bioihbjkbjnl/mcl2 huggingface dataset:
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Antipyrine and Benzocaine otic solution; Antipyrine Otic Solution; Benzocaine Otic Solution; Placebo Otic solution
Intervention description: antipyrine 54 mg and benzocaine 14 mg; Antipyrine 54 mg and glycerine dehydrated to 1.0 mL; benzocaine 14 mg and glycerine dehydrated to 1.0 mL; Placebo otic solution will be glycerin that is dehydrated
Intervention MeSH terms: Antipyrine; Benzocaine; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 2 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective is to compare the effect of treatment with a combination of ear
      solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute
      otitis media.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical Diagnosis of Acute Otitis Media

          -  Moderate to severe pain

          -  Normally active and in good health as determined by the PI

          -  Parent or legal guardian consent

          -  Caregiver available to complete diaries during study

        Exclusion Criteria:

          -  History of or current Perforated tympanic membrane

          -  Tympanostomy tubes

          -  Acute or chronic otitis externa

          -  seborrheic dermatitis

          -  Received any otic topical or systemic antibiotic within 14 days of enrollment

          -  Receiving medication on a chronic basis for pain

          -  Known hypersensitivity to investigational product.

          -  clinical significant mental illness as determined by the PI

          -  Exposed to another investigational agent within 30 days before study entry. Any
             condition the PI believed will interfere with the ability to comply with all study
             procedures

          -  History of glucose 6-phosphate dehydrogenase deficiency

          -  History or currently anemic

          -  Congenital methemoglobinemia

          -  Recent history of acute gastroenteritis within 14 days of enrollment
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: 40 mg glatiramer acetate; Placebo
Intervention description: parenteral drug
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under
      the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone®
      (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting
      multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and
      neuroprotective properties, which are believed to be of therapeutic value in ALS. The study
      treatment duration is 1 year (52 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.

          2. Subject has experienced his/her first ALS symptoms within 3 years prior to the
             screening visit.

          3. Slow VC test equal or greater than 70% of the predicted value.

          4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.

          5. Stable dose of riluzole for at least 8 weeks prior to screening.

          6. Age - 18-70 (inclusive).

        Exclusion Criteria:

          1. The use of invasive or non-invasive ventilation.

          2. Subject having undergone gastrostomy.

          3. Subject with any clinically significant or unstable medical condition.

          4. Subjects participating in any other clinical trial (within 12 weeks prior to screening
             and thereafter).

          5. Additional criteria per protocol.
Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Condition: Cerebral Vasospasm
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Intervention: Milrinone; Placebo
Intervention MeSH terms: Milrinone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subarachnoid Hemorrhage; Cerebral Vasospasm; Milrinone; Hyperdynamic Therapy

Summary:

      The purpose of this study is to evaluate the usefulness of adding Milrinone to the current
      standard treatment for cerebral vasospasm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age

          -  Aneurysmal subarachnoid hemorrhage, proven on CT angiogram or digital subtraction
             angiography

          -  Aneurysm treated, either by endovascular embolization or surgical clip ligation

          -  Evidence of increased velocities on transcranial dopplers (TCDs) and/or radiographic
             evidence of vasospasm as seen on angiogram

          -  Cerebral vasospasm as demonstrated by patient's clinical exam (new focal deficit or
             change in mental status not attributable to any other cause)

        Exclusion Criteria:

          -  Recurrent subarachnoid hemorrhage

          -  Untreated ruptured aneurysm, for any reason

          -  Patients who die prior to treatment for aneurysm

          -  Patients who are not able to complete at least 6 months of follow-up

          -  Patients who are admitted already in vasospasm (i.e. a delayed admission)

          -  Creatinine clearance less than 20 ml/min

          -  Women with a positive pregnancy test or who are lactating

          -  Other comorbidity which may adversely affect patient outcome, at the discretion of the
             principal investigator
Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor
Condition: Cesarean Section; Surgical Site Infection; Nosocomial Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Cross Infection
Intervention: 2% chlorhexidine gluconate cloth; 4% Chlorhexidine gluconate vaginal scrub
Intervention description: applied to their abdomen; applied as a vaginal cleanse in the operating room prior to cesarean section
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 319.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cesarean section; Labor; Surgical Site Infections; Chlorhexidine gluconate

Summary:

      Surgical site infections (SSI) are the second most common cause of nosocomial infections
      accounting for 15% of all nosocomial infections among hospitalized patients and 38% of
      nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e.
      SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal
      deliveries. Additionally, infectious morbidity is thought to be highest in those patients who
      have cesarean sections after undergoing labor.

      Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria,
      reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI.

      Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant
      surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is
      limited. This study intends to evaluate the effectiveness of use of both chlorhexidine
      gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean
      section that have previously been laboring. Patients will be randomized to one of two groups:
      wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal
      scrub in addition to standard preoperative scrub as compared to standard preoperative scrub
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women at > 24 weeks gestation who are admitted in labor or admitted for induction of
             labor at Mount Sinai Hospital

        Exclusion Criteria:

          -  Allergy to chlorhexidine

          -  Unplanned or emergency cesarean section

          -  Women at <24 weeks gestation

          -  Estimated fetal weight <500 grams

          -  Fetal face presentation regardless of gestational age.
Neuromuscular Blockade in Patients With Severe Renal Impairment
Condition: Neuromuscular Blockade; Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Cisatracurium + Neostigmine; Rocuronium + Sugammadex
Intervention description: Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate; Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex
Intervention MeSH terms: Rocuronium; Cisatracurium; Neostigmine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single site, randomized, controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blinded
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is intended to be a single-site, prospective, randomized, double-blinded study
      that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery
      with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to
      receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of
      rocuronium). A standardized anesthetic protocol that is usual and customary for the type of
      operation the patient is having will be provided to the anesthesia teams of enrolled
      subjects. The remainder of the anesthetic care of the subject will not deviate from the
      standard of care. All patients will be monitored with continuous pulse oximetry
      postoperatively for 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-80 years old

          -  Severe renal impairment (CrCl < 30 mL/min)

          -  Undergoing non-emergent surgery that requires neuromuscular blockade

          -  Planned extubation in the operating room immediately after surgery

          -  American Society of Anesthesiologists (ASA) physical status classification 3 to 4

          -  Willing and able to consent in English or Spanish

          -  No personal history of neuromuscular disease

        Exclusion Criteria:

          -  Age less than 18 or older than 80

          -  Patient does not speak English or Spanish

          -  Planned postoperative intubation/ventilation

          -  Allergy to sugammadex, neostigmine, glycopyrrolate, cisatracurium, or rocuronium

          -  Family or personal history of malignant hyperthermia

          -  Patient refusal

          -  Pregnant or nursing women

          -  "Stat" (emergent) cases

          -  Pre-existing muscle weakness of any etiology

          -  Patients on toremifene (a selective estrogen receptor modulator)

          -  Women on oral contraceptives who do not wish to use a non-hormonal method of
             contraception for 7 days following surgery
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; 13vPnC
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a
      Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days)
             at the time of consent (the day of birth is considered day of life 1).

          -  Healthy infant determined by medical history, physical examination, and clinical
             judgment to be eligible for the study.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal vaccine.

          -  Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.

          -  Previous receipt of >1 dose of hepatitis B vaccine.

          -  Prior hepatitis B vaccine must have been administered at age <30 days.

          -  Major known congenital malformation or serious chronic disorder. Receipt of
             blood/plasma products or immunoglobulins
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
Condition: Spinal Cord Injury; Bone Loss; Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Intervention: Alendronate; Calcium; Vitamin D
Intervention description: Weekly oral alendronate 70 mg for 12 months; Daily oral 1000 mg Calcium; Daily oral 1000 IU
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Alendronate; Vitamins; Calcium Carbonate; Antacids; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Teriparatide; Alendronate; Alendronic Acid; Osteoporosis; Bone Fracture; Bone Loss; Spinal Cord Injury; Bone Diseases; Metabolic Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Nervous System; Wounds and Injuries; Bone Density Conservation Agents; Physiological Effects of Drugs; Pharmacologic Actions

Summary:

      The purpose of this study is to determine if a year of alendronate treatment will maintain or
      increase bone mass density (BMD) compared to baseline BMD values in people with chronic
      spinal cord injury (SCI).

      This study will also investigate 1) if alendronate therapy will increase bone strength in
      people with chronic SCI, 2) the number of participants with adverse events from alendronate,
      and 3) the effects of alendronate on serum markers of bone metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination on
             Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT01225055).

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for
             the duration of study participation, and for 90 days following completion of therapy.

          -  Ability to understand and the willingness to sign a written informed consent.

        Exclusion Criteria:

          -  Individual with renal insufficiency (calculated creatinine clearance < 30 ml/min).

          -  Individuals who are not able to sit or stand upright for at least 30 minutes after
             taking their medication.

          -  Individuals with poor dental hygiene.

          -  Individuals with esophageal abnormalities.

          -  Individuals who are not able to tolerate alendronate treatment.

          -  Individuals who will not be able to return for all study visits.

          -  Patients may not be receiving any other investigational agents.

          -  Other medical conditions that in the opinion of the investigator would preclude the
             subject from completing the study
Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
Condition: Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Intervention: ondansetron; placebo ondansetron; Ondansetron
Intervention description: ondansetron 0.2 mg bid, oral preparation, 16 weeks; Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.; Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Intervention MeSH terms: Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous
      drinking, HIV-infected men and women, using the serotonin receptor (5-HT3) antagonist
      ondansetron. The investigators predict that participants who are treated with active doses of
      ondansetron will reduce their drinking more and show better HIV treatment participation and
      progress compared to participants who are treated with placebo. This study will provide
      important new safety and efficacy results on drinking and HIV outcomes following alcohol
      pharmacotherapy in HIV-infected persons.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be at least 18 years old and HIV-infected

          -  All subjects will be actively drinking at hazardous levels (1) AUDIT score => 4 for
             women or =>8 for men, or 2) => 2 binge drinking episodes/month, or 3) >7 drinks/week
             for women or >14 drinks/week for men)

        Exclusion Criteria:

          -  Liver Function Tests (LFTs) > 5 X normal

          -  Magnesium or potassium > 3 X normal

          -  Qtc => .460 and or a family history of long QT syndrome (LQT)

          -  Inability to read and comprehend English

          -  Actively psychotic or other severe mental health symptoms that would prevent
             appropriate participation

          -  Current enrollment in alcoholism treatment program

          -  Pregnancy; Ondansetron is currently a category B drug. While animal data have not
             identified any harmful effects to mother or fetus, there have not been adequate human
             controlled trials to recommend routine use in this population
A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3209590; Insulin Degludec
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3209590 is safe and effective in
      participants with type 2 diabetes that have already been treated with basal insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria
             treated with basal insulin and up to 3 of the following oral antihyperglycemic
             medication (OAM):

               -  dipeptidyl peptidase-4 (DPP-4) inhibitors

               -  sodium-glucose cotransporter (SGLT-2) inhibitors

               -  biguanides

               -  alpha-glucosidase inhibitors

               -  sulfonlyureas

          -  HbA1c value of 6.5% to 10%, inclusive

          -  Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

        Exclusion Criteria:

          -  Type 1 diabetes mellitus or latent autoimmune diabetes

          -  Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to screening

          -  Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New
             York Heart Association Class III or IV heart failure, or cerebrovascular accident
             (stroke)

          -  Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver
             disease

          -  Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2

          -  Active or untreated malignancy

          -  Chronic (>14 days) systemic glucocorticoid therapy