bioihbjkbjnl/mcl2 huggingface dataset:
IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty
Condition: Pain, Postoperative; Opioid Use
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen; Acetaminophen
Intervention description: Oral acetaminophen, intravenous placebo; Intravenous acetaminophen, oral placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine how well two different methods of administrating
      Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR)
      surgery. The methods of administration are orally, via a pill that is to be swallowed, and
      intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol
      will reduce opioid consumption and opioid-related side effects after THR.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult

          -  Scheduled for an elective primary THA with a participating surgeon,

          -  Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural
             Analgesia (PCEA)

          -  English-speaking

          -  Patients that did not receive pre-operative opioids

        Exclusion criteria:

          -  Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney
             functioning tests.

          -  Hypersensitivity or contraindication to protocol medication

          -  Contraindication for CSE and PCEA

          -  Incapable to provide consent/answer questions in English

          -  Revision or urgent surgery

          -  Receiving Periarticular Injections

          -  History of opioid use

          -  Patients on disability or worker's compensation
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Geltim LP 1 mg/g; Xalatan
Intervention description: one drop in the conjunctival sac of each eye in the morning (84 days).; one drop in the conjunctival sac of each eye in the morning (84 days).
Intervention MeSH terms: Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Bilateral Glaucoma; Bilateral ocular hypertension; Bilateral primary open angle glaucoma; Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day); With local intolerance signs in at least one eye

Summary:

      This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of
      Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially
      treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance
      to prostaglandin eye drops.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Association of the 4 following criteria:

               1. - Bilateral primary open angle glaucoma or bilateral ocular hypertension already
                  treated and controlled by mono-therapy of Xalatan® (1drop per day),

               2. - With local intolerance signs.

        Exclusion Criteria:

          -  Presence of severe objective ocular sign.

          -  Any ocular hypertension other than primary ocular hypertension or primary chronic open
             angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).

          -  Absolute defect in the ten degrees central point of the visual field.

          -  Best far corrected visual acuity ≤ 1/10.
ORCA - Oracea® for Rosacea: A Community-based Assessment
Condition: Rosacea
MeSH terms: Rosacea
Intervention: doxycycline (Oracea®) 40 mg modified release as monotherapy; doxycycline (Oracea®) 40 mg modified release as add-on therapy
Intervention description: Take once daily in the morning; Take once daily in the morning
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1421.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the effectiveness, safety, subject satisfaction and
      quality of life with Oracea® when used as monotherapy or as add-on therapy to existing
      topical regimens for the treatment of rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18 and older

          -  Subjects with diagnosis of rosacea (IGA of 2 to 4)

        Exclusion Criteria:

          -  Subjects who used a topical or systemic acne treatment within 4 months of the baseline
             visit (retinoids and isotretinoin)

          -  Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline
             visit

          -  Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the
             baseline visit and/or who plan to have these treatments during the study

          -  Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add
             on medications

          -  Subjects who have stomach or GI problems, kidney disease or have an active systemic
             fungal infection or a vaginal yeast infection are excluded
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
Condition: Metastatic Renal Cell Carcinoma; Metastatic Melanoma
MeSH terms: Carcinoma; Melanoma; Carcinoma, Renal Cell
Intervention: Aldesleukin
Intervention MeSH terms: Aldesleukin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Renal Cell Carcinoma; Metastatic Melanoma; Aldesleukin; IL-2

Summary:

      This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic
      renal cell cancer or metastatic melanoma.
    

Eligibility criteria:

        Inclusion criteria:

          -  Performance Status Eastern Cooperative Oncology Group: 0 or 1.

          -  Adequate organ function.

        Exclusion criteria:

          -  Pregnancy or lactation.

          -  Prior treatment with any form of IL-2.

          -  Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply
1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
Condition: Kidney Failure
MeSH terms: Renal Insufficiency; Diabetes Insipidus
Intervention: DDAVP; saline solution
Intervention description: 0.3 mcg/kg subcutaneous; saline solution 1 ml subcutaneous
Intervention MeSH terms: Vasopressins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 162.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vasopressin; bleeding; biopsy; ultrasonography

Summary:

      The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine
      (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single
      centre, double blind, randomized controlled study in patients, with acute and chronic
      nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females > 16 and < 80 years of age.

          2. Blood pressure < 140/90 mmHg.

          3. Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min.

          4. Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen
             in the normal range.

        Exclusion Criteria:

          1. Biopsy of transplant kidney

          2. Poorly controlled hypertension

          3. Single kidney

          4. Renal cancer

          5. Hydro/pyonephrosis

          6. Renal size significantly reduced

          7. Severe obesity

          8. Coagulation disorder

          9. Serum creatinine > 1.5 mg/dl and/or creatinine clearance < 60 ml/min
Theracal Pulpotomy in Primary Molars
Condition: Deep Caries
Intervention: Theracal LC; Formocresol
Intervention description: pulpotomy; Pulpotomy
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 4 Years
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Theracal; formocresol; pulpotomy

Summary:

      Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol
      pulpotomy in primary molars.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy, cooperative children

          -  mandibular primary molars with vital pulp exposures

        Exclusion Criteria:

          -  clinical or radiographic evidence of irreversible pulpitis

          -  physiological root resorption
Sequential and Hybrid Therapies for H Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases
Intervention: 14-day sequential treatment; 14-day hybrid treatment
Intervention description: 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days; esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Helicobacter pylori infection

Summary:

      Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in
      which the first component consists of a proton pump inhibitor and amoxicillin given for 7
      days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be
      similar with the exception that the amoxicillin will be continued throughout the 14 days. The
      secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic
      resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  consecutive H. pylori-infected outpatients, at least 18 years of age, with
             endoscopically proven peptic ulcer diseases or gastritis

        Exclusion Criteria:

          -  previous H. pylori-eradication therapy

          -  ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks

          -  patients with allergic history to the medications used

          -  patients with previous gastric surgery

          -  the coexistence of serious concomitant illness (for example, decompensated liver
             cirrhosis, uremia)

          -  pregnant women.
Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
Condition: Pertrochanteric Fracture
Intervention: Marcaine, Duramorph , ketorolac; Bupivacaine (Marcaine); General Anesthetics
Intervention description: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.; 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.; Placebo group will only receive standard of care general anesthesia
Intervention MeSH terms: Ketorolac; Morphine; Bupivacaine; Anesthetics; Anesthetics, General
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the
      effects of surgical site injection on pain and narcotic utilization in participants who
      undergo surgery for lower extremity fractures. 200 participants with lower extremity
      fractures who are admitted for operative fixation will be included in the study. Participants
      will be randomized to receive either a pain cocktail injection around the fracture site and
      surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation
      progress, length of stay, narcotic utilization, and satisfaction scores will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric,
             and femoral shaft fracture

        Exclusion Criteria:

          -  Pregnant women

          -  Treatment with Arthroplasty

          -  Patients who receive a peripheral nerve block

          -  Patients who receive intra-op or post-op ketamine

          -  Patients with concomitant TBI or MR

          -  Polytrauma patients

          -  Pathologic Fractures

          -  Patients who live greater than 10 miles from NYU or who will not be followed by an NYU
             provider

          -  Patients with a contraindication to any of the medications on the study list due to
             other medical problems such as renal or liver disease or due to allergy/intolerance

          -  Patients with prior extremity weakness resulting from stroke or other neurological
             condition

          -  Prior or current history of narcotic use

          -  Patients with advanced dementia

          -  NYUMC Students, Residents, Faculty
Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus
Condition: Kidney Transplant
Intervention: ramipril; ramipril
Intervention description: Capsule - initial treatment is 5 mg (active)- oral - once per day; Capsule - initial treatment is 5 mg (placebo) - oral - once per day
Intervention MeSH terms: Ramipril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to determine the efficacy of ramipril in preventing a
      urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to
      sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving cyclosporine (CsA) or tacrolimus (TAC) since the first month
             post-transplant.

          -  In addition to a calcineurin inhibitor (CNI), subjects must be treated with either
             corticosteroids at a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone
             (2 to 12mg/day for methylprednisolone or the alternate day equivalent) or a
             steroid-free regimen for a minimum of 12 weeks before randomization or either MMF
             (>/=500mg/day), mycophenolate sodium (MPS) (>/=360 mg/day) or AZA (>/=50mg/day).
             Subjects must be taking a minimum of 2 immunosuppressive drugs if on a steroid-free
             regimen.

          -  Subject is 3 to 60 months after renal transplantation.

          -  Subject is greater than 12 weeks after treatment for any acute rejection.

        Exclusion Criteria:

          -  Subjects who are currently receiving, or have received within 4 weeks before
             enrollment, RAAS blockade.

          -  Subjects with a calculated GFR < 40mL/min (per the Modification of Diet in Renal
             Disease [MDRD-7] or abbreviated MDRD formula).

          -  Subjects with a urine protein to creatinine ratio (U p/c) of >0.3.

          -  Subjects with a history of uncontrolled systolic blood pressure (SBP >140 mm Hg).

          -  Subjects with severe hepatic impairment (Grade C Child-Pugh score). Additional
             Inclusion / Exclusion Criteria apply.
Escitalopram in Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Escitalopram
Intervention description: Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; GAD; Antidepressant; Anxiolytic

Summary:

      The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of
      treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of
      patients who respond to escitalopram during the treatment period, and to evaluate safety of
      escitalopram.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient suffers from GAD, diagnosed according to ICD-10 (International
             Classification of Diseases)

          -  The patient meets criteria as set out in the national SPC for escitalopram

          -  The patient is, in the opinion of the investigator, otherwise healthy on the basis of
             a physical examination, medical history and vital signs

        Exclusion Criteria:

          -  The patient has/has had an alcohol or drug abuse-related disorder, as defined in
             ICD-10

          -  The patient has contraindications to escitalopram

          -  The patient has a history of severe drug allergy or hypersensitivity, or known
             hypersensitivity to escitalopram

          -  The patient has a serious illness and/or serious sequelae thereof, including liver or
             renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine,
             neurological, infectious, neoplastic, or metabolic disturbance

          -  The patient is pregnant or breast-feeding

          -  The patient, if a woman of childbearing potential, is not using adequate contraception
Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: liposomal bupivacaine; Bupivacaine
Intervention description: Experimental; Active Comparator
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare pain control after arthroscopic rotator cuff repair
      surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene
      block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these
      types of surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients aged greater than 18 years of age that are undergoing arthroscopic
             rotator cuff surgery

        Exclusion Criteria:

          -  Patients with allergy to local anesthetics

          -  Patients with daily use of opioids for more than 3 weeks prior to surgery

          -  Patients who refuse

          -  Patients with coagulopathy

          -  Patients who are non-english speaking

          -  Patients who do not have access to a telephone
Valsartan Intensified Primary Care Reduction of Blood Pressure Study
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy; Valsartan and amlodipine; Usual care; Valsartan; Valsartan and hydrochlorothiazide (HCTZ) - combination arm
Intervention description: Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally; From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally; As directed by investigator; Valsartan 160mg per day to 320mg per day orally; Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide; Amlodipine, Valsartan Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2337.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; valsartan

Summary:

      This study will assess the efficacy of an intensive blood pressure management strategy
      compared to usual care in a primary care (general practice) setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  newly diagnosed or currently treated hypertensive patients who have not attained their
             blood pressure target and require active pharmacological treatment as recommended by
             the local guidelines as judged by the general practitioner

        Exclusion Criteria:

          -  significantly elevated blood pressure (severe hypertension)

          -  requiring 3 or more antihypertensive drugs

          -  severe kidney disease or dialyses

          -  clinical diagnosis requiring concomitant therapy with antihypertensive treatment that
             would be outside the therapies allowed under study protocol

        Other protocol-defined inclusion/exclusion criteria may apply