bioihbjkbjnl/mcl2 huggingface dataset:
Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
Condition: Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Intervention: Radio-radial fixator; Percutaneous pinning
Intervention description: Using the Distal Radius Fixator from Synthes. A single splint for 5 days.; Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Radius fractures; Radio-radial fixator; Percutaneous pinning; Grip strength

Summary:

      The treatment of extra-articular distal radius fractures is still controversial. In Canada,
      most patients with unstable fractures are treated with pinning and cast. Results are often
      associated with shortening and lack of function.

      The purpose of the study is to compare stabilization with a radio-radial fixator to the usual
      method, suggesting that the radio-radial fixator will provide more strength at 6 months
      follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Distal radius fracture Frykman I or II

          -  Unstable fracture according to Lafontaine's criteria

          -  Fracture line more than 1cm form the joint line

          -  Closed fracture

          -  Age > 18 years

          -  Surgery performed between 72 hours from the trauma

          -  Monotrauma

          -  Patient signed the informed consent

        Exclusion Criteria:

          -  Distal radius fracture Frykman III-VI (intra-articular fracture)

          -  Open fracture

          -  Polytraumatism

          -  Stable or non-displaced fracture
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: RPC1063; Placebo
Intervention MeSH terms: Ozanimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1012.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether RPC1063 is effective in the treatment of
      Ulcerative Colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 to 75 years (at screening for Cohort 1 and 2)

          -  UC confirmed on endoscopy

          -  Moderately to severely active UC (May score 6-12)

          -  Currently receiving treatment with aminosalisylate, prednisone, or budesonide

          -  Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be
             stopped prior to randomization

        Exclusion Criteria:

          -  Have severe extensive colitis as evidence by:

          -  Physician judgment that the patient is likely to require colectomy or ileostomy within
             12 weeks of baseline.

          -  Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or
             bowel perforation.

          -  Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD
             or microscopic colitis, radiation colitis, or ischemic colitis

          -  Clinically relevant cardiovascular conditions or other relevant diseases that could
             impact the implementation or interpretation of the trial, or put the patient at risk

          -  History of uveitis or unknown macular edema

          -  Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG)
             measured during screening
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Finerenone (BAY94-8862); Placebo
Intervention description: 10 mg or 20 mg Finerenone tablet to be given orally, once daily.; Matching placebo to be taken orally, 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: 7352.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; Kidney diseases

Summary:

      The purpose of this study was to evaluate whether oral finerenone (study drug), in addition
      to standard daily therapy, is effective and safe in treating patients with type 2 diabetes
      mellitus and diabetic kidney disease, when compared to a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women ≥18 years of age

          -  Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes
             Association

          -  Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent
             very high albuminuria at the Run-In and Screening Visit

          -  Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin
             receptor blocker (ARB) at maximal tolerated labeled dose without adjustments

          -  Serum potassium <=4.8 mmol/L

        Exclusion Criteria:

          -  Confirmed significant non-diabetic renal disease, including clinically relevant renal
             artery stenosis

          -  Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP)
             ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or
             mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)

          -  Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and
             persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit
             [class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)]

          -  Dialysis for acute renal failure within 12 weeks of Run-in visit

          -  Renal allograft in place or scheduled kidney transplant within next 12 months

          -  Glycated hemoglobin (HbA1c) >12%
Acute Renal Failure Trial Network (ATN) Study
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Intervention: renal replacement therapy
Intervention description: renal replacement therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Renal Failure; Renal Replacement Therapy; multi-site randomization trial; Hemodialysis; Hemofiltration; Critical Illness; Hemodiafiltration

Summary:

      This is a multi-center, prospective, randomized, parallel-group trial of an intensive
      strategy vs conventional strategy of renal replacement therapy for the treatment of acute
      renal failure secondary to acute tubular necrosis in critically ill patients. The primary
      hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10%
      compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to
      45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality,
      1-year all cause mortality, and recovery of renal function by day 28. The study will recruit
      1164 patients over a period of 3 years, 8 months and each patient will be actively followed
      for 60 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute renal failure clinically consistent with a diagnosis of acute tubular necrosis

          -  Plan for renal replacement therapy by clinical team

          -  Receiving care in a critical care unit

          -  One non-renal organ failure or sepsis

          -  Age 18 or older

          -  Patient or surrogate provides informed consent

        Exclusion Criteria:

          -  Baseline serum creatinine > 2 mg/dL (177 mol/L) in males, > 1.5 mg/dL (133 mol/L) in
             females

          -  Acute renal failure clinically believed to be due to an etiology other than acute
             tubular necrosis

          -  More than 72 hours since meeting both of the following conditions:

               1. Fulfillment of the definition of ARF; and

               2. BUN > 100 mg/dL (36 mmol/L)

          -  More than 1 hemodialysis treatment or more than 24 hours since starting continuous
             renal replacement therapy

          -  Prior kidney transplant

          -  Pregnancy

          -  Prisoner

          -  Weight > 128.5 kg

          -  Non-candidacy for renal replacement therapy

          -  Moribund state

          -  Patient not expected to survive 28 days because of underlying terminal chronic medical
             condition

          -  Comfort-measures-only status

          -  Participation in a concurrent interventional study

          -  Patient/surrogate refusal

          -  Physician refusal
MabionCD20 Compared to MabThera in Lymphoma Patients
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Rituximab; Doxorubicin; Vincristine; Cyclophosphamide; prednisone
Intervention description: 375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.; 50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle; 1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle; 750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle; 100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20
      (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients
      with CD20-positive diffuse large B-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histological confirmed CD20 (cluster of differentiation 20) positive
             diffuse large B cell lymphoma (DLBCL)

          2. Patients that had been diagnosed according to the WHO classification;

          3. Performance status ≤ 2 on the ECOG (Eastern Cooperative Oncology Group) / WHO (world
             Health Organization) scale, performance status of 3 will be accepted if impairment is
             caused by DLBCL complications and improvement is expected once therapy is initiated;

        Exclusion Criteria:

          1. Life expectance less than 6 months;

          2. Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal
             therapy for treatment of lymphoma within 28 days prior to treatment;

          3. Rituximab, other anti-CD20 mAb (Monoclonal Antibodies) drug treatment, treatment with
             any cell depleting therapies - e.g., anti-CD4 (cluster of differentiation 4) anti-CD5
             (cluster of differentiation 5), anti-CD3 (cluster of differentiation 3), anti-CD19
             (cluster of differentiation 19), anti CD11 (cluster of differentiation 11), anti-CD22
             (cluster of differentiation 11), BLys/BAFF (B Lymphocyte Stimulator/B-cell activating
             factor) within 1,5 years before screening;
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Pregabalin
Intervention description: Orally-administered pregabalin
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability

Summary:

      The study will evaluate the long-term safety and tolerability of pregabalin in pediatric
      patients, age 1 month through 16 years, with partial onset seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Partial onset seizures, incompletely controlled on 1-3 medications

          -  At least 1 seizure per 28 days, on average

          -  Completion of study A0081074

        Exclusion Criteria:

          -  Primary generalized seizures

          -  Progressive CNS pathology

          -  Failure to tolerate pregabalin in study A0081074
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Ocular Hypertension
Intervention: Bimatoprost; Lumigan®
Intervention description: Eyedrops; Eyedrops
Intervention MeSH terms: Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent signed and dated.

          -  Both eyes with diagnosed open-angle glaucoma or ocular hypertension

        Exclusion Criteria:

          -  History of trauma, infection, clinically significant inflammation within the 3
             previous months.

          -  Uncontrolled diabetic patient.

          -  Pregnancy or breast feeding.
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Triptorelin (Decapeptyl®)
Intervention description: One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 339.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally advanced or metastatic Prostate Cancer

Summary:

      The purpose of this study is to evaluate the effect of an initial hormonal treatment
      gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in
      patients with histologically confirmed and advanced stages of prostate cancer. Their
      characteristics, according to risk factors such as PSA and Gleason score will be determined
      at baseline and 1, 3 and 6 month post-treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve
             to androgen deprivation therapy, and a candidate for hormonal treatment.

          -  An estimated survival time of at least twelve months according to the investigator's
             assessment.

          -  A performance status score ≤ 2 according to the World Health Organisation (WHO)
             criteria.

        Exclusion Criteria:

          -  Previous surgical castration.

          -  Previous or has planned curative prostate cancer therapy (radiation/surgery)

          -  Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)

          -  Patients with risk of a serious complication in the case of tumour flare (vertebral
             metastases threatening spinal cord compression or significant obstructive uropathy)
Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
Condition: Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident
MeSH terms: Stroke; Myocardial Infarction; Atherosclerosis; Infarction; Ischemia
Intervention: Vorapaxar 2.5 mg; Placebo
Intervention description: Vorapaxar 2.5 mg oral tablet; matching placebo oral tablet
Intervention MeSH terms: Vorapaxar
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in
      participants with established atherosclerotic disease who are enrolled into the TRA 2°P -
      TIMI 50 Study (P04737) (NCT00526474).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence or a history of atherosclerosis involving the coronary, cerebral, or
             peripheral vascular systems

        Exclusion Criteria:

          -  The study will include participants who meet none of the exclusion criteria for the
             parent protocol (P04737) and also the following:

               -  history or evidence of age-related macular degeneration on baseline evaluation

               -  history of diabetic macular edema, or evidence of treated diabetic retinopathy on
                  baseline evaluation

               -  history or evidence of other retinal diseases, including retinal injury, on
                  baseline evaluation

               -  history or evidence of retinal surgery, including laser photocoagulation, on
                  baseline evaluation

               -  history or evidence of glaucoma on baseline evaluation

               -  history or evidence of high intraocular pressure of >22 mm Hg on baseline
                  evaluation

               -  evidence of center foveal thickness of >190 µm on baseline OCT examination

               -  presence of vacuoles in the retina on baseline OCT
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Fostamatinib Disodium; Placebo
Intervention description: Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.; Placebo tablet PO bid (morning and evening)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether fostamatinib is safe and effective in the
      treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of persistent/chronic ITP for at least 3 months

          -  Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue
             therapy) from at least 3 qualifying counts

        Exclusion Criteria:

          -  Clinical diagnosis of autoimmune hemolytic anemia

          -  Uncontrolled or poorly controlled hypertension

          -  History of coagulopathy including prothrombotic conditions
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: TNX-102 SL; Placebo SL Tablet
Intervention description: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
Intervention MeSH terms: Cyclobenzaprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Sleep; Fibromyalgia; FM

Summary:

      This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken daily at bedtime for the treatment of fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is male or female 18 to 65 years of age, inclusive.

          -  The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the
             2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology
             Preliminary Diagnostic Criteria)

          -  The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit
             within protocol defined range.

        Exclusion Criteria:

        - History of or evidence for a diagnosis of borderline personality disorder (BPD).