bioihbjkbjnl/mcl2 huggingface dataset:
PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Condition: Hemorrhagic Stroke; Venous Thromboembolism; Deep Venous Thrombosis
MeSH terms: Stroke; Hemorrhagic Stroke; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Enoxaparin; Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization
Intervention description: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke; placebo standard therapy
Intervention MeSH terms: Enoxaparin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hemorrhagic stroke; venous thromboembolism; prevention

Summary:

      Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism.
      Intermittent pneumatic compression combined with elastic stockings have been shown to be
      superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis
      after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are
      ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic
      stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism
      in patients with ICH because the use of anticoagulants may cause an enlargement of the
      hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and
      safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous
      intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated
      compression stockings and/or intermittent pneumatic compression and/or early mobilization)
      will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke
      onset.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intracranial spontaneous hemorrhage on brain CT scan

          -  Intracranial hemorrhage during treatment with oral anticoagulants

          -  Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for
             cerebellar hemorrhage).

        Exclusion Criteria:

          -  cerebral hemorrhage due to intracranial vascular malformation

          -  rebleeding on CT scan after 72 hours from stroke (before randomization)
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide
Intervention description: 0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of an investigational
      treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look
      at how teduglutide moves through the body (pharmacokinetics).
    

Eligibility criteria:

        This study has 3 stages, consisting of an optimization/stabilization period (Stage 1), a
        24-week treatment period in which all patients will receive teduglutide (Stage 2), and a
        long-term extension (Stage 3).

        During the long-term extension (Stage 3), patients will continue to receive teduglutide for
        up to an additional 24 months or until teduglutide is commercially available, whichever
        comes earlier.
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
Condition: Major Depression Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Adjunct brexpiprazole; ADT
Intervention description: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.; Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as
      adjunctive treatment in an elderly population with major depressive disorder and an
      inadequate response to antidepressant treatment
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  • The patient is a man or woman aged ≥65 yrs

               -  The patient has Major Depressive Disorder according to Diagnostic and Statistical
                  Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).

               -  The patient has an inadequate response to at least one adequate antidepressant
                  treatment in the current Major Depressive Episode (MDE).

               -  The patient has had the current MDE for ≥8 weeks

               -  The patient is currently treated with a protocol specified ADT for at least 6
                  weeks

               -  The patient is judged to benefit from adjunctive treatment with brexpiprazole
                  according to the clinical opinion of the investigator.

               -  Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at
                  screening and baseline

               -  Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and
                  baseline

        Main Exclusion Criteria:

          -  • The patient has a clinically significant unstable illness

               -  The patient has newly diagnosed or unstable diabetes

               -  The patient has a Mini Mental State Exam (MMSE) score <24

               -  The patient has received Transcranial Magnetic Stimulation (TMS) and/or
                  electroconvulsive therapy (ECT) less than 6 months prior to the Screening.

               -  The patient, in the opinion of the investigator or based on Columbia-Suicide
                  Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at
                  significant risk of suicide

        Other protocol defined inclusion and exclusion criteria may apply
Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block
Condition: Perianal Surgery
Intervention: Dixon's up-and-down method
Intervention description: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Perianal surgery; hyperbaric bupivacaine; saddle block

Summary:

      The optimal anesthetic technique would provide excellent operating conditions, rapid
      recovery, early discharge, no postoperative side effects, and high patient's satisfaction. In
      addition to increasing the quality and decreasing the costs of the anesthetic services (1).
      Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific
      type of surgery - has become very popular technique) 2(for some orthopedic and gynecological
      surgeries [3-9].

      Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards
      S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries
      (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle
      block (11, 12).

      Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been
      used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has
      yet to be determined.

      The objective of this study is to determine the minimal effective dose of hyperbaric spinal
      bupivacaine required to induce a reliable and satisfactory saddle block for perianal
      surgeries (using a modified Dixon's up-and-down method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists physical Status I and II patients.

          -  Scheduled for outpatient elective perianal surgery.

        Exclusion Criteria:

          -  Patients unwilling to participate.

          -  Contraindications to regional anesthesia.

          -  Morbid obesity.

          -  Bleeding disorders.

          -  Mental health problems.

          -  Language barrier.

          -  Taking psychotropic or analgesic medication.

          -  History of allergic reactions to amide local anesthetics.
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
Condition: Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
MeSH terms: Stomach Neoplasms
Intervention: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm); Fluorouracil/cisplatin (control arm)
Intervention description: 25 mg/m² body surface area (BSA) orally 2 times daily from Days 1 through 21 followed by a 7 day rest period, plus cisplatin 75 mg/m2 BSA on Day 1 each 28 day cycle Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.; 5-FU: 800 mg/m2 BSA/24 hours by continuous intravenous infusion (CIV) from Days 1 through 5 plus cisplatin 80 mg/m2 BSA on Day 1 each 21 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.
Intervention MeSH terms: Cisplatin; Fluorouracil; Tegafur
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastric Cancer , S-1, Phase 3

Summary:

      The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin
      compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and
      gastro-esophageal junction cancer previously untreated with chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has given written Informed Consent.

          -  Histologically confirmed, unresectable, metastatic diffuse gastric cancer including
             carcinoma of the gastro-esophageal junction.

          -  No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant
             chemotherapy more than 12 months ago.

          -  Life expectancy of at least 3 months.

          -  Able to take medications orally.

          -  Eastern Cooperative Oncology Group performance status 0 to 1.

          -  Adequate organ function (bone marrow, kidney and liver).

        Exclusion Criteria:

          -  Certain type(s) of non-measurable lesion(s), if the only one(s).

          -  Certain serious illness or medical condition(s).

          -  Lost greater than or equal to 10% of body weight in the 3 months proceeding signing
             the Informed Consent Form.

          -  Treatment with drugs interacting with S-1, 5-FU, or cisplatin.

          -  Pregnant or lactating female.

          -  Known hypersensitivity to fluoropyrimidines or cisplatin.

        Other protocol-defined inclusion/exclusion criteria may apply.
A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Tezacaftor/Ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group,
      multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and
      older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele
      with a gating defect that is clinically demonstrated to be ivacaftor responsive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect
             that is clinically demonstrated to be ivacaftor responsive

          -  FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening

          -  Stable CF disease as judged by the investigator.

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             subject.

          -  Pregnant and nursing females (females of childbearing potential must have a negative
             pregnancy test at Screening and Week -4 Visits).

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements
Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferric carboxymaltose
Intervention description: IV iron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a single arm, open-label, multi-center, multi-national, non-randomized study that will evaluate the efficacy and safety of a one course treatment with FCM in participants who had an unsatisfactory response to oral iron in study 1VIT17044.
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients
      with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol
      1VIT17044
    

Eligibility criteria:

        Inclusion Criteria:

          1. Unsatisfactory response to oral iron or those that required a concomitant
             intervention, (defined as, blood transfusion, use of IV or oral iron outside of
             protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study
             protocol 1VIT17044], change in IBD treatment).

          2. Hgb <11 g/dL

          3. Ferritin ≤300 ng/mL and TSAT <30%

        Exclusion Criteria:

          1. Known history of hypersensitivity reaction to any component of FCM.

          2. History of acquired iron overload, hemochromatosis, or other iron accumulation
             disorders.

          3. History of significant diseases of the liver, hematopoietic system, cardiovascular
             system, psychiatric disorder, or other conditions which, in the opinion of the
             investigator, may place a subject at added risk for participation in the study.

          4. Any existing non-viral infection.

          5. Known history of positive HBsAg or HCV with evidence of active hepatitis.

          6. Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).

          7. Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin
             B12 or folic acid deficiency) that has not been corrected.

          8. Administration and / or use of an investigational product (drug or device) within 30
             days of screening.

          9. Alcohol or drug abuse within the past six months.

         10. Female participant who is pregnant or lactating, or sexually active females who are of
             childbearing potential not willing to use an acceptable form of contraceptive
             precautions during the study.

         11. Unable to comply with study procedures and assessments.
A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PF-06410293; adalimumab
Intervention description: SC injection; SC injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 455.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after
      switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in
      combination with methotrexate in subjects with moderately to severely active rheumatoid
      arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.

          -  Moderately to severely active RA based on local standard of care.

        Exclusion Criteria:

        -Evidence of untreated or inadequately treated latent or active TB.
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Moses laser enucleation of prostate
Intervention description: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: Male
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for
      the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses
      Pulse laser system provide for improved energy delivery which may decrease blood loss and
      operative time. We seek to evaluate Moses technology for enucleation of the prostate in the
      setting of BPH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at
             greater than 80 grams

        Exclusion Criteria:

          -  Anyone actively on anticoagulation perioperatively
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Condition: Pulmonary Hypertension Associated With HFpEF
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Oral treprostinil
Intervention description: Sustained-release oral tablets for TID administration
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pulmonary Hypertension; HFpEF; 6-Minute Walk Test; Oral Treprostinil

Summary:

      This was an open-label study to evaluate the safety of continued therapy with oral
      treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term,
      open-label data regarding the effect of continued long-term oral treprostinil therapy for the
      treatment of pulmonary hypertension (PH) associated with heart failure with preserved
      ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and
      every 12 weeks thereafter until either oral treprostinil was commercially available to treat
      PH associated with HFpEF or the study was discontinued by the Sponsor.

      The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow
      enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March
      2020. Due to the lower than expected number of subjects enrolled, the planned secondary
      efficacy-related endpoints were not analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

        1. The subject participated in Study TDE-HF-301, remained on study drug, was compliant with
        study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of
        that study.

        Exclusion Criteria:

          1. The subject was pregnant or lactating.

          2. The subject was prematurely discontinued from Study TDE-HF-301 for any reason.

          3. The subject developed a concurrent illness or condition during Study TDE-HF-301,
             which, in the opinion of the Investigator, represented a risk to the subject's overall
             health if they enrolled in this study.