bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
Condition: Patent Ductus Arteriosus; Preterm Infant; Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth; Ductus Arteriosus, Patent
Intervention: Ibuprofen and acetaminophen; Ibuprofen and placebo
Intervention description: Intravenous ibuprofen given concomitantly with oral acetaminophen; Intravenous ibuprofen given concomitantly with oral placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 5 Days
Maximum age: 21 Days
Healthy volunteers: No
Keywords: patent ductus arteriosus; acetaminophen; ibuprofen; bronchopulmonary dysplasia; mechanical ventilation

Summary:

      The purpose of the present study is to determine whether treatment of hemodynamically
      significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and
      oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard
      treatment strategy of using intravenous ibuprofen alone among preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Preterm infant ≤27 6/7

          2. Written parental consent is obtained

          3. Infant requires respiratory support

          4. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at
             least two of the following:

               1. Ductus size ≥ 1.5 mm

               2. Maximum flow velocity through the ductus ≤ 2 m/s

               3. Left atrium to aorta ratio ≥ 1.4

               4. Wide pulse pressure

               5. B-type natriuretic peptide (BNP)

          5. Attending neonatologist made decision to treat patent ductus arteriosus

        Exclusion Criteria:

          1. No parental consent

          2. Infants > 21days of postnatal age

          3. Congenital anomalies such as cardiac or multiple anomalies

          4. Infection (e.g., septicemia, pneumonia)

          5. Bleeding disorder or platelet count< 50,000/ml

          6. Acute kidney injury (AKI)defined as oliguria (urine output< 0.5 ml/kg/hr for 16hrs)
             and/or serum creatinine > 1.5 mg/dl

          7. Elevated liver enzymes (>2 fold from upper normal limits)

          8. Pulmonary hypertension or right to left shunt through the ductus arteriosus

          9. Diagnosis of necrotizing enterocolitis

         10. Unable to tolerate oral medications at the time of enrollment.
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: GW876008; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome safety

Summary:

      This is a double-blind, placebo-controlled, randomised crossover study to investigate the
      efficacy and safety of GW876008
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has been diagnosed with IBS consistent with the Rome II Criteria as
             adapted in Appendix 3 of the protocol

          -  The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a
             flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years
             of randomization. Otherwise, the appropriate procedure(s) must be performed and normal
             results obtained during the 7-day procedure window (prior to randomization):

        If the subject is < 50 years of age and has not had a colonic examination within 5 years of
        the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed.

        If the subject is = 50 years of age and has not had a colonic examination within 5 years of
        the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be
        performed.

          -  Colonic procedure results must be known prior to randomization into the study and
             dispensing study medication

          -  During the two-week screening phase, the subject must have conducted self assessments
             on = 10 days of 14 day (with 80% compliance on daily IVRS calls) compliance assessment
             using the telephone data entry system

        Exclusion Criteria:

          -  As a result of any of the medical interview, physical examination, evaluation of
             mental state and psychiatric history or screening investigations the physician

          -  Subject reported no stool for 7 consecutive days during the two-week screening phase
             responsible considers the subject unfit for the study

          -  The subject has a concurrent illness or disability that may affect the interpretation
             of clinical data, or otherwise contraindicates participation in this clinical study
             (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine,
             metabolic, gastrointestinal, haematological, or neurological condition).
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Condition: Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: Canakinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gouty; Gouty arthritis; Gout flares; Anti-interleukin-1β monoclonal antibody

Summary:

      This 24-week open-label extension study is designed to provide additional long-term safety
      data up to a total of 1-year for patients rolling over from the core study, and to collect
      further efficacy and tolerability data for all the patients, irrespective whether they have
      an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885)
      in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed the core study CACZ885H2251. A patient is defined as completing
             the core study if he/she completed the study up to and including the last visit (Visit
             9).

          -  Patients who have signed a written informed consent before any trial procedure is
             performed.

        Exclusion Criteria:

          -  Patients for whom continuation in the extension 1 is not considered appropriate by the
             treating physician.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive pregnancy test (serum or urine).

          -  Female patients who were physiologically capable of becoming pregnant, unless they
             were:

               -  Female patients whose career, lifestyle, or sexual orientation precluded
                  intercourse with a male partner.

               -  Female patients whose partners had been sterilized by vasectomy or other means.

               -  Using an acceptable method of contraception with a failure rate (Pearl Index
                  (PI)) < 1.

               -  Reliable contraception had to be maintained throughout the study and for 2 months
                  after study drug discontinuation.

        Other protocol defined inclusion/exclusion criteria may apply
Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: PCI-32765
Intervention description: Taken orally, once daily in the morning
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed; Refractory

Summary:

      This research study is a Phase II clinical trial. Phase II clinical trials test the
      effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in
      treating a specific cancer. "Investigational" means that PCI-32765 is still being studied and
      that research doctors are trying to find out more about it-such as the safest dose to use,
      the side effects it may cause, and if PCI-32765 is effective for treating different types of
      cancer. It also means that the FDA has not yet approved PCI-32765 for use in patients,
      including people with Waldenstrom's Macroglobulinemia.

      PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent.
      PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell receptor
      (BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk protein,
      which then results in malignant cell death. This drug has been used in laboratory experiments
      and other research studies in B-cell malignancies and information from those other research
      studies suggests that PCI-32765 may be a treatment strategy for B-cell malignancies,
      including Waldenstrom's Macroglobulinemia.

      In this research study, the investigators are testing the safety and efficacy of PCI-32765 as
      a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia

          -  Measurable disease

          -  Have received at least one prior therapy for WM therapies

          -  Disease free of prior malignancies

          -  Able to adhere to study visit schedule and other protocol requirement

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Any other serious medical condition

          -  Concurrent use of other anti-cancer agents or treatments

          -  Prior exposure to PCI-32765

          -  Known CNS lymphoma

          -  Significant cardiovascular disease

          -  Any disease affecting gastrointestinal function
The EVICEL® Gastrointestinal Study
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Intervention: EVICEL Fibrin Sealant
Intervention description: Intraoperative
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin
      Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects undergoing primary elective GI surgery

          -  Subjects ≥ 18 years of age who are willing to participate in the study and provide
             written informed consent prior to any study-related procedures

        Exclusion Criteria:

          -  Avastin use within 30 days prior to surgery;

          -  Known hypersensitivity to the human blood products or the components of the
             investigational product;

          -  Female subjects who are pregnant or nursing;

          -  Exposure to another investigational drug or device in a clinical trial within 30 days
             prior to surgery or planned/intended for the 90 day follow up period after surgery.
A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
Condition: HIV-1
Intervention: UK-453, 061; UK-453, 061; EFV +TVA
Intervention description: UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.; UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.; Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1. Treatment Naive; HIV Infections; treatment naive

Summary:

      This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as
      efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected
      patients who have not been previously treated with antiretroviral drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age available for a follow-up period of at least
             96 weeks.

          -  HIV 1 RNA viral load of greater then 1,000 copies/mL

          -  Negative urine pregnancy test.

        Exclusion Criteria:

          -  Suspected or documented active, untreated HIV-1 related opportunist infection or other
             condition requiring acute therapy at the time of randomization.

          -  Subjects with acute Hepatitis B and/or C within 30 days of randomization.

          -  Absolute CD4 count <200 cells/mm3.
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
Condition: Quality of Recovery; Same Day Surgery; Nausea and Vomiting, Postoperative; Vaginal Prolapse
MeSH terms: Uterine Prolapse; Vomiting; Prolapse; Postoperative Nausea and Vomiting
Intervention: Dexamethasone; Normal saline
Intervention description: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.; Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 51.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Quality of Recovery, Dexamethasone, Same day surgery

Summary:

      To the investigators knowledge there are no studies in the literature evaluating the effect
      of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women over the age of 18

          2. Women scheduled for vaginal POP reconstructive surgery with or without concomitant
             anti-incontinence procedure and with or without hysterectomy

          3. ASA class 1-2

        Exclusion Criteria:

          1. Daily use of steroids, antiemetics in the month prior to surgery

          2. Chronic pain requiring daily opioid treatment

          3. History of allergy/intolerance to Dexamethasone

          4. ASA class 3

          5. Numerical Pain score of more than 4 at baseline

          6. Renal/Liver disease

          7. Diabetes mellitus

          8. Pregnancy

          9. Inability to answer questionnaires

         10. Any systemic infections

         11. Immuno compromised status

         12. Patients with planned overnight stay
Lucentis in Advanced Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: ranibizumab
Intervention description: Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months
Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase
      III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in
      improved visual function in such patients.Since ranibizumab has been shown to be the most
      effective therapy for exudative macular degeneration we propose to treat all patients in this
      study with monthly ranibizumab intravitreal injections.

      Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads"
      and Group #2 for "tails".

      Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then
      as needed therapy.

      Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as
      needed therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will be eligible if the following criteria are met:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study.

          -  Age > 50 years.

          -  Low vision AMD patients with a VA of 20/400 or worse.

          -  Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT
             or fresh appearing subretinal hemorrhage on fundus examination.

        Exclusion Criteria:

        Subjects who meet any of the following criteria will be excluded from this study:

          -  Pregnancy (positive pregnancy test) or lactation.

          -  Premenopausal women not using adequate contraception. The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated.

          -  Participation in another simultaneous medical investigation or trial.

          -  Concurrent eye disease in the study eye that could compromise visual acuity (e.g.,
             diabetic retinopathy, advanced glaucoma).
Extension of the MIME Robotic System for Stroke Rehabilitation
Condition: Stroke; Impaired Upper Extremity Function
MeSH terms: Stroke
Intervention: robotic therapy; conventional functional training; robotic therapy; conventional functional training
Intervention description: 12 sessions of robot therapy for arm and hand function; 12 sessions of conventional therapy for the arm and hand from a physical therapist; 12 sessions of robot therapy for arm and hand function; 12 sessions of conventional therapy for the arm and hand from a physical therapist
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: stroke; function; arm; hand; robotic; therapy; motor; movement; treatment

Summary:

      The goal of this project is to develop and test a new robotic system to accommodate practice
      of tasks requiring reach, grasp and release of objects. Our previous work has shown that the
      MIME robot is safe and effective for improving reach in stroke subjects. But adequate control
      of hand movements is critical to a functional upper limb, and is often resistant to
      conventional therapeutic interventions. Many stroke survivors have residual ability to flex
      the fingers, but extension is often limited and impeded by increased passive stiffness in
      flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent
      study, 38% of stroke survivors reported that impaired hand function was the most disabling
      motor impairment they faced.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study;

          -  trace ability to move the wrist and fingers in extension;

          -  voluntary shoulder elevation to approximately 45 deg;

          -  be between the ages of 21 and 90.

        Exclusion Criteria:

          -  Have cognitive deficits that could negatively affect their ability to complete
             protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State
             Examination (Bleeker, 1988);

          -  have excessive pain in any joint of the affected extremity that could limit ability to
             cooperate with the protocols;

          -  have an upper extremity injury or conditions prior to stroke that could limit
             participation;

          -  have severe hemispatial neglect.

          -  have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer
             1975); and

          -  have severe sensory loss.