bioihbjkbjnl/mcl2 huggingface dataset:
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Condition: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: Metformin; Placebo Comparator
Intervention description: Standard of Care Observation
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bronchoscopy; Metformin

Summary:

      The purpose of this study is to learn whether it is better to receive the drug Metformin with
      standard of care for lung cancer or just standard of care.
    

Eligibility criteria:

        Inclusion Criteria

          -  Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be
             proven SCC at the time of surgery)

          -  Medically fit for surgical resection (based on surgeon assessment)

          -  Current or prior smoker

          -  Age > 18 years old

          -  Both Male and Female

          -  Willing and able to consent to study, undergo study interventions, and take study drug

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

          -  Subject must start Metformin within 90 days of surgery.

        Exclusion Criteria

          -  Currently taking metformin or other diabetic drugs

          -  Current or previous congestive heart failure, renal failure or liver failure

          -  Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater

          -  Existing untreated or prior cancer <5 years from diagnosis

          -  Received neo-adjuvant platinum-based chemotherapy or targeted therapy

          -  Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical
             resection
GB001 in Adult Subjects With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: GB001; Placebo
Intervention description: film-coated oral tablet; film-coated oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 481.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: GB001; eosinophilic asthma; moderate asthma; severe asthma

Summary:

      A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate
      the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance
      therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect
      to asthma worsening at the end of 24 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria

          -  A diagnosis of asthma by a physician at least 12 months before Screening Visit.

          -  Treated with medium or high dose inhaled corticosteroid (ICS) plus additional
             controller for at least 12 months prior to Screening Visit. Subjects must maintain a
             stable ICS dose regimen during the 4 weeks prior to the Screening Visit.

          -  Forced Expiratory Volume in 1 second (FEV1) of ≤ 85% of predicted normal

          -  Demonstrated reversibility of at least 12% in FEV1

          -  Evidence of uncontrolled asthma

          -  Eosinophilic asthma

          -  No changes in ICS dose and compliant with standard of care asthma therapy during
             run-in period.

        Exclusion Criteria

          -  Current smokers (any substance)

          -  Serious co-morbidities

          -  Fridericia's correction QT factor (QTcF) ≥450 msec (male) or ≥470 msec (female)

          -  Use of other investigational drugs within 30 days, or within 5 half-lives, whichever
             is longer, prior to Screening Visit

          -  Regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal
             antibodies for asthma

          -  Pregnant or breastfeeding

        Other protocol-defined inclusion/exclusion criteria may apply.
Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: rosuvastatin
Intervention description: Taken orally once a day for 4 weeks
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crestor; TFBP; rosuvastatin

Summary:

      Research studies have shown a strong association between cancer and blood clots in the veins
      (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary
      embolism) which in severe cases may be life threatening. Studies have demonstrated that
      increases in microparticles may contribute to the development of deep vein thrombosis in
      cancer patients. The purpose of this research study is to see if rosuvastatin lowers the
      number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles
      that are generated from different types of blood cells in the body. In people who have
      cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor
      for deep vein thrombosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic adenocarcinoma of the breast (Stage IV)

          -  Actively receiving endocrine therapy for at least 6 weeks (with or without HER2
             therapy)

          -  Minimum age 18 years

          -  ECOG Performance status of 0, 1 or 2

          -  Normal organ and marrow function as defined in the protocol

        Exclusion Criteria:

          -  Participants may not be receiving any other study agents

          -  Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5
             weeks

          -  Any statin therapy within the last 3 weeks

          -  Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or
             Asian-Indian origin)

          -  Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil,
             ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease
             inhibitors

          -  Conditions predisposing to renal failure secondary to rhabdomyolysis

          -  Recent history of heavy alcohol use as judged by the treating physician

          -  Known to be pregnant (testing not required) or nursing

          -  History of rhabdomyolysis on statin therapy

          -  Known history of Hepatitis C or active hepatitis B infection (baseline testing not
             required)

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements
Low Dose ICG for Biliary Tract and Tumor Imaging
Condition: Cholecystitis; Hepatocellular Carcinoma; Liver Metastases
MeSH terms: Cholecystitis
Intervention: Indocyanine green; PINPOINT Endoscopic Fluorescence
Intervention description: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).; The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.
Masking: Double (Participant, Investigator)
Masking description: To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Biliary Tract; Indocyanine Green (ICG); Tumors; Near-infrared Fluorescence

Summary:

      Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green
      (ICG) allows for the intraoperative identification of liver anatomy. The investigators have
      new data that a much lower dose improves this visualization. Confirmation of this hypothesis
      would mean that ICG can be administered on the same day of surgery in order to augment
      real-time intraoperative visualization, thereby providing a safe, feasible, and
      cost-effective strategy for the surgical treatment of liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing standard of care laparoscopic hepatic or biliary operations or
             Patients undergoing standard of care laparoscopic resection for hepatic tumors:
             hepatocellular carcinoma or metastatic tumor

        Exclusion Criteria:

          -  Patients with a history of adverse reactions or known allergy to ICG, iodine, or
             iodine dyes and Pregnant and/or lactating patients.
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: imatinib mesylate; Treosulfane; etoricoxib; pioglitazone; dexamethasone
Intervention MeSH terms: Pioglitazone; Dexamethasone; Dexamethasone acetate; Etoricoxib; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone-refractory; prostate cancer; multitargeted; tyrosinkinase

Summary:

      The purpose of this study is to evaluate the efficacy, tolerability and safety of a
      multi-targeted therapy in patients with hormone-refractory prostate cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed prostate carcinoma, which has proven progression after
             primary hormone therapy (surgical or medicinal castration).

          -  Patients must have increasing PSA levels (within 3 months prior to enrollment) with at
             least two consecutively increasing PSA levels.

          -  PSA value before inclusion must be at least 5 ng/ml

          -  At least 18 years of age.

          -  At least capable of self care and up of at least 50% of waking hours (ECOG performance
             status 0 - 2), adequate bone marrow function and lab results.

        Exclusion criteria:

          -  Change of hormone therapy within 6 weeks prior inclusion

          -  Prior chemotherapy

          -  Therapy with Imatinib, or therapy with other inhibitors of tyrosinkinase.

          -  Second neoplasm diagnosed within 5 years before study start.

          -  Patients who require therapy with warfarin

          -  Known diagnosis of HIV, hepatitis B, or hepatitis C infection.

          -  Severe, unstable, or uncontrolled medical disease which would confound diagnoses or
             evaluations required by the protocol, including severe cardiac insufficiency

          -  Surgical therapy within 4 weeks before inclusion.

          -  Prior therapy with isotopes strontium or rhenium.

          -  Radiation therapy to > 25% of bone marrow within 4 weeks before inclusion.

          -  Treatment with other experimental substances within 30 days before study start.

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)
Condition: Multifocal Motor Neuropathy (MMN)
MeSH terms: Neuritis
Intervention: Vivaglobin
Intervention MeSH terms: Immunoglobulins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess efficacy, safety, and convenience of purified human
      antibodies administered under the skin in the treatment of MMN patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented clinical diagnosis and electrophysiological evidence of MMN

          -  Patients who have previously responded to intravenous immunoglobulin (IVIG) and have
             been on stable treatment with IVIG for at least 12 weeks prior to screening

          -  Patients treated with the equivalent of ≥0.4g/kg body weight (bw) IVIG per month

          -  Provision of informed consent by patient

        Exclusion Criteria:

          -  Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) concentration
             >2.5 times the upper normal limit (UNL)

          -  Creatinine concentration >1.5 times the UNL

          -  Known allergic reactions to blood products

          -  Any skin disease interfering with the assessment of injection site reactions

          -  Any other medical condition, which in the opinion of the investigator, might interfere
             with successful completion of the protocol

          -  Any condition likely to interfere with the evaluation of the study drug or
             satisfactory conduct of the trial

          -  Participation in a study with an investigational drug within three months prior to
             enrolment

          -  Patients treated with the equivalent of >2.0g/kg bw IVIG per month
Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Nitazoxanide; Placebo
Intervention description: Tablet, 500 mg with food twice daily for 5 days; Tablet, twice daily with food for 5 days
Intervention MeSH terms: Nitazoxanide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: influenza; influenza like illness

Summary:

      This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a
      placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that
      treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed
      influenza infection. Secondarily, we hypothesize that treatment with nitazoxanide will reduce
      the complications of influenza, severity of symptoms, time lost from work, time to return to
      normal daily activities, and viral shedding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 65 years

          -  Fever, respiratory symptoms and constitutional symptoms compatible with influenza
             infection

          -  Influenza A or B infection in the local community

          -  Onset of illness no more than 48 hours before presentation

          -  Willing and able to provide comply with protocol requirements

        Exclusion Criteria:

          -  Severity of illness requiring or anticipated to require in-hospital care

          -  High risk of complications from influenza per IDSA (Infectious Diseases Society of
             America) guidelines or current CDC (Centers for Disease Control) criteria

          -  Females pregnant, breast-feeding or sexually active without birth control

          -  Vaccination for seasonal influenza or H1N1 on or after August 1, 2009

          -  Treatment with antiviral medication for influenza within 1 month prior to screening

          -  Treatment with nitazoxanide or any investigational drug within 1 month prior to
             screening

          -  Known sensitivity to nitazoxanide or any excipients

          -  Unable to take oral medications

          -  Chronic kidney or liver disease or known impaired hepatic and/or renal function

          -  Other pre-existing chronic infection undergoing or requiring medical therapy

          -  Pre-existing illness placing subject at unreasonably increased risk by participation
             in study

          -  Unlikely to comply with the requirements of this protocol
Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?
Condition: Ventral Hernia; Umbilical Hernia; Incisional Hernia; Postoperative Complications; Pain, Postoperative
MeSH terms: Hernia, Umbilical; Hernia; Pain, Postoperative; Postoperative Complications; Incisional Hernia; Hernia, Ventral
Intervention: Transabdominal Plane Block; Non Transabdominal Plane Block
Intervention description: 0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total; Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Transabdominal plane block; ventral hernia; umbilical hernia; incisional hernia; hernia repair

Summary:

      The purpose of this study is to determine if a Transabdominal Plane Block will decrease
      patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical,
      incisional) hernia repair with mesh.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 and older

          -  elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount
             Sinai Hospital

        Exclusion Criteria:

          -  age younger than 18

          -  allergic reaction to bupivacaine

          -  allergic reaction to opioids

          -  opioid substance abuse
Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
Condition: Type 2 Diabetes Mellitus; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0736; Comparator: Placebo; Comparator: HCTZ
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 620.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study will assess the efficacy and tolerability of MK0736 in patients with Type 2
      Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting
      Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients
      will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The
      study will also include a 3 week, posttreatment follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 to 75 years of age

          -  Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)

          -  Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood
             pressure (SBP; 120 to 159 mm Hg)

          -  LDL-C < 140 mg/dL

          -  On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or
             Angiotensin Receptor Blocker (ARB)

        Exclusion Criteria:

          -  History of Type I Diabetes mellitus or ketoacidosis

          -  Patients taking 3 or more blood pressure lowering medications

          -  Have severe chronic heart failure

          -  History of certain diseases or conditions such as cardiac arrhythmias, heart attack,
             stroke, unstable angina, or decompensated vascular disease

          -  History of cancer within the last 5 years

          -  Human immunodeficiency virus (HIV) Positive

          -  Have received treatment with any investigational drugs within the past 30 days

          -  History of alcohol or drug abuse within the past 3 years

          -  Body Mass Index ( BMI) >= 41 kg/m2