cyrilzakka/clinical-trials huggingface dataset:
Leadership Training Affect Physician Career Satisfaction

The aim of the study is to evaluate the impact of organizational interventions for physician development on wellbeing, and investigate wellbeing and other characteristics of physicians with and without formal leadership roles.

1. Compare the incidence of job satisfaction, stress, and burnout overall between physicians who have undergone some sort of leadership training and those who have not.
2. Compare the incidence of job satisfaction, stress, and burnout overall between physicians with and without formal leadership roles.
3. Determine additional factors associated with job satisfaction, stress, and burnout levels.
4. Evaluate intrinsic and extrinsic motivating factors associated with physicians currently in formal leadership roles and those interested in pursuing formal leadership roles in the future.
5. Determine whether more satisfied physicians seek leadership roles or whether seeking leadership roles leads to greater satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years
* Be a current licensed physician practicing at Methodist Health System( MHS )
* Literate in English
* Able and willing to provide consent

Exclusion Criteria:

* \<18 years of age
* Not a current licensed physician at MHS
* Illiterate in English
* Unable or unwilling to provide consent
A Study to Learn About the Study Medicine (CIBINQO) in People With Atopic Dermatitis.

The purpose of this study is to learn about the safety and effectiveness (how well the study treatment works) of the study medicine (CIBINQO) for the potential treatment of atopic dermatitis in people under Japanese medical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Participants receiving this Product for treatment of AD.
2. Participants start receiving this Product (commercial product) for the first time and no earlier than the contract date of this Study, or Participants who continues to receive this drug after hospital transfer can be registered retrospectively.

Exclusion Criteria:

1. Participants previously enrolled in this Study at the same site.
Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.

If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?

This is a randomised controlled trial on 34 patients undergoing routine elective surgery at the Princess Anne Hospital, Southampton. The study will take place from September 2018 to January 2019 and involve preoxygenating all participants for three minutes using the Optiflow™ device. During this time, participants will be instructed to either read aloud a standardised text or to breathe through their nose with a closed mouth. At the end of 3 minutes, the primary outcome, ETO2, will be measured and recorded.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-35, ASA category 1 or 2

Exclusion Criteria:

* Inability to read/ follow instructions, Heavily sedated
StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation

Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels \<75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients \>12 months after KTx at several KTx centers. Patients will be randomly assigned 1:1 to an intensified BP management group (BP target ≤60th pct) and a standard BP management group (BP target \<90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial's centralized BP office. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplantation \&gt;12 months ago
* Arterial hypertension

Exclusion Criteria:

* Cardiac malformation
* Treatment for a rejection episode within three months prior to inclusion
Evaluating the Hope@School Prevention Program

This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).

The primary objectives of the study are:

To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health.


Eligibility Criteria:
Inclusion Criteria:

* Age between 8 and 18 years
* Attends school included in the study
* Consents to participate

Exclusion Criteria:

- Younger than 8 and older than 18 years
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.


Eligibility Criteria:
Inclusion Criteria:

1. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
2. Not in MDA at the time of screening
3. Has 3 or more tender and 3 or more swollen joints
4. Treated with methotrexate 15 mg (weekly) for at least 4 weeks

Exclusion Criteria:

1. Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
2. History of methotrexate intolerance/toxicity
3. Medical conditions(s) precluding methotrexate dose increase above 15 mg
4. Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general
Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden

Introduction: Many reimbursement authorities use economic evaluation to help guide decisions regarding the adoption of new treatments in reimbursement systems. Survival and quality of life are often the main measure of benefit used in an economic evaluation - expressed as a quality adjusted life year (QALY). In addition though, some decision makers will also consider the impact of a treatment on a patient's ability to continue working (expressed in terms of productivity). The aim of the present study is to estimate quality of life weights (utilities) and productivity loss for women with metastatic breast cancer (Human Epidermal Growth Factor Receptor 2 positive or HER 2+).

Methods: Separate surveys will be used to assess utilities and productivity in HER2+ metastatic breast cancer (MBC). To capture utilities health state descriptions or vignettes describing progressive disease, stable disease, and seven grade 3/4 adverse events (diarrhoea, fatigue, anaemia, leukopenia, anorexia, decreases in left ventricular ejection fraction (LVEF), and skin rash) will be developed. The vignettes will be developed based on a literature review and in depth interviews with women with MBC in the Netherlands and Sweden. Clinical experts in both countries will review the health states for content validity. The health states will be translated using forward and back translation. Members of the general public will rate the states (100 men and women in NL; 100 women aged 50+ in Sweden) using the visual analogue scale and Time Trade Off method to determine utility values. In a separate survey women who are currently being treated or have recently completed their treatment for MBC will be surveyed regarding the impact of disease on their ability to work using a validated work productivity measure (Work Productivity and Activity Impairment) in women in the Netherlands and Sweden.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18

Exclusion Criteria:

N/A
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition

The purpose of the study is to understand how the body uses amino acids in burned patients during the time they cannot eat normally. Amino acids occur naturally in the body and the food we eat. The body combines amino acids to make protein. It uses the proteins to do things such as heal wounds, fight infection, and provide energy. We are studying two ways of receiving nutrition: through a vein or through a tube. We are also studying two different types of food: with or without glutamine. The results of this study will be used to determine the best type and way to supply nutrients during a severe burn injury. We hope to learn how to help the body use nutrients more efficiently to better repair wounded tissues and recover earlier from injury.

We hypothesize that:

1. Burn patients will experience an increased conversion of glutamine to glutamate and a decreased conversion of glutamate to glutamine as compared to healthy subjects. The net direction is from glutamine to glutamate in burn patients and would render glutamine as a conditionally essential amino acid.
2. Because of the limited ability of liver to oxidize glutamate, it is possible that large doses of glutamine may cause increased gluconeogenesis in burn patients, thus aggravating the glucose homeostasis secondary to insulin resistance.
3. Enterally and parenterally fed glutamine and glutamate have different metabolic fate in the splanchnic bed and peripheral regions, therefore the doses should be tailored according to the route of administration.

This study, using stable isotope tracers, aims to track the metabolic fate of glutamine and glutamate in body with the goal of enhancing nutritional efficiency.

Eligibility Criteria:
Inclusion Criteria:

* One or more of the following:

  * 5% Total Body Surface Area Thermal Burn
* Inhalation Injury
* Resting Energy Expenditure of \>15% of the predicted Basal Metabolic Rate Using Harris-Benedict.
* Receiving Enteral or Parental Nutritional Support

Exclusion Criteria:

* Pre-existing:
* Thyroid disease
* Congestive Heart Failure (Ejection fraction \<20%)
* Malignancy currently under treatment
* Medical conditions requiring glucocorticoid treatment
* Decision not to treat because of severity of injury
* Presence of Anoxic brain injury with no expectation for recovery
* Self-Inflicted thermal injury
* Ileus, gut paralysis, or facial injuries
* No NG or OG tube as part of their clinical care
Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia

In this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Moreover, different HFNC flows would be applied, to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

High-flow nasal cannula (HFNC) oxygen therapy has been shown to improve oxygenation, reduce the need for intubation for patients with acute hypoxemic respiratory failure (AHRF) and avoid reintubation for post-extubation patients who had high-risk factors. HFNC refers to the delivery of gas at flows that exceed the patient peak inspiratory flow during tidal breathing, However, patient peak tidal inspiratory flow (PTIF) is found to vary greatly among different patients, from 20 to 50 L/min, making it difficult to properly set HFNC in a way to achieve the desired effects. In two recently published studies in intubated patients, PTIF varied from 25-65 L/min or 40-80 L/min, thus this study aims to investigate the correlation between pre-extubation PTIF in different modalities of SBT and post-extubation PTIF for adult patients, who are indicated to use HFNC immediately after extubation. In addition, the investigators aim to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

Eligibility Criteria:
Inclusion Criteria:

* Adult intubated patients aged between 18 to 90 years
* Pass spontaneous breathing trial and receive the order to be extubated
* Have at least one of the indications to use HFNC after extubation

Exclusion Criteria:

* Need to use inhaled epoprostenol via HFNC
* Pregnant
* Unable to use resuscitation mask, such as facial trauma, claustrophobia
* Non-English speaker
* Inability to verbally communicate
* Using extracorporeal membrane oxygenation (ECMO)
* Hemodynamically unstable
* Difficult airway
Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD

Non-inferiority efficacy of telithromycin versus azithromycin


Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients, either sex, aged 45 years or older.
* Patients with a documented history of chronic bronchitis with a basal FEV1 \<70% and \>35% made in the previous 12 months and who had had at least one or more AEBC in the previous year and with FEV1/FVC \<70% (lung function tests made in the previous 12 months).
* Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis presumably due to bacterial infection based on all of the following signs and symptoms of AECB: increased sputum purulence, and at least 1 of the 2 following signs and symptoms (increased dyspnea, increased sputum volume).
* Patients with negative chest radiography (posterior/anterior and lateral views) to rule out a pneumonia within 48 hours before initiation of study medication or at the latest 24 hours after initiation of study medication (it was necessary to not include patients with pneumonia associated with AECB).
* Patients with sputum specimens collected at inclusion for gram stain and bacteriological culture.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exposure to Intense and Prolonged Noises During Pregnancy

Hearing is an essential element for the development of language and conditions an appropriate cognitive, psychological and social development of children. Therefore, congenital deafness represents a real public health problem, justifying the implementation of a national neonatal screening for hearing disorders in newborns.

The intensity at which the fetus perceives sound at 27-29 weeks of amenorrhea (SA) is about 40 decibels (dB), it recognizes its mother's voice from the 33rd SA, and then its perception capacity evolves to the adult level at term. These data suggest that the fetus is sensitive to its sound environment from the 3rd trimester of pregnancy. The development of hearing could be damaged in case of prolonged exposure to intense noise. Studies have demonstrated an harmful effects of long and sustained exposure to noise on hearing in adults. In addition, a recent survey showed that 40% of the population of Ile-de-France felt that noise had a significant impact on their health . The effects of prolonged loud noise exposure on human fetal hearing are not fully understood and few studies have assessed the prevalence of women exposed to loud and lengthy noise in a population of postpartum women. This study aims evaluating the prevalence and the impacte of an exposure to Intense and Prolonged Noises during Pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Woman who gave birth at the Nancy Regional Maternity Hospital
* Woman having received complete information on the organization of the research and not having objected to her participation and the use of her data
* Woman affiliated to a social security scheme or beneficiary of such a scheme
* Woman understanding French and able to complete a self-questionnaire or having the possibility of being assisted for the filling

Exclusion Criteria:

* Woman for whom a diagnosis of malformation or genetic anomaly of the fetus was established in the antenatal period
Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.

The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.

This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A \& B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

1. Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count \> 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
2. Initial surgical management planned for immediate laparoscopic cholecystectomy.
3. Patients who are fit for laparoscopy and general anesthesia.
4. Patient who agree to provide short term outcome data and agree to provide contact information.

Exclusion Criteria:

1. Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
2. Patients with other associated abdominal pathology.
3. Patients with any previous abdominal surgery or any significant systemic disease.
4. Septic shock.
5. Pregnancy/ Breast-feeding mothers.
6. Participation in an additional drug or device study and inability to offer informed consent.
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis

This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;
2. Diagnosis of SLE according to the ACR criteria (1997);
3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;
4. Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
5. proteinuria \> 1g/24hr or Scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 WBC/high power field (hpf) (excluding infection), \> 5 RBC/hpf);
6. Provision of written informed consent by subject or guardian

Exclusion Criteria:

1. Inability or unwillingness to provide written informed consent ;
2. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;
3. Scr \> 4mg/dl (354umol/L);
4. Needing pulse intravenous MP or intravenous immunoglobulin;
5. Lupus encephalopathy;
6. Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);
7. History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;
8. Known hypersensitivity or contraindication to tacrolimus, corticosteroids
9. Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;
10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening;
11. Pregnancy, nursing or use of a non-reliable method of contraception.
Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis

Epidemiological studies have shown a 2-3 fold increased long-term risk of arterial cardiovascular disease after venous thrombosis, most predominant in the first year following initial venous thrombosis. The results of recent observational studies that showed 40-50% risk reductions for first venous thrombosis occurrence when using a statin are in this aspect promising. The results are also somewhat surprising, because the mechanism behind this effect is unclear. Dyslipidemia may be the most plausible explanation to be considered. However, as dyslipidemia is not related to an increased risk of venous thrombosis, it is unlikely that statins decrease venous thrombosis risk by lipid lowering activities. Recent observations indicate that coagulation can activate the initial formation of atherosclerosis. Our hypothesis is therefore that the coagulation profile in persons with venous thrombosis is improved when using a statin, ultimately leading to less atherosclerosis: another well known property of statin use.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Persons with (initial or recurrent) confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who after a time period of at least 3 to 12 months are allowed to stop, - or stopped using \< 1 month anticoagulant treatment as indicated by their treating physician
* Persons aged 18 years or above

Exclusion Criteria:

* Persons already using statins or lipid lowering drugs, or any other disallowed concomitant medications (erythromycin, HIV protease inhibitors, or cyclosporine)
* History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
* Life expectancy less than 6 months
* Pregnant woman or woman with childbearing potential who are not willing to use contraception
* Active liver or kidney disease or dysfunction or muscle disorders
* Unstable medical or psychological condition that interferes with study participation