cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safe Use of SECURIDRAP® SELFIA®

Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use.

Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.

The proposed study is a prospective, multicenter, interventional and non-comparative research.

This clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.

This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.

The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.

Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old
* Patient having a medical prescription for SÉCURIDRAP® SELFIA®
* Patient in phase or state of disorientation
* Patient with nocturnal behavior disordre
* Patient with major cognitive impairment
* Patient at risk of falling into bed
* Patient subject to guardianship or curatorship
* Patient beneficiary or affiliated to a social security scheme
* Patient who has given their participation agreement aand informed consent

Exclusion Criteria:

* Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
* Patient in psychiatry
* Patient with severe agitation
* Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
* Patient with intolerance to the medical device
* Patient able to extract himself from SÉCURIDRAP® SELFIA®
* Patient able to unlock the bed rails by himself
* Patient without social coverage or not benefiting from it through a third party
* Patient minor, pregnant woman, persons deprived of their liberty
* Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion
Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height

The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final height.

case-control

Eligibility Criteria:
Inclusion Criteria:

* Patients with SGA treated with growth hormone in one of the following Genotropin studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and after having stopped GH treatment for 5-10 years
* Untreated SGA (based on birth weight and/or length below -2 standard deviations \[SDs\] for gestational age) matched to treated SGA by body mass index (+ or = 10%) and gender:

  * Subjects born SGA with normal final height (within +/- 1.3 SD of their target height); or
  * Subjects born SGA with short stature (height SDs \> 1.3 below target at final height).

Exclusion Criteria:

* Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
* Familial dyslipidemia
Assessment of the SurroundScope in Urologic Surgical Procedures

The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope

The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope. 270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will compare the use of the 270Surgical system (The "SurroundScope") to standard laparoscope during partial nephrectomy and nephrectomy urological surgeries;

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Capable of giving informed consent.
* Scheduled for laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy

Exclusion Criteria:

* Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
* Patients with contraindications to undergo laparoscopic surgery.
* Patients with American Society of Anesthesiology (ASA) class\* \>3
* Advanced cirrhosis with failure of hepatic function
* Patients who have participated in another interventional clinical study in the last month.
* Pregnancy
* Unable to consent (due to cultural, language or neurological barriers)
Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient

This study evaluates from the patient's perspective which elements of the own artistic creative process are the source of a beneficial change for him/her and how those elements influence in their end of life experience.

In previous quantitative studies about the effect of an art therapy intervention in adult cancer inpatients of the Palliative Care Unit, the investigators evidenced significant improvements in the symptom control of malaise, anxiety, depression and pain.

This study is designed to deepen the understanding of specific action mechanisms which lead to those therapeutic benefits and quality of life implications for patients with life-threatening illness in which a situation of suffering is frequently detected.

The investigators will determine from the subjective patient's experience which specific elements of the artistic creative process (including production of art and art products) may lead to changes in the symptom perception, in meaning and healing process and in the personal perspective about the end of life situation.

Eligibility Criteria:
Inclusion Criteria:

* advanced-cancer adult inpatients of the Palliative Care Unit
* informed consent

Exclusion Criteria:

* altered cognitive function (Mini-Mental Test \< 24)
* physical decline (palliative care team's criteria) that impedes the art therapy process
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure

single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Eligibility Criteria:
Inclusion Criteria:

obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity

* patients fit for laparoscopic surgery
* give approval to share in the study
* previous restrictive bariatric procedure

Exclusion Criteria:

* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia

Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.

Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.

Patients undergoing colon or rectal surgery will be randomly assigned to one of two groups: Patients in study group 1 (SG1) will have their urinary catheters removed at 48 hours post-operatively; Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period. We will be primarily examining rates of urinary retention in both groups. We will also be examining rates of urinary tract infection, chest infection (frequently a result of poor mobility after surgery), and wound infection and other complications after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Competent to consent to participate in trial
* Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).
* Receiving epidural analgesia post-operatively
* If male, international prostate symptom score \<20.

Exclusion Criteria:

* Previous lower urinary tract surgery
* Chronic lower urinary tract disease
* Intermittent self-catheterisation
* Neurogenic bladder
* Urethral catheter inserted \>24 hours pre-operatively
* Presence of pelvic sepsis/abscess at surgery
* Previous trans-abdominal pelvic surgery
* Urethral catheter required for urine output monitoring beyond 24 hours post-operatively
* Presence of enterovesical fistula
* Pre-operative use of medications which alter detrusor function
* Pregnancy
A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors

Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

Patients must have:

* advanced solid tumors and have confirmed cMET dysregulation
* at least one measurable lesion as defined by RECIST 1.1.
* recovered from all toxicities related to prior anti-cancer therapies
* adequate organ function
* ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

Patients must not have:

* known hypersensitivity to any of the excipients of INC280 or to benzodiazepines or known intolerance and hypersensitivity to caffeine
* symptomatic central nervous system (CNS) metastases who are neurologically unstable
* presence or history of carcinomatous meningitis
* history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 ms (male patients), ≥ 460 ms (female patients) on the screening ECG
* Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280
* Major surgery within 4 weeks prior to starting INC280
* Patients receiving unstable or increasing doses of corticosteroids.
* Impairment of GI function or GI disease that may significantly alter the absorption of INC280
* Patients who have received or consumed, or are expected to receive or consume midazolam or caffeine-containing products (e.g., tea, coffee, cola), within 2 days prior to Day 1 and during the whole duration of the DDI phase (i.e., from Day -2 to Day 12)

Other protocol-defined inclusion/exclusion criteria may apply
Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey

Periodontitis is a multifactorial, chronic inflammatory disease caused by many factors such as pathogenic microorganisms, host response, environmental and systemic factors. Immune mechanisms triggered by host-bacteria interaction can initiate tissue destruction by leading to the release of large amounts of inflammatory mediators such as IL-1β. It is thought that IL-10 has a regulatory role by limiting the initiation and progression of the acute inflammatory response with its anti-inflammatory effect. The high detection of RANKL and RANKL/OPG ratios in periodontitis indicates that these markers play a role in bone destruction. Elucidating the connections between the immune system and bone-related cytokines will contribute significantly to the resolution of these complex mechanisms underlying periodontal diseases. Risk factors for periodontal diseases include gender, age, smoking and some hereditary factors. Cortisol is an important marker of psychological stress. It is emphasized that stress and depression reduce immune system function and cause chronic inflammation. Thus, it indirectly provokes periodontal tissue destruction.

This study consists of patients and healthy volunteers. Saliva will be collected only once from healthy volunteers; from patients at the beginning and after non-surgical periodontal treatments are performed by the researchers. In the collected saliva; clinical parameters and salivary RANKL, OPG, IL-10, IL-1β, cortisol levels will be determined in periodontitis and periodontally healthy individuals living in two different geographical regions in Turkey (Ankara -Erzurum); it will be determined whether non-surgical periodontal treatment has an effect on cytokines determined in saliva and clinical status at the end of 1-month follow-up period; periodontal pathogenesis and host response will be evaluated in smoker and non-smoker groups. Analyses will be performed by ELISA method.

The study is based on the hypothesis that "different regional and geographical conditions determining climate, culture, environment, life, stress situations affect the course of periodontitis disease and host response". A regional comparison will be made between markers that affect the course of periodontitis disease and play a role in its pathogenesis in patients with different climate, living and cultural conditions, according to location.

Eligibility Criteria:
Inclusion Criteria:

* 35-60 years of age
* good cooperation
* a minimum of 20 permanent teeth, excluding third molars

Exclusion Criteria:

* systemic diseases
* taking any medications
* received antibiotic treatment in the last three months
* those who had undergone periodontal treatment six months ago
* pregnant or breastfeeding patients
* prosthetic restorations
* undergoing orthodontic treatment
To Design an Experimental Intervention, 62 Youth Volleyball Players Were Divided Into an Experimental Group and a Control Group and Underwent 10 Weeks of Non-stationary Strength Training Versus Traditional Strength Training: Compared the Effects of Non-stationary Strength Training on the Athletes

Purpose: Volleyball has a high influence in the world, and there are many professional volleyball players and a large number of volleyball fans in all countries. China's volleyball level ranks among the top in the world, and the Chinese women's volleyball team has won many world-class volleyball championships, but the world ranking has declined in recent years for many reasons, such as athletes' personal ability, clinical performance in the game, and injuries, etc. Functional training can effectively improve the body's functionality and reduce the risk of sports injuries. Functional training can effectively improve the body's own functionality, reduce the risk of sports injuries and thus improve the body's sports performance, while non-stationary strength training, as a kind of functional training, has little research on the effects of this training on athletes, especially youth volleyball players. In this study, inspector investigated the effects of non-stationary strength training on Functional Movement Screen (FMS), Vertical Jump Height, Leg Strength and Y Balance Test of Chinese youth volleyball players from the grassroots reserve of Chinese volleyball players.

METHODS: Sixty-four subjects participated in this experiment, 32 in the experimental group of which 18 were males and 14 were females and 32 in the control group of which 18 were males and 14 were females. The subjects were then subjected to 12 weeks of non-stationary strength training intervention in the experimental group and 12 weeks of conventional strength training in the control group, after which the pre-test, mid-test and post-test scores of FMS, Vertical Jump Height, Leg Strength and Y Balance Test were tested in the experimental and control groups. Repeated measures MANCOVA was performed using SPSS with subjects' YEAR, TALL and WEIGHT as covariates to explore changes in several dependent variables across groups and across gender. Since a female athlete in the control group was injured during the skill training in the middle of the experiment, the data of this athlete was excluded to ensure the accuracy of the data, and non-parametric tests and post hoc tests were utilized at a later stage to verify the accuracy of the repeated measures MANCOVA data.


Eligibility Criteria:
Contains Criteria:

* No congenital disorders (affecting athletic training performance)
* Meet the requirements of the FMS test
* Have a 2nd grade or higher athletic rating or two or more years of training in an athletic school
* Age 11-18 years old

Exclusion Criteria:

* Congenital heart disease
* Sports injuries that interfere with training progress prior to testing
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.


Eligibility Criteria:
Inclusion Criteria:

Male and female children will be eligible for participation in this study if:

* they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
* they are clinically healthy;
* their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
* their legal representative agrees to keep a Volunteer Diary.

For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:

* negative pregnancy test at study start;
* they agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Children will be excluded from participation in this study if they:

* have a history of any previous TBE vaccination;
* have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA \> 126 VIEU/ml and / or neutralization test \> 1:10);
* have a history of allergic reactions, in particular to one of the components of the vaccine;
* have received antipyretics within 4 hours prior to the first TBE vaccination;
* suffer from a disease that cannot be effectively treated or stabilized;
* suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
* suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
* are known to be HIV positive (a special HIV test is not required for the purpose of the study);
* suffer from a febrile illness at study entry;
* have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
* are participating simultaneously in another clinical trial.
* if female, are pregnant or breast feeding

Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body temperature \>= 38° C, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.
Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers

This is a three-period crossover study to compare GW876008 and placebo to see if GW876008 will normalise blood flow responses after different emotional stimuli.


Eligibility Criteria:
Inclusion Criteria:

* The subject should not have been taking and medication for the treatment of IBS for 1 month prior to the study
* Negative serum pregnancy tests (serum a-HCG negative) at Screening (Visit 1), and negative urine pregnancy tests at Visits 1, 2, 3 prior to study medication dose.
* Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).
* Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG at screen).

Exclusion Criteria:

* Subjects who are pregnant or nursing.
* Current evidence, or history of (at any time in the past) of a biochemical or structural abnormality of the digestive tract. including (but not limited to): inflammatory bowel disease (Crohn's disease or ulcerative colitis); functional dyspepsia; lactose intolerance, not on a stable diet; Celiac Disease
* Subjects who are taking NSAIDs on a regular basis or within 48 hours of a study day.
* The subject has a positive pre-study urine drug/alcohol screen.
* A positive pre-study HIV 1 / 2, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of the start of the study.
A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting

The investigators will evaluate the effectiveness of "Living Everyday Above-and-beyond Pain" (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life, interaction with the health care system and their health care utilization. This is a pilot study to evaluate mainly feasibility. The investigators will make use of both experimental and qualitative methods gather evidence of the programs success, strengths and weaknesses.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* diagnosed with chronic pain

Exclusion Criteria:

* chronic pain related to cancer, pelvic pain or headache
* inability to speak or write in English
* patient is unable to attend and participate in group treatment sessions on their own
* substance use or mental health problems of a severity making group treatment participation impossible
* currently participating in another cognitive-behavioral pain management program
* patient is receiving palliative care or has been diagnosed with an illness expecting to cause death within one year