bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®); Artificial Tears REFRESH ENDURA®
Intervention description: Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery; REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
Intervention MeSH terms: Cyclosporine; Lubricant Eye Drops; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: LASIK

Summary:

      This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion
      administered twice daily following LASIK surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is scheduled for bilateral LASIK surgery

          -  Patient is in good general health

          -  Eye glasses prescription of -1 to -8

        Exclusion Criteria:

          -  Significant Dry Eye

          -  Presence of eye disease

          -  Uncontrolled systemic disease
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Condition: Brain Neoplasms
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Intervention: Temozolomide; Whole brain irradiation
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Brain metastases; Temozolomide; Whole-brain radiotherapy; Phase II trial

Summary:

      RATIONALE

        -  Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High
           daily dose temozolomide combined with fractionated radiotherapy may make tumor cells
           more sensible to treatment.

      PURPOSE

        -  This randomized phase II trial, assess in patients with brain metastases from solid
           tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve
           the results obtained with WBRT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Karnofsky performance status (KPS) ≥ 50

          -  Life expectancy ≥ 12 weeks

          -  Histologically confirmed non lymphomatous solid tumors at primary site

          -  Brain metastases diagnosed with cranial MRI/CT.

          -  Extracranial metastases or primary tumor uncontrolled are allowed

          -  Hemoglobin ≥ 10 g/dl

          -  Absolute neutrophil count of > 1500/mm3

          -  Platelet count of ≥ 100,000/mm3

          -  Blood urea nitrogen (BUN) ≤ 25 mg/dl,

          -  Serum creatinin ≤ 1.5 mg/dl

          -  Serum bilirubins ≤ 1.5 mg/dl,

          -  Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper
             normal limit

        Exclusion Criteria

          -  Pregnant or breast feeding woman

          -  History of allergic reaction to iodinated contrast media

          -  Inability to swallow

          -  Systemic chemotherapy in previous 3 weeks

          -  Oral chemotherapy in previous 2 weeks

          -  Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm

          -  Meningeal carcinomatosis
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Abaloparatide Transdermal (50 mcg); Abaloparatide Transdermal (100 mcg); Abaloparatide Transdermal (150 mcg); Abaloparatide Injection (80 mcg); Abaloparatide Placebo
Intervention description: Abaloparatide Transdermal Microneedle Active Patch; Abaloparatide Transdermal Microneedle Active Patch; Abaloparatide Transdermal Microneedle Active Patch; Abaloparatide Subcutaneous Injection; Abaloparatide Transdermal Microneedle Placebo Patch
Intervention MeSH terms: Abaloparatide; Parathyroid Hormone-Related Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Since the abaloparatide injection arm was administered subcutaneously (SC), it was not possible to blind this arm of the study. Therefore, abaloparatide-SC was considered a reference drug, but the centralized BMD assessments and bone marker evaluations remained blinded to all treatment assignments.
Enrollment: 250.0
Sex: Female
Maximum age: 85 Years
Healthy volunteers: No
Keywords: BA058; Abaloparatide-SC; abaloparatide; Abaloparatide-TD; Osteo; Osteoporosis; Transdermal; Patch

Summary:

      To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise
      healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density
      (BMD) and serum markers of bone metabolism when compared to transdermal placebo and
      abaloparatide injection for 6 months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal woman, less than 85 years old.

          -  BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture
             (within 5 years).

          -  Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.

          -  Laboratory tests within the normal range, including serum calcium, Vitamin D,
             parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.

        Exclusion Criteria:

          -  BMD T-score ≤-5.0 at the lumbar spine or hip.

          -  History of bone disorders (for example, Paget's disease) other than postmenopausal
             osteoporosis.

          -  Significantly impaired renal function.

          -  History of any cancer.
Maraviroc in Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Maraviroc; Maraviroc Placebo
Intervention description: 300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.; Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
Intervention MeSH terms: Maraviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate whether maraviroc, an investigational drug given
      with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in
      adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be legal age of consent

          -  Must have active rheumatoid arthritis based upon the American College of Rheumatology
             (ACR) 1987 (Revised Criteria); minimum disease criteria required for entry into the
             efficacy component of the study

          -  Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II,
             or III

          -  Must be receiving methotrexate for at least 12 weeks duration and on a stable dose for
             4 weeks.

        Exclusion Criteria:

          -  Diagnosed with any other inflammatory arthritis or a secondary non-inflammatory
             arthritis that would interfere with disease activity assessments.

          -  Subject receiving prior treatment with certain medications for rheumatoid arthritis

          -  Tuberculosis and/or a positive tuberculin reaction

          -  Significant trauma or major surgery within 2 months

          -  History of alcohol and/or drug abuse outside of a defined period of abstinence

          -  History of or a finding at screening of postural hypotension

          -  Any condition that would affect the oral absorption of the drug

          -  History of cancer and in remission less than 3 years or Grade III-IV congestive heart
             failure

          -  Having an infection of human immunodeficiency virus (HIV), Hepatitis B or C or
             evidence of any active infection

          -  Abnormalities of clinical or laboratory assessments completed at the screening visit
             such as elevated liver enzymes, decreased hemoglobin or an abnormal ECG

          -  Having a positive chemokine receptor 5 (CCR5) delta 32 mutation

          -  Requiring the use of certain medications

          -  Lactating or pregnant women or subjects have reproductive potential unwilling to use
             an adequate method of birth control

          -  Chronic or recent serious or life-threatening infection; severe , progressive and/or
             uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
             cardiac, neurological disease within 12 weeks of the first dose.
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Stereotactic Body Radiotherapy; Gemcitabine; 4D pancreatic protocol CT scan; FDG PET scan
Intervention description: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator; Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes; Patients will undergo this imaging procedure prior to treatment for planning purposes.; Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Stereotactic Body Radiotherapy (SBRT); pancreas cancer; locally advanced; local control; Gemcitabine

Summary:

      This study will assess the efficacy of treating locally advanced pancreatic cancer using
      Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine
    

Eligibility criteria:

        Inclusion Criteria:- Pancreatic tumors not to exceed 10 cm in greatest axial dimension

          -  Histologically confirmed malignancies of the pancreas

          -  Unresectable by CT criteria or exploratory laparotomy or laparoscopy

          -  Patients with metastatic disease may be treated if they are symptomatic from the
             primary tumor

          -  Performance status of 0, 1, or 2

          -  No chemotherapy two weeks prior or two weeks following radiosurgery

        Exclusion Criteria:

          -  patients who have had prior radiotherapy to upper abdomen

          -  patients receiving any prior pancreatic cancer therapy

          -  children, pregnant, and breastfeeding women, and lab personnel are excluded

          -  uncontrolled intercurrent illnesses

          -  any concurrent malignancy
NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia
Condition: Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: 6-mercaptopurine
Intervention description: Standard dose 25 mg/m^2/day. Can be increased up to 75 mg/m^2/day if the myelosuppression is acceptable (ANC>0.5 T-count >50)
Intervention MeSH terms: Mercaptopurine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia, Lymphocytic, Acute [C04.557.337.428.511]; 6-mercaptopurine; methotrexate; asparaginase

Summary:

      The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and
      antileukemic response during the initial 3 months of individualised therapy of children and
      young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual
      toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used
      in the two-months post-remission treatment phase of lower risk childhood ALL. This will be
      performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m^2)
      every 3rd week. Thus, the trial will also test the feasibility of this particular drug
      combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  B-lineage ALL

          -  1-17.9 years

          -  WBC <100, clinical remission obtained day 2

          -  Written consent to participation.

        Exclusion Criteria:

          -  t(9;22)

          -  Hypodiploidy

          -  11q23-aberrations

          -  TPMT-deficiency

          -  Intolerance to MTX or 6MP
Effect of Valsartan on Carotid Artery Disease
Condition: Carotid Artery Diseases; Atherosclerosis
MeSH terms: Carotid Artery Diseases; Atherosclerosis
Intervention: Valsartan; Placebo
Intervention description: Valsartan was titrated to a target dose of 320 mg orally daily; A matched placebo pill will be given orally daily.
Intervention MeSH terms: Valsartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Angiotensin receptor blockade; Oxidative stress; Endothelial dysfunction

Summary:

      The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called
      valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan
      will increase the blood levels of markers responsible for repair of the vessel wall, reduce
      oxidation and inflammation, improve the function of the blood vessels, and arrest or slow
      down the progression of atherosclerosis over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 0.65 mm intima-media thickness of the carotid artery measured by ultrasound

          -  Males aged 21-80 years or women without child bearing potential up to age 80

          -  Can be on concomitant therapy with aspirin, thiazide diuretics, calcium antagonists
             (for treatment of hypertension), or beta-receptor antagonists.

          -  May be on statin if on stable dose for at least 2 months before recruitment

        Exclusion Criteria:

          -  Angiotensin-converting enzyme (ACE) inhibitor or ARB therapy in the previous 3 months.

          -  Initiation or change in dose of statin therapy within 2 months before the study

          -  Inability to return to Emory for follow-up blood drawing and MR imaging

          -  Age < 21 or > 80 years

          -  Premenopausal females with potential for pregnancy

          -  Current neoplasm

          -  Chronic renal failure [creatinine > 2.5 mg/dL]

          -  Diabetes with hemoglobin (Hb) A1c > 8.5

          -  Anticipated change in lipid lowering therapy

          -  Inability to give informed consent

          -  MR exclusion criteria

          -  Blood pressure > 140 mmHg systolic and > 90 mmHg diastolic

          -  Low-density lipoprotein (LDL) cholesterol level >130 mg/dl

          -  Acute coronary syndrome within 2 months

          -  Acute cerebrovascular accident within 2 months
A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer
Condition: Oropharyngeal Cancer
MeSH terms: Papilloma; Oropharyngeal Neoplasms
Intervention: TORS; Adjuvant Radiation Therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T1-2 N2 M0,; stage IVa SCCA; oropharynx; negative for PNI,; negative surgical margins

Summary:

      To determine 2-year local (primary tumor site) control and toxicity rates in patients
      receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely
      resected, HPV-positive SCCA of the oropharynx.

      To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS,
      omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of
      the oropharynx.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years or older Histologically confirmed diagnosis of squamous cell
             carcinoma of the oropharynx, stage IVa, p16-positive on immunohistochemistry
             Pathologic T1 or T2 disease, resected with negative margins ( 2mm) Pathologic N2a,
             N2b, or N2c disease ECOG Performance Status 0-1

          -  Patients must sign an informed consent document that indicates they are aware of the
             investigational nature of the treatment in this protocol as well as the potential
             risks and benefits - - - Ability to understand and the willingness to provide written
             informed consent

        Exclusion Criteria

          -  Prior radiation therapy to the head and neck Prior chemotherapy within the past 5
             years Presence of T3 or T4 disease Presence of close (2 mm) or positive margins PNI on
             TORS resection of the primary cancer Presence of N0 or N1 disease in neck dissection
             Presence of distant metastatic (M1) disease

          -  Uncontrolled intercurrent illness including, but not limited to, symptomatic
             congestive heart failure, unstable angina pectoris, connective tissue disease or
             psychiatric illness/social situations that would limit compliance with study
             requirements.
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Nitrous Oxide
Intervention description: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
Intervention MeSH terms: Nitrous Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: PTSD

Summary:

      The purpose of this study is to understand nitrous oxide effects in post traumatic stress
      disorder (PTSD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-80

          -  Veterans of the United States Uniformed Services

          -  primary diagnosis of PTSD

          -  sufficient severity of PTSD symptoms

          -  fluency in English

          -  capacity to provide informed consent

        Exclusion Criteria:

          -  psychiatric or medical conditions that make participation unsafe

          -  pregnant or nursing females

          -  allergy to nitrous oxide
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: nivolumab; nivolumab; nivolumab
Intervention description: Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons; Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons; Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced/Metastatic; clear cell component

Summary:

      The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal
      Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response
      relationship exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component

          -  Previous treatment with at least one anti-angiogenic agent

          -  Progressed within 6 months of study enrollment

          -  Subjects should not have had more than 3 prior treatments for locally advanced or
             metastatic disease

          -  Must have available tumor tissue for submission

          -  Subjects must also meet various laboratory parameters for inclusion

        Exclusion Criteria:

          -  Subjects with any active autoimmune disease or a history of known autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply