bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Methylnaltrexone bromide
Intervention MeSH terms: Bromides; Methylnaltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid-Induced Constipation

Summary:

      This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the
      safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will
      be tested in late stage, advanced illness patients who have constipation caused by opioid
      pain relievers. This study will last 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all
             post baseline efficacy, safety, and health outcomes assessments.

          -  Is receiving opioids on a regular schedule, not just as needed to control pain.

          -  Likely to continue to need treatment of OIC for the duration of participation in the
             study.

        Exclusion Criteria:

          -  Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or
             clinically important active diverticular disease as determined by the investigator.

          -  Currently using an opioid antagonist or partial antagonist.

          -  Has any other clinically important abnormalities such that risk to patient of
             participation outweighs the potential benefit of therapy as determined by the
             investigator
Preemptive Local Anesthesia in Vaginal Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: bupivacaine and epinephrine; Placebo
Intervention description: 20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.; 20 ml normal saline injection.
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: preemptive analgesia; paracervical block; vaginal hysterectomy

Summary:

      Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a
      painful stimulus. This trial is examining the effects of a local anesthetic given at the
      point of innervation prior to performing a vaginal hysterectomy with suspension sutures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing vaginal hysterectomy with McCall's culdoplasty
Anterior Cruciate Ligament Pain Study
Condition: Anterior Cruciate Ligament Reconstruction
Intervention: Ropivacaine 0.5%; Percocet 7.5/325; Naprosyn 500 mg
Intervention description: Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.; Percocet 7.5/325 will taken as needed up to every four hours.; Naprosyn 500 mg will be taken twice daily.
Intervention MeSH terms: Naproxen; Acetaminophen, hydrocodone drug combination; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 115.0
Sex: All
Healthy volunteers: No

Summary:

      The objective of this study is to compare the pain control benefit of two different types of
      nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory
             Orthopaedic and Spine Center

          -  Patients willing and able to provide written informed consent

          -  Parents willing and able to provide written informed consent for minors

        Exclusion Criteria:

          -  Patients who are pregnant or lactating

          -  Patients with liver dysfunction or renal failure

          -  Patients with a known allergy to ropivacaine

          -  Patients with a local infection

          -  Patients who take chronic pain medications

          -  Patients with an opioid tolerance

          -  Patients with known coagulopathy or bleeding risk.

          -  Patients who are getting neuraxial anesthesia for surgery
Corticosteroids With Vedolizumab in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Prednisone; Placebo; Vedolizumab
Intervention description: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
Intervention MeSH terms: Prednisone; Vedolizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Vedolizumab; Corticosteroids; Prednisone; Crohn's disease

Summary:

      Use of co-induction with corticosteroid therapies may accelerate the remission rate when used
      with vedolizumab. Further, this may lead to higher rates of response and remission at week 10
      than would be seen with vedolizumab monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at entry 18 to 70

          -  CDAI score > 220

          -  Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been
             stable for > 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued
             (>2 weeks from last dose) prior to initiation of vedolizumab.

          -  Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10
             or more aphthous ulcers

          -  Able to provide written informed consent.

          -  Patient is planned for or eligible to initiate vedolizumab

        Exclusion Criteria:

          -  Concurrent use of anti-TNFα antibodies.

          -  No corticosteroids within prior 3 months (other than budesonide controlled ileal
             release)

          -  No stoma at the time of enrollment

          -  No absolute contraindication to systemic corticosteroid use such as hypersensitivity
             to any part of the formulation, systemic fungal infection, or recent administration of
             live or live attenuated vaccine within prior two weeks.

          -  Pregnant women or plans for pregnancy within 3 months of study inclusion

          -  Presence of stoma, more than three small-bowel resections, or documented history of
             short bowel syndrome

          -  Intestinal stricture requiring surgery

          -  Abdominal abscess

          -  Inability or unwillingness to provide informed consent

          -  Any other condition, which, in the opinion of the investigators would impede
             competence or compliance or possibly hinder completion of the study
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
Condition: Anemia, Iron-Deficiency; Kidney Failure, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Sodium Ferric Gluconate complex in sucrose; Ferrous sulfate tablets
Intervention description: Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses; ferrous sulfate 325 mg three times daily for 6 weeks
Intervention MeSH terms: Ferric gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency; Anemia; Chronic kidney disease; Erythropoietic agents; Sodium Ferric Gluconate; Anemia, Iron-Deficiency/drug therapy/etiology; Kidney Failure, Chronic/blood/complications/therapy; Erythropoietin, Recombinant/adverse effects/therapeutic use

Summary:

      This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate
      (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease
      patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe anemia

          -  Iron deficiency

          -  Moderate to severe chronic kidney disease

          -  Receiving therapy with erythropoietic agent

        Exclusion Criteria:

          -  Receiving dialysis

          -  Known sensitivity to Ferrlecit® or any of its components

          -  Clinically unstable
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Condition: Candidiasis, Vulvovaginal
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Intervention: Clotrimazole vaginal tablet; Fluconazole
Intervention description: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4); 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Intervention MeSH terms: Fluconazole; Clotrimazole; Miconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No

Summary:

      The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs
      Fluconazole for the treatment of severe vulvovaginal candidiasis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a
             numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3)
             with a minimum VVC Composite Signs/Symptoms score of 7

          2. Subject completes the informed consent process

          3. Subject agrees to take study medication when scheduled

          4. Subject complies with all clinical trial instructions. Commits to all follow-up visits

        Exclusion Criteria:

          1. had any other sexually transmitted disease or gynaecological abnormality requiring
             treatment

          2. had a disease known to predispose to candidiasis such as diabetes mellitus, or were
             receiving antibiotics or corticosteriods

          3. were pregnant

          4. had used antifungal medication in the week before entry

          5. were expected to menstruate within seven days of the start of treatment

          6. infected more than one candida species
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: DNR:; Ara-c
Intervention description: DNR：45mg/m2 d1-3; DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 1 Year
Maximum age: 14 Years
Healthy volunteers: No
Keywords: ara-c; As2O3; pediatric; acute

Summary:

      Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low
      relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining
      ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C
      in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the
      relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at
      presentation were higher than those WBC counts less than 10×109/L (31% and 3.5%,respectively)
      in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to
      an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role
      of the Ara-C remains controversial. And there are very limited data reported on children with
      APL so far.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute Promyelocytic Leukemia (APL)

        Exclusion Criteria:

          -  > 14
Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Condition: CVD
Intervention: Argatroban; non-argatroban treated group
Intervention description: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment; Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
Intervention MeSH terms: Argatroban; Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Argatroban; intracranial artery stenting; extracranial artery stenting; occlusion; restenosis

Summary:

      Argatroban is a selective thrombin inhibitor, and previous study had suggested that
      argatroban use post PCI could potentially prevent reocclusion. But there has no study on
      large sample of argatroban treated restenosis post cranial stenting. This study will test the
      safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with
      intracranial and extracranial artery stenting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For extracranial artery lesion, stenting was considered for symptomatic stenosis≥50%
             or asymptomatic stenosis≥70%; according to intracranial artery lesion, stenting was
             considered for symptomatic stenosis≥70% in invalid patients after intensive medical
             therapy.

          -  Successfully had intracranial or extracranial artery stenting

        Exclusion Criteria:

          -  Evidence of hemorrhagic brain infarction, intracranial and extracranial hematoma, or
             intraventricular hemorrhage, or Gastrointestinal ulcers in 3 months

          -  Hypersensitivity to contrast agent

          -  Malignant hypertension

          -  Difficult to perform the intracranial and extracranial artery stenting

          -  Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.

          -  Serum creatinine >1.5 mg/dL

          -  Hypersensitivity to test drugs

          -  Difficult to hand follow-up visit
A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: sildenafil citrate
Intervention description: Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multicenter open label study to assess the efficacy of sildenafil rapid dose titration to
      100 mg in men with erectile dysfunction, based on the Erectile Function (EF) domain score of
      the International Index of Erectile Function (IIEF) questionnaire.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented Clinical diagnosis of Erectile Dysfunction (ED) by International Index of
             Erectile Function (IIEF) Erectile Function (EF) Domain score less than or equal to 25.

          -  Subjects must be in a stable relationship

        Exclusion Criteria:

          -  Subject with resting sitting hypotension (BP <90/50 mmHg) or hypertension (BP>170/110
             mmHg) and orthostatic hypotension.

          -  Subjects receiving any PDE (Phosphodiesterase)-5 inhibitors within 4 weeks prior to
             the date of screening.

          -  Subjects with severe hepatic impairment, a known history of retinitis pigmentare.

          -  Subjects with significant cardiovascular disease in the last 3 months (per medical
             history.
Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A
Condition: Haemophilia A
MeSH terms: Hemophilia A
Intervention: Optivate 500IU
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Healthy volunteers: No
Keywords: Haemophilia A

Summary:

      Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma
      inhibitor levels for at least 100 Exposure Days (EDs) for each subject.

      Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and
      adverse events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent or, if less than 18 years of age written assent (where
             possible) and their parent/guardian's written informed consent.

          -  Severe haemophilia A (< 1%# FVIII:C).

          -  Previously Treated Patients (PTPs) with > 150 exposure days on prior Factor VIII
             therapy (of which at least the last 50 EDs or 2 years treatment can be confirmed by
             way of subject records).

          -  Immunocompetent with CD4 count > 200 / µl.

          -  HIV negative or a viral load < 200 particles / µl.

               -  subjects suffering from severe haemophilia A (<2%) may be enrolled, but only
                  after approval by BPL. Subjects with a Factor VIII of <2% may not constitute more
                  than 50% of the total patient population. A separate statistical evaluation will
                  be conducted for the <1% and <2% populations.

        Exclusion Criteria:

          -  • History of inhibitor development to FVIII or a positive result on the Nijmegen
             Bethesda at screening (quantitative result of > 0.6 BU) prior to the administration of
             Optivate®.

               -  Known or suspected hypersensitivity to the investigational medicinal product or
                  its excipients.

               -  Clinically significant liver disease, renal disease, or coagulopathy other than
                  haemophilia A.

               -  History of unreliability or non cooperation (including not being able to complete
                  the study diary).

               -  Participating in, or have taken part in another trial within the last 30 days.
Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)
Condition: Sedation
MeSH terms: Emergencies
Intervention: propofol; Ketamine
Intervention description: propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation; ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ketamine; propofol; procedural sedation; moderate procedural sedation in the ED

Summary:

      This study is a clinical trial of moderate sedation with propofol versus moderate sedation
      with ketamine for procedural sedation in the Emergency Department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who require moderate procedural sedation with propofol in the ED

        Exclusion Criteria:

          -  age > 17 years

          -  pregnant

          -  intoxicated

          -  cannot give informed consent

          -  allergy to ketamine or propofol

          -  patient will require deep procedural sedation

          -  ASA physical status score > 2
Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
Condition: Blood Loss, Surgical
MeSH terms: Hemorrhage; Blood Loss, Surgical
Intervention: Vasopressin
Intervention description: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 152.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: myomectomy; vasopressin; blood loss

Summary:

      The main purpose of this study is to compare blood loss at the time of laparoscopic or
      robotically-assisted laparoscopic myomectomy when using different amounts of dilute
      vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus.
      Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic
      surgery; although very little is know about the optimal dosage and administration.

      The investigators plan to perform a randomized clinical trial on patients scheduled for
      minimally invasive myomectomy. All patients will get the same overall amount of vasopressin.
      Patients will be assigned by chance to one of two groups: one group will receive higher
      volume of a more dilute vasopressin solution. The other group will receive a lower volume of
      a more concentrated solution. The investigators will collect information on operative blood
      loss and complications related to surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The inclusion criteria for our study include all women who are candidates for a
             laparoscopic or robotic-assisted laparoscopic myomectomy and are willing to accept
             randomization.

          -  The exclusion criteria: for our study include: suspected malignancy or
             contraindication to morcellation of uterine tissue, history of adverse reaction or
             allergy to vasopressin, and active cardiovascular or pulmonary disease that would
             indicate a contradiction to use of vasopressin.