bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Insulin Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Insulin or Placebo
Intervention description: intranasal, 40IU, 4 times daily
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cognition, psychopathology

Summary:

      This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal
      insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia
      subjects to examine insulin's effect on psychopathology and cognition. In addition, the study
      will examine insulin's effects on weight, food intake, resting energy expenditure, and body
      composition.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65 years.

          2. Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.

          3. Stable dose of the current antipsychotic drug for at least one month.

          4. Well established compliance with outpatient treatment per treating clinician's
             judgement.

          5. Able to complete the cognitive assessment battery (must be English speaking).

          6. Female subjects will be eligible to participate in the study if they are of
             non-childbearing potential or of child-bearing potential and willing to practice
             appropriate birth control methods (complete abstinence from sexual intercourse, female
             sterilization, sterilization of male partner, implants of levonorgestrel, injectable
             progestogen, oral contraceptives, intrauterine devices, or double barrier methods of
             contraception using spermicide with either a condom or diaphragm) during the study.

        Exclusion Criteria:

          1. Inability to provide informed consent.

          2. Current substance abuse.

          3. Psychiatrically unstable per treating clinician's judgement.

          4. Significant medical illnesses including uncontrolled hypertension, diabetes, seizure.
             disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.

          5. Pregnancy or breastfeeding.
Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
Condition: Ankylosing Spondylitis; Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis
Intervention: Indomethacin; Diclofenac; Meloxicam; Celecoxib
Intervention description: Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks; Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks; meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks; Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Intervention MeSH terms: Celecoxib; Diclofenac; Indomethacin; Meloxicam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ankylosing spondylitis; spondyloarthritis

Summary:

      This is a 6-week randomized, double-blind trial of 4 different non-steroidal
      anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of
      pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of ankylosing spondylitis (AS) by treating rheumatologists, or a
             diagnosis of axial spondyloarthritis (axSpA) with a pelvis MRI with significant bone
             marrow edema on STIR sequences;

          -  Minimum of 18 years old;

          -  Are taking NSAIDs on a regular basis for AS or axSpA (defined as more than 20 days in
             the past month) and willing to withhold medication for one week; or having active
             symptoms that require initiation of NSAIDs;

          -  Concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the past
             three months;

          -  Have active disease after initial washout period, defined by BASDAI >=4/10, or back
             pain numerical rating scale (NRS)>=4/10

        Exclusion Criteria:

          -  Patients who have concurrent rheumatic diseases other than AS or axSpA;

          -  Patients who have oral corticosteroid in the past two weeks; patients who have acute
             peripheral arthritis;

          -  Patients with a fibromyalgia score >= 13;

          -  Patient with extensive cardiac history, history of gastrointestinal bleeding that
             required blood transfusion, chronic kidney diseases, abnormal liver function tests; or
             female patients who are pregnant.

        Use of low-dose of aspirin (<100mg daily) is allowed in the study.
Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir
Condition: Diabetes Mellitus
Intervention: Detemir; Detemir; Detemir
Intervention description: Detemir dosed at 50% of calculated basal insulin infusion requirements; Detemir dosed at 65% of calculated basal insulin infusion requirements; Detemir dosed at 80% of calculated basal insulin infusion requirements
Intervention MeSH terms: Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; hyperglycemia; open heart surgery; cardiothoracic surgery; detemir; insulin infusion; intravenous insulin

Summary:

      In this study we will determine the proper method for transitioning patients from a
      continuous insulin infusion to periodic injections of a newer long-acting insulin called
      detemir (Levemir).
    

Eligibility criteria:

        Inclusion Criteria:

          -  diabetes mellitus

          -  post-cardiothoracic surgery

          -  requiring an insulin infusion of at least 1 unit/hour

          -  Age 18-75

        Exclusion Criteria:

          -  Glucocorticoids

          -  total parenteral nutrition (TPN) or tube feeds

          -  Pregnancy

          -  Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be
             expected

          -  Expected length of stay less than 48 hours following cessation of the insulin drip

          -  Patients using subcutaneous insulin pumps

          -  Diabetic ketoacidosis

          -  End-stage renal disease

          -  End-stage liver disease

          -  Coma

          -  Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV),
             suicidality

          -  Unable to give consent in English
Retapamulin for Reducing MRSA Nasal Carriage
Condition: Methicillin-Resistant Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Intervention: Retapamulin; Placebo
Intervention description: Two times a day for 5 days; Two times a day for 5 days
Intervention MeSH terms: Retapamulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MRSA; MRSA resistant to mupirocin

Summary:

      The investigators will conduct a randomized placebo-controlled double-blinded study of nasal
      decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among
      adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC >256)
      strains.

      Objectives:

        1. To determine the percent of intervention vs. control patients with successful MRSA nasal
           decolonization as determined by bilateral nares swabs following a 5-day twice-a-day
           regimen of retapamulin.

        2. To determine the time to decolonization based upon interim and final bilateral nares
           swabs.

        3. To determine the acceptability of retapamulin by surveying participants about their
           experience and adverse events experienced during this study.

      The duration of participant follow-up is expected to last up to 7 weeks.

      This study will evaluate the safety and effectiveness of Altabax (retapamulin) during
      decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and
      high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is
      no approved substitute topical agent for decolonization of the MRSA nasal reservoir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Have a type of MRSA that is resistant to mupirocin (a drug used to treat MRSA)

        Exclusion Criteria:

          -  Allergic to retapamulin

          -  Unable to use retapamulin via your nose (i.e. nose surgery, etc.)

          -  Are pregnant and/or breastfeeding
A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Leuprolide
Intervention description: Subcutaneous Injection
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leuprolide acetate; Prostate cancer

Summary:

      The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian
      prostate cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A patient for whom the physician has decided to initiate treatment with a Luteinizing
             Hormone Releasing Hormone (LHRH) agonist in standard clinical practice

          -  Biopsy-proven prostate adenocarcinoma

          -  Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or
             radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer
             patient who has not received chemotherapy and has no plans to undergo treatment with
             chemotherapy at study entry.

          -  Patient who indicates that once the study is completed, he expects having access to
             androgen deprivation therapy (ADT), either medical or surgical, within the local
             healthcare system (either through public/ private health insurance or out of pocket
             payment).

        Exclusion Criteria:

          -  Patient with castrate resistant prostate cancer

          -  Patient who previously underwent bilateral orchiectomy

          -  Patient who has received prior treatment with LHRH analogues

          -  Prior or concomitant treatment with systemic chemotherapy. A patient where there is a
             likelihood to receive systemic chemotherapy should not be enrolled

          -  Life expectancy of < 1 year due to comorbidities

          -  Participation in another interventional clinical trial within one month prior to study
             entry or during the duration of the study

          -  Patient who plans to receive intermittent ADT at the time of study entry

          -  Patient receiving non-palliative radiotherapy within 3 months prior to study entry

          -  Patient receiving adjuvant ADT in combination with definitive radiotherapy

          -  Patient with metastatic hormonal treatment-naive prostate cancer, for whom
             chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.

          -  Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist
             analogs or any of the components of ELIGARD®

          -  Patient with any contraindication for ELIGARD® use based on local prescribing
             information
Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
Condition: Secondary Hyperparathyroidism; Dialysis
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Paricalcitol injection; Paricalcitol capsules
Intervention description: Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly; Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
Intervention MeSH terms: Ergocalciferols
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dialysis; Hyperparathyroidism; Zemplar

Summary:

      Prospective, non-randomized, multi-center study to assess the efficacy and safety of
      paricalcitol injection or oral administered over 6 months to patients with secondary
      hyperparathyroidism on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL)

          -  Patients in a chronic hemodialysis or peritoneal dialysis program previously treated
             with vitamin D metabolites or without previous treatment

          -  Patients in which treatment with paricalcitol injection or oral is clinically
             indicated according to the criteria of the participating investigator

          -  Patients providing their signed informed consent to participate in the trial

        Exclusion Criteria:

          -  Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml)

          -  Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin
             level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x
             phosphorus >= 70

          -  Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product
             ingredients

          -  Patients who have participated in clinical studies within the last month or who are
             currently enrolled in clinical studies

          -  Patients who cannot tolerate or take phosphorus binders that do not contain Calcium
             and/or Aluminum

          -  Patients that in the opinion of the investigator, for any reason, are not good
             candidates for therapy with Synthetic Analogues of Vitamin D
Combined Vaginal Misoprostol and Perivascular Vasopressin
Condition: Leiomyoma; Laparoscopy; Uterine Myomectomy
MeSH terms: Leiomyoma
Intervention: Standard; Standard-vaginal misoprostol
Intervention description: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle; 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Robot-assisted; Laparoscopic; vasopressin; misoprostol; blood loss

Summary:

      Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood
      vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and
      thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at
      as an additional method to decrease operative blood loss given its ability to increase
      uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted
             laparoscopic myomectomy.

        Exclusion Criteria:

          1. History of adverse reaction or allergy to Vasopressin.

          2. History of adverse reaction or allergy to Misoprostol.

          3. Medical contraindication to use of Vasopressin or Misoprostol

          4. Suspicion of possible reproductive cancer with contraindication of morcellation of
             uterine tissue.

          5. Significant medical condition or laboratory result that in the opinion of the
             Investigator indicate an increased vulnerability to study subject which exposes the
             subject to an unreasonable risk as a result of participating.

          6. Any clinically significant even or condition uncovered during the surgery, such as
             excessive bleeding or decompensation, that might render the subject medically unstable
             to continue the study or complicate the subject's intraoperative or postoperative
             course.

          7. Pregnant women
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travatan; Cosopt; Placebo (Timolol Vehicle)
Intervention description: Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s); treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s); Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Intervention MeSH terms: Timolol; Travoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy and safety in patients treated with travoprost versus
      dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular
      hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with open-angle glaucoma or ocular hypertension

        Exclusion Criteria:

          -  By Age
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
Condition: Prostate Disease; Malignancy; Benign Prostatic Hyperplasia; Prostate Cancer; Prostate Adenocarcinoma; Anxiety and Fear; Pain
MeSH terms: Prostatic Neoplasms; Prostatic Hyperplasia; Prostatic Diseases; Hyperplasia; Anxiety Disorders
Intervention: Self-Administered Nitrous Oxide; Oxygen
Intervention description: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.; Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Intervention MeSH terms: Nitrous Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized 1:1 to either SANO (treatment) or oxygen (placebo control) after completion of baseline assessment. The results of the randomization will not be disclosed to patients as part of the study (patient-blinded).
Masking: Double (Participant, Care Provider)
Masking description: The operating urologist and study participant will be blinded to group assignment for the duration of the study.
Enrollment: 143.0
Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prostate biopsy; nitrous oxide; prostate cancer; ambulatory; patient experience of care

Summary:

      Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing
      prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or
      laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices
      and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to
      determine whether administration of nitrous oxide at the time of prostate biopsy will improve
      a patient's experience of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biological male

          -  Aged 18 to 85 years

          -  Scheduled for clinically-indicated prostate needle biopsy

          -  Suitable for nitrous oxide/oxygen with willingness to be randomized to inhaled SANO or
             inhaled oxygen during the procedure

          -  Access to an email and computer

        Exclusion Criteria:

          -  Perioral facial hair impeding good mask seal

          -  Learning disabilities and/or inability to cognitively complete survey questions

          -  Taken a pre-procedure benzodiazepine or narcotic.

          -  Has any of the following medical conditions:

               1. Inner ear, bariatric or eye surgery within the last 2 weeks,

               2. Current emphysematous blebs,

               3. Severe B-12 deficiency.

               4. Bleomycin chemotherapy within the past year.

               5. Class III or higher heart failure.

               6. Undergoing novel therapy for prostate cancer
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: risedronate; Placebo risedronate oral tablet
Intervention description: 35 mg/week by mouth; One tablet by mouth every week as directed
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo controlled trial.
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: Male
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Non-metastatic

Summary:

      Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as
      leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal
      suppression and demonstrate increased bone turnover and consequent bone loss at the hip and
      spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-metastatic prostate cancer

          -  Men to receive Gonadotropin-releasing Hormone-agonist therapy

        Exclusion Criteria:

          -  Other cancers except skin cancer

          -  Evidence of metabolic bone disease

          -  Prior use of bisphosphonates