bioihbjkbjnl/mcl2 huggingface dataset:
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Condition: Hepatitis C, Chronic; DIABETES MELLITUS Type 2
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Diabetes Mellitus, Type 2
Intervention: nitazoxanide; conventional interferon alfa; Ribavirin
Intervention description: nitazoxanide 500mg twice daily; Inj interferon 3 Million International Units thrice weekly; ribazole
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Nitazoxanide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 35 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Nitazoxanide,; Sustained viral response; Type 2 DIABETICS

Summary:

      The purpose of this study is to investigate if nitazoxanide used in combination with
      interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic
      patients by improving their sustained viral response by more than 80%.Considering that the
      study is being conducted in a third world country like Pakistan, the standard treatment of
      hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in
      efficacy to peginterferon and also cost effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatitis C genotype 3a

          -  Hepatitis C Virus(PCR)RNA Detected

          -  Alanine transaminase >60

          -  Diabetic HbA1c<8

          -  BMI>23

        Exclusion Criteria:

          -  Previously treated Hepatitis C patients

          -  Pregnant females

          -  Decompensated liver disease,Child class B OR above

          -  Thyroid disease,Thyroid stimulating hormone>10,0.05

          -  Absolute neutrophil count<1500,Platelets<80,000,Hb<10g Female,<11g Male

          -  Severe cardiac disease,New York Heart Association2

          -  Moderate to severe depression assessed by Beck Depression Inventory scale
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
Condition: Pelvic Organ Prolapse
MeSH terms: Urinary Retention; Prolapse; Pelvic Organ Prolapse
Intervention: Nitrofurantoin; Placebo
Intervention description: Patients will receive nitrofurantoin 100mg once daily or a placebo. Pills will be identical.; Placebo
Intervention MeSH terms: Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The specific aim of this randomized double-blind placebo-controlled trial is to determine if
      extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic
      urinary tract infection (UTI) compared with placebo for patients undergoing short term
      indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary
      retention following pelvic organ prolapse and/or urinary incontinence surgery.

      Consented patients who undergo urogenital surgery and fail their post-operative voiding trial
      will be randomized to either extended release nitrofurantoin 100mg or an identical appearing
      placebo capsule to be taken daily while performing CISC or while indwelling catheter is in
      place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of
      surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and
      incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women.

      Primary and secondary outcomes will be evaluated with Student t test and chi squared or
      Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to
      nitrofurantoin prophylaxis from 33% to 13%, with 80% power, and a two-sided alpha of 0.05,
      and a 10% dropout rate, we should recruit a total of 154 patients.
    

Eligibility criteria:

        Inclusion Criteria:

        - Women who have undergone surgery for the correction of pelvic organ prolapse and/or
        urinary incontinence and failed a postoperative voiding trial

        Exclusion Criteria:

          -  Known drug allergy to nitrofurantoin

          -  History of renal insufficiency

          -  Renal transplant

          -  Renal nephropathy

          -  Recent history of more than 3 UTIs per year

          -  History of nitrofurantoin-induced pulmonary injury or nitrofurantoin associated
             cholestatic jaundice/hepatic dysfunction

          -  Known immunocompromised condition (organ transplant, chemotherapy, immune suppression
             associated with autoimmune disease).
A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Oseltamivir; Placebo
Intervention description: Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.; Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Intervention MeSH terms: Oseltamivir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 477.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal
      prophylaxis of influenza in immunocompromised participants (as represented by transplant
      recipients). Transplant recipients enrolled when influenza is circulating in the community
      will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily
      (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will
      be recorded throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Negative rapid diagnostic test for influenza at baseline;

          -  Immunocompromised participant (liver and/or kidney recipient or allogenic
             hematopoietic stem cell transplant).

        Exclusion Criteria:

          -  Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or
             nasal congestion;

          -  Influenza vaccination in 6 weeks prior to randomization;

          -  Positive rapid diagnostic test for influenza;

          -  Solid organ transplant within 6 months of randomization;

          -  Antiviral treatment for influenza in 2 weeks prior to randomization.
Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Intervention: Venlafaxine XR; Placebo
Intervention description: Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d; six month intervention with placebo drug
Intervention MeSH terms: Norepinephrine; Venlafaxine Hydrochloride; Serotonin; Serotonin and Noradrenaline Reuptake Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; Chronic Mediation Treatment; Double-Blind; Placebo Controlled; Venlafaxine XR; Relapse

Summary:

      This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine
      XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of
      treatment versus 12 months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  GAD diagnosis by structured interview

          -  Hamilton Anxiety Scale score of 18 or MORE

          -  Clinical Global Impressions Severity Scale score of at least 4

          -  Hamilton Depression Scale score of 18 or less

          -  Hamilton Depression Scale suicide item score less than 2

          -  Use of an effective form of contraception throughout the study

        Exclusion Criteria:

          -  Hypersensitivity to venlafaxine XR

          -  History of seizures

          -  Episode of major depressive disorder in the previous 6 months

          -  History of any psychotic illness, bipolar disorder, or dementia

          -  Substance abuse and dependence during the past 6 months

          -  Other anxiety disorders with the exception of social phobia as long as GAD is primary

          -  Regular use of anxiolytics or antidepressants within 7 days of study onset

          -  Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low
             dose usage of benzodiazepines will not prevent participation)

          -  Use of other psychotropic medication besides benzodiazepines during the study
Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery
Condition: Neuromuscular Blockade; Surgery; Anesthesia; Spinal Diseases
MeSH terms: Spinal Diseases
Intervention: sufficient dose of rocuronium; sugammadex 10 min after position change
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Neuromuscular blockade; Surgical rating scale; Rocuronium; Sugammadex; Spinal surgery; General anesthesia

Summary:

      The investigators aim to investigate operating conditions, postoperative recovery and overall
      satisfaction of surgeons between deep neuromuscular blockade (NMB) group and restricted NMB
      group during spinal surgery under general anesthesia. The investigators hypothesize that this
      study can present good surgical conditions, postoperative recovery outcomes and overall
      satisfaction of surgeons in deep NMB group, thereby proving the advantages of deep NMB as
      well as flaws of restricted NMB in spine surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) physical status I-II adult patients
             scheduled for elective spinal (cervical or lumbar) surgery under general anesthesia

        Exclusion Criteria:

          -  Pregnancy

          -  Present medication known to interfere with neuromuscular blockade

          -  Diseases affecting neuromuscular transmission

          -  History of hypersensitivity on rocuronium or sugammadex

          -  Emergent spinal surgery

          -  Spinal surgeries which have lesions more than 3 spinal levels

          -  Spinal surgeries which have duration less than 1 hour

          -  Spinal surgeries which are not performed under prone position

          -  Spinal surgeries which are not performed under total intravenous anesthesia (TIVA).

          -  Patients who will have hemodynamic instability (mean blood pressure increase or fall
             of > 30% from baseline lasting for more than 5 min) during surgery

          -  Patients who will have blood loss > 1 L during surgery

          -  MEP monitored spinal surgeries
Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Condition: Wound Infection
MeSH terms: Wound Infection; Wounds and Injuries
Intervention: Cefazolin PostOperatively; Cefazolin Preoperatively
Intervention description: Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used.; Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.
Intervention MeSH terms: Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vulvectomy; wound infection; wound complication; prophylactic antibiotic; Post-operative wound complications following vulvectomy

Summary:

      This randomized prospective study will specifically investigate the efficacy of a 24 hour
      post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in
      preventing wound infection and wound breakdown following vulvectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All female patients 18 years of age or older undergoing surgery for vulvar carcinoma
             (this includes female patients undergoing any form of vulvectomy - radical, vulvectomy
             without groin node dissection, and partial vulvectomy)

          -  Disease State will not affect inclusion in the study. Women with previous surgery for
             vulvar carcinoma will be included as will those undergoing initial operation.

          -  Number of subjects: 160

        Exclusion Criteria:

          -  Women simultaneously undergoing treatment for other forms of cancer

          -  Women under the age of 18

          -  Pregnant patients
The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals
Condition: Healthy
Intervention: Olanzapine
Intervention description: All subjects will take a single 2.5 mg dose of olanzapine (Zyprexa Zydis) followed by a 5 mg dose for 14 days. (2.5 mg/d for 1 day, 5 mg/d for 14 days).
Intervention MeSH terms: Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers; antipsychotic drugs; brain metabolism

Summary:

      The primary aim of this study is to investigate antipsychotic drug effects on healthy brain
      metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 21-50 years old

          -  Male or female

          -  Without psychiatric diagnosis according to a structured psychiatric interview (SCID)

          -  Without history of a psychotic disorder among parents, siblings, or children

        Exclusion Criteria:

          -  Significant medical or neurological illness

          -  Diagnosis diabetes mellitus, uncontrolled hypertension, severe hypotension, coronary
             artery disease, metabolic syndrome, glaucoma, liver impairment, decreased renal
             function, respiratory disorders, peptic ulcer disease (absolute and relative
             contraindications to use of antipsychotic drugs)

          -  Body mass index (BMI) over 30

          -  Taking any other medications, including over the counter supplements with the
             exception of oral contraceptives for women

          -  Pregnancy. Females of child-bearing age must be using an effective contraceptive
             method

          -  History of smoking, substance abuse or dependence

          -  Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and
             stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc.,
             brain stimulator devices, implanted drug pumps, ear implants, eye implants or known
             metal fragments in eyes, exposure to shrapnel or metal filings, other metallic
             surgical hardware in vital areas, certain tattoos with metallic ink, certain
             transdermal patches, metal-containing IUDs)

          -  Medical condition that would prevent blood draws
Evaluation of Reader Training Processes
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir F 18
Intervention description: No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 241.0
Sex: All
Healthy volunteers: No

Summary:

      This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation
      in the clinic and by expert readers.
    

Eligibility criteria:

        Inclusion Criteria:

        - Scan obtained for clinical reasons

        Exclusion Criteria:

        - None
Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.
Condition: Retinal Vein Occlusion; Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Macular Edema; Retinal Vein Occlusion
Intervention: Ranibizumab Intravitreal injections
Intervention description: Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody
      fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic
      macular edema (DME), retinal vein occlusion and age-related macular degeneration.

      Currently, there is limited epidemiologic information in Chile regarding the incidence of DME
      and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy
      of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and
      functional improvement following this treatment and to increase the local experience
      regarding the use of anti-VEGF in the treatment of diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or
             fluorescein angiography, and/or OCT) in at least one eye.

          2. Vision impairment due to DME (BCVA ETDRS letter score at 4 meters between 20 and 70
             letters (6/12 - 3/60 at Snellen chart).

        Exclusion Criteria:

          1. Laser photocoagulation in the study eye for the last 3 months.

          2. Any history of any intraocular surgery in the study eye within the past 3 months.

          3. Blood pressure >160/100 mmHg.

          4. Proliferative Diabetic Retinopathy.

        Any other protocol inclusion/exclusion criteria that may apply.
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Intervention: Taliglucerase alfa
Intervention description: Taliglucerase alfa for infusion every two weeks for 12 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: gaucher disease; pediatric

Summary:

      This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase
      alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to
      treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV)
      infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12
      months. At the end of the 12-month treatment period eligible subjects will be offered
      enrollment in an open-label extension study if taliglucerase alfa is not commercially
      available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 2 to <18 years old.

          -  Diagnosis of Gaucher disease with leukocyte acid β-glucosidase activity ≤30% of the
             mean of the reference range for healthy subjects.

          -  Subjects who have not received enzyme replacement therapy (ERT) in the past or who
             have not received ERT in the past 12 months and have a negative
             anti-glucocerebrosidase antibody assay.

          -  Subjects who have not received substrate reduction therapy (SRT) in the past 12
             months.

          -  Subjects whose clinical condition, in the opinion of the investigator, requires
             treatment with enzyme replacement therapy (ERT).

        Exclusion Criteria:

          -  Currently taking another investigational drug for any condition.

          -  Presence of neurological signs and symptoms characteristic of Gaucher disease with
             complex neuronopathic features other than longstanding oculomotor gaze palsy.

          -  Presence of unresolved anemia due to iron, folic acid, or vitamin B12 deficiency

          -  Previous hypersensitivity reaction to Cerezyme® (imiglucerase) or Ceredase®
             (alglucerase).

          -  History of allergy to carrots.

          -  Presence of HIV, HBsAg or hepatitis C infections.

          -  Subject's parent(s) or legal guardian(s) are unable to understand the nature, scope
             and possible consequences of the study.

          -  Presence of any medical, emotional, behavioral or psychological condition that in the
             judgment of the Investigator would interfere with the subject's compliance with the
             requirements of the study.