cyrilzakka/clinical-trials huggingface dataset:
Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During HFS

The harmful effects of stress on health professionals are expressed both in terms of their health (physical or mental) and the quality of work (reduced memory capacity, deterioration in patient care). These adverse effects highlight the importance of implementing effective coping strategies and/or early learning of stress management methods in medical training programs.

Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback is one of the new techniques used to reduce the stress level.

No research has yet tested the effects of HRV induced by relaxation breathing technique before managing a simulated critical situation.

This is a randomized, controlled study conducted at the university simulation centre in healthcare of Lyon, France. The high-fidelity simulation (HFS) will be used as a research tool and the topics included will be the HFS residents summoned to critical care situations as part of their training curriculum. The study has received prior approval from the UCBL1. Ethics Committee. After information (protocol and objective of the study), signature of consent, and one minute of relaxing breathing training, the residents as active participants in HFS, will be included in the study. They will be equipped with Hexoskin® jackets collecting heart rate, heart rate variability, breathing rate continuously and an Empathica® connected watch for continuous measurement of electrodermal activity. Then each resident will be randomized into one of the three intervention groups that are:

* a relaxing breathing exercise coupled with biofeedback
* a breathing exercise without biofeedback
* a control occupation (observation of normal biological results). Each intervention will last five minutes and will be conducted between the briefing and the scenario.

Main objective :

The objective of this study is to compare during HFS, the performance of residents during critical care scenarios. The performance analysis will be performed by two independent and blinded evaluators, based on the video recordings of scenarios. The overall performance will be the addition of technical skills (specific rating grid for each scenario on 100 pts) and non-technical skills assessed by the OTTAWA GRS grid (adjusted to 100 pts).

Secondary objectives :

* Compare the effects of the three interventions on reducing psychological stress.
* Compare the effects of the three interventions on reducing physiological stress.
* Compare the effects of the three interventions on increasing cardiac coherence scores.

Eligibility Criteria:
Inclusion Criteria:

* Adult person
* Registered in specialized diploma of medical training.
* Invited for a high-fidelity simulation session at the Lyon university simulation center.
* Have signed an informed consent form.

Exclusion Criteria:

* pregnant woman
Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy

Kidney donors represent healthy patients and their anticipated postoperative course should be uncomplicated and brief. This study looks to optimize the perioperative pain regimen of laparoscopic donor nephrectomy patients by minimizing or eliminating narcotics from the immediate post-operative period. Current postoperative standard of care after donor nephrectomy require narcotic analgesics. While narcotics are potent pain medications, they are often associated with complications including nausea, vomiting and dysfunction of the gastrointestinal tract causing prolonged complications.

The investigators seek to evaluate a peri-operative pain regimen limiting the usage of narcotics. This incorporates a perioperative analgesic course utilizing combination of an intravenous non-steroidal anti-inflammatory drug (NSAID), intravenous acetaminophen, and intravenous ketamine. All three have been demonstrated to be effective for the control of perioperative pain while decreasing narcotics use.

Prior to surgery, participants will be consented and randomly assigned to receive the standard of care perioperative pain management using intravenous narcotics as a patient-controlled analgesia (PCA) by itself plus placebo or along with the new protocol. The study will demonstrate it the new protocol will limit or eliminate the need for narcotics as a patient-controlled dose during the postoperative period.

Upon discharge from the hospital, patients will be followed in clinic and via home questionnaires annually for 5 years to evaluate satisfaction, renal function and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* all individuals undergoing laparoscopic donor nephrectomies at Stony Brook Hospital

Exclusion Criteria:

* Patients excluded as a potential kidney donor or surgical candidate (renal failure, cancer, uncontrolled hypertension or diabetes, cognitively impaired adults, children, history of stroke, complicated coronary history or pregnant)
* Patients with a history of chronic pain or chronic pain medication use
* Patients who are undergoing open nephrectomies
* Allergy to NSAID or acetaminophen
* Hepatic disease or elevated transaminases
* Peptic Ulcer Disease
* Probenecid use
* History of traumatic brain injury
* Contraindications of Ketamine Use (recent head trauma, open eye injury or glaucoma)
The Austrian Spinal Cord Injury Study

Traumatic spinal cord injury (tSCI) is a debilitating disease that leads to neurological deficits and often has long-term effects including severe lifelong disability. Given the devastating personal and economic consequences of SCI, it is critical to collect high-quality, prospective data. SCI has not been systemically assessed in Austria, and data regarding the etiology, incidence and prevalence are missing or significantly limited. More importantly to the individuals suffering from SCI, health care for SCI patients in Austria is not concentrated in specialized SCI centers but fragmented, which might result in a less effective recovery and rehabilitation of patients. Accordingly, the Paracelsus Medical University Salzburg (PMU) and the Austrian Social Insurance for Occupational Risks (AUVA) initiated the Austrian Spinal Cord Injury Study (ASCIS) at the beginning of 2012. ASCIS is defined as an organized network that uses observational methods to collect uniform longitudinal clinical data that can provide insight into current patient care parameters and evaluates the outcome of SCI patients. ASCIS was initiated with the aim to develop a registry for patients with tSCI in Austria as a base for addressing research questions, improving patient outcomes and establishing a platform for future clinical trials. Furthermore, a major goal of ASCIS is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and bring new standardized assessment tools to the clinical setting. Due to the involvement of acute trauma hospitals and rehabilitation centers, ASCIS is uniquely positioned to capture detailed hospital-related information on the (very)-acute, rehabilitation and chronic phases of tSCI patients. Additionally, ASCIS is cooperation partner of the European Multi-Center Study about Spinal Cord Injury (EMSCI).


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from paresis or plegia after trauma
* First ASCIS assessment possible within the first 3 days after incidence
* Patient capable and willing of giving written informed consent
* No cognitive impairment which would preclude an informed consent (including severe traumatic brain injury)

Exclusion Criteria:

* Nontraumatic paresis or plegia (e.g. disc-herniation, tumor, AV-malformation, myelitis)
* Previously known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
* Peripheral nerve lesion above the level of lesion (e.g. Plexus brachialis impairment)
* Previously known polyneuropathy
* Severe craniocerebral injury
A Multi-centre Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)

To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.


Eligibility Criteria:
Inclusion Criteria:

* Patient's written informed consent must be obtained prior to inclusion.
* Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy.
* Willing to undergo a colonoscopy for diagnostic or surveillance purposes
* Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy
* Willing, able and competent to complete the entire procedure and to comply with study instructions.
* Females of childbearing potential must employ an adequate method of contraception.

Exclusion Criteria:

* History of gastric emptying disorders.
* History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.
* History of phenylketonuria.
* Known glucose-6-phosphate dehydrogenase deficiency.
* Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.
* History of colonic resection.
* Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs).
* Presence of congestive heart failure (NYHA III + IV).
* Acute life-threatening cardiovascular disease.
* Documented history of severe renal insufficiency (creatinine clearance \<30 ml/min).
* Other contraindication described in the summary of product characteristics (SmPC) of either preparation.
* Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly.
* Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months.
* Females who are pregnant, nursing or planning a pregnancy.
* Patients who, in the opinion of the investigator, may not be compliant with the study requirements.
* Previous participation in this clinical study.
Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department

The aim of the study is the characterization of parameters from medical history, physical examination and diagnostics, which correlate with and could be used to predict diuretic efficacy.

This prospective observational study is conducted to identify and further isolate possible predictors for the efficacy of diuretics and to identify potential new predictors.

The study also observes if specific diuretic regimes (e.g. combination of loop diuretics and distal effective diuretics for sequential nephron blockade) have a greater diuretic effect. This is not yet proved.

The data of the study shall to help to determine criteria, allowing to choose an effective diuretic regime in different patient cohorts already at the beginning of therapy and to identify patients at high risk.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Edema (peripheral and/or pulmonal) of cardiac or renal genesis.

Exclusion Criteria:

* Persons who are in a dependency/employment relationship with the investigators.
* Accommodation in an institution by judicial or administrative order.
* Patients in need of ascites puncture and/or thoracentesis on admission day.
Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery

Digital 3D animation and cadaveric videos have been increasingly used in surgical education and provide tremendous opportunity to develop new surgical educational tools, particularly during this Coronavirus-19 pandemic period.

This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons. Initially, an electronic questionnaire assessing the knowledge about laparoscopic rectal surgery will be created and validated by the board-certificated colorectal surgeons. Exploratory and confirmatory factor analyses will be utilized to test the structure validity of the questionnaire. After the questionnaire will be sent to the graduates completing the general surgery residency program in Turkey, the volunteers will be then randomized into four groups based on the study material including a textbook, 3D animation, cadaveric video, and both 3D animation + cadaveric video. A step-by-step educational 3D animation and a cadaveric video will be prepared in order to teach the technical steps of laparoscopic rectal surgery. Volunteers in four groups were given 2 weeks to review their educational material. After the 2-weeks of the study period, the volunteers will be asked to answers the same electronic questionnaire imported in the edited live laparoscopic rectal surgery. Pre- and post-educational assessment of the questionnaire among the groups will be performed and compared.


Eligibility Criteria:
Inclusion Criteria:

* General surgeon who graduated at least 5 years ago from the residency
* General surgeon who is proficient to perform open rectal surgery
* General surgeon who was scrubbed in/assisted for laparoscopic rectal surgery
* General surgeon who is not able to perform laparoscopic rectal surgery by itself

Exclusion Criteria:

* None
A Telemedicine Brief Mindfulness Intervention in Post-COVID-19

Background: Several studies suggest that SARS survivors still presented with high levels of psychological distress overall at 1, 3, 12, and 18 months after hospital discharge. Nonetheless, there are no data available in the literature regarding the implementation of interventions that are psychological interventions, let alone specific ones. In particular, the practice of mindfulness, formalized in the protocols such as Mindfulness Based Stress Reduction (MBSR) and Mindfulness Based Cognitive Therapy (MBCT). Based Cognitive Therapy (MBCT), have proved to be very effective in reducing stress related to chronic conditions and of depression. However, these protocols typically require a high level of engagement for participants, which is why, in the present exploratory study, the investigators opted to evaluate the implementation of a Mindfulness-based protocol that is short and less intense, but which has shown good results on health-related outcomes, even with a single session.

Objectives: In this perspective, it becomes important to detect the presence of psychological distress in those who have contracted COVID-19 and are now undertaking a rehabilitation program, from the perspective of promoting well-being and prevention of possible aggravation if not prolongation of mental suffering in the long term.

Study Design: Randomized and Controlled (RCT), two-arm pilot study with three data captures (baseline=T0, 3 weeks=T1, 3 months=T2).

Participants: People who have previously tested positive for COVID-19, now negative and hospitalized at the IRCCS Santa Maria Nascente of the Fondazione Don Carlo Gnocchi in Milan.


Eligibility Criteria:
Inclusion Criteria:

* Previously positive for COVID-19 and now negative and undergoing treatment Pulmonary rehabilitation;
* Compatibility to participate in the study as judged by the physician;
* Able to provide Informed Consent.

Exclusion Criteria:

* The physician's unfavorable opinion of inclusion in the study because he or she is unable to provide Informed Consent;
* Patients with lung cancer;
* Documented psychiatric disorders;
* Immunodepression;
* Patients with terminal or neurodegenerative diseases (e.g., other forms of cancer, Amyotrophic Lateral Sclerosis (ALS)).
Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects

This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.


Eligibility Criteria:
Inclusion Criteria:

Male Ascites Cirrhosis

-

Exclusion Criteria:

Prior treatment with aldosterone antagonist Uncontrolled heart disease or diabetes Current malignancy Current medication interacting with aldosterone antagonists
QOL Outcomes in CRS With Polyps

Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16% in the western population. The main outcome measure for chronic disease treatment, such as CRS, is quality of life. Several large multi-institutional studies have shown that improvement in disease specific Quality of life was greater in patients who had surgery for their CRS with polyps. The timing of surgery in these patients has not been well studied but it is generally agreed upon that surgical candidates much had failed medical management. The definition of medical management varies greatly but usually includes some form of nasal or oral steroids and a prolonged ( \>10 days) course of antibiotics.

Another known way to improve QOL is through education and individualized optimization. This has been utilized successfully in other fields with good success and improved QOL. Similar studies looking at combining non-surgical optimization and education have not been performed in CRS. This study aims to address this potential area for improvement in patient quality of life outcomes. Investigators plan to assess the potential role for pre-operative non-surgical medical and educational optimization in CRS standard of care treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults with Rhinosinusitis with polyps who have had appropriate treatment qualifying them for surgery and are good surgical candidates

Exclusion Criteria:

* Cystic fibrosis, Cilia disorders, other specialized forms of sinus disease
The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers

This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.


Eligibility Criteria:
Inclusion Criteria:

* BMI : 18-30 kg/m2 (Body Mass Index \[BMI\] \[kg/m2\] = Body weight \[kg\] Height2 \[m2\])
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
* Medical history without major pathology

Exclusion Criteria:

* Evidence of clinically relevant pathology
* Mental handicap
* History of relevant drug and/or food allergies
* Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center
* Smoking within 60 days prior to drug administration and through the follow-up visit
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
Evaluation of a MRI-based Prostate Cancer Screening Program

The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.

Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. According to European guidelines we will include men \> 50 years of age and men \>45 years of age and a family history of PCA as well as African-Americans \>45 years of age. In this study, bpMRI will be used for opportunistic prostate cancer screening.

The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.

Eligibility Criteria:
Inclusion Criteria:

* well-informed men with the wish for prostate cancer screening
* prostate biopsy naïve
* life expectancy \> 10 years
* men \> 50 years of age
* men \> 45 years of age with a family history of prostate cancer
* African-Americans \> 45 years of age

Exclusion Criteria:

* prostate biopsy performed prior to study
* life expectancy \< 10 years
* acute urinary tract infection
* NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)
* IPSS score 20 (leads to initiation of urologic diagnostics and treatment)

Contraindications for MRI:

* Heart pacemaker
* Artificial heart valves (some types are eligible)
* Cochlea implant
* ICD
* Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.)
* Severe claustrophobia