bioihbjkbjnl/mcl2 huggingface dataset:
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Condition: Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
MeSH terms: Pain, Postoperative
Intervention: diclofenac; Norco
Intervention description: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.; The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Intervention MeSH terms: Acetaminophen; Diclofenac; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the level of pain control in patients receiving
      non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the
      postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  english speaking

          -  candidates for endoscopic sinus surgery as determined by medical necessity by the
             treating rhinologist

          -  scheduled for surgery at Texas Sinus Institute

        Exclusion Criteria:

          -  allergy to either NSAIDs or opioids

          -  contraindication to NSAIDs (ex. gastritis, chronic kidney disease)

          -  surgical plan exceeding basic endoscopic sinus surgery

          -  use of anticoagulation

          -  the presence of any pain disorder

          -  the current usage of any analgesic medication

          -  history of opioid addiction

          -  pregnancy

          -  history of chronic pain or fibromyalgia

          -  current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin,
             tramadol, etc)
Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation
Condition: Acute Respiratory Failure; Intubation Complication
MeSH terms: Respiratory Insufficiency; Shock
Intervention: intravenous crystalloid fluid, 500 mL
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 337.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Endotracheal intubation is common in the care of critically ill patients. Complications of
      airway management in this setting are frequently encountered and may be associated with an
      increased risk of death. The prevention of complications during urgent and emergent
      endotracheal intubation is a key focus for airway management research. Post-intubation
      hypotension (PIH), a common complication of endotracheal intubation in the critically ill,
      may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but
      this approach has not been examined in a prospective trial. There are no randomized trials of
      intravenous fluid administration to prevent PIH in critically ill adults. The investigators
      propose a randomized trial of fluid loading to prevent PIH in critically ill adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is admitted to participating study unit

          -  Planned procedure is endotracheal intubation and planned operator is a provider
             expected to routinely perform endotracheal intubation in the participating unit

          -  Administration of sedation with or without neuromuscular blockade is planned

          -  Age ≥ 18 years old

        Exclusion Criteria:

          -  Operator believes fluid loading to be absolutely indicated or contraindicated for the
             safe care of the patient

          -  Urgency of intubation precludes safe performance of study procedures

          -  Pregnancy

          -  Prisoners

          -  Age < 18 years old
Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Condition: Cervical Cancer; Cervical Precancerous Lesions
MeSH terms: Uterine Cervical Neoplasms
Intervention: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
Intervention description: The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22729.0
Sex: Female
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen
      would offer similar immunogenicity and protection as that of a three-dose regimen to girls
      against persistent HPV infection and cervical neoplasia caused by HPV types included in the
      vaccine. The Government of India stopped vaccination in all the HPV vaccine trials in the
      country in April 2010 due to reasons not related to this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Apparently healthy, ambulant girls aged 10 - 18 years

          -  Unmarried girls

          -  Girls with intact uterus

          -  Resident in the villages chosen for the study

        Exclusion Criteria:

          -  Girls with any severe and/or debilitating illness

          -  Past history of allergy to any medication
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Condition: Gastroparesis; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Gastroparesis
Intervention: Immediate-release omeprazole; Delayed-release omeprazole
Intervention description: Immediate-release omeprazole 40 mg qam for 7 days; Delayed-release omeprazole 40 mg qam for 7 days
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gastroparesis; Gastroesophageal reflux disease; heartburn

Summary:

      The purpose of this study is to compare the blood drug levels of two prescribed medications,
      immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to
      determine which drug is better absorbed in patients with a slow stomach emptying
      (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug
      omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium
      bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a
      protective coating. Immediate-release omeprazole suspension may have a more rapid
      pharmacokinetic profile and greater overall drug absorption in gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning
             feeling rising from the stomach or lower chest up towards the neck"

          -  Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating,
             dyspepsia, early satiety, or effortless regurgitation.

          -  Prior abnormal 4-hour gastric emptying scan within the past 3 years

        Exclusion Criteria:

          -  History of esophageal or gastric surgery

          -  Severe gastroparesis with any of the following: vomiting with dehydration requiring IV
             hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding
             jejunostomy tubes

          -  Presence of gastric electrical stimulator

          -  Symptoms of retching with vomiting more than 2 days per week

          -  Diagnosis of diabetes

          -  Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)

          -  Disorders of small bowel absorption

          -  Diagnosis of gastric outlet, small bowel or colon mechanical obstruction

          -  Diagnosis of acid hypersecretory syndrome

          -  Disorders affecting proton pump inhibitor metabolism (such as liver failure)

          -  Known allergy or side effects to proton pump inhibitor

          -  Non-ambulatory patients: bed-ridden, nursing home resident, etc.

          -  Pregnancy
Assessing Pyridium for Post-Sling Urinary Retention
Condition: Urinary Retention
MeSH terms: Urinary Retention
Intervention: Phenazopyridine
Intervention description: to be given preoperatively
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 98.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Midurethral sling; Pyridium

Summary:

      There has been preliminary data showing that pyridium can decrease the risk of difficulty
      urinating after midurethral sling. This study is designed to have two groups of patients. One
      group will receive pyridium pre-operatively, while the other group will have routine
      preoperative care. Both groups will have their bladder tested prior to going home. It will be
      evaluated if there is a difference in the difficulty to urinate post-operatively in both
      groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any female patient undergoing a midurethral sling surgery, regardless of concomitant
             pelvic reconstructive or gynecological surgery

        Exclusion Criteria:

          -  Patients with complications from surgery requiring indwelling catheter,
             bladder/urethral perforation requiring indwelling catheter

          -  Acute bleeding requiring indwelling catheter for accurate urine output calculation

          -  Patients undergoing concomitant surgery other than gynecological, preoperative voiding
             dysfunction defined as postvoid residual >150cc, or spinal anesthesia

          -  Women who are pregnant, including women of childbearing age who test positive on
             preoperative urine pregnancy test
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: Amoxicillin-Potassium Clavulanate; Placebo
Intervention description: Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.; Patients in this arm will receive 7 days of placebo after surgery.
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic rhinosinusitis; Sinus surgery; Antibiotics

Summary:

      Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery.
      There is minimal data to support this. The investigators' study will aim to demonstrate that
      patients' quality of life and rate of post operative infection is the same whether they
      receive or do not receive antibiotics post operatively. The investigators hypothesis is that
      the disease specific quality of life of patients taking post-operative antibiotics is not
      inferior to the quality of life of patients who do not take post-operative antibiotics, and
      the rate of post-operative infections are the same. The investigators' specific aim is to
      compare validated symptom scores between post-operative populations who are given or are not
      given antibiotics. Rates of infections in the first 10 days after surgery will be recorded.
      The investigators will also compare endoscopic grades of sinus cavities during the
      post-operative follow up exams as an additional outcome measure.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by
        the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their
        surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy
        is defined as a course of broad spectrum or culture-directed antibiotics used in
        conjunction with a nasal steroid.

        Exclusion Criteria:

          1. Penicillin, cephalosporin, amoxicillin/clavulanate allergy

          2. Cystic Fibrosis

          3. Immunodeficiency

          4. Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery

          5. Odontogenic causes of sinusitis

          6. Fungal ball

          7. Infected mucocele

          8. Complication of sinusitis (meningitis, orbital complication, cellulitis, brain
             abscess)

          9. Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)

         10. Age <18

         11. Pregnant women
Tissue Sealant Use in LASIK Enhancement Surgery
Condition: Epithelial Ingrowth
Intervention: Tissue sealant
Intervention description: Application of tissue sealant on eyes undergoing LASIK enhancement
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LASIK, Ingrowth, Tissue sealant

Summary:

      The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent
      epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects age 21 and older

          -  Subjects with healthy eyes

          -  Subjects who have previously undergone LASIK surgery

          -  Subjects with residual refractive error.

        Exclusion Criteria:

          -  Subjects under the age of 21.

          -  Subjects with excessively thin corneas.

          -  Subjects with topographic evidence of keratoconus.

          -  Subjects with ectatic eye disorders.

          -  Subjects with autoimmune diseases.

          -  Subjects who are pregnant or nursing.
PRET: Patients Prone to Recurrence After Endovascular Treatment
Condition: Intracranial Aneurysm; Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Intracranial Aneurysm; Aneurysm; Hemorrhage; Recurrence
Intervention: endovascular coil embolization
Intervention description: standard endovascular coil embolization with or without adjunct techniques
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 447.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: large aneurysm; recurrence; hydrocoil

Summary:

      The PRET study aims at comparing two types of coils used in the endovascular treatment of
      intracranial aneurysms. The first type made of platinum has been used for more than 15 years.
      The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that
      expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET
      study is that the newer hydrocoil will be more effective and yet as safe as the older
      platinum coil.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting at least one aneurysm 'prone to recurrence after endovascular
             treatment' (PRET), defined for the sake of this study as:

               -  PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension
                  ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms);
                  for ruptured lesions, patients should be in WFNS grade I, II or III.

               -  PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and
                  judged by the neurovascular team to require elective treatment.

          -  The anatomy of the lesion is such that endovascular treatment is possible with both
             types of coils (not necessarily certain or probable)

          -  The endovascular physician is content to use either type of coils (platinum or
             hydrogel-coated coils) but no other type of coils

          -  Patient is 18 or older

          -  Life expectancy is more than 2 years

        Exclusion Criteria:

          -  Presence of other aneurysms requiring treatment during the same session

          -  Patients with associated cerebral arteriovenous malformations

          -  When parent vessel occlusion, without simultaneous endosaccular coiling of the
             aneurysm, is the primary intent of the procedure

          -  Any absolute contraindication to endovascular treatment, angiography, or anaesthesia
             such as severe allergies to contrast or medications
EASY: Extended Access to Sollpura Over Years
Condition: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Liprotamase
Intervention description: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No
Keywords: exocrine pancreatic insufficiency; cystic fibrosis; pancreatic enzyme replacement therapy

Summary:

      Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and
      amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be
      formulated without enteric coating for administration either as a capsule or as a dosing
      solution dissolved in water or juice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency
             who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral
             Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic
             Fibrosis)

        Exclusion Criteria:

          -  Any medical, psychological, or social condition that may put the subject at increased
             risk by participating in this study.

          -  Females who are nursing, pregnant, intending to become pregnant, or intending to nurse
             during the time of the study.
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
Condition: Endometriosis; Infertility
MeSH terms: Infertility; Endometriosis
Intervention: Leuprolide acetate in depot suspension; No intervention
Intervention description: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Female
Minimum age: 21 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Endometriosis,infertility,in vitro fertilization

Summary:

      This prospective randomized trial evaluates whether one can predict which infertile women
      with endometriosis who are candidates for in vitro fertilization will benefit from prolonged
      therapy with a GnRH agonist by the determination of the absence of endometrial expression of
      the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which
      all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for
      in vitro fertilization and then undergo randomization to a three month course of a depot
      preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian
      stimulation or standard therapy. prio
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infertility

          -  Surgical diagnosis of endometriosis

          -  Normal ovarian reserve testing

          -  Regular menses

        Exclusion Criteria:

          -  Irregular menses

          -  Undiagnosed abnormal uterine bleeding

          -  Pregnancy

          -  Prior adverse reaction to any GnRH agonist

          -  Ovarian cystic or solid mass > 3cm in mean diameter at study entry

          -  Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis
             within 6 months of study entry

          -  Current hepatic, renal, hematologic or psychiatric disorder
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