bioihbjkbjnl/mcl2 huggingface dataset:
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: rasagiline (Pharmacodynamics); Placebo
Intervention description: Rasagiline 1 mg/day for 12 weeks; Placebo 1 tablet each day
Intervention MeSH terms: Rasagiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Cognitive impairments; Negative symptoms

Summary:

      This is a study of a new medication for the treatment of cognitive impairments (thinking
      difficulties) and negative symptoms in people with schizophrenia. The new medication is
      rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration
      for the treatment of Parkinson's disease. It is used to treat cognitive problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.

          -  Current treatment with one or more second generation antipsychotics, except
             ziprasidone

          -  On same second generation antipsychotic(s)for at least 56 days

          -  On same dose of second generation antipsychotic(s)for at least 30 days

          -  22-item SANS: Total score (i.e.all items minus global items and poverty of content of
             speech)greater than 20 or global Rating of Affective Flattening greater than or equal
             to 3 or global Rating of alogia greater than or equal to 3

          -  BPRS: Sum of the four positive symptom items less than or equal to 16 (items
             4,11,12,15)

          -  BPRS: Sum of the four Anxiety/Depression Factor items less than or equal to 14 (items
             1,2,5,9)

          -  Simpson-Angus Scale: Total score less than or equal to 8

        Exclusion Criteria:

          -  DSM-IV Major Depressive Disorder within last 6 months

          -  Current treatment with ziprasidone

          -  DSM-IV diagnosis of alcohol or substance dependence within the last 6 months

          -  DSM-IV criteria for alcohol or substance abuse within the last month

          -  evidence of illicit substance use, as identified with urine toxicology screen

          -  History of an organic brain disorder, mental retardation,epilepsy, or a medical
             condition, whose pathology or treatment could alter the presentation or treatment of
             schizophrenia or significantly increase the risk associated with the proposed
             treatment protocol. See those listed below

          -  Uncontrolled hypertension defined as BP exceeding 145/90 on 3 consecutive readings
             despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency

          -  Pregnancy or lactation in females

          -  Pheochromocytoma

          -  Melanoma

          -  Hepatic insufficiency
Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair
Condition: Duration of Pain Relief
Intervention: dexamethsone; Bupivacaine
Intervention MeSH terms: 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: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: anterior cruciate ligament; block duration

Summary:

      Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic
      nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it
      in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief
      after surgery at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-75, no contraindication to regional anesthesia

        Exclusion Criteria:

          -  peripheral neuropathy
PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: PV-Isolation RF; PV-Isolation Cryo
Intervention description: Radiofrequency; Cryo-Balloon
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: catheter ablation; randomized; cryo; radiofrequency; atrial fibrillation; cryo-balloon; PV-Isolation

Summary:

      This study is designed as a randomized, controlled, prospective, non-inferiority clinical
      trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated)
      will be compared to the standard ablation technique (segmental isolation of the pulmonary
      veins) with radiofrequency energy. The primary study aim is to investigate whether the new
      cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable
      Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as
      radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins
      (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of
      atrial arrhythmias without persistent complications after six and twelve months. Furthermore,
      the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic
      nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during
      the procedure, levels of cardiac inflammatory markers are compared between the treatment
      groups. The short and long-term clinical success as well as the costs of both systems will
      also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented paroxysmal PAF: PAF diagnosis, 2 episodes of PAF within the last 3 months,
             at least 1 episode of PAF must be documented.

          -  Age 18-75

          -  Documented effectiveness failure of at least 1 AAD including beta-blockers

        Exclusion Criteria:

          -  AAD usage < 3 half life periods (except beta-blocker)

          -  LA size > 55 mm

          -  LA thrombus

          -  Previous LA ablation/surgery, structural heart disease, heart failure class III-IV

          -  Hypertrophic cardiomyopathy

          -  Mitral prosthesis

          -  Unstable angina

          -  Uncontrolled hyperthyroidism

          -  Stroke or TIA within 6 months

          -  Myocardial infarction within 2 months

          -  Cardiac surgery within 3 months

          -  Thrombocytosis, thrombocytopenia

          -  Any condition contraindicating chronic anticoagulation

          -  EF < 40%

          -  Pregnancy

          -  Life expectancy < 1 year
Intraarticular Antibiotic in TKA
Condition: Antibotics in Cementless Knees
Intervention: Tobramycin Powder; Vancomyscin
Intervention description: Everyone gets tobramycin powder.; Everyone gets the vancomyscin powder.
Intervention MeSH terms: Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine the intra-articular concentration of vancomycin and
      tobramycin after administration of vancomycin and tobramycin powder in primary cementless
      total knee arthroplasty and determine the serum concentrations of these antibiotics
      postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age over 18

          2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee
             osteoarthritis

        Exclusion Criteria:

          1. Diminished mental capacity

          2. Vancomycin allergy

          3. Tobramycin allergy

          4. Chronic kidney disease stage III and stage IV
Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: "Probiotics" and "Metronidazole"; Metronidazole Vaginal
Intervention description: Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days); Metronidazole Suppositories,qd, 7 days
Intervention MeSH terms: Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus
      rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal
      suppositories(7 days) is better than using metronidazole vaginal suppositories only in
      preventing the recurrence of bacterial vaginosis (BV).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 18 to 65 years old, with history of sexual activity, premenopausal women；

          2. Nugent Score ≥ 7 for diagnosing BV；

          3. Sign informed consent.

        Exclusion Criteria:

          1. mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV)
             infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;

          2. History of systemic organic diseases or psychiatric diseases;

          3. Planning for or during pregnancy, lactation, menstruation;

          4. within 5 days of onset of the disease, any antibiotics has been used;

          5. Long-term use of contraceptives or immunosuppressant;

          6. Anaphylactic constitution or allergic to known ingredients of research drugs.
Cranial Blocks for Postoperative Anesthesia
Condition: Craniotomy Surgery
Intervention: Liposomal bupivacaine; Bupivacaine Injection; Saline
Intervention description: Used as cranial block for craniotomy surgery; Used as cranial block for craniotomy surgery; Used as cranial block for craniotomy surgery
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
Masking: Double (Participant, Care Provider)
Masking description: On the morning of the procedure, participants will be assigned sequentially to the lowest unassigned randomization number. The surgeon performing the procedure and operating room staff will not be blinded to the intervention, since they will see whether the patient is receiving liposomal bupivacaine, bupivacaine or saline. However, all providers obtaining post-operative data from the patients will be blinded as to which treatment the patient received, in addition to the patient themselves.
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: craniotomy

Summary:

      This study compares the standard of care to the standard of care plus the administration of
      bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years of age

          -  Need for elective supratentorial craniotomy

          -  Preoperative GCS > 13

        Exclusion Criteria:

          -  Preoperative GCS ≤ 13

          -  Child (<18 years of age)

          -  Inability to understand or use the visual analog scale (VAS)

          -  Proven or suspected allergy to local anesthetics

          -  Craniotomy incision extending beyond the field of the block

          -  Patients chronically (more than 2 wk) treated with narcotic medications

          -  Previous scalp incision

          -  Bilateral craniotomies

          -  Allergies to local anesthetics

          -  GCS verbal score < 4 after extubation

          -  Patients whose surgeries extend past 6 hours (will be placed on standard of care and
             removed from study)

          -  Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants

          -  Lactating Mothers
Prevention of Tuberculosis in Prisons
Condition: Tuberculosis, Pulmonary; Antibiotic Prophylaxis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Intervention: Isoniazid 900 milligrams; Placebo
Intervention description: Oral tablet, with the isoniazid 900mg, given two weekly. The administration will be supervised.; Oral tablet, without the active ingredient, similar in size, weight, color, taste and odor.
Intervention MeSH terms: Anti-Bacterial Agents; Isoniazid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 467.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis; Primary prevention; Prisoners; Controlled Clinical Trial; Isoniazid

Summary:

      The purpose of this study is to determine if the isoniazid is effective in the prevention of
      tuberculosis in a prison population, exposed to the high endemicity of the disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age above 18 and under 45 at the time of inclusion;

          -  Sign the informed consent form.

        Exclusion criteria:

          -  Be indigenous;

          -  Active TB or previous use of isoniazid;

          -  Score Alcohol Use Disorders Identification Test ≥15.

          -  Reactive serology for HIV, hepatitis B and C;

          -  Reactive result for quantiferon, considering as positive the result of Tube 1 and / or
             Tube22 above 0.2 IU / mL;

          -  Liver enzymes (Aspartate aminotransferase and Alanate aminotransferase) three times
             the upper limit;

          -  History or treatment for epilepsy;
Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine; Ketorolac; Placebo
Intervention MeSH terms: Ketorolac; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cesarean section

Summary:

      The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine
      (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer
      similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will
      reduce the pain experienced after cesarean section and need for narcotic pain medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiology (ASA) class 1,2, and 3

          -  English speaking women at a gestational age > 37 weeks

          -  scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia

        Exclusion Criteria:

          -  BMI > 50 kg/m2

          -  history of intravenous drug or opioid abuse

          -  previous history of chronic pain syndrome

          -  history of opioid use in the past week

          -  allergy or contraindication to any of the study medications

          -  non-English speaking
Anesthesia for Pain After Ankle Fracture Surgery
Condition: Chronic Pain; Ankle Fracture Surgery; Regional Anesthesia
MeSH terms: Chronic Pain; Fractures, Bone; Ankle Fractures
Intervention: Ropivacaine; Nerve block
Intervention description: Single injection of ropivacaine immediately prior to surgery.; insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This pilot study will test the hypothesis that prolonged regional peripheral nerve block will
      reduce development of chronic pain in patients undergoing surgery for ankle fracture compared
      to standard of care. Subjects will be followed for one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Referred for surgery for open reduction and internal fixation for ankle fracture

        Exclusion Criteria:

          -  Unable to give informed consent in English

          -  Unable to complete surveys in English

          -  Unable to understand instructions for using pump in English

          -  Unavailable for followup

          -  Polytrauma; undergoing other surgeries or having other orthopedic injuries related to
             the precipitating cause of the ankle fracture

          -  Infection

          -  Peripheral vascular disease

          -  Diabetes

          -  Currently undergoing chemotherapy

          -  Pregnancy

          -  Currently lactating

          -  Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs

          -  Severe renal impairment (Class 3 or worse kidney disease)

          -  Liver disease (cirrhosis or liver failure)

          -  Prior allergic reaction to any type of local anesthetic

          -  Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic
             doses started because of hospital admission are not an exclusion)

          -  Currently taking antidepressants or other psychiatric medications

          -  Single shot local nerve block prior to surgery was ineffective

          -  Selected for neuraxial anesthesia rather than general anesthesia for the open
             reduction surgery

          -  Already receiving chronic analgesic therapy for a separate chronic pain condition
Prophylactic Antibiotics in Admitted Cirrhotics
Condition: Cirrhosis, Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Intervention: Ceftriaxone; Normal saline
Intervention description: Antibiotic; 50cc intravenous once daily
Intervention MeSH terms: Ceftriaxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded placebo-controlled trial
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this pilot study, the investigators aim to assess feasibility of subject identification
      and data collection, including specimen processing, as well as the rate of enrollment for a
      future, larger study of the effect of empiric antibiotics for all patients with advanced
      cirrhosis admitted to the hospital without an existing indication for new antibiotic use.
      Specifically, the investigators will assess the incidence of infection after the time of
      enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics
      vs placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MELD-Na >= 18

          -  Cirrhosis as defined by liver biopsy or a composite assessment of available results
             from imaging, elastography, prior records, and laboratory studies

        Exclusion Criteria:

          -  Inability to obtain consent (from subject or next of kin/legal authorized
             representative (LAR)

          -  Allergy to cephalosporins

          -  Pregnancy (due to limited prospective data regarding safety of ceftriaxone)

          -  Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or
             apparent infection

          -  Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater,
             immunosuppression for solid organ transplant)

          -  H/o recurrent C difficile infection within the past year (>2) or requiring fecal
             microbiota transplant (FMT)

          -  Enrollment in the study protocol during a previous admission