bioihbjkbjnl/mcl2 huggingface dataset:
Immediate vs. Delayed Postpartum Etonogestrel Implant
Condition: Continuation Rate of Contraceptive Implant
Intervention: Etonogestrel implant
Intervention description: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Intervention MeSH terms: Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Etonogestrel Implant; Implanon; Nexplanon; Long Acting Reversible Contraception

Summary:

      The investigators are examining if there is a difference in continuation rates of the
      etonogestrel contraceptive implant between women who have the device placed immediately after
      delivery, before leaving the hospital, and women who have the device placed at the routine
      6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30
      in each group. All participants will follow-up at the same postpartum clinic 6 weeks after
      delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete
      a brief survey. The investigators hypothesize that continuation rates of Implanon will be
      higher in the immediate postpartum placement arm than in the delayed placement arm.
    

Eligibility criteria:

        Inclusion Criteria:

        1)Age 12-40 years 2)Must deliver at Duke Hospital 3)Must have a working telephone number
        4)No contraindications to receiving this method of contraception, which include: known or
        suspected pregnancy, active liver disease or hepatic tumor, current or past history of
        thrombosis or thromboembolic disorder, undiagnosed abnormal genital bleeding, known or
        suspected breast cancer or history of breast cancer, hypersensitivity to any of the
        components of the device.

        -

        Exclusion Criteria:

          1. Not meeting inclusion criteria

          2. Use of chronic medical therapy that has an adverse interaction with etonogestrel.
             Medications that will be cause for exclusion from the study include:

        1. Non-nucleoside reverse transcriptase inhibitors 2. ritonavir-boosted protease inhibitors
        3. Certain anticonvulsants - phenytoin, carbamazepine, barbiturates, primidone, topiramate,
        oxcarbazepine 4. Rifampin 5. St. John's Wort

        -
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Condition: Fatigue
MeSH terms: Hepatitis; Fatigue
Intervention: KRG (Korea Red ginseng); Placebo (for KRG)
Intervention description: 3 weeks of KRG capsule (3,000 mg/day); Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Fatigue; Panax ginseng; Chronic hepatitis; Non-alcoholic Fatty Liver Disease; Adiponectin

Summary:

      Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity,
      and cancer related anti-fatigue.

      Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to
      receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines,
      adiponectin, fatigue severity scale, and antioxidant activity were check and compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L,
             and Fatty liver or Hepatitis

        Exclusion Criteria:

          -  viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis,
             hemochromatosis, Wilson's disease, drug induced liver injury, or cancer
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
Condition: Liver Transplantation
Intervention: Cyclosporine (Sandimmun® i.v.); Cyclosporine (Sandimmun® Optoral)
Intervention description: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.; Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Liver transplantation, Cyclosporine

Summary:

      The aim of this exploratory study is to evaluate the rejection rate in patients treated with
      cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo
      liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h
      monitoring. In addition, this study will assess the safety of this treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria

          -  About to undergo a primary liver transplant (including living donor, split liver).

          -  Expected to be capable of study participation for full 6 months post-transplantation.

          -  Allograft biopsies will be possible.

        Exclusion Criteria

          -  The surgery is a multi-organ transplant.

          -  The patient has previously been transplanted with any other organ.

          -  The graft derives from a non-heart beating donor.

        Other protocol-defined inclusion/exclusion criteria may apply.
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
Condition: End Stage Liver Disease; Hepatitis C
MeSH terms: Hepatitis C; Liver Diseases; End Stage Liver Disease
Intervention: Treatment with Direct Acting Antiviral tablet
Intervention description: HCV Treatment for 12 Weeks
Intervention MeSH terms: Antiviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; Epclusa; ESLD

Summary:

      This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to
      HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV
      transmission upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient is Age ≥ 18 years

          -  Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver
             transplant

          -  HCV naïve

          -  Able to sign informed consent

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Human immunodeficiency virus (HIV) positivity

          -  Need for dual organ transplant

          -  Any contra-indication to liver transplantation per center protocol
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Condition: Pituitary Tumor; Pain
MeSH terms: Pituitary Neoplasms; Pituitary Diseases
Intervention: IV Caldolor; IV Placebo
Intervention description: IV Caldolor (IV ibuprofen) intraoperatively and postoperatively; IV Placebo intraoperatively and postoperatively
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo-controlled intervention trial involving 100 treated
      subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects
      will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in
      the standard post-operative medication arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient undergoing ENTS surgery for resection of pituitary tumor.

          -  Adults >18 years and <80 years of age.

          -  English speaking and literate or able to understand the use of a pain scale.

          -  Body Mass Index >19 and <40 kg/m2

        Exclusion Criteria:

          -  Renal failure (acute or chronic) or creatinine >2.0

          -  Allergy or intolerance to acetaminophen, ibuprofen, or opioids

          -  Pre-operative opioid tolerance, dependence, or abuse

          -  Anaphylaxis to opioids

          -  History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery

          -  Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range,
             defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin>
             3x upper limit of normal range

          -  Subject unwilling or unable to sign informed consent for the study

          -  Pregnancy

          -  Incarcerated patients
The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
Condition: Headache
MeSH terms: Headache
Intervention: Prochlorperazine; Ketamine; Diphenhydramine; Ondansetron; Normal Saline
Intervention description: prochlorperazine 10 mg IV; Ketamine 0.3 mg/kg IV; Diphenhydromine 25 mg IV; Ondansetron 4 mg IV; Normal Saline 500 cc IV Bolus
Intervention MeSH terms: Diphenhydramine; Promethazine; Ketamine; Ondansetron; Prochlorperazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind Randomized Clinical Control Trial
Masking: Double (Participant, Care Provider)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache, Migraine

Summary:

      This study compares the efficacy of low dose Ketamine versus Compazine for the control of
      headache in patients presenting to the Emergency Department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 65 years

          -  Temperature < 100.4° F

          -  Diastolic Blood Pressure <104 mm Hg

          -  Normal neurological exam and mormal mental status

        Exclusion Criteria:

          -  Pregnant or breastfeeding.

          -  Meningeal signs are present

          -  Acute angle closure glaucoma is suspected.

          -  Head trauma within the previous two weeks

          -  Lumbar puncture within the previous two weeks

          -  Thunderclap onset of the headache

          -  Weight more than 150 kg or less than 40 kg.

          -  Known allergy to one of the study drugs.

          -  History of schizophrenia or bipolar disorder.

          -  History of intracranial hypertension.

          -  Is a prisoner

          -  Patient declined informed consent

          -  Non-English speaking patient.

          -  Attending provider excludes patient
Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Liposomal bupivacaine; Placebo - injection
Intervention description: Extended-release local anesthetic; Injectable normal saline solution
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: liposomal bupivacaine; posterior repair

Summary:

      The specific aim of this randomized double-blind clinical trial is to evaluate the effect of
      intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy
      and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as
      measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ
      prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of
      injectable normal saline administered in a standardized technique into the posterior vaginal
      compartment at the time of posterior repair and/or perineorrhaphy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English-speaking women ages 18 and older undergoing posterior repair and/or
             perineorrhaphy at our institution for pelvic organ prolapse

        Exclusion Criteria:

          -  Planned regional anesthesia

          -  Allergy or contraindication to bupivacaine

          -  Allergy or contraindication to opioids

          -  Allergy or contraindication to non-steroidal medications

          -  Planned laparotomy

          -  Chronic pain diagnosis and/or chronic narcotic use
To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
Condition: Heartburn
MeSH terms: Heartburn
Intervention: esomeprazole 40 mg
Intervention description: esomeprazole 40 mg once daily, 8 weeks
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Patients, Single

Summary:

      Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving
      rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant
      improvement of heartburn after 8-week treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 20 years or more

          -  Documented history of reflux esophagitis verified by endoscopy in the past, including
             the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment

          -  Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily,
             for a period of 4 to 8 weeks. The subject must take Rabeprazole at least 4 days a week
             in the past 7 days prior to Visit 1.

          -  Persisting symptoms of heartburn during the past 7 days prior to Visit 1, judged by
             the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort
             sufficient to cause interference with normal activities) to severe symptoms (i.e.
             incapacitating, with inability to perform normal activities) OR At least 4 days with
             symptoms including mild ones (i.e. awareness of sign or symptom, but easily
             tolerated).

          -  The subject needs to be able to understand and read the official languages of the
             country.

        Exclusion Criteria:

          -  Use of other PPIs and/or H2RA during rabeprazole treatment

          -  Previous use of esomeprazole 40 mg during the 12 weeks before enrolment

          -  Current or historical evidence of gastrointestinal pathology

          -  History, signs or symptoms of clinically significant or uncontrolled cardiovascular,
             pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or
             hepatic disease as judged by the investigator to interfere with the conduct of the
             study, the interpretation of study results, subject compliance, or the health of the
             subject during the study.

          -  Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or
             pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy,
             endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of
             an ulcer are not exclusion criteria.
Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Intervention: Betamethasone; Methylprednisolone
Intervention description: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg); The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Betamethasone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses of steroid to be given will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). We will instruct patients who meet the inclusion criteria to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, immediately after the injection, five minutes after the injection, and once a day for a minimum of 7 days after the injection. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Two common corticosteroids used for trigger finger treatment are betamethasone and
      methylprednisolone. Both injections are effective in treating trigger finger and the decision
      of which to use in treatment is currently a matter of the current practice and physician
      preference. The goal through this randomized trial is to see whether there is a difference
      between these two corticosteroids in inducing flare reactions and if there are any
      differences in the peak level of pain and their duration. Findings indicating a statistically
      significant difference in the incidence and/or intensity of the flare reactions would be
      clinically significant and would be evidence supporting the switch of current practice to one
      corticosteroid over the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Single trigger injection

          -  First time for the digit

          -  No prior surgery on digit

        Exclusion Criteria:

          -  Current oral steroid use

          -  Rheumatoid arthritis

          -  More than one single digit involved

          -  Previous injection in same digit

          -  Prior surgery on same digit

          -  Other injections in the same clinic on the same day
Switching Medication to Treat Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Risperidone; Olanzapine; Ziprasidone; Quetiapine; Aripiprazole
Intervention description: As prescribed by routine prescriber (not dictated by study protocol); As prescribed by routine prescriber (not dictated by study protocol); As prescribed by routine prescriber (not dictated by study protocol); As prescribed by routine prescriber (not dictated by study protocol); As prescribed by routine prescriber (not dictated by study protocol)
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effectiveness of switching medications in decreasing
      schizophrenia symptoms in individuals who are currently taking an antipsychotic medication
      for the treatment of schizophrenia.
    

Eligibility criteria:

        Inclusion criteria:

          -  SCID diagnosis of schizophrenia or schizoaffective disorder

          -  Partially remitted outpatients, defined as persons who have received clear symptomatic
             benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy
             or inability to tolerate an efficacious dose) or suffer significant side effects

          -  Treatment with antipsychotic medications for at least 2 months

          -  Received at least 1 outpatient mental health service every 3 months for the past 6
             months

        Exclusion criteria:

          -  Severe symptoms or side effects that indicate the necessity for a medication change

          -  Currently taking 3 or more antipsychotic medications for ongoing daily administration
             (PRN medications and mood stabilizers are allowable)

          -  Treatment with clozapine

          -  One or more nights spent in a psychiatric hospitalization within the past 3 months

          -  Received services from a crisis intervention program within the past 3 months

          -  Require placement in a skilled nursing facility as a result of a physical condition or
             disability

          -  Criminal charges pending (once charges clear, the person will be considered)

          -  Pregnant or breast feeding

          -  Contraindication to any of the medications to which the patient might be assigned
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)
Condition: Infertility
MeSH terms: Infertility
Intervention: Crinone 8% Vaginal Gel; Intramuscular Progesterone
Intervention description: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.; Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 468.0
Sex: Female
Minimum age: 21 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Infertility; In vitro fertilization; Embryo transfer; Crinone; Intramuscular Progesterone; Progesterone support

Summary:

      The goal of this research study is to compare the pregnancy rates for two different types of
      progesterone supplementation after in-vitro fertilization (IVF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women of reproductive age (21-39) with infertility who are appropriate candidates for
             IVF/ET and have an FSH < 15 mIU/ml

          -  Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of
             Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

        Exclusion Criteria:

          -  Women who have had more than 3 previous IVF/ET cycles