bioihbjkbjnl/mcl2 huggingface dataset:
Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: Vicriviroc maleate
Intervention description: VCV 30 mg tablet once daily by mouth.
Intervention MeSH terms: Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency
      virus (HIV) treatment-experienced participants who successfully completed 48 weeks of
      treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol
      A5211 (or who responded favorably to treatment but discontinued participation due to viral
      tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion
      criteria, but were unable to enroll due to protocol closure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of ACTG Protocol A5211, or favorable response in A5211 but
             discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion
             criteria but unable to enroll due to protocol closure.

          -  Participants must also be on a ritonavir-containing antiretroviral regimen at entry,
             and have acceptable hematologic and laboratory parameters.

          -  Female participants of reproductive potential must agree to use 2 reliable methods of
             contraception, including a barrier method, and must have a negative urine pregnancy
             test prior to dosing.

        Exclusion Criteria:

          -  History of seizure or drug use that increases risk of seizure, current use of CYP3A4
             inducers, prior history of malignancy, active drug or alcohol use or dependence that
             would interfere with study requirements

          -  Female participants who are breast-feeding, pregnant, or plan to become pregnant

          -  Participation in a clinical trial with another investigational drug.

          -  Participants with serious illness requiring systemic therapy and/or hospitalization
             must not begin VCV (if not already on VCV) until participant completes therapy or is
             clinically stable on therapy for at least 14 days prior to enrollment.
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency (EPI); Cystic Fibrosis (CF)
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: MS1819; Porcine PERT
Intervention description: MS1819 in enteric capsules. It contains is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.; Porcine PERT is being used a comparator to MS1819 as a second drug/intervention.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2, 2x2 Crossover
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency; EPI; Cystic Fibrosis; CF

Summary:

      The primary objectives of this study are to assess the safety and efficacy of MS1819 in
      enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with
      exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The exploratory
      objective of the extension phase (EP) is to find a dose of MS1819 in immediate release
      capsules that is safe and results in CFA values in a therapeutic range.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus either a
             new/historic sweat chloride ≥60 mmol/L (measured while not on a CFTR modulator) or
             genotype.

          2. Under stable dose of porcine PERT

          3. A fair or better nutritional status

          4. Fecal elastase <100 µg/g

          5. Standard-of-care medications including CFTR modulators are allowed

        Exclusion Criteria:

          1. History or diagnosis of fibrosing colonopathy

          2. Any chronic diarrheal illness unrelated to pancreatic insufficiency

          3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper
             limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit

          4. Feeding via an enteral tube during 6 months before screening

          5. Forced expiratory volume ≤30% at the Screening visit
A Study for Participants With Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: LY2216684; Placebo; Escitalopram
Intervention description: 3-mg and 6-mg tablets; 10-mg capsules
Intervention MeSH terms: Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 469.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in
      treating adults with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet criteria for major depressive disorder (MDD) without psychotic features.

          -  Have education level and a degree of understanding such that the participant can
             communicate with the site study personnel.

          -  Judged to be reliable and agree to keep all appointments for clinic visits, tests, and
             procedures, including venipuncture, and examinations required by the protocol.

        Exclusion Criteria:

          -  Have had any additional, ongoing psychiatric condition other than major depression or
             dysthymia that was considered the primary diagnosis within 6 months of the first study
             visit.

          -  Have a lifetime history of Bipolar I or II Disorder, psychotic disorder, or a
             factitious disorder.

          -  Are judged to be at high risk for imminently harming themselves or others.

          -  Have a serious medical illness, including any cardiovascular, hepatic, respiratory,
             hematologic, endocrinologic, neurologic disease, or clinically significant laboratory
             or electrocardiogram (ECG) abnormality. Clinically significant lab abnormalities are
             those which, in the judgment of the investigator, indicate a serious medical problem
             or require intervention.

          -  Have any diagnosed medical condition which could be exacerbated by treatment with
             LY2216684, including hypertension, increased heart rate, arrhythmias, heart disease,
             narrow angle glaucoma, or urinary hesitancy.
A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Bevacizumab; Paclitaxel; Gemcitabine
Intervention description: Bevacizumab was supplied as a sterile liquid in glass vials.; Paclitaxel was supplied as a sterile liquid in glass vials.; Gemcitabine was supplied as a sterile liquid in glass vials.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm study assessed the efficacy and safety of first-line treatment with Avastin
      (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in
      patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel
      150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment
      cycle until disease progression, death, or withdrawal of consent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients, ≥ 18 years of age.

          -  Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients
             with bone metastasis only.

          -  HER-2 negative disease.

          -  Candidates for chemotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

        Exclusion Criteria:

          -  Previous chemotherapy for metastatic or locally advanced breast cancer.

          -  Previous radiotherapy for treatment of metastatic breast cancer.

          -  Any prior adjuvant treatment with anthracyclines completed < 6 months prior to
             enrollment.

          -  Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or
             clopidogrel (> 75mg/day).
Does More Practice Improve Arm Movement After Stroke?
Condition: Stroke
MeSH terms: Stroke
Intervention: Intensive task-specific upper extremity rehabilitation
Intervention description: The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stroke; upper extremity; paresis; function; translational research

Summary:

      Arm weakness happens a lot after a stroke. People often get physical or occupational therapy
      after their stroke to learn how to use their arm again. This study will help figure out how
      much therapy should be given to restore as much arm function as possible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ischemic or hemorrhagic stroke as determined by a stroke neurologist and consistent
             with neuroimaging

          -  Time since stroke will include subjects 6-months or more post-stroke

          -  Cognitive skills to actively participate (score of 0-1 on items 1b and 1c of the NIH
             Stroke Scale (NIHSS)

          -  Unilateral upper extremity weakness (score of 1-3 on item 5 (arm item) on the NIHSS)

        Exclusion Criteria:

          -  Subject unavailable for 2-month follow-up

          -  Inability to follow-2-step commands

          -  Psychiatric diagnoses

          -  Current participation in other stroke treatment (i.e.- Botox)

          -  Other neurological diagnoses

          -  If participant lives further than one hour away and is unwilling to travel for
             assessment and treatment sessions.

          -  Pregnancy
Genistein in Treating Patients With Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: genistein; placebo; therapeutic conventional surgery
Intervention description: Given orally; Given orally; Radical prostatectomy for treatment of prostate cancer
Intervention MeSH terms: Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This randomized phase II trial is studying how well genistein works in treating
      patients with prostate cancer.
    

Eligibility criteria:

        Inclusion

          -  Participants must have a pathologic diagnosis of prostate cancer within the past 6
             months, have clinical stage T1-3 disease, PSA >= 10, Gleason score >= 8, and have
             elected to undergo radical prostatectomy; those found to have detectable circulating
             prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to
             proceed onto the treatment phase of the protocol; pathology slides used for diagnosis
             will be submitted to the SPORE tissue pathology core for review

          -  ECOG performance status 0-1

          -  Hemoglobin > 9.0gm/dl

          -  Platelets >= 100 K/uL

          -  ANC > 1000/uL

          -  AST (SGOT)/ALT (SGPT) < 3X upper limit of normal

          -  Creatinine < 2.0 mg/dl

          -  Total bilirubin < 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a
             familial defect in bilirubin metabolism will be considered on an individual basis)

          -  Participants must agree not to take soy supplements

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to take study agent for at least 2 weeks prior to radical prostatectomy

        Exclusion

          -  History of venous thrombosis within past year

          -  Participants must not be receiving active therapy for neoplastic disorders (including
             hormone or radiation therapy for prostate cancer)

          -  Participants may not be receiving any other investigational agents

          -  Known soy intolerance

          -  Medical conditions that, in the opinion of the investigators, would jeopardize either
             the patient or the integrity of the data obtained
A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction
Condition: Acute Myocardial Infarction; Moderate Renal Impairment
MeSH terms: Renal Insufficiency; Myocardial Infarction; Infarction
Intervention: CSL_112; Placebo
Intervention description: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.; 0.9% weight/volume sodium chloride solution (ie, normal saline)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a phase 2, multicenter, double-blind, randomized, placebo controlled,
      parallel-group study to investigate the renal safety and tolerability of multiple dose
      intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate
      renal impairment (RI) and acute myocardial infarction (AMI).
    

Eligibility criteria:

        Inclusion Criteria:

        • Men or women, at least 18 years of age, with evidence of moderate renal impairment (an
        eGFR ≥ 30 and <60 mL/min/1.73 m2) and myocardial necrosis in a clinical setting consistent
        with a type I (spontaneous) acute myocardial infarction (AMI).

        Exclusion Criteria:

          -  Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of
             the index event that are consistent with a diagnosis of AMI but are likely not due to
             primary myocardial ischemia

          -  Ongoing hemodynamic instability

          -  Planned coronary artery bypass surgery

          -  Evidence of hepatobiliary disease

          -  History of acute kidney injury (AKI) after previous exposure to an intravenous
             contrast agent.

          -  History of nephrotic range proteinuria.

          -  Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency,
             antibodies to IgA , or hypersensitivity to CSL112 or any of its components.

          -  Other severe comorbid condition, concurrent medication, or other issue that renders
             the subject unsuitable for participation in the study.
Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome
Intervention: Dexmedetomidine; Placebo
Intervention description: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.; Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the efficacy and safety of dexmedetomidine during
      Non-invasive positive pressure ventilation (NPPV) for patients with acute respiratory failure
      compared to standard analgesic/sedation practices
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Acute respiratory failure requiring the initiation of NPPV

          -  Admission to the medical ICU service at Tufts Medical Center or Winchester Hospital

        Exclusion Criteria:

          -  Patients with delirium (intensive care delirium screening checklist score ≥ 4) or
             disorientation (not oriented to person or place)

          -  Receiving NPPV for ≥ 8 hours (includes treatment with NPPV at an outside hospital)

          -  Intubation and mechanical ventilation in the past month based on hospital admission
             note

          -  Age ≥ 85 years

          -  Inability of the potential subject to give informed consent

          -  Current treatment with antipsychotic agent based on hospital admission note

          -  Heart rate ≤ 50 bpm

          -  Systolic blood pressure ≤ 90 mmHg

          -  History of heart block without pacemaker use or severe ventricular dysfunction (EF
             ≤25%) based on hospital admission note

          -  Acute alcohol withdrawal based on hospital admission note

          -  History of end stage liver failure (based on presence of ≥ 1 or more of the following:
             AST/ALT ≥ 2 times ULN, INR ≥ 2, total bilirubin ≥ 1.5

          -  Irreversible brain disease consistent with severe dementia based on hospital admission
             note

          -  Pregnancy (all women of child-bearing age will undergo a pregnancy test prior to study
             enrollment)

          -  Treatment with clonidine or dexmedetomidine in the past 30 days based on hospital
             admission note

          -  Known allergy or sensitivity to clonidine or dexmedetomidine
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Condition: Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolus; Reconstructive Surgery
MeSH terms: Pulmonary Embolism; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Drug-Related Side Effects and Adverse Reactions
Intervention: Fixed dose; Variable dose
Intervention description: Participants will receive 40 mg enoxaparin twice daily; Participants will receive 0.5mg/kg enoxaparin twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into one of two groups (enoxaparin 40mg twice daily or enoxaparin 0.5mg/kg twice daily, rounded to the nearest milligram).
Masking: Double (Participant, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their
      operative procedures. Thus, plastic & reconstructive surgery patients are among those at
      highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study
      seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing
      aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients
      randomized to receive two different enoxaparin dose regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  receiving plastic and reconstructive surgery under general anesthesis

          -  Expected post-operative stay of 2 days or more

        Exclusion Criteria:

          -  Contraindication to use of enoxaparin

          -  intracranial bleeding/stroke

          -  Hematoma or bleeding disorder

          -  Heparin-induced thrmbocytopenia positive

          -  Creatinine clearance less than or equal to 30 mL/min

          -  Serum creatinine greater than 1.6 mg/dL

          -  epidural anesthesia

          -  patients placed on non-enoxaparin chemoprophylaxis regimens

          -  gross weight exceeding 150kg
Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty
Condition: Hip Arthropathy
MeSH terms: Joint Diseases
Intervention: Nerve Block; Periarticular Injection (PAI); Ropivacaine; Dex
Intervention description: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service.
QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; Intraoperatively, the surgeon will perform PAI per standard of care with the medications:
1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA; 60 ml 0.2% ropivacaine; 10 mg DEX/ 80 mg MPA
Intervention MeSH terms: Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral
      cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective
      analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty
      (THA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective unilateral primary THA

          -  All surgical approaches

          -  American Society of Anesthesiologist (ASA) status I, II and III.

        Exclusion Criteria:

          -  Patient refusal;

          -  Age less than 18 years

          -  Those with cognitive dysfunction, psychiatric disorder, or non-English speaking
             patients that cannot consent or communicate clear understanding of the protocol with
             research team;

          -  Coagulopathy;