bioihbjkbjnl/mcl2 huggingface dataset:
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
Condition: Ventral Hernia Repair
MeSH terms: Infections; Hernia; Hernia, Ventral
Intervention: Gemcitabine/ clindamycin; Normal saline
Intervention description: Comparison of saline solution rinse vs antibiotic rinse; Comparison of saline solution rinse vs antibiotic rinse
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design would be a registry-based RCT through the AHSQC to evaluate the effect of dual antibiotic irrigation at the time of mesh placement during open RM +/-TAR OVHR.
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Infection; hernia repair

Summary:

      This is a study to determine if the incidence of infection at the Surgical SitE is impacted
      if with Antibiotic Irrigation is used during Ventral Hernia Repair (RINSE Trial)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 y/o.

          -  Elective, open ventral hernia repair in a retromuscular fashion, with or without TAR.

          -  Clean, clean-contaminated, or contaminated wounds.

        Exclusion Criteria:

          -  Age <18 y/o.

          -  Pregnancy.

          -  Emergency hernia repair.

          -  Laparoscopic, robotic, or hybrid approach.

          -  Dirty wounds.

          -  Use of biologic or absorbable synthetic mesh.

          -  Onlay, intraperitoneal or preperitoneal mesh placement.
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
Condition: Postmenopausal Women With Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: GP2411; EU-Prolia (EU-authorized Prolia®)
Intervention description: 60 mg /mL subcutaneous injection every 6 months; 60 mg /mL subcutaneous injection every 6 months
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 527.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prolia; GP2411; denosumab; postmenopausal osteoporosis

Summary:

      This study was conducted to assess if there were any clinically meaningful differences in
      pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between
      GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women, diagnosed with osteoporosis

          -  Aged ≥ 55 and ≤ 80 years at screening

          -  Body weight ≥ 50 kg and ≤ 90 kg at screening

          -  Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar
             spine as measured by DXA

          -  At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by
             DXA

        Exclusion Criteria:

          -  Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)

          -  History and/or presence of one severe or more than two moderate vertebral fractures or
             hip fracture

          -  History and/or presence of bone metastases, bone disease or metabolic disease

          -  Ongoing use of any osteoporosis treatment or use of prohibited treatment

          -  Other bone active drugs

          -  History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or
             hypercalcemia
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
Condition: Heart Failure; Heart Failure, Systolic; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Intervention: LCZ696; Enalapril matching placebo; Enalapril; LCZ696 matching placebo
Intervention description: sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets; Placebo to Enalapril 10 mg film-coated tablets; Enalapril 10 mg film-coated tablets; Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Intervention MeSH terms: Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: heart failure; systolic heart failure; heart failure with reduced ejection fraction; erectile dysfunction; Enalapril; Enalaprilat; LCZ696; Sacubitril/valsartan

Summary:

      The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs.
      Enalapril on improvement in erectile function and ability in male patients with chronic heart
      failure with reduced ejection fraction and erectile dysfunction.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced
             ejection fraction (LVEF < 40%)

          -  Patients must be living in a stable and sexually active heterosexual partnership for
             at least 6 months prior study start

          -  Patients must have a mild to moderate erectile dysfunction (determined by using the
             IIEF-5 questionnaire)

          -  Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior
             study start

          -  Patients must be literate in German

        Key Exclusion Criteria:

          -  History of hypersensitivity to any of the study drugs or its excipients or to drugs of
             similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected
             contraindications to the study drugs

          -  Previous history of intolerance to recommended target doses of ACEIs or ARBs

          -  Known history of angioedema

          -  Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
             symptoms that may require intravenous therapy)

          -  Symptomatic hypotension

          -  Impaired renal function

          -  Penile anatomical defects and Peyronie's disease

          -  Diabetes mellitus Type I or insulin-dependent Type II

          -  Known prostate cancer
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy
Condition: Hip Disease
Intervention: Bupivacaine + dexamethasone; Ultrasound
Intervention description: Anesthetic that will help treat pain and sensation after hip arthroscopy; Ultrasound will help guide the anesthesiologist in performing the nerve block
Intervention MeSH terms: Dexamethasone; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Hip arthroscopy is performed frequently and the postoperative course often involves moderate
      to severe pain. There remains no definitive perioperative pain regimen that has been proven
      to be effective and safe for this ambulatory procedure. Some institutions perform peripheral
      nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs
      lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While
      some case reports exist, there have not been any studies evaluating the QLB for hip
      arthroscopy patients. As previously mentioned, the technique is easy to perform,
      well-tolerated by patients, and avoids side effects such as hypotension, urinary retention,
      or the quadriceps weakness associated with lumbar plexus blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for hip arthroscopy

          -  Ability to follow study protocol

          -  English Speaking

        Exclusion Criteria:

          -  Hepatic or renal insufficiency

          -  Younger than 18 years old and older than 80

          -  Allergy or intolerance to one of the study medications

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (daily opioids use for longer than 3 months)

          -  Patients contraindicated to undergo a spinal anesthetic

          -  Non English Speakers
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CSL312; Placebo
Intervention description: Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody; Buffer without active ingredient
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to
      investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in
      the prophylactic treatment of hereditary angioedema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH
             hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.

        Note: For subjects taking any prophylactic HAE therapy during the 3 months before
        Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing
        the prophylactic therapy.

        Exclusion Criteria:

          -  Concomitant diagnosis of another form of angioedema such as idiopathic or acquired
             angioedema, recurrent angioedema associated with urticarial or hereditary angioedema
             type 3
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: octreotide capsules; Matching placebo
Intervention description: octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration); Matching placebo capsules
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Octreotide Capsules, Acromegaly, OPTIMAL, MYCAPSSA

Summary:

      Octreotide capsule is a novel, orally-administered formulation of the commercially-available
      injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated
      maintenance of biochemical response up to 13 months in the majority of patients with
      acromegaly previously managed with somatostatin analog injections (reference below).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented evidence of active acromegaly

          -  Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least
             6 months with a stable dose for at least the last three months of therapy

          -  Biochemically controlled

        Exclusion Criteria:

          -  Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as
             indicated in the label

          -  Pituitary surgery within six months

          -  Conventional or stereotactic pituitary radiotherapy any time in the past

          -  Patients who previously participated in CH-ACM-01 or OOC-ACM-302

          -  Any clinically significant uncontrolled concomitant disease

          -  Symptomatic cholelithiasis

          -  Pegvisomant, within 24 weeks

          -  Dopamine agonists, within 12 weeks

          -  Pasireotide, within 24 weeks
A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Abilify MyCite®
Intervention description: Combination product of aripiprazole tablet embedded with sensor and wearable patch.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To compare inpatient psychiatric hospitalization rates while participants are on oral
      standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be willing and able to give written informed consent, adhere to
             trial procedures and able to read and understand English.

          -  Male and female participants 18 to 65 years of age.

          -  Participants must possess a smartphone and is familiar with its use and is willing to
             download and interact with the Abilify MyCite® app. Participants with a smartphone,
             that is not compatible with the Abilify MyCite® app will be offered a loaner phone for
             the trial period.

          -  Clinical diagnosis of schizophrenia and able to ingest oral medication.

          -  Positive and Negative Syndrome Scale (PANSS) total score between 60-90.

          -  Participants currently prescribed oral atypical antipsychotic medication including
             aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.

          -  Participants are required to have had an inpatient hospitalization for schizophrenia
             within the last 48 months prior to entering the trial.

          -  Skin on the anterior chest just above the lower edge of the rib cage that is free of
             any dermatological problems.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who are pregnant.

          -  Sexually active males or women of childbearing potential (WOCBP) who do not agree to
             practice 2 different methods of birth control or remain abstinent during the trial and
             for 30 days after the last dose of Abilify MyCite®.

          -  Any participants who participated in another clinical trial within 30 days of
             enrollment.

          -  Participants who are currently being treated with an LAI antipsychotic or have been
             treated with an LAI in the retrospective 6-month phase.

          -  Participants with a current DSM-5 diagnosis other than schizophrenia.

          -  Participants with a known allergy to adhesive tape or any pertinent components of the
             patch or aripiprazole tablet embedded with an IEM sensor.
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Sapacitabine; Decitabine
Intervention description: Oral sapacitabine capsules; Decitabine intravenous
Intervention MeSH terms: Decitabine; Sapacitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: AML

Summary:

      This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at
      least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the
      doctor does not recommend the use of standard intensive treatment or the patient has decided
      not to receive standard intensive treatment after being fully informed about its benefits and
      risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating
      cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug
      regimen is more likely to keep AML in check as long as possible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed AML based on WHO (World Health Organization) classification

          -  Age 70 years or older for whom the treatment of choice is low-intensity therapy by
             investigator assessment or who has refused intensive induction therapy recommended by
             investigator

          -  ECOG (Eastern Cooperative Oncology Group) performance status 0-2

          -  Adequate renal function

          -  Adequate liver function

          -  Able to swallow capsules

          -  Agree to practice effective contraception

          -  Ability to understand and willingness to sign the informed consent form

        Exclusion Criteria:

          -  AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor
             without bone marrow involvement

          -  Having received any systemic anti-cancer therapy for AML or received treatment with
             hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic
             syndrome (MDS) or myeloproliferative disease (MPD)

          -  Known or suspected central nervous system (CNS) involvement by leukemia

          -  Uncontrolled intercurrent illness

          -  Known hypersensitivity to decitabine

          -  Known to be HIV-positive
Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
Condition: Transfusion; Age of Blood
Intervention: Blood transfusion
Intervention description: Blood transfusion in ICU patients aged 18 and over.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Two staff not involved in the direct care of each patient checked the red-cell units, and concealed the collection and expiry dates from clinical staff using a bag with opaque panels (Australia, Ireland and Saudi Arabia), or an obscuring sticker (NZ and Finland).
Enrollment: 4994.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In Australia, blood for transfusion has a "use by" date of 42 days after collection. The
      actual age of blood given to patients depends on what is available at the time and the rate
      of usage. During the last decade, it has been reported that blood transfusion in patients
      admitted to intensive care was associated with an independent increase of mortality. Some
      research suggests that transfusion of fresher blood might help patients in the intensive care
      unit to reach a better recovery. This project will test whether patients who receive
      'fresher' blood do better than patients who receive 'standard issue' blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in
             whom the decision has been made by medical staff to transfuse at least one RBC unit.

        Exclusion Criteria:

          -  Age younger than 18

          -  Previous RBC transfusion during the current hospital admission (including transfusion
             in another hospital for transferred patients)

          -  Diagnosis of transplantation or hematologic diseases

          -  Pregnancy

          -  Cardiac surgery during the present hospital admission

          -  Expected to die imminently (<24hrs)

          -  The treating physician believes it is not in the best interest of the patient to be
             randomised in this trial.

          -  Known objection to the administration of human blood products

          -  Participation in a competing study (see below)
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
Condition: Severe Haemophilia A
MeSH terms: Hemophilia A
Intervention: Human cl rhFVIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The rationale of this study is to further fine-tune and individualize prophylactic treatment
      of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above
      1% between doses. Because trough FVIII levels are likely to be important predictors of the
      efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe Haemophilia A (FVIII:C < 1%)

          -  Male patients >= 18 years of age

          -  Previous treatment with a FVIII concentrate for at least 150 EDs

          -  Good documentation regarding dosing and bleeding frequency in the 6 months preceding
             study start

          -  Immunocompetence (CD4+ count > 200/uL)

        Exclusion Criteria:

          -  Any coagulation disorder other than Haemophilia A

          -  Present of past FVIII inhibitor activity

          -  Severe liver or kidney disease