cyrilzakka/clinical-trials huggingface dataset:
POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection

This Nationwide stepped-wedge cluster randomized trial is designed to evaluate if the implementation of a best practice algorithm for postoperative care results in a decrease in incidence of major complications and death after pancreatic resection as compared to current practice.

Rationale

Pancreatic resection is a major abdominal operation with 50% chance of postoperative complications. A feared complication is severe pancreatic fistula, in which there is leakage of enzyme rich fluid into the abdominal cavity. Adequate complication management appears to be the most important factor in improving outcomes of patients undergoing pancreatic resection.

Objective

To investigate whether implementation of a best practice algorithm for postoperative care focusing on early detection and step-up management of postoperative pancreatic fistula results in a lower rate of major complications and death after pancreatic resection as compared to current practice

Study design

A nationwide stepped-wedge, cluster randomized, superiority trial. In this design all participating centers cross over from current practice to best practice according to the algorithm, but are randomized to determine the exact order. At the end of the trial, all centers will have implemented the best practice algorithm.

Study population

All centers performing pancreatic surgery in the Netherlands (i.e. the Dutch Pancreatic Cancer Group).

Intervention

Cluster level education on postoperative care according to a best practice algorithm, focusing on early detection and step-up management of postoperative pancreatic fistula. This algorithm is based on findings in Dutch observational cohort studies, systematic literature analyses, an inventory in current protocols on postoperative care and expert opinion. The proposed algorithm is validated in a multicenter cohort and consensus upon this algorithm is reached with pancreatic surgeons from all centers of the Dutch Pancreatic Cancer Group. The final algorithm was reviewed critically by the advisory committee of internationally respected experts in the field of pancreatology before implementation in this trial.

Comparison

Postoperative care according to current practice.

Endpoints

The primary outcome was measured in all patients undergoing pancreatic resection and is a composite of major complications (i.e. postpancreatectomy bleeding, new-onset organ failure and death). Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, number of patients receiving adjuvant chemotherapy, healthcare resource utilization and costs analysis. Follow-up will be 90 days after pancreatic resection.

Eligibility Criteria:
Inclusion Criteria for Clusters:

* All Dutch centers performing pancreatic surgery (i.e. performing at least 20 pancreatoduodenectomies a year)

Exclusion Criteria for Clusters:

* None

Inclusion Criteria for Patients:

* Patients underoging pancreatic resection for any indication

Exclusion Criteria for Patients:

* None (i.e. complete enumeration)
Effects of Caffeine Ingestion on the Biomechanics of Healthy Young Subjects

Caffeine is one of the few supplements that have enough scientific evidence to state that can notably improve performance, as different remarkable organizations in the sports nutrition context have classified it as an ergogenic aid with strong evidence regarding its efficacy and that is apparently safe. The beneficial effect of this substance on physical and cognitive performance has been identified in aerobic and anaerobic efforts, including aerobic and muscular endurance, power, or strength.

However, it seems that the benefits of caffeine are usually measured only by its effect on performance, while a comprehensive analysis of its impact on other aspects of the movement technique of the exercise is not considered. Therefore, although caffeine generates better performance, a null or negative effect may occur on technique execution. As such, some consequences might arise (e.g., an increase in injury risk or a decrease in energy efficiency).

The objective of this randomized controlled trial is to assess the influence of caffeine on certain biomechanical parameters of the technique of physical exercises in circumstances without fatigue and under neuromuscular fatigue. The study hypothesis is that caffeine generates modifications in the technical execution of certain movements in fatigued and unfatigued circumstances due to its physiological effects, which may be beneficial for performance and injury prevention.

The participants will have to attend 5 sessions (enrollment, familiarization, control, placebo, and caffeine), at least 7 days apart. In the last 3 sessions, different measurements will be done to their technique while jumping, squatting, and running, without fatigue and with it. Other data will be collected throughout the study to contextualize and analyze in more detail the obtained information.

A detailed description of the study can be found in the protocol uploaded with this registry entry.

Eligibility Criteria:
Inclusion Criteria:

* An uninterrupted training time of at least 1 year in the subjects' regular exercise modality (either the person is still training or interrupted the training period during the last year, and with no more than 4 months of detraining).
* A good exercise technique of the assessed movement patterns (running, squatting, and jumping).

Exclusion Criteria:

* Not being 18-30 years old.
* Having any relevant medical condition.
* Pregnancy.
* Smoking.
* Regular medication consumption / Medication consumption the days before the sessions during the study.
* Other supplementation regular consumption / Other supplementation consumption during the study (excluding sports foods, provided that their goal and nutrients have the objective of substituting the ingestion of regular food (e.g., isotonic drinks, carbohydrates gels, protein powder...), without adding other components that may act as ergogenic substances).
* Habitual caffeine consumption of \>25mg/day-0,99mg/kg/day.
Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals

SARS-COV-2 has created an unprecedented health crisis, resulting in unprecedented mobilization of all hospital professionals. The massive influx of patients overwhelmed the human, therapeutic and material resources available, and teams were confronted with an unusually heavy workload in a highly stressful emergency context. These professionals were thus exposed to a risk of over-investment in a context of acute and repetitive stress over an indefinite period of time, combining a heavy workload, emotional challenges and specific ethical issues. These factors simultaneously affected the professional sphere but also the personal and family spheres (lockdown, risk of contamination). In this context, the mental health of hospital staff is considered to be more important than ever, as emphasized on numerous occasions by the Director General of Health and the French Minister for Health and Solidarity. Mental health involves the way in which individuals respond specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the question of the mental health of hospital professionals cannot be considered without taking into account the strategies implmented to combat stress, and the factors that contribute or not to the construction and stabilization of the work environment (collaboration, support).


Eligibility Criteria:
Inclusion Criteria:

All professionals working in hospitals Professionals involved in the organization of psychological and ethical support may also be interviewed to provide the information necessary to describe and evaluate the support provided and how it changed over time.

Exclusion Criteria:

None
Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD).

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique. Some studies have showed that its positive effects in patients with Alzheimer's disease. The aim of this study was to evaluate the effect of rTMS on sleep and cognitive function in patients with mild to moderate AD, and to evaluate the glymphatic system function's mediating role between sleep and cognitive function. The study involves participants receiving 10 sessions of high frequency rTMS treatment applied to the dorsolateral prefrontal cortex over a 5 days period or sham rTMS. Neuropsychological testing and polysomnography will be used as the primary outcome measures. In addition, magnetic resonance imaging will be used to explore the effect of rTMS on the glymphatic system function in patients with Alzheimer's disease. Follow-up assessments of the patients' status will be conducted at one and three-month intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Participant meets 2014 IWG-2 criteria for hippocampal amnestic syndrome, typical of AD, with progressive episodic memory impairment confirmed by neuropsychology. Cerebrospinal fluid markers (Aβ40, Aβ42, T-tau, p-tau) consistent with AD, or AV-45 PET imaging showing significant cortical tracer retention, in line with AD pathophysiology.
2. Age range: 55-80 years.
3. No visual or hearing impairment.
4. Right-handed.
5. Han nationality.
6. Signed informed consent.
7. Reliable caregivers as information providers.
8. MMSE score: 10-27; CDR: 0.5-2 points.
9. If receiving approved AD treatment (e.g., acetylcholinesterase inhibitor or memantine), dose must be stable for ≥3 months prior to screening and unchanged unless medically necessary.

Exclusion Criteria:

1. History of seizures or epilepsy diagnosis;
2. Stroke history;
3. Nervous system diseases causing brain dysfunction (schizophrenia, severe anxiety/depression, dementia, Huntington's, brain tumors, Parkinson's, metabolic encephalopathy, encephalitis, MS, epilepsy, brain trauma, hydrocephalus);
4. Severe liver/kidney/lung dysfunction, anemia, gastrointestinal disease, arrhythmia, recent MI;
5. Barbiturate/benzodiazepine use within 2 weeks;
6. MRI/TMS contraindications (metallic implants);
7. Systemic diseases causing cognitive impairment (hypothyroidism, folate/B12 deficiency, infections, alcohol/drug abuse);
8. Aphasia, consciousness disturbance, inability to cooperate;
9. TMS/tDCS/DBS has been processed;
10. Underlying pathology other than AD;
11. Focal brain lesions on T1/T2 images;
12. Refusal to sign informed consent.
LSD-Perceptual-Choice-Study

The aim of the study is to characterize the effects of low doses of LSD (d-lysergic acid diethylamide) on behavioral and neural indicators of feedback and feedforward signaling in perceptual decision-making.

The study team will subject healthy participants to multiple perceptual decision-making tasks after the administration of low doses of LSD (d-lysergic acid diethylamide) as a pharmacological challenge. The investigators want to illuminate the behavioral and neural effects of psychedelics on prior beliefs and evidence processing. Each subject will participate in 3 x 5 h study sessions separated by at least 7 days. Subjects will be under continuous supervision until approximately 4.5h after substance administration. The participants are asked to perform the following cognitive tasks alongside EEG measurement after administration of either LSD or placebo: Changepoint task, history bias task, surround suppression task, auditory steady-state response paradigm, motor localizer task.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to adhere to the study protocol and sign the consent form
* ≥ 18 and ≤ 65 years of age at Screening
* Body mass index 18-29
* Fluent understanding of German
* Normal or corrected-to-normal vision
* Willingness to not operate a traffic vehicle or heavy machinery 24 hours after substance administration
* Willingness to refrain from taking illicit psychoactive substances, including cannabis, for the duration of the study
* Willingness to not consume more than one alcoholic standard drink the night before the study sessions and not consume alcohol for 24 h after each study session
* Willingness to abstain from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
* Willingness to use effective birth-control throughout the study duration
* Adequate task performance in the decision-making tasks during a practice session in the screening visit

Exclusion Criteria:

* Recent (\<30 days) or current participation in another clinical trial
* Women that are pregnant, nursing, or planning to become pregnant during the study period
* Current use of contraindicated/psychoactive medications or illicit drugs
* Lifetime use of classical psychedelics more than 20 times, or any time within the previous two months
* Consumption of \>5 cigarettes per day or \>20 alcoholic standard drinks per week
* Severe chronic or acute medical condition
* Hypertension (\>140/90 mmHg) or hypotension (\<85mmHg systolic)
* Current or lifetime major mental health disorder
* Personal or family (first-degree) history of a primary psychotic disorder
Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal. The pathogenesis of PCS has not been identified; therefore there is no consensus of medical treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients with cholesterol gallstones, and to promote biliary lipid secretion.

The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS and symptoms change after laparoscopic cholecystectomy


Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologic diseases scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* Current immunosuppressive therapy
* Chemotherapy within 4 weeks before operation
* Radiotherapy completed longer than 4 weeks before operation
* Inability to follow the instructions given by the investigator
* Severe psychiatric or neurologic diseases
* Drug- and/or alcohol-abuse according to local standards
* Participation in another intervention-trial with interference of a primary or secondary endpoint of this study
* Lack of compliance
* Lack of informed consent
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.

The Cupola system is a non-invasive device for pigment/tattoo removal based on ultrasound technology. The safety of the device was demonstrated in a previous pilot study approved by the Herzog Helsinki committee #167-09, Ministry of Health April 2010 #HT-5293) showing that no risk was associated with the procedure.

This study is designed to determine the efficacy of the device for tattoo removal in up to 6 treatments in different treatment intervals. Three areas of the tattoo that are similar in size, color, and intensity will be chosen. One area will not be treated; the second will receive 6 treatments in 2-3 week intervals; the third will receive 3 treatments in 4-6 week intervals. The evaluations will include color measurements, photography, subject comfort and skin condition.

Eligibility Criteria:
Inclusion Criteria:

1. Tattoos

   * Age of tattoo - more than 1 year since application
   * Type - decorative (not cosmetic)
   * Not previously treated
2. General

   * At least 18 years of age
   * Agrees to sign the Informed Consent
   * Willingness to remove tattoo
   * Willingness to have photographs and color measurements of the treated area taken and to be used for marketing and educational presentation and/or publications
   * Willingness to follow the treatment schedule and post treatment care requirement for tattooing and removal
   * Not planning to remove the tattoo in a different procedure during the time of the experiment

Exclusion Criteria:

1. Skin conditions

   * Skin type 5 and 6
   * History of keloid formation
   * Active herpes simplex
   * Psoriasis or vitiligo
2. Other medical conditions

   * HIV or Hepatitis
   * Pregnancy or intention to become pregnant in the next 6 months
   * No allergic reaction during the tattooing process.
3. Medication

   * Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive
   * Taking isotretinoin (Accutane) currently or within the last 6 months
   * Minocyclin
Machine Learning Prediction of Multiple Infections in Elderly Surgical Patients

Utilizing machine learning techniques, investigators developed the geriatric infection assessment model, leveraging domestic databases to predict multiple postoperative infections in elderly patients. The model addresses the current gap in predictive tools tailored for elderly surgical patients in China, offering insights into both overall and specific infection risks.

Backgrounds:

Postoperative infections are a leading cause of adverse perioperative outcomes, particularly for elderly patients. Given the varied diagnostic presentations of infection, there is a significant gap in the use of predictive tools to identify those at high risk of developing such complications.

Objective:

Investigators aimed at developing machine learning models to predict various postoperative infection risks in elderly patients, facilitating early detection and intervention.

Methods:

A retrospective analysis was conducted on 42,540 elderly patients who underwent non-cardiac surgery at the First Medical Center of the Chinese PLA General Hospital between January 2012 and August 2018, forming the Training set. From this, a 30% subset was randomly designated as the Test set. The models incorporated 51 variables including key infection-related factors. Three machine learning techniques-Logistic Regression (LR), Random Forest (RF), and Gradient Boosting Machines (GBM)-were utilized to develop predictive models for overall and specific postoperative infections, categorized according to the European Perioperative Clinical Outcome (EPCO) definitions. Model performance was gauged by metrics such as the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC), accuracy, and precision. To enhance model interpretability, investigators employed the RF model's Variable Importance (VIMP) and Shapley Additive Explanations (SHAP) algorithm. For a demonstrable prediction of specific infection types, data of randomly selected 5 patients were fed into the model with the resulting probabilities depicted in a radar chart.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65 years;
2. Patients undergoing surgeries not involving local anesthesia.

Exclusion Criteria:

1. Patients undergoing neurosurgery or cardiac surgery;
2. Patients with preoperative infections (including pneumonia, SSIs, UTIs, and bloodstream infections).
ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

The purpose of this study is to test and compare the efficacy of Endoscopic Third Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of Normal pressure Hydrocephalus.

Normal pressure Hydrocephalus is a reversible disorder of cognition and gait disorder.Currently the shunting of CSF is the recommended treatment of these patients. Even though shunts are known to be beneficial treatment of Hydrocephalus they often need treatment or revision for infection or malfunction. Endoscopic Third Ventriculostomy is a treatment without complications of shunt and is known to benefit obstructive forms of hydrocephalus.Few studies have also shown that it may be efficacious treatment Normal pressure Hydrocephalus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with NPH
* Meet at least 2 of 3 Hakim and Adams diagnostic criterion for NPH (dementia, gait instability and urinary incontinence)
* Ventriculomegaly defined by CT or MRI, Evans' index \> 0.3
* Clinical improvement after 3 day trial of CSF drainage.
* MMSE\>24
* Informed consent from patient
Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line

100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center

Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).

RENACALL is a prospective intermediate care study whose main aim is to evaluate the impact of a therapy management platform on the management of patients suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with Sutent®.

100 mRCC patients treated receiving first line Sutent® treatment shall be included in the study, and shall benefit both from conventional follow-up and from additional therapy management platform-based follow-up. Platform follow-up shall consist in regular phone calls to accompany patients in their real life home management of their treatment with sunitinib (prevention, advice and guidance of patients towards options)..

Eligibility Criteria:
Inclusion Criteria:

Man or woman aged 18 or over;

* Patient suffering from a/mRCC, receiving sunitinib first-line treatment, as per SPC recommendations;
* Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic effects due to radiotherapy or surgical procedure prior to initiation of sunitinib;
* Patient who can be monitored for 6 months.
* Female patient of child-bearing age using a form of contraception during treatment with Sunitinib and for at least 28 days after termination of treatment with Sunitinib;
* Patient having signed his/her consent form;
* Patient affiliated with a social security scheme.

Non-inclusion criteria

* Patient participating in a clinical trial during sunitinib treatment;
* Patient managed by a home hospitalisation service during sunitinib treatment;
* Patient taking part in therapeutic education programmes, or benefiting from nursing consultation, or from any other significant treatment support and likely to impact adverse event management.
* Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation;
* Patient refusing the use of his/her personal data.
* Patient with an ECOG performance status upon inclusion \> 2;
* Patient presenting with a serum creatinine level \>1.5 times the upper limit of the normal level;
* Patient presenting with a bilirubin level \> 2 mg/dl, aspartate transaminase (ASAT) or alanine transaminase (ALAT) \>2.5 times the upper limit of the normal value, or \>5 times the upper limit of the normal value in the presence of liver metastases upon initiation of sunitinib treatment.
* Patients who are staff members of a centre involved in the study, or close to one of the staff members of a centre directly involved in conducting the study, or patients employed by Pfizer and involved in conducting the study