cyrilzakka/clinical-trials huggingface dataset:
Impact of SAVR and TAVR on Patient's Activity and Mobility

This is an independent, investigator-initiated, prospective multicenter observational study with restricted grant provided by Edwards Lifesciences that aims to describe baseline (preoperative) physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing aortic stenosis (AS) treatment with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) implanted with Edwards valve type ("SAPIEN 3" and "SAPIEN XT" for TAVR; "INSPIRIS RESILIA", "EDWARDS INTUITY" and "Carpentier-Edwards PERIMOUNT Magna-Ease" for SAVR).

Secondary objectives of this study are: to evaluate the validity of wearable devices in assessing physical function in such patients and subjects' compliance in wearing the device also after a very long follow-up time up to 12 months; to assess and compare 6-month postoperative changes in Health-Related Quality of Life (HRQoL), sleep quality, cognitive function of patients undergoing AS treatment with either TAVR or SAVR.

Smart watch activity tracker "Vívoactive® HR" devices by "Garmin©" will be used in the study. Devices will be distributed to the patients at time of baseline assessment, along with a Bluetooth-paired smartphone provided with a prepaid data-only SIM-card and study-customised interface. Patients will be asked to wear the device 24 hours a day, 7 days a week, from the baseline assessment to the last follow-up, 12 months after baseline.


Eligibility Criteria:
Inclusion Criteria:

* Severe native aortic valve stenosis symptomatic for heart failure or angina;
* Indication to isolated TAVR or SAVR given by heart team;
* TAVR through the trans-femoral approach;
* SAVR by any access;
* Implantation of an Edwards valve type (SAPIEN 3 and SAPIEN XT for TAVR; INSPIRIS RESILIA, EDWARDS INTUITY and Carpentier-Edwards PERIMOUNT Magna-Ease for SAVR);
* Signed informed consent.

Exclusion Criteria:

* Use of walking aids;
* Dyskinesia or Parkinson's disease;
* Reduced survival expectancy due to severe co-morbidities (\<1 year);
* Lack of any of inclusion criteria.
Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men

Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500 - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance considering the increasing number of persons suffering from impaired glucose tolerance or diabetes and the unique opportunities provided by the mountainous regions of the Alps to perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude between 1500 - 3500 m. Metabolic responses to exercise may be largely mediated by interleukin 6 (IL-6), which is predominantly derived from the contracting limbs and may support the maintenance of metabolic homeostasis during exercise. In addition, IL-6 is elevated with acute and chronic altitude exposure at least partly mediated via adrenergic stimulation. Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations and differences in serum IL-6 concentrations might help to explain distinctions between responses of glucose metabolism to CE and EE at low and moderate to high altitude.

32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic condition will be a break of approximately 12 month. Measurements of glucose metabolism, IL-6 plasma concentration will be performed pre, mid (day 5) and post intervention. Moreover anthropometric, strength and exercise capacity characteristics will be performed pre and post intervention.

We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in normoxia.

Not desired.

Eligibility Criteria:
Inclusion Criteria:

* Pre-diabetes
* male
* age 50-65 years

Exclusion Criteria:

* smoking
* BMI \> 30 kg/m2
* diseases not compatible with intervention
4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition

This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT) scans and treatment-planning systems may help in planning radiation therapy for patients with non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from participating is expected. However, at the discretion of the treating physician, the information gained from the additional imaging will be used to improve treatment accuracy. No patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II, or III trial, trial with "blinded" treatment arm, gene or a vaccine trial, or a multi-institutional trial.

OBJECTIVES:

* Quantify the magnitude and distribution of inter- and intrafraction anatomic variations, including the temporal stability of the tumor/respiration signal correlation.
* Improve the acquisition and reconstruction of 4D CT scan images by advancing the 4D CT scan data collection process and evaluating 4D CT scan image reconstruction using different respiratory inputs.
* Quantify the uncertainty of deformable image-registration algorithms.
* Develop and investigate the efficacy of inter- and intrafraction probabilistic planning-based 4D image-guided adaptive radiotherapy (IGART) strategies for clinical application.
* Determine the expected geometric, dosimetric, and radiobiological improvements from the 4D IGART system.

OUTLINE: Patients undergo insertion of ≥ 1 small radio-opaque marker into (or in the vicinity of) the primary lesion or suspect lymph nodes via bronchoscopy. X-rays are performed to document the position of the markers.

Patients undergo 4D CT scan before each radiotherapy session and once a week after a radiotherapy session. Patients also undergo x-ray imaging before and during radiotherapy, optical and internal marker motion recording before and after radiotherapy, and audiovisual feedback during radiotherapy.

Patients undergo image-guided adapted radiotherapy based on these data.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of non-small cell lung cancer stages I-IV
* Partial pressure oxygen (pO2) \> 92%-obtained at the time of or within 3 months prior to initial consultation with the radiation oncologist
* Tumor(s) must be visualized on a CT
* Positron emission tomography (PET) is performed during staging or treatment planning process
* All patients must be informed on the investigational nature of this study and must give informed consent in accordance with institutional guidelines

Exclusion Criteria:

* Pregnant women may not participate; women of reproductive potential must be informed of the need to practice an effective contraceptive method
* Unstable coronary artery disease
* Uncorrectable coagulopathy
* Severe pulmonary hypertension
* Poor tolerance of conscious sedation
OPPOSITE: Outcome Prediction of Systemic Treatment in Esophagogastric Carcinoma

Patients with locally advanced, resectable gastric or esophagogastric junction adenocarcinoma will receive a biopsy of the primary tumor, followed by standard-of care neoadjuvant systemic treatment; after neoadjuvant therapy tumor biopsies will be taken from different sites of the resection specimen.

* Aim 1: Organoid cultures of pre-treatment tumor biopsies will be established and exposed to the same chemotherapy as the corresponding patient; in vitro response to treatment will be correlated with the in vivo response of patients.
* Aim 2: Whole genome, methylome and RNA sequencing of tumors biopsies and organoids will be performed prior to as well as after systemic treatment. Histological and clinical outcome will be correlated with molecular subtypes.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed, resectable adenocarcinoma of the GEJ (type I-III) or the stomach (cT2, cT3,cT4, any cN category, M0), or any cT cN+ M0 with the following specifications:

* ECOG-Score ≤ 2
* Patient is fit to undergo surgery (either subtotal or total gastrectomy, transhiatal or abdominothoracic esophagectomy)
* No preceding cytotoxic or targeted therapy
* No prior partial or complete tumor resection
* Exclusion of distant metastasis by CT or MRI of thorax and abdomen, and optionally bone scan (if osseous lesions are suspected due to clinical signs)

Exclusion Criteria:

* Patients with distant metastasis
* Known hypersensitivity against components of the neoadjuvant systemic treatment
* Documented history of congestive heart failure NYHA ≥III, myocardial infarction within the past 3 months before the start of neoadjuvant treatment
* Uncontrollable high-risk cardiac arrhythmia, e.g. significant ventricular arrhythmia
* Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated early stage cancers such as basal cell carcinoma of the skin and in situ carcinoma of the cervix or the bladder.
Prostate Cancer Stereotactic Radiotherapy

Primary purpose of the study is to develop a stereotactic radiation treatment (RT) to prostate cancer which minimizes treatment related toxicity. Movement of the prostate during a radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation toxicity to rectum will be reduced by using a rectum fixation during a treatment.

Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with 20 x 3 Gy fractionation schedules. With the data collected from these groups treatment marginals to prostate will be defined and used to treat group III (40 patients) with 5 x 7.25 Gy.

Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging could be used to evaluate radiation treatment response in intermediate prostate cancer. Androgen deprivation therapy is not allowed in this study.

New local prostate cancer patients needing external radiotherapy are included into three radiation dose groups;

Group I will be treated normal dosing (39 x 2 Gy) and study group II with hypofractionated dosing (20 x 3 Gy) and group III extreme hypofractionated dosing. Primary goal is to develop safe and effective curative radiotherapy for these patients

Second aim is to study Diffusion-weighted magnetic resonance image (DW MRI) in radiation treatment response in intermediate prostate cancer.

Patients are followed by MRI, PSA, bone scans and quality of life questionaries.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven prostate Cancer
* One or two risk factors for intermediate prostate cancer:

  * Gleason score 7
  * T2b-T2c
  * PSA 10-20 microg/l
* No need for androgen deprivation therapy
* Eligible fo MRI
* Radical radiotherapy

Exclusion Criteria:

* Locally advanced or metastatic prostate cancer
* Previous radiotherapy to pelvic reason
* Other severe disease
* Previous cancer within 5 years
* Severe urinary symptoms at the start of the study (over 20)
* Wide cavity after transurethral resection of prostate (TURP)
Impact on Patients' Vaccine Hesitancy of a Motivational Interviewing Training in Initial Medical Training Course

In France, vaccination coverage of adolescents remains suboptimal, partly because of a loss of confidence, favoring the re-emergence of epidemics. Despite the extension of mandatory vaccination, some vaccines are still recommended.

Motivational Interviewing (MI), which reinforces a person's own motivation and commitment to change, has been shown to be effective in addiction, nutrition, physical activity and vaccination (Promovac study in Quebec). However, it has not been evaluated in the French cultural context (with mandatory vaccination).

The main objective will be to measure the effect of training in MI for general medical interns at the end of their studies on the vaccine hesitancy (VH) of parents of adolescents consulting in primary care, using a validated scale: VCS.

A multicenter study will be conducted in two university departments of general medicine (Marseille and Nice), comparative, clustered exposure/non-exposure type. It will compare the HV of parents of adolescents during consultations by 2 different groups of interns:

* a group of interns trained in MI,
* a group of interns not trained in MI. The randomization will be done by random draw from the 3rd year list of GP interns not in SASPAS training.

After the MI training, each intern in the "exposed" and "unexposed" groups will have 4 months to include at least 3 parents of adolescents seen in consultation.

Descriptive analyses will be performed followed by statistical analysis by modeling the standardized HV score using hierarchical linear regression.

Training of interns in MI applied to vaccination will increase their knowledge, skills and confidence in using this technique.

We can expect a decrease in VH among parents in primary care who consulted a physician trained in MI.


Eligibility Criteria:
Inclusion Criteria:

* Interns who are not in SASPAS for the semester from early November 2020 to the end of April 2021 and who will complete the SASPAS internship in the following semester (May 2021 to October 2021).

Exclusion Criteria:

* Intern on availability or inter-CHU internship for the semester November 2020 to end of April 2021
* Interns who have already received training at the MI
Supporting Physicians With Education And Know-how in Identifying and Motivating Overweight Kids

The proposed study is a randomized control trial evaluating the efficacy of two training programs in increasing physician identification, documentation, and motivation of overweight children. Pediatric primary care physicians will be recruited from the College of Physician and Surgeons of Ontario and randomized into two practice-based interventions (behavioural/educational) which are a one-time training attendance. The educational intervention will focus on the medical management of pediatric obesity, the use of Body Mass Index charts, and information about how obese children would like to be approached by their physicians. The behavioural intervention will incorporate Motivational Interviewing tools in addition to an abbreviated training program received by the educational intervention group.

There are no prospective, randomized clinical studies on training physicians to effectively manage pediatric obesity using both Motivational Interviewing (MI) tools and advice from overweight children. A novel aspect of this study is that the skills taught during the trainings are made so that physician can easily incorporate them into their busy practice. The generated findings from focus groups with obese children, merged guidelines for the medical management of childhood obesity, and training in specific MI tools, also make this study unique. Primary Objective:

To determine which of two interventions (behavioural/education) is most effective in increasing discussion initiation around weight with overweight children by calculating, plotting, and tracking BMI, and increasing self-reported efficacy in counseling overweight pediatric patients. HYPOTHESIS: The behaviour change intervention will be most effective because it will achieve greater changes in the above mentioned behaviours that are maintained for 6 to 12 months. These outcomes will be influenced by counselling efficacy, frequency, and type of reported barriers and not physician demographics.

Secondary Objectives:

To evaluate current physician practices of BMI calculating, plotting and/or tracking, and discussion initiation with overweight pediatric patients, and the factors that influence these behaviours. HYPOTHESIS: Physicians do not consistently calculate, plot, and/or track BMI and/or discuss weight with their pediatric patients. These practices will be primarily influenced by physicians' characteristics, counselling efficacy, frequency and type of reported barriers

Eligibility Criteria:
Inclusion Criteria:

1. Toronto area pediatricians and family physicians who are members of the College of Physicians and Surgeons of Ontario
2. Available to attend workshop at the Hospital for Sick Children
3. Pediatric patient population of at least 25% (office audit to be completed by office staff) (to ensure sufficient contact with children and their families
4. No sub-specialty practice in obesity or related co-morbidities (This study is aimed at changing communication in primary care offices for well-child patient visits)

Exclusion Criteria:

N/A
TUDCA as a Therapy for Ulcerative Colitis (UC)

This is a Phase I open label study examining the efficacy and safety of TUDCA (tauroursodeoxycholic acid) in ulcerative colitis treatment.

TUDCA (tauroursodeoxycholic acid) is a dietary supplement that has shown to reduce cellular stress related to inflammation. In this Phase I study, patients with active ulcerative colitis will be receive TUDCA for six weeks. Safety and tolerability will be assessed. Efficacy will be assessed using ulcerative colitis disease activity measurements as well as markers of intestinal inflammation before and after treatment. The overall goal of this project is to determine TUDCA can provide a new therapeutic option with a desirable safety profile for patients with ulcerative colitis focused on the inflamed intestinal epithelium.

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 18 Years to 65 Years;
* Confirmed ulcerative colitis disease through radiographic, endoscopic and/or histologic criteria;
* Confirmed with active ulcerative colitis (defined as a complete Mayo score ≥ 5 with endoscopic subscore of ≥ 1) See Appendix for Mayo Score using recent adaptation to include any friability on endoscopy to be scored as "2".
* On a stable dose of medications for inflammatory bowel disease (IBD) (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than TUDCA.

Exclusion Criteria:

* Those that received other chemical chaperone therapies in the 3 months prior to screening;
* Individuals accompanied by gallstones, other intestinal disorders or cancers, or any possible cholestatic pathologies that could alter the enterohepatic circulation of the bile acids, including previous cholecystectomy or short bowel syndrome;
* Subjects with alcohol or drug abuse within the recent year;
* Serious heart, lung, kidney, digestive, nervous, mental, or autoimmune diseases
* Those with plans for abdominal surgery;
* Those unable or unwilling to provide informed consent or failure to comply with the test requirements;
* Pregnant, lactating women;
* Those receiving or planning to receive medicines that inhibit the absorption of the bile acids in the intestine;
* All female subjects must have birth control and not plan to become pregnant during the study. As TUDCA may interfere in the absorption of oral contraceptives, the acceptable methods of birth control should include abstinence or 2 of the following intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, and /or condoms.
* Subjects with baseline liver transamines (AST or ALT) \> 1.5 X the upper limit of normal.
* Patients with complete biliary obstruction and known hypersensitivity or intolerance to TUDCA or any of the components of Tudcabil (or to other bile acids).
* Patients with moderate-to-severe hepatic impairment.
* Evidence of worsening liver function based on the 2 initial laboratory values used to establish the baseline.
Title: "Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations."

Suicide has become a major public health problem among young people around the world. This study will examine the effects of higher secondary school-based suicide prevention (HSSSP) program on youth suicidal thoughts and impulsive behavior (STIB). Therefore, the purpose of this study is to examine the effects of didactic approach for youth STIB on the HSSSP program.

This study is designed to address this issue at the secondary school level. Therefore, this research is divided into two studies. In the first study, our goal was to arrange a Baseline assessment for the screening process of adolescents at risk of suicide. while in second study we aim to implement a didactic approach based on religious teachings and culture milieu and examine its effects as an evidence based suicide prevention program.

Suicide has become a major public health problem around the world. according to a recent report by the World Health Organization (WHO) suicide is the fourth leading cause of death among youth. Suicidal thoughts and suicide attempts are on the rise among youth. Therefore, evidence-based prevention programs need to fill this gap with interventions at the higher secondary schools.

For decades, research and prevention efforts have been failed in developing meaningful predictions and reductions in suicide. However, significant efforts are needed to stop the rising tide of suicide. For the purpose, it is important to understand the suicidal thought at first as not everyone who commits suicide attempts suicide first.

Therefore, in this study an attempt has been made to investigate profoundly the understanding of suicide which has been emerged a serious problem around the globe and in particular in Pakistani society. The researcher has planned to conduct psychological measures with established psychometric properties to look at the relationship between suicidal ideation and impulsivity anticipating suicidal behavior. During study the role of moderators i.e. social effectiveness and level of religiosity shall also be investigated. Findings of this study shall comprehensively provide data in order to design an inclusive prophylactic strategy known as didactic intervention to prevent the suicidal act before it occurs. It is expected that this approach grounded on religious teaching and cultural milieu in line with the best practices, will be adapted. Subsequently, this study also aims to evaluate the effectiveness of the didactic approach as an evidence based suicide prevention program in higher secondary schools with selective prevention programs.

Eligibility Criteria:
Inclusion Criteria:

* Higher Secondary School Students
* Young people at risk of suicide: those who are impulsive and have suicidal thoughts.

Exclusion Criteria:

* Who has a history of suicide attempts