bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Spinal Ketorolac After Acute Opioid Exposure
Condition: Healthy
Intervention: ketorolac; placebo; remifentanil; Capsaicin
Intervention description: single intrathecal injection of ketorolac 2 mg; subject will receive a placebo (preservative free normal saline) spinal injection; All subjects will receive a remifentanil infusion; Topical capsaicin pain model utilized for each subject
Intervention MeSH terms: Ketorolac; Remifentanil; Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy volunteers; analgesia; pain; Healthy subjects

Summary:

      This research study is being done because pain is a significant problem for patients with a
      variety of medical problems and following surgery or traumatic injury. Currently available
      pain medications may not treat all types of pain or may treat pain only at doses that produce
      side effects and complications. The medication in this study may have a role in better
      treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic,
      pain reliever), given into the fluid in the back near the spine has any effect on pain or
      discomfort in the skin sensation that will take place after applying capsaicin (chili pepper)
      cream. The sunburn-like sensation that people experience after having capsaicin cream applied
      is similar to, but much milder than, the pain that some people have after surgery and after
      certain types of nerve injuries. This study will test the effects of combining two
      medications that are often given together to control postoperative pain or pain from a nerve
      injury. The investigators are especially interested in answering two questions about the
      effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic
      painkiller):

        1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on
           your skin, which develops after applying capsaicin cream?

        2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy

          -  American Society of Anesthesiologist (ASA) I or II classification

          -  between the ages of 18-55

          -  weigh less than 250 pounds

          -  without chronic pain

        Exclusion Criteria:

          -  taking analgesics in the last 2 weeks

          -  positive urine drug screen

          -  pregnancy

          -  currently taking any prescription antidepressants or other medications that are mood
             altering

          -  liver or kidney disease

          -  stomach ulcers

          -  allergies to ketorolac, lidocaine, or capsaicin cream

          -  lung disease (COPD)
Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients
Condition: Atrial Fibrillation; Heart Valve Diseases; Venous Thrombosis
MeSH terms: Atrial Fibrillation; Thrombosis; Venous Thrombosis; Heart Valve Diseases
Intervention: Dosing warfarin every 12 weeks, sham INRs 2 out of 3 times
Intervention description: Warfarin is dosed according to INR to maintain INR 2.0-3.0 or for mechanical mitral valves or mechanical aortic valves with atrial fibrillation INR 2.5-3.5
Intervention MeSH terms: Warfarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: warfarin; prothrombin time; monitoring

Summary:

      Patients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation)
      have a high risk of blood clot formation. Such clots can result in a stroke. The patients are
      treated with warfarin - a "blood thinner" - to prevent these complications. The treatment has
      to be monitored with a blood test called Prothrombin time (PT) every 1-4 weeks. The dose of
      warfarin has to be changed whenever the PT result is outside of the treatment range. If the
      result is too low there is an increased risk of blood clots. If, instead, the result is too
      high there is a risk of bleeding. One third of the patients have very stable PT results and
      hardly ever have to change the dose.

      The investigators hypothesis is that these patients can go less often, e.g. every 12 weeks,
      for the blood tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients on long-term warfarin (for prophylaxis of arterial embolism in patients with
             atrial fibrillation or mechanical heart valve replacement, or secondary prophylaxis
             after VTE) with a target INR of 2.0-3.0 or 2.5-3.5,

          -  Anticoagulant therapy managed by the clinic (HHS - General Hospital) for at least 6
             months prior to enrolment, and

          -  Maintenance dose of warfarin unchanged for the previous 6 months or longer.

        Exclusion Criteria:

          -  Age <18 years,

          -  Life expectancy of less than 1 year,

          -  Attending physician believes the patient is not suitable for the study (e.g.
             psychiatric disorder, history of non-compliance),

          -  Geographic inaccessibility or

          -  Failure to obtain written consent.
Treating Smokers With Mental Illness
Condition: Smoking Cessation; Cigarette Smoking; Schizophrenia; Psychotic Disorders; Major Depressive Disorder; Bipolar Disorder I; Bipolar II Disorder; Mental Illness
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Intervention: Nicotine patch; Nicotine lozenge; Therapy; Information
Intervention description: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use; Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use; In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase; Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mental illness; tobacco treatment

Summary:

      This is a smoking cessation study that will enroll smokers who have been diagnosed with a
      severe mental illness. The study will use a combination of intensive tobacco treatment
      counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting
      smoking over the course of six months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  have a severe mental illness diagnosis

          -  be a daily smoker

          -  be willing to reduce the number of cigarettes smoked per day leading to a quit attempt

          -  want to try to quit smoking

          -  be willing to use nicotine replacement therapy

          -  be able to communicate in English

        Exclusion Criteria:

          -  anyone who has had an active psychotic episode or been hospitalized due to suicidal
             ideation in the last six months

          -  pregnancy

          -  taking Chantix or Clozapine

          -  having a terminal illness
Minocycline in Patients With Alzheimer's Disease
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Minocycline
Intervention description: 50mg, twice daily for 6 months.
Intervention MeSH terms: Minocycline; Tetracycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Neuroinflammation; Mild Cognitive Impairment; Alzheimer's Disease; Minocycline

Summary:

      Cognitively normal individuals, patients with Mild Cognitive Impairment (MCI) or Alzheimer's
      Disease (AD) will undergo clinical screening, neuropsychological tests, blood and urine
      analyses, quantitative magnetic resonance imaging (MRI) and proton (1H ) and carbon 13 (13C)
      magnetic resonance spectroscopy (MRS). Each individual will receive minocycline oral
      administration for 4 weeks initially, after which MRI, MRS and neuropsychological results
      will be recorded. If no adverse side effects occur, subjects will continue minocycline
      administration for an additional 5 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cognitively normal elderly subjects between the ages of 55-90 and patients aged 55 -
             90 years who have mild cognitive impairment (MCI) or clinically defined Alzheimer's
             disease.

        Exclusion Criteria:

          -  Any person with medical devices such as cardiac pacemakers/defibrillators or
             neuro-implants as they are contra-indications for MRI/MRS exam.

          -  Since the effects of MRI are unknown to the fetus or unborn child, any person who is
             or may be pregnant will be excluded from the study.

          -  History of known allergy or intolerance to minocycline or any other tetracycline

          -  Impaired renal function (plasma Creatinine) or blood urea nitrogen (BUN) levels
             exceeds twice normal upper limit which can result in higher serum levels of
             tetracycline, azotemia, hyperphosphatemia and acidosis.
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
Condition: Thrombotic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: Danazol
Intervention description: Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.
Intervention MeSH terms: Danazol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TTP; Thrombotic Thrombocytopenic Purpura

Summary:

      The purpose of the study is to find out if administration of danazol with plasma exchange and
      corticosteroids will reduce the number of plasma exchanges required to control Thrombotic
      Thrombocytopenic Purpura (TTP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  TTP with platelets less than 100,000 and microangiopathic hemolytic anemia

          -  Age greater than 18 and less than 60

          -  LDH > 2x upper limit of normal

          -  PT and PTT normal

          -  Patients must give signed informed consent

          -  Pre-menopausal woman must have negative pregnancy test.

          -  TTP not related to underlying cancer, treatment of cancer or transplantation.

          -  TTP not associated with drugs.

        Exclusion Criteria:

          -  LFTs AST/ALT > 2x upper limit of normal

          -  Hepatitis B and Hepatitis C infection.

          -  HIV with active opportunistic infections

          -  Acute or chronic Disseminated Intravascular Coagulation (DIC), defined as D-dimer
             8ug/ml and fibrinogen<100 mg/dl

          -  TTP related to drugs, malignancy and transplantation.

          -  Pregnancy

          -  Concurrent other investigational drug use during this study.

          -  Porphyria.
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Arm 1 stereotactic body radiation therapy; Arm II stereotactic body radiation therapy
Intervention description: Patients undergo 1 high-dose fraction; Patients undergo 3 high-dose fractions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer

Summary:

      RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
      tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation
      therapy is more effective in treating patients with non-small cell lung cancer.

      PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy
      regimens and to see how well they work in treating patients with stage I or stage II
      non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-small cell lung cancer

          -  T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is
             Excluded)

          -  Surgically resectable primary disease, however patient evaluated by thoracic
             oncologist and deemed medically inoperable OR patient refuses surgical resection

          -  Age >= 18

        Exclusion Criteria:

          -  Prior thoracic radiation therapy

          -  T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement

          -  Node positive or metastatic disease

          -  Tumor location within the zone of the proximal bronchial tree. The proximal bronchial
             tree is defined as the carina, right and left main bronchi, right and left upper lobe
             bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and
             right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined
             as a volume 2cm in all directions around the proximal bronchial tree.

          -  No other conditions deemed by the PI or associates to make the patient ineligible for
             protocol investigations, procedures, and high-dose external beam radiotherapy (e.g.,
             unable to lie still and breathe reproducibly)

          -  Pregnant or unwilling to use adequate contraception
A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Daclatasvir; Placebo
Intervention description: Capsule, Oral, Approximately 182 days from initial dosing; Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during
      dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C
      infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronically infected with Hepatitis C Virus (HCV) genotype 1

          -  Treatment naive or treatment non-responders or treatment intolerant; and not
             co-infected with HIV or Hepatitis B Virus

          -  HCV RNA viral load of ≥10*5 IU/mL

          -  BMI 18 to 35kg/m²

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness which is not stable or is not
             controlled with medication and not consistent with Hepatitis C Virus infection

          -  HIV and/or HBV positive

          -  Major surgery within 4 weeks of study drug administration and any gastrointestinal
             surgery that could impact the absorption of study drug

        WOCBP will be enrolled as in-patient for 16 days
Riluzole Augmentation Pilot in Depression (RAPID) Trial
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Riluzole; Sertraline; placebo
Intervention MeSH terms: Riluzole; Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Major Depression; Major Depressive Disorder; Depression; Riluzole; Glutamate; Sertraline

Summary:

      The investigators are doing a research study to find out if riluzole, when taken along with a
      standard antidepressant (sertraline) can help people with major depression.

      This research study will compare riluzole + sertraline to placebo + sertraline. The
      investigators hypothesize that adding riluzole will lead to a better antidepressant response,
      in less time, then sertraline alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (ages 18-75) who meet DSM-IV criteria for a major depressive episode,

          -  Hamilton Depression Rating Scale (HDRS) >22, and

          -  No antidepressant treatment for at least three weeks

        Exclusion Criteria:

          -  Active drug or alcohol disorder in the past 3 months

          -  History of psychosis, history of mania or hypomania

          -  Epilepsy or history of seizures

          -  Hypothyroidism

          -  Congenital QTc prolongation

          -  Liver disease

          -  Lung disease

          -  Acute suicide or homicide risk

          -  Pregnant women, breastfeeding women, women of childbearing age not using contraception

          -  Unstable medical illness

          -  Elevated thyroid-stimulating hormone (TSH>5.0mlU/L), or

          -  Abnormal liver function tests (ALT>50 U/L or AST>50 U/L)

          -  ADD / ADHD (Attention deficit hyperactivity disorder)

        Disallowed therapies include: other psychotropic medications, including antipsychotics,
        mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates,
        or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve
        stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
Condition: Neoplasms, Squamous Cell
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Squamous Cell
Intervention: gefitinib (Iressa); cisplatin; radiotherapy; Gefitinib (Iressa)
Intervention description: 250 mg oral tablet; intravenous infusion; radiation therapy; 500 mg oral tablet
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Squamous Cell Carcinoma; Head and Neck Squamous Cell Cancer; Squamous Cell Carcinoma; Squamous Cell Cancer

Summary:

      The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg
      when given either concomitantly or as maintenance to a standard therapy of radiotherapy
      (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free)
      rate at 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of
             the head and neck

          -  No prior surgery or chemotherapy/biological therapy/radiation therapy

          -  Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

          -  Life expectancy of more than 12 weeks

        Exclusion Criteria:

          -  Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.

          -  Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal
             disease; or coexisting malignancies.