bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
Condition: Arthroplasty
MeSH terms: Acute Pain
Intervention: Tapentadol IR (CG5503); Placebo; Oxycodone HCL IR; Tapentadol IR (CG5503)
Intervention description: Fixed Dose 50, 75, & 100 mg BID for 3 days; Fixed Dose Matching placebo for 3 days; Fixed Dose 10 mg BID for 3 days; Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 367.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Arthralgia; Pain; Pain Assessment; Hip Replacement; Tapentadol

Summary:

      The purpose of this study is to test in patients who have had hip replacement surgery the
      effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503
      compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to
      assess the safety of the drug for 9 days after patients completed the double blind period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to undergo standard primary (first-time) one-sided total hip replacement
             surgery due to degenerative joint disease (arthritis), not due to some inflammatory
             process, (eg. infection)

          -  Baseline pain intensity >= 4 on an 11-point (0 to 10) Pain Intensity rating scale,
             rated within 30 minutes before randomization

          -  Women must be postmenopausal, surgically sterile, or practicing or agree to practice
             an effective method of birth control throughout the study

        Exclusion Criteria:

          -  Patients will be excluded from the study if they have a history of seizure disorder or
             epilepsy

          -  history of malignancy within the past 2 years before starting the study

          -  history of alcohol or drug abuse

          -  evidence of active infections that may spread to other areas of the body

          -  clinical laboratory values reflecting moderate or severe kidney insufficiency

          -  currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic
             antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI),
             (selective serotonin reuptake inhibitor [SSRI] treatments are allowed if taken for at
             least 30 days before the screening period of the study at an unchanged dose)
A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; 50 mg etanercept; 80 mg ixekizumab
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Etanercept; Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1346.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to
      etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic
             psoriasis for at least 6 months prior to randomization

          -  At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization

          -  Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and
             Severity Index (PASI) score of at least 12 at screening and at randomization

          -  Candidate for phototherapy and/or systemic therapy

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Pustular, erythrodermic, and/or guttate forms of psoriasis

          -  History of drug-induced psoriasis

          -  Prior use of etanercept

          -  Clinically significant flare of psoriasis during the 12 weeks prior to randomization

          -  Concurrent or recent use of any biologic agent

          -  Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens
             and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had
             topical psoriasis treatment within the previous 2 weeks prior to randomization

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to randomization and during the study

          -  Have participated in any study with interleukin 17 (IL-17) antagonists, including
             ixekizumab

          -  Serious disorder or illness other than plaque psoriasis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers
Condition: Surgery
Intervention: Chlorhexidine gluconate; DynaHex-2; Vehicle
Intervention description: 2% CHG solution on cloth; 2% CHG solution; Excipients of CHG product only
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 340.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preoperative surgical skin preparation

Summary:

      Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on
      the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or Females

          -  18 years of age or older

          -  Signed informed consent

          -  Good Health

          -  Six inches of abdomen and groin areas without tattoos, or skin disorders

        Exclusion Criteria:

          -  Dermatological Conditions

          -  Sensitivity to latex

          -  Sensitivity to CHG
Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol; Methotrexate
Intervention description: Subcutaneous (SC) injection; Methotrexate dose between 6 to 8 mg/week.
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 285.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Certolizumab Pegol; Cimzia

Summary:

      The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as
      add-on medication to methotrexate over the long term in Japanese RA patients transferred from
      Study 275-08-001 (NCT00791999), and to evaluate the effects of different dosing regimens on
      the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20)
      responders who completed Study 275-08-001.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who participated in Study 275-08-001 and meet all of the criteria described
             below.

               -  Patients who did not reach ACR20, and prematurely discontinued Study 275-08-001
                  at Week 16 or completed Study 275-08-001 by Week 24.

               -  Patients who are able to receive treatment with MTX, by Week 52.

        Exclusion Criteria:

          -  Patients who experienced an important protocol deviation as mentioned below during
             Study 275-08-001.

          -  Patients who received live or attenuated vaccines during Study 275-08-001(Except for
             influenza or pneumococcal vaccines).

          -  Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-001.

          -  Patients who required treatment for the same infection at two or more different times
             during Study 275-08-001

          -  Women who are pregnant, are lactating, of childbearing potential and wish to conceive
             during the study and post-study 3 months.

          -  Patients whom the investigator has decided to be inappropriate for participation in
             the study
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ZD4054; Placebo
Intervention description: ZD4054 10 mg oral tablet once daily; Matching placebo oral tablet once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 896.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone Resistant Prostate Cancer; Endothelin A Receptor Antagonist; Endothelin A; Endothelin A antagonist

Summary:

      Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054
      (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

        -  This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054
           (Zibotentan) can improve survival compared with placebo.

        -  ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and
           spread by blocking Endothelin A receptor activity. This trial will look at the effects
           of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone
           metastases.

        -  All patients participating in this clinical trial will receive existing standard
           prostate cancer treatments in addition to trial therapy.

        -  Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive
           placebo in addition to standard prostate cancer therapy. By participating in this trial
           there is a 50% chance that patients will receive an agent that may slow the progression
           of the tumour.

        -  No patients will be deprived of standard prostate cancer therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who answer TRUE to the following criteria may be eligible to participate in this
        trial.

          1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has
             spread to the bone (bone metastases)

          2. Increasing Prostate Specific Antigen (PSA) over a one month period

          3. No pain, or mild pain from prostate cancer

          4. Currently receiving treatment with surgical or medical castration

        Exclusion Criteria:

        Patients who answer TRUE to the following may NOT eligible to participate in this trial.

          1. Currently using opiates based pain killers)

          2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)

          3. Suffering from heart failure or had a myocardial infarction within last 6 months

          4. A history of epilepsy or seizures
Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin 20mg; Placebo; Metformin ≥ 1000 mg
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed as a prospective, multi-centre, parallel group, double-blind
      randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of
      MP-513 (Teneligliptin) in combination with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form obtained from the subject, in accordance.

          -  The subject is aged ≥18 years at signature of the informed consent form.

          -  Hospitalization status: outpatient.

          -  The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3
             months at the screening visit (Day -28).

          -  The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000
             mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and
             diet and exercise regimen has not been changed for at least 8 consecutive weeks at the
             screening visit (Day -28). Subjects who cannot do exercise due to complication are not
             limited to this criteria.

          -  The subject's HbA1c is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day
             -14.

        Exclusion Criteria:

          -  The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.

          -  The subject has received insulin within 1 year prior to the screening visit (Day -28),
             with the exception of insulin therapy during hospitalization or insulin therapy for
             medical conditions not requiring hospitalization (< 2 weeks' duration).

          -  The subject has received an anti-diabetic drug within 8 weeks prior to the screening
             visit (Day -28).
Aripiprazole Once-monthly in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole once-monthly
Intervention description: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      To obtain information on the safety, tolerability and effectiveness of aripiprazole
      once-monthly in a manner consistent with its intended use in everyday clinical practice in
      patients with schizophrenia who completed Study 14724A / NCT01795547.
    

Eligibility criteria:

        Patients will be recruited among those who complete treatment with aripiprazole in Study
        14724A / NCT01795547.

        Inclusion Criteria:

          -  The patient is judged to potentially benefit from 24-week treatment with aripiprazole
             once-monthly according to the clinical opinion of the investigator.

          -  The patient agrees to protocol-defined use of effective contraception.

        Exclusion Criteria:

          -  The patient has been diagnosed with a primary psychiatric disorder other than
             schizophrenia during Study 14724A / NCT01795547.

          -  The patient has a clinically significant unstable illness diagnosed during Study
             14724A / NCT01795547.

          -  The patient is at significant risk of harming himself/herself or others according to
             the investigator's judgement or according to Columbia-Suicide Severity Rating Scale
             (C-SSRS).

          -  The patient has a disease or takes medication that could, in the investigator's
             opinion, interfere with the assessments of safety, tolerability or efficacy, or
             interfere with the conduct or interpretation of the study.

          -  The patient has one or more clinical laboratory test values outside the reference
             range, based on the blood or urine samples taken during the conduct of Study 14724A /
             NCT01795547 that are, in the investigator's opinion, of potential risk to the
             patient's safety.

          -  The patient is, in the investigator's opinion, unlikely to comply with the protocol or
             is unsuitable for any reason.

        Other inclusion and exclusion criteria may apply.
Liothyronine (T3) for Bipolar Depression
Condition: Depression; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Liothyronine (T3); placebo
Intervention description: liothyronine (T3) up to 50 micrograms a day; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: bipolar disorder; depression; treatment; randomized controlled trial

Summary:

      This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with
      bipolar disorder. In this study patients will be randomized to receive T3 or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65;

          2. DSM-IV diagnosis of BP I or BP II as per SCID;

          3. Currently presenting with at least moderate levels of depression (HAM-D > 15;

          4. Patient has to be on stable dose of at least one mood stabilizer (lithium, valproate,
             carbamazepine, lamotrigine, second generation antipsychotics) for at least 4 weeks as
             per history;

          5. Antidepressants and/or additional mood stabilizers are allowed, but dose should be
             stable for at least 2 weeks;

        Exclusion Criteria:

          1. Evidence of acute mania or hypomania (as measured by CARS-M > 7);

          2. Abnormal (outside of lab normal range) thyroid function tests;

          3. Current thyroid hormone treatment;

          4. Any medical condition considered a contraindication for treatment with T3 (i.e.
             history of myocardial infarction, cardiac arrhythmia, severe cardiac insufficiency,
             Autoimmune Thyroid Disease /Hashimoto's Thyroiditis as determined by anti-thyroid
             antibody testing, previous or current thyroid adenoma, hyperthyroidism);

          5. EKG showing rhythm other than sinus or repolarization phase abnormalities;

          6. Current alcohol or substance abuse or dependence in past month as per SCID;

          7. Score of 3 or more on the suicide item of the HAM-D;

          8. Females who are pregnant, breastfeeding, or of childbearing age and not using adequate
             birth control.
Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Diclofenac
Intervention description: 35 mg bid or tid Capsules
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 602.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the
      treatment of osteoarthritis pain of the knee or hip.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ [greater than or equal to] 40 years of age

          -  If a participant in the previous DIC3-08-05 study, completed the study and did not
             discontinue for lack of efficacy or safety

          -  Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain

          -  Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or
             acetaminophen for his/her OA pain and is anticipated to benefit from continuous
             treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a
             subject who has used these treatments for ≥ [greater than or equal to] 20 days of the
             last 30 days before screening

        Exclusion Criteria:

          -  Has a known history of allergic reaction or clinically significant intolerance to
             acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including
             diclofenac

          -  Requires chronic use of opioid or opioid combination products to control OA pain of
             the knee or hip

          -  Has any clinically significant unstable cardiac, respiratory, neurological,
             immunological, hematological, or renal disease

          -  Has significant difficulties swallowing capsules or is unable to tolerate oral
             medication
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Condition: Non-Constipation Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Rifaximin; Placebo
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 623.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IBS; Abdominal pain; Bloating; Diarrhea; Rifaximin

Summary:

      To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in
      providing adequate relief of IBS symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed IBS diagnosis per Rome II for diagnosis of IBS.

          -  Colonoscopy within 2 years as part of IBS diagnostic evaluation.

          -  Has active symptoms of non-constipation IBS at baseline as measured by average daily
             scores for abdominal pain/discomfort, bloating, and stool consistency.

        Exclusion Criteria:

          -  Symptoms of constipation.

          -  History of other gastrointestinal diseases.

          -  Type 1 or 2 diabetes.

          -  Lactose intolerance not controlled by lactose-free diet.