cyrilzakka/clinical-trials huggingface dataset:
SUCCESS Tracking Study

The overall purpose of this research is to evaluate the long-term outcomes associated with participation in Medifast Direct and Take Shape For Life weight-loss programs in comparison with non-Medifast weight-loss programs. Another important goal of this research is to determine whether the differences between Medifast Direct and Take Shape For Life programs affect weight-loss and maintenance of weight-loss in customers.

Researchers desire to capture the behaviors and outcomes of those individuals who would enroll in these programs without the additional encouragement to be a participant in a research study. The study will employ an observational prospective design intended to introduce as little interference as possible with subjects' behaviors. This is in order to capture the pure effects of the weight-loss programs themselves, and to reduce the potentially confounding effects of merely participating in a research study. Subjects who have already committed to a weight-loss program (Medifast Direct, Take Shape For Life , or other) will be recruited to join this study, and will be asked to complete several questionnaires over a period of up to 6 ⅓ years after enrollment. Questionnaires will measure information regarding anthropometrics, sociodemographics, and health \& quality of life outcomes. The overall goal of this research is to be able to describe and compare the long-term dieting behaviors and outcomes among participants in Medifast Direct and Take Shape For Life programs in comparison with other dieters.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females between the ages of 18 - 69 years
* BMI ( \> 25.0 kg/m2)
* Beginning a weight loss diet plan (MD, TSFL, or one of a number of commercially available plans)NOTE: subjects must have already committed to a weight-loss plan in order to be eligible for this study. The recruitment process is specifically designed so as NOT to appear to encourage subjects to begin a weight-loss plan. Rather, the purpose of this research is to track information about persons who have already committed to a weight-loss program.
* Willing and able to give informed consent
* Willing and able to comply with study protocol

Exclusion Criteria:

* Unable to give informed consent
* Previous hospitalization for psychiatric disorder or eating disorder
* Current, uncontrolled medical conditions
* Taking unstable doses of weight-loss or appetite-affecting medications (e.g., SSRIs, steroids, Ritalin)
* Taking prescription weight-loss drugs (Phentermine, Sibutramine, Orlistat, etc...)
* Have undergone, or plan to undergo, weight loss surgery (e.g. gastric bypass, lap band, duodenal switch) in the next 6 1/3 years
* Plan to undergo weight-altering cosmetic surgery procedures (e.g. breast reduction/augmentation, tummy tuck, liposuction, or other skin removal procedures) in the next 6 1/3 years
PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5
* Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions
* Symptoms related to SFA ISR defined by PSVR \> 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study
* The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection)
* Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery)
* The target lesion must no extend beyond the stent margin
* Successful crossing of the target lesion, inflow and outflow lesions with a guidewire
* Patient belongs to the French health care system
* Written informed consent

Exclusion Criteria:

* No atheromatous disease
* Asymptomatic lesion
* Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel
* Acute limb ischemia
* Patient on oral anticoagulation therapy
* Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc.
* Life expectancy \< 1 year
* Patient involved in another trial
* Refusing patient
* Pregnancy
Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity

Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people in the United States. As the most commonly identified genetic cause of obesity, PWS is often confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS, but clinically do not have PWS. The purpose of this study is to evaluate the clinical features and genetic basis of PWS and EMO, and to determine how these conditions affect a person throughout a lifetime.

PWS is a complex neurobehavioral syndrome. Clinical features include obesity, increased appetite, low muscle tone, cognitive impairment, distinct behavioral features, hypogonadism, and neonatal failure-to-thrive. It is the most commonly recognized genetic cause of obesity; however, many obese children do not in fact have PWS. These individuals are therefore diagnosed with EMO, a condition that shares features with PWS. The development of new advances and strategies for treating PWS and EMO requires a thorough understanding of the conditions at both the clinical and molecular levels. One goal of this study is to collect long-term data on individuals with PWS and EMO in order to gain a better understanding of the natural progression of the conditions, from the neonatal period well into adulthood. Specific to PWS, this study will establish a genotype-phenotype correlation among the different sub-types and will evaluate the effects of growth hormone treatment on disease progression. Lastly, the study will compare PWS with EMO in terms of clinical features and genetic basis.

Participation in this natural history study will entail an initial evaluation, followed by yearly study visits until the age of 3 and then every 2 years thereafter. Each study visit will last between 3 and 4 hours, and will include a physical exam (including a DEXA scan to determine body composition), psychological testing, an interview with the study physician, and an evaluation of the participant's diet history. In addition, blood tests will be completed for genetic testing and photos will be taken to evaluate disease progression. Cognitive and behavioral assessments will also be conducted and will last between 10 and 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals enrolling in the Prader-Willi syndrome group will have a confirmed diagnosis of Prader-Willi syndrome, as confirmed by molecular and cytogenetic testing
* Individuals enrolling in the Early-onset Morbid Obesity group will have a documented medical history of their weight exceeding 150% of the ideal body weight or a body mass index greater than 97% before the age of 4 years; they will also be under the age of 30 years.

Exclusion Criteria:

* Known genetic, chromosomal, or hormonal cause of cognitive impairment other than Prader-Willi syndrome
Apneic Oxygenation With a Nasal Cannula in the Obese and Morbidly Obese Surgical Patient

This prospective, randomized, double-blind study is intended to enroll a total of 100 patients with a BMI ≥ 40 kg/m2 and another 100 patients with a BMI ≥ 30 kg/m2 (but less than 40 kg/m2) undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either 15 L/min O2 or 15 L/min air from a standard nasal cannula during a simulated prolonged laryngoscopy. The anesthesia provider will do a direct laryngoscopy to ensure that the patient has a Cormack-Lehane grade I-II airway. Patients who have grade III-IV airways will be excluded from further study procedures and not analyzed. The rest of the anesthetic will not deviate from the standard of care. Anesthesia providers will be blinded as to whether patients are receiving oxygen or air during the apneic period.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Obesity (BMI ≥ 30 kg/m2 ≤ 40 kg/m2)
* Morbid obesity (BMI ≥ 40 kg/m2)
* Scheduled for a non-emergent operation that requires general endotracheal anesthesia
* Willing and able to consent in English or Spanish
* No current history of advanced pulmonary or cardiovascular disease

Exclusion Criteria:

* Age less than 18 or older than 70
* BMI \< 30 kg/m2
* Patient does not speak English or Spanish
* Family or personal history of malignant hyperthermia
* Patient refusal
* Monitored anesthesia care (MAC) or regional anesthesia planned
* Pregnant or nursing women
* "Stat" (emergent) cases
* Moderate to severe pulmonary disease (e.g., asthma, COPD, pulmonary fibrosis, pulmonary hypertension)
* Respiratory infection within the past 14 days (e.g., pneumonia, bronchitis)
* SpO2 \< 97% on room air
* Moderate to severe cardiac disease (e.g., CHF, CAD, aortic stenosis)
* Severe gastroesophageal reflux disease (GERD)
* Nasal obstruction (e.g., tumor)
* Elevated intracranial pressure (e.g., brain tumor)
* History of difficult airway
Real-World Treatment Study of Koselugo (Selumetinib)

As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.

This study will provide information on the Korean patient population that is treated with the study drug.


Eligibility Criteria:
Inclusion Criteria:

1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
Decreasing On-Shift Stress With a Crisis Intervention Cart

This Intervention study anticipates that 100 nurses, patient care technicians and unit secretaries in the acute care setting at four Methodist Health System facilities will provide surveys to participants who had interventions

Once the intervention has been used, the participants will complete a survey in order to determine if stress levels are decreasing. Initial data collection will be over the course of two months ( April 1, 2022 through June 1, 2022) and participation will vary based upon staffing and the set criteria for Crisis Intervention Cart deployment.

Eligibility Criteria:
Inclusion Criteria:

* Part of MHS (i.e., MCMC, MMMC, MRMC, MDMC, MLMC, MSMC)
* The hospital has at least one Crisis Intervention Cart study clinical site investigator on-staff
* Hold license as a Registered Nurse OR
* Hold position as a patient care technician or unit secretary
* Must be able to read English
* Provide direct patient care or hold a unit-based leadership position (i.e., Nursing Clinical Coordinator, Nurse Manager, Clinical Team Lead)
* Full-time, part-time, or PRN employee

Exclusion Criteria:

* Hospitals and clinical units will be excluded if they are outside MHS
* Participants will be excluded if they at Director-level or above
Clinical and Radiological Outcomes of Centralization of Radial Club Hand

Assess the recurrence of deformity after wrist Centralization in cases of radial club hand and effect of the procedure on the ulnar lengthening , ulnar bowing , hand function and parent satisfaction.

Radial club hand is a deficiency along the radial side of the extremity. Although considerable forearm and hand anomalies are the classic findings, proximal deficiencies also can occur throughout the arm and shoulder girdle. The elbow abnormalities can include deficiences of the olecranon, capitellum, coronoid fossa, and medial epicondyle.

In 1733, Petit first described radial club hand in an autopsy of a neonate with bilateral club hands and absent radii.

Initial surgical treatment of radial club hand involved an ulnar osteotomy to correct the bow, along with splitting of the distal ulna for insertion of the carpus. Reconstruction of the radius with a bone graft to support the carpus was reported in the 1920s, and non-vascularized epiphyseal transfer was reported in 1945. Results of these procedures were disappointing. They had multiple causes of failure, including disruption of the ulnar growth plate and subsequent increase in limb-length discrepancy, inadvertent ankylosis or arthrodesis of the wrist and loss of motion, and failure of the transplanted bone to grow, with eventual loss of radial support.

Centralization of the carpus on the distal ulna has emerged as the preferred surgical technique for correcting radial clubhand.in 1893, Sayre described it consisting of seating the distal ulna into a surgically created carpal notch. Pioneers in congenital hand surgery developed the basis for this procedure. Numerous modifications have been described to obtain or maintain correction of the wrist on the ulna.

Wrist centralization involves aligning the distal ulna with the middle finger metacarpal and passing a large Kirschner wire or a a small Steinmann pin through the middle finger metacarpal , carpus ,and ulna for temporary stability. This is followed by soft tissue balancing in order to counteract the volar and radial directed force vectors consisting of reefing the ulnocarpal wrist capsule and transferring the extensor carpi ulnaris muscle distally and flexor carpi ulnaris muscle dorsally on the wrist.

Eligibility Criteria:
Inclusion Criteria:

* All patients which had done centralization in our department who are available for follow up with complete records within the past 10 years.
* Cases with radial club hand Grade 3, 4 according to Bayne-Klug classification.
* Follow up duration should be at least two years.

Exclusion Criteria:

* Patients with follow up less than 2 years.
* Cases with Radial club hand Grade 1 , 2 according to Bayne-Klug classification
Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer

Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients


Eligibility Criteria:
Inclusion Criteria:

* Female patients with age between 18 and 70 years.
* Newly diagnosed breast cancer, stages IIb-IIIc.
* KPS performance status≥70.
* Measurable disease according to RECIST version 1.1.
* Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
* Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
* Adequate hepatic and renal function.
* AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
* Serum creatinine≥44 µmol/L and ≤133 µmol/L.
* Written informed consent are acquired.
* Not in pregnancy or the pregnancy tests of females is negative.

Exclusion Criteria:

* Severe heart failure (NYHA grade II or higher).
* Active and uncontrolled severe infection.
* Have accepted any other anti-tumor drug within 30 days before the first dose or
* received radiation treatment.
* Other situations that investigators consider as contra-indication for this study.
Ceftobiprole's Cerebrospinal Fluid Penetration in Patients With External Ventricular Derivation (CEFTO-EVD)

The Cerebrospinal fluid penetration of ceftobiprole has been studied in an animal model of meningitidis. Ceftobiprole is bactericidal, well tolerated and it has anti-biofilm activity. Altogether, these pharmacodynamics and pharmacokinetic properties of ceftobiprole are suitable for its use in case of External Ventricular Derivation(EVD)-related ventriculitis. Nowadays there are no human studies on the penetration and efficacy of ceftobiprole in the CSF. The study aims to evaluate characteristics of the CSF penetration of Ceftobiprole after intravenous administration in patients with EVD, that need for a concomitant infection this therapy (prescribed by an Infectious Diseases doctor).

According with Inclusion and Exclusion criteria, patients with an EVD and concomitant ceftobiprole therapy will be enrolled in the study.

In particular, ceftobiprole will be prescribed by an expert infectivologist, in accordance with the MHRA guidelines.

Once the patients will be enrolled, Ceftobiprole will be administered by 2 hr i.v. infusion at the following dosage:

* normal renal function: 500mg every 8 hr
* mild renal impairment (50-80mL/min): 500mg every 8 hours
* moderate (30-49mL/min): 500mg every 12 hours
* severe (\<30mL/min): 250mg every 12 hours.

The following blood and CSF sample will be drowned only during the third dose of antibiotic therapy. Blood Samples (1 mL each) will be obtained at the following time points: before and at the end of infusion of ceftobiprole, then 0.5, 1, 2, 2.5, 3 and 4 hr after drug administration (total of 8 samples), using a single venous or arterial line cannulation. CSF samples: 0.5ml will be drawned from implanted EVD with a sterile field at the same blood sample time-point, and at 6, 8 and 10 hr after the end of drug administration (11 samples total).

CSF and blood will be spin-down at 3000 rpm for 10 minutes and then stored at -80°C.

Samples will be sent all in once by courier to Laboratory of Clinical Pharmacology and Pharmacogenetics, University of Turin, Department of Medical Sciences, Amedeo di Savoia Hospital, Turin (Italy) in order to determine the serum and CSF concentration.

Ceftobiprole concentrations (both in plasma/serum and CFS) will be analyzed with EMA validated LC-MS/MS methods.

MDR1 gene polymorphisms will be analyzed with RT-PCR instrument, using commercial genetic probes on the blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Patients with External Ventricular Derivation (EVD)
* Patients who receive ceftobiprole for any infection where Ceftobiprole could be used, as judged by an expert infectivologist
* Patients or their relatives/parents who consent to study participation

Exclusion Criteria:

* Patients with end-stage renal insufficiency
* Patients with a BMI\>30
* Pregnancy
* Moribund patients
* Allergy to cephalosporine or ceftobiprole
* Refusal to participate in the study
Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach

RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

OBJECTIVES:

Primary

* Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy.

Secondary

* Determine the survival without local relapse and overall survival of patients treated with this regimen.
* Determine the tolerance to this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the stomach

  * Locally advanced or metastatic disease
* Measurable disease

  * At least 1 unidimensionally measurable target lesion at least 2 cm in diameter
* No known symptomatic brain metastases
* No bone metastases

PATIENT CHARACTERISTICS:

Age

* 18 to 75

Performance status

* ECOG 0-2

Life expectancy

* At least 3 months

Hematopoietic

* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic

* Bilirubin less than 2 times normal
* AST and ALT no greater than 2.5 times normal
* Alkaline phosphatase no greater than 2.5 times normal

Renal

* Creatinine less than 1.6 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Cardiovascular

* No serious cardiac failure within the past 12 months
* No myocardial infarction within the past 12 months
* No cardiac insufficiency
* No angina

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled serious infection
* No significant brain or psychiatric disorders
* No intolerance to cortisone or polysorbate 80
* No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
* No other illness or medical condition that would preclude study participation
* No peripheral neuropathy greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* More than 21 days since prior participation in another clinical study
* No other concurrent experimental medication