bioihbjkbjnl/mcl2 huggingface dataset:
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.
Sugammadex vs Placebo to Prevent Residual Neuromuscular Block
Condition: General Surgery
MeSH terms: Delayed Emergence from Anesthesia
Intervention: Sugammadex; Placebo
Intervention description: Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.; Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Postoperative respiratory depression; Neuromuscular Agents

Summary:

      The study is designed to determine whether patients who receive sugammadex immediately after
      tracheal extubation will exhibit a decrease in the incidence of postoperative residual
      paralysis and an associated decrease in the incidence of postoperative respiratory
      depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing surgery with general anesthesia

          -  Patients weighing > or = 80 pounds

          -  Patients not intubated prior to surgery

          -  Patients who are able to give informed consent

        Exclusion Criteria:

          -  Patients unable to give informed consent.

          -  Patients whose condition will not allow for placement of the electrode PadSet of
             ExSpiron

          -  Patients who are anticipated to remain intubated in recovery period.
Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia
Condition: Hyperglycemia Steroid-induced; Insulin Resistance, Diabetes
MeSH terms: Insulin Resistance; Hyperglycemia
Intervention: NPH Insulin; glargine; Insulin Aspart
Intervention description: Intermediate acting insulin; basal insulin; prandial insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients receiving single dose steroids who become hyperglycemic will be randomized to two treatment arms in a parallel design: (1) NPH added to basal/bolus insulin; (2) increase in doses of basal and bolus insulin
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: steroid; prednisone; methylprednisolone; hyperglycemia; insulin; hypoglycemia

Summary:

      Glucocorticoids are known to cause an increase in insulin resistance, leading to
      hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and
      outpatient setting, steroids are used for their anti-inflammatory property to treat a variety
      of conditions. There is a paucity of information regarding the best way to treat
      steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin,
      an intermediate-acting insulin, given at the time of steroid administration to the patient's
      standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen
      which will consist primarily increasing the prandial doses at lunch and supper in order to
      determine which regimen is superior for glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving once daily dosing of methylprednisolone or prednisone in a dose of
             10 mg/day or greater

          -  Hyperglycemic (Glucose level > 126 mg/dL)

          -  Diabetic and nondiabetic patients

          -  Expected duration of hospital stay and time on steroids >= 3 days

          -  Patient of appropriate caregiver able to give Informed Consent

        Exclusion Criteria:

          -  Patients with 2 or more doses of methylprednisolone/prednisone per day

          -  Steroids other than methylprednisolone or prednisone

          -  Pregnancy

          -  estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2
Fingolimod Effect on Cytokine and Chemokine Levels
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod 0.5 mg
Intervention description: 66 relapsing remitting MS (RRMS) patients were recruited. Patients who met all inclusion and none of the exclusion criteria were treated by Fingolimod 0.5 mg.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: A 6-month, multicenter, prospective, interventional, single arm, open label study investigating the effects of fingolimod administered according to local label recommendations on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fingolimod,cytokine,chemokine,RRMS

Summary:

      The main purpose of this study was to measure the serum levels of cytokines and chemokines
      that are known to increase during multiple sclerosis relapses.

      Cytokines are a broad and loose category of small proteins that are important in cell
      signaling.

      The second purpose of the study was to test the cytokine/chemokine changes measured in the
      3rd and 6th months on the efficacy parameters.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Written informed consent must be obtained before the beginning of te study

          2. Nonresponder RRMS patients

          3. Last relapse of the patient should be at least 2 months before study entry.

          4. Last interferon or glatiramer acetate dose of the patient should be at least 1 month
             before study entry.

        Key Exclusion Criteria:

          1. Patients with secondary progressive MS.

          2. Patients with known contraindications for fingolimod treatment.

          3. Other coexistent autoimmune diseases

          4. Pregnant or nursing (lactating) women
Shiga Microalbuminuria Reduction Trial-2
Condition: Type 2 Diabetes Mellitus; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Intervention: Aliskiren; any angiotensin receptor blockers
Intervention description: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.; The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
Intervention MeSH terms: Angiotensin Receptor Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypertension; Albuminuria; Direct renin inhibitor; Angiotensin receptor blocker; Type 2 diabetes

Summary:

      The purpose of this study is to compare the effects of a direct renin inhibitor (DRI),
      aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes
      under strict blood pressure control with angiotensin receptor blocker (ARB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Segment: outpatients

          -  Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP
             more than130/80 mmHg

          -  Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment

          -  Microalbuminuria: 10 < and < 300 mg/gCr

          -  Informed consent: patients who understand well about this study based on own voluntary
             will and can give a written consent

        Exclusion Criteria:

          -  Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary
             hypertension

          -  Type 1 diabetes

          -  Patients whose investigator regards as difficult to comply with study protocol in
             reference to the package insert of aliskiren

          -  Patients who have history of operation in gastrointestinal tract surgery, and
             anamnestic or concurrent gastrointestinal disorders, which may interfere with drug
             absorption

          -  Serum potassium > 5.6 mEq/L (hyperkalemia)

          -  Urinary microalbumin < 10 or > 300 mg/gCr

          -  Patients who participated in another clinical study within three months
Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
Condition: Lymphoid Malignancies
MeSH terms: Neoplasms
Intervention: Idelalisib
Intervention description: Idelalisib 150 mg tablet administered orally twice daily
Intervention MeSH terms: Idelalisib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to provide idelalisib to participants receiving
      GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit

          -  Evidence of a personally signed informed consent

        Key Exclusion Criteria:

          -  Known hypersensitivity or intolerance to any of the active substances or excipients in
             the formulation of idelalisib

          -  Toxicities that would preclude initiating therapy with idelalisib prior to enrollment

          -  Concurrent participation in another therapeutic clinical trial

          -  Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past
             28 days.

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study of Exparel Versus Epidural for Pain Control After Thoracotomy
Condition: Pain Following Thoracotomy Surgery
Intervention: Epidural; Intercostal Bupivicaine (Exparel)
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Thoracotomy; Pain

Summary:

      Unilateral intercostal nerve blocks provide pain control as effectively as a continuous
      thoracic epidural, and will a lower incidence of side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older

          -  Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).

        Exclusion Criteria:

          -  Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;

          -  Current enrollment in another post-thoracotomy analgesic research protocol;
             pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or
             postherpetic neuralgia in a thoracic distribution);

          -  Daily opioid therapy;

          -  Current gabapentin or pregabalin therapy;

          -  Allergy to any study medication; coagulation or infectious issues that would preclude
             epidural catheter placement;

          -  Severe psychological disorders or inability to understand the study protocol;
             -Prisoners or other institutionalized individuals;

          -  Severe hepatic, renal or cardiovascular disorders.

          -  Women who are pregnant will not be included in this study.
Steroids in Bilateral Total Knee Replacement
Condition: Postoperative Inflammatory Response
Intervention: Hydrocortisone; Saline
Intervention description: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times; Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Intervention MeSH terms: Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Bilateral total knee replacement; cytokine; desmosine

Summary:

      Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a
      major marker of inflammation is known to increase during total joint replacement surgery. IL6
      has been found to be elevated postoperatively in patients with hip fractures and has been
      linked to mental status changes and possibly other complications. It is known to lead to
      shock and participate in the inflammatory state seen in sepsis. High levels have further been
      linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress
      syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low
      dose steroids given in two doses in the initial perioperative period decreased the amount of
      IL6 released compared to placebo, but this was not sustained past 24 hours.

      Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in
      urine samples. It is considered to be a marker of lung injury and is found to be elevated in
      patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the
      investigators have found that urine desmosine levels rise with bilateral total knee
      replacement compared to unilateral total knee replacement indicating possible lung injury.

      Therefore the investigators hypothesize:

      Continued low dose steroids given three times over a 24 hour period will:

        1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement
           and maintaining this reduction in IL6 beyond 24 hours.

        2. Decrease urinary desmosine levels, and hence be protective of lung injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for bilateral total knee replacement

          -  Between 50-90 years of age

        Exclusion Criteria:

          -  Patients on steroid therapy

          -  Patients that require stress-dose steroid pre-operatively

          -  Patients that smoke

          -  Patients that are diabetic

          -  Patients younger than 50 or older than 90 years
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
Condition: Bariatric Surgery Candidate
Intervention: Zoledronic Acid; Calcium citrate + vitamin D; Vitamin D3
Intervention description: 5mg zoledronic acid; Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3; 1000IU Vitamin D3 gummy
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Zoledronic Acid; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 25 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Roux-en-Y gastric bypass, sleeve gastrectomy

Summary:

      This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs
      after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men must be age ≥ 50

          -  Women must be age ≥ 25 and postmenopausal

          -  Planning to receive RYGB or SG surgery

        Exclusion Criteria:

          -  Age < 25

          -  Prior bariatric surgery

          -  Weight ≥ 400 lbs

          -  Liver or renal disease

          -  Hypercalcemia, hypocalcemia, or hypomagnesemia

          -  Serum 25-hydroxyvitamin D < 20 ng/mL

          -  History of bone-modifying disorders

          -  Use of bone-active medications

          -  Known sensitivity to bisphosphonates

          -  Extensive dental work involving extraction or dental implant within the past 2 months
             or planned in the upcoming 6 months
Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
Condition: Type 2 Diabetes
Intervention: Insulin Aspart; Insulin Aspart 30; Insulin Aspart 70
Intervention description: Patients received insulin aspart before breakfast and before lunch.; Patients received biphasic insulin aspart 30 before breakfast and before lunch.; Patients received biphasic insulin aspart 70 before breakfast and before lunch.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: insulin aspart 30; insulin aspart 70; insulin aspart; postprandial glucose and lipid metabolism; consecutive mixed meals

Summary:

      The aim of the study is to investigate meal-related treatment with either premixed Insulin
      Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free
      fatty acids excursions after a standard breakfast and lunch.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type-II Diabetes

          -  BMI > 27 kg/m2

          -  age 35 to 75 years

          -  HbA1c < 8.5%

          -  informed consent

          -  treatment with pre-mixed insulin

          -  stabile dose of insulin for at least 4 weeks

        Exclusion Criteria:

          -  Type-I Diabetes mellitus

          -  HbA1c > 8.5 %

          -  Serum Creatinine > 1.7 mg/dl

          -  Alaninaminotranferase or Aspartataminotransferase > 3x Upper Limit of Normal

          -  treatment with sulfonylurea or gliptins

          -  treatment with glitazones

          -  manifest clinical infections

          -  treatment with glucocorticoids or antipsychotic drugs

          -  psychiatric diseases

          -  alcohol abuse

          -  myocardial infarction or stroke within the previous 3 months

          -  surgery within the previous 3 months