bioihbjkbjnl/mcl2 huggingface dataset:
Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery
Condition: Pain
Intervention: Intrathecal morphine; Placebo
Intervention description: 5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg; Saline intrathecal given in the same manner as the intervention groups.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomized into 2 groups. The placebo group will receive intrathecal saline. The morphine group will receive intrathecal morphine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All patients will receive intrathecal intervention and will not know which group they are assigned to. The provider performing the procedure and collecting the data will also be blinded to the intervention assignment.
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized clinical trial in patients undergoing robotic myocardial
      revascularization with intraoperative extubation. Patients will be randomized into placebo or
      intrathecal morphine groups to assess postoperative pain scores and patient satisfaction.
      Patients will also be assessed for side effects from the intervention.
    

Eligibility criteria:

        Inclusion Criteria:

        • patient undergoing elective robotic myocardial revascularization without anticipated use
        of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.

        Exclusion Criteria:

          -  Emergency surgery

          -  Preoperative use of inotropes/IABP

          -  Preoperative use of opoids

          -  Ejection fraction less than 40%

          -  Anticipated use of cardiopulmonary bypass

          -  Previous cardiothoracic surgery

          -  Anticipated postoperative tracheal intubation

          -  severe pulmonary disease

          -  morbid obesity (BMI >35 kg/m2)

          -  severe hepatic impairment

          -  severe renal dysfunction (creatinine > 1.5)

          -  any contraindication to intrathecal injection (patient refusal, difficult patient
             anatomy, pre-existing coagulopathy, morphine allergy)
Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Intervention: Hybrid regimen; Reverse hybrid regimen; Levofloxacin quadruple regimen
Intervention description: two-step (dual-quadruple) treatment; one-step two-phase (quadruple-dual) treatment; non-Clarithromycin non-Bismuth quadruple therapy
Intervention MeSH terms: Levofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled (interventional) study conducted at Zagazig University Hospital, internal medicine department clinic
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Helicobacter Pylori Infection; Quadruple Therapy; Egypt

Summary:

      The overall prevalence of H. Pylori in the developing countries is 50.8%, with the highest
      one presented in Africa (79.1%). Hybrid therapy is supposed to be more effective as a
      first-line regimen for Helicobacter pylori infection in Egypt than the Reverse hybrid and
      non-bismuth Levofloxacin quadruple therapies. We are aiming here to compare the Hybrid,
      Reverse hybrid, and Levofloxacin quadruple therapies as first-line therapy, trying to reach
      the safest, cost-effective, and compliance-inducing regimen in Egypt. We will conduct a
      randomized controlled (interventional) study at Zagazig University Hospital, internal
      medicine department clinic, on 330 patients. 110 patients will be allocated to each regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive Helicobacter pylori antigen in the stool

          -  Treatment-naive

        Exclusion Criteria:

          -  Previous treatment for Helicobacter pylori

          -  Drug hypersensitivity
Osimertinib Study in Indian Patients
Condition: Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Osimertinib
Intervention description: Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.
Intervention MeSH terms: Osimertinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Non small cell lung cancer (NSCLC)

Summary:

      This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of
      osimertinib in Indian adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient of either gender and ≥18 years of age

          2. Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an
             appropriate test, who have progressed on or after EGFR TKI therapy by an independent
             clinical judgment of treating physician based on locally approved prescribing
             information

          3. Each patient must sign an informed consent form (ICF)

        Exclusion Criteria:

          1. Patient with either the history of hypersensitivity to excipients of the study drug or
             to drugs with a similar chemical structure or class to the study drug.

          2. Pregnant and/or lactating women

          3. Patients participating in any current or future interventional trial will not be
             enrolled in the current study
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Condition: Mild Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Intervention: Glyburide; Placebo
Intervention description: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.; Sham dose adjustments of the placebo will be made.
Intervention MeSH terms: Glyburide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 395.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized prospective trial which addresses the question of whether use of an oral
      hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will
      result in achieving euglycemia in a shorter period of time and, in turn, result in less
      frequent maternal and neonatal morbidities. This study is designed to test the hypothesis
      that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling
      lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at
             gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical
             information

          -  An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl

          -  Gestational age of less than or equal to 28 weeks and 0 days at the time of
             consent/randomization

          -  Singleton gestation

        Exclusion Criteria:

          -  Established pregestational diabetes

          -  Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation.
             Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still
             be considered for this study if they present again for glucose tolerance testing
             between 24 and 27 weeks.

          -  Multiple gestations

          -  Known major fetal anomaly or fetal demise

          -  Any renal disease with serum creatinine of >1.0

          -  Known liver disease such as hepatitis

          -  Maternal or fetal conditions likely to require imminent or very preterm delivery such
             as preeclampsia, preterm premature rupture of the membranes, preterm labor, and
             intrauterine fetal growth restriction

          -  Known hypersensitivity or allergic reaction to Glyburide
Validation of a Real-time Urodynamic Measure of Urinary Urgency
Condition: Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin Succinate
Intervention description: Participants take 10mg daily solifenacin succinate for 30 days
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder; Urinary Urgency; Solifenacin; Vesicare(R)

Summary:

      Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more
      bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy
      continues to surround the term 'urgency' and there is no good tool to evaluate the severity
      of urgency. This fact has constrained the performance of clinical research in this field. The
      cause of urinary urgency is not fully understood and may vary from patient to patient.

      Although clinicians regularly obtain measures of bladder sensation during cystometry, little
      attention has been paid to the patient experience of urinary urgency. In this study, the
      researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary
      urgency in women with overactive bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment
             with anticholinergic medication.

          -  Demonstrated detrusor overactivity with or without incontinence during urodynamic
             testing.

          -  Are able to consent and fill out study documents, complete repeated urodynamic
             testing, and follow-up in 4 weeks.

        Exclusion Criteria:

          -  Have been treated with any anticholinergic medication in the previous month.

          -  Have an elevated post -void residual volume as determined during their routine
             clinical care.

          -  Have had a urinary tract infection in the last month, as determined by history.

          -  Have untreated narrow angle glaucoma, by patient history.

          -  Have a known allergy or intolerance to solifenacin, as determined by patient history.
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
Condition: Shoulder Arthroplasty
Intervention: Liposomal bupivacaine; Bupivacaine with adjuvants
Intervention description: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine); Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Shoulder Replacement Surgery; Interscalene Nerve Block; Liposomal Bupivacaine; Shoulder pain; Regional anesthesia; Brachial plexus blockade

Summary:

      The purpose of this study is to determine whether the use of plain bupivacaine with common
      adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to
      the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing total shoulder arthroplasty (not a reverse)

          -  Age ≥ 18 years

          -  Ability to understand and the willingness to sign an IRB-approved informed consent
             document.

          -  ASA patient status I-III patients

          -  Weight Greater than or equal to 50 kg

        Exclusion Criteria:

          -  Contraindications to an interscalene block or phrenic blockade

          -  Infection at injection site

          -  Pre-existing neurological dysfunction affecting the operative extremity

          -  Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of
             long-acting opioids

          -  BMI >40

          -  Uncontrolled diabetes (A1c >8.0)

          -  Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or
             opioid) in the postsurgical period for pain not strictly related to the surgery

          -  Contraindications to any pain-control agents planned for surgical or postsurgical use
             (i.e., bupivacaine, hydromorphone, etc.)

          -  Patients who are wards of the state

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to bupivacaine or liposomal bupivacaine.

          -  Patients with moderate-severe hepatic or renal impairment
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Condition: Preeclampsia Severe
MeSH terms: Pre-Eclampsia
Intervention: Nifedipine 30 MG; Placebos
Intervention description: Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.; At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
Intervention MeSH terms: Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: preeclampsia severe, Nifedipine 30MG, placebo controlled

Summary:

      This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to
      placebo in 110 patients after decision has been made to proceed with induction of labor for
      the diagnosis of preeclampsia with severe features.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7
             and 41 6/7 weeks gestation based on the best obstetric estimate by The American
             College of Obstetricians and Gynecologists (ACOG) criteria.

          -  Diagnosis of preeclampsia with severe features with decision made to induce labor. The
             patient may or may not have already received acute treatment for severe blood
             pressures.

        Exclusion Criteria:

          -  Known allergy or adverse reaction to Nifedipine or any medical condition where
             Nifedipine is contraindicated, such as galactose intolerance, severe gastrointestinal
             (GI) structure, and GI hypomotility disorder.

          -  Currently receiving Nifedipine XL as part of hypertension management prior to
             induction of labor

          -  Participation in another trial that affects the primary outcome without prior approval

          -  Physician/provider or patient refusal

          -  Participation in this trial in a prior pregnancy

          -  Triplet or higher order pregnancy
Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
Condition: Post-operative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Ondansetron 4 MG; Ondansetron 8mg
Intervention description: dose as per arm selection; dose as per arm selection
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ambulatory surgery; post-operative nausea and vomiting; general anesthesia

Summary:

      The aim is to evaluate the effectiveness of three different regimens of prophylactic
      ondansetron on the incidence and severity of post-operative nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I, II, III presenting for ambulatory surgery to be performed under general
             anesthesia

        Exclusion Criteria:

          -  Patients with allergies or contraindications to study medications
Estrogen Diastolic Heart Failure
Condition: Menopause
MeSH terms: Heart Failure
Intervention: Estradiol/Norethindrone acetate; Placebo
Intervention description: Estradiol/Norethindrone acetate 1mg/0.5 mg; inactive ingredient
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: Female
Minimum age: 45 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12
      weeks to determine if markers of systolic and diastolic function change by echocardiography
      as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  28 healthy recently postmenopausal women with last menstrual bleeding 12 months at
             study entry. Women with last menstrual bleeding within 12 months at study entry are
             those who are peri-menopausal and for whom the drug is FDA approved.

        Exclusion Criteria:

          -  History of hysterectomy, oophorectomy or both

          -  History of heart disease including cardiac transplantation, heart failure, bypass
             surgery or percutaneous intervention, and valve disease defined as moderate or severe
             valve regurgitation or stenosis

          -  History of bone disease including non-traumatic vertebral fractures on radiography

          -  Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin
             A1C >8, uncontrolled hypertension defined as a systolic blood pressure >160 mmHg,
             awaiting organ transplant)

          -  Previous or current cancer, excluding basal cell carcinoma

          -  Previous or current thromboembolic disease

          -  Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)

          -  Current or previous use of HRT within the past 3 months

          -  Current or recent (<12 months) substance abuse, including tobacco use

          -  No drug interactions with HRT

          -  No racial or ethnic groups will be excluded
Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Condition: Infraorbital Hollows
Intervention: Restalyne; Perlane
Intervention description: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.; One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to determine the efficacy and longevity of the use of
      Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and
      to measure patient satisfaction with this treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older

          -  No significant medical illness

          -  Subjects with the willingness and ability to understand and provide informed consent

        Exclusion Criteria:

          -  Under 18 years of age

          -  Pregnancy or Lactation

          -  Subjects who have had previous surgical treatment of the lower eyelid area or previous
             use of filling agents in the under eye area

          -  Subjects with a known allergy to the components in Restylane® or Perlane®

          -  Subjects currently taking blood thinners or who have had chemotherapy or radiation
             within the last 6 months

          -  Subjects with liver/kidney disease or compromise or who are immunocompromised

          -  Subjects with a known susceptibility to keloid formation or hypertrophic scarring

          -  Subjects with an open, non-healing sore or infection near the site of injections

          -  Subjects who are unable to understand the protocol or to give informed consent

          -  Subjects with mental illness