bioihbjkbjnl/mcl2 huggingface dataset:
An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures
Condition: Epilepsy; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam
Intervention description: Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Levetiracetam; Infusion; Epilepsy; Partial Onset Seizures

Summary:

      To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as
      adjunctive treatment in subjects with Partial Onset Seizures after switching from the
      equivalent Levetiracetam oral dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female aged ≥ 16 years

          -  Subject has Partial Onset Seizures that are classifiable according to the 1981
             International League Against Epilepsy (ILAE) classification of Epileptic Seizures

          -  Subject weighs ≥ 40 kg

          -  Subject is currently taking Levetiracetam (LEV) as an adjunctive antiepileptic oral
             treatment with 1 to 3 other Antiepileptic Drugs (AEDs)

        Exclusion Criteria:

          -  Subject has problems with venous accessibility

          -  Subject has participated in another clinical/pharmacological study during the last 4
             weeks prior to the Screening Visit

          -  Subject is pregnant or lactating

          -  Subject has a history of suicide attempt(s) or presents with current depressive signs,
             current suicidal ideation, and/or behavior

          -  Subject has clinically significant Electrocardiogram (ECG) abnormalities according to
             the investigator
Effects of Acupuncture in the Treatment of Infant Colic
Condition: Infant Colic
MeSH terms: Colic
Intervention: Acupuncture with Seirin 020x15 mm sterile acupuncture needle
Intervention description: Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 90.0
Sex: All
Minimum age: 3 Weeks
Maximum age: 3 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infant Colic; Acupuncture; General Practice

Summary:

      Standardized acupuncture treatment for infant colic is a common treatment in general practice
      for doctors educated in medical acupuncture.

      The investigators plan to study whether the perceived opinion on positive results can be
      verified in a multi-center clinical trial. The investigators aim to measure the effect of
      standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized
      singe blinded prospective multi-center study, starting September 2009. The study will be done
      in thirteen locations in Norway by specialists in General Practice trained in acupuncture.

      The investigators intend to include a total of 130 patients, 65 in the intervention group and
      65 in the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants under 3 months of age with birth weight over 2500 g and/or over 36th week of
             gestation.

          -  Further fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable
             crying in an otherwise healthy child under 3 months of age, and with more than 3 hours
             of crying per day for more than 3 days a week for more than 3 weeks."

        Exclusion Criteria:

          -  Infants over 3 months of age with birth weight under 2500 g and/or under 36th week of
             gestation.

          -  Not fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable
             crying in an otherwise healthy child under 3 months of age, and with more than 3 hours
             of crying pr.day for more than 3 days a week for more than 3 weeks."
A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: AZD3355; AZD3355; AZD3355; AZD3355; placebo
Intervention description: 30 mg orally in the morning and 30 mg in the evening for 1 day; 90 mg orally in the morning and 90 mg in the evening for 1 day; 120 mg orally in the morning and 120 mg in the evening for 1 day; 240 mg orally in the morning and 240 mg in the evening for 1 day; Placebo capsules orally in the morning and placebo capsules in the evening for 1 day
Intervention MeSH terms: Lesogaberan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GERD; lesogaberan; impedance; pH; pharmacokinetics; safety; tolerability

Summary:

      The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on
      the number of reflux episodes, in patients who have GERD and still experience symptoms
      despite proton pump inhibitor (PPI) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide informed consent

          -  History of GERD with persistent symptoms despite treatment with PPI

          -  Otherwise normal physical health

        Exclusion Criteria:

          -  History of GERD with symptoms that has not improved at all during treatment with PPI

          -  Prior surgery of the upper gastrointestinal tract

          -  History of significant heart disease, cardiovascular, respiratory, hepatic, renal,
             metabolic, psychiatric or gastrointestinal disorders besides GERD
Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.
Condition: Medication Adherence
Intervention: Experimental
Intervention description: Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioid Pain Medication; Medication Safety; Correct storage; Correct disposal; Correct Use

Summary:

      The purpose of this project is to test whether an online pain medication intervention is a
      feasible and effective way to increase opioid pain medication safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be willing and able to provide consent

          -  Have the ability to read and write English

          -  Diagnosis of non-cancer chronic pain

          -  Prescribed opioids and taking consistently for 3 months.

          -  Over 18 years old

        Exclusion Criteria:

          -  Previously visited painACTION
A Study of Pertuzumab in Participants With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Pertuzumab
Intervention description: Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.
Intervention MeSH terms: Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in
      participants with hormone-refractory prostate cancer who have had no previous chemotherapy.
      Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and
      the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50
      participants may enter either cohort, for a total enrollment between 46 and 73 participants
      across 9 study centers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than (>) 18 years of age

          -  Histologically documented adenocarcinoma of the prostate resistant to hormone therapy,
             progressed at 4 to 6 weeks following anti-androgen withdrawal

          -  Prostate-specific antigen (PSA) values at least 20 ng/mL among those with asymptomatic
             or mildly symptomatic disease

          -  Karnofsky performance status (KPS) at least 80 percent (%)

          -  Castrate testosterone less than (<) 50 ng/dL

          -  Life expectancy at least 12 weeks

          -  Left ventricular ejection fraction (LVEF) at least 50%

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

          -  Prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer

          -  Systemic corticosteroids within 1 month prior to Screening

          -  Bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any
             investigational agent with 28 days of study drug

          -  Prior cumulative doxorubicin dose of > 360 mg/m^2 or equivalent

          -  Central nervous system (CNS) or pulmonary metastases

          -  Other malignancies, except adequately treated basal or squamous cell skin cancer

          -  Significant cardiovascular disease

          -  Active/uncontrolled concurrent illness or infection

          -  Major surgery or traumatic injury within 4 weeks of study drug
Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Intervention: nab-Paclitaxel; Gemcitabine; Chemoradiation; Capecitabine; Surgery
Intervention description: Surgical intervention
Intervention MeSH terms: Paclitaxel; Gemcitabine; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Neoplasms; Pancreatic Cancer; Locally advanced pacriatic cancer; nab-Paclitaxel; Abraxane; Gemcitabine; ABI-007

Summary:

      This clinical study is in subjects who are 18 years old or older with locally advanced
      pancreatic cancer who have not received prior treatment for their pancreatic cancer. The
      study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of
      treatment. Subjects who complete the treatment will choose, with their treating physicians,
      what additional treatment should be given: more nab-Paclitaxel plus gemcitabine,
      Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients

          -  No prior anticancer therapy for pancreatic cancer

             •≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts,
             hepatic function, and renal function

          -  Signed informed Consent

        Exclusion Criteria:

          -  Active bacterial, viral, or fungal infection

          -  Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV)
             infection, or receiving immunosuppressive or myelosuppressive

          -  Subjects with sensory neuropathy, ascites, or plastic biliary stent.

          -  Serious medical risk factors involving any of the major organ systems, or serious
             psychiatric disorders (including but not limited to connective tissue disorders, lung
             disease, and cardiac or seizure disorders)

          -  Women who are pregnant or breast feeding
Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: 5-FU; Oxaliplatin; leucovorin; mesorectal excision
Intervention description: 5-FU: continuous infusion via portable pump during all RT (approximately 33 days); Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1); Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin; mesorectal excision
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum

Summary:

      RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage
      II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated
      with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce
      distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated
      by benefits demonstrated in stage III colon cancer.

      Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and
      RT followed by total mesorectal excision (TME) and adjuvant

      PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant
      combination chemotherapy with radiation works in treating patients undergoing surgery for
      rectal cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histologically proven adenocarcinoma of the rectum with no distant metastases.

          -  T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT

          -  The distal border of the tumor must be at or below the peritoneal reflection, defined
             as within 12 centimeters of the anal verge by protoscopic examination.

          -  No prior chemotherapy or pelvic irradiation.

          -  ECOG performance status 0-1

          -  Age 18 to 70 years

          -  ANC >= 1500/mm3 and platelets >= 100,000/mm3

          -  Serum creatinine <= 1.5 x ULN; bilirubin <= 1.5 x ULN; ALT<= 2.5 x ULN

        Exclusion Criteria

          -  Pregnant or lactating females; patients not practicing active contraception while
             sexually active.

          -  No other serious medical condition

          -  A psychiatric disorder that would prohibit the subject from participating fully.

          -  Peripheral neuropathy > grade 1

          -  History within the past 5 years of a cancer diagnosis except for non-melanomatous skin
             cancers or in situ cervix carcinoma.

          -  HIV positive patients
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Intervention: Seasonal flu vaccine
Intervention description: This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Seasonal influenza; Vaccine

Summary:

      This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza
      vaccine administered to elderly subjects
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males and females volunteers of 65 years of age or older

          -  Mentally competent

          -  Willing and able to give written informed consent prior to study entry.

          -  Able to comply with all the study requirements.

          -  In general good health

        Key Exclusion Criteria:

          -  Any serious chronic or acute disease

          -  History of any anaphylactic reaction and/or serious allergic reaction following a
             vaccination

          -  Known or suspected impairment/alteration of immune function

          -  Bleeding diathesis or conditions associated with prolonged bleeding time that in the
             investigator's opinion would interfere with the safety of the subject

          -  Within the past 6 months, they have had laboratory confirmed influenza disease or
             received influenza vaccine

          -  Fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study
             vaccination

          -  Individuals who received any other vaccines within 4 weeks prior to enrollment in this
             study or who are planning to receive any vaccine within 4 weeks from the study
             vaccines
E3 Breast Cancer Taxotere Combination
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vandetanib (ZD6474); Docetaxel
Intervention description: once daily oral dose; intravenous infusion
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: 64.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Zactima

Summary:

      To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using
      the progression event count methodology
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females with histological/cytological confirmation of breast cancer.

          -  Subjects with a measurable lesion or bone lesions

        Exclusion Criteria:

          -  Previous radiotherapy within 6 weeks

          -  Significant cardiac events, arrhythmias or other cardiac conditions
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: N-acetylcysteine + high-dose naltrexone (150 mg); High-dose naltrexone (150 mg) alone; Low-dose naltrexone (50 mg) alone
Intervention description: All subjects will be evaluated weekly for 12 weeks.; All subjects will be evaluated weekly for 12 weeks.; All subjects will be evaluated weekly for 12 weeks.
Intervention MeSH terms: Acetylcysteine; Naltrexone; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: N-acetylcysteine; naltrexone

Summary:

      The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine +
      high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in
      reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than
      low-dose naltrexone (50 mg) alone in reducing alcohol drinking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-65 years

          -  alcohol dependence by DSM-IV criteria

          -  heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5
             or more standard drinks per day for men and 4 or more standard drinks for women)

          -  able to provide informed consent

          -  a score of 6 or more on the Penn Alcohol Craving Scale (PACS)

          -  subject agrees not to take over-the-counter analgesics during the study

        Exclusion Criteria:

          -  current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)

          -  current psychotic disorders or bipolar disorders

          -  current suicidal or homicidal ideation

          -  positive illicit drug screen test (except marijuana)

          -  ongoing narcotic use or risks for narcotic use during the study

          -  increased risk for severe alcohol withdrawal by a score of 10 or more on the Clinical
             Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)

          -  clinically significant cardiac, hepatic, renal, neurologic, or pulmonary disease

          -  baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater
             than 3 times normal

          -  current use of disulfiram, acamprosate or topiramate

          -  pregnant or nursing, or inadequate birth control methods in women of childbearing
             potential

          -  alcohol breathalyzer level 0.08 or more at the screening visit

          -  severe alcohol withdrawal (delirium tremens or withdrawal seizures) within the past
             year

          -  currently requiring inpatient treatment for treating alcohol dependence