bioihbjkbjnl/mcl2 huggingface dataset:
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
Condition: Non-cancer Pain; Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: placebo; prucalopride
Intervention description: placebo; 1 or 2 mg prucalopride once daily before breakfast
Intervention MeSH terms: Prucalopride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid induced constipation/prucalopride chronic non-cancer pain; Subjects with chronic non-cancer pain suffering from OIC

Summary:

      The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks
      of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from
      opioid induced constipation.
    

Eligibility criteria:

        Inclusion criteria to be assessed at screening:

          1. Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.

          2. Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance
             treatment with opioids;has been on stable daily opioid dose during at least the
             previous 2 weeks; and is expected to remain on stable daily dose of opioids for at
             least 15 weeks after Visit 1.

          3. Subject is suffering from OIC (i.e. secondary to chronic opioid use).

          4. Subject agrees to stop his/her laxative treatment and is willing to use rescue
             medication.

        Main exclusion criteria to be assessed at screening:

          1. Constipation is thought to be drug-induced (except for opioids)

          2. Disallowed medication is being used

          3. Subject was on chronic therapy for chronic constipation prior to start of opioid
             therapy

          4. Subject is suffering from secondary causes of chronic constipation.
Hypertonic Resuscitation Following Traumatic Injury
Condition: Shock, Traumatic
MeSH terms: Shock; Shock, Traumatic; Wounds and Injuries
Intervention: 7.5% hypertonic saline/6% Dextran-70 (HSD); 7.5% hypertonic saline (HS); 0.9% normal saline
Intervention description: 250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.; 250 cc dose given as a one-time IV bolus in the pre-hospital setting.; 250 cc dose given as a one-time IV bolus in the pre-hospital setting.
Intervention MeSH terms: Dextrans
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 895.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Trauma; Shock

Summary:

      The purpose of this study is to determine if hypertonic saline with and without dextran can
      improve overall survival in victims of trauma with shock.

      Injury and lost blood from trauma can cause your body to be in shock (low blood pressure
      related to blood loss). This decreased blood flow can lead to organ damage. In order to
      restore the blood pressure and blood flow, the medics give fluids into the patients' veins as
      soon as possible. This is called "resuscitation." The resuscitation fluid most commonly used
      is "isotonic" or one that is the same concentration as the blood. The investigators are
      trying to determine if infusing a "hypertonic" fluid (or one more concentrated than the
      blood) can increase the blood pressure and restore blood flow more efficiently. The
      hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD)
      and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly
      more concentrated than your blood. Dextran is a sugar solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Blunt or penetrating trauma

          -  Prehospital Systolic Blood Pressure (SBP) <= 70;OR

          -  Prehospital SBP 71-90 AND Hear Rate (HR) ≥108

          -  15 years of age or older, or 50kg or more if age unknown

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Age younger than 15 or less than 50kg if age unknown

          -  Ongoing prehospital cardiopulmonary resuscitation (CPR)

          -  Administration of more than 2000cc crystalloid or any colloid or blood products

          -  Severe hypothermia (suspected Temperature less than 28 degrees celsius)

          -  Drowning or asphyxia due to hanging

          -  Burns Total Body Surface Area (TBSA) more than 20%

          -  Isolated penetrating injury to the head

          -  Inability to obtain prehospital intravenous access

          -  Time of call received at dispatch to study intervention greater than four hours

          -  Known prisoners
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Active Substance: Brivaracetam
Pharmaceutical Form: Tablet
Concentration: 10 mg and 25 mg
Route of Administration: Oral
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 668.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Epilepsy; Partial Onset Seizures; open label

Summary:

      This trial, evaluating the long-term safety and tolerability of brivaracetam will provide
      subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive
      treatment, the opportunity to receive open label brivaracetam treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/ female subjects from 16 years and on. Subjects under 18 years may only be
             included where legally permitted and ethically accepted

          -  Subjects with epilepsy who have participated in previous brivaracetam trials which
             allow access to the present study

          -  Subjects for whom the investigator believes a reasonable benefit from the long term
             administration of brivaracetam may be expected

          -  Female subjects without childbearing potential. Female subjects with child bearing
             potential are eligible if they use a medically accepted contraceptive method for the
             duration of the study

          -  Subject/ legally acceptable representative considered as reliable and capable of
             adhering to the protocol, visit schedule or medication intake according to the
             judgment of the Investigator

        Exclusion Criteria:

          -  Severe medical, neurological and psychiatric disorders or laboratory values which may
             have an impact on the safety of the subject

          -  Poor compliance with the visit schedule or medication intake in the previous
             brivaracetam study

          -  Pregnant or lactating women

          -  Participation in any clinical study of another investigational drug or device during
             the study
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella
Intervention: Comparator: ProQuad™ (V221); Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Intervention description: 0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV); 0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1027.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study is being conducted to demonstrate that V221 may be administered concomitantly with
      pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles,
      mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health

          -  12 to 15 months of age

          -  Negative clinical history to measles, mumps, rubella, varicella and/or zoster

          -  Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at
             least 2 months prior to the receipt of any of the study vaccines

          -  Signed consent

        Exclusion Criteria:

          -  Previous administration of any measles, mumps, rubella, or varicella vaccine either
             alone or in any combination

          -  Any condition resulting in depressed immunity

          -  Any allergy to any vaccine component as stated in the package circulars

          -  Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the
             study vaccination

          -  History of seizure disorder

          -  Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine
             within 30 days

          -  Recent febrile illness
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: PF-02341066; Pemetrexed; Docetaxel
Intervention description: PF-02341066, 250 mg BID will be administered orally on a continuous schedule; Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle; Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle
Intervention MeSH terms: Docetaxel; Pemetrexed; Crizotinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 347.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Neoplasms ALK gene crizotinib

Summary:

      This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus
      pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific
      gene profile involving the ALK gene after failure of one previous chemotherapy regimen that
      included one platinum drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically or cytologically proven diagnosis of non-small cell lung cancer

          -  positive for the ALK fusion gene (test provided by a central laboratory)

          -  must have had disease progression after only one prior chemotherapy and that regimen
             but must have included one platinum drug

          -  tumors must be measurable

        Exclusion Criteria:

          -  prior treatment with PF-02341066

          -  current treatment in another clinical trial
Stepped Care to Optimize Pain Care Effectiveness
Condition: Pain
Intervention: Stepped care
Intervention description: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
Intervention MeSH terms: Analgesics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Telecare; Collaborative care

Summary:

      Pain is the most common physical symptom in primary care, accounting for an enormous burden
      in terms of patient suffering, quality of life, work and social disability, and health care
      and societal costs. Pain is particularly prevalent among veterans. Four major barriers to
      optimal care include underdetection of pain, inadequate initial treatment, failure to monitor
      adherence and symptom response, and failure to adjust treatment in patients not responding or
      intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize
      Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary
      care.
    

Eligibility criteria:

        Inclusion Criteria:

        SCOPE will enroll 250 primary care veterans with persistent (3 months or longer)
        musculoskeletal pain of moderate severity and randomize them to either the stepped care
        intervention or usual care control group.

        Exclusion Criteria:

        Individuals who:

          -  have filed a pain-related disability claim in the last 6 months;

          -  do not speak English;

          -  have moderately severe cognitive impairment;

          -  have schizophrenia, bipolar disorder, or other psychosis;

          -  are actively suicidal;

          -  have current illicit drug use; or

          -  have an anticipated life expectancy of less than 12 months.
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
Condition: Pain
MeSH terms: Neoplasms; Cancer Pain
Intervention: Oxycodone CR; R331333 (referred to as JNS024 ER or CG5503)
Intervention description: One 5 mg to 40 mg capsule twice daily for 4 weeks.; One 25 mg to 200 mg capsule twice daily for 4 weeks.
Intervention MeSH terms: Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 343.0
Sex: All
Minimum age: 20 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Pain; R331333 (JNS024ER, CG5503), tapentadol (NUCYNTA); Opioid analgesic; Oxycodone CR (OXYCONTIN CR); Chronic malignant tumor related cancer pain

Summary:

      The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as
      JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone
      Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant,
      tumor-related cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented clinical diagnosis of any type of cancer

          -  Diagnosis of chronic malignant tumor-related cancer pain with an average score for
             pain intensity in the past 24 hours of >=4 on the 11-point numerical rating scale
             (NRS) on the day of randomization (Day -1)

          -  Have not received treatment with opioid analgesics within 28 days before screening
             (Note: codeine phosphate [<=60 mg/d] or dihydrocodeine phosphate [<=30 mg/d] for
             antitussive use are allowed)

          -  Dissatisfied with pain relief by the current treatment and for whom the investigator
             or designee judges that treatment with opioid analgesics is required

        Exclusion Criteria:

          -  Have complicated with uncontrolled/clinically significant arrhythmia

          -  Have previous or concurrent presence of any disease which may develop increased
             intracranial pressure, disturbance of consciousness, lethargy, or respiratory problems
             such as traumatic encephalopathy with cerebral contusion, intracranial hematoma,
             disturbance of consciousness, brain tumor, cerebral infarction, transient ischemic
             attack, epilepsy or convulsive diseases

          -  Have history of alcohol and/or drug abuse

          -  Have any disease for which opioids are contraindicated such as serious respiratory
             depression of serious chronic obstructive pulmonary disease, bronchial asthma attack,
             cardiac failure secondary to chronic pulmonary disease, paralytic ileus, status
             epileptics, tetanus, strychnine poisoning, acute alcohol poisoning, hypersensitivity
             to opium alkaloid, hemorrhagic colitis, or bacterial diarrhea
Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee; Menopause
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hyperthermia
Intervention: Shortwave diathermy
Intervention description: continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: Female
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diathermy; Short-wave therapy; Osteoarthritis; Knee

Summary:

      The purpose of this study is to determine whether shortwave diathermy is effective in
      reducing knee pain and increasing function of the patients with knee osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  peri- or postmenopausal women aged >50 years

          -  primary knee osteoarthritis

        Exclusion Criteria:

          -  inability to walk

          -  severe joint instability

          -  history of previous shortwave diathermy

          -  intra-articular injection within 3 months

          -  metallic implant around knee joint

          -  suspicious of malignancy around knee joint

          -  significant cardiovascular disease

          -  inability to understand how to score the symptoms
LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
Condition: Non Infectious Uveitis
MeSH terms: Uveitis
Intervention: DE-109 Intravitreal Injections; Sham Procedure; DE-109 Intravitreal Injections; DE-109 Intravitreal Injections (Open Label)
Intervention description: 440 ug of DE-109 Injectable Solution; The sham procedure mimics an intravitreal injection without penetrating the eye.; Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug); After double-masked treatment period (injections every 2 months), eligible subjects would enter the open-labeled period and had DE-109 440 ug injections every 2 months (Month 6, Month 8, and Month 10)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months
      in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).

      There is a 6-month, single-arm, open-label period after completion of the 6-month double-
      masked, controlled period allows the evaluation of the efficacy and safety of intravitreal
      injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo
      or sham control.
    

Eligibility criteria:

        Inclusion Criteria:

        Non-Infectious Active Uveitis of the Posterior Segment

        Exclusion Criteria:

        Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected
        infectious uveitis
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Intervention: exenatide twice daily (BID); premixed insulin aspart twice daily (BID)
Intervention description: subcutaneous injection (5 mcg or 10 mcg), twice a day; subcutaneous injection (titrated appropriately), twice a day
Intervention MeSH terms: Insulin Aspart; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 494.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; Byetta; Amylin; Lilly

Summary:

      This study in Germany is designed to compare the effects of twice-daily exenatide plus
      metformin and twice-daily premixed human insulin aspart plus metformin with respect to
      glycemic control, as measured by HbA1c, combined with the percentage of patients with at
      least one treatment-emergent hypoglycemic episode. Patients will be treated with study
      therapy for approximately 26 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been treated with diet and exercise and a stable, maximally tolerated dose of
             immediate-release or extended-release metformin, or the combination of metformin (any
             dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start

          -  Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than
             2 weeks within 3 months prior to study start, and have not received any insulin
             formulation for more than 14 days (other than in emergency situations) and within 14
             days prior to study start

          -  Have an HbA1c between 6.5% and 10.0%, inclusive

          -  Have a body mass index (BMI) between 25 kg/m^2 and 40 kg/m^2, inclusive

        Exclusion Criteria:

          -  Have type 1 diabetes or known latent autoimmune diabetes in adults

          -  Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy
             (excluding topical and inhaled preparations) or have received such therapy within 2
             weeks prior to study start

          -  Are receiving treatment for gastrointestinal disease with a drug directly affecting
             gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide
             antibiotics)

          -  Have used any prescription drug to promote weight loss within 3 months prior to study
             start

          -  Have received treatment within 30 days prior to study start with a drug that has not
             received regulatory approval for any indication at the time of study entry

          -  Have previously completed or withdrawn from this study or any other study
             investigating exenatide or GLP-1 analogs