bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
Condition: Complicated Skin or Skin Structure Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Daptomycin; Vancomycin
Intervention MeSH terms: Vancomycin; Daptomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous
      (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment
      of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in
      participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive
      vancomycin in a home-infusion setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Complicated skin or skin structure infection (cSSSI)

          -  Intravenous vancomycin home infusion ordered for 7-14 days

        Exclusion Criteria:

          -  Pregnant or lactating female

          -  Concurrently receiving other systemic antibiotics with gram positive activity

          -  Known or suspected allergy or hypersensitivity to daptomycin or vancomycin

          -  Known or suspected vancomycin-resistant enterococci (VRE)

          -  Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary
             tract infection

          -  Known or suspected human immunodeficiency virus (HIV), cancer, or autoimmune disease
             such as lupus

          -  Receiving systemic concomitant immunosuppressive agents such as chemotherapy,
             corticosteroids, tacrolimus, sirolimus, or cyclosporine, during the duration of the
             study

          -  Requirement for non-study gram positive systemic antibiotics

          -  Known to be allergic or intolerant to intravenous vancomycin or daptomycin

          -  Participants with known or suspected creatinine clearance (CLcr) < 30 milliliters per
             minute (mL/min)

          -  In skilled nursing facility

          -  In hospice or admission to hospice is planned
ACL Repair and Multimodal Analgesia
Condition: Pain
Intervention: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine; placebo pills and injectables
Intervention description: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane; receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds
Intervention MeSH terms: Acetaminophen; Ketamine; Gabapentin; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effectiveness of an aggressive multimodal regimen versus
      standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for
      patients having surgery in our outpatient surgicenter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of orthopedic surgeons on the study team scheduled for ACL repair using
             hamstring graft from the same leg will be considered for inclusion in this study.
             Other inclusion criteria are as follows:

               -  American Society of Anesthesiologists (ASA) physical status 1-3

               -  BMI of < 40 kg/m2

               -  Consents to general anesthesia and pre-operative femoral nerve block for case

        Exclusion Criteria:

          -  Any contraindication to a femoral nerve block

          -  Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine,
             acetaminophen, hydromorphone, oxycodone

          -  Peripheral or central nervous system disease

          -  Renal or hepatic impairment

          -  History of opioid dependence or current regular narcotic use

          -  Significant psychiatric disease

          -  Pregnancy or lactation (by verbal report)

          -  Seizure Disorder

          -  History of post-operative nausea and vomiting

          -  Latex allergy

          -  Clinically significant cardiac or pulmonary disease
24-hr Intraocular Pressure Control With SIMBRINZA ®
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Vehicle
Intervention description: Inactive ingredients used as a placebo for masking purposes
Intervention MeSH terms: Brimonidine Tartrate; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate differences between treatments in mean change from
      baseline in 24-hr intraocular pressure (IOP) at Week 4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either open-angle glaucoma or ocular hypertension;

          -  Able to attend all study related visits and be housed overnight at clinical site for
             the study assessments;

          -  Willing and able to sign an informed consent form;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential who are pregnant, intend to become pregnant during the
             study, breast-feeding, or not using adequate birth control;

          -  Diagnosed with any form of glaucoma other than open angle glaucoma or ocular
             hypertension;

          -  Ocular surgeries or procedures excluded by the protocol;

          -  Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;

          -  Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to
             approximately 20/80 Snellen) in either eye;

          -  Other protocol-specific exclusion criteria may apply.
Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients
Condition: COVID, Coronavirus
MeSH terms: Coronavirus Infections
Intervention: Hyperbaric Oxygen Therapy
Intervention description: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a prospective randomized controlled, double blind clinical trial performed on
      laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The
      trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or
      Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the
      standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and
      others.

      The evaluation procedure includes symptom monitoring, room air saturation, vital signs
      monitoring, pulmonary function and blood tests at baseline, one day and one week after the
      last session. In addition, one hour prior to and post session saturation and vitals will be
      monitored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Within 7 days of patient's need of oxygen supply

          -  Positive SARS-CoV-2 RT-PCR

          -  At least one risk factor for bad prognosis of COVID-19: hypertension, diabetes
             mellitus, ischemic heart disease, smoking, age>50, etc.

          -  Respiratory insufficiency: Room Air SpO2 <94% or PaO2/FiO2<300mmHg

          -  Age>18

          -  Ability to sign an informed consent

        Exclusion Criteria:

          -  Negative SARS-CoV-2 RT-PCR

          -  HBOT contraindication: pneumothorax, pneumomediastinum, claustrophobia, ear/sinus
             disease which aren't allowed in HBOT, known chronic pulmonary disease: severe
             emphysema or known pulmonary bullae.

          -  Pregnancy

          -  Inability to sign an informed consent
Study of Metoclopramide in Small Bowel Capsule Endoscopy
Condition: Pill Capsule Endoscopy Completion Rates
Intervention: Metoclopramide; Placebo
Intervention description: A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.; A placebo capsule made to look like the metoclopramide capsule.
Intervention MeSH terms: Metoclopramide
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to
      either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior
      to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design.
      The outcomes to be assessed are capsule study completion rates, gastric transit time, small
      bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose
      of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any
      effect on pill capsule completion rate, gastric transit time, small bowel transit time, and
      pill capsule completion rates in diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women over the age of 18 undergoing pill capsule endoscopy to investigate
             unexplained rectal bleeding, anemia, iron deficiency, abdominal pain, altered bowel
             habits, and/or weight loss.

        Exclusion Criteria:

          -  Inability to sign consent for research participation

          -  Inability to swallow PillCam™, placebo, or metoclopramide capsule

          -  Known hypersensitivity/allergy to metoclopramide

          -  Active congestive heart failure or respiratory failure requiring ventilator assistance

          -  Presence of cardiac pacemaker or implanted electromedical device

          -  Known bowel obstruction/stricture/fistula or intrauterine pregnancy

          -  Known history of Whipple procedure (pancreaticoduodenectomy), Billroth II surgery
             (partial gastrectomy with gastrojejunostomy), or gastric bypass surgery due to risk of
             capsule retention in a blind intestinal limb necessitating surgical retrieval

          -  Known history of seizure disorder, renal failure requiring dialysis, or
             pheochromocytoma

          -  Lactating women
Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: bimatoprost 0.01% ophthalmic solution; bimatoprost 0.03% ophthalmic solution
Intervention description: One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.; One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 806.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution
      compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or glaucoma in each eye

          -  Requires intraocular pressure (IOP)-lowering therapy in both eyes

          -  Best corrected visual acuity of 20/100 or better in each eye

        Exclusion Criteria:

          -  Ocular seasonal allergies within 2 years

          -  Required chronic use of ocular medications during the study (intermittent use of
             artificial tears is allowed)

          -  Ocular surgery or laser within 3 months

          -  Anticipated wearing of contact lenses during the study
Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Oxymetazoline HCL 1.0% Cream; Energy-Based Therapy
Intervention description: Oxymetazoline HCl cream 1.0% once daily application; Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when
      used as an adjunctive treatment to energy-based therapy for participants with moderate to
      severe persistent facial erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

        -Documented clinical diagnosis of rosacea.

        Exclusion Criteria:

          -  History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma,
             orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis
             obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled
             cardiovascular disease, or any other current uncontrolled systemic disease

          -  Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea
             fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis,
             demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus
             erythematosus, or chronic recurring facial acne

          -  Current treatment with monoamine oxidase (MAO) inhibitors

          -  Current treatment with niacin ≥ 500 mg/day

          -  Greater than 3 inflammatory lesions on the face

          -  History or current evidence of drug or alcohol abuse within 12 months prior to the
             screening visit.
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B
Intervention description: In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 16 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Long-term follow-up; Hepatitis B antibody persistence

Summary:

      The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen
      (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of
      the study vaccine. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who had received at least one dose of the study vaccine in the primary study
             (103860/064)

          -  Written informed consent obtained from each subject before each blood sampling visit
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
Condition: Acute Bipolar Mania
MeSH terms: Mania
Intervention: Quetiapine fumarate; lithium
Intervention description: eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.; 300mg tablet, oral
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute bipolar mania; Seroquel XR; Seroquel XR plus lithium; Quetiapine fumarate

Summary:

      The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy
      compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation
      of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using
      the last observation carried forward method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and/or male inpatients or outpatients, aged over 18 years and under 65 years

          -  Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition (DSM-IV) criteria

          -  YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of
             at least one manic episode that required hospitalization and/or treatment with a mood
             stabilizer or antipsychotic.

          -  Female patients must have a negative urine human chorionic gonadotropin (HCG) test at
             enrolment and must be using a reliable method of birth control, ie, barrier method,
             oral contraceptive, implant, dermal contraception, long-term injectable contraceptive

        Exclusion Criteria:

          -  Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder)
             DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation

          -  Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
             a danger to self or others

          -  Administration of a depot antipsychotic injection within one dosing interval (for the
             depot) before randomization/baseline

          -  Known intolerance or hypersensitivity to, or lack of response to previous treatment
             with quetiapine fumarate or lithium
Reducing Pain of Lidocaine Injection
Condition: Pain of Anesthesia at Breast Biopsy
Intervention: 1% Lidocaine; 1% Lidocaine plus sodium bicarbonate
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 21 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding
      sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core
      biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can
      cause pain for approximately 15 seconds until the numbing effect begins. It is possible that
      this pain is caused because lidocaine is acidic. Some physicians believe that reducing the
      acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of
      injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1%
      lidocaine mixed with sodium bicarbonate - are used as routine standard of care by
      radiologists today. The purpose of this study is to determine if either approach is more
      comfortable for patients having breast procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 Years of age

          -  Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging

        Exclusion Criteria:

          -  Less than 21 Years of age

          -  Allergic to Lidocaine or Sodium Bicarbonate

          -  Not mentally capable of consenting
Triomune Bioequivalence With Innovators
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Triomune; Zerit/Epivir/Viramune
Intervention description: Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day; Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.
Intervention MeSH terms: Lamivudine; Nevirapine; Stavudine; Stavudine, lamivudine, nevirapine drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV;Bioequivalence;Triomune

Summary:

      The null hypothesis is that there is a difference in the the relative rate and extent of
      absorption into the systemic circulation of Triomune and brand-name
      Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is
      that there is no difference in the the relative rate and extent of absorption into the
      systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in
      HIV-infected Africans. This is a non-inferiority study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV-infected men and non-pregnant women;

          2. On Triomune for at least 4 weeks;

          3. 18 years or greater;

          4. Residing within 15km of Kampala city center

        Exclusion Criteria:

          1. Unable to sign or understand informed consent

          2. Concurrent medication known to interact with any of the components of Triomune

          3. Patients with active TB, malabsorption, nausea, emesis, abdominal discomfort, chronic
             diarrhoea, documented active clinically relevant hepatitis;

          4. Patients expected to change their drug regimen or dosage during the study

          5. Those planning to move out of Kampala in the next two months;

          6. Hemoglobin <7.0 mmol/l (men) or <6.5 mmol/l (women);

          7. Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of
             normal;

          8. Serum creatinine > 1.5 times the upper limit of normal