bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: 70 mg/mL pre-filled syringe administered subcutaneously; Matching placebo in pre-filled syringe administered subcutaneously
Intervention MeSH terms: Erenumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 900.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: AMG334; erenumab; episodic migraine; headache; CGRP; Calcitonin Gene-related; migraine; adult

Summary:

      This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic
      migraine
    

Eligibility criteria:

        Key inclusion criteria:

          1. Documented history of migraine in the 12 months prior to screening

          2. 4-14 days per month of migraine symptoms

          3. >=80% diary compliance during the Baseline period

        Key exclusion criteria:

          1. >50 years old at migraine onset

          2. Pregnant or nursing

          3. History of cluster or hemiplegic headache

          4. Evidence of seizure or major psychiatric disorder

          5. Score of 19 or higher on the BDI

          6. Active chronic pain syndrome

          7. Cardiac or hepatic disease
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
Condition: Disease, Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: brentuximab vedotin; placebo
Intervention description: Every 21 days by IV infusion (1.8 mg/kg); Every 21 days by IV infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Disease, Hodgkin; Drug Therapy; Hematologic Diseases; Immunotherapy; Lymphoma; Monomethylauristatin E

Summary:

      This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate
      the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC)
      compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following
      autologous stem cell transplant (ASCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with HL who have received ASCT in the previous 30-45 days

          -  Patients at high risk of residual HL post ASCT

          -  Histologically-confirmed HL

          -  ECOG of 0 or 1

          -  Adequate organ function

        Exclusion Criteria:

          -  Previous treatment with brentuximab vedotin

          -  Previously received an allogeneic transplant

          -  Patients who were determined to have a best clinical response of progressive disease
             with salvage treatment immediately prior to ASCT

          -  History of another primary malignancy that has not been in remission for at least 3
             years

          -  Post ASCT or current therapy with other systemic anti-neoplastic or investigational
             agents
Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
Condition: Polycystic Kidney Disease, Adult
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Lixivaptan
Intervention description: Oral vasopressin V2 receptor antagonist
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single group, open-label study
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, open-label, roll-over study to demonstrate the continued hepatic and
      non-hepatic safety and renal efficacy of lixivaptan in participants with ADPKD who previously
      experienced abnormal liver chemistry test results while treated with tolvaptan, were
      permanently discontinued from the drug for that reason, and subsequently completed study
      PA-ADPKD-303, the open-label lead-in study with lixivaptan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with ADPKD who completed study PA-ADPKD-303

          -  Continued control of hypertension without the use of a diuretic

          -  Continued adherence to prohibitions on concomitant medications stated in the study
             PA-ADPKD-303 protocol

          -  Willing to practice acceptable methods of birth control (both males who have partners
             of child-bearing potential and females of childbearing potential).

          -  Able to provide informed consent.

        Exclusion Criteria:

          -  Any contraindication to continued treatment with lixivaptan

          -  Clinically significant incontinence, overactive bladder, or urinary retention (e.g.,
             benign prostatic hyperplasia)

          -  New York Heart Association Functional Class 3 or 4 heart failure or other significant
             cardiac or electrocardiogram (ECG) findings that could pose a safety risk to the
             participant

          -  Hypovolemia on physical examination at Screening

          -  The following laboratory results based on serum drawn at Visit 24 of PA-ADPKD-303:

               -  Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values
                  >1.5 × ULN

               -  Total bilirubin values >1.5 × ULN

          -  eGFR <20 mL/min/1.73 m^2 based on laboratory results from Visit 26 of PA-ADPKD-303

          -  A finding at Screening that precludes safe participation in the study or participants
             who are likely to be non-compliant with study procedures in the opinion of the
             Investigator or medical monitor
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: DVS SR
Intervention description: Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 283.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

Summary:

      This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate
      Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major
      Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study B2061032 and who in the investigator's opinion, would benefit from
             long term treatment with DVS SR

          -  Willingness and ability to comply with scheduled visits, treatment plan, and
             procedures

        Exclusion Criteria:

          -  Requires precaution against suicide

          -  Not in generally healthy medical condition

          -  Poor compliance with study drug or study procedures during participation in study
             B2061032
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
Condition: Diabetes Mellitus; Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: VEGF Trap-Eye (BAY86-5321); VEGF Trap-Eye (BAY86-5321); Macular Laser Photocoagulation (Control)
Intervention description: Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).; Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).; Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema (DME); VEGF Trap-Eye; Best-corrected visual acuity (BCVA)

Summary:

      To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the
      best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy
      study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 years with type 1 or 2 diabetes mellitus

          -  Subjects with DME secondary to diabetes mellitus involving the center of the macula in
             the study eye

          -  Decrease in vision determined to be primarily the result of DME in the study eye

          -  BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

        Exclusion Criteria:

          -  Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day
             1

          -  More than 2 previous macular laser treatments in the study eye

          -  Previous use of intraocular or periocular corticosteroids in the study eye within 120
             days of Day 1

          -  Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium,
             bevacizumab, ranibizumab etc.) within 90 days of Day 1

          -  Active proliferative diabetic retinopathy (PDR) in the study eye, with the exception
             of inactive, regressed PDR

          -  Uncontrolled diabetes mellitus, as defined by HbA1c > 12%

          -  Only 1 functional eye even if that eye is otherwise eligible for the study
Randomized Open Investigation Determining Steroid Dose
Condition: Covid19
MeSH terms: COVID-19
Intervention: Weight-based dexamethasone dose
Intervention description: Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized in a parallel fashion into either the standard dexamethasone dose of 6 mg or weight-based dexamethasone of 0.2 mg/kg (maximum dose of 20 mg)
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dexamethasone; COVID-19; COVID pneumonia; respiratory failure; steroids

Summary:

      Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of
      steroids may be more effective. The purpose of this research study is to compare the current
      standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum
      dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater or equal than 18 years old

          -  COVID-19 infection confirmed by positive PCR test

          -  Hypoxemia defined by an oxygen saturation < 94% or the need for supplemental oxygen

        Exclusion Criteria:

          -  Corticosteroid use for > 48h within the past 15 days prior to enrollment

          -  Use of steroids with doses higher than the equivalent to dexamethasone 6 mg

          -  Use of immunosuppressive drugs

          -  Pregnant women

          -  Chronic oxygen use

          -  Known history of dexamethasone allergy

          -  DNR / DNI

          -  Patient or proxy cannot consent
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained-Release (DVS SR); Desvenlafaxine Succinate Sustained-Release (DVS SR); placebo
Intervention description: 25 mg tablet, once daily dosing for 8 weeks; 50 mg tablet, once daily dosing for 8 weeks; Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder

Summary:

      The primary purpose of this study is to compare the antidepressant efficacy and safety of two
      doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder.
      The study will also assess changes in sexual function and general and functional quality of
      life outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive
             symptoms for at least 30 days prior to screening)

          -  Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20

          -  Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4

        Exclusion Criteria:

          -  Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from
             screening to baseline

          -  Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia
             Suicide-Severity Rating Scale scores Other eligibility criteria also apply
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.
Intervention description: Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis; secukinumab; AIN457H; SpondyloArthritis

Summary:

      The purpose of this study was to assess the clinical efficacy, safety and tolerability of
      secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS
      despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor
      necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the
      registration of secukinumab in Japan for the treatment of active AS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or
             radiologist's report) fulfilling the Modified New York criteria for AS with active AS
             assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI
             question #2) at Baseline

          -  Patients should have been on NSAIDs at the highest recommended dose for at least 3
             months prior to baseline with an inadequate response or failure to respond, or less
             than 3 months if therapy had to be withdrawn due to intolerance, toxicity or
             contraindications

          -  Patients who have been on a TNFα inhibitor (not more than one) must have experienced
             an inadequate response to previous or current treatment given at an approved dose for
             at least 3 months prior to baseline or have been intolerant to at least one
             administration of an anti-TNFα agent

        Exclusion Criteria:

          -  Patients with total ankylosis of the spine

          -  Patients previously treated with any biological immunomodulating agents except for
             those targeting TNFα

          -  Active ongoing inflammatory diseases other than AS that might confound the evaluation
             of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis

          -  Known infection with HIV, hepatitis B or hepatitis C at screening or baseline
Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients
Condition: Bariatric Surgical Pain
MeSH terms: Pain, Postoperative
Intervention: Lidocaine; Placebo
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the feasibility and safety of administering continuous
      intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y
      Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration
      versus placebo (dextrose administration) (initiated at the time of anesthesia induction and
      continued until extubation) will reduce postoperative narcotic requirements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients between the ages of 18-65 years old

          -  BMI ≥ 40 kg/m2, ≤ 60 kg/m2

          -  Undergoing a primary laparoscopic RYGB by Dr. Murr

          -  Agree to be followed 24 hours postoperatively

          -  Normal K+ and Mg++ serum levels

        Exclusion Criteria:

          -  BMI less than 40 kg/m2, > 60 kg/m2

          -  Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr

          -  Allergy to lidocaine

          -  Allergy to hydromorphone or ketorolac

          -  Allergy to corn or amide anesthetics

          -  Use of (thioridizine)

          -  Pregnancy

          -  Abnormalities of ALT or AST

          -  Intra-operative diagnosis of cirrhosis or portal hypertension

          -  Intraoperative complications per surgeon

          -  Intraoperative extensive adhesions per surgeon

          -  Chronic pain syndrome and chronic use of narcotics

          -  Severe back pain secondary to degenerative joint disease
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin; Telaprevir; Pegylated Interferon alpha 2-a (PegIFN)
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Tablet; Film-coated tablet; Pre-filled syringe
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Interferon Free; Hepatitis C Treatment Naive; Hepatitis C Virus; Hepatitis C Genotype 1

Summary:

      This is a study to evaluate the efficacy and safety of three experimental drugs compared with
      telaprevir (a licensed product) in people with hepatitis C virus infection who have not had
      treatment before.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females between 18 and 65 years, inclusive, at time of Screening

          -  Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing abstinence/specific forms of birth control

          -  Subject has never received antiviral treatment for hepatitis C infection

          -  Chronic HCV Genotype-1 infection prior to study enrollment

        Exclusion Criteria:

          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
             Immunodeficiency virus antibody (HIV Ab)

          -  Females who are pregnant or plan to become pregnant, or breastfeeding

          -  Any current or past clinical evidence of cirrhosis

          -  Screening laboratory analyses that showing abnormal laboratory results

          -  Use of contraindicated medications within 2 weeks of dosing and subject with
             contraindication for telaprevir, pegIFN and RBV

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol

          -  Positive screen for drugs or alcohol
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
Condition: Castration-Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Placebo
Intervention description: MDV3100, 160 mg orally per day; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1199.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Castration-resistant

Summary:

      This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients
      with castration-resistant prostate cancer who have been previously treated with
      docetaxel-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Progressive prostate cancer

          -  Medical or surgical castration with testosterone less than 50 ng/dl

          -  One or two prior chemotherapy regimens. At least one chemotherapy regimen must have
             contained docetaxel

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Adequate bone marrow, hepatic, and renal function

          -  Able to swallow the study drug and comply with study requirements

          -  Informed consent

        Exclusion Criteria:

          -  Metastases in the brain or active epidural disease

          -  Another malignancy within the previous 5 years

          -  Clinically significant cardiovascular disease

          -  Gastrointestinal disorder affecting absorption