bioihbjkbjnl/mcl2 huggingface dataset:
Sodium Nitrite in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Reperfusion Injury; Infarction
Intervention: Sodium Nitrite
Intervention description: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acute myocardial infarction; Reperfusion injury; Nitric oxide

Summary:

      The purpose of this study is to determine whether the intravenous infusion of sodium nitrite
      safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction
      resulting in improved left ventricular function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute ST segment elevation myocardial infarction

          -  Eligible for percutaneous coronary intervention

        Exclusion Criteria:

          -  Cardiogenic shock

          -  Cardiac arrest

          -  Prior infarct in the infarct related artery

          -  Hemoglobinopathy, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency
Study of Breast Cancer Prevention by Letrozole in High Risk Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Letrozole; Placebo
Intervention description: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.; Placebo tablet daily for 6 months then optional open label letrozole for 6 months.
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: Female
Minimum age: 30 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      This is a multi-institution double-blind placebo-controlled trial whose main objective is to
      determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by
      Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have
      random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or
      borderline atypia, and a minimum Ki-67 of >1.5%.

      The primary hypothesis is that proliferation and expression of other estrogen response genes
      will be favorably modulated by six months of letrozole relative to placebo without
      substantially increasing hot flashes or worsening overall quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women at high risk for development of breast cancer

          -  stable dose of hormone replacement therapy

          -  have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in
             benign breast epithelial cells acquired by RPFNA

          -  Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry

          -  Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and
             mammogram at 6 months and 12 months (if participating in the open label portion of the
             study) following initiation of study drug

        Exclusion Criteria:

          -  Prior history of osteoporosis or osteoporotic fracture.

          -  Prior history of invasive breast cancer or other invasive cancer within five years
             from date of study entry.

          -  Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs

          -  Receiving treatment for rheumatoid arthritis or fibromyalgia

          -  Current history of poorly controlled migraines or perimenopausal symptoms

          -  Currently receiving other investigational agents.

          -  Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane,
             letrozole, etc.) at any time in the past.
Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
Condition: Substance Abuse; Substance Dependence; Cognitive Impairment
MeSH terms: Substance-Related Disorders; Cognitive Dysfunction
Intervention: Cognitive Training + Work Therapy; Work Therapy
Intervention description: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy; 20 hours per week of work therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Substance Abuse; Substance Dependence; Cognitive Impairment

Summary:

      The initial phase of substance abuse treatment is a vulnerable period for relapse. Cognitive
      impairments are common during this phase and may reduce the ability to benefit from other
      forms of substance abuse and rehabilitation services. The study compares a rehabilitation
      program that combines work therapy with computer-based cognitive training of attention,
      memory and executive functions to work therapy alone in a 3 months outpatient substance abuse
      program. It is hypothesized that cognitive training will increase days of sobriety during the
      active intervention and better substance abuse outcomes at 6 month follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the initial phase of treatment for substance abuse or dependence at VACHS.

          -  Fluency in English 6th grade or higher reading level DSM-IV criteria for any current
             drug use disorder

          -  Willingness to attend follow-up assessments at 13 and 26 weeks

          -  Willingness to submit to observed urine toxicology and breathalyzer screenings

        Exclusion Criteria:

          -  Untreated psychotic disorder

          -  Current prescribed treatment of opioids or benzodiazepines

          -  Having a legal case that may lead to incarceration during study period

          -  Residential plans that would interfere with participation

          -  Developmental disability or medical illness that may significantly compromise
             cognition or prevent work activity
Fluoxetine for Visual Recovery After Ischemic Stroke
Condition: Acute Stroke; Visual Field Loss
MeSH terms: Stroke; Ischemic Stroke
Intervention: Fluoxetine; Placebo
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Acute ischemic stroke; Homonymous hemianopia; Homonymous quadrantanopia; Visual field loss; Post-stroke recovery; Fluoxetine; Selective serotonin reuptake inhibitor

Summary:

      The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake
      inhibitor commonly used for depression, enhances visual recovery after an acute ischemic
      stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field
             loss.

        Exclusion Criteria:

          -  Known hypersensitivity to fluoxetine or other selective serotonin reuptake inhibitors

          -  National Institutes of Health Stroke Scale score greater than 5

          -  Premorbid modified Rankin Scale score greater than 2

          -  Premorbid monocular or binocular visual field deficits

          -  Premorbid retinopathy or optic neuropathy

          -  Premorbid depression

          -  History of cognitive impairment, dementia, or neurodegenerative disorder

          -  History of seizure disorder

          -  History of mania or hypomania

          -  History of hyponatremia

          -  History of angle-closure glaucoma or elevated intraocular pressure

          -  Current alcohol abuse or impaired liver function

          -  Current use of an antidepressant medication

          -  Current use of a medication likely to have an adverse interaction with fluoxetine

          -  Current use of a medication likely to impair post-stroke recovery

          -  Contraindication to MRI

          -  Pregnancy or lactation

          -  Hemorrhagic transformation of the index stroke, resulting in mass effect

          -  Enrollment in another clinical trial at the time of the index stroke
Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization
Condition: Leiomyoma
MeSH terms: Leiomyoma
Intervention: Superior hypogastric nerve block; 0.75% Ropivacaine; Subcutaneous injection; 1% Xylocaine
Intervention description: 21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.; 20 ml of 0.75% Ropivacaine; Injection into subcutaneous tissues in periumbilical region; 5ml of 1% Xylocaine
Intervention MeSH terms: Lidocaine; Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 44.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: embolization; analgesia

Summary:

      Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However
      the procedure is often very painful and, in many centres, patients are admitted overnight
      with patient controlled analgesic (PCA) pumps for pain control and discharged the next day
      with heavy pain medications. The goal of this study is to evaluate the effectiveness of a
      superior hypogastric nerve block (SHGNB) in controlling the pain post-UFE.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All women with symptomatic fibroids or adenomyosis that have requested and been
             approved for uterine artery embolization

          2. Ability to comply with the requirements of the study procedures

        Exclusion Criteria:

          1. Patients in whom the vascular anatomy prevents access to the superior hypogastric
             nerve plexus safely

          2. Patients who have known allergy to the anesthetic agent

          3. Patients with signs of skin infection at the entry site of the needle used to place
             the nerve block

          4. Patients with signs of infection such as fever

          5. Patients with history of inflammatory bowel disease of with signs of colitis

          6. Patients with uncorrectable abnormal coagulation status (INR >1.5 and plt < 50000
             without use of anticoagulation agents)

          7. Patients with preexisting conditions, which, in the opinion of the investigator,
             interfere with the conduct of the study.

          8. Patients who are uncooperative, cannot follow instructions, or who are unlikely to
             comply with follow-up appointments or fill-out the post-procedural pain
             questionnaires.

          9. Patients with a mental state that may preclude completion of the study procedure or is
             unable to provide informed consent
Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD1579 2.5%; CD1579 5%; Vehicle
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 236.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris

Summary:

      This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%)
      versus vehicle in the treatment of acne vulgaris in the Japanese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women at the age of 12 or older at the Screening visit.

          -  Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory
             lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions
             (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

        Exclusion Criteria:

          -  Those with more than two nodular acne lesions or any cysts.

          -  Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or
             any drug induced acne.

          -  Those who have clinically significant abnormal findings or conditions on skin other
             than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially
             interfere with study assessments according to Investigator's judgment
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: bevacizumab [Avastin]; irinotecan; temozolomide
Intervention description: 10mg/kg iv every 2 weeks; 125mg/m2 iv every 2 weeks; 75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
Intervention MeSH terms: Bevacizumab; Irinotecan; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in
      combination with conventional involved field radiotherapy, in patients with newly diagnosed
      glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive
      Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide
      75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po
      daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until
      disease progression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-70 years of age;

          -  glioblastoma, confirmed histologically;

          -  no previous chemotherapy or radiotherapy for glioblastoma;

          -  non-methylated MGMT promoter in the tumor.

        Exclusion Criteria:

          -  prior systemic treatment for glioblastoma multiforme;

          -  prior treatment with Avastin;

          -  significant cardiovascular disease;

          -  other active malignant disease.
Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: gemcitabine; oxaliplatin; Radiation
Intervention description: Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.; Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.; The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will examine a sequence of treatments including pre-operative chemotherapy and
      radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have cytologic or histologic confirmation of carcinoma arising in the
             pancreas.

          -  Patients must be deemed resectable or borderline resectable based on criteria in
             section 4.2 prior to registration.

          -  Patients must have an expected life expectancy of at least 12 weeks and a Zubrod
             performance status of < 2.

          -  Patients must have adequate organ function defined as follows: absolute neutrophil
             count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin <
             3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary
             stent).

          -  Patients must be free of other active systemic malignancy, ongoing infection,
             including HIV infection, or any other serious uncontrolled, concomitant systemic
             disorders or psychiatric condition that would interfere with the safe delivery of
             protocol therapy.

          -  Patients must be aware of the investigational nature of the therapy and provide
             written informed consent.

          -  Patients must have no history of previous chemotherapy for pancreatic cancer or any
             abdominal radiation therapy.

          -  Patients must not have used any investigational agent in the month before enrollment
             into the study.

        Exclusion Criteria:

          -  Patients with neuroendocrine tumors are excluded.

          -  Patients with preexisting peripheral neuropathy > grade 2 are ineligible.

          -  Pregnant or nursing women are ineligible and patients of reproductive potential must
             agree to use an effective contraceptive method during participation in this trial and
             for 6 months after trial.
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: KAE609; Coartem
Intervention description: Exploration of different doses of KAE609 to establish safety profile.; Control Arm
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized to KAE609 and Coartem in parallel treatment arms. Increasing doses of KAE609 (single dose and multiple dose) were evaluated in dose escalated manner in sequential cohorts
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uncomplicated Plasmodium falciparum Malaria.

Summary:

      KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in
      sequential cohorts with increasing doses.This study aims to determine the maximum safe dose
      of the investigational drug KAE609 in malaria patients.
    

Eligibility criteria:

        KEY Inclusion Criteria:

          1. Male and female patients ≥ 18 years with a body weight ≥ 45 kg.

          2. Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained
             thick film.

          3. P. falciparum parasitaemia of 500 to 50 000 parasites/µL.

          4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history
             of fever during the previous 24 hours.

          5. Written informed consent must be obtained before any study assessment is performed. If
             the patient is unable to write, then a witnessed consent according to local ethical
             standards is permitted.

        KEY Exclusion Criteria:

          1. Mixed Plasmodium infections.

          2. Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016
             criteria (WHO 2016).

          3. Known liver abnormalities, liver cirrhosis (compensated or decompensated), known
             active or history of hepatitis B or C (testing not required), known gallbladder or
             bile duct disease, acute or chronic pancreatitis.

          4. Clinical or laboratory evidence of any of the following:

          5. AST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of
             total bilirubin

          6. AST/ALT > 1.0 and ≤ 1.5 x ULN and total bilirubin is > ULN

          7. Total bilirubin > 2 x ULN, regardless of the level of AST/ALT

          8. History of photodermatitis/increased sensitivity to sun.

          9. Pregnant or nursing (lactating) women.

         10. Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or
             hypomagnesemia.

         11. Moderate to severe anemia (Hemoglobin level <8 g/dL).

        Other protocol-defined inclusion/exclusion criteria may apply
Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV
Condition: HIV-1-infection
Intervention: Oral Lenacapavir; F/TAF; Subcutaneous Lenacapavir; TAF; BIC; B/F/TAF
Intervention description: Tablets administered without regard to food; Tablets administered without regard to food; Administered in the abdomen via subcutaneous injections; Tablets administered without regard to food; Tablets administered without regard to food; Tablets administered without regard to food
Intervention MeSH terms: Emtricitabine tenofovir alafenamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly
      GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral (ARV) naive with no use of any ARV within one month of screening. Use
             of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP)
             (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to
             screening is permitted

          -  HIV-1 ribonucleic acid (RNA) ≥ 200 copies/mL at screening

          -  Cluster Determinant 4+ (CD4+) cell count ≥ 200 cells/microliter at screening

        Key Exclusion Criteria:

          -  Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.