bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Oral Antibiotic Treatment on C. Difficile
Condition: C. Difficile; Diarrhea; Enterocolitis
MeSH terms: Enterocolitis; Diarrhea
Intervention: Fidaxomicin; Metronidazole; Vancomycin
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Vancomycin; Fidaxomicin; Amebicides
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The overall aim is to characterize and to compare the extent and quantity of C. difficile
      stool shedding, perianal colonization and environmental contamination in patients who
      received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective,
      randomized, microbiologic and molecular, study of environmental contamination from patients
      with proven C. difficile associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients with microbiology-proven CDAD

          -  provides informed consent

          -  eligible to receive oral antibiotic therapy

        Exclusion Criteria:

          -  prisoners

          -  pregnant women

          -  children <18 years

          -  patients who have contra-indications for perianal swabs, those who has medical
             conditions that would invalidate the results of the swabs

          -  patients requiring intravenous therapy for treatment of CDAD

          -  patients who do not consent and those who withdraw consent
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Condition: Bacterial Infections; Acute Bacterial Skin and Skin Structure Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial
Intervention: Dalbavancin; Usual Care
Intervention description: Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.; Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Intervention MeSH terms: Dalbavancin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Critical Pathways; Health Facilities; Clinical Protocols; Patient Satisfaction; Absenteeism; Anti-Bacterial Agents; Quality of Life; Economics, Medical; Health Resources; Health resource utilization; Acute bacterial skin and skin structure infection (ABSSSI)

Summary:

      The purpose of this study is to assess the effect of a new critical pathway (use of
      guideline-based patient identification criteria and for those who meet these criteria, use of
      dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin
      Structure Infections)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted patients who meets the clinical definition for Acute Bacterial Skin and Skin
             Structure Infections (ABSSSI)

          -  Known or suspected gram-positive infection.

        Exclusion Criteria:

          -  Known or suspected gram-negative infections, anaerobic infections, or fungemia

          -  Known or suspected infections that are severe, life threatening or are not included in
             the ABSSSI Food and Drug Administration (FDA) guidance

          -  Injection drug users with a fever

          -  Severe neurological disorder leading to immobility or confined to a wheelchair

          -  Bilateral Lower extremity involvement of the suspected infection.
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Adalimumab; Methotrexate
Intervention MeSH terms: Adalimumab; Methotrexate; Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine changes in immune cells and proteins in response to
      treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus
      adalimumab, both given in combination with methotrexate.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Symptoms of RA for no more than 12 months prior to enrollment

          -  Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR)
             2010 criteria for classification of RA

          -  Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a
             stable oral dose for at least 4 weeks, Subjects must randomize on the maximum
             tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week),
             dose of MTX < 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to
             higher doses

          -  At least 3 tender & 3 swollen joints

          -  Anti-cyclic citrullinated peptide (CCP) > 3X the upper limit of normal and positive
             rheumatoid factor

        Exclusion Criteria:

          -  History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus,
             etc)

          -  Prior use of non-biologic therapy other than methotrexate

          -  Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs
             (DMARD) therapy

          -  Subjects with chronic or recent acute serious infection

        Other protocol defined inclusion/exclusion criteria could apply
The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations
Condition: Snake Envenomation
MeSH terms: Poisoning; Snake Bites
Intervention: Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy); Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy); Placebo
Intervention description: Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; active maintenance therapy with 2 vials administered 6, 12, and 18 hours after initial control is achieved.; Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; placebo maintenance therapy administered 6, 12, and 18 hours after initial control is achieved.; Placebo therapy in place of initial and maintenance antivenom therapy. Note that open-label rescue therapy is mandated if the envenomation syndrome becomes severe, or if progression of envenomation signs/symptoms has not spontaneously halted by 6 hours.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 12 Months
Healthy volunteers: No
Keywords: Snake envenomation; Antivenins; Disability evaluation; Activities of daily living

Summary:

      Most patients bitten by copperhead snakes do not currently receive antivenom. Some snakebite
      victims have long term problems with the function of the limb that was bitten. This study
      will determine whether early administration of antivenom to patients with mild to moderate
      copperhead snakebites reduces long-term complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Envenomation by copperhead snake (Agkistrodon contortrix) within 6 hours

          -  Mild or moderate severity envenomation

        Exclusion Criteria:

          -  Allergy to antivenom or components

          -  Severe envenomation (hypotension, severe swelling, compartment syndrome, bleeding,
             etc.)

          -  Uncertain snake ID

          -  Prior treatment with antivenom
Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients
Condition: Surgical Conditions
MeSH terms: Disease
Intervention: Rocuronium
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized control trial (RCT) that studies the surgical conditions during moderate
      and deep neuromuscular blockade in 100 morbidly obese patients receiving elective
      laparoscopic surgery for bariatric surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I-III

          -  BMI > 34 kg/m2

          -  Elective bariatric surgery.

        Exclusion Criteria:

          -  Known or suspected neuromuscular disorders impairing neuromuscular function

          -  Allergies to muscle relaxants, anesthetics or narcotics

          -  A(family) history of malignant hyperthermia

          -  Women who are or may be pregnant or are currently breast feeding

          -  Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output <
             0.5 ml/kg/h for at least 6 h.
A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: 0.1% brimonidine tartrate ophthalmic solution; 0.01% bimatoprost ophthalmic solution; 0.2% hypromellose lubricant eye drops; latanoprost 0.005% ophthalmic solution
Intervention description: 1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.; 1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.; 1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.; 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
Intervention MeSH terms: Brimonidine Tartrate; Bimatoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic
      solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine
      tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated
      with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular
      pressure (IOP) lowering medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or glaucoma in at least 1 eye

          -  Visual acuity of 20/100 or better in both eyes

        Exclusion Criteria:

          -  Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)

          -  Intraocular or glaucoma surgery in the past 3 months
Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients
Condition: Obesity
Intervention: DMAC; CMAC
Intervention description: The D blade will constitute the experimental treatment and in a cross over fashion will be tested against CMAC blade; The CMAC Blade will constitute the active comparator treatment and in a cross over fashion will be tested against D-blade
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Laryngoscopy; Airway Management; Intubation

Summary:

      The investigators hypothesize that the D-MAC (Dblade with C-MAC system) may be a suitable
      alternative device for difficult laryngoscopy and tracheal intubation in morbidly obese
      patients. The D-MAC will enable superior view of the glottic structures as well as easier
      endotracheal intubations than the C-MAC blade. This is the first study to investigate the
      individual and comparative performances of C-MAC and D-MAC in this patient cohort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years

          -  ASA I-III

          -  BMI ≥ 40 kg/m2

        Exclusion Criteria:

          -  Necessary awake intubation

          -  Mallampati IV

          -  < 2 finger breath or 4 cm mouth opening

          -  Previous history of difficult intubation

          -  ASA IV-V

          -  Unstable cervical, thoracic and/or lumbar fracture

          -  Known history of congestive heart failure or a severe disease that alters pulmonary
             mechanics (e.g. chronic obstructive pulmonary disease, restrictive lung diseases)
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
Condition: Hypertension
MeSH terms: Hypertension
Intervention: HCTZ + Amlodipine; Valsartan/HCTZ
Intervention description: 12.5 mg HCTZ capsules
25 mg HCTZ capsules
5 mg amlodipine capsules
10 mg amlodipine capsules; 160 mg film-coated valsartan tablets
320 mg film-coated valsartan tablets
12.5 mg HCTZ capsules
25 mg HCTZ capsules
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 412.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Obesity, hypertension, valsartan/hydrochlorothiazide

Summary:

      The purpose of this study is to compare the blood pressure lowering efficacy of
      valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of
      obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  40 years of age or older

          -  Moderate or severe high blood pressure defined as systolic blood pressure (the top
             number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom
             number) less then 110 mmHg

          -  Central (abdominal) obesity

        Exclusion Criteria:

          -  Systolic blood pressure (the top number) greater than or equal to 180 mmHg and
             diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg

          -  Currently taking more then 3 medications to treat high blood pressure

          -  Inability to stop all current blood pressure medications if any up to 4 weeks

          -  History of Type 1 or Type 2 diabetes

          -  History of stroke, mini-stroke (transient ischemic attack) or heart attack within the
             last 6 months

          -  History of or current diagnosis of congestive heart failure

          -  History of cancer within the past 5 years with the exception of localized basal cell
             carcinoma or squamous cell carcinoma

          -  Women who are pregnant or nursing

          -  Alcohol or drug abuse within the last 2 years

        Other protocol-defined inclusion/exclusion criteria may apply
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture; Contracture
Intervention: XIAFLEX
Intervention description: One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Dupuytren's Contracture

Summary:

      The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal
             joint of the 4th or 5th finger.

          -  Subject has only one finger affected by the disease.

          -  Patients will be 35 years of age of older.

          -  Patients will be able to read, speak, and understand English or have available
             adequate translation assistance and be able to provide voluntary written consent to
             participate.

        Exclusion Criteria:

          -  Female patients who are nursing or pregnant, or plan to become pregnant during the
             treatment phase.

          -  Patient has a chronic muscular, neurological or neuromuscular disorder that affects
             the hands.

          -  Patient has known allergy to collagenase or any other excipient of Xiaflex.

          -  Patient has received any collagenase treatments before the first dose of Xiaflex.

          -  Patient with abnormal coagulation, including patients who have received anticoagulant
             medications other than low-dose aspirin within 7 days of the injection.
Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone
Condition: Anxiety
Intervention: meloset (melatonin); stresnil ( melatonin and alprazolam); (alprax) alprazolam; placebo
Intervention description: 3 mg melatonin tablet 1-2 hour prior surgery; 3 mg melatonin and 0.5 mg alprazolam 1-2 hr before anesthesia; 0.5 mg alprazolam; similar looking placebo tablet
Intervention MeSH terms: Melatonin; Alprazolam; Azaperone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: premedication; premedicants; preoperative anxiety; melatonin; alprazolam

Summary:

      Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and
      thus paradoxically increases episodes of arousal during sleep and thus causes restlessness
      and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the
      perception of sound sleep in the perioperative period.

      Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will
      be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of
      0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P),
      approximately 90 minutes before surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  (ASA 1&2),

          -  aging 18 to 65 years

          -  having anxiety VAS score of more than 2

          -  posted for general anaesthesia with estimated duration of < 3 hours.

        Exclusion Criteria:

          -  patients taking analgesics, sedatives, antiepileptics or antidepressants,

          -  suffering from obesity (BMI ≥ 28) or neuropsychiatric disease,

          -  having allergy to the study drugs
HCV Positive Heart Donors
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Transplant with HCV positive donor, followed by surveillance and treatment of viremia
Intervention description: Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Healthy volunteers: No

Summary:

      Study subjects active on the waiting list for a heart transplant at the NYU Langone
      Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from
      a donor who tests positive for HCV. The study will entail surveillance for the development of
      HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated
      with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are
      treated with Mavyret will be monitored for clearance of viremia and for sustained virologic
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Listed for an isolated heart transplant at NYU Langone Health

          -  Able to travel to the NYU Langone Health for routine post-transplant visits and study
             visits for a minimum of 6 months after transplantation

          -  No active illicit substance abuse

          -  Weight at least 50kg

          -  Women of childbearing potential must agree to use birth control in accordance with
             Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to
             the increased risk of birth defects and/or miscarriage

          -  Both men and women must agree to use at least one barrier method after transplant to
             prevent any secretion exchange

          -  Able and willing to provide informed consent

        Exclusion Criteria:

          -  HIV positive

          -  HCV RNA positive or history of previously treated HCV

          -  Hepatitis B surface antigen positive or on active antiviral treatment for HBV

          -  Pregnant or nursing (lactating) women

          -  Use of strong CYP3A inducers