bioihbjkbjnl/mcl2 huggingface dataset:
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Dalantercept
Intervention description: Subcutaneous dose of dalantercept once every 3 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied
      in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks
      the development of blood vessels that supply tumors.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically and/or cytologically confirmed, recurrent or metastatic SCCHN of
             mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to
             further local therapy (surgery, or radiation including re-irradiation); patients with
             unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if
             they meet all other entry criteria.

          -  Previously treated with at least one platinum-containing regimen or contraindicated
             for treatment with a platinum containing therapy. (Note: platinum therapy can occur
             upfront or after recurrence of disease. Failure of platinum therapy is not required.)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

        Key Exclusion Criteria:

          -  Nasopharyngeal carcinoma, paranasal sinus, salivary gland or primary skin SCCHN.

          -  Any other active malignancy for which chemotherapy or other anti-cancer therapy is
             indicated.

          -  Chemotherapy or other anti-cancer therapy or radiation therapy within 5 times the
             half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not
             known.

          -  Treatment with another investigational drug or device, or approved therapy for
             investigational use, within 5 times the half-life of the drug or within 3 weeks prior
             to study day 1 if the half-life is not known.

          -  Major surgery within 4 weeks prior to study day 1 (patients must have recovered
             completely from any previous surgery prior to study day 1).

          -  Clinically significant cardiovascular risk.

          -  Clinically significant active pulmonary risk.

          -  Clinically significant active bleeding.

          -  Peripheral edema ≥ Grade 1 within 4 weeks prior to study day 1.

          -  Pregnant or lactating female patients.
Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Intervention: testosterone ophthalmic solution; vehicle of testosterone ophthalmic solution
Intervention description: testosterone ophthalmic solution for 128 days; vehicle of testosterone ophthalmic solution for 128 days
Intervention MeSH terms: Methyltestosterone; Pharmaceutical Solutions; Ophthalmic Solutions; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Meibomian Gland Dysfunction; Dry Eye Syndrome

Summary:

      The objective of this study is to assess the safety and efficacy of testosterone 0.03%
      ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.
    

Eligibility criteria:

        Inclusion Criteria (subjects must):

          -  Be ≥ 60 years of age

          -  Have a corrected visual acuity of LogMAR +0.5 (ETDRS)

          -  Have a documented history of Meibomian Gland Dysfunction

          -  Have a TFBUT ≤ 5 seconds

          -  Have an ocular discomfort score ≥ 1

          -  Have an IOP ≤ 25 mmHg at Visit 1 in both eyes

          -  Report use of and/or desire to use an artificial tears

        Exclusion Criteria (subjects may not):

          -  Have contraindications to the use of the study medications

          -  Have a known allergy or sensitivity to the study medications

          -  Have any ocular infections, or active ocular inflammation

          -  Have used ocular medications within 24 hours prior to Visit 1

          -  Be a current contact lens wearer

          -  Require the use of any other ophthalmic medication, other than tear substitutes and
             study medication provided, for the duration of the trial

          -  Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or
             require the use of systemic or topical antihistamines or steroids during the course of
             the study

          -  Have a history of prostate cancer
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
Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Condition: Hodgkin Lymphoma; Lymphoma, Large B-Cell, Diffuse; Post-transplant Lymphoproliferative Disorder
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoproliferative Disorders
Intervention: baltaleucel-T
Intervention description: Autologous EBV-specific T cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epstein-Barr Virus; DLBCL; PTLD; EBV; CIVIC; HL; T cell

Summary:

      To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the
      treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and
      Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The study will include three primary cohorts, with any of the following EBV+ diseases:

             Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous
             transplantation following salvage therapy OR 2) relapse following autologous
             transplantation.

             Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.

             Cohort C - PTLD, rituximab treatment failure.

          2. Presence of active lymphoma or active PTLD, based on imaging performed within the
             previous 3 months.

          3. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.

          4. Absolute lymphocyte count (ALC) >500/µL

          5. Male or female ≥ 12 years of age

          6. Weight ≥ 35 kg

          7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky
             score ≥ 60, as age appropriate

          8. Able to understand and comply with the requirements of the study and to provide
             written informed consent or age appropriate assent for pediatric patients.

        Exclusion Criteria:

          1. Known central nervous system (CNS) lymphoma

          2. Primary refractory HL or DLBCL

          3. Bulky disease

          4. Relapse or progression following previous autologous EBV specific T cell treatment.

          5. Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of
             alternative corticosteroid within 10 days prior to obtaining 200 mL starting material

          6. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus
             (HTLV).

          7. Patient is pregnant or lactating

          8. Systemic fungal, bacterial, viral or other infection that is not controlled

          9. Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)

         10. Known history of primary immunodeficiency
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Ranibizumab 0.3 mg; Ranibizumab 0.5 mg; Sham injection
Intervention description: 6 mg/ml ranibizumab solution for intravitreal injection; 10 mg/ml ranibizumab solution for intravitreal injection; Non-treatment control for sham intravitreal injection.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DME; Diabetic macular edema; ranibizumab; Diabetic macular edema with center involvement

Summary:

      This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual
      acuity in patients with diabetic macular edema with center involvement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetic macular edema with center involvement in at least one eye

          -  Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening

          -  Laser photocoagulation in the study eye can be withheld for at least 3 months after
             randomization

        Exclusion Criteria:

          -  Patients with uncontrolled systemic or ocular diseases

          -  Have any history of any intraocular surgery in the study eye within the past 6 months
             preceding screening

          -  Conditions that require chronic concomitant therapy with systemic or topical ocular
             corticosteroids

        Other protocol-defined inclusion/exclusion criteria applied to the study.
The Effects of Aldara as an Adjunct to Laser Treatment
Condition: Port Wine Stains
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Intervention: Imiquimod; non-medicated petroleum cream
Intervention description: commercially available topical antiviral drug; Over the counter topical cream used to aid the healing process in skin lesions
Intervention MeSH terms: Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 2 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: laser; pediatric; skin pigmentation

Summary:

      The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser
      treatment of vascular malformations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient between the ages of 2 and 60 years with a vascular malformation
             that is seeking cosmetic treatment.

          -  All races will be included as well as male and female.

          -  Clinical data on the usage of Aldara below the age of 2 years is limited and therefore
             all patients in the study will have to be at least 2 years of age.

          -  The majority of port wine stains are initially treated during childhood

          -  In order to determine the effectiveness of Aldara as an adjunct to laser therapy of
             Port Wine Stains, some of the patients in the study need to have lesions that have not
             undergone previous treatment.

        Exclusion Criteria:

          -  Patients under the age of 2 or over the age of 60.

          -  Patients that have serious medical problems that would put them at risk of the
             anesthesia.

          -  Patients that have sensitivity reactions to the ingredients in the product including
             imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum,
             polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl
             alcohol, methylparaben, and propylparaben.

          -  Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.
Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Formoterol Fumarate in the Pressair DPI, Low Dose; Formoterol Fumarate in the Pressair DPI, High Dose; Foradil Aerolizer, Low Dose; Foradil Aerolizer, High Dose; Placebo
Intervention description: Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days; Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days; Foradil Aerolizer 12 micrograms, twice a day for 14 days; Foradil Aerolizer 24 micrograms, twice per day for 14 days; Placebo in the Pressair for 14 days
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol
      fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to
      moderate asthma.

      This study will include a screening visit followed by a 4 month treatment period.
    

Eligibility criteria:

        Inclusions:

          -  Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as
             defined in the GINA Guidelines) which is unlikely to exacerbate during the study
             (e.g., due to seasonal allergen exposure).

          -  Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30
             days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the use
             of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1.

          -  Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of
             predicted for age, height, and gender using NHANES III (NHANES 2010) when
             bronchodilator medications have been withheld the appropriate length of time per the
             List of Concomitant Medications (Appendix III)

          -  Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after
             the administration of 360 µg of albuterol.

          -  Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the
             qualifying FEV1 at Visit 1

        Exclusions:

          -  Patients with any clinically significant respiratory conditions other than mild to
             moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung
             disease

          -  Patients with a severe asthma exacerbation requiring hospitalization in the previous
             12 months

          -  Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for at
             least 6 hours prior to visit
Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue
Condition: Metabolic Syndrome; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance
Intervention: Rosiglitazone; Placebo
Intervention description: One 8mg capsule daily for 6 weeks.; One capsule daily for 6 weeks.
Intervention MeSH terms: Rosiglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Insulin resistance is a common condition that can lead to type 2 diabetes. One of the
      commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin
      resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that
      rosiglitazone may work by increasing blood vessel growth in fat cells. The purpose of this
      research is to see if rosiglitazone also increases blood vessel growth in human fat cells.
      The investigators will compare results from before and after being on rosiglitazone for 6
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Overweight but otherwise in good general health.

          2. Age 18 - 55 years.

          3. Normal glucose tolerance.

          4. Stable weight with BMI (27-44).

          5. Stable medication use for the preceding month.

          6. BP < 150/90.

          7. Negative pregnancy test (*HCG), if female and of childbearing potential.

          8. Practicing, and willing to continue to practice appropriate contraception throughout
             the study if a female of childbearing potential.

        Exclusion Criteria:

          1. Serious medical illness.

          2. Pregnancy.

          3. Tobacco use within the past 6 months.

          4. Prior or current treatment with a thiazolidinedione.

          5. Patients who have received an investigational drug in the past 30 days.

          6. Use of systemic corticosteroids.

          7. Known or suspected allergy to Rosiglitazone or any component of the preparation
The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Ischemia
Intervention: Heme arginate 3mg/kg; Heme arginate 1mg/kg; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: carboxyhemoglobin; neutrophil; reactive oxygen species; reperfusion injury

Summary:

      Ischemia reperfusion injury may be attenuated by HO-1 induction. Our previous data confirmed
      strong HO-1 induction in peripheral blood cells following heme arginate infusion in healthy
      humans. Furthermore, we could demonstrate the amelioration of experimental ischemia
      reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured
      by functional MRI.

      Therefore, we propose that HO-1 induction in the human heart may be a suitable target to
      mitigate cardiac ischemia-reperfusion injury.

      The HO-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and
      after aortic cross-clamping in subjects with or without preceding heme arginate treatment in
      two different dosages. The HO-1 expression will also be measured in the clinical trials in
      peripheral blood mononuclear cells. As additional outcome, levels of myoglobin,
      creatine-kinase and troponin T and reactive oxygen species will be measured in plasma
      according to standard laboratory procedures.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed informed consent

          -  Men and women aged between 40 and 85 years (inclusive)

          -  Body mass index < 35 kg/m2

          -  Ability to communicate well with the investigator in the local language and to
             understand and comply with the requirements of the study

        Exclusion criteria (any of the following):

          -  Known hypersensitivity to the study drug or any excipients of the drug formulation

          -  Treatment with another investigational drug within 3 weeks prior to screening

          -  History or clinical evidence of any disease and/or existence of any surgical or
             medical condition, which might interfere with the absorption, distribution, metabolism
             or excretion of the study drug

          -  Severe renal failure (glomerula filtration rate < 30 ml/min)

          -  Moderately or severe impaired left ventricular function (ejection fraction < 40%)

          -  Moderately or severe impaired right ventricular function

          -  Systolic pulmonary pressure > 45 mmHg

          -  Acute or recent (<7 days) myocardial infarction

          -  Child bearing potential