bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Nivolumab; Ipilimumab; Cabazitaxel; Prednisone
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Prednisone; Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness, safety and tolerability of
      nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate
      cancer (mCRPC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Current evidence of metastatic disease documented by either bone lesions on
             radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic
             resonance imaging (CT/MRI).

          -  Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone
             (GnRH) analogue or a surgical/medical castration with testosterone level of
             ≤1.73nmol/L (50ng/dL)

        For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

          -  Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma
             of the prostate and evidence of Stage IV disease (as defined by American Joint
             Committee of Cancer criteria (AJCC criteria) prior to randomization

        Exclusion Criteria:

          -  Presence of visceral metastases in the liver

          -  Active brain metastases or leptomeningeal metastases

          -  Active, known, or suspected autoimmune disease or infection

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or
             any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
             pathways

        For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

          -  Prior radiation therapy within 14 days prior to first dose of nivolumab combined with
             ipilimumab

          -  Have received systemic anti-cancer therapy after the last dose of study treatment
             (ipilimumab or cabazitaxel)

        Other protocol-defined inclusion/exclusion criteria apply
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix; Degarelix; Degarelix; Degarelix; Degarelix; Degarelix; Degarelix
Intervention description: Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).; Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).; Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).; Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).; Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).; Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).; Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).; Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and
      Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males aged 18 or over

          -  Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine
             treatment was indicated (except neoadjuvant hormonal therapy)

          -  Has completed Study FE200486 CS07

          -  Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QMF149; Salmeterol
Intervention description: delivered via Concept1 device; delivered via Accuhaler®
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 629.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to
      salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with
      COPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines

          -  Patients with a post-bronchodilator FEV1 < 70% of the predicted normal, and a
             post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101).

          -  Current or ex-smokers who have a smoking history of at least 10 pack years (defined as
             the number of packs of 20 cigarettes smoked per day multiplied by number of years the
             patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An
             ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics
             and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening
             (Visit 1).

          -  Patients who develop a COPD exacerbation between screening (Visit 1) and treatment
             (Visit 201) will not be eligible but will be permitted to be re-screened after a
             minimum of 6 weeks after the resolution of the COPD exacerbation.

          -  Patients who have had a respiratory tract infection within 4 weeks prior to screening
             Visit 1.

          -  Patients who develop a respiratory tract infection between screening (Visit 1) and
             treatment (Visit 201) will not be eligible, but will be permitted to be re-screened 4
             weeks after the resolution of the respiratory tract infection.

          -  Patients requiring long term oxygen therapy prescribed for >12 hours per day.

          -  Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to
             age 40 years.

        Other protocol-defined inclusion/exclusion criteria may apply.
The Fibrin Pad Cardiovascular Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: EVARREST™; Topical hemostat; Standard of Care
Intervention description: EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).; Equine collagen with Human Fibrinogen and Human Thrombin; SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of
      EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture
      line bleeding in cardiovascular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical
             procedure utilizing cardiopulmonary bypass;

          -  Subjects must be willing to participate in the study and provide written informed
             consent.

        Exclusion Criteria:

          -  Subjects with known intolerance to blood products or to one of the components of the
             study product or unwilling to receive blood products;

          -  Exposure to another investigational drug or device in a clinical trial within 30 days
             prior to surgery or anticipated in the 30 day follow up period after surgery.

          -  Female subjects who are pregnant or nursing.
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Condition: Chronic Pancreatitis; Insulin Resistance; Normal or Mildly Abnormal Stool Fat Levels
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Insulin Resistance
Intervention: Pioglitazone; Placebo
Intervention description: Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic pancreatitis; Insulin resistance

Summary:

      The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve
      pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or
      laboratory evidence of chronic pancreatitis.

      The goal of the investigators is to gather information from this study to help gain
      understanding of a potential therapy for chronic pancreatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Insulin resistance or mild diabetes mellitus

          -  Symptoms of abdominal pain

          -  Xray test showing damage to the pancreas

          -  Normal or mildly abnormal stool fat levels

        Exclusion Criteria:

          -  Mentally disabled patients

          -  Women who are planning pregnancy, pregnant or lactating/nursing

          -  Chronic pancreatitis is due to other specific conditions

               -  Autosomal dominant pancreatitis

               -  Classic cystic fibrosis with lung involvement

               -  Autoimmune pancreatitis

               -  Pancreatic cancer

               -  Biliary obstruction (non-pancreatic cause)

               -  Abdominal trauma

               -  Hypercalcemia

               -  Hypertriglyceridemia

          -  Surgical resection of the head of the pancreas

          -  Alcohol consumption within prior 2 months

          -  Specific medical conditions

               -  Gastric surgery

               -  Celiac sprue

               -  Crohns disease

               -  Heart failure

               -  Kidney failure

               -  Cirrhosis or liver disease

               -  Osteoporosis

               -  Blood clotting disorder

               -  Visual problems

               -  Low albumin

               -  Low BMI

          -  Specific medications *Diabetes drug treatment is allowed except for short-acting
             insulin, long-acting insule more than 15 units daily, pioglitazone, rosiglitazone,
             orlistat, acarbose, miglitol or voglibose.
CJD (Creutzfeldt-Jakob Disease) Quinacrine Study
Condition: Creutzfeldt-Jakob Disease
MeSH terms: Creutzfeldt-Jakob Syndrome
Intervention: Quinacrine; Placebo
Intervention description: 100mg by mouth three times a day; 100mg by mouth three times a day
Intervention MeSH terms: Quinacrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dementia; spongiform encephalopathy; nervous system disorder; acridine; prion; neuropharmacologic agent

Summary:

      The purpose of this clinical trial is to determine the effectiveness of the medication
      quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable or definite sCJD: Definite--biopsy confirmed sCJD; Probable--a
             progressive dementia with either a typical EEG or a typical MRI consistent with sCJD,
             and at least two of the following clinical features: myoclonus, pyramidal or
             extrapyramidal signs, visual symptoms, cerebellar signs, akinetic mutism, other focal
             higher cortical neurologic signs (e.g. neglect, apraxia, aphasia)

          -  18 years of age or older

          -  Able to swallow

          -  Able to follow simple one-step commands

          -  Have had a brain MRI within 6 months and an EEG within 3 months ruling out other
             etiologies such as masses, strokes, or non-convulsive status epilepticus

          -  Consent to autopsy in the event of their death during or after the study

        Exclusion Criteria:

          -  History of other significant or life-threatening disease, including: cancer; end-stage
             liver or renal disease; severe heart disease

          -  History of other disease requiring regular supportive care

          -  Liver disease

          -  Active alcoholism

          -  Bone marrow suppression

          -  Severe hypotension

          -  Severe psoriasis

          -  Poorly controlled diabetes

          -  Women who are pregnant or breast-feeding

          -  Men, or women of childbearing age, not practicing reliable contraception

          -  Serious allergies to quinacrine or other acridines

          -  Current or recent use of quinacrine (within 6 months)

          -  < 18 years of age

          -  Any other contraindication to taking quinacrine

          -  Genetic form of prion disease is identified prior to study enrollment

          -  Current use of anti-arrhythmics (at discretion of investigator)

          -  G6PD (Glucose 6-Phosphate Dehydrogenase) deficiency (at discretion of investigator)
Smell Changes & Efficacy of Nasal Theophylline
Condition: Olfactory Disorder; Anosmia; Viral Infection; Theophylline Causing Adverse Effects in Therapeutic Use; Smell Disorder
MeSH terms: Virus Diseases; Anosmia; Olfaction Disorders
Intervention: Theophylline; Saline Nasal
Intervention description: Theophylline delivered via high-volume, low-pressure nasal saline irrigation; Lactose delivered via high-volume, low-pressure nasal saline irrigation
Intervention MeSH terms: Theophylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomized arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Olfactory dysfunction; Anosmia; Hyposmia; Post-viral; Theophylline; Adverse effects; Smell

Summary:

      This study evaluates the efficacy and safety of nasal theophylline irrigation in treating
      smell loss related to a viral respiratory infection. Half the participants will undergo nasal
      theophylline irrigation treatment while the other half will undergo placebo nasal irrigation
      with saline alone. All participants will have their sense of smell tested before and after 6
      weeks of treatment. All participants will also be regularly asked about any potential side
      effects related to treatment. In addition, the first 10 participants will have their blood
      drawn to measure their theophylline level after 1 week of starting treatment to ensure it is
      not abnormally elevated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjective or clinically diagnosed olfactory dysfunction of 6 months to 36 months
             duration after a presumed viral upper respiratory infection

          -  Ability to read, write, and understand English

        Exclusion Criteria:

          -  Dependence on theophylline for comorbid conditions such as asthma and chronic
             obstructive pulmonary disease

          -  History of an allergic reaction to theophylline or other methylxanthines

          -  Prior sinonasal or anterior skull base surgery

          -  Nasal polyposis

          -  History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease,
             Lewy body dementia, frontotemporal dementia)

          -  Pregnant or breastfeeding mothers

          -  Current use of medications with significant (≥40%) interactions with theophylline,
             which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine,
             interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine,
             thiabendazole, ticlopidine, and troleandomycin
Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: erlotinib hydrochloride; gemcitabine hydrochloride
Intervention description: given orally; given IV
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 70 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. It is not yet known whether gemcitabine and erlotinib are more effective when given
      alone or together in treating non-small cell lung cancer.

      PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how
      well they work when given alone or together as first-line therapy in treating older patients
      with stage IIIB or stage IV non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria Histologic or cytologic diagnosis of stage NSCLC ECOG Performance Status
        (PS) 0-2 Absolute Neutrophil Count (ANC) ≥ 1.5 Platelets ≥ 100,000 Hemoglobin ≥ 8.0 g/dl
        Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 2.5 upper limit of
        institutional normal (ULN) Alkaline phosphatase ≤ 4 x ULN Total Bilirubin below or equal to
        upper institutional normal limits Serum Creatinine ≤ 1.5 x ULN Patients may have received 1
        prior treatment in the adjuvant setting, but time since prior chemotherapy must be ≥1 year.
        Although the protocol specifically says adjuvant therapy, we believe neoadjuvant is similar
        and patients who have received neo-adjuvant (pre-operative) rather than classic adjuvant
        (post-operative) therapy are similar and should not be distinguished. Therefore, patients
        may have received

        1 prior treatment in the neo-adjuvant setting as well. Treated brain metastases are
        eligible provided the patient is asymptomatic and meets the above criteria, including PS.
        Measurable disease by RECIST criteria Ability to give informed consent

        Exclusion Criteria Patients with a history of severe hypersensitivity to gemcitabine.
        Incompletely healed from previous oncologic or other major surgery. Pregnancy or breast
        feeding (women of childbearing potential are not expected to be enrolled in this study
        given minimum age) Patients with severe co-morbid illness. Patients unable to participate
        in the QOL assessments.