cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following inclusion criteria:

* Have pyuria (white blood cells in the urine)
* Clinical signs and/or symptoms of cUTI (including acute pyelonephritis)
* Have a pretreatment baseline urine culture specimen
* The subject's infection would require initial treatment with IV antibiotics
* The subject must require initial hospitalization to manage the cUTI by the standard of care.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

* History of any hypersensitivity or allergic reaction to any β-lactam (eg, cephalosporins, penicillins, carbapenems)
* Confirmed fungal urinary tract infection
* Intractable UTI anticipated to require more than 10 days of study drug therapy
* Complete, permanent obstruction of the urinary tract\\
* Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter that will not be removed during IV study drug administration
* Suspected or confirmed perinephric or intrarenal abscess
* Suspected or confirmed prostatitis
* Ileal loops or vesico-ureteral reflux
* Impairment of renal function including a calculated CrCl of \< 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria
* Renal transplantation
* Life expectancy less than 3 months
* Evidence of significant hepatic, hematological, or immunologic disease or dysfunction
* Past or current history of epilepsy or seizure disorder
* Women who are pregnant or nursing
THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral head within the acetabular cup during weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP), metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound analysis as an impulse excitation technique for testing hip conditions and for measuring femoral head sliding in the acetabular component of human hip joints by acoustic means. Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for subjects implanted using various surgical approaches. It could be hypothesized that subjects having various surgical approaches could lead to an increase or reduction of in vivo hip separation. Therefore, the objective of this study is to analyze a total of 30 subjects implanted with either an anterior (10 patients), anterior-lateral (10 patients), or posterior-lateral (10 patients) surgical approach to determine if any of these surgical approaches leads to less or more in vivo hip separation. All subjects will be analyzed under in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.


Eligibility Criteria:
Inclusion Criteria:

* Post-operative clinical evaluation judged successful using Harris Hip Scoring (HHS) system (HHS\>90)
* Body weight less than 270 lbs
* No evidence of post-operative hip subluxation or dislocation
* Do not walk with detectable limp
* Be able to actively abduct their operated hip against gravity without difficulty
* Must be willing to sign Informed Consent and Health Insurance Portability and Accountability (HIPAA) forms

Exclusion Criteria:

* Pregnant, lactating or females not using reliable form of birth control
* Patients that do not meet study requirements
* Patients unwilling to sign Informed Consent or HIPAA forms
Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting

This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.

This is a randomized, open-label, multi-center, phase 4 study. The overall goals of this study are to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of cSSSI due to Gram-positive bacteria in participants who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting. Study objectives include evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider.

Eligibility Criteria:
Inclusion Criteria:

* Complicated skin or skin structure infection (cSSSI)
* Intravenous vancomycin home infusion ordered for 7-14 days

Exclusion Criteria:

* Pregnant or lactating female
* Concurrently receiving other systemic antibiotics with gram positive activity
* Known or suspected allergy or hypersensitivity to daptomycin or vancomycin
* Known or suspected vancomycin-resistant enterococci (VRE)
* Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
* Known or suspected human immunodeficiency virus (HIV), cancer, or autoimmune disease such as lupus
* Receiving systemic concomitant immunosuppressive agents such as chemotherapy, corticosteroids, tacrolimus, sirolimus, or cyclosporine, during the duration of the study
* Requirement for non-study gram positive systemic antibiotics
* Known to be allergic or intolerant to intravenous vancomycin or daptomycin
* Participants with known or suspected creatinine clearance (CLcr) \< 30 milliliters per minute (mL/min)
* In skilled nursing facility
* In hospice or admission to hospice is planned
Impact of Intensive Care Unit Nurse Participation in Post - ICU Follow Up Clinic

The objective of this study is to learn more about the impact of a longitudinal encounter between critical care nurses and former intensive care unit patients. This study will enroll 10 patients that had been admitted in an ICU to meet with a former nurse that had taken care of them in the ICU. The study will enroll 20 nurses that had taken care of these patients in the ICU. The study will randomize 10 nurses to be in the encounter group and 10 nurses to be assigned to the control group. Only nurses assigned to the encounter group will meet with the patients at their post-ICU clinic.


Eligibility Criteria:
Patients:

Inclusion Criteria:

* Patients that were admitted to the ICU that are appropriate for follow-up.

Nurses:

Inclusion Criteria:

* Registered nurse in an intensive care unit and took care of the enrolled patient
A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections

This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' \[PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin\]. The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* skin or skin structure infection requiring hospitalization;
* clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment;
* material from site of infection is clinically purulent or seropurulent.

Exclusion Criteria:

* presenting with sustained shock (SBP\<90mm Hg for \> 2 hours, despite adequate fluid resuscitation);
* known or suspected concomitant bacterial infection requiring antibiotic treatment;
* skin infection or chronic non-healing ulcer of \> 2 weeks duration;
* patients in whom surgery is the primary treatment.
Early Mobilization After Colorectal Surgery

Early mobilization (i.e. initiation of out of bed activities from the day of surgery) is considered an important component of postoperative care after colorectal surgery. Having a health professional dedicated to facilitate early mobilization has the potential to enhance postoperative recovery by preventing the negative effects of prolonged bed rest (e.g. increased risk for complications, muscle loss, deconditioning and functional decline); however, the need to implement this resource-intensive approach is not evidence based. This study aims to contribute evidence about the role of facilitated early mobilization as a strategy to enhance recovery after colorectal surgery.

The primary research question of this study is: to what extent does postoperative facilitation of early mobilization impact on recovery of functional walking capacity at 4 weeks after surgery in comparison to standard care (preoperative education).

The hypothesis is that, by 4 weeks after surgery, facilitated early mobilization will result in a greater proportion of participants returning to preoperative levels of functional walking, as measured by the six-minute walk test (6MWT).

Eligibility Criteria:
Inclusion Criteria:

* Adult people (\>18 years)
* Colonic or rectal diseases (i.e. cancer, inflammatory bowel disease, diverticulitis) planned for surgical resection

Exclusion Criteria:

* Metastatic disease
* Medical conditions that preclude postoperative mobilization (e.g. neurological or musculoskeletal diseases)
* Inability to understand English or French
* Admission to intensive care immediately after the surgery
Alternate-Day Buprenorphine Administration. Phase I - 3

The purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.


Eligibility Criteria:
Please contact site for information.
Remote Intervention for Weight Regain After Sleeve Gastrectomy

The study is designed to assess the effect of a 3-month remote comprehensive intervention program by a multidisciplinary team combined with mobile supportive text messages aimed to raise the level of happiness and subjective wellbeing, on weight outcomes and physical and behavioral parameters among bariatric surgery patients after sleeve gastrectomy who had a weight regain of ≥10% from nadir, compared to a control group which will receive standard care of a single meeting with the study's registered dietitian at the clinic and then be advised to continue follow up.

One hundred patients will be recruited to the study and randomized to intervention or control group. The comprehensive 3-month remote intervention program by the multidisciplinary study team includes 6-weeks of online meetings with the study registered dietitian, sleep and physical activity consultants, followed by another 6-weeks of online meetings with the study RD, overall 12 weeks containing a total of 12 remote consultations (6 dietitian, 3 physical activity consultant, 3 sleep consultant). In addition, the intervention group will receive weekly text messages to their mobile phone, meant to enhance happiness and subjective wellbeing.

The control group will receive standard care of a single meeting with the study's registered dietitian at the clinic including nutrition and behavioral recommendations and then advised to continue follow up, engage in physical activity and general lifestyle recommendations.

Both groups will undergo comprehensive tests at baseline and at the end of intervention after 3 months. Patients from both groups who will arrive to the follow-up appointment after 3 months will receive a participation reward which will include a gift card on the sum of 154 NIS for purchasing a multivitamin package for bariatric patients.

Finally, 3 and 6 months after intervention completion, self-reported data will be collected via phone calls including weight, physical activity (type, times per week and duration per time), professional follow up and adherence to BS recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Age at the time of BS ≥18 years
* Patients who underwent primary SG at least 2 years ago and regained at least 10% weight from nadir.
* Read and speak Hebrew.

Exclusion Criteria:

* Patients who underwent more than one BS in their past.
* Use of weight loss drug therapy currently or 1-month prior to trial entry.
* Currently attending a weight loss program and lost more than 5% of weight at the last month.
* Current pregnancy and women who gave birth in the last 6 months.
* Medical contraindications such as active cancer, organ transplant or unbalanced psychiatric disorders.
Infectious Complications After Esophagectomy

Infectious complications represent the most common postoperative adverse events following esophagectomy for cancer, such as pneumonia (15% of cases). These complications increase immediate risks, lengthen hospital stays, and worsen patient quality of life.

The population includes patients admitted to intensive care after esophagectomy for cancer between January 1, 2017, and December 31, 2024.

The study focuses on this population due to the increasing incidence of esophageal cancer, the increased use of surgery for these indications, and the importance of postoperative infections in these complex procedures, despite their understudied nature in the current literature. Identifying modifiable risk factors could lead to corrective measures and thus improve the prognosis of postoperative patients.

The research focuses primarily on the incidence, types, factors, and prognosis associated with the occurrence of infections after esophagectomy for cancer. It also includes an analysis of the pathogens involved, their resistance profiles, and the antibiotic therapies used in first-line probabilistic treatment.

The retrospective, multicenter study consists of the retrospective and pseudonymous collection of data from the medical reports of patients, covering the period from January 2017 to December 31, 2024, who were treated in each participating intensive care unit.

The investigators at each participating center will be responsible for screening and including patients, as well as obtaining their non-opposition.

Patients who were hospitalized for esophagectomy will be included, provided there are no exclusion criteria.

The following data will be collected after pseudonymization: only the first letter of the patient's last name and the first letter of their first name will be recorded, along with a study-specific coded number, which will differ for each center and indicate the order of inclusion of subjects. A correspondence table will be kept at each center for a period of 15 years. This table will be stored within each participating center.

At each participating center, data entry will be coordinated by the investigator responsible for the center. The collected data will be pseudonymized and stored in a secure database located at each participating center.

* If the patient is alive: the patient will be informed about the study. Data collection will begin only after the patient has been informed and only if the patient does not express opposition to the use of their data.
* If the patient is deceased and the vital status of the patient is known to the investigator: in this case, the investigator will verify in the patient's medical record that the patient has never expressed written opposition to the use of their data for research purposes. If the patient has never objected, their data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Underwent esophagectomy for cancer between January 1, 2017, and December 31, 2024
* Scheduled admission to intensive care for postoperative monitoring

Exclusion Criteria:

* Opposition to the use of data
Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System

The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient has given their free and informed consent
* The patient must be insured or the beneficiary of an insurance policy
* The patient is aged at least 18 years and less than 75 years old.
* Patients have a BMI between 18 and 40kg/m2
* Diabetic patient admitted for glycemic instability with indication for treatment using an external insulin pump but otherwise in a stable clinical state

Exclusion Criteria:

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The patients is under judicial protection or state guardianship
* The subject refuses to sign the consent form
* It proves impossible to give the subject clear information.
* The patient is pregnant, parturient or breastfeeding
* The patient is clinically unstable
* BMI less than 18 or over 40
* Existence of a severe rapidly progressive ischemic retinopathy or proliferative retinopathy.
* Serious psychiatric problems
* Chronic cutaneous infection
Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use

The researchers hypothesize that existing-prescription notifications directed to pharmacists are more likely to lead to a prescription change than existing-prescription notifications directed to prescribers. Furthermore, the researchers hypothesize that the availability of a pharmacist referral option is associated with a higher rate of prescription changes for initial-prescription alerts that are directed to the prescriber at the time of initial-prescribing errors.

Findings from this project will establish a framework for implementing prescriber-pharmacist collaboration for high risk medications, including anticoagulants

Please note that the 3rd and 4th outcome measures are conditional on the outcomes of the 1st and 2nd outcome measures respectively.

Please note that enrollment of 300 will provide sufficient power to study.

Eligibility Criteria:
Prescribers:

Inclusion Criteria:

* Michigan Medicine provider with prescribing privileges
* Providers in ambulatory care settings
* Prescribe DOAC to patients 18 years and older

Exclusion Criteria:

* Providers in inpatient settings
* Providers who are members of the study team
Comparison of the Effectiveness of SPAir-Q Among Different Age Groups

Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. This study aims to compare the effectiveness of the Air-Q laryngeal mask airway (LMA) across different age groups (young, middle-aged, and elderly patients) and to evaluate complications associated with supraglottic airways (SGA).

"Supraglottic airway devices (SGA) used perioperatively are known to require lower anesthetic depth and result in fewer airway complications such as coughing and sore throat after awakening from anesthesia compared to endotracheal intubation. Due to these advantages, SGAs are particularly beneficial in elderly patients, as they experience a reduction in functional reserves, are more affected by cardiopulmonary diseases, and are more sensitive to anesthetic drugs

SGAs are inserted through the oral route, and the SGA cuff is placed between the base of the tongue, hypopharynx, and upper esophageal sphincter (UES) to provide proper ventilation. Some previous studies have reported structural and physiological changes in the pharyngeal airway and UES with aging . It has been found that the shape and size of the pharyngeal airway in elderly individuals differ from those of young adults. Additionally, there are changes in the function and structure of the UES with age. These age-related changes may affect the performance of SGAs in the elderly population.

Recently, SGAs that do not require manual cuff inflation have been used more frequently in various clinical settings due to the advantages of eliminating the need for manual cuff inflation and cuff pressure monitoring. The Air-Q is connected to an airway tube through a communication port that allows for self-regulation of cuff pressure in response to airway pressure."

Eligibility Criteria:
Inclusion Criteria:

* 18-85 year-old patients
* American Society of Anesthesiologist Physical Status classification I-III,
* Undergoing an elective operation under general anesthesia in our hospital

Exclusion Criteria:

* Predicted difficult airway (Mallampati class 4, mouth opening \< 3 cm, or thyromental distance \< 6 cm)
* body mass index (BMI) \> 40 kg/m2
* Patients with a high risk of aspiration (e.g., history of gastrectomy, gastroesophageal reflux disease, or hiatal hernia),
* Unstable vital signs,
* Cervical spine problems, Respiratory complications (e.g. recent pneumonia).
Efficacy and Safety of 1 g Vs 2 g Per Hour Intravenous Maintenance Dose of MgSO4 in Women With Severe Pre-eclampsia

Preeclampsia is commonly viewed as one of the hypertensive pregnancy disorders, which cover a spectrum of clinical presentations from chronic hypertension ( hypertension occurring prior to 20 weeks of gestation) and gestational hypertension (hypertension occurring after 20 weeks of gestation) To more severe forms, including preeclampsia, eclampsia (its convulsive form), and HELLP syndrome (hemolysis, elevated liver enzyme S, and low platelets)

Treatment for patients who have developed preeclampsia or eclampsia mainly consists of control of hypertension, magnesium sulphate for prevention of eclampsia and convulsions, and planning for delivery.

Magnesium sulfate has been used to prevent eclamptic convulsion since 1925, its efficacy was confirmed by a large randomized controlled trial in 2002. Eclampsia could be prevented in more than 50% after magnesium sulfate administration . The World Health Organization recommended magnesium sulfate as the most effective, safe, and low-cost drug for the prevention of seizure in severe preeclampsia and eclampsia . The recommended dose of magnesium sulfate is 4 to 6 gram intravenous loading dose, followed by maintenance intravenous drip at the rate of 1 to 2 gram per hour .

Although different magnesium sulfate regimens have been tested, two dosing regimens are internationally recommended and widely used. The Pritchard regimen is a predominantly intramuscular regimen given as a loading dose of 4 g intravenously , and 5 g Intramuscular into each buttock followed by a maintenance dose of 5 g Intramuscular every 4 hours. This regimen is popular in resource-limited settings where intravenously administration of magnesium sulfate may not be feasible. However, it is associated with pain and a higher risk of infection at the injection site.

The Zuspan regimen is given as a 4 gram intravenously loading dose followed by continuous intravenously infusion of 1 gram per hour.

Either 1 gram or 2 gram maintenance dose of Magnesium Sulphate has been reported to reduce the development of eclampsia. Randomized controlled trials offering direct comparison between these 2 doses are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women admitted to Women health hospital with a diagnosis of severe pre-eclampsia

Exclusion Criteria:

* 1- Women with Non-proteinuric hypertension, 2- severe renal impairment 3- Myasthenia gravis 4- High amount of magnesium in blood 5- Low or high amount of calcium in blood 6- Myocardial damage, diabetic coma, heart block