bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
Condition: Kidney Failure; Graft vs Host Disease
MeSH terms: Renal Insufficiency; Graft vs Host Disease
Intervention: Tacrolimus; Sirolimus; prednisone
Intervention MeSH terms: Sirolimus; Prednisone; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Kidney; Transplant

Summary:

      This study evaluates two different immunosuppression drug regimens in patients with a recent
      kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and
      Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  End-stage renal disease, with patients scheduled to receive a kidney transplant.

          -  Women who are of childbearing potential who are not pregnant and agree to use a
             medically acceptable method of contraception throughout the treatment period and for 3
             months following discontinuation of study drugs. Any woman becoming pregnant during
             the treatment period must discontinue the use of study drugs;

          -  Signed informed consent.

        Exclusion Criteria:

          -  Evidence of active systemic or localized major infection at the time of initial study
             drug administration;

          -  Multiple organ transplants;

          -  Any pathology or medical condition that can interfere with this protocol study
             proposal.

        Other exclusion applies.
Oral Contraceptives and Body Mass Index
Condition: Body Weight; Contraceptive Usage
MeSH terms: Body Weight
Intervention: All participants (Aviane); Portia; Aviane
Intervention description: 20 mcg EE/0.1 mg LNG cyclically; 30 mcg EE/0.15 mg LNG cyclically; 20 mcg EE/0.1 mg LNG continuously dosed
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol; Polyestradiol phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Body weight; Oral contraception; Efficacy

Summary:

      The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral
      contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-35

          -  BMI > 30kg/m2

          -  Proof of a normal breast and pelvic exam within last 9 months

          -  Self reported normal menstrual periods (24-35 days)

          -  Good general health

          -  In the investigator's opinion, are subject's veins suitable the repeat blood draws
             dictated by study protocol

          -  Single progesterone level during screening visit ≥ 3ng/mL

          -  Hematocrit ≥ 36%

        Exclusion Criteria:

          -  Contradictions to COCs (history of deep vein thrombosis,myocardial infection,
             uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke,
             migraines with neurologic changes, breast cancer, impaired liver function,
             uncontrolled thyroid disease, hypersensitivity or allergy to birth control)

          -  Smoker (must smoke 0 cigarettes)

          -  Actively seeking/involved in a weight loss program

          -  Currently pregnant/seeking pregnancy in the next 6 months

          -  Currently breast-feeding

          -  Past or current diagnosis of polycystic ovarian disease

          -  Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants:
             6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6
             months)

          -  Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St.
             John's Wort)
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
Condition: Pain
MeSH terms: Renal Colic
Intervention: Ketoprofen 100mg; Parecoxib 40mg
Intervention description: Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection; Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
Intervention MeSH terms: Ketoprofen; Parecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 340.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Renal Colic Pain Urinary Tract Colic

Summary:

      This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled
      trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib
      40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in
      outpatients presenting at emergency room settings. This trial is designed to show
      non-inferiority of parecoxib related to ketoprofen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient male or female with a confirmed diagnosis of acute renal colic with moderate
             to severe pain according to the VAS and Categoric pain scales

        Exclusion Criteria:

          -  The patient has significant renal or hepatic conditions other than uncomplicated
             kidney stones.

          -  The patient has a history of clinically significant hypersensitivity to any NSAIDs,
             cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross
             sensitivity to the medications used in this study.
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
Condition: Overactive Bladder; Urinary Urge Incontinence; Urinary Bladder, Neurogenic; Painful Bladder Syndrome
MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Cystitis, Interstitial
Intervention: Onabotulinumtoxin A (BoNT); belladonna; Morphine; Placebo; Active B&O suppository of belladonna
Intervention description: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.; Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.; matching placebo to B&O suppository; belladonna 16.2mg and morphine 7.5mg
Intervention MeSH terms: Morphine; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os)
      can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder
      for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial
      cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Met clinical criteria under outside care or during the Principal Investigator's
             routine standard of care for BoNT injection therapy

          -  No contraindication to BoNT therapy as outlined by drug manufacturer guidelines

          -  Participants have elected to have the BoNT injection therapy prior to being offered
             enrollment into the study for either overactive bladder (OAB), neurogenic detrusor
             overactivity (NDO), or refractory interstitial cystitis (IC)

        Exclusion Criteria:

          -  Currently pregnant

          -  Currently nursing a baby

          -  Anticipated geographic relocation within the first 3 months following treatment

          -  Allergy to morphine, belladonna, or opiates

          -  Patients will be excluded if participating in another research study

          -  Individuals unable to provide informed consent or to complete two-week follow-up
             bladder testing (post-void residual) or data collection will also be excluded
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
Condition: Osteoarthritis of the Glenohumeral Joint
MeSH terms: Osteoarthritis
Intervention: intraarticular corticosteroid injections (IACSI); corticosteroid injections; Ultrasound
Intervention description: ultrasound-guided IACSI will be administered; Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder; ultrasound-guided IACSI
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This study will examine the effectiveness of a single cortisone injection in patients with
      shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors
      to help predict how a patient with shoulder osteoarthritis will respond to a cortisone
      injection utilizing ultrasound guidance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will
             be recruited from the patient population seeking treatment at the Orthopaedics Sports
             Medicine Institute.

          -  those who have failed previous treatment including over-the-counter analgesics and
             activity modification

          -  have elected to receive a medically-indicated, ultrasound-guided IACSI in the
             shoulder.

        Exclusion Criteria:

          -  Patients will be excluded from the study for any of the following reasons:

          -  Post traumatic osteoarthritis

          -  Inflammatory osteoarthritis

          -  Imaging confirmed rotator cuff tear

          -  Prior ipsilateral shoulder surgery

          -  Memory loss or inability to complete study measures

          -  History of allergy to injection medications

          -  Diabetic patients with patient-reported fasting blood glucose >200

          -  Prior injection in the ipsilateral shoulder within three months
Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant
Condition: Renal Transplant Rejection; Immunosuppression
Intervention: Everolimus
Intervention description: Replacement of tacrolimus by everolimus, 30 days after transplat. It was done after kidney biopsy (excluding acute rejection), blood and urine analysis.
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic allograft nephropathy; cytokines; kidney transplant; calcineurin inhibitors withdrawn

Summary:

      Currently, acute kidney injury is diagnosed by increased serum creatinine. However,
      creatinine is not a reliable marker for acute changes in renal function.

      The biology of the renal graft is influenced by chemokines from reperfusion (just after the
      kidney transplant) and throughout its course, when acute and chronic inflammatory changes
      occurs. Moreover, the evaluation of changes in urinary cytokines reflects kidney interstitial
      patterns, and can predict renal function, acute rejection episodes and their response to
      treatment.

      Today there are several studies comparing the relative immunosuppression of renal function,
      but few noticed its relationship with cytokines and chemokines. Thus, we proposed studying
      the inflammatory consequences of early calcineurin inhibitors (ICN) withdrawing in transplant
      patients by urine analysis. Kidney biopsy was done before ICN withdrawn and replaced by
      everolimus (3 months after transplant), and 1 year after transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over 18 years old and under 65 years old

          -  Recipients of first kidney transplant

          -  Donor younger than 65 years old

          -  PRA (panel reactive antigen) ≤ 30% in class I or class II

          -  No acute rejection episodes

          -  Proteinuria <1000 mg / day

        Exclusion Criteria:

          -  multiple organ transplant recipient

          -  Chronic liver failure

          -  Asymptomatic bacteriuria or urinary infection at randomization time

          -  Creatinine ≥ 2 mg / dL at randomization time (90 days after transplant)

          -  Presence of uncontrolled hypercholesterolemia (≥ 350 mg / dL, ≥ 9.1 mmol / L) or
             hypertriglyceridemia (≥ 500 mg / dL, ≥ 5.6 mmol / L) at randomization time (90 days
             after transplant)
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: CP-690,500 5 mg; CP-690,550 10 mg
Intervention description: CP-690,550 5 mg tablet BID; CP-690,550 10 mg tablet BID
Intervention MeSH terms: Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ulcerative colitis; inflammatory bowel disease

Summary:

      This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission
      designed to evaluate flexible dosing of CP-690,550.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2
             years consecutively.

          -  In stable remission on CP-690,550 10 mg BID

          -  Agree to use highly effective contraception

          -  Negative pregnancy test

          -  Comply with visits, treatments, lab tests, diary and other study procedures

          -  Signed and dated informed consent document.

        Exclusion Criteria:

          -  Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study
             A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis or findings suggestive of Crohn's disease

          -  Likely to require surgery for ulcerative colitis during study

          -  Expected to receive any prohibited medication

          -  Expected to receive live or attenuated virus vaccination during study

          -  Women who are pregnant or breastfeeding or planning to become pregnant during the
             study

          -  Evidence of colonic malignancy or any dysplasia

          -  Acute or chronic medical or psychiatric condition that may increase risk of
             participation

          -  Investigator site staff member

          -  Subjects likely to be uncooperative or unable to comply with study procedures

          -  Participation in other studies involving investigational drugs during study

          -  Subjects with any of the following risk factors for pulmonary embolism at baseline as
             defined by EMA's PRAC:

               -  has heart failure;

               -  has inherited coagulation disorders;

               -  has had venous thromboembolism, either deep venous thrombosis or pulmonary
                  embolism;

               -  is taking combined hormonal contraceptives or hormone replacement therapy;

               -  has malignancy (association is strongest with cancers other than non-melanoma
                  skin cancers);

               -  is undergoing major surgery
Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Condition: Trauma/Injury Problem
MeSH terms: Wounds and Injuries
Intervention: Transfusion of blood products
Intervention description: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Transfusion; Whole Blood; Trauma; Coagulopathy; Component Therapy; Civilian; Military

Summary:

      The proposal will assess if patients who require massive transfusion can be accurately
      predicted early after emergency department arrival and assess if the use of stored whole
      blood during initial resuscitation will reduce transfusion needs compared to transfusion with
      component therapy and thus improve outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older.

          2. Meet Code 3 status; Code 3 is determined by the following criteria (Patients must meet
             at least one of the following physiologic and/or anatomic criteria):

               -  Physiologic criteria indicating high risk or life threatening injuries

               -  GCS <10 (Glasgow Coma Scale)

               -  SBP <90 (Systolic blood pressure)

               -  RR <10 or >29 (Respiratory rate)

               -  HR >120 (Heart rate)

               -  intubated

               -  Base Deficit > 6

               -  Anatomic criteria indicating high risk or life threatening injuries

               -  Any penetrating injury to torso, groin, or neck

               -  Amputation proximal to the ankle or wrist

               -  Uncontrolled external hemorrhage

               -  Two or more long bone fractures

               -  Pelvic fracture

               -  Paraplegia or quadriplegia

               -  Combination trauma with burns ≥ 20% BSA (body surface area)

          3. Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.

        Exclusion Criteria:

          1. Death thought to be imminent, suggesting a futile resuscitation effort

          2. Known or assumed religious objection to blood products

          3. Do not resuscitate order in place

          4. Women who present to the ED who are obviously pregnant.

          5. Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community
             consultation.
Effect of HSV-2 Suppressive Therapy on Sexual Behavior
Condition: Genital Herpes
MeSH terms: Herpes Genitalis
Intervention: acyclovir; acyclovir
Intervention description: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence; 400 mg acyclovir orally twice daily for 1 year
Intervention MeSH terms: Acyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine what effect suppressive therapy has on sexual
      behavior and quality of life among persons with genital herpes (HSV) who have multiple sex
      partners.

      Study terminated; investigator relocated and study funding ended. Results were never analyzed
      because data were not collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from
             anogenital site

          -  2 or more vaginal or anal sex partners in the past 12 months

          -  Not currently in a monogamous sexual relationship of >= 6 months duration

          -  Willing and able to be randomized and comply with the study protocol

        Exclusion Criteria:

          -  Pregnancy or intention to become pregnant within the next year

          -  Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of
             enrollment/randomization

          -  6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months
             prior to starting suppressive therapy if on suppressive therapy during the prior 12
             months

          -  HIV seropositive or known immunocompromising medical condition. HIV negative test must
             be performed within 60 days of Visit 1 (enrollment/randomization). For current or
             former participants in HIV vaccine clinical trials for whom HIV vaccine-induced
             seropositivity potentially leading to vaccine study unblinding may be a concern, a
             report from the Seattle HVTU documenting that the participant is HIV uninfected based
             on HIV testing done within 60 days of Visit 1 will be accepted in lieu of HIV testing
             done at our clinic.

          -  Intention to move from the Seattle area within the next year

          -  Known allergy, intolerance, or medical contraindication to acyclovir

          -  Inability to understand, speak, and read English