cyrilzakka/clinical-trials huggingface dataset:
Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)

Total prostatic cystectomy with enterocystoplasty is the most extensive urological surgical procedure and one with the highest complication rate, especially infectious complication. The mortality rate remains substantial (2 to 5%).

Examination of hundreds of TPCs made every year in the Urology Department of Foch Hospital, shows that nosocomial urinary infection is constant, especially when the TPC is followed by the constitution of an ileal bladder replacement.

This is due to the intervention itself and duration of postoperative urinary cathéters (ureteral and bladder). This leads to increase surveillance and antibiotic treatment, given the risks of declared infection in this context.

Detailed analysis of the last 20 TPCs with enterocystoplasty showed the presence of germs in significant numbers, in all cases.

Urell® (also sold under the Trademark Ellura®) contains a cranberry juice extract with a high content of bioactive, soluble Proanthocyanidins (PACs) . The daily dose is 36 mg total PACs measured by the DMAC/A2 method. The PACs prevent uropathogenic E.col bacteria from adhering to uroepithelial cells . Their long term use does not create any resistance of the bacteria.

The excellent prophylactic effet of Urell® had been previously observed in the same Center under different conditions.

Therefore a further demonstration was justified, of the prophylactic efficacy of Urell® in the perioperative setting of total prostato-cystectomy with substitute enterocytoplasty, where the slightest urinary infection, symptomatic or not, prolongs hospitalization and requires antibiotic treatment because of its harmful and sometimes major consequences.


Eligibility Criteria:
Inclusion Criteria:

* patient aged \> 18 years old
* patient with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty
* signed informed consent
* patient with healthcare insurance

Exclusion Criteria:

* patient without signed informed consent
* patient deprived of liberty by judicial or administrative decision
Novara Registry of Platinum-Chromium Platform Stents

Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . This analysis aims to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population using quantitative angiographic analysis (QCA).

Aims: Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms .

The aim of this analysis is to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population .

Methods: Quantitative angiographic analysis (QCA) of PtCr stents deployed in consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 will be performed by an independent core laboratory. In particular QCA : nominal stent lenght ratio will be calculated for every PtCr stent.

Clinical follow up with data about overall and cardiac mortality, myocardial infarction and target vessel revascularization will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* PCI with at least 1 platinum-chromium platform-based stent
* presence of at least 2 ortogonal angiographic projections of the deployed stent to allow proper quantitative coronary angiography

Exclusion Criteria:

* age \<18 \>90
Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population

Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin treatment and hematuria in general population is not well known. The investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years, male or female

Exclusion Criteria:

* No result of urinalysis
* No record of medical history (including medication)
HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass

The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss.

We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≤ 28 days
* Admission after cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* Lack of parental consent
Compare Outcomes of SMG and CPAP in OSA

The objectives of this study is to compare short-term outcomes of CPAP and Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.

The objectives of this study is to compare short-term outcomes of CPAP and Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively. Wash-in period 2 weeks and Wash-out periods 2 weeks are required before start each treatment.

Eligibility Criteria:
Inclusion Criteria:

1. OSA patients aged over 18 YO at Siriraj hospital
2. AHI 5 - 30 events/ h or AHI \> 30 events/h but lowest O2 saturation \> 70%
3. Positive consented form

Exclusion Criteria:

1. Patients with severe Temporomandibular joint diseases or limited mandible advancement (\< 5 mm)
2. Patients with severe periodontal diseases or inadequate teeth (\< 3 teeth in each quadrant)
3. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, COPD, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
4. Patients who could not tolerate the side effects of CPAP or SMG
5. Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
Bleeding in Patients Undergoing CABG (Coronary Artery Bypass Graft) During Dual Antiplatelet Therapy

The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)


Eligibility Criteria:
Inclusion Criteria:

consecutive patients undergoing acute CABG with or without valve replacement within 7 days after last intake of dual antiplatelet therapy

Exclusion Criteria:

concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest
Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae

To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI.

Adults with a definite diagnosis of ESBL-E UTI between January-2015 and October-2019 were enrolled in a multicenter retrospective case-control study. Cases were treated with temocillin ≥50% of the effective antibiotic therapy duration. Control exclusively received carbapenem over the effective antibiotic therapy duration.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Diagnosis of UTI defined by at least two of the following symptoms :chills,temperature \>38°C (fever), flank or pelvic pain, nausea or vomiting, dysuria, urinary frequency, or urinary urgency, costovertebral angle tenderness on physical examination
* Positive urine culture with ≥ 103 CFU/mL of a single strain of ESBL-E
* Confirmed ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems

Exclusion Criteria:

* Multibacterial infection
* Opposition to data collection according to GDPR
Study of Obeldesivir in Nonhospitalized Participants With COVID-19

The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.


Eligibility Criteria:
Key Inclusion Criteria:

* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted.
* Willing and able to complete the coronavirus disease 19 (COVID-19) symptom questionnaire prior to first dose and daily throughout the study period.
* Initial onset of COVID-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization.

  * Stuffy or runny nose.
  * Sore throat.
  * Shortness of breath (difficulty breathing).
  * Cough.
  * Low energy or tiredness.
  * Muscle or body aches.
  * Headache.
  * Chills or shivering.
  * Feeling hot or feverish.
* Not currently hospitalized or requiring hospitalization.

Key Exclusion Criteria:

* Any risk factors for progression to severe disease.
* Planning to receive a direct acting antiviral or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19.
* Received any direct acting antiviral drug or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19 \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
* Received any convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 prophylaxis at any time prior to study entry.
* Received an COVID-19 vaccine (including booster dose) \< 120 days before randomization.
* Self-reported COVID-19 diagnosis \< 120 days before randomization.
* Anticipated need for hospitalization \< 48 hours after randomization.
* New oxygen requirement \< 24 hours before randomization.
* Known influenza, or any other suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug.
* Known history of chronic liver disease, limited to cirrhosis, nonalcoholic steatohepatitis, alcoholic liver disease, and autoimmune hepatitis.
* Undergoing dialysis, or known history of chronic kidney disease.
* Persistent symptoms from previous COVID-19 illness that may interfere with the evaluation of response to the study drug.
* Pregnant or breastfeeding.
* Unwilling to use protocol-mandated contraception.
* Any other factor, including inability to complete the patient-reported outcome (PRO) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study.
* Concurrent participation/enrollment in a separate therapeutic clinical study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Rivaroxaban Plus ASA in Embolic Stroke of Undetermined Source(AREST-ESUS)

Approximately 17% of all patients with stroke are classified as having ESUS, which is associated with a considerable rate of stroke recurrence 4-5 % per year.

Despite recent scientific advances in acute ischemic stroke treatment in recent decades,consensus treatment of all guidelines is still ASA

This is an outcome assessor blind, randomized, parallel, placebo-controlled pilot study on ischemic stroke of undetermined source which will be conducted in Bu Ali Sina hospital in Sari, Iran.

Patients with recent stroke with criteria of ESUS, will be randomized to Rivaroxaban 2.5 mg BID plus ASA 80 mg daily or ASA 80 mg plus placebo (1:1 ratio) and have visit every 3 month until 1 year

Eligibility Criteria:
Inclusion Criteria:

1. signing the inform consent
2. recent ischemic stroke ( 7-60) days with criteria of ESUS
3. only one risk factors of potential embolic source including:

   1. PTFV1 in standard ECG ≥0.05 mm.s or ≥0.005 mv.s
   2. LVH in standard ECG( Sokolow index≥ 35 mm) or on echocardiography
   3. Moderate or severe valvular disorder on echocardiography (except MS)
   4. PFO without indication of occlusion
   5. Left atrium enlargement in echocardiography

Exclusion Criteria:

1. History of hypersensitivity to the investigational medicinal product
2. Indication for anticoagulation
3. Indication for dual antiplatelet therapy
4. Contraindication to investigational medications
5. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
6. Gastrointestinal bleed or major surgery within 3 months
7. Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
8. HAS-BLED score \>3
9. Severe non-cardiovascular comorbidity with life expectancy \< 3 months
10. Severe renal failure, defined as Glomerular Filtration Rate (GFR) \<15ml/min, Dialysis, transplant, Cr \>2.26 mg/dL
11. Severe hepatic insufficiency, Cirrhosis or Bilirubin \>2x Normal or AST/ALT/AP \>3x Normal
12. Modified Rankin Scale of \>=4 at time of randomization or inability to swallow medications.
13. Hemorrhagic transformation of infarction detected by Brain CT or MRI at the time of drug application
14. Radiological or microbiological evidence of COVID-19 infection
Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients

The purpose of the registry is to evaluate an organizational model fixing roles and behaviors of subjects involved in the remote monitoring of patients implanted with pacemakers and defibrillators.

The evaluation will estimate the clinical efficiency and the impact on health service resources of the organizational model when this is implemented in the daily clinical practice.

After a number of studies which assessed technical reliability and clinical implications of remote monitoring systems, a further step should approach the issue of how remote monitoring can be implemented as a part of routine activities of a cardiology outpatient clinic. A clear definition of roles and workflow to timely manage information and properly react to adverse events is required. The HomeGuide Registry proposes an organizational model specifying roles and procedures for outpatient clinics using a specific remote monitoring system in routine follow-up. The HomeGuide model is essentially based on an interaction between one or more allied professionals (expert and trained nurses or technicians) and a responsible physician. The main objective of the HomeGuide Registry is to evaluate:

1. Clinical efficiency of remote patient management;
2. Health service resources required by a remote patient management.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a BIOTRONIK pacemaker or ICD with Home Monitoring (HM) technology
* Ability to utilize the HM system throughout the study
* Ability to give informed consent
* Ability to return for regular follow-ups for two years

Exclusion Criteria:

* Patients who do not fulfill all inclusion criteria
Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection

Currently, it is the standard of care practice to perform daily routine CXR when a chest tube is in situ following pulmonary resection. However, previous research as well as experience of thoracic surgeons suggested this kind of management has poor diagnostic and therapeutic value. Eliminating daily routine CXR for adult patients having undergone pulmonary surgery might decrease the frequency of radiation exposure and hospitalization costs per patient without increasing reintervention rates, length of hospital stays, readmission rates or any adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females who plan to receive VATS pulmonary resections confined to lobectomies, segmentectomies and wedge resections.
* Willingness to adhere to randomized treatment.
* Ability to answer self- and interviewer- administered questions in English
* Understand and sign a written informed consent form in English

Exclusion Criteria:

* Previous thoracic surgery history in the same side.
* Exploration, biopsy, lung volume reduction surgeries (LVRS), bilobectomies, sleeve resections or pneumonectomies performed.
Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo

Providers in integrated Community Case Management (iCCM) programs in low resource settings often see children without any danger signs, presenting with fever but not having pneumonia, malaria, or diarrhea. These children are sent home (often with analgesic only), and caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if conditional return advice (i.e. return in 2 or 3 day only if your child is still sick") results in the same proportion of children remaining with fever one week after identification, as the current universal return advice.

Fevers in childhood are common and usually self resolve. In rural Democratic Republic of Congo (and many other settings), when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to World Health Organization (WHO) guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the CHW provides an antipyretic only, sends the child home, and advises all such cases to come back in 3 days. We hypothesize, however, that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days, only if symptoms have not resolved.

To test this hypothesis, we are conducting a cluster-randomized, community-based non-inferiority trial in two zones of Kalemie, Katanga Province, Democratic Republic of Congo. In this area, the International Rescue Committee (IRC) has been supporting the training, scale-up, and rollout of community health workers who conduct iCCM as per WHO guidelines and with Ministry of Health oversight. CHWs have unique non-overlapping catchment areas, and groups of CHWs (average 5-7) are associated with health clinics. We will utilize this group structure as the unit of randomization; health clinics (and thereby, groups of CHWs) will be randomly allocated to one of two groups in terms of the advice given to caretakers of children who have no danger signs, have neither malaria, pneumonia, nor diarrhea, and are thus classified as having fever of non-identified origin.

* Group 1 (Universal follow-up): CHWs in this group will advise caretakers to follow up in 3 days
* Group 2 (Conditional follow-up): CHWs in this group will advise caretakers to follow up in 3 days if symptoms/signs remain the same (or worsen).

Eligibility Criteria:
Inclusion Criteria:

* Agree to recruitment script provided by CHWs at the time of identification of eligible

Exclusion Criteria:

* None
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer

This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving Xeloda according to product label

Exclusion Criteria:

* Contraindications according to label and off-label use
Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis

Outcomes from the investigators' recent investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically improvements in the postural balance and walking speed of individuals with MS.

This investigation will evaluate mobility and postural balance improvements in individuals with MS who participate in a therapeutic protocol consisting of activity based exercises, and in individuals with MS that participate in challenging physical therapy protocol.

Background: Outcomes from the investigators' recent exploratory investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically relevant improvements in the postural balance and walking speed of individuals with MS.

Objective: The investigators anticipated that the promising results were due to the novel challenging postural balance and mobility exercises. The purpose of this investigation was to test this notion by evaluating the mobility and postural balance improvements that could be achieved in a cohort of individuals with MS who participated in a therapeutic protocol that consisted of activity based exercises, and a cohort of individuals with MS that participated in the challenging physical therapy protocol.

Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of multiple sclerosis
* Kurtzke Expanded Disability Status of 3.0 - 6.5
* Able to walk on a treadmill at a minimum of 0.5 miles per hour while holding onto handrails
* Cognitively and emotionally competent
* A Mini-Mental State Examination score \> 21
* Composite score on the computerized Sensory Organization Test of \< 70

Exclusion Criteria:

* Documented MS-related relapse in the previous 6 months
* Major MS-specific medication changes within the previous 3 months
* Presence of another major co-morbidity such as neurological disorders, uncontrolled pain, hypertension, and diabetes
Navigator vs Standard Needle Injection for Hip

The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥18 years of age, of any race or ethnicity;
* Capable of completing self-administered questionnaires;
* Patients with suspected intra-articular hip pain who have failed conservative care (conservative care defined as a standard regimen of home or outpatient physical therapy, activity modification, trial of at least one NSAID) for at least 3 months;
* Candidate for a hip injection;
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Institutional Review Board/Ethics Committee.
* Subjects are able to understand and speak English

Exclusion Criteria:

* History of intra-articular injection within the last 3 months prior to the injection procedure;
* Complex regional pain syndrome;
* History of prior hip surgery;
* History of substance abuse;
* Known history of hypersensitivity to local anesthetics of the amide type;
* Contraindicated for Celestone (betamethasone sodium phosphate);
* Contraindicated for Lidocaine Hydrochloride;
* Is a prisoner or ward of the state;
* Are unable to meet the treatment and follow up protocol requirements.