cyrilzakka/clinical-trials huggingface dataset:
Emotional Management in Adolescents

This study aims to give information about the content of the school-based emotion regulation program study designed for adolescent children to develop their emotion regulation skills. The study is a randomized controlled trial with adolescents aged 14-16 years (9th and 10th grade). Two high schools were selected for the research in Ankara, Türkiye. A face-to-face formal training consisting of four modules of four weeks (50 min/week). Based on the Vibrational Energy Theory, the program will be applied to the intervention group to be selected by the randomization method. The training topics include recognizing and accepting emotions, directed thinking and process orientation, and acceptance and willingness (reinforcement module) modules. With this intervention, adolescents' emotion regulation skills and psychological well-being are expected to increase, and anxiety levels will decrease. The program to be implemented will contribute to the acquiring and developing emotion regulation skills that deal with processes such as awareness, control, management, and acceptance of emotions in adolescents.

Key Words: adolescence, emotion, regulation, school


Eligibility Criteria:
Inclusion Criteria:

* . Criteria for inclusion in the research;

  * continuing their education in the 9th-10th grade,
  * agreeing to participate in the study,
  * giving written consent to participate in the study by their parents,
  * stating that they can participate in the four-week program,
  * speaking Turkish.

Exclusion Criteria:

* The criteria for exclusion from the study were:

  * the student has a medically diagnosed mental problem that will prevent the student from following the program,
  * the student has a psychological medical diagnosis, and
  * he/she is receiving psychiatric medication or therapy.
Study of BMS-986158 in Subjects With Select Advanced Cancers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers


Eligibility Criteria:
Inclusion Criteria:

* Must have select advanced cancers with specific genetic profiles
* Must have received appropriate standard of care
* At least one measurable lesion at baseline
* Expected to have life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Exclusion Criteria:

* Concomitant second malignancies
* Uncontrolled or significant cardiovascular disease
* Inadequate bone marrow function
* Chronic gastrointestinal illness
* Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor

Other protocol defined inclusion/exclusion criteria could apply
Miswak Efficacy Compared With Chlorhexidine

Gingivitis is a form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Mouthwashes containing chemical or herbal substances are adjunctive tools in improving oral hygiene. Miswak mouthwash is a herbal mouthwash. Chlorhexidine mouthwash is the most efficient antimicrobial and antiplaque agent. The aim of the study is to assess the effectiveness of the miswak mouthwash with 0.12% chlorhexidine. This study was a blind randomized clinical trial.

Materials and Methods: A total of 60 patients aged (20-55) years old who attended the Periodontics Clinics at College of Dentistry, Al-Iraqia University were allocated for use the mouthwash either miswak mouthwash or 0.12% chlorhexidine gluconate Kin Gingival® (Laboratorios KIN, Spain) twice daily (once in the morning and one before bedtime) for seven days. Gingival, bleeding, and plaque indices were recorded at baseline and after 7 days of treatment.

Gingivitis is the mildest form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Accumulation of dental biofilm has been established as the initial cause of this disease. It is determined by redness of the gum margins, edema, bleeding upon brushing, and loss of periodontal attachment loss. Gingivitis exists in both acute and chronic forms. Acute gingivitis is identified as trauma, micro-organisms, and specific infections while chronic inflammation is related to bacterial biofilm which covers the gum and adjoining the teeth. Elimination and control of plaque are very important in the maintenance of periodontal health. Chlorhexidine mouthwash has is a tremendous effect when it is used as a mouthwash for a long time; therefore, the Food and Drug Administration (FDA) recommends limiting the use of chlorhexidine mouthwash up to 6 months to minimize or limit its side effects. Additionally, the World Health Organization (WHO) encouraged to consider the possible use of herb extracts and natural plants mouthwashes instead of chemical mouthwash just as miswak mouthwash. Miswak mouthwash is a herbal mouthwash that is available locally and culturally accepted. It is prepared from a plant called Salvadora persica which comes from a tree (Arak) that grows in Africa and west India.

Eligibility Criteria:
Inclusion Criteria:

* Adults with existence at least 20 natural teeth in the mouth
* Existence of lateral maxillary teeth
* Existence of central teeth
* Existence of mandibular teeth

Exclusion Criteria:

* Patients have no history of drug use
* Patients have no any disease relevant occurrence
* Pocket depth\<3 mm
* Smokers
* Pregnancy
McKenzie Exercise Vs Harmonic Technique in Chronic Low Back Pain

The purpose of this study was to investigate the effects of HT compared with McK exercise on pain and disability in patients with LBP.


Eligibility Criteria:
Inclusion Criteria:

* Had persistent back pain at least eight weeks or during the last year subjects must suffer from LBP at least three times and each time lasted more than a week.

Exclusion Criteria:

* Had a history of fracture or surgery in the spine, pelvis and lower extremities through last year
* History of neuromuscular disease
* The referral and radicular pain in the lower extremities and neurological or sensory disturbance in the lower extremities
* Urinary incontinence and pain severity higher that 7 based on visual analogue scale (VAS)
Analysis of the Loss of Muscle Force, Muscle Power and Motor Control Degradation to Predict the Risk of Falls in Patients With Knee Osteoarthritis

The twofold goal of this study is to understand the link between muscle power, muscle strength, and muscle control degradation with the risk of falling, and to develop a framework for the comprehensive and quantitative assessment of muscle power (and strength) in an elderly population of patients with knee osteoarthritis, who are at higher risk of falling. The main question it aims to answer is:

● Are muscle power and motor control degradation better predictors of falls than muscle strength in the aging population?

Participants will undergo:

* Muscle force assessment on a dynamometer
* Muscle power assessment on a dynamometer and on isntrumented stairs
* Home-based mobility monitoring
* Full lower limb MRI acquisition
* Gait assessment

Falls are a critical yet common event among the elderly, with huge societal and economic impact (reduced quality of life and high costs for the healthcare system). Experimental measures to quantify the residual muscle strength and power may provide useful information to predict the risk of falls in the elderly. Isometric and isokinetic muscle contractions, performed on a dynamometer or during functional tasks can be collected, together with electromyography (to assess muscle activity) and imaging data (to quantify and characterize muscular tissue).

Such data can be collected at different time points to monitor subjects over time, and to inform virtual representation of the human musculoskeletal system (digital twins) to identify possible motor control deficits. Moreover, this same information can be used to better characterize/assess elder individuals at risk of falling (e.g., subjects with knee osteoarthritis), to prevent future falls.

All subjects enrolled in the PowerAGING study will be followed up for 24 months (5 visits in total: M0, M6, M12, M18 and M24 follow-up). At each visit, a series of experimental tests to quantify muscle power and muscle force, as well as a home-based mobility assessment (via single inertial sensor worn for 5 consecutive days), will be performed. In addition, only at start and end, the subjects will undergo a full lower limb MRI and a gait assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 65 and 80 years
* Kellgren score II e III
* No history of falls in the last 12 months

Exclusion Criteria:

* Any musculoskeletal, neurological, rheumatic or tumoral diseases
* Dementia
* Diabetes
* Inguinal or abdominal hernia
* Severe Hypertension (Level 3)
* Severe Cardio-pulmonary insufficiency
* Diagnosis of Osteonecrosis in the lower limb joints
* Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)
* Previous interventions or traumas to the joints of the lower limb
Alternative Haemodiafiltration in Summer Season for Chronic Kidney Disease Patients

Hemodiafiltration is a renal replacement technique combining diffusion and convection to enhance solute removal. Post dialyser replacement fluid is administered to achieve the target fluid balance. The skin is the largest human organ playing an important role in thermal and Na regulation and skin blood flow is 8.5-10%of cardiac output .

Sweat contains electrolytes, creatinine and urea, with higher excretion by mild physical exercise. These findings motivate studies investigating the effect of stimulated sweating on volume control in kidney disease patients. Using sweat as the vehicle for removing molecules normally excreted in the urine was identified some decades ago. sweat urea concentration could reach 5.5 to 50 times the serum concentration .

Physical inactivity was reported as the fourth leading cause of death from chronic disease worldwide. Warm water immersion (37-46◦C) increases limb blood flow, and muscle heating activates regulators of mitochondrial biogenesis. water immersion represent diffusion .the average person sweats between (0.8- 1.4) liters during an hour of exercise, drinking water represent water replacement .

Particularly, urea concentrations in sweat are persistently elevated in uremic patients. The 24-hour urinary urea excretion in summer was 1/4 the quantity in winter in uremic patients, indicating the compensatory urea excretion in sweat gland fluid . Sweat glands are inactive except above 29°C, due to a concentration gradient within the stratum corneum, results in continuous water convection from within the body through the skin and into the environment.

In our study we stimulate sweating of chronic kidney disease patients through mild physical activity as walking then they immersied in water to enhance waste excretion through skin.Evaluation of these patients will be done through following up blood pressure,laboratory investigations as kidney function test sodium, potassium,phosphorus levels and uric acid.

Eligibility Criteria:
Inclusion Criteria:

chronic kidney disease group:

1. stage 3,4
2. Age(18-60)yrs old.
3. Not on dialysis.
4. Without uremic symptoms nor standard indication for dialysis

Exclusion Criteria:

1. History of cerebrovascular accidents.
2. History of advanced cardiac disease (heart failure, recent acute coronary syndrome, and cardiac arrhythmia).
3. Active skin lesion
4. volume overload. 5- advanced liver cirrhosis, respiratory failure, and malignancy.
The T2D Profile - Studies of the Omics Profile in Type 2 Diabetes

The T2D Profile study examines the longitudinal molecular profiles of newly diagnosed type 2 diabetes (T2D), before and during guideline-based diabetes treatment.

The study included a total of 3 visits: At baseline and after 1 and 3 months of diabetes treatment according to standard of care. Visits included clinical examinations, questionnaires and clinical chemistry. In addition, samples were collected at each visits for comprehensive molecular profiling including proteomics, genomics, transcriptomics, metabolomics, lipidomics, antibody profiling, mass cytometry and gene profiling of fecal microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate in the study.
* Age 50-65 years.
* T2D diagnosis (fasting p-glucose ≥7.0 mmol/L or an oral glucose tolerance test 2 hour p-glucose ≥11.1 mmol/L \[or ≥12.2 mmol/L if measured capillary\] at two separate occasions).

Exclusion Criteria:

* Diabetes medication before study start.
* Severe hyperglycemia requiring hospitalization or immediate insulin treatment, as judged by the investigator.
* Presence of any clinically significant disease which, in the opinion of the investigator, may interfere with the subject´s ability to participate in the study.
* Any major surgical procedure or trauma within 4 weeks of the first study visit.
Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis

SchizOMICS is a Phase IV, multicenter, dose-flexible, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of aripiprazole versus paliperidone using multi-omics data in patients with a first psychotic episode. The trial will include a total of 244 patients, with two arms of treatment with paliperidone and aripiprazole (1:1).

The main objectives of the study are:

1. To compare the efficacy and safety of aripiprazole and paliperidone in the treatment of first episode psychosis (FEP) subjects in real-world clinical settings at 3 months.
2. To elucidate whether non-responders after 3 months of adequate treatment may display different molecular signatures at baseline based on multi omics data and systems biology analysis.
3. To uncover whether the appearance of side effects after 1 year of adequate treatment may be related to different molecular signatures based on multi-omics data and lifestyle phenotype using systems biology analysis.


Eligibility Criteria:
Inclusion Criteria:

1. 15-40 years;
2. living in the catchment area;
3. experiencing a first episode of psychosis;
4. no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks;
5. Diagnostic and Statistical Manual of Mental Disorders fth Edition (DSM-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder.

Exclusion Criteria:

1. meeting DSM-5 criteria for drug dependence;
2. meeting DSM-IV criteria for mental retardation;
3. having a history of neurological disease or head injury.
Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).

Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.

To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.

The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.

In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.

Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.


Eligibility Criteria:
Inclusion Criteria:

* screening or surveillance colonoscopy
* age over 18
* informed consent

Exclusion Criteria:

* history of inflammatory bowel diseases
* history of hereditary colorectal cancers and polyposis syndrome
* inability to give informed consent
* use of antiplatelet agent and anticoagulants
* pregnancy
A Comparison Between Using Video Stylet and Video Laryngoscope in Difficult Intubation of Traumatic Patients .

The aim of this study is to compare the visualization of the glottis, the time for tracheal intubation, the success rate of intubation, and the need for manoeuvres to optimize the view using video stylet or video laryngoscope in patients with expected difficult intubations.

The airway, breathing and circulation support '' ABCs" of trauma resuscitation were born from the assumption that correcting hypoxemia and hypotension reduces morbidity and mortality. Definitive care for severely injured or polytrauma patients includes the ability to provide advanced airway management in a variety of settings: in the emergency department, 20% to 30% intubations are for trauma. Airway management in traumatic patient presents numerous unique challenges beyond placement of an endotracheal tube, without comes dependent on the provider's ability to predict and anticipate difficulty and have a safe and executable plan. In severely injured patients, the cervical spine must be protected by in-line immobilisation during airway management. If orotracheal intubation is required, then manual in-line stabilisation is recommended to facilitate tracheal intubation to secure a space for tongue displacement into the submandibular space. However, manual in-line stabilisation can make alignment of the oral, pharyngeal and laryngeal axes difficult, resulting in a poor direct laryngoscopic view and prolonging the intubation time. Video stylets, which are portable and easier to prepare than flexible fiberoptic bronchoscopes, could be better option for tracheal intubation in patient with cervical immobilization. Previous studies have shown the usefulness of video stylets for tracheal intubation in cervical immobilized patients.

Video laryngoscopes provide a better laryngeal view. They are easy to use and have a high success rate and short intubation time in patients with predicted difficult airways. Successful use of video laryngoscopy is increasing for airway management of patients with trauma in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Any patient in the age group of (5 - 80) and has
* Suspected difficult intubation.
* High mallampati score (class 111, 1V).
* Suspected cervical fracture.
* Maxillofacial trauma.
* Fracture base of the skull.
* Polytrauma.

Exclusion Criteria:

* Patients with low mallampati score (class 1, 11).
* Patients undergoing elective surgeries and not suspected to have difficult intubations.
* Patients aged below 5 years and above 80 years.
Impact of the "Standing Patient" Pathway on Preoperative Anxiety.

For 25 years, the concept of Rapid Rehabilitation After Surgery or RRAC has developed to bring about a global care of the patient by establishing a safe and quality climate. With this concept of RRAC or fast track surgery, it is the idea that a patient will recover sooner than he is lying later. "Fast care" is based on the principle that any patient is valid before he / be operated and therefore do not need to come to a bed in the operating room.

The ambulatory surgery department of the CHU of Caen welcomes and supports adults and children over 8 years old. The following specialties are covered: dental surgery and stomatology, digestive and visceral surgery, orthopedic surgery, otolaryngological surgery, vascular surgery, gynecological surgery, urological surgery. The ambulatory surgery unit is experimenting with patient support at the operating theater on foot by the service stretcher team since December 2015. It seems that this technique makes it possible to improve the quality of care by respecting the dignity and autonomy; in fact to wander the patient preserves his glasses, his hearing aids, capillary prosthesis ... The patient is an actor and not dependent, he is accompanied and not taken away. The preservation of autonomy improves their feelings, especially in terms of dignity. It also appears to be a technique for participating in the reduction of preoperative anxiety, an important factor for postoperative follow-up.

However, studies reporting the benefit of this technique have rather evaluated the feelings of patients. To the best of our knowledge, there are no studies that have evaluated their benefit on anxiety reduction by questionnaires or ad hoc scales. Assessing anxiety with appropriate tools seems essential to determine a real impact.

We hypothesize that accompanying the patient to the operating room on foot would reduce preoperative anxiety. We have not yet found any studies showing that the "standing patient" pathway had an impact on preoperative anxiety. We propose to carry out a randomized study comparing the anxiety score using the APAIS scale at the operating room installation between patients benefiting from the "standing patient pathway" versus the patients receiving the care standard, that is to say the stretcher transport to the operating theater.

The duration of this study is evaluated at 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Major patient.
* Patient hospitalized for surgery.
* Patient supported in the south block.
* Patients agreeing to participate in the study.
* Patient speaking and understanding French.

Exclusion Criteria:

* Patient with reduced mobility.
* Patient with a mental disability.
* Patient suffering from a severe psychiatric pathology.
* Major patient protected.
* Patient does not speak or understand French.
* Refusal of the patient to participate in the study.
* Patient who has been premedicated
Dose Reduction of Postoperative Radiation for Soft Tissue Sarcoma of the Arms and Legs

The investigators are doing this study to find out whether lowering the dose of postoperative radiation therapy and targeting a smaller area of tissue for treatment is as effective as the standard dose and volume of radiation therapy to control soft tissue sarcoma after surgery. They also want to find out whether the study approach causes fewer and less severe long-term side effects than the standard approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with a primary soft tissue sarcoma of the extremity, confirmed by MSKCC pathologic review
* Age at the time of enrollment of ≥18 years
* Patients must have undergone margin-negative oncologic resection of their primary tumor, as confirmed by MSKCC pathologic review
* Patients must be able to start radiation within 3 months from time of surgery

  °If patient is receiving adjuvant chemotherapy, patient must start RT no longer than 3 months past their chemo treatment.
* Female patients of childbearing potential must have a negative serum pregnancy test within 14 days of radiation start (or if urine test, within 24 hours of radiation start)
* Sexually active patients of childbearing potential must agree to use effective contraception.
* The use of chemotherapy will not be dictated by this trial. Patients are allowed to receive chemotherapy at the discretion of the disease management team (as is standard practice to make individualized decisions for each patient regarding the use of chemotherapy).

Exclusion Criteria:

* Patients with positive margins after surgical resection as indicated by MSKCC pathologic review
* Patients with diagnosis of superficial myxofibrosarcoma with indistinct/infiltrative borders on preoperative MRI16 (see Appendix Figure 1 for reference figure)
* Patients with multifocal disease in the extremity
* Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
* Patients with a differentinvasive cancer requiring active treatment at the time of enrollment.
* Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study