bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain
Condition: Postoperative Delirium; Postoperative Pain; Opioid Use; Hospital Length of Stay
MeSH terms: Delirium; Emergence Delirium
Intervention: Gabapentin
Intervention description: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 750.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: gabapentin; pain; surgery; delirium; cognitive decline

Summary:

      This will be a double blind, placebo-controlled study of patients ≥65 years of age undergoing
      surgery of the spine, hips and knees replacement at the University of California, San
      Francisco (UCSF) Medical Center. Intraoperative anesthetic and postoperative pain management
      will be standardized. Patients will be randomized to receive either placebo or gabapentin
      preoperatively, and continued postoperatively until discharge. Intraoperative anesthetic and
      other postoperative pain management strategies will be standardized. Postoperative delirium
      will be measured using structured interviews. Cognitive function will be measured using a
      battery of neurocognitive tests pre- and post-operatively. Using an intention to treat
      strategy, we, the researchers at UCSF, will compare the incidence of postoperative delirium
      and cognitive dysfunction, the amount of postoperative pain, and narcotic requirements
      between the two groups. The primary outcome will be postoperative delirium. Secondary
      outcomes will be postoperative pain and opioids use, and length of hospital stay, and
      cognitive dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥65 years of age undergoing surgery involving the spine, hip or knee
             replacement.

          -  English speaking.

          -  Anticipated to stay in the hospital for at least 48 hours.

        Exclusion Criteria:

          -  Patients who take gabapentin preoperatively, or have known sensitivity to the drug, or
             those unable to be randomized to receive gabapentin.

          -  Subjects who are unable to provide informed consent.

          -  Patients with a history of narcotic tolerance.

          -  Patients with planned two stage spinal procedures (anterior-posterior spinal fusion to
             be done on two separate days).
A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP 690,550 5 mg; CP 690,550 10 mg; Etanercept 50 mg; Placebo
Intervention description: CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks; CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks; Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks; Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.
Intervention MeSH terms: Etanercept; Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CP-690,550; Etanercept; Moderate; Severe; Chronic; Plaque; Psoriasis; Efficacy; Safety; Tofacitinib; Xeljanz; OPT Compare; OPT; head-to-head; non-inferiority; Psoriasis vulgaris; short-term; Itch; Pruritus; Plaque psoriasis; DLQI

Summary:

      To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550
      for treatment of moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);

          -  Have plaque-type psoriasis covering at least 10% of total body surface area

          -  Considered by dermatologist investigator to be a candidate for systemic therapy or
             phototherapy of psoriasis

        Exclusion Criteria:

          -  Non-plaque or drug induced forms of psoriasis

          -  Cannot discontinue current systemic and/or topical therapies for the treatment of
             psoriasis

          -  Cannot discontinue phototherapy

          -  Any uncontrolled significant medical condition
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
Condition: Adenomatous Polyposis Coli
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Intervention: Celecoxib; Placebo
Intervention description: celecoxib, 16 mg/kg/day, for 5 years; Masked, placebo comparator
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: FAP

Summary:

      To test whether celecoxib can be used to prevent colon polyp formation in children with
      familial adenomatous polyposis (FAP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 10-17 years

          -  Confirmed deleterious FAP genotype based on central genetic testing or personal
             history ot >2 colorectal adenomas and a parent with the diagnosis of FAP and either A,
             B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal
             history of colorectal adenomas and a first degree relative with FAP C: No genotype
             identified with a personal history of > 2 adenomas and have a parent with FAP

          -  Less than 30 polyps, which need to be removed to render the colon polyp-free before
             study drug can be given

        Exclusion Criteria:

          -  Diagnosis of attenuated FAP based on central genetic testing in the absence of a
             personal history of >2 colorectal adenomas and a first degree relative (parent or
             sibling) with FAP.

          -  Sensitivity to COX-2 inhibitors
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: ABT-712; Placebo
Intervention description: ABT-712 extended-release tablet; Placebo tablet
Intervention MeSH terms: Acetaminophen; Hydrocodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Effect on sleep interference by pain

Summary:

      The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of
      ABT-712, compared to placebo, administered over a 4-week period in participants with moderate
      to severe mechanical chronic low back pain (CLBP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects who voluntarily sign the informed consent

          -  Diagnosis of CLBP of 6 months duration

        Exclusion Criteria:

          -  Incapacitated or bedridden subjects

          -  Subjects with history of surgical or invasive intervention
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Condition: Hormone Refractory Prostate Cancer; Bone Metastases
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Intervention: Radium-223 dichloride (Xofigo, BAY88-8223); Placebo; Best standard of care (BSoC)
Intervention description: Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.; Isotonic saline 6 IV administrations separated by 4 weeks intervals.; Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.
Intervention MeSH terms: Radium Ra 223 dichloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 921.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone Refractory Prostate Cancer; Bone Metastases; Radium-223

Summary:

      ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical
      study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone
      refractory prostate cancer and skeletal metastases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate

          -  Known hormone refractory disease

          -  Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy

          -  No intention to use cytotoxic chemotherapy within the next 6 months

          -  Either regular (not occasional) analgesic medication use for cancer related bone pain
             or treatment with EBRT (External Beam Radiation Therapy) for bone pain

        Exclusion Criteria:

          -  Treatment with an investigational drug within previous 4 weeks, or planned during the
             treatment period

          -  Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and
             where docetaxel is available

          -  Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the
             treatment period, or failure to recover from adverse events due to cytotoxic
             chemotherapy administered more than 4 weeks ago

          -  Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for
             the treatment of bony metastases within previous 24 weeks

          -  Other malignancy treated within the last 5 years (except non-melanoma skin cancer or
             low-grade superficial bladder cancer)

          -  History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic
             CT or chest x-ray within previous 8 weeks
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Glatiramer Acetate (GA) 40 mg; glatiramer acetate 20 mg
Intervention description: Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months; Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1155.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the
      treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA),
      a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug
      that has anti inflammatory and neuroprotective properties. The study treatment duration is 12
      months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.

          2. Subjects must be of the relapsing-remitting (R-R) type.

          3. Subject has experienced prior to screening at least one documented relapse in 12
             months or at least 2 documented relapses in the 24 months or one documented relapse
             between 12 - 24 months with at least 1 documented T1-Gd enhancing lesion in the MRI
             performed 12 months prior screening.

          4. Disease duration for at least 6 months.

          5. Ambulatory with converted Kurtzke EDSS score of 0 - 5.

          6. Relapse free and stable neurological condition at least for 30 days prior screening.

          7. Age - 18-55 (inclusive)

        Exclusion Criteria:

          1. Previous use of Copaxone (glatiramer acetate)

          2. Treatment with corticosteroids within 30 days prior screening or between screening and
             baseline.

          3. Chronic corticosteroids treatment - more than 30 consecutive days.

          4. Subject with any clinically significant or unstable medical condition.

          5. Subjects participating in any other clinical trial (within 12 weeks prior to screening
             and thereafter).

          6. Known history of sensitivity to Gadolinium and inability to successfully undergo MRI
             scanning.
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Intervention: Lafutidine; Famotidine; Omeprazole
Intervention description: Lafutidine 20mg/day; Famotidine 40mg/day; Omeprazole 20mg/day
Intervention MeSH terms: Omeprazole; Famotidine; Lafutidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 495.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux
             esophagitis according to the Los Angeles classification

        Exclusion Criteria:

          -  Gastric or duodenal ulcers (excluding ulcer scars)

          -  Concurrent presence of Barrett's esophagus

          -  A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks

          -  Other conditions considered by the attending physician to potentially affect the
             assessment of efficacy and safety
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Intervention: Esomeprazole
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 32.0
Sex: All
Maximum age: 1 Month
Healthy volunteers: No
Keywords: neonates; infants; GERD; reflux

Summary:

      The purpose of this study is to assess the difference between esomeprazole and placebo in the
      treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring
      in neonatal patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Full-term or gestational age >/= 28 to 44 weeks

          -  In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent

          -  Patient must be on a stable mode of feeding or with minimal variations for at least 2
             days prior to randomization

        Exclusion Criteria:

          -  Patients with a need for resectional or reconstructive surgery of the gastrointestinal
             tract

          -  Patients with any condition that may require surgery during the course of the study

          -  Patients with acute respiratory distress within 72 hours prior to enrollment
Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Warfarin; Rivaroxaban placebo; Warfarin placebo
Intervention description: Participants orally administered rivaroxaban 15 mg OD (CrCL [creatinine clearance] >= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min); Participants orally administered a warfarin potassium tablet (INR [international normalized ratio] target was 1.6-2.6 for patients >70 years and 2.0-3.0 for patients <70 years); Participants orally administered a rivaroxaban placebo tablet; Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)
Intervention MeSH terms: Warfarin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1280.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: BAY59-7939; Rivaroxaban; Non-Valvular Atrial Fibrillation; Japanese Patients; Phase III; 12620

Summary:

      This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke
      prevention in patients with atrial fibrillation (originally described in Japanese).
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 years or older

          -  Japanese male or female

          -  Non- valvular atrial fibrillation documented by ECG

          -  Patients with a risk of stroke and non-CNS systemic embolism

        Exclusion Criteria:

          -  Significant mitral stenosis

          -  Patients in whom anticoagulants are contraindicated
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine 10 mg/day; Vortioxetine 20 mg/day; Fluoxetine 20mg/day; Placebo
Intervention description: 10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed; Encapsulated tablet, orally
Intervention MeSH terms: Vortioxetine; Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 683.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: paediatric

Summary:

      Investigation of the efficacy and safety of a new potential treatment of Major depressive
      disorder (MDD) in paediatric participants (age 7 to 11 years).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of
             Mental Disorders, 5th Edition (DSM-5™).

          2. The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.

          3. The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.

          4. The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit

          5. The participant has provided assent to participation and parent(s)/legal
             representative (s) signed the Informed Consent Form.

        Exclusion Criteria:

          1. The participant has participated in a clinical study <30 days prior to the Screening
             Visit.

          2. The participant has previously participated in a study with vortioxetine.

        Other protocol defined inclusion and exclusion criteria may apply
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Octreotide acetate 30 mg suspension
Intervention description: Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: acromegaly; octreotide acetate; partial responder patients

Summary:

      This study evaluated the safety and efficacy of an increased frequency of octreotide acetate
      injections or an increase in dose in partially responsive acromegalic patients with
      persistently uncontrolled disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written voluntary informed consent.

          -  Patients with biochemically documented active acromegaly who are currently receiving
             somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28
             days; lanreotide up to 120 mg/28 days) for at least 6 months.

          -  Patients with uncontrolled disease defined as patients with a decrease of baseline
             levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a
             conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28
             days) for at least 6 months.

          -  Baseline (mean of 3 samples) GH level > 2 µg/L.

          -  Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age
             and gender.

        Other protocol-defined inclusion/exclusion criteria applied to the study.