cyrilzakka/clinical-trials huggingface dataset:
Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)

Stress and rumination are linked with the development of many mental disorders. The ECOSTRESS study has shown that poor OSCE performance has a positive effect on the occurence of state-rumination among 4th year medicine students in the context of mock exams.

The goal of IMSR study is to assess the effectiveness of a post-OSCE meditation intervention to decrease psychological stress and rumination.

This randomized, controlled and monocentric study will be conducted during the OSCE tests contributing towards the final exam grades for 4th year medicine students at the Claude Bernard Lyon 1 university.

Before the test (OSCE), all the students will receive information about the study and formalize their consent.

The students' OSCE performance will be evaluated by an independent examiner as part of the students' exams. Upon finishing the OSCE, the students will be divided into two groups: one subjected to post-OSCE meditation and the other one subjected to a control intervention (neutral content video).

Before both interventions, all the students will be submitted to short questionnaires regarding their feelings.

During the 6-min intervention they will be get equipped with an ear pulse sensor.

Following both interventions, all the students will be submitted to short questionnaires regarding their stress and rumination levels.

The main objective is to assess the effectiveness of meditation intervention to diminish post-OSCE rumination level. The second objective is to have a deeper understanding of the cause of rumination following the OSCE..

Eligibility Criteria:
Inclusion Criteria:

* Adult person
* Registered as medical student at the university
* Participating at OSCE examination
* Have signed an informed consent form.

Exclusion Criteria:

* None
the Change of Cholesterol Efflux Capacity and Coronary Artery Disease in Real Clinical Practice

The purpose of this study is to investigate the change of cholesterol efflux capacity in patients with coronary artery disease treated with secondary prevention drugs, and the correlation with the prognosis.

In this clinical trial, serum samples and associated clinical data of patients with coronary artery disease were collected from Department of Cardiology of Lu'an Shili Hospital and the First Affiliated Hospital of Jinan University. Blood samples collected from all the participants at baseline (prior to the follow-up) and the time points of follow-up were placed into ordinary test tubes and stored at 4°C for less than 4 hours. The blood was then centrifuged, and serum was separated and stored at -80°C. The change of cholesterol efflux capacity, HDL-C subclasses (preβ1-HDL, HDL2, HDL3), the concentration and activity of plasma LCAT were measured. A follow-up form was designed according to the research purpose and discussed among the team members. The follow-up was performed through telephone by the trained investigators with good communication skills and knowledge on the diagnosis and treatment of coronary artery disease. Patients were followed up every six months from the day of discharge. The results of the follow-up were entered into the database, a process that was carried out by a designated person and double-checked by an independent person. The primary clinical endpoints were composite atherosclerotic cardiovascular disease outcomes, defined as nonfatal myocardial infarction, nonfatal stroke, or cardiovascular mortality. Secondary clinical endpoints were revascularization, including percutaneous coronary intervention and coronary artery bypass grafting, and Class IV heart failure requiring hospitalization.

Eligibility Criteria:
Inclusion Criteria:

Signed informed consent; First diagnosis of CAD through CAG; aged 30-70.

Exclusion Criteria:

Patients with severe liver or kidney damage; Taking statins within the last 3 months; Patients who had been diagnosed with CAD and treated with oral medication; Chronic diseases of the blood system; Familial hyperlipidemia patients; Patients combining autoimmune disease; Patients combining acute infectious disease; Patients who undertaken surgery or injury; Patients who combining cancer; Patients who taking glucocorticoid replacement therapy.
A Multi-omics-based Metabolic Typing Study of Gastric Cancer

In the study, the investigators obtained gastric cancer tissues from 480 gastric cancer patients who had undergone surgery at the Zhejiang Cancer Hospital's biospecimen bank between 2012-2019, and obtained relevant clinical information. The gastric cancer tissues were subjected to transcriptomic, metabolomic and other multi-omics testing, and analyzed for the metabolic changes of gastric cancer, and proposed to discover relevant therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* 18≤age≤80
* Histologically or cytologically confirmed gastric cancer
* Undergo surgery for radical or palliative gastric cancer (both open and laparoscopic)
* Patients with survival follow-up information

Exclusion Criteria:

* Two or more kinds of malignant tumors at the same time
* Incomplete or missing case information
* Preoperative diagnosis of residual gastric cancer
A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants

The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics, ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants will be placed by pediatric dentistry residents. Sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. Photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric dentists.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients: American Society of Anesthesiologists (ASA) I or II
* Good cooperation: Frank1 3 or 4
* Aged between 6-16 years old at the day of sealant placement
* Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars.

Exclusion Criteria:

* Teeth with a history of past or current caries
* Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies
* Teeth with clinical or radiographic evidence of pathology
* Teeth with a history of restoration or sealant
* Patients who are poorly behaved
Clonidine and Left Ventricular Dysfunction

The objectives of this study are:

1. To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF).
2. To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF.

The study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized in a 1:1 ratio to:

1. placebo (n=35) or to
2. clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months.

The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (MRI) and echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Age: 60 and greater
* Gender: Both
* Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects

The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system.

Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics).

Eligibility Criteria:
Inclusion Criteria:

* No ear disease
* No neurologic disease
* No surgery for ear, brain or musculoskeletal system

Exclusion Criteria:

* Diabetes mellitus
* Drug use effective on central nervous system
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome

The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.


Eligibility Criteria:
Inclusion Criteria:

1. Boys diagnosed with fragile X syndrome
2. Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
3. Age 8 to 18 years inclusive
4. Ability to travel to Stanford
5. Vineland Adaptive Behavior Scales standard score between 50 and 75 points

Exclusion Criteria:

1. Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
2. Materials in body that would preclude an MRI scan (e.g., dental braces).
PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate.

This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.

Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence.

The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue.

The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity.

In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages.

Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Mid- and low rectal cancer
* Age ≧ 18
* TME
* ASA ≦ 3
* No previous stoma formation
* Informed consent for participation

Exclusion Criteria:

* Patients lost during the follow-up
* Refusal of the patient from further participation in the study
* Inability of stoma formation
Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation

This project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people undergoing post-acute rehabilitation.

The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting.

This project will be conducted in a VA post-acute rehabilitation site. Older veterans (\>= 60 years) who were previously community-dwelling (N = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. Data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. Follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. The main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. Data will be analyzed for all randomized participants in an intention to treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged \> or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation

Exclusion Criteria:

* severe sleep apnea
* severe cognitive impairment
* not enrolled within one week of admission to rehabilitation unit
* too ill to participate
* and planned discharge to a nursing home for total nursing care
Closure of the Appendiceal Stump

Laparoscopic appendectomy is a well-defined surgical technique. However, concerns remain about whether closure of the appendiceal stump should be done with clips, endoloops, staples, or other techniques. If tying is to be used in the closure of the appendiceal stump, there is no consensus on which technique (intracorporoyal, extracorporoyal, etc.) should be used for ligation. For this reason, there is a need for studies on different binding techniques and instruments currently used. The aim of this study was to compare the use of unilateral intracorporeal knot and polymer endoclip closure during laparoscopic appendectomy.

Patients who are scheduled to undergo laparoscopic appendectomy after the ethics committee approval will be included consecutively. Patients will be randomized into 2 groups: those who will be closed with a polymer endoclip (Group 1) and those who will be closed with an intracorporeal node with a single instrument (Group 2). Data such as age, gender, body mass index, comorbidities, previous abdominal surgeries, medications used by the patients, as well as the presence of ileus, perforation, and diffuse peritonitis will be recorded. After laparoscopic dissection, the appendiceal stump will be closed with a polyper homologous clip in Group 1 and the stump will be closed with an intracorporial node with a single instrument in Group 2. The operation times of the patients, the time elapsed after the end of the dissection until the pathology specimen comes out of the skin (to be determined as the closure time), complications such as ileus, intra-abdominal abscess, bleeding and fistula related to stump closure problems encountered in the postoperative period will be recorded and compared. Patients will be followed by the corresponding author In both surgical methods, it is routinely used to close the appendiceal stump and in the polymer clip application, a clip with a locking mechanism is used when the stump is tightened with an applicator. In the intracorporial node with one hand, the surgical node is made by circulating the tip of the suture material around the appendix with a single instrument (the other end is kept fixed outside the abdomen)

Eligibility Criteria:
Inclusion Criteria

* Patients who are diagnosed with acute appendicitis

Exclusion Criteria:

* bleeding diathesis
* cirrhotic acid,
Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.

In sepsis, the removal of middle molecular weight molecules such as cytokines (also called blood purification), has shown a great interest in intensive care during the last decades. Indeed, these cytokines are involved in the development of the multi-organ failure syndrome when patients are in septic shock. There is some evidence to suggest that extracorporeal therapies (hemofiltration-hemodialysis)are interesting tools to modulate the inflammatory response and to restore the immune homeostasis.

However, hemodialysis using "conventional" membranes does not allow the removal of middle molecules. Conversely, high-volume hemofiltration is an appropriate therapy but it has a lot of drawbacks due to the high ultrafiltration rates (removal of beneficial small molecules, technical and economical issues due to the use of large amounts of fluid replacement). Finally, high cut-off hemofiltration has been reported to be associated with significant albumin loss.

Therefore, continuous "enhanced middle molecule clearance" hemodialysis could be an interesting alternative, making possible the removal of these middle molecules without significant albumin loss and with some theoretical advantages (reduced cost due to the possibility to produce the dialysate from a water circuit, decreased nursing workload).

The aim of this study is to assess the clearances of different kind of molecules (small, middle and large) when continuous enhanced middle molecule clearance hemodialysis is applied to septic patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged over 18 years.
* ICU patients with septic shock and AKI requiring continuous renal replacement.
* Patient able to agree to be enrolled in the study with informed consent. If the patient can not provide consent, only the consent of family members will be sought if they are present and, to default, the opinion of trustworthy person under article L.1111-6 of the French Health Code. If there is no family present, or trustworthy person designated, the subject will not be included in the study.

Exclusion Criteria:

* Pregnancy or lactation.
* Participation in another research protocol.
* People particularly vulnerable as defined in Articles L.1121-5, L.1121-6, L.1121-7, L.1121-8 et L.1122-1-2 of the French Health Code.
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years.
2. Severe aortic stenosis with bicuspid anatomy.
3. NYHA≥2 and/or syncope and/or angina.
4. Patient judged by the Heart Team as indicated for TAVR.

Exclusion Criteria:

1. Age \<18 years
2. Asymptomatic patients
3. Pure aortic regurgitation.
A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer

This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or chemotherapy.

Male patients with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either All patients must have at least one readily accessible soft tissue/nodal tumor lesion (for intra-tumoral application of ONCOS-102 and biopsy.

Study Description:

* All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure.
* ONCOS-102 administration will start within 3 weeks of leukapheresis at Week 5 (35 days since baseline +/- 2 days), and 3 further doses will be administered on a weekly basis
* Cyclophosphamide A priming bolus dose of CPO (300 mg/m2 intravenously) will be given 1-3 days before the first (Week 5) and the fifth (Week 14) of ONCOS-102 administration.
* DCVAC/PCa therapy will start 6 weeks after leukapheresis at Week 8. DCVAC/PCa will be administered subcutaneously in cycles, always on Day 1 (+/- 3 days) of the corresponding cycle.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Radiographically documented metastatic disease with evidence of disease progression Laboratory parameters per protocol
* Surgically or medically castrate
* Patients who have progressed following:
* a. at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or
* b. one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or
* c. failure of two lines of chemotherapy; or
* d. failure of pre-chemotherapy abiraterone or enzalutamide and subsequent chemotherapy

Exclusion Criteria:

* Patients with neuroendocrine or small cell cancer of the prostate 2. History of other malignant disease (with the exception of the primary prostate cancer and non-melanoma skin tumors) in the past 5 years Pre-defined co-morbidities
* Administration of experimental therapy within the last 4 weeks before start of screening
* Treatment with immunotherapy within the last 3 months before start of screening
* Treatment with radiopharmaceutical drugs within 8 weeks before start of screening
* Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start
* History of organ transplantation
A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

- Overtly healthy males and females

Exclusion Criteria:

* Eye abnormalities or disease
* History of vitiligo or any skin color disorder
* Have a history psychiatric or brain disease including seizures
* Have smoked within the last 3 months
* Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
* Have known allergies to dabigatran etexilate and related compounds