bioihbjkbjnl/mcl2 huggingface dataset:
Dacarbazine and Carmustine in Metastatic Melanoma
Condition: Melanoma Metastatic
MeSH terms: Melanoma
Intervention: Dacarbazine; Carmustine; Neulasta
Intervention description: Dacarbazine IV - Day 1; Carmustine IV- Day 2; Neulasta SC - Day 3
Intervention MeSH terms: Dacarbazine; Carmustine
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: 18 Years
Healthy volunteers: No
Keywords: Melanoma Metastatic

Summary:

      The purpose of this study is to determine whether dacarbazine and carmustine at the doses and
      schedule used in this study will help to increase tumor shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a histologically-proven diagnosis of metastatic malignant melanoma
             which has progressed on at least one prior systemic therapy.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and
             estimated survival of at least 3 months.

          3. Patients must be felt to have recovered from effects of prior cancer therapy, such as
             past expected leukocyte nadir for chemotherapy (> 2 weeks).

          4. Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl;
             platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and
             AST must be less than 3 times the upper limit of normal; creatinine must be less than
             or equal to 1.8 mg/dl.

          5. Women of childbearing potential must have a negative pregnancy test and adequate
             precautions to prevent pregnancy during treatment must be taken.

          6. Patient consent must be obtained prior to entrance onto study.

          7. Patients must have no evidence of significant cardiovascular disease including history
             of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure,
             uncontrolled angina or cerebrovascular accident.

        Exclusion Criteria:

          1. Evidence of significant cardiovascular disease including history of recent (< 6
             months) myocardial infarction, uncompensated congestive heart failure, uncontrolled
             angina, or cerebrovascular accident.

          2. Prior history of psychiatric disorder that could be exacerbated by or which could
             preclude completion of this therapy.

          3. Pregnancy or lactation.

          4. Prior chemotherapy with carmustine
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
Intervention: indacaterol; formoterol; placebo to indacaterol; placebo to formoterol; short acting β2- agonist
Intervention description: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).; Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.; Placebo TWISTHALER® device; Placebo AEROLIZER® device; 100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 568.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QMF; indacaterol; TWISTHALER® device

Summary:

      This study will evaluate the dose response relationship among four doses of indacaterol as
      well as placebo delivered via the TWISTHALER® device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior
             to initiation of any study-related procedure (which include any adjustment to their
             current COPD treatment)

          -  Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by
             the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

               -  Smoking history of at least 10 pack years

               -  Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% and ≥30%
                  of the predicted normal value.

               -  Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%

        Exclusion Criteria:

          -  Pregnant women, nursing mothers, or females of childbearing potential, regardless of
             whether or not sexually active, if they are not using acceptable methods of
             contraception.

          -  Patients who have been hospitalized for an exacerbation of their airways disease
             within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.

          -  Patients with a history of asthma.

          -  Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1,
             will be not allowed to enter the study.

          -  Other clinically significant conditions which may interfere with the study conduct or
             patient safety as specified in the protocol.

        Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Safety Study in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Dose 4 QD; Dose 3 QD; placebo; Dose 2 QD; Dose 1 BD
Intervention description: QD once daily; QD once daily; placebo; QD once daily; BD twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GW642444; once daily dosing; asthma; efficacy; safety; FEV1

Summary:

      The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate
      the efficacy and safety of selected doses and dose intervals of the novel long acting beta
      agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving
      inhaled corticosteroid treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient

          -  ≥18 years of age at Visit 1

          -  Male or Eligible Female

          -  Diagnosis of asthma at least 12 weeks prior to Visit 1

          -  Disease reversibility

          -  Current anti-asthma therapy

          -  Appropriately signed and dated informed consent has been obtained

          -  Able to comply with all the study requirements

        Exclusion Criteria:

          -  History of Life-Threatening Asthma

          -  No use of systemic corticosteroids for any indication within 8 weeks prior to Visit

          -  No concurrent diseases/abnormalities that would put the safety of the subject at risk
             through study participation

          -  Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity
             to lactose or magnesium stearate

          -  History of severe milk protein allergy

          -  Non-compliance with study medication and other study-related requirements

          -  No use of inhaled tobacco products within the past three months or historical use of
             10 pack years or more

          -  Administration of prohibited medications and non-drug therapies and corresponding
             timeframes as outlined in the protocol
Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis
Condition: Sickle Cell Disease; Vaso-Occlusive Crisis
MeSH terms: Anemia, Sickle Cell
Intervention: Ketamine
Intervention description: The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ketamine; Sickle Cell Disease; Vaso-Occlusive Episode

Summary:

      Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with
      opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate
      (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist,
      ketamine mitigates this. Intravenous (IV) ketamine has demonstrated efficacy in reducing
      post-operative, chronic, and cancer-related pain in pediatrics, as well as in reducing time
      to pain control in the emergency department (ED) in adults. Limited studies suggest efficacy
      in adult opioid-refractory SCD patients. This study is investigating the safety and
      tolerability of adjuvant low-dose IV ketamine bolus for pediatric SCD VOE in the ED, as well
      as its efficacy in improving pain control and reducing hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All English-speaking, sickle cell patients who receive their care at UCSFBCHO in the
             Department of Hematology who are 8-to-25-years-old presenting to the emergency
             department for VOC were asked to enroll.

        Exclusion Criteria:

          -  Prior adverse reaction to ketamine

          -  Patients were asked during the consent process if they have ever received ketamine,
             and if so, if they had any serious adverse reaction, such as difficulty breathing,
             dysphoria, hallucinations, or allergic reaction. If they have, ketamine was not given
             to these patients.

          -  Patients who have received ketamine and experienced nausea or vomiting will be asked
             if they wish to receive the medication. If they do not, they did not receive ketamine.
Polypill For Prevention of Cardiovascular Disease
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Red Heart Pill 2b (Polypill); Standard Practice
Intervention description: Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg); Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to provide data on the feasibility of conducting a large
      clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme
      inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease
      (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would
      significantly reduce the estimated 10-year total CVD risk score with high adherence and no
      significant increase in adverse effects compared to the standard practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Estimated 10-year total CVD risk score > 20%. The total CVD risk assessment will be
             based on the recently developed WHO CVD risk prediction charts

          -  No contraindication for treatment with aspirin, angiotensin converting enzyme
             inhibitors, low-dose diuretics, or statins

          -  Informed consent given

        Exclusion Criteria:

          -  Patients with established angina pectoris, coronary heart disease, myocardial
             infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary
             revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG)
             or hypertensive retinopathy (grade III or IV)

          -  Patients with secondary hypertension

          -  Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal
             disease.

          -  Known renal failure or impairment

          -  Atrial fibrillation

          -  ALT > 1.5 times the upper limit of normal

          -  History of liver cirrhosis or hepatitis

          -  History of recent gastrointestinal bleeding (within the last year)

          -  Women in child bearing period

          -  History of life-limiting diseases or events

          -  Unwillingness to sign informed consent.
AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients
Condition: Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: AZD6244; docetaxel; Placebo
Intervention description: oral capsules, 75mg twice daily; 75mg/m2 iv on day 1 of every 21 day cycle; placebo
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Non small cell lung cancer (NSCLC); KRAS mutation

Summary:

      The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel
      versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic
      non small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic non small cell lung cancer (IIIB-IV)

          -  Failure of first line anti-cancer therapy (either radiological documentation of
             disease progression or due to toxicity) in advanced disease or subsequent relapse of
             disease following first line therapy

          -  Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon
             enrolment to ship to AZ appointed central laboratory, or mutation status confirmed
             locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation
             status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg
             Genzyme or Lab 21).

        Exclusion Criteria:

          -  Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung
             cancer (excluding radiotherapy)

          -  Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior
             treatment with paclitaxel is acceptable)

          -  Having received an investigational drug within 30 days of starting treatment, or have
             not recovered from side effects of an investigational drug

          -  Brain metastases or spinal cord compression unless asymptomatic, treated and stable
             off steroids and anti-convulsants for at least 1 month
A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: HBM9036 0.25% Ophthalmic Solution; placebo
Intervention description: Ophthalmic Solution; Ophthalmic Solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic
      Solution versus placebo in the treatment of dry eye
    

Eligibility criteria:

        Inclusion Criteria

          1. Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or
             desire to use eye drops;

          2. Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;

          3. Be willing and can adjust current treatment for dry eye according to the protocol,
             judged by the Investigator;

          4. Must be willing to complete all study assessments required by the protocol.

        Exclusion Criteria:

          1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1;

          2. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the
             last 12 months, or had femtosecond small incision lenticule extraction (SMILE) within
             the last 12 months, or had phacoemulsification within the last 3 months, or had dry
             eye or aggravation of dry eye caused by other ocular operations has not been stable;

          3. Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to
             Visit 1;
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
Condition: Breast Cancer; Metastases; Bone Metastases in Subjects With Advanced Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
Intervention: Denosumab; IV Bisphosphonates
Intervention description: Denosumab administered by subcutaneous injection; Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid
Intervention MeSH terms: Denosumab; Diphosphonates
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Cancer

Summary:

      This study is to evaluate various doses and schedules for denosumab administration and
      characterize the safety profile in this indication.
    

Eligibility criteria:

        Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma

          -  At least one bone metastasis
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Medisorb naltrexone 75 mg; Medisorb naltrexone 150 mg; Medisorb naltrexone 300 mg; Hydromorphone (10 mg/mL); Naloxone Challenge and Oral Naltrexone Tolerability Testing
Intervention description: Single administration via intramuscular (IM) injection.; Single administration via IM injection.; Single administration via IM injection.; Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals.; Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration.
Intervention MeSH terms: Naltrexone; Hydromorphone; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opiate Dependence

Summary:

      This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults
      to assess the presence, duration, and degree of opiate blockade as well as the safety and
      tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio
      to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or
      300 mg.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Adults who had used opioids: non-medically for at least 1 year; at least once per week
             for at least some period during their use history; and fewer than 3 times per week on
             average for the 30 days prior to screening.

          -  Provided written informed consent

          -  Demonstrated a positive response to hydromorphone challenge during screening

          -  Willing to use contraception for study duration if of childbearing potential

        Primary Exclusion Criteria:

          -  Any clinically significant medical condition or laboratory abnormality at screening

          -  Participated in a clinical trial within prior 30 days

          -  Dependent on opioids

          -  Seeking treatment for opioid abuse

          -  Psychosis or any major mood or anxiety disorder

          -  Pregnancy or lactation
Dose-response Study of OPC-12759 Ophthalmic Suspension
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: 0.5% OPC-12759; 1% OPC-12759; 2% OPC-12759; placebo
Intervention MeSH terms: Rebamipide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 290.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: OPC-12759; Dry eye syndromes

Summary:

      The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension
      in dry eye patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatient.

          2. Subjective complaint of dry eye that has been present for minimum 20 months.

          3. Primary ocular discomfort severity is moderate to severe.

          4. Corneal - conjunctival damage is moderate to severe.

          5. Unanesthetized Schirmer's test score of 7mm/5minutes or less.

          6. Best corrected visual acuity of 0.2 or better in both eyes.

        Exclusion Criteria:

          1. Presence of anterior segment disease or disorder other than that associated with
             keratoconjunctivitis sicca.

          2. Anticipated use of any topically-instilled ocular medications or patients with cannot
             discontinue the use during the study.

          3. Anticipated use of contact lens during the study.

          4. Any history of ocular surgery within 12 months.

          5. Female patients who are pregnant, possibly pregnant or breast feeding;

          6. Known hypersensitivity to any component of the study drug or procedural medications.

          7. Receipt of any investigational product within 4 months.