in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the
      upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new
      agents and combination of agents are likely to have the greatest potential impact.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Adenocarcinoma of the breast confirmed by biopsy

          -  Female Patients >18 years of age

          -  Normal cardiac function

          -  Ability to perform activities of daily living with minimal assistance

          -  Chemotherapy naïve or have received prior chemotherapy > 5 years ago

          -  Adequate bone marrow, liver and kidney function

          -  Be informed of the investigational nature of this study

          -  Sign an informed consent form

          -  Sentinel lymph node and/or axillary dissection prior to enrollment

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Life expectancy of < than 6 months

          -  History of significant heart disease

          -  Prior chemotherapy or hormonal therapy

          -  Concurrent Trastuzumab therapy

          -  History of significant psychiatric disorders

          -  History of active uncontrolled infection

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ruxolitinib cream
Intervention description: ruxolitinib cream 1.5% will be applied twice daily as a thin film
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ruxolitinib; Itch; Chronic Pruritus

Summary:

      The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in
      participants with Atopic Dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has clinically confirmed diagnosis of active AD for at least a 6-months.

          -  Participant has chronic pruritus related to AD for at least 3 months .

          -  Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds)
             affected by AD of 1%-20% on Day 1.

          -  Participant has an IGA score of at least 2 on Day 1.

          -  Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening
             visit.

          -  Willingness to avoid pregnancy or fathering children.

          -  Participant must be willing to comply with all study procedures and restrictions
             including discontinuation of all current therapies for AD and pruritus (unless
             otherwise specified), and must be available for the duration of the study.

        Exclusion Criteria:

          -  Female participnat who is breastfeeding, pregnant, or planning to become pregnant
             during the study.

        Participant had significant flares or unstable course in AD.

          -  Participant has clinically infected AD or has used antibiotics (systemic or topical)
             for their infected AD within 2 weeks prior to the run-in period.

          -  Participant has a history of skin disease or presence of skin condition that, in the
             opinion of the investigator, would interfere with the study assessments.

          -  Participant has any clinically significant medical condition or
             physical/laboratory/vital sign abnormality that would, in the opinion of the
             investigator, put the participant at undue risk or interfere with interpretation of
             study results.

          -  Participant has received treatment with JAK inhibitors (systemic or topical) within 4
             weeks prior to the run-in period.

          -  Participant is unlikely, in the opinion of the investigator, to be compliant with
             study procedures and requirements.
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Condition: Glioblastoma; Gliomas
MeSH terms: Glioblastoma; Glioma
Intervention: Temozolomide; Temozolomide
Intervention description: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.; Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the
      study to see if it is possible to increase the benefit of temozolomide when given after
      radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer
      when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide
      than patients treated with radiotherapy alone. Patients will receive standard low dose
      temozolomide during radiation. After radiation, they will be randomized to receive either
      more intense temozolomide or continuous low dose temozolomide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic evidence of a malignant glioma.

          -  Tissue block or unstained slides must be available for MGMT analysis.

          -  Age 18-70

          -  KPS > 50

          -  Granulocyte count >1.5 X 109/L

          -  Platelet count >99 X 109/L

          -  SGOT < 2.5X upper limit of normal (ULN).

          -  Serum creatinine < 2X ULN.

          -  Bilirubin < 2X ULN.

          -  All patients must sign written informed consent.

        Exclusion Criteria:

          -  Any prior chemotherapy, radiotherapy and biologic therapy for glioma.

          -  Any prior experimental therapy for glioma.

          -  Other concurrent active malignancy (with the exception of cervical carcinoma in situ
             or basal cell ca of the skin).

          -  Serious medical or psychiatric illness that would in the opinion of the investigator
             would interfere with the prescribed treatment.

          -  Pregnant or breast feeding women.

          -  Refusal to use effective contraception.
Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Simtuzumab
Intervention description: 200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Idiopathic; Pulmonary; Fibrosis; IPF

Summary:

      The primary objective of this study is to evaluate the long term safety and tolerability of
      simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had
      previously participated in Gilead clinical trial AB0024-201.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Previous participation in Phase 1 Gilead clinical trial

          -  Diagnosis of idiopathic pulmonary fibrosis

          -  Females of childbearing potential and non-vasectomized males must agree to use highly
             effective methods of contraception

          -  Females must discontinue nursing

          -  Comply with study requirements

          -  Have adequate organ function

        Key Exclusion Criteria:

          -  History or evidence of clinically significant disorder, condition or disease that
             would pose a risk or interfere with the study

          -  Pregnant or lactating

          -  Clinically significant heart, hepatic or renal disease

          -  History of cancer within 5 years of screening

          -  Infection that is not controlled despite antibiotics or other treatment

          -  History of bleeding diathesis within the last 6 months of Day 1

          -  Known history of human immunodeficiency virus, hepatitis B or C

          -  Concern's for subjects compliance

          -  Other conditions that might put the subject at high risk for treatment complications
             or reduce the chance to obtain data required

          -  Placed on a lung transplant list

          -  Previous participation in an idiopathic pulmonary fibrosis clinical trial other than
             for simtuzumab

        Note: Other protocol defined Inclusion/Exclusion criteria may apply