bioihbjkbjnl/mcl2 huggingface dataset:
Haloperidol vs Conventional Therapy for Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Haloperidol; Conventional Therapy
Intervention description: Intravenous dose of haloperidol 5 mg.; Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Randomized controlled trial comparing haloperidol combined with conventional therapy and
      conventional therapy alone in patients with symptomatic gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous diagnosis of GP including those without formal gastric emptying studies.

          -  Patients presenting with unresolving nausea, vomiting, and abdominal pain that is
             attributable to their GP.

        Exclusion Criteria:

          -  History of QT prolongation or presence on a 12 leads electrocardiogram.

          -  Presence of concomitant acute abdominal pathology including but not limited to
             hepatobiliary disease, ischemia, and abdominal aneurysm.

          -  Prisoners

          -  Hypotension (systolic blood pressure below 90 mm Hg)

          -  Pregnant women

          -  Patients who are cognitively impaired and/or unable to consent for the study

          -  Age <18

          -  Allergy to haloperidol
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
Condition: Anemia, Iron Deficiency; Delivery Complication
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferrous sulfate; Iron dextran
Intervention description: one tablet 325 milligrams three times a day; 1000 mg intravenous infusion
Intervention MeSH terms: Dextrans; Iron-Dextran Complex
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blinded placebo controlled clinical trial. We will be using intravenous and oral placebos for each interventions
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postpartum, iron deficiency anemia, intravenous iron

Summary:

      This trial will be a comparative pragmatic open label feasibility randomized controlled trial
      of oral daily versus IV iron in anemic postpartum patients.

      Two randomly assigned groups will be compared during the postpartum period:

        1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6
           weeks TID.

           IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home
           over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.

        2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9%
           500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron
           dextran infusion in 100mL 0.9% sodium chloride.

      2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Delivery at our institution

          -  Hemoglobin below 9 g/dl in postpartum day 1

          -  Singleton gestation

        Exclusion Criteria:

          -  Diagnosis of malabsorptive disorder or history of gastric bypass procedure

          -  Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia,
             sickle cell, etc.)

          -  Significant cardiovascular disease, including but not limited to myocardial infarction
             or unstable angina within 6 months prior to study inclusion or current history of NYHA
             Class III or IV congestive heart failure

          -  Patient has received blood transfusion or there is a plan to transfuse

          -  Lactose intolerance
Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Condition: Clostridium Difficile Infection; Prophylaxis; Vancomycin
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Vancomycin Oral
Intervention description: This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Intervention MeSH terms: Vancomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if oral vancomycin used as primary Clostridium
      difficile prophylaxis can reduce the incidence of this infection in high-risk patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  "High-risk" patients defined as: age older than 65, on gastric acid suppression, and
             select antibiotics

          -  Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor
             antagonists

          -  Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin),
             clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin
             (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem

        Exclusion Criteria:

          -  Failure to meet all three requirements for "high risk"

          -  Vancomycin allergy

          -  Active clostridium difficile infection prior to inclusion

          -  Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin
             taper)

          -  Receipt of medications that also treat Clostridium difficile (metronidazole,
             rifaximin, fidaxomicin)

          -  Pregnant or breastfeeding
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Mencevax ACWY
Intervention description: 1 subcutaneous injection.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 249.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Meningococcal disease; Meningitidis serogroups A, C,W & Y diseases; Meningococcal vaccine

Summary:

      GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal
      Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to
      collect clinical data in the local target population in order to assess the occurrence of
      rare adverse events after vaccination as per the requirement of Philippines Bureau of Food
      and Drugs Directive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parent/guardian can and
             will comply with the requirements of the protocol.

          -  A Filipino male or female > 2 years of age at the time of the first vaccination.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Written informed consent obtained from the subject and/or from the parent/ guardian of
             the subject.

        Exclusion criteria:

          -  Subjects suffering from acute severe febrile illness.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant.

          -  History of chronic alcohol consumption and/or intravenous drug abuse.

          -  Any contraindications as stated on the Prescribing Information.
A Study to Compare Neostigmine vs Sugammadex in Length of PACU Stay in Patients Undergoing Sleeve Gastrectomy Surgery
Condition: Postoperative Nausea and Vomiting; Respiratory Conditions Due to Other External Agents
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Intervention: Sugammadex; Neostigmine
Intervention description: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.; Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sugammadex; post anesthesia care unit recovery

Summary:

      The investigators will track bariatric patients who received sugammadex versus neostigmine in
      the post anesthesia care unit until discharge and assess their length of stay and possible
      nausea / vomiting / hypoxia episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients having sleeve gastrectomy

          -  Surgeries performed by a particular surgeon - Dr. Sam Wasser

          -  Body Mass Index greater than 35

          -  American Society of Anesthesiologists Score II and III patients

        Exclusion Criteria:

          -  Patients having a different type of bariatric surgery including but not limited to
             duodenal switch, gastric bypass, hand-assisted laparoscopic sleeve gastrectomy

          -  Sleeve gastrectomy's performed by other surgeons than Dr. Sam Wasser.

          -  Pregnancy

          -  Allergic to sugammadex, Zofran or scopolamine

          -  Chronic Obstructive Pulmonary Disease or Asthma that is uncontrolled

          -  American Society of Anesthesiologists Score I, IV, V patients
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male; Pain, Postoperative
Intervention: Liposomal Bupivacaine; Standard Bupivacaine
Intervention description: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.; After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study model is a randomized double blind control trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The study is a drug trial comparing the post-operative pain control provided by liposomal
      bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the
      local anesthetic) for men undergoing testicular sperm extraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men scheduled for surgical sperm retrieval for infertility

          -  Men 18 years and older who can provide informed consent

          -  No documented allergy to bupivacaine or celecoxib

        Exclusion Criteria:

          -  Prior history of substance abuse

          -  Any narcotic use within the last 3 months

          -  Concomitant use of aspirin

          -  Any of the following comorbidities: renal failure, heart disease, peptic ulcer
             disease, cerebrovascular disease, significant liver disease, untreated depression,
             chronic pain disorder, or bleeding diatheses

          -  Medical history or concurrent illness that the investigator considers sufficiently
             serious to interfere with the conduct, completion, or results of this trial, or
             constitutes an unacceptable risk to the subject
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Trifarotene cream; Doxycycline hyclate; Trifarotene Vehicle; Doxycycline Placebo
Intervention description: Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.; Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.; Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.; Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
Intervention MeSH terms: Doxycycline; Trifarotene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 202.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789)
      50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and
      effective for the treatment of severe AV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4
             (Severe)

          -  Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to
             120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2
             nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose

          -  Agrees to provide written informed consent

          -  Participant is a female of non-childbearing potential (premenarchal or postmenopausal
             [absence of menstrual bleeding for 1 year prior to Screening, without any other
             medical reason], hysterectomy or bilateral oophorectomy)

        Exclusion Criteria:

          -  Participant with any acne cyst on the face

          -  Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne
             (chloracne, drug-induced acne, etc.)

          -  Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion,
             eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments
             in the opinion of the investigator

          -  Participants who is at risk in terms of precautions, warnings, and contraindications
             for trifarotene or doxycycline hyclate

          -  Currently receiving any prescription testosterone therapy (e.g., testosterone
             cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or
             on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone
             [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate,
             testosterone propionate, testosterone phenylpropionate) or testosterone supplements
             (e.g., Tribulus).
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Lastacaft ®; Tears Naturale ® (Placebo)
Intervention MeSH terms: Alcaftadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by
      In-Vivo Confocal Microscopy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a positive history of ocular allergies and a positive skin test to protocol
             defined allergens

          -  Have a positive CAC reaction at Visit 1

          -  Have a positive conjunctival inflammation score at Visit 1

        Exclusion Criteria:

          -  May not use disallowed medications in specified washout period

          -  May not have an ocular or system disease the investigator feels with impact subject
             safety or trial parameters

          -  May not have active ocular infection
Intravenous Lidocaine and Ketorolac for Pain Management
Condition: Pain
Intervention: Lidocaine; Ketorolac Tromethamine; Normal Saline Drip; Normal Saline Push
Intervention description: 1.5 mg/kg IV lidocaine drip (given over 10 minutes); IV ketorolac 30mg push; Normal Saline Drip Placebo given over 10 minutes; Normal Saline Push Placebo
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Pain; Lidocaine; Ketorolac

Summary:

      The literature regarding analgesic modalities, their combinations and routes of
      administrations for patients with pain related to renal colic is expanding. NSAID's (IV
      ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic either
      alone or in combinations. Despite their synergism and analgesic superiority when administered
      together, both classes of these medications possess a set of unfavorable side effects that
      limit their use. Emerging data of the use of IV lidocaine for patients with renal colic
      demonstrated good analgesic efficacy and safety profile. However, none of the trials directly
      compared lidocaine to ketorolac or the combination of both as viable options in patients
      unable to tolerate or to have serious contraindications to opioids. We designed a
      double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and
      feasibility of non-opioid analgesics and their combinations in patients with renal colic. The
      hypothesis and proposed study will try to determine if a combination of IV lidocaine and
      reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid
      analgesic modality is effective for controlling pain of renal colic origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Emergency Medicine Patient

          -  clinical diagnosis of acute renal colic

          -  pain score of >=5 out of 10 on the numeric rating scale

          -  - age 18 - 64 years of age

        Exclusion Criteria:

          -  documented or suspected pregnancy, breastfeeding

          -  contraindication to nonsteroidal anti-inflammatory drugs or lidocaine

          -  known renal dysfunction

          -  received analgesics within 4 hours before presentation

          -  history of bleeding diathesis

          -  history of peptic ulcer disease

          -  current use of warfarin

          -  HR<50 or >150

          -  history of cardiac arrhythmias

          -  peritonitis or presence of any peritoneal sign

          -  altered mental status

          -  weight > 100kg
Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
Condition: Shock, Surgical; Shock; Hypotension and Shock; Kidney Transplant; Complications; Intraoperative Hypotension; Postoperative Hypotension
MeSH terms: Hypotension; Shock; Shock, Surgical
Intervention: Angiotensin II
Intervention description: If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.
Intervention MeSH terms: Angiotensin II; Giapreza; Angiotensinogen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current standard of catecholamine vasopressor management of perioperative hypotension in
      kidney transplant patients carries significant risks and falls short in many ways. Currently,
      there is an absence in the scientific literature and research describing the hemodynamic
      effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang
      II) in perioperative kidney transplant patients. Phase 3 registration trials have
      demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock
      patients compared to traditional vasopressor agents and the novel mechanism of action may
      provide additional protection in renal transplant patients. The pilot study entails giving
      informed and consenting kidney transplant recipients Ang II (Giapreza) as their first
      vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in
      kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic
      effects of Ang II (Giapreza) in the renal transplant population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients > 18 years of age

          -  Receiving deceased donor kidney transplant

          -  Pre-transplant Ejection Fraction (within past 18 months) > 50%

          -  Intraoperative or postoperative distributive shock (according to hospital and study
             protocol) requiring vasopressor support

        Exclusion Criteria:

          -  Pregnant patients (they would be excluded from receiving a transplant)

          -  Prisoners

          -  History of mesenteric ischemia

          -  History of aortic dissection

          -  History of abdominal aortic aneurysm

          -  Allergy to mannitol

          -  Absolute neutrophil count < 1000 cell/mm3 (within past 18 months)

          -  Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease