bioihbjkbjnl/mcl2 huggingface dataset:
HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Cancer
MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: Sorafenib
Intervention MeSH terms: Sorafenib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C positive

Summary:

      This research study is a Phase IV clinical trial. Phase IV trials are used to further test
      and monitor the safety of a drug approved by the FDA and to see if the drug has any other
      indications that can be used to treat different diseases.

      Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of
      liver cancer. It is also currently being tested in various other cancers. Sorafenib works by
      slowing down and/or stopping the development of new cancer cells and new blood vessels. By
      slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed
      that sorafenib prevents or slows down the growth of tumors.

      The researchers of this study would like to study the effects of sorafenib on hepatitis C by
      drawing additional research blood samples from people infected with hepatitis C who are
      receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in
      the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically and/or radiologically confirmed advanced HCC

          -  Detectable HCV RNA with anti-HCV-positivity

          -  Life expectancy of at least 3 months

          -  Willing to use adequate contraception

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Undetectable HCV RNA

          -  Uncontrolled hypertension

          -  Active or clinically significant cardiac disease

          -  Thrombolic, embolic, venous or arterial events within 6 months of informed consent

          -  Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks
             before study entry

          -  Previously untreated or concurrent cancer except cervical cancer in situ, treated
             basal cell carcinoma or superficial bladder tumor

          -  Presence of non-healing wound, ulcer or bone fracture

          -  History of organ allograft

          -  Known or suspected allergy or hypersensitivity to any of the study drugs

          -  Any malabsorption condition

          -  Inability to comply with the protocol and/or not willing or not available for follow
             up

          -  Major surgery within 30 days prior to start of study drug
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan/Amlodipine; Nifedipine
Intervention description: Valsartan/Amlodipine 80/5mg single pill combination (SPC); Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg
Intervention MeSH terms: Amlodipine; Valsartan; Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 564.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypertension; Valsartan Amlodipine single pill combination; BP control; ABPM; Hypertensive patients not adequately controlled by mono antihypertensive drugs

Summary:

      The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine
      (EXforge®) with nifedipine, as well as vascular function index.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult outpatients had uncontrolled hypertension at both screening and
             randomization despite current antihypertensive monotherapy (initial dose of
             Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI),
             Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

        Exclusion Criteria:

          -  Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP)
             level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and
             randomization.

          -  Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated
             hemoglobin >8.0%)

          -  Patients had evidence of hepatic disease or renal impairment

          -  Other exclusion criteria included evidence of secondary hypertension or history of
             cardio-vascular disease.

          -  Women who were pregnant, nursing, or of childbearing potential and not using
             acceptable contraception.

        Other protocol-defined inclusion/exclusion criteria applied.
Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
Condition: Colonoscopy
Intervention: Polyethylene Glycols; Natrium picosulfate / Magnesium citrate; Polyethylene glycol / Ascorbic acid
Intervention MeSH terms: Ascorbic Acid; Magnesium citrate; Picosulfate sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1044.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study evaluates the efficacy and tolerability of low volume preparations compared with
      conventional 4L polyethylene glycol prior to colonoscopy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects referred to diagnostic or therapeutic colonoscopy

        Exclusion Criteria:

          -  ileus

          -  known or suspected bowel obstruction

          -  active bowel inflammation

          -  pregnancy

          -  any presence of serious medical conditions

          -  history of prior colonic or rectal surgery

          -  inability to obtain valid data from subject
Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy
Condition: Sedation; Endoscopy
Intervention: Propofol; Midazolam
Intervention description: 70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).; 70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged < 70, 0.03 mg/Kg if aged > 70.
Intervention MeSH terms: Midazolam; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for
      gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for
      providing optimal sedation regimen and avoiding under or oversedation. The objective of the
      study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus
      propofol NAPS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age < 18 years

          -  American Society of Anesthesiologists risk I-II

          -  patients undergoing to Gastroscopy or Colonoscopy

        Exclusion Criteria:

          -  significant systemic disease

          -  allergic reactions to any of study drugs

          -  chronic use of opioids or psychiatric disorders

          -  pregnancy

          -  Mallampati score > 2

          -  age < 18 years
Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
Condition: Pain, Postoperative; Cesarean Section
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine; TAP block; QL block; ESP block
Intervention description: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine; Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.; Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.; Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this prospective single center, randomized study is to determine if ultrasound
      guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane
      (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.
    

Eligibility criteria:

        Inclusion Criteria:

          1. American Society of Anesthesiologists (ASA) Physical Status 1-3

          2. Age greater than or equal to 18 years

          3. Scheduled for elective cesarean section

          4. English speaking

        Exclusion Criteria:

          1. ASA Physical Status 4-5

          2. Diagnosis of chronic pain

          3. Chronic opioid use (opioid use in the past 3 months)

          4. Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor),
             gabapentin, or pregabalin (Lyrica)

          5. Inability to cooperate with or understand protocol

          6. Inability to communicate pain scores or need for analgesia

          7. Infection at the site of block placement

          8. Intolerance or allergy to local anesthetics

          9. Neurologic deficit or disorder

         10. Blood thinning disorder or taking anticoagulant medication

         11. BMI > 50 kg/m2

         12. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s),
             or alcohol within the past 2 years

         13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, may interfere with study assessments or compliance

         14. Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the investigator, may increase the risk of surgery or
             complicate the subject's postoperative course
Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Recurrence; Schizophrenia; Psychotic Disorders
Intervention: Risperidone microspheres; Risperidone; Olanzapine; Quetiapine; Ziprasidone; Aripiprazole; Paliperidone
Intervention description: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.; Target dose is 4 mg/day.; Target dose is 15 mg/day.; Target dose is 600 mg/day.; Target dose is 120 mg/day.; Target dose is 20 mg/day.; Target dose is 6 mg/day.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate; Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapse; Prevention; Schizophrenia; Injectable Medication

Summary:

      This study is designed to find out whether taking antipsychotic medication once every two
      weeks by injection compared to taking daily oral medication will help people with
      schizophrenia maintain better control of their symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All schizophrenia and schizoaffective patients whose clinicians are considering
             long-term treatment with an "atypical" (second generation) antipsychotic medication

          -  Worsening of illness (schizophrenia) within 12 months of study entry as defined by:
             hospitalization, increased level of clinical care, and/or present clinical Global
             Impressions Severity rating of moderate or worse

        Exclusion Criteria:

          -  First episode patients as defined by a patient who: has never received antipsychotic
             medication and has never been hospitalized for psychiatric illness; or, is receiving
             antipsychotic medication for the first time associated with a first diagnosis of
             schizophrenia.

          -  Pregnant or breastfeeding

          -  Patients with unstable medical conditions

          -  Patients with previous history of failure to respond to an adequate trial of clozapine

          -  Patients with a known allergy to risperidone or a previous history of failure to
             respond to an adequate trial of risperidone. However, patients with known allergies or
             failure to respond to any of the other medications (aripiprazole, olanzapine,
             quetiapine or ziprasidone) will not receive that medication if they are randomized to
             the oral medication arm, but are not excluded from the study
Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)
Condition: Human Immunodeficiency Virus; Smoking
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Bupropion; Varenicline; Cognitive Behavioral Therapy; Nicotine Replacement Therapy; Relapse Prevention Text Messaging
Intervention description: Smoking cessation pharmacotherapy prescribed in accordance with package insert.; Smoking cessation pharmacotherapy prescribed in accordance with package insert.; Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention; Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).; Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit.
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus; Smoking; Veterans

Summary:

      Smoking is a significant cause of damage to health and quality of life specifically for
      Veterans with human immunodeficiency virus (HIV). Smoking cessation interventions for this
      population are lacking. The primary aim of this project is to explore smoking cessation
      treatment preferences among Veteran smokers living with HIV. The study team will refine the
      design and content of a smoking cessation treatment for Veteran smokers living with HIV. The
      intervention uses mobile health and telehealth technology to personalize smoking cessation
      counseling and medications and provide relapse prevention text messaging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  VHA patient

          -  HIV positive serostatus

          -  currently smoking 7 cigarettes per week

          -  willing to complete study procedures. Exclusion criteria are:

        Exclusion Criteria:

          -  current hospitalization

          -  acute risk for suicide documented in the medical record

          -  inability to complete study procedures.
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab [MabThera/Rituxan]
Intervention description: 375mg/m2 iv every 8 weeks
Intervention MeSH terms: Rituximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 545.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy
      following a MabThera-containing induction regimen in first line or relapsed patients with
      follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface
      area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is
      1-2 years, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;

          -  patients who have received adequate (>=8 cycles) induction therapy with MabThera as
             first line treatment, or treatment for relapsed disease;

          -  demonstrated partial or complete response to induction therapy.

        Exclusion Criteria:

          -  stable or progressive disease after most recent induction therapy;

          -  transformation to high grade lymphoma;

          -  patients with prior or concomitant malignancies, except non-melanoma skin cancer or
             adequately treated in situ cancer of the cervix.
Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Acamprosate (Campral)
Intervention description: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
Intervention MeSH terms: Acamprosate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol Dependence; Family Medicine Setting; University of North Carolina at Chapel Hill

Summary:

      This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol
      problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more
      effective for helping with drinking in a Family Medicine clinic.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  1. Men and women ages 21 to 65 years with a diagnosis of alcohol dependence.

          -  2. History of at least 2 heavy drinking days (men > 5 drinks/day; women > 4
             drinks/day) per week, on average, during the month prior to screening.

          -  3. Ability to understand and sign written informed consent.

          -  4. Willingness to refrain from drinking for at least three days prior to
             randomization.

          -  5. Willingness to consider a goal of abstinence or a significant reduction in drinking
             as an objective.

        EXCLUSION CRITERIA:

          -  1. Clinically significant medical disease that might interfere with the evaluation of
             the study medication or present a safety concern.

          -  2. Clinically significant psychiatric disease, e.g. bipolar disorder, psychosis, that
             might interfere with study participation or present a safety concern. [Subjects with
             depression or an anxiety disorder who are receiving medication and are clinically
             stable for at least one month will not be excluded.]

          -  3. Suicidal ideation or behavior, history of suicide attempt.

          -  4. Renal Impairment; estimated creatinine clearance <50 ml/min.

          -  5. Substance use disorder other than alcohol or nicotine dependence or cannabis abuse.

          -  6. Pregnant or breastfeeding women and women of childbearing potential who do not
             practice a medically acceptable form of birth control (oral or depot contraceptive, or
             barrier methods such as diaphragm or condom with spermicidal).

          -  7. Individuals requiring inpatient treatment or more intense outpatient treatment for
             their alcohol dependence. Individuals may be considered for the trial upon completion
             of medical detoxification.
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Acthar Gel; Placebo
Intervention description: Acthar Gel 1 mL (80U) for subcutaneous injection; Placebo for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsing, Remitting Multiple Sclerosis; RRMS

Summary:

      This study will enroll about 66 participants who experienced a relapse of RRMS that steroids
      did not help. The doctor will put participants into a treatment group. Each person has an
      equal chance of being in either one of two groups (like flipping a coin). One group will
      receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days.
      The other group will receive a shot every day for 14 days, too, but there is no medicine in
      it (called placebo).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)

          -  Had a relapse with onset ≤42 days prior to the Baseline Visit

          -  Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of
             specific high dose corticosteroids within 28 days of the onset of the first relapse
             symptom

          -  Had failed to obtain improvement of at least 1 point in one or more functions on the
             Function Systems Score (FSS) 14 days following their first dose of high dose
             corticosteroids

          -  Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the
             Baseline Visit