cyrilzakka/clinical-trials huggingface dataset:
VTE Prevention Following Total Hip and Knee Arthroplasty

Consented patients undergoing elective total hip and total knee arthroplasty will be randomized to receive either aspirin alone or aspirin and rivaroxaban for prevention of venous thromboembolism.

Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone.

This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study
2. Written informed consent in accordance with federal, local and institutional guidelines

Exclusion Criteria:

1. Previous documented VTE (proximal DVT or any PE)
2. Hip or lower limb fracture in the previous three months, not related to present surgery
3. Metastatic cancer
4. Life expectancy less than 6 months
5. History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
6. History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin
7. History of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban
8. Creatinine clearance less than 15 ml per minute
9. Pre-operative platelet count less than 100 x 109 /L
10. Need for long-term anticoagulation due to a pre-existing co-morbid condition or due to the development of VTE following surgery but prior to randomization
11. Received anticoagulation post operatively
12. Bilateral THA/TKA or simultaneous hip and knee arthroplasty
13. Major surgical procedure within the previous 3 months
14. Requirement for major surgery post arthroplasty within a 90 day period
15. Chronic daily aspirin use with dose greater than 100 mg a day
16. Women of childbearing potential who are not abstinent or do not use effective contraception or are breast-feeding throughout the study drug period
17. Unwilling or unable to give consent
18. Previous participation in the EPCAT III study
19. Under 18 years of age
20. Concomitant use of drugs that are strong inhibitors of P-gp AND CYP3A4 (e.g., systemic treatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of P-gp AND CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort)
21. Known allergy to food dye
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty

Cardiac Rehabilitation, as art and acting science multiprofessional, is based on the training with exercises that provides the post-infarct patients to satisfactorily re-establish the patient's clinical condition and that improve the functional capacity of these individuals.

Evidence shows that aerobic exercise training provides improvements in the endothelial function of this population. However, we do not yet have strong evidence of other modalities of exercise in these parameters in post-infarction patients treated with angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Post-acute myocardial infarction patients
* Ergometric test 30 days after the infarction
* Ejection fraction\> 40% (Simpson's method)
* Regular use of optimized drugs

Exclusion Criteria:

* Unable to perform the randomized exercise
Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer

For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).

There is two types of maintenance :

* continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.
* switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.

Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.

The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented Non Small Cell Lung Cancer non resectable or non irradiable stage III or stage IV
* EGFR wild type or non feasible EGFR
* 90 \>Age ≥ 70
* ECOG Performance status : 0, 1 or 2
* Mini-Mental Test Status (MMS) \> 23

Exclusion Criteria:

* Mixed non-small cell and small cell tumors
* Patients with EGFR mutated tumor
* Patient with EML4-ALK translocation
* Evolutive or symptomatic metastasis of central nervous system
* Superior vena cava syndrome
* Calcemia \> 2,70 mmol/L
Glycemic Impact on Glioblastoma Outcomes

This pilot study aims to evaluate the feasibility of close glucose monitoring and management of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized based on individual blood glucose levels. Although the glycemic interventions used in this study include standard medications and methods of glucose monitoring used for patients with diabetes, this pilot study will specifically evaluate the feasibility of using these approaches in patients with GBM, appreciating their additional medical, functional and social challenges.

The purpose of this pilot study is to determine the feasibility of using close monitoring and management of glucose levels in patients undergoing radiation and chemotherapy for glioblastoma.

The glucose management will include the use of standard metformin a common treatment for patients with early type 2 diabetes that has also shown anti-tumor effects in GBM, and will be further personalized based on individual blood glucose levels. Additional anti-hyperglycemic management will be provided at the discretion of the Endocrinologist.

Close glucose monitoring will include flash glucose monitoring (FGM) with a device called an FreeStyle Libre Pro Flash Glucose Monitoring System, finger-prick glucose measures (standard approach for patients with diabetes) and weekly blood tests (our current standard for patients with GBM).

In addition to determining the feasibility of using these approaches, this pilot study will help identify the simplest and most effective approach of managing glucose levels in patients with GBM appreciating their additional medical, functional and social challenges.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years old) with a new histologically-confirmed diagnosis of glioblastoma who are planned to receive a 6-week course of concurrent radiation and temozolomide
* Has evidence of random glucose of at least 7.8 mmol/L or fasting blood glucose of at least 6.1 mmol/L (meeting criteria for oral diabetic medications)
* Able to provide informed consent
* Able to understand and follow instructions regarding self-administered capillary glucose measurements

Exclusion Criteria:

* Contraindication to MRI with gadolinium
* Taking anti-hyperglycemic medications at the time of study eligibility screen
* Unable to participate in neurocognitive evaluation in English
Long-Term Outcomes of Children With Congenital CMV in New York State

PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms.

In particular, our study will provide new information about many facets of congenital CMV, including:

* Developmental, hearing, neurologic, and vision outcomes
* The spectrum and timing of symptoms
* The impact congenital CMV has on the baby and its family
* How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV

Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications.

Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment.

Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.


Eligibility Criteria:
Inclusion Criteria:

* Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 - October 1, 2024)
* cCMV evaluation provided by a designated NYS cCMV clinical referral site
* Family willing and able to complete all study procedures
* Study participants meet criteria for one of the following four categories:
* 1. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive
* 2. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive
* 3. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test
* 4. Category 4 (Premature infants with confirmed CMV infection on late positive NBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND Positive cCMV confirmatory test obtained within 14 days of a positive NBS

Exclusion Criteria:

* Neonate whose parents refuse participation in the long-term follow-up study
Long Term Postoperative Cognitive Dysfunction in the Elderly Patients

The purposes of this study are to determine whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on the result about POCD.

In present aging society, a surgery in geriatric patient is increasing. Patients older than 60 year are particularly affected for postoperative cognitive dysfunction (POCD) (26-41%). The patients experiencing POCD are at an increased risk of death in the first year after surgery. So, POCD is important because it can influence to patient's quality of life.

In the investigator's hospital, laparoscopic cholecystectomy is performed with increasing frequency in aging patients. So the investigator's study will be conducted in elderly patients during laparoscopic cholecystectomy. The anesthetic methods are divided into the following 3 kinds: sevoflurane, propofol, dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. The control group include a spouse of the patient which must be older than 60 year and does not have anesthetic history.

After the surgery, the patients are discharged from the hospital, the investigators will check the postoperative cognitive function 4 times: 1week, 3months, 6months, 1 year later using the Korean version of telephone interview for cognitive status (TICS). The Korean version of TICS was validated tool for examination of cognitive function and this tool and mini-mental state examination (MMSE) be linked directly. The test will be administered to spouse simultaneously by telephone.

Sample size was calculated for the primary outcome parameters (whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia), and the investigators hypothesized that two groups are in this study, one group is for postanesthetic patients, another is for their spouses. Total sample size was calculated to 190.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* diseases of the central nervous system, including dementia (Mini Mental Examination Score \<24),
* consumption of major tranquilizers or antidepressants
* previous neuropsychological testing
* the patient's inability to comply and follow procedures or poor comprehension of the language used in the study.
* Parkinson's disease
* Patients with a severe visual or auditory handicap, illiteracy
* alcoholism (intake of \>5 units of alcohol daily during the last 3 months)
* drug dependence
* those not expected to complete the postoperative tests were excluded as well
Promoting Health by Self Experience (PHASE) Randomized Controlled Trial

Promoting Health by Self Experience (PHASE) randomized controlled trial

Study Hypothesis:

A personal experience in health promotion will affect the health prevention activities of the health providers and thus will impact their prevention activities toward their patients compared with a control (no-intervention) group.

Objective: To evaluate the effectiveness of a personal experience and personal initiation program on the health prevention activities of the health providers and the following impact on their patients compared with a control (no-intervention) group.

Methods: A randomized controlled trial Randomization: Health providers of all disciplines will be recruited from 10 clinics of Clalit Health Services, Dan district and randomized using cluster (by clinic) randomization, into an intervention and a control group. In each clinic 15 health care providers and 50 patients will be interviewed providing a total of 150 health care providers and 500 patients.

Intervention: The intervention will be delivered by psychologists and social workers trained in group facilitation and experimental learning. The program is based on theories of experimental learning and Bridges model of change. In each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months. No intervention will be provided to the control clinics.

Outcomes: changes in quality measurements of both intervention and non-intervention clinics. Among health providers changes in attitudes, personal views and life style as well as health prevention activities will be assessed by questionnaires. A random sample of 50 patients age 21-50 from each of the participating clinics will be selected and interviewed using a questionnaire. The questionnaires will include questions regarding the administration of screening tests, treatment of abnormal measurements, life style changes and satisfaction with the performance of the clinic and health care providers. The evaluation for both health care providers and patients will be performed at baseline and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Health providers in selected clinics
* Patients age 21-50 in selected clinics

Exclusion Criteria:

* Patients age younger than 21 and older than 50
* Health providers from clinics not in the area of the study
Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery

The aim of this study was to investigate the pathogenic role of obesity on blinding eye diseases in a population of severely obese patients with no history of eye diseases, and to verify whether weight loss induced by bariatric surgery may have a protective effect.

This was a pilot, monocentric, prospective, and open label study conducted at First Affiliated Hospital of Jinan Universityreceived.Patients with body mass index ≥ 32.5Kg/m2; or patients with body mass index of 27.5-32.5Kg/m2 and metabolic diseases were consecutively recruited.All participants underwent complete ophthalmological evaluation， Keratograph 5M and optical coherence tomography.Patients who underwent bariatric surgery were evaluated also 3 months, 6 months and 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with BMI≥32.5Kg/m2；
2. patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases;

Exclusion Criteria:

1. Patients with pre-existing ocular diseases or visual alterations were excluded to avoid confounding factors related to pre-existing retinal pathology, independent from obesity per se.
2. Patients with dementia, Parkinson's disease, Alzheimer's disease, multiple sclerosis or other severe neurological diseases were also excluded since ophthalmologic parameters may be altered in these conditions.
3. Patients with lens opacities that made impossible the posterior segment examination, or with a refractive error \> +5 or \<-8 diopters spherical equivalent were also excluded.
Skin Glue to Reduce Intravenous Catheter Failure in Children

Intravenous (IV) catheter placement is the most common medical procedure in emergency department settings. IVs are used to deliver medications, fluids and blood products to patients. At the Children's Hospital of Eastern Ontario, approximately three-quarters of children admitted to hospital have an IV inserted while they are in the emergency department. However, a challenge associated with IVs is that they sometimes stop working or fall out before treatment has been completed (this is known as IV failure). When IVs fail, a new IV often needs to be placed. Children rank IV placement as one of the leading causes of pain in the hospital setting. The investigators are interested in understanding whether there are strategies that can help keep IVs in place longer for children admitted to hospital.

Previous studies investigating whether certain types of bandages over IV sites are helpful in keeping IVs in longer found all bandages performed about the same. However, a recent study of adult patients showed that using medical-grade skin glue to secure the IV significantly reduced IV failure rates when compared to usual care. There have been no similar studies in children. The objective of this study is to understand whether placement of skin glue at IV insertion sites is effective in decreasing IV failure rates in children. This study will take place in the emergency department at Children's Hospital of Eastern Ontario (CHEO). Consenting children will be randomly assigned to receive IV placement either with or without skin glue (one drop at the IV insertion site and another drop under the hub of the catheter), along with otherwise standard securement with a transparent dressing. The investigators will look at the numbers of children in each group whose IVs fail before their intended treatment course is complete. This study has the potential to improve patient and family satisfaction, decrease nursing workload and reduce healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

1. Age 0 days to 18 years
2. Patient must require a PIVC as part of their management plan
3. Patient must be physically in the ED at the time of PIVC insertion

Exclusion Criteria:

1. At the time of insertion, the treating physician anticipates the patient will likely be discharged from the ED (with or without the PIVC in place)
2. Known allergy to skin glue, glue removal wipe, or standard catheter securement materials
3. Active infection at site of PIVC insertion
4. Insurmountable language barrier (patient's parent/guardian is unable to understand English or French well enough to give informed consent and participate in follow-up)
5. Previous enrolment in the trial
6. PIVC is expected to be used for chemotherapy (note: these are changed every 4 days even with good blood return)
7. Life-threatening or critical presentation in which consent is unable to be obtained
Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response

While the stress response, characterised by an increase in heart rate, blood pressure, and cortisol, has evolved to ensure the survival of the organism in face of danger, chronic stress due to psychological stressors can be harmful. The opposite of the stress response is the "relaxation response". Mind-body techniques such as meditation, guided imagery and music therapy are thought to induce this response. The relaxation response is characterized as a wakeful hypometabolic state, where a decrease in central nervous system arousal is observed. Some studies reported a reduction in stress hormones, and in symptoms of anxiety and depression following the use of mind-body relaxation techniques. Other studies noted a reduction in stress measured using physiological measurements such as heart rate and blood pressure.

Light therapy is another technique that is suggested to induce physiological changes similar to those seen in the relaxation response. Some studies have shown a reduction in heart rate, blood pressure, oxygen consumption and carbon dioxide production following exposure to blue light.

These relaxation therapies can be useful for the general population and for vulnerable groups where alternative therapies, such as medication and psychotherapy, are difficult. Limited amount of studies have quantified the decrease in stress in physiological measurements such as heart rate and blood pressure.

The aim of this study is to investigate which relaxation technique among five different interventions (and one control) is the most effective in improving relaxation and reducing stress in adult women of reproductive age (18-45 years). The results of this study will be used to inform the intervention of a study testing the impact of relaxation therapy on breastfeeding outcomes in mothers of late preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (18-45 years)
* Fluent in English

Exclusion Criteria:

* Any condition that may affect blood pressure, heart rate or energy expenditure i.e hypertension, hyperthyroidism, heart failure
* Smokers
* Recent surgeries or injuries
The Influence of an Intervention Program on Altering Health Behavioral Patterns Among IDF's Staff

The goal of this study is to determine the effectiveness of a general intervention that includes encouragement of physical activity and healthy living habits of officers and permanent staff in the IDF


Eligibility Criteria:
Inclusion Criteria:

* IDF'S staff member
* Age \>26
* One or more risk factor

Exclusion Criteria:

* Cardio vascular condition
* Respiratory disease
* Other healthy conditions according to the physician's decision