bioihbjkbjnl/mcl2 huggingface dataset:
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
Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma
Condition: Osteoarthritis
MeSH terms: Hemorrhage
Intervention: Group 1 Tranexamic Acid; Group 2 Platelet rich plasma
Intervention description: 2 gr of tranexamic acid will be applied on the surgical site.; 16ml of platelet rich plasma will be applied of the surgical site
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Blood loss; Tranexamic acid; Platelet rich plasma; Total knee arthroplasty

Summary:

      The investigators will include patients who will be schedule for total knee arthroplasty with
      a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a
      verbal and clear detailed information will be given on the intraoperative approach. The first
      group will receive topical tranexamic acid and the second group topical platelet rich plasma;
      both in the surgical site. Both groups will be assessed before and after the intervention
      with laboratory results (hemoglobin, hematocrit levels) and drainage drain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18 years

          2. Patient candidates for primary total knee replacement

          3. Patients willing to participate in the study and sign de inform consent

        Exclusion Criteria:

          1. Patients with previous history of thromboembolic event in the last 6 months

          2. Patients candidates for revision total knee replacement

          3. Patients candidates for tumoral total knee replacement

          4. Patients candidates for bilateral total knee replacement

          5. Patient with cognitive deficit

          6. Previous history of coagulopathy
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551 Foam; Vehicle Foam
Intervention description: 122-0551 Foam applied twice daily to treat psoriasis; Vehicle Foam applied twice daily to treat psoriasis
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study has been designed to determine and compare the efficacy and safety of
      122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%
             and no more than 12% affected body surface area.

          -  Subject has an Investigator's Global Assessment (IGA) score of at least three
             (moderate) at study start.

          -  If subject is a woman of childbearing potential, she must have a negative urine
             pregnancy test and agree to use an effective form of birth control for the duration of
             the study.

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          -  Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk
             by study participation.

          -  Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
             of photo based therapy for the treatment of their psoriasis within 30 days prior to
             study start.

          -  Subject has used any systemic methotrexate, retinoids, systemic corticosteroids
             [including intralesional, intra-articular, and intramuscular corticosteroids],
             cyclosporine or analogous products within 90 days prior to study start.

          -  Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental
             therapy) within five half-lives of the biologic prior to study start.
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: BMS-936558 (Nivolumab); Placebo matching BMS-936558 (Nivolumab); Dacarbazine; Placebo matching Dacarbazine
Intervention MeSH terms: Nivolumab; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the clinical benefit, as measured by overall
      survival, of nivolumab with that of. dacarbazine in patients with previously untreated,
      unresectable, or metastatic melanoma
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women ≥18 years of age

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as
             per the staging system of the American Joint Committee on Cancer

          -  Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1

          -  Tumor tissue from an unresectable or metastatic site of disease must be provided for
             biomarker analyses

          -  Known BRAF wild-type, as per regionally acceptable V600 mutational status testing.
             BRAF mutant patients and those with indeterminate or unknown BRAF status are not
             permitted to randomize

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases

          -  Ocular melanoma

          -  Any active, known, or suspected autoimmune disease
BAX 326 (rFIX) Continuation Study
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: BAX 326 (Recombinant factor IX)
Intervention description: The treatment with BAX 326 will be at the discretion of the investigator and will consist of either twice weekly prophylactic treatment with 50 IU/kg, modified prophylaxis, or on-demand treatment.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery
      over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of
      life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately
      severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric
      study 251101.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Subject and/or legal representative has/have voluntarily provided signed informed
             consent

          -  Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical
             study 251101 (pediatric study)

          -  Subject was 12 to 65 years old at the time of screening for Study 250901 or < 12 years
             old at the time of screening for Study 251101

          -  Subject has severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B
             (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested
             at screening at the central laboratory

          -  Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study
             250901 or Pediatric Study 251101

        Main Exclusion Criteria:

          -  Subject received factor IX product(s) other than BAX 326 upon completion of Baxter
             Pivotal Study 250901 or Pediatric Study 251101

          -  Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B

          -  For subjects transferring from Pivotal Study 250901: Subject's weight is < 35 kg or >
             120 kg

          -  Subject is planned to take part in any other clinical study, with the exception of BAX
             326 Surgery study as described in this protocol, during the course of the Continuation
             Study
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: otelixizumab infusion plus physician determined standard of care; placebo infusion plus physician determined standard of care
Intervention description: infusion; infusion
Intervention MeSH terms: Muromonab-CD3
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Type 1 diabetes; new onset type 1 diabetes; T1DM; Type l diabetes; juvenile diabetes

Summary:

      The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads
      to greater improvement in insulin secretion as compared with placebo infusion. Insulin
      secretion will be assessed using mixed meal-stimulated C-peptide.

      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3
      otelixizumab, 1/3 placebo). These study agents will be administered as an addition to
      insulin, diet, and other physician determined standard of care treatments.

      DEFEND-1 is now closed to enrollment.

      DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require
      subjects with new onset type 1 diabetes. Please check back here for more details.

      In the meantime, established and new onset type 1 diabetes patients in North America are
      welcome to consider the TTEDD study:

      http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD&rank=1
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 12-45

          -  Diagnosis of diabetes mellitus, consistent with ADA criteria

          -  No more than 90 days between diagnosis and administration of study compounds

          -  Requires insulin for type 1 diabetes mellitus, or has required insulin at some time
             between diagnosis and administration of study compounds.

          -  Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50
             nmol/L

          -  Positive for one or more of the autoantibodies typically associated with T1DM:
             antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine
             phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin
             autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and
             negative for the other autoantibodies will only be eligible if the subject has used
             insulin for less than 7 days total.

        Exclusion Criteria:

          -  Other, significant medical conditions based on the study doctor's evaluation
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: CT-P13 SC (Infliximab); Placebo SC
Intervention description: Subcutaneous injection of CT-P13 SC; Subcutaneous injection of Placebo SC
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 548.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC
      over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female aged 18 to 75 years, inclusive.

          -  Patient has moderately to severely active UC with a modified Mayo score of 5 to 9
             points with endoscopic subscore of ≥ 2 points

        Exclusion Criteria:

          -  Patient who has previously received 2 or more biologic agents and/or JAK inhibitors

          -  Patient who has previously received either a TNFα inhibitor or biologic agent within 5
             half-lives
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Condition: Agitation in Patients With Dementia of the Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation
Intervention: AVP-786; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sequential parallel comparison design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Agitation; Dementia; Alzheimer's disease

Summary:

      Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of
      probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for
      Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association
      (AA) workgroups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National
             Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria

          -  The participant has clinically significant, moderate/severe agitation at the time of
             screening and for at least 2 weeks prior to randomization

          -  The diagnosis of agitation must meet the International Psychogeriatric Association
             (IPA) provisional definition of agitation

          -  Either out patients or residents of an assisted-living facility or a skilled nursing
             home

          -  Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is
             >= 4 (moderately ill) at screening and baseline

          -  Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at
             screening and baseline

          -  Caregiver who is able and willing to comply with all required study procedures. In
             order to qualify as a reliable informant (i.e., caregiver) capable of assessing
             changes in participant's condition during the study, the individual must spend a
             minimum of 2 hours per day for 4 days per week with the participant.

        Exclusion Criteria:

          -  Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular
             dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)

          -  Participants with co-existent clinically significant or unstable systemic diseases
             that could confound the interpretation of the safety results of the study (e.g.,
             malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable
             pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated
             cardiomyopathy, or unstable valvular heart disease)

          -  Participant with myasthenia gravis
Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery
Condition: Cardiac Complication During Procedure
Intervention: Fibrinogen
Intervention description: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibrinogen; cardiac surgery; high risk; cardiopulmonary bypass; bleeding; blood transfusion

Summary:

      The aim of the study is to show that first line treatment with concentrated fibrinogen has
      superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and
      cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        All patients who are scheduled for elective complex cardiac surgical procedures including

          -  double procedures (aortic valve replacement (AVR)+CABG, mitral valve
             repair/replacement (MVR)+CABG, AVR+MVR)

          -  Redo-sternotomies

          -  Aortic root repair +/- AVR

        Exclusion Criteria:

          -  Any known congenital or pre-existing bleeding disorder

          -  pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)

          -  severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150
             U/l)

          -  inability to provide informed consent

          -  emergency surgery

          -  pregnancy or nursing

          -  age under 18 years

          -  intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)

          -  allergy to concentrated fibrinogen or other components in the product

          -  anemia (Hgb < 110)

          -  diagnosed deep vein thrombosis (DVT)

          -  pulmonary embolism

          -  acute stroke

          -  acute myocardial infarction