cyrilzakka/clinical-trials huggingface dataset:
Effect of a Prevention Program on Program Facilitators

The study will examine, through quantitative and qualitative research, how the delivery of the program "In Favor of Myself" to school children influences the program facilitators themselves, and the effect on their self-esteem, body-image, and media literacy.

In recent decades, the existence of prevention and intervention programs has gained momentum and has become an important part of our culture. Programs are delivered around the world in a wide variety of fields and subjects. They serve as an auxiliary tool for the improvement, awareness, empowerment, treatment and response to a range of social and personal behavioral issues and behaviors, eradication of harmful behaviors, and more.

In the literature there is ample evidence and proof of the nature of the effects and impact of different programs on the group of participants involved. Many successes in these programs relate to the contents of the program, the level of interest among the participants, the way the program is delivered, the degree of interaction between the facilitators and the participants, and more.

Yet there is little reference in the literature to the aspect that examines the program facilitators themselves and the potential impact that the programs will have on a variety of aspects and personal measures in the lives of the facilitators. Among these measures is the experience of instruction, including the experience of teaching and learning embodied in it, the involvement of the ego and the involvement of the facilitator in the tasks, the impact on the values and the personal level of the facilitators, including impact on their self-esteem.

This study will examine, through quantitative and qualitative research, how the delivery of the program "In Favor of Myself" to school children influences the program facilitators themselves, and the effect on their self-esteem, body-image, and media literacy.

The research hypothesis is that the self-esteem, body image, media literacy, the sense of ability, and personal empowerment of the group of facilitators who delivered the program will be increased, and their behavior will change according to the subjects of the program.

Eligibility Criteria:
Inclusion Criteria:

* College students participating in the relevant course
* Completed study questionnaire before and after delivering the prevention program.

Exclusion Criteria:

* None.
Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)
* Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board
* Patients who are scheduled to have implantable cardiac monitoring

Exclusion Criteria:

* Transient ischemic attack
* Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)
* Presence of complex aortic atheroma (≥4mm in plaque thickness or presence of mobile components)
* Presence of ≥50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area
* Unwillingness or inability to comply with the procedures described in this protocol
* Life expectancy \< 1 years for any non-cardiac or cardiac causes
Clinical Comparison of Two Daily Disposable Soft Contact Lenses

The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Understand and sign an Informed Consent Form;
* Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Refractive, ocular, or intraocular surgery, as specified in the protocol;
* Eye condition or injury, as specified in the protocol;
* Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
* Currently wearing clariti® 1 day contact lenses;
* Habitually wearing monovision or multifocal lenses during the last 3 months;
* Other protocol-specified exclusion criteria may apply.
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD

This study aims to evaluate the effects of an online exercise and peer support intervention for people living with COPD. In the framework of a randomized control trial, 24 adults with COPD will be recruited to participate in the study and will be randomly assigned to either the control or intervention group. The control group will participate in an 8-week virtual program based on the exercise component of a standard home-based pulmonary rehabilitation program (one online consultation and 7 phone calls with a kinesiologist). The intervention group will participate in a twice a week online intervention that includes an exercise component based on individuals' activities of daily living and a peer support component where individuals will be taught and encouraged to discuss behaviour change techniques that have been shown to help support increased participation in physical activity and/or exercise. The goal of this study is to determine the efficacy of the novel online exercise intervention and whether the benefits are above other intervention options.


Eligibility Criteria:
Inclusion Criteria:

* Individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a COPD diagnosis, be medically able to participate in exercise (confirmed by healthcare professional in the past 2 years), have access to a computer with a camera and internet, speak English or French, and have the intention to become physically active in the next 2 months or have been minimally active (\<150 minutes per week) in the past 2 months

Exclusion Criteria:

* less than 18 years of age, diagnosed with a cognitive impairment, not diagnosed with COPD by a medical professional, unable to participate in exercise or unconfirmed in the past 2 years from a medical professional, no access to a computer and internet.
Massive Open Online Course (MOOC) for Women with Breast Cancer

The goal of this clinical trial is to promote Person-Centered Care and improve Health Literacy and Digital Health Literacy in women with breast cancer through the development of a Massive Open Online Course (MOOC) co-created with women with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult women ( ≥18 years old)
* Speak Spanish
* With internet at home or smartphone
* Currently have or have had breast cancer (currently disease-free)
* Families/caregivers of women with breast cancer and healthcare professionals involved in breast cancer management (oncologists, gynaecologists, nurses, psycho-oncologists, etc.)

Exclusion Criteria:

* No exclusion criteria were applied based on diagnosis date, current or past treatment, nationality, Health Literacy and Digital Health Literacy level and knowledge about Person-Centred Care or breast cancer.
* In the assessment of the MOOC's acceptability and effectiveness, participants involved in co-creating the MOOC will be excluded.
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.

Rationale: Docetaxel has some efficacy against non-small cell lung cancer (NSCLC). This drug is Food and Drug Administration approved in combination with cisplatin (Platinol) for the treatment of unresectable, locally advanced or metastatic NSCLC in patients who have not previously had chemotherapy for this condition. Docetaxel is also approved for second line treatment of metastatic NSCLC. Research indicates that capecitabine, in combination with docetaxel, has efficacy against NSCLC. Capecitabine appears to have anti-cancer activity through several enzymes. This drug is metabolized in the body to another agent called 5-FU. During this conversion process, 5-FU requires thymidine phosphorylase (TP), a cellular characteristic associated with tumor growth. There are higher levels of TP expression in tumors as compared to normal tissue. The drug administration schedule in this study is designed to optimize efficacy against the TP target through both docetaxel and capecitabine. This study will measure biological changes to TP and other enzymes to help researchers gain more information about how capecitabine and docetaxel works against NSCLC.

Purpose: This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC. Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies.

Treatment: Patients in this study will receive docetaxel and capecitabine. Docetaxel will be administered through intravenous infusions. Capecitabine will be provided through oral pills. A four-week period constitutes one cycle. Docetaxel will be given weekly for three weeks followed by one week of rest. Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Must have advanced NSCLC
* No prior chemotherapy
* Eastern Cooperative Oncology Group(ECOG)Performance Status:0 or 1
* Must have measurable disease (RECIST criteria)
* life expectancy of at least 12 weeks
* adequate organ function including

Exclusion Criteria:

* Pregnant or lactating women
* Psychiatric disorders that would interfere w/consent or follow-up
* Patients with uncontrolled diabetes mellitus, defined as random blood sugar \> 250mg/dL.
Immunoinflammatory Regulation of Esketamine in Septic Patients

Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Clinical studies have shown that esketamine combined with propofol for sedation has been proven to be safe and effective for septic patients in the ICU due to its cardiovascular stability. Previous studies have demonstrated that esketamine has anti-inflammatory effects against depression and surgical stress. Our preliminary experimental studies have found that esketamine had strong anti-inflammatory effects in the acute phase of sepsis. However, it is not clear whether esketamine could reduce excessive inflammation and improve immunosuppression in septic patients primarily sedated with a continuous infusion of propofol.

This intervention study is to investigate whether three consecutive days of intravenous esketamine infusions via infusion pump (0.07 mg/kg/h) could reduce excessive inflammation and improve immunosuppression in septic patients requiring mechanical ventilation in the ICU under sedation primarily with propofol.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ age ≤60 years old;
* SOFA score ≥2;
* Mechanical ventilation should be required for at least 24 hours when included in the study;
* Informed consent is obtained.

Exclusion Criteria:

* Age \< 18 years old or ≥ 60 years old;
* Previous solid organ or bone marrow transplantation;
* Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), or hematologic malignancies (leukemia and lymphoma, etc.);
* Received radiotherapy or chemotherapy within the past 30 days, or received immunosuppressant drugs (tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, FK506, etc.), or continuous treatment with prednisolone more than 10 mg/day (or equivalent doses of the other hormones);
* Unstable angina pectoris or myocardial infarction in the past six months;
* Acute brain injury (traumatic brain injury, subarachnoid hemorrhage, acute ischemic stroke, acute intracranial hemorrhage, acute intracranial infection, etc.);
* Poorly controlled hypertension and congestive heart failure;
* Increased intraocular or intracranial pressure;
* Chronic kidney disease, received continuous renal replacement therapy in the past 30 days, or acute renal failure requiring CRRT;
* Severe chronic liver disease (Child-Pugh class B or C);
* Alcohol dependence, mental illness or severe cognitive impairment;
* Pregnancy or lactation;
* Informed consent is not obtained.
Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.

Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration.

Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or fluorescein angiography, and/or OCT) in at least one eye.
2. Vision impairment due to DME (BCVA ETDRS letter score at 4 meters between 20 and 70 letters (6/12 - 3/60 at Snellen chart).

Exclusion Criteria:

1. Laser photocoagulation in the study eye for the last 3 months.
2. Any history of any intraocular surgery in the study eye within the past 3 months.
3. Blood pressure \>160/100 mmHg.
4. Proliferative Diabetic Retinopathy.

Any other protocol inclusion/exclusion criteria that may apply.
Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice

The study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The investigators will investigate how CBT, specifically the treatment procedures and manuals proposed by Clark and Wells (1995), can be transferred from controlled trials into the less structured setting of routine clinical care, and whether the health care system benefits from such developments. Private practitioners (N=36) will be randomized to one of two treatment conditions (i.e., training in manualized CBT vs. treatment as usual without specific training). The investigators plan to enroll 160 patients (80 per condition) to be able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25% (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. The following research questions can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3) Will treatment effects in routine psychotherapeutic treatments be comparable to those of the controlled, strictly manualized treatment of the main study?


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of Social Phobia (SCID-I)
* Liebowitz Social Anxiety Inventory Scale (LSAS) equal to or greater than 30
* age between 18 and 70 years

Exclusion Criteria:

* psychotic disorder, risk of self-harm, acute substance related disorders, personality disorders except for Cluster C (SCID-II)
* organic mental disorder
* severe medical conditions
* ongoing psychotherapy or initiation
* psychopharmacological treatment
Videomusic and Psychic Trauma

This project is interested in the flow of consciousness and its modalizations during psychological trauma (post-traumatic stress disorder) and its resolution. It is based on the premise that in PTSD, consciousness becomes more rigid, less fluid, due to the memory always imposing itself on the consciousness. The resolution of the trauma and the subsequent reduction of anxiety might improve the fluidity of consciousness and thus lead to an overall improvement in the psychological state of PTSD patients. In cases of PTSD, music has been shown to reduce anxiety from the very first session and has a very positive effect on all PTSD symptoms.

In this project the following elements will be evaluated : on one hand, the changes in consciousness and its fluidity and, on the other hand, the evolution of anxiety following the listening of a new kind of work, videomusic (which associates a video scenario with music) exemplifying (metaphorizing) the trauma and its resolution.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age
* Patients diagnosed with Simple Post Traumatic Stress according to DSM 5 criteria
* Patient able to express consent prior to participation in the study
* Patient affiliated to or beneficiary of a social security regimen

Exclusion Criteria:

* Other serious psychiatric pathologies
* Serious chronic pathologies, especially neurological ones
* Epilepsy
* Blindness or deafness
* Psychiatric decompensation
* Pregnant Women
* Patient under judicial protection (guardianship, curatorship...) or justice safeguard
* Any other reason that, in the opinion of the investigator, could interfere with study objective evaluation
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.

Overall, only limited evidence exists regarding the clinical benefit of antithrombotic prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported incidence of VTE.

The aim of this multicenter, randomized study is to assess the clinical benefit of extended (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who had
* planned laparoscopic surgery for
* colorectal cancer will be included in the study provided no exclusion criteria will be found

Exclusion Criteria:

* age \< 18 years
* surgery for non-cancer disease
* duration of surgery \< 45 min
* other indication for anticoagulant therapy
* known cerebral metastases
* kidney or liver failure
* known hemorrhagic diathesis or high risk for bleeding
* history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia
* pregnancy or lactation
* refusal of informed consent.
Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction

Tadalafil is an effective oral therapy in erectile dysfunction. L-arginine is a pro drug that increase the level of nitrous oxide in the smooth muscles so can increase the strength and duration of erection. this clinical trials compare the daily oral L-arginine plus tadalafil in treatment of erectile dysfunction in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 DM

Exclusion Criteria:

* Patients with history of pelvic trauma, major pelvic surgical intervention, hypogonadism, hyperprolactinemia, hypertension, chronic prostatitis, chronic liver disease, smokers, history of chronic intake of CNS or anti-androgen drugs and patients with Peyronie's Disease or any fibrotic anomalies
Seraseal for Endoscopic Hemostasis

Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal is applied after an initial failure of the institutional standard method. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.

Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, certified for intraoperative use in humans (CE No 0653), is topically applied to the bleeding site. The delivery device consisted of a 5ml syringe containing Seraseal plugged to standard delivery catheters, either ERCP catheters or dye spraying catheters (Boston Scientific, USA) that are inserted via the working channel of the endoscope. Once the bleeding is identified at endoscopy, the delivery catheter is inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip. Seraseal is then delivered in short spray bursts or direct shots (for 1-2 seconds) until hemostasis is confirmed. A maximum of 5ml of Seraseal is administered in each patient. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.

Two groups are formed for analysis of this proof of concept study:

In group A, Seraseal is applied as initial method for hemostasis. If successful, the bleeding site is then observed for 5 minutes. If bleeding remains active or recurs, the institutional standard of care for hemostasis is applied.

In group B, Seraseal is applied as rescue therapy after an initial failure of the institutional standard method. If Seraseal is successful, the bleeding site is then observed for 5 minutes. If the bleeding remains active or recurs after Seraseal, alternative methods of hemostasis will be applied.

Eligibility Criteria:
Inclusion Criteria:

* active gastrointestinal hemorrhage

Exclusion Criteria:

* no sign of active bleeding at endoscopy