cyrilzakka/clinical-trials huggingface dataset:
PREVENTION-ACHD Risk Score

Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young patient population. The reason for this is the fact that this is a heterogenous group of patients and SCD is a relatively rare event. Because of this there have been no prospective studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD have shown that this treatment does appear to be effective. Researchers from the Academic Medical Center have identified several risk factors for sudden cardiac death. A risk score was created using this data, which has been validated in an internal and external cohort in a retrospective setting. The design of this study, including the conception of the risk score, its calculation method and validation will be published in an international scientific peer-reviewed journal.

The hypothesis of this study is that the risk score accurately predicts the risk of sudden cardiac death.


Eligibility Criteria:
Inclusion Criteria:

* adult (≥18 years old) patient with a diagnosis of a congenital heart defect.

Exclusion Criteria:

* Patients of whom follow up is not possible, e.g. no permanent home address, living outside of or expecting to move out of the area wherein travelling to the investigating hospital outpatient clinic is possible.

  * Patients with documented sustained ventricular tachycardia or ventricular fibrillation.
  * Patients for whom the risk is not calculable because of a congenital heart disease diagnose not represented in the risk score.
  * Patients for whom the risk score is not calculable because of missing data
  * Patients with recent (\<3 months ago) myocardial infarction.
  * Patients in whom the high SCD-risk status depends on an impaired ejection fraction that is expected to improve, e.g. due to tachycardiomyopathy.
  * Patients with a guideline defined contraindication for ICD implantation.
Powering Up Stroke Rehabilitation Through HIIT

Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors.

Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (MICT) Design and subjects: Assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors.

Interventions: Participants will be randomly allocated to one of three groups: the HIIT group, the MICT group, or a stretching group (active control). Each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions.

Main outcome measures: Assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). The primary outcome measure will be muscle power. Secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, cardio-autonomic response, and psychosocial response.


Eligibility Criteria:
Inclusion criteria:

* Men and postmenopausal women aged 50-80 years
* 1-5 years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography
* Able to walk 10 meters independently with or without a walking aid
* Class I or II according to the New York Heart Association Functional Classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity)

Exclusion criteria:

* Presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months
* Undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months
* Participation in ongoing stroke rehabilitation services or structured exercise programme
* Cognitive or communication issues that could limit the ability to follow instructions
* Contraindications to HIIT, graded exercise testing, or failure to pass medical clearance from a specialist
Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger

The aim of the study is to compare the therapeutic effects of hyaluronic acid versus steroid injections in treating trigger fingers using ultrasound guidance

A prospective randomized controlled study designed to compare the outcomes of injecting patients with trigger finger with hyaluronic acid versus corticosteroid under ultrasound guidance

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years)
* Patients with a clinical diagnosis of trigger finger grade 1-3 on the Quinnell grading scale and confirmed diagnosis by ultrasound.

Exclusion Criteria:

* Quinnell's classification grade IV (contracture)
* Prior injection within 6 months
* Prior operation of the affected finger
* Presence of any contracture in the proximal interphalangeal or metacarpophalangeal joint, and
* History of diabetes, hypothyroidism, and
* Rheumatic or connective tissue disease
* Allergy to triamcinolone or hyaluronic acid
* Pregnancy
* Secondary triggering e.g. Trauma, infection
* Trigger finger symptoms duration \>6 months
Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology

The main objective of this pilot study is to evaluate the impact of a self-management intervention using wearable biometric technology on post-COVID-19 syndrome. In addition, this pilot-study will provide information regarding validity, feasibility, patient compliance and satisfaction, valuable for the design of a future large-scale study.

This pilot-study uses a one-group before-after design. Subjects: a convenience sample of 20 adults 18 years and older in the Winnipeg Health Region with a post-COVID-19 infection (≥ 3 months since acute infection) complaining of mild to severe persistent respiratory symptoms. Intervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). Participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (M-F) including while performing the recommended exercises (30-45 min/3 times a week). They should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using Hexoskin app installed on an iPad provided by the research team or on the participants' personal device if preferred. Patients will also complete an online survey reporting symptoms intensity and activities completed, 3 times a week (over 6 weeks). Participants would be able to contact the research assistant overseeing the intervention at any time of the study if they have questions or concerns (text message or email). Otherwise, they will receive a follow-up phone call every week or if a significant change in their biometrical data is identified.

Eligibility Criteria:
Inclusion Criteria:

* Post-COVID-19 ≥ 3 months after infection.
* Mild to severe persistent respiratory symptoms
* Access to a home internet

Exclusion Criteria:

* History of neurological disease or mental illness
* Inability to ambulate independently without supervision
* Inability to complete basic tasks on a smart phone or tablet
A Multi-Component Alcohol and Sex Risk Intervention for College Students

Hazardous alcohol use, sexually transmitted infections, and sexual violence are interrelated and highly prevalent public health concerns in college student populations. The current study seeks to develop a tri-pronged sex-positive intervention that addresses risky alcohol use, unsafe sex, and sexual violence for college men and women (ages 18-24). The study involves a small randomized pilot trial to demonstrate the feasibility and acceptability of the recruitment methods and research design. Preliminary evidence of intervention efficacy will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Must be student at the site university

Exclusion Criteria:

* Students who have participated in relevant site specific studies will be excluded
French Attitude Registry in Case of ICD Lead Replacement

The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced.

There are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe.

The risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%.

Regarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued.

Main objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the sensor replaced.


Eligibility Criteria:
Inclusion Criteria:

* Patient to receive a replacement defibrillation lead not motivated by an infection and having been informed.
* Patient who agreed to participate in the study
* Patients aged 18 years and over

No Exclusion Criteria
Effect of Early Pulmonary Rehabilitation After Lung Transplantation

The purpose of this observation study is to evaluate the effects of an early, 3 week lasting rehabilitation program, that starts roundabout 4 weeks after lung or combined lung transplantation, on physical activity, functional and physical condition (6-min-walk, FEV1, ADL-score) and quality of life (SF36) in lung transplant recipients with a different length of stay on the waiting list and a different duration of hospitalization in the transplantation centre after transplantation.

To which extend a prolonged duration from listing for lung transplantation until a successful transplantation or a long length of hospitalization may influence the success of a pulmonary rehabilitation, that starts after discharge from the transplantation centre, is still unknown.

Long waiting periods before transplantation and surgical, infectious or immunological complications after transplantation influence the physical condition and the quality of life of the organ recipient.

A poor physical condition before transplantation results in an unfavourable outcome in the first 12 months after transplantation.

At present it is unclear, whether a structured pulmonary rehabilitation may overwhelm differences between patients with a prolonged course roundabout the transplantation compared or not. At present it is not clear whether it is necessary for lung transplant recipients to participate in a rehabilitation program including structured exercise training.

The aim of this observational study is to assess the effect of a short-term pulmonary rehabilitation, that starts immediately after discharge from the transplantation centre on patients with a prolonged waiting period or an extended postoperative hospitalization.

* Hypothesis: a structured pulmonary rehabilitation early after transplantation may overwhelm poor physical and functional conditions after a prolonged period on the transplant waiting listor a prolonged hospitalization after transplantation resulting in a significant improvement in all transplanted patients
* Antithesis: a prolonged period on the waiting list before transplantation or a prolonged hospitalization after transplantation can not be influenced significantly by an early transplant rehabilitation resulting in a persistent lack of functional status and quality of life compared with a short waiting period or a normal duration of hospitalization after transplantation.
* Outcomes: functional status (6-min. walk, exercise capacity, FEV1, ADL), and quality of life (SF36) will be assessed at the beginning and on discharge from the rehabilitation centre.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of single or double lung transplants
* Recipients of combined (heart and lung or heart an liver) transplants
To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis

This study intends to irradiate the acupoints of both lower extremities of hemodialysis patients with far-infrared therapeutic apparatus to explore its effect on foot blood circulation, peripheral artery occlusion disease (PAOD) symptoms and ankle-brachial index (Ankle-Brachial Index, ABI) value.

After irradiating the lower extremity acupoints of hemodialysis patients with far-infrared rays, it is expected to improve the blood circulation of the lower extremities of hemodialysis patients, thereby improving the symptoms of indirect claudication and raising the ankle-brachial index to the normal range, and reducing the incidence of peripheral arterial disease in hemodialysis patients. The results of this study can provide an empirical reference for future clinical care.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients diagnosed with chronic renal failure in a hemodialysis unit and receiving hemodialysis for at least three months 2. Willing to participate in interventional treatment with far-infrared radiation 3. Willingness to cooperate with intervention measures and inspection time 4. Receive hemodialysis treatment three times a week

Exclusion Criteria:

1. There are contraindications for ABI examination (such as breast cancer lymph node dissection in the past), bilateral upper limb arteriovenous access, etc.), and a double- lumen dialysis venous catheter is placed in the groin
2. Bedridden or unable to walk
3. History of distal amputation, DVT, CABG s/p due to trauma, ischemia or infection
4. Consciously unclear and unable to cooperate
5. Patients with wounds from calf to instep
Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY

Purpose:

The purpose of our study is to investigate the feasibility and effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients, in order to implant in patients with keratocouns disease using VisuMax Femtosecond laser - Smile module surgery which primary objective in to increase central corneal thickness and secondary objective is to improve visual acuity and reducing K-values.

Methods:

All the patients were clinically diagnosed with progressive keratoconus. Twenty (20) patients underwent SMILE surgery (first group), and twenty (20) patients underwent lenticule implantation (second group). Visual acuity, corneal topography, electron microscop,anterior segment optical coherence tomography, were analyzed.

Outcome:

Central corneal thickness were improved at the same day of surgery and vision started to improve at first week postoperatively in the second group (lenticule implant group). Corneal topography showed a statistically significant decrease in the anterior K1 and K2. All the grafts from both groups were clearly visible by anterior segment optical coherence tomography observation and electron microscope. The central corneal thickness was stable during the 6-month study period. No complications were observed during short term follow-up.

Opinion:

In our opinion, the present study may suggest that this procedure, using fresh lenticule with stromal stem cells and live keratocites is safe, reliable, and effectively increases corneal thickness and improves visual acuity with no adverse effects, which may provide new avenues in the treatment of corneal ectasia.

Key Words:

keratoconus,small incision,fresh lenticule, stromal implantation,stromal stem cells, Smile surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically diagnosed with progressive keratoconus

Exclusion Criteria:

* Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery
Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy

Any kind of anatomical lung resection for lung cancer with curative intent has to be accompanied by formal mediastinal lymph node dissection. Video-assisted mediastinoscopic lymphadenectomy through a cervical access (VAMLA) along with thoracoscopic lobectomies in the same setting offers improved radicality through bilateral mediastinal dissection, provide accurate staging, does not require single lung ventilation and hence ideally supports the concept of minimally invasive surgery.

Due to the VAMLA associated radicality, the investigator believes that using of VAMLA along with lobectomy could improve the oncological outcome of lung cancer patients. Furthermore, the absence of single lung ventilation during VAMLA could attenuate the surgically induced immunosuppression.

Any kind of anatomical lung resection for lung cancer with curative intent has to be accompanied by formal mediastinal lymph node dissection. Video-assisted mediastinoscopic lymphadenectomy through a cervical access (VAMLA) along with thoracoscopic lobectomies in the same setting offers improved radicality through bilateral mediastinal dissection, provide accurate staging, does not require single lung ventilation and hence ideally supports the concept of minimally invasive surgery.

Due to the VAMLA associated radicality, the investigator believes that using VAMLA along with lobectomy could improve the oncological outcome of lung cancer patients. Furthermore, the absence of single lung ventilation during VAMLA could attenuate the surgically induced immunosuppression.

The present study aims at:

1. The current project primarily aims at identifying the effect of reduced single lunge ventilation time during VAMLA-VATS lobectomy on the intraoperative production of oxygen radicals as well as its effect on the immune competence of patients undergoing VAMLA-VATS lobectomy as compared to those receiving VATS lobectomy Along with conventional unilateral lymphadenectomy.
2. Secondary, in line with the hypothesis that radical bilateral lymphadenectomy might results in a more complete oncological staging as compared to unilateral lymphadenectomy or lymph node sampling. The current project aims to compare the pre- and postoperative staging in patients undergoing VAMLA, as VAMLA enables a proper examination of all bilateral mediastinal lymph nodes.
3. Patient Follow-up will be continued for at least 5 years postoperatively in order to compare the oncological outcome namely local and distant recurrence, tumor-associated and overall survival in patients undergoing VAMLA-VATS Lobectomy as compared to those with VATS lobectomy. This issue is, however, a second endpoint of this study and will be independent of the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* adult
* non small cell lung cancer
* operable tumor
* indicated for endoscopic lung surgery

Exclusion Criteria:

* pregnancy
Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome

This study valuates the serum Tenascin-C concentration in patients with acute coronary syndrome.

It is found that Tenascin-C plays an important role in ventricular remodeling, heart failure, aortic dissection, rheumatic heart disease and other cardiovascular diseases, which may be a new marker for the diagnosis and prognosis prediction of these diseases. However, there is few relevant studies about the Tenascin-C concentration in patients with acute coronary syndrome.This study valuates the serum Tenascin-C concentration in patients with acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

.diagnosed as acute coronary syndrome,including STEMI,non-STEMI,and UAP.

* with left ventricular ejection fraction（LVEF）\>=45%
* written informed consents are obtained
* admitted within 24 hours after chest pain attacked

Exclusion Criteria:

* complicated with rheumatic heart disease, coronary arteritis, hypertrophic cardiomyopathy or dilated cardiomyopathy
* complicated with malignant tumor,the immune system diseases, blood system diseases, recently (within 2 weeks) taking glucocorticoid drugs, the use of immunosuppressive agents and cerebral infarction
* with acute or chronic infection, surgery or trauma in the last month
* secondary hypertension, severe liver dysfunction,severe renal insufficiency
* with abnormal thyroid function or allergy to iodine agent
* refusal to sign the informed consent
Lidocaine Infusion for Major Abdominal Pediatric Surgery

In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.

The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.

Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric
* Abdominal surgery
* ASA class I and II

Exclusion Criteria:

* history of hepatic diseases
* history of cardiac diseases
* history of renal diseases
* allergy to local anesthetics
* epilepsy