bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Risperidone Long-Acting Injectable (RLAI)
Intervention description: The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Risperidone; Risperidal Consta

Summary:

      The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting
      injectable formulation of risperidone (an antipsychotic medication) and its influence on
      quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of
      emotional instability, detachment from reality, often with delusions and hallucinations, and
      withdrawal into the self).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or
             out-patients)

          -  Participants currently having their symptoms well controlled with a stable dose of
             oral antipsychotic medication

          -  Participants who have signed informed consent form Exclusion Criteria:

          -  Participants who have never received any previous antipsychotic treatment

          -  Participants who have received clozapine during the last 3 months

          -  Participants with a serious unstable medical condition, including laboratory
             abnormalities

          -  Participants with a history of, or current symptoms of tardive dyskinesia (a
             complication of neuroleptic therapy involving involuntary movements of facial muscles)
             or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be
             characterized by confusion, reduced consciousness, high fever or pronounced muscle
             stiffness)

          -  Female participants who are pregnant or breast-feeding, or are of childbearing age
             without adequate contraception
Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Itraconazole
Intervention description: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
Intervention MeSH terms: Itraconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Aspergillus Fumigatus; randomized controlled clinical trials

Summary:

      This clinical trial will attempt to determine whether we can improve clinical outcomes for
      patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of CF as defined by two or more clinical features of CF and a documented
             sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or
             a genotype showing two well characterized disease causing mutations

          -  Patient must be known to be chronically colonized with Aspergillus fumigatus.

          -  Patients must be clinically stable at randomization, no use of new inhaled, oral or
             intravenous antibiotics or oral or intravenous corticosteroids during the 14-day
             period prior to randomization.

          -  6 years of age and older

          -  Patients must weigh at least 20 kg

          -  Post-menarche females must be using an effective form of contraception.

        Exclusion Criteria

          -  Inability to give informed consent.

          -  Respiratory culture positive for B.cepacia complex

          -  Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal
             within a 30 day period prior to randomization

          -  Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper
             limit of normal within a 30 day period prior to randomization

          -  Neutropenia, absolute neutrophil count&lt; or = 1000 within a 3-day period prior to
             randomization

          -  History of biliary cirrhosis documented by liver biopsy or imaging.

          -  History of portal hypertension.

          -  Investigational drug use within 30 days of randomization date.

          -  History of alcohol, illicit drug or medication abuse within 1 year of randomization.

          -  Women who are pregnant, breastfeeding or trying to conceive
Assessing Dextenza Insert After SMILE Procedure
Condition: Post Procedural Infection
Intervention: Dexamethasone ophthalmic insert 0.4 mg; Topical Prednisolone Acetate Ophthalmic Drops
Intervention description: intracanalicular dexamethasone insert; Topical Prednisolone acetate ophthalmic drops per standard of care:
Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This three-month prospective, open-label, single-center, randomized investigator initiated
      clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower
      canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral
      SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA
      insertion
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older

          -  Scheduled for bilateral SMILE surgery

          -  Willing and able to comply with clinic visits and study related procedures

          -  Willing and able to sign the informed consent form

        Exclusion Criteria:

          -  Patients under the age of 18.

          -  Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)

          -  Active infectious systemic disease

          -  Active infectious ocular or extraocular disease

          -  Obstructed nasolacrimal duct in the study eye(s)

          -  Hypersensitivity to dexamethasone

          -  Patients being treated with immunomodulating agents in the study eye(s)

          -  Patients being treated with immunosuppressants and/or oral steroids Patients with
             severe disease that warrants critical attention, deemed unsafe for the study by the
             investigator
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: ACT-385781A (Actelion Epoprostenol); Flolan®
Intervention description: per Prescribing Information; per Prescribing Information
Intervention MeSH terms: Epoprostenol; Tezosentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; PAH; EPITOME-1

Summary:

      This is an open-label, non-randomized extension to study AC-066A401. The study will assess
      safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a
      means for continuing treatment after ending participation in study AC-0066A401.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent prior to initiation of any study-mandated procedure

          2. Patients who completed participation in study AC-066A401

          3. Patients who have not obtained authorization for commercial ACT-385781 and Flolan at
             the time of ending participation in study AC-066A401

        Exclusion Criteria:

          1. Patients who prematurely discontinued study drug in study AC-066A401

          2. Patients for whom continued treatment with either ACT-385781 and Flolan is no longer
             considered appropriate

          3. Known hypersensitivity to the investigational drug or comparative drug or drugs of the
             same class, or any of their excipients

          4. Any known factor or disease that might interfere with treatment compliance, study
             conduct or interpretation of the results such as drug or alcohol dependence or
             psychiatric disease

          5. Known concomitant life-threatening disease with a life expectancy < 12 months
Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: "Probiotics" and "Metronidazole"; Metronidazole Vaginal
Intervention description: Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days); Metronidazole Suppositories,qd, 7 days
Intervention MeSH terms: Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus
      rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal
      suppositories(7 days) is better than using metronidazole vaginal suppositories only in
      preventing the recurrence of bacterial vaginosis (BV).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 18 to 65 years old, with history of sexual activity, premenopausal women；

          2. Nugent Score ≥ 7 for diagnosing BV；

          3. Sign informed consent.

        Exclusion Criteria:

          1. mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV)
             infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;

          2. History of systemic organic diseases or psychiatric diseases;

          3. Planning for or during pregnancy, lactation, menstruation;

          4. within 5 days of onset of the disease, any antibiotics has been used;

          5. Long-term use of contraceptives or immunosuppressant;

          6. Anaphylactic constitution or allergic to known ingredients of research drugs.
Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ibuprofen 600 mg; ibuprofen 600 mg and acetaminophen 650 mg
Intervention description: identical appearing tablets containing 600 mg of ibuprofen; identical appearing tablets of the combination of ibuprofen and acetaminophen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: identical appearing tablets and random allocation
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Aim: The purpose of this study was to compare ibuprofen versus an ibuprofen/acetaminophen
      combination for postoperative pain control in patients requiring root canal treatment with a
      tooth that is painful to cold and biting.

      Methodology: Following regular root canal treatment, patients randomly received identical
      appearing tablets of 600 mg ibuprofen or 600 mg ibuprofen/650 mg acetaminophen to be taken
      every 6 hours as needed for pain. A 4-day diary was used to record pain and medication use.
    

Eligibility criteria:

        Inclusion Criteria:

          1. mandibular (bottom) or maxillary (top) posterior (back) tooth requiring root canal
             treatment

          2. mandibular (bottom) or maxillary (top) posterior (back) tooth with symptomatic
             irreversible pulpitis and symptomatic apical periodontitis (painful tooth to cold and
             biting)

        2. between the ages of 18 and 65 years of age 3. American Society of Anesthesiologist
        classification I

        Exclusion Criteria:

          1. patients younger than 18 or older than 65 years of age

          2. American Society of Anesthesiologist classification II or higher

          3. allergies or contraindications to ibuprofen

          4. allergies or contraindications to acetaminophen

          5. pregnancy

          6. inability to give informed consent
Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Condition: Reperfusion Injury
MeSH terms: Reperfusion Injury
Intervention: Ascorbic Acid; 5 % Dextrose Water or Normal Saline
Intervention description: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.; 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Free Radicals; Ascorbic Acid; Cardiac Surgery; Prevention of Reperfusion Injury

Summary:

      It has been shown that the stress that occurs during cardiac surgery leads to early decrease
      of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to
      complications after surgery.

      This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the
      outcome and complications after cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients 18 years or older undergoing elective or urgent (prior to hospital
             discharge) cardiac surgery.

        Exclusion Criteria:

          -  History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate
             dehydrogenase deficiency) or the chronic use of steroids.
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Condition: Pelvic Organ Prolapse
MeSH terms: Pain, Postoperative; Prolapse; Pelvic Organ Prolapse
Intervention: IV Acetaminophen; IV normal saline
Intervention description: IV normal saline
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IV acetaminophen; Postoperative pain; Pelvic organ prolapse surgery; Pelvic organ prolapse repair

Summary:

      The purpose of this study is to determine whether preoperative IV Acetaminophen reduces
      postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic
      organ prolapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 18 years of age

          -  scheduled to undergo surgery for POP via a vaginal or minimally invasive
             (laparoscopic/robotic) route at the University of Pittsburgh Medical Center

          -  women anticipated to have a hospital stay ≥24 hours

        Exclusion Criteria:

          -  allergy/intolerance to acetaminophen

          -  hepatic dysfunction

          -  significant alcohol use - defined as patient reported consumption of more than 7
             standard drinks per week and/or 3 drinks per day
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: onabotulinumtoxinA
Intervention description: Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 716.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will assess the long-term efficacy, safety, and tolerability of
      onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day
             or longer)

        Exclusion Criteria:

          -  Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral
             sclerosis

          -  Headache attributed to another disorder

          -  Infection or skin disorder at injection sites

          -  Previous treatment with botulinum toxin of any serotype for any reason

          -  Anticipated need for botulinum toxin of any type for any reason during the course of
             the study

          -  Previous participation in any botulinum toxin clinical trial
Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
Condition: Chronic Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Prednisolone Sodium Phosphate Ophthalmic Solution 1%; Tears Naturale II Ophthalmic Solution
Intervention description: One drop in each eye, four times/day for 4 days.; one drop in each eye, four times/ day (QID) for 4 days
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of the modified Conjunctival
      Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to
      treatment with a proven ocular anti-inflammatory medication,

      Prednisolone, assessed by the following measures:

      Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival
      redness
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age & either sex, any race

          -  Willing and able to follow all instructions

          -  Positive history of ocular allergies

          -  Reproducible positive ocular allergic reaction induced by conjunctival allergen
             challenge

        Exclusion Criteria:

          -  Have planned surgery during trial period

          -  Female currently pregnant, planning a pregnancy or lactating

          -  Use of disallowed medications

          -  Have ocular infections, or ocular conditions that could affect study parameters

          -  Have moderate to severe dry eye

          -  Have used an investigational drug or device within 30 days of start of study

          -  Female that is currently pregnant, planning a pregnancy or lactating
A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease
Condition: Coronary Artery Disease; Heart Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases
Intervention: Perflutren Lipid Microsphere Injectable Suspension
Intervention description: Activated DEFINITY 10ug/kg by bolus injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study is designed to see if stress echocardiography can be used as a screening exam in
      peri-, or post-menopausal women with a risk of developing of coronary artery disease and
      experiencing future cardiac events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peri or Post menopausal women either:

               -  without symptoms but with risk factors for heart disease OR

               -  experiencing atypical chest pain, OR

               -  experiencing exertional dyspnea AND 2 or more risk factors for CAD

          -  Must be able to perform an exercise stress test

        Peri-or post-menopausal (including surgical menopause) based on history.

          -  Post-menopausal is defined as females age 40-65 who self-report the absence of
             menstrual periods for at least 12 months.

          -  Peri-menopausal is defined as females age 40-65 who self-report the absence or
             irregularity of menstrual periods for 6-12 months.

          -  Surgical menopause is defined as females who have had a bilateral
             salpingo-oophorectomy with or without hysterectomy.

        Exclusion Criteria:

          -  Previous confirmed heart disease