bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Condition: Dysmenorrhea; Pain
MeSH terms: Dysmenorrhea
Intervention: Naproxen
Intervention description: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Intervention MeSH terms: Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: cross-organ sensitivity; bladder pain; NSAID; visceral pain

Summary:

      The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea
      will improve pain report from baseline. In addition, we will determine whether cross-organ
      influences from the uterus on bladder pain sensitivity change from baseline after reduced
      menstrual pain experience over six months. Finally, a battery of quantitative sensory tests
      and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with
      improvements in menstrual and bladder pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Reproductive-age women (age 18-45) with dysmenorrhea

          -  Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least
             one day during menses or during withdrawal uterine bleeding from cyclic OCs without
             painkillers

          -  Menstrual pain in the region between the umbilicus and the perineum, above the level
             of the inguinal ligament

          -  Indication the participant has attempted to resolve pain by medical means (including
             NSAIDs and/or OCPs)

        Exclusion Criteria:

          -  Presence of active pelvic or abdominal malignancies (primary or metastatic)

          -  Absence of regular menses (including current pregnancy, recent pregnancy, or active
             breast feeding)

          -  Active genitourinary infection in the last four weeks

          -  Unable to read or comprehend the informed consent in English

          -  Unwilling to complete study procedures

          -  Presence of hypertension or risk for developing hypertension

          -  Unwillingness to take naproxen and/or placebo

          -  Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism,
             cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)

          -  Formal urological diagnosis such as overactive bladder or bladder pain syndrome.
Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Belladonna and Opium Suppository; Rectal Exam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Belladonna and Opium Suppositories

Summary:

      Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a
      variety of ailments. These procedures often require that the bladder be filled and emptied
      with sterile water or saline several times during the procedure, and often result in the
      patient receiving a catheter at the end of the procedure. One common side effect is that
      patients experience bladder spasm or discomfort for a period of time after these procedures.
      Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the
      post-operative setting to relieve these symptoms.

      The principle objectives of this study are:

        1. To determine if the addition of a B and O supprette suppository at the end of
           cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and urinary
           discomfort that patients experience in the post-operative setting.

        2. To determine if using peri-operative B and O supprette suppositories reduces the need
           for pos-operative oral Ditropan and use of narcotic pain medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing lithotripsy procedure at GW Hospital

        Exclusion Criteria:

          -  The criteria for exclusion for those patients who agree to participate in the study
             will be patients with glaucoma, severe hepatic or renal disease, bronchial asthma,
             respiratory depression at the time of administration, convulsive disorders, allergy to
             anti-muscarinics or opiates, history of anorectal surgery, pre-operative use of
             antimuscarinics, chronic pain, chronic use of analgesics, or a history of alcohol or
             opioid dependency.
Zoledronic Acid Administration in Acute Spinal Cord Injury
Condition: Disuse Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries
Intervention: Zoledronic acid
Intervention description: At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Spinal Cord Injury; Disuse Osteoporosis; Zoledronic acid; Bisphosphonates; Dual Energy X-ray Absorptiometry

Summary:

      In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on
      preservation of regional and total skeletal mass (DXA).

      Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI,
      as evidenced by serial densitometry determinations (DXA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Within 3 months of the date of acute SCI.

          2. Motor-complete and incomplete SCI [American Spinal Injury Association Impairment Scale
             (AIS) of sensorimotor impairment (AIS A, B, and C)]

        Exclusion Criteria:

          1. Extensive life-threatening injuries (in addition to SCI)

          2. Femur or tibia fracture or extensive bone trauma

          3. History of prior bone disease (Paget's disease, overactive parathyroid, osteoporosis)

          4. Post-menopausal women

          5. Known allergy to bisphosphonates

          6. Severe underlying chronic illness

          7. Current diagnosis of cancer or history of cancer

          8. I am currently receiving corticosteroids

          9. Pregnancy or lactation

         10. I have been diagnosed with kidney problems

         11. As determined from the prescreening blood tests by the study physician Serum
             creatinine > 2.0 mg/dl

         12. As determined from the prescreening blood tests by the study physician Corrected
             calcium < 8 mg/dl or > 11 mg/dl

         13. As determined from the prescreening blood tests by the study physician Elevated liver
             function enzymes > 2 x upper limit of normal (ULN)

         14. I am taking a bisphosphonate for heterotopic ossification (HO) (an overgrowth of bone
             typically diagnosed shortly after SCI in the pelvic region)

         15. I have an existing dental condition or dental infection.
Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
Condition: Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Healthy
MeSH terms: Schizophrenia; Psychotic Disorders; Mood Disorders
Intervention: Memantine; Placebos
Intervention description: To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.; To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This application seeks to determine if neurophysiological metrics of memantine (MEM)-enhanced
      early auditory information processing (EAIP) in schizophrenia (SZ) mediate gains in auditory
      processing fidelity (APF) and auditory learning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of schizophrenia OR schizoaffective-depressed OR healthy subjects

          -  ages 18-50 for all subjects

          -  double barrier contraception for all subjects

          -  not pregnant for all subjects

        Exclusion Criteria:

          -  DSM-IV Axis I or II Diagnosis for for healthy subjects

          -  MEM or amantadine for patients

          -  current substance abuse for all subjects

          -  current recreational drug use for all subjects

          -  history of other significant medical illness (e.g. cancer, diabetes, heart disease,
             HIV, seizures) for all subjects

          -  open head injury or closed head injury with loss of consciousness > 1 min for all
             subjects

          -  hearing or visual impairment for all subjects

          -  pregnancy for all subjects

          -  dementia for all subjects

          -  mental retardation for all subjects
Ultrasound Guided Octreotide LAR Injection in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Octreotide LAR 30 MG Injection
Intervention description: Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.
Intervention MeSH terms: Octreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acromegaly; Octreotide LAR; Ultrasound guidance

Summary:

      Approximately half of patients with acromegaly do not respond to treatment with somatostatin
      receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the
      standard of care regular injection is inaccurately delivered in the intramuscular (IM)
      compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM
      injections and increase drug levels, thereby improving efficacy of octreotide LAR for the
      treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR
      drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in
      patients with acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active acromegaly based on evidence of a pituitary tumor

          -  Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of
             growth hormone (GH) < 1 ng/mL during an oral glucose tolerance test

          -  Previous treatment with a stable dose of octreotide LAR for at least 3 months

          -  No previous treatment with a stable dose of octreotide LAR for at least 3 months after
             receiving 3 months of octreotide LAR during a run-in phase prior to any other
             study-related activity

        Exclusion Criteria:

          -  Uncontrolled diabetes mellitus

          -  Pregnant or breast feeding

          -  Current gallstones

          -  History of hepatic disease, except patients with < 3 X ULN LFTs indicative of hepatic
             steatosis

          -  Past or current history of cancer, except for basal cell carcinoma or in situ cancer
             of the cervix

          -  History of glucocorticoid therapy within the past 6 months, current treatment with any
             chemotherapeutic agents or exogenous GH therapy

          -  History of investigational drugs administered or received within 30 days of study
             entry

          -  Known hypersensitivity to octreotide LAR

          -  Any other concomitant illnesses or therapy that would interfere with evaluation of
             efficacy or safety or increase the risk for study interruption or discontinuation in
             the opinion of the investigator or sponsor
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Greenlight XPS Laser; BiVAP Saline Vaporization of the prostate
Intervention description: Treatment of BPH with Greenlight XPS laser; treatment of BPH with BiVAP Saline Vaporization
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: enlarged prostate

Summary:

      This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus
      BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic
      Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up
      visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male over the age of 18 years

          -  present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical
             intervention

          -  subjects must read, understand and sign the Informed Consent

          -  AUA ≥ 15

          -  Qmax < 15mL/sec

          -  Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months

          -  Prostate volume ≥ 30g

        Exclusion Criteria:

          -  PVR > 300ml

          -  Current urine retention

          -  Previous surgical or invasive treatments (TURP, TUMT, TUNA)

          -  PSA ≥ 4 (must have negative biopsy within last 12 months)

          -  Neurogenic bladder

          -  Obstruction due to urethral stricture

          -  Any disorder or condition of the subject that the investigator believes will counter
             indicate their inclusion in the study
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
Condition: Surgical Conditions
MeSH terms: Disease
Intervention: Deep neuromuscular block
Intervention description: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A deep neuromuscular block (NMB) is often associated with improved surgical conditions
      especially in laparoscopic surgery. We previously showed that deep NMB is superior to a
      moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia
      and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to
      investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia
      maintenance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with renal or prostatic disease who are will undergo an elective
             laparoscopic renal surgical procedure or laparoscopic prostatectomy;

          -  American Society of Anesthesiologists (ASA) class I-III

          -  > 18 years of age;

          -  Ability to give oral and written informed consent.

        Exclusion Criteria:

          -  Known or suspected neuromuscular disorders impairing neuromuscular function;

          -  Allergies to muscle relaxants, anesthetics or narcotics;

          -  A (family) history of malignant hyperthermia;

          -  Women who are or may be pregnant or are currently breast feeding;

          -  Renal insufficiency, as defined by glomerular filtration rate < 30 ml/h creatinine.

          -  Previous retroperitoneal surgery at the site of the current surgery.

          -  Body mass index > 35 kg/m2
Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
Condition: High Risk Abdominal Wounds
MeSH terms: Wounds and Injuries
Intervention: Negative Pressure treatment
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Prevena; faster healing time; surgical site infection

Summary:

      The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in
      high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).

      Hypothesis:

      Historically, the average rates of infective complications in surgical wounds types are 7.7%
      in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena
      ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce
      these rates by 50%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All five of the following criteria must be present for enrollment into the study:

               1. Signed written informed consent must be provided by the patient or by patient's
                  legally acceptable representative, if patient unable to consent.

               2. Age > 18 years

               3. Abdominal operation entering the peritoneal cavity under general anesthesia for
                  colostomy or ileostomy reversal or enterocutaneous fistula excision

               4. Clean - contaminated OR contaminated OR dirty wound (as defined by Wound
                  Infection Surveillance) OR use of skin flaps for skin closure.

               5. Complete closure of the surgical wound including the skin.

        Exclusion Criteria:

          -  1) Known allergic reaction at the wound dressing parts of the Prevena ™ Incision
             Management System.

        (Included but not limited to: sensitivity to silver, allergic or hypersensitivity reaction
        to acrylic adhesives).

        2) Inability to close the abdominal wall at the index procedure. 3) Inability to close the
        skin at the index procedure. 4) Patients under 18 years old. 5) Pregnant women test
Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Postoperative Nausea and Vomiting
Intervention: Ramosetron
Intervention description: ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days
Intervention MeSH terms: Ramosetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 86 Years
Healthy volunteers: No
Keywords: postoperative nausea and vomiting

Summary:

      The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic
      protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam &
      propofol, hydration & oxygen supplement, preemptive & multimodal contemporary pain management
      and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on
      this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during
      multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and
      vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide
      additional antiemetic effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary osteoarthritis, knee

          -  Scheduled for elective total knee arthroplasty

          -  Signed written informed consent

        Exclusion Criteria:

          -  Refusing participate

          -  Contraindication to regional anesthesia

          -  Severe impairment of bowel motility

          -  administration of other antiemetics within 24hours before surgery

          -  systemic steroid within 24hours before surgery

          -  history of cardiovascular & respiratory disease

          -  renal & hepatic failure
Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis
Condition: Acute Kidney Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Intervention: ertapenem
Intervention description: One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.
Intervention MeSH terms: Ertapenem
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ertapenem; continuous hemodialysis; pharmacokinetics

Summary:

      Critically ill patients in the intensive care unit often receive continuous hemodialysis to
      treat their kidney failure. Ertapenem is an antibiotic often used in these patients.
      Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate
      treatment of their infection. This study will determine how much ertapenem is removed by
      continuous hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized in ICU

          -  Receiving Continuous hemodialysis

          -  Prescribed ertapenem

          -  Informed consent granted

        Exclusion Criteria:

          -  < 18 years of age

          -  Allergy to ertapenem or other carbapenem antibiotic

          -  Severe, life-threatening reaction to penicillin or cephalosporins

          -  Patients experiencing or with history of CNS disorders (eg: seizure, stroke)

          -  Patients experiencing CNS infection

          -  Inability to complete 24 hours of CVVHD

          -  Concurrent use of other extracorporeal therapies such as extracorporeal membrane
             oxygenation, plasmapheresis or intermittent hemodialysis

          -  Inability to obtain informed consent

          -  Pregnant and/or breastfeeding women