cyrilzakka/clinical-trials huggingface dataset:
Discontinuation of Antibiotic Susceptibility Testing on Enterococcus Faecalis Positive Urine Cultures in Hospitalized Patients: an Impact on Antibiotic Prescriptions? (FaecaCible)

The objective of the study is to evaluate the impact of not reporting antibiotic susceptibility tests on antibiotic consumption for Enterococcus faecalis positive urine cultures in adult hospitalized patients. The secondary objectives are to evaluate the impact of this intervention on antibiotic prescription rates as well as on antibiotic consumption according to: patient gender, type of antibiotic therapy (probabilistic/documented) and diagnosis (urinary tract infection or colonization). It is hypothesized that antibiotic consumption is lower after the application of the absence of antibiotic susceptibility reporting compared to before.


Eligibility Criteria:
Inclusion Criteria:

* Person having received complete information on the organization of the research and not having objected to the exploitation of these data
* Adult patients (More than 18);
* Having performed a urine culture at the Nancy University Hospital, taken from the 2nd urine stream, by urinary catheter or via a suprapubic catheter and whose culture is positive for monomicrobial E. faecalis with a bacteriuria threshold greater than or equal to 10\^3 CFU/field;
* Hospitalized at the Nancy University Hospital at least 72 hours after validation of the antibiotic susceptibility test in the pre-intervention period and at least 72 hours after validation of the culture in the post-intervention period.

Exclusion Criteria:

* Inpatients in hematology, critical care/intensive care, consultation and day hospital units;
* Urine cultures performed in ambulatory units ;
* Urine culture performed in the critical care/intensive care/hematology units;
* Patients discharged from hospital/deceased/transferred to intensive care within 72 hours of the validation of the antibiotic susceptibility test or the validation of the urine culture;
* Patients with associated E. faecalis bacteremia;
* Urine culture without an antibiotic susceptibility test for the pre-intervention period;
* Urine culture with a monomicrobial history of less than 1 week;
* Culture of urine from pyelic punctures or nephrostomy tubes - conservation of those from second streams, urinary catheters and suprapubic catheters).
Assessment of Cardiac Sparing in Fetal Hypoxia

The fetal heart plays a central role in the adaptive mechanisms for hypoxemia and placental insufficiency. Longitudinal data on the hemodynamic sequence of the natural history of fetal growth restriction show that the umbilical artery and middle cerebral artery are the first variables to become abnormal . These arterial Doppler abnormalities are followed by abnormalities in the right cardiac diastolic indices, followed by the right cardiac systolic indices, and finally by both left diastolic and systolic cardiac indices .

Preserving the left systolic function as the last variable to become abnormal ensures an adequate left ventricular output , which supplies the cerebral and coronary circulations.This defence is contingent on the fetal cardiovascular system, which in late gestation adopts strategies to decrease oxygen consumption and redistribute the cardiac output away from peripheral vascular beds and towards essential circulations, such as those perfusing the brain.

Adding cardiac Doppler may improve management of the IUGR fetus(intrauterine growth retardation), Doppler ultrasound is valuable in defining the degree of cardiovascular compromise in at-risk pregnancies. The severity of fetal blood flow redistribution shows the degree of fetal adaptation and provides information on how long the pregnancy can be continued safely.

The aime of the study is assessment of cardiac output redistribution in fetal hypoxia by estimating relative right to left side cardiac output wich reflect cardiac sparing in (IUGR).


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20-35 years.
2. Women with BMI from 20-30 kg/m2.
3. Pregnant women in singleton fetuses from 32 to 34 weeks gestation.
4. Women with late fetal growth restriction fetuses. It refers to an estimated fetal weight or abdominal circumference \<10th centile. Those women had increased the resistant index (RI) in umbilical arteries above the 95th percentile at the time of recruitment (case group).
5. Normal pregnant women (control group).

Exclusion Criteria:

1. Women with estimated fetal weight below the 5th or 3rd percentile.
2. Women with premature pre-labor rupture of membranes.
3. Women with antepartum hemorrhage
4. Women with fetal congenital anomalies.
5. Women with absent or reversed diastolic flow in the umbilical artery at the time of recruitment.
6. Women with preeclampsia or on anti-coagulant thereby.
7. Women who refused to participate in our study.
National Approach to Standardize and Improve Mechanical Ventilation

This is a pre-post implementation cohort study. This is a data driven quality improvement project which aims to improve the care of mechanically ventilated patients through the implementation of a bundle of evidence based practices, with a goal of reducing ventilator associated events and mortality.

NASAM is a national collaborative quality improvement project in Saudi Arabia which aims to:

1. Reduce the rate of ventilator-associated events
2. Improve the compliance with NASAM bundle elements
3. Reduce the mortality of mechanically ventilated patients

The plan of this quality improvement project is to extend the implementation to a total of 100 ICUs in collaboration with multiple health systems across the country. A significant component of this project includes measuring the safety culture of ICUs.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to intensive care units

Exclusion Criteria:

* Age less than 14 years old
International Prospective Registry on Local Treatment Approaches in MLS

To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)

In order to confirm the promising results of the 36 Gy dose level in the DOREMY trial (NCT02106312) and to compare outcome with other local treatment approaches.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11)
* ECOG PS 0-2
* Written informed consent to share coded information in this international Registry

Exclusion Criteria:

* Prior radiotherapy to the target area
* Pregnancy
Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer

The principal objective of this study consists in the assessment of Immunogenic Cell Death (ICD) induction in neoplastic tissues derived from bladder cancer patients treated ex vivo with Mitomycin C (MMC). The evaluation is performed using cellular and molecular analyses of treated versus untreated samples derived from the same patient

Urothelial or transitional cell carcinoma of the bladder is the fourth most common cancer in males worldwide, with about 60-80% of newly diagnosed patients having non-muscle-invasive bladder cancer (NMIBC). NMIBC management consist in transurethral resection of bladder tumor (TURBT) followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin C (MMC) or the immunotherapy bacillus Calmette-Guérin. These therapies result in low progression rates, but are not efficacious in all patients, leading to high tumor recurrence. Immunogenic cell death (ICD) may be one of the mechanisms of action of MMC intravesical therapy in bladder cancer.

The primary objective of the study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues. As secondary targets we aim to:

1. identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature'),
2. asses the genetic and environmental factors- urinary microbiome composition- responsible for MMC treatment efficacy,
3. evaluate whether ICD induction correlates with clinical staging and response (clinical endpoints for MMC-treated patients are recurrence at three month and one year after enrollment).

Eligibility Criteria:
Inclusion Criteria:

- Male and females, \> 40 years old

For bladder cancer patients:

- bladder cancer patients- patinets with first tumor occurrence or patient with a recurrence after more than 2 years from the removal of the prior malignancy

Exclusion Criteria:

* Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
* Treated with antibiotics at time of enrollment or during the month before enrollment
* Positive history of sexually transmitted diseases
* Urinary infection ongoing or recent (during the three months before enrollment)
* Suffering from chronic intestinal inflammation

ONLY for controls:

* Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
* Treated with antibiotics at time of enrollment or during the month before enrollment
* Positive history of sexually transmitted diseases
* Urinary infection ongoing or recent (during the three months before enrollment)
* Suffering from chronic intestinal inflammation
Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants

The purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (HLHS) after stage 1 procedures.

In recent years, survival after neonatal cardiac surgery has improved significantly. As life span has improved in HLHS/single ventricle variants (SVV) survivors, focus has shifted to the understanding and management of associated health problems. Growth failure is a well-recognized major co-morbidity in these patients.

Infants with HLHS/SVV demonstrate progressive growth failure after stage 1 procedures, which appears to stabilize only after stage 2 procedures. Poor nutritional status increases risk for post-operative infections, extends hospital length-of-stay, and adversely affects neurodevelopmental outcomes.

To date, evidence-based feeding strategies that support adequate weight gain and improve nutritional status have not been identified after stage 1 procedures. Continuous enteral feeding regimens have resulted in improved growth in a diverse population of infants with congenital heart disease and have been shown to decrease energy expenditure in premature infants and adults. A randomized, controlled study of HLHS/SVV infants who underwent stage 1 procedures at a single medical center was conducted with the primary objective of comparing weight gain at hospital discharge between infants receiving a continuous feeding regimen versus an intermittent feeding regimen. Secondary objectives were to compare growth and markers of nutritional status at hospital discharge between the two groups. The investigators hypothesized that infants with HLHS/SVV who receive a continuous enteral feeding regimen versus an intermittent feeding regimen will demonstrate improved weight gain, growth, and nutritional status after stage 1 procedures at hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

- Subjects with HLHS/SVV who underwent stage 1 procedures (Norwood or Hybrid procedure) who were inborn or transferred into the Neonatal Intensive Care Unit at Columbia University Medical Center

Exclusion Criteria:

- Excluded subjects were those with associated major congenital malformations (e.g. congenital diaphragmatic hernia, gastroschisis) or chromosomal anomalies, and/or those who were small for gestational age at birth.

- Subjects in whom a nasogastric tube or gastrostomy tube was not required for feeding at the time of enrollment and/or who were transferred to outside institutions for recovery after surgery.
A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression

The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with saredutant 100 mg once daily.

The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label treatment with saredutant 100 mg once daily in outpatients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria

Exclusion Criteria:

* Total score of \<22 on the Montgomery-Asberg Depression Rating Scale (MADRS).
* Duration of the current depressive episode is less than 1 month or greater than 2 years.
* Total score of \<25 on the Mini Mental State Examination (elderly patients ≥65 years only).
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 6 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate.
Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy

The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.

In order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. The patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. Patients will record if they are taking their Miralax as prescribed daily. They will also record their bowel movements and pain levels during evacuation. Prior to surgery, in the pre-operative area, medication compliance will be assessed once again. Post operatively all patients will take polyethylene glycol for seven days, once a day. They will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. The primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures

Exclusion Criteria:

* Age under 18 or over 90
* Planned laparotomy
* Planned posterior colporrhaphy
* Regular pre-operative use of stool softeners/laxatives
* Presence of colostomy
* Inability to give informed consent
* Inability to take medication by mouth
* Chronic kidney disease (Cr \> 1.2)
* Esophageal strictures
* Persistent nausea and vomiting
* Bowel obstruction
* Inflammatory bowel disease
The Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes

Coffee has been found to have beneficial effects on cognitive function and blood sugar control. Benefits include reduced risk of cognitive decline and improved performance on cognitive tests, as well as reduced risk of diabetes and improved blood sugar control in people with diabetes, a population that is at a higher risk of cognitive decline. These effects have been observed for both caffeinated and decaffeinated coffee, and have been associated with the polyphenol chlorogenic acid (CGA). This polyphenol has been found to be more bioavailable in certain coffees, known as "speciality coffee" as defined by the Specialty Coffee Association of America, depending on agriculture, roasting, and brewing method.

This current project will bring together these previous findings to explore the effects of specialty coffee on cognitive function and glycaemic control in people with type 2 diabetes through a randomized control trial with two groups: a high CGA specialty coffee group and a conventional coffee control group. Participants will be quasi-randomly assigned to one of these two groups following the completion of a 4-week run-in period during which participants will consume conventional coffee only. The length of the experimental arms is 8 weeks, therefore the total length of the study is 12 weeks. At the beginning and the end of each experimental arm participants will undertake a cognitive assessment online using the Gorilla platform, and a series of questionnaires relating to health and mood measures (details in procedure). Cognitive function will also be assessed at the beginning of the 4-week run-in period.


Eligibility Criteria:
Inclusion Criteria:

* Age 55-70 years
* Formal diagnosis of Type 2 Diabetes for 3 years or more
* Current coffee drinkers, 4 or fewer cups daily (a cup is 8 oz)

Exclusion Criteria:

* Insulin-dependent
* Consuming on average more than 4 cups of coffee daily
* Regularly consuming specialty coffee (participants will be provided with a list of these coffees)
Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects

This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.


Eligibility Criteria:
Inclusion Criteria for Rheumatoid Arthritis (RA) Subjects:

* Male or female subjects age greater than or equal to 18 years and less than or equal to 75 years.
* Subjects with RA diagnosis per the 2010 Rheumatoid Arthritis Classification Criteria per American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR.)
* BMI less than or equal to 35 kg/m2 at Screening.
* Active RA characterized by DAS28 score of less than or equal to 5.1 at Screening.
* Have been stabilized on their current dose (up to 25 mg/week) of methotrexate(MTX) for at least 4 weeks before randomization.

Exclusion Criteria for Rheumatoid Arthritis (RA)Subjects:

* Subjects with severe active RA and are not on a stable therapeutic regimen at Screening.
* Subjects without significant articular RA.
* Relevant history of significant respiratory disease (e.g., chronic bronchitis, asthma in last 5 years, chronic obstructive pulmonary disease, tuberculosis, interstitial lung disease, such as pneumonitis and pulmonary alveolar proteinosis, as well as significant inhalation exposure to silicon and other substances) that required treatment and/or follow up under the direction of a physician.
* Presence of GM-CSF autoantibodies above normal at Screening.
* Abnormal chest x-ray or PFTs as judged by the investigator at Screening as clinically significant.
* Positive Quantiferon test.
* History of clinically relevant hypersensitivity reactions (e.g., to gold therapy)
* History of medication use that might have carryover effects during the study.
* Previous administration of a GM-CSF modulator within 6 months of randomization, or previous administration of a monoclonal antibody or immunoglobulin fusion protein that is not (or worded as "other than") a GM-CSF modulator within 3 months of randomization.
* Use of any biological therapy other than the test article during the study (informed consent to termination visit)
* Subjects who consume greater than 14 alcoholic drinks per week for males or 7 alcoholic drinks per week for females.
* Weight greater than 120 kg at Screening.
* Use of parenteral and/or intra-articular steroids, immunosuppressants, investigational drugs, and oral anticoagulant drugs within 4 weeks prior to randomization. Oral steroid treatment is permitted if the dosage is less than or equal to 10 mg of prednisone daily, is stable for a minimum of 4 weeks before the study and remains unchanged throughout the study.
The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program

The WORLD study is a single-center, year-long randomized controlled trial in free-living women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a moderate-fat (MF) diet for weight management in a parallel-arm design. The two phases of the study were a weight-loss phase (phase 1) and a weight-maintenance phase (phase 2) (Figure 1). During phase 1, months 1 through 4, participants consumed a hypo-caloric diet consistent with the 2005 Dietary Guidelines in the free-living environment. During phase 2, months 5 through 12, participants shifted into weight maintenance. It was hypothesized that a weight-loss intervention at the extremes of dietary fat recommendations of the 2005 Dietary Guidelines would be equally effective for weight loss while achieving comparable nutrient adequacy. Also, Overall, the lower-fat and moderate-fat diets would both be nutritionally adequate, based on the Healthy Eating Index.


Eligibility Criteria:
Inclusion Criteria:

* 21-50 years
* BMI: 25-39.9 kg/m2
* LDL-C: 100-189.9 mg/dL

Exclusion Criteria:

* Triglycerides \> 350 mg/dL
* History of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease
* High alcohol consumption (\<14 drinks/week)
* Use of medication or supplements for lowering blood lipid levels (i.e., statin, fibrates, psyllium, fish oil capsules, soy lecithin, phytoestrogens)
* Lactating, pregnant, or wanting to become pregnant during the study
* Weight loss or gain ≥ 10% body weight in the previous 6 months
* Eating Attitudes Test-26 score \> 20
* Beck Depression Inventory-II score ≥ 29
* Gormally Cognitive Factors Related to Binge Eating Scale score \> 30
* Physical Activity Readiness Questionnaire score \> 2