cyrilzakka/clinical-trials huggingface dataset:
Comparison of Cloxacillin and Benzylpenicillin in Penicillin Susceptible S. Aureus Bacteraemia

The goal of this study is to investigate if benzylpenicillin is a better treatment option than cloxacillin in patients with penicillin-susceptible Staphylococcus aureus bacteraemia.

The overall research idea of is a RCT is to test the hypothesis that benzylpenicillin is superior to cloxacillin in the treatment of PSSA bacteraemia.

Population: Adult patients (\>18 years) with PSSA bacteraemia will be eligible for enrolment in the study. Exclusion criteria are allergy to penicillin, inability to give informed consent, and concomitant growth of other clinically significant bacteria in blood cultures. We are planning a nation-wide study.

Intervention: Benzylpenicillin treatment of PSSA bacteraemia will be evaluated. As soon as S. aureus has been identified in blood cultures and the susceptibility testing indicates penicillin susceptibility (Two-three days from start of treatment), patients will be randomized to continue therapy with either cloxacillin or benzylpenicillin. The duration of treatment depends on the type of infection, and details about length of therapy and dosage will be decided by the specific patient diagnosis (i.e., endocarditis, arthritis). Repeated blood cultures and echocardiography are important in the diagnostic work-up of S. aureus bacteraemia and will be included in the study protocol. Patients will also be monitored regarding adverse events, such as liver and renal impairment, rash, diarrhoea, thrombophlebitis et c., and treatment failure, relapse, and mortality.

Control: The study drug (benzylpenicillin) will be compared to cloxacillin, which is the current drug of choice for methicillin susceptible S. aureus in Sweden. Both drugs will be used at clinically recommended doses, with appropriate adjustments for renal impairment if needed. Outcome: Primary outcome is; to be alive for 90 days without any complications. Complications are defined as having any of relapse (90 days after antibiotic finished), need of change or addition of antibiotics due to side effects or treatment failure or adverse events.

Eligibility Criteria:
Inclusion Criteria:

Aged ≥18 with penicillin susceptible S. aureus bacteraemia (PSSA), and able to provide written informed consent.

Exclusion Criteria:

* allergy to penicillin,
* inability to give informed consent,
* concomitant growth of other clinically significant bacteria in blood cultures
* neutropenia

  -≥ 96h with prior antibiotics
* When the per oral follow up medication can not be flukloxacillin or penicillinV/Amoxicillin (ie prosthetic joint infection)
* Patients in terminal palliation, where death is expected within 7 days.
* Where the treating physician believes cloxacillin is not a first-line treatment.
CHOICE: Carotid Stenting For High Surgical-Risk Patients

The purposes of this study is to 1) Provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions. 2) Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.

The CHOICE study will provide a mechanism for collection of data from Abbott Vascular's Carotid Stent Systems and Embolic Protection Systems when used by a broad group of physicians under commercial use conditions. The original CAPTURE and EXACT studies had built-in features that limited the ability to collect on-going real world data because they restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (up to 50 patients per site). This study will not have these restrictions. The CHOICE study will also provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patient or patient's legally authorized representative provided informed consent.
2. Patient is considered at high risk for carotid endarterectomy (CEA).
3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
4. Patients physician intends to use an RX Acculink with either the RX Accunet or Emboshield Nav 6 in the carotid artery OR the patients physician intends to use an Xact with the Emboshield or Emboshield Nav6 in the carotid artery as per the FDA approved Indications for Use as outlined.

Exclusion Criteria:

There are no exclusion criteria for this study
Can the Usage of Regional Block Room Save the Time of Anesthesia Team

Study of time usage of anesthesia team inside the main operating room compares between 2 groups of

* Performing regional anesthesia inside the operating room
* Performing regional anesthesia in the block room

Study purpose: How much will the investigators save time in the main operating room if we perform the regional anesthesia in the block room?

Anesthesia-controlled time means anesthesia pre-procedure time plus anesthesia post-procedure time.

We also compares the anesthesia-controlled time in 3 groups of

* general anesthesia
* regional anesthesia
* general anesthesia combined with regional anesthesia

Eligibility Criteria:
Inclusion Criteria:

* elective orthopedic surgical patients that require for anesthesia ( start 9AM-4PM)

Exclusion Criteria:

* surgery under local infiltration
Single Versus Multiple Visits Endodontic Treatment

Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year

Patients with necrotic teeth with apical periodontitis will be selected according to the eligibility criteria and patients are then randomized to either single visit or multiple visit using triple paste intracanal medicament. Postoperative pain will then assessed using numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing will be assessed every 3 months up to one year.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients; age between 16-55 years old.
2. Males or Females.
3. Maxillary or mandibular single-root tooth or a multi-rooted tooth with:

   * Non-vital response of pulp tissue.
   * Radiographic evidence of periapical lesions (minimum size 2.0 mm × 2.0 mm) related to one root in case of multi-rooted teeth.
   * Asymptomatic patients.
4. Positive patients' acceptance for participation in the study.

Exclusion Criteria:

1. Primary teeth, and permanent teeth with immature apex.
2. Teeth previously accessed or endodontically treated.
3. Patients with diabetes and immune-compromising disease.
4. Patients allergic to metronidazole, ciprofloxacin, or minocycline.
5. Vital cases or necrotic without periapical lesion.
6. Pregnant women.
7. Teeth with unfavorable conditions for rubber-dam application.
8. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.
Safety Study of ISIS 325568 in Healthy Volunteers

The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.

To evaluate the safety of a single subcutaneous injection of ISIS 325568 administered at four increasing dose levels (50, 100, 200, 400 mg/week) and to evaluate the safety and tolerability of multiple doses of ISIS 325568 (three intravenous doses during Study Week 1, followed by once weekly subcutaneous administration for 5 weeks) at each of the four dose levels

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65 years
2. Males or females. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, subject or partner must be using an acceptable contraceptive method during the trial and for 9 weeks after the last dose of study drug.
3. Give written informed consent to participate in study and availability for all study requirements
4. Fasting plasma glucose ≤ the upper limit of the laboratory's reference range (ULN)
5. HbA1C ≤ ULN
6. BMI \< 30 kg/m2

Exclusion Criteria:

1. Clinically significant abnormalities in medical history or physical examination
2. Abnormalities on laboratory examination (ALT \> ULN, AST \> ULN, bilirubin \> ULN, creatinine \> ULN, urine protein positive by urine dipstick, platelets \< lower limit of normal and any other clinically significant laboratory findings)
3. History of clinically significant abnormalities in coagulation parameters
4. Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
5. Active infection requiring antiviral or antimicrobial therapy
6. Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor.
7. Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year)
8. Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
9. History of alcohol or drug abuse
10. Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening.
11. Blood donation within three months of screening
Lymphocytes Subpopulation in Cancer Patients

This study aims to exam the subpopulation of lymphocytes and evaluate the clinico-pathologic correlations.

The host's inflammatory response in the tumor microenvironment could effect cancer progression and prognosis. As components of systemic inflammatory response, lymphocytes, neutrophils, and platelets are being recognised to have an important role in carcinogenesis and tumor progression. To date, a number of peripheral blood-derived inflammation-based scores such as the neutrophil-lymphocyte ratio (NLR), platelet- lymphocyte ratio (PLR) and so on have been proposed as prognostic markers in numerous types of cancers. But, very little is known of their impact in subpopulation of lymphocytes. The investigators try to evaluate the activity of lymphocytes in peripheral blood and find out the relationship among clinical prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. cancer patients of Uijeongbu St. Mary's Hospital
2. never treated with chemotherapy
3. Age between 20\~80 years-

Exclusion Criteria:

1. treated with chemotherapy before
2. No informed consent form
Determining the Barriers and Motivations to Clinical Trial Participation

Purpose: To comprehensively explore the barriers and motivators for participation in HIV clinical trials in a purposive sample of HIV positive patients receiving care at the UNC ID (Infectious Diseases) clinic Participants: HIV positive patients seen at the UNC ID Clinic. Participants will be purposively sampled based on gender, race and previous participation in HIV clinical trials. Blacks and patients who have never participated in clinical trials will be oversampled.

Procedures (methods): Cross-sectional study using in-depth semi-structured qualitative interviews to determine the barriers and motivators for participation in HIV clinical trials. Patient interviews will be audiotaped, transcribed verbatim and analyzed using Atlas.ti software to understand the barriers and motivators for participation in HIV clinical trials.

Study Population: 48 HIV positive adult (at least 18 years of age) patients receiving care at the UNC ID Clinic will be enrolled in the study. Purposive sampling by race, gender and previous participation in HIV clinical trials will be used to ensure adequate representation in each category. Participation in a clinical trial will be defined as having participated in a trial of highly active antiretroviral therapy (HAART) for duration of \> 48 weeks. Non-trial participation will be defined as having been offered the opportunity to participate in a clinical trial but have never participated in any clinical trial or participated in a trial that included a one-time sample collection with no follow up visits.

STUDY METHODS

Questionnaire: The questionnaire consists of open-ended questions to be administered to participants. The questionnaire items were composed by reviewing related studies. Two versions of the questionnaire will be administered, one for participants with a history of participation in clinical trials and one for participants who were approached but have never been in a clinical trial (See Appendix 1.) The questionnaire will be revised after pre-testing to incorporate changes before it will be administered to all 48 participants.

Interview: The interview will be conducted at the UNC ID clinic by one research assistant. The interview will take approximately 45 minutes and will be audiotaped.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive adults,
* at least 18 years of age,
* receiving care at the UNC ID clinic,
* have previously been approached for (or offered) participation in a clinical trial.

Exclusion Criteria:

* Non native English speaking patients
* Unable to provide informed consent
* Have never been offered participation in a clinical trial
Treatment for Completers of the Study B7A-MC-MBCM

To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.


Eligibility Criteria:
Inclusion Criteria:

* Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment.

Exclusion Criteria:

* Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.
Complex Treatment of a Chronic Anal Fissure

This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.

Chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. This condition is attended by severe pain syndrome during and after bowel movement (defecation). This condition is most frequent in younger and working-age adults; therefore, the treatment issue is of particular relevance.

The main cause of chronic anal fissure development is spasm of the internal sphincter. It should be eliminated in the first instance, in order to provide the effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed.

Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency).

In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early post-operative period.

Botulinum Toxin Type A application in complex treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence).

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic anal fissure

Exclusion Criteria:

* Inflammatory diseases of the colon
* Pectenosis
* Previous surgical interventions on the anal canal
* IV grade internal and external hemorrhoids
* Rectal fistula
* Severe somatic diseases at the decompensation stage
* Pregnancy and lactation
* Individual intolerance and hypersensitivity to botulinum toxin
* Myasthenia gravis and myasthenia-like syndromes
* Anal sphincter insufficiency
Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.

OBJECTIVES:

* Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma.
* Determine the pharmacokinetics of this drug in this patient population.
* Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.

Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma

  * At least 50% of malignant cells must react with HeFi-1
  * HIV positive or HIV negative
* Measurable disease
* No symptomatic CNS disease
* Must have failed or be ineligible for standard chemotherapy regimen

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* More than 2 months

Hematopoietic:

* Not specified

Hepatic:

* No significant hepatic disease
* Bilirubin no greater than 2 mg/dL

Renal:

* No significant renal disease
* Creatinine no greater than 3 mg/dL

Cardiovascular:

* No significant cardiovascular disease

Pulmonary:

* No significant pulmonary disease

Other:

* No significant endocrine, rheumatologic, or allergic disease
* No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis
* Not pregnant
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior murine antibody therapy

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy to measurable disease

Surgery:

* Not specified

Other

* At least 4 weeks since prior cytotoxic therapy to measurable disease
Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnoses of type 1 or type 2 diabetes mellitus
* Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) \> 6.5% and \< or = 10.0%.
* Body mass index (BMI) of \< or = 40 kg/m2
* Non-smokers (never smoked or former smokers \[= 6 months since cessation\]) and a urine cotinine level \< or = 100 ng/dL
* Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%
* For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment

Exclusion Criteria:

* History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings
* Elevated liver function test (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 times the normal reference range or bilirubin \> 1.5 times the reference range)
* Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
* Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
* Exposure to any investigational product(s) in the past 12 weeks
* For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine \> 1.4 mg/dL in female subjects and \> 1.5 mg/dL in male subjects
Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B
* Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Unwilling to use double barrier method of contraception
* Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
* Received Hepatitis B therapy in the past
* Use of immunomodulatory therapy in past 12 months
* History of or symptoms of hepatic decompensation or pancreatitis
* Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
* Concurrent medication likely to preclude compliance with schedule of evaluations
* Use of other investigational drugs within 30 days of enrollment
* Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply