bioihbjkbjnl/mcl2 huggingface dataset:
Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial
Condition: Hemorrhagic Shock
MeSH terms: Shock, Hemorrhagic
Intervention: Whole blood
Intervention description: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      Despite advances in trauma resuscitation, a paucity of therapeutic interventions are
      available early enough to reduce the downstream morbidity and mortality attributable to
      hemorrhage, shock and coagulopathy. Due to the time sensitive nature of the treatment of
      hemorrhage, the ideal resuscitation intervention would entail use of a blood product
      containing all essential hemostatic components, closest to time of injury, where prevention
      or reversal of the devastating downstream consequences of shock and coagulopathy can occur.
      This proposal will characterized the efficacy of whole blood resuscitation initiated in the
      prehospital setting to patients in hemorrhagic shock which represents this ideal intervention
      post-injury. These results will have great potential to dramatically change the way trauma
      resuscitation occurs today.
    

Eligibility criteria:

        Inclusion Criteria:

        Injured patients being transport via an air medical service with hypotension (SBP =/<
        90mmHg with tachycardia >108 OR SBP=/<70 without the tachycardia requirement)

        Exclusion Criteria:

        Age < 18 or > 89 years

        Isolated fall from standing injury mechanism

        Brain matter exposed or penetrating brain injury (GSW)

        CPR > 5 mins with out ROSC

        Isolated burns without evidence of traumatic injury

        Isolated Drowning or Hanging

        No Intravenous or Intraosseous access

        Known prisoner or known pregnancy

        Referral Hospital Admission

        Wearing No PPOWER bracelet

        Objection to study voiced by subject or family at scene
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: capecitabine [Xeloda]; Taxotere; Taxotere
Intervention description: 825mg/m2 po bid on days 1-14 of each 3 week cycle; 75mg/m2 iv on day 1 of each 3 week cycle; 100mg/m2 iv on day 1 of each 3 week cycle
Intervention MeSH terms: Capecitabine; Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2611.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere
      alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer.
      Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either
      1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle
      or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study
      treatment is until disease progression, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients 18-70 years of age;

          -  adenocarcinoma of the breast;

          -  previous invasive breast cancer if diagnosed >5 years before entering study;

          -  no evidence of metastatic disease.

        Exclusion Criteria:

          -  history of severe hypersensitivity reaction to Taxotere;

          -  previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;

          -  treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
Safety and Efficacy of Cariprazine for Mania
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: Cariprazine; Placebo
Intervention description: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute Mania; Bipolar I Disorder

Summary:

      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes
      associated with bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as
             confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual
             of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without
             psychotic symptoms

          -  Voluntarily hospitalized for current manic episode

          -  Patients with normal physical examination, laboratory, vital signs,and/ or
             electrocardiogram (ECG)

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
             disorder that was the primary focus of treatment within the previous six months
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Cadazolid; Vancomycin; Cadazolid-matching placebo; Vancomycin-matching placebo
Intervention description: Cadazolid 250 mg as oral suspension twice daily.; Vancomycin 125 mg as oral capsules 4 times daily; Placebo matching cadazolid and administered orally twice daily; Placebo capsules matching vancomycin and administered orally 4 times per day
Intervention MeSH terms: Vancomycin; Oxazolidinones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 631.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile infection; Post-antibiotic diarrhea

Summary:

      This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin
      in subjects with Clostridium difficile-associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent.

          -  Male or female ≥ 18 years of age. Females of childbearing potential must agree to use
             an adequate and reliable method of contraception.

          -  Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first
             recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid
             or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive
             C. difficile toxin test on a stool sample produced within 72 hours prior to
             randomization.

        Exclusion Criteria:

          -  More than one previous episode of CDAD in the 3-month period prior to randomization.

          -  Evidence of life-threatening or fulminant CDAD.

          -  Likelihood of death within 72 hours from any cause.

          -  History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.

          -  Antimicrobial treatment active against CDAD administered for > 24 hours except for
             metronidazole treatment failures (MTF)

          -  Known hypersensitivity or contraindication to study drugs, oxazolidinones, or
             quinolones.

          -  Unable or unwilling to comply with all protocol requirements.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             full participation in the study or compliance with the protocol
Phase III Insulin Add-On Asia Regional Program - ST
Condition: Diabetes
Intervention: Dapagliflozin; Dapagliflozin Placebo
Intervention description: Tablet; Tablet
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 477.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose is to determine if after 24 weeks of oral daily administration, there will be a
      greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with
      Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2
      diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c
             ≥ 7.5% and ≤ 11.0% obtained at screening visit

          -  Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at
             least 8 weeks prior to enrollment

        Inclusion criteria for randomization:

        HbA1c ≥ 7.5 and ≤ 10.5% at Day -14

        Exclusion Criteria:

          -  Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of
             Enrollment

          -  History of diabetic ketoacidosis of hyperosmolar nonketotic coma

          -  Clinically diagnosed Type 1 diabetes mellitus

          -  Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV

          -  Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg
             and/or diastolic blood pressure (DBP) ≥ 110 mmHg

          -  History of unstable or rapidly progressing renal disease

          -  History of severe hepatobiliary disease

          -  Mallingancy within 5 years of the screening/enrollment visit
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
Condition: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Obinutuzumab; Bendamustine; Venetoclax
Intervention description: Administered via intravenous infusion; Administered via intravenous infusion; The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. Participants were instructed to take venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.
Intervention MeSH terms: Venetoclax; Bendamustine Hydrochloride; Obinutuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Cancer; Chronic Lymphocytic Leukemia; 17p Deletion; Debulking; Obinutuzumab; Bendamustine; Tumor lysis syndrome; Venetoclax; Small Lymphocytic Lymphoma

Summary:

      This is a multi-cohort, open-label study in previously untreated participants with chronic
      lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p
      deletion, to evaluate a debulking strategy that would enable all participants to receive
      subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate hematology, kidney and liver function as described in the protocol

          -  Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic
             lymphoma (SLL) according to 2008 Modified International Workshop on Chronic
             Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG)
             criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1

          -  CLL requires treatment according to the IWCLL criteria

          -  Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count
             [ALC] ≥ 25 × 10^9/L) OR High tumor burden (any LN ≥ 10 cm OR ALC ≥ 25 × 10^9/L and LN
             ≥ 5 cm)

        Exclusion Criteria:

          -  Presence of 17p deletion at Screening

          -  Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or
             Hodgkin's lymphoma)

          -  Prolymphocytic leukemia
An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol; Placebo
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/mL
Route of Administration: Subcutaneous use; Active Substance: Placebo
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 0.9 % saline
Route of Administration: Subcutaneous use
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia; Psoriasis

Summary:

      The purpose of this study is to investigate the efficacy and safety of two dose levels of
      certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when
      administered every 2 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided informed consent

          -  Adult men or women >= 18 years

          -  Chronic plaque psoriasis for at least 6 months

          -  Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and
             Physician's Global Assessments score >= 3

          -  Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Erythrodermic, guttate, generalized pustular form of psoriasis

          -  History of current, chronic, or recurrent infections of viral, bacterial, or fungal
             origin as described in the protocol

          -  Congestive heart failure

          -  History of a lymphoproliferative disorder including lymphoma or current signs and
             symptoms suggestive of lymphoproliferative disease

          -  Concurrent malignancy or a history of malignancy as described in the protocol

          -  History of, or suspected, demyelinating disease of the central nervous system (e.g.,
             multiple sclerosis or optic neuritis)

          -  Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
             study or within 5 months following last dose of study drug (in Czech Republic and
             Germany) and within 3 months for all other countries. Male subjects who are planning a
             partner pregnancy during the study or within 10 weeks following the last dose of study
             drug

          -  Any other condition which, in the Investigator's judgment, would make the subject
             unsuitable for participation in the study

          -  Other protocol-defined exclusion criteria may apply
Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
Condition: Pediatric Crohn's Disease
MeSH terms: Crohn Disease
Intervention: TA-650
Intervention description: TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Infliximab; REMICADE; TA-650; pediatric Crohn's disease

Summary:

      The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's
      Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease
      after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after
      week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and
      pharmacokinetics are also evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have been diagnosed as Crohn's disease at least 3 months prior to
             screening.

          -  Have active Crohn's disease despite adequate conventional therapy.

        Exclusion Criteria:

          -  Patients with severe intestinal strictures (strictures which may affect the number of
             defecations, etc., or dilation of the colon or strictures in the proximal small bowel
             observed on barium radiograph, or strictures precluding the insertion of endoscope), a
             diagnosis of short bowel syndrome, or previous stoma surgery.

          -  Patients who have a history of treatment with infliximab, or biological products
             (anti-TNFα agents and anti-IL-6 agents, etc.).
Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; insulin glargine
Intervention description: Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.; Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart
      (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with
      metformin + at least one OAD (oral anti-diabetic drug).

      The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension
      period is registered as NN5401-3726.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For MAIN period (NN5401-3590):

          -  Diagnosis of type 2 diabetes mellitus for at least 6 months

          -  Insulin naïve subjects

          -  Treatment with metformin and at least one other oral antidiabetic drug for at least 3
             months before trial start

          -  Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)

          -  Body Mass Index (BMI) no higher than 40.0 kg/m^2

          -  For EXTENSION period (NN5401-3726):

          -  Informed consent obtained before any trial-related activities

          -  Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

        Exclusion Criteria:

          -  For MAIN period (NN5401-3590):

          -  Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or
             thiazolidinedione(s) within the last 3 months prior to trial start

          -  Cardiovascular disease diagnosed within 6 months before trial start

          -  For EXTENSION period (NN5401-3726):

          -  Anticipated change in concomitant medication known to interfere significantly with
             glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase
             (MAO) inhibitors

          -  Anticipated significant lifestyle changes during the trial, e.g. shift work (including
             permanent night/evening shift workers), as well as highly variable eating habits as
             judged by the physician)

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements
A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: epoetin beta [NeoRecormon]; epoetin beta [NeoRecormon]
Intervention description: Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.; Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to <10.5 g/dL had occurred.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 605.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate whether anemia prevention with NeoRecormon has an additional impact
      on reducing cardiovascular risk over conventional anemia treatment in patients mostly with
      stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is
      2+ years and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  not receiving renal replacement therapy.

        Exclusion Criteria:

          -  women who are pregnant or lactating;

          -  previous treatment with erythropoietin or other erythropoietic substance;

          -  blood transfusion within the last 3 months;

          -  need for dialysis expected in the next 6 months;

          -  administration of another investigational drug within 30 days preceding study start,
             or during the study.