cyrilzakka/clinical-trials huggingface dataset:
Activation Failure of Knee Extensors After Anterior Cruciate Ligament Rupture Depending on the Contraction Mode

The primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode.

The goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes.

The main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects.

Secondary objectives are:

* To analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode.
* To observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

A. ACL-injured groups (surgically or conservatively treated):

1. Age between 18 and 50 years
2. Free, informed consent signed by the participant and the investigator.
3. Session 1: Delay of 2 to 6 weeks after injury, with a quiet knee (range of motion 110- 0°, minimal effusion, maximal contraction pain ≤ 2/10)
4. Session 2: Duration of 36 to 42 weeks after injury, with a quiet knee (range of motion 110-0°, minimal effusion, maximal contraction pain ≤ 2/10)
5. Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)

B. ControlGroup:

1. Age between 18 and 50 years
2. Free, informed consent signed by the participant and the investigator.
3. Sport practitioners: at least once per week practicing activities like collective sports, racket sports, combat sports, skiing, or on-loading activities with changing of directions.
4. Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)

Exclusion Criteria:

* 1. Subjects fitted with an implanted electronic device such as a cardiac pacemaker 2. Professional athlete 3. Pregnant women 4. Subject with systemic pathology or treatment affecting the musculoskeletal system 5. Subject with a history of neurological pathology or traumatic pathology, or pathology that required orthopedic treatment and/or surgery of the knee, hip and/or lumbar spine 6. Contraindication to isokinetic testing: incapacitating pain, evolving pathological process, non- healed fracture, unbalanced cardiovascular pathology (angina pectoris, arterial hypertension) 7. Contralateral knee injury 8. Subject inability to follow procedures or insufficient knowledge of project language 9. Data acquisition issue or injury during testing
Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia

Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. For each patient presenting with a suspicion of VAP and requiring a bronchoalveolar lavage (BAL), the diagnosis of API will be evaluated by biological examinations performed on blood and BAL. Medical and surgical history as well as clinical and biological data will be collected for 28 days or until discharge from the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 years),
* On invasive ventilation for more than 48 hours,
* Suspected VAP, defined by the appearance or worsening of a radiological pulmonary infiltrate, associated with 2 of the following clinical criteria:

  * Fever ≥ 38° C or hypothermia ≤ 36.5° C
  * Leukocytes \> 12x109 or \< 4x109/L
  * Purulent tracheal secretions

Exclusion Criteria:

* Neutropenic patients (neutrophils \< 0.5G/L),
* Previous diagnosis of IPA,
* Minor patients.
Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody

This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.


Eligibility Criteria:
Inclusion Criteria:

* Stage III or Stage IV melanoma
* No evidence of disease following resection of melanoma lesions
* Recovered from all prior surgical or adjuvant treatment-related toxicities

Exclusion Criteria:

* History of chronic inflammatory or autoimmune disease
* History of inflammatory bowel disease
Impact of Work Environment Absent of Natural Light on Vitamin D Levels

Three types of workers exposed to different levels of natural sunlight will be tested for Vitamin D blood level, PTH, Ca, P, albumin and alkaline phosphatase.

In addition, each tested worker will be asked to fill a questionnaire for demographic, medical and personal habit information.


Eligibility Criteria:
Inclusion Criteria:

* people employed in their current work place at least 6 months,

Exclusion Criteria:

* people who consume food additives containing Vitamin D.
* people who have a chronic illness which harms the Vitamin D absorption, such as Celiac, chronic Pancreatitis, Cystic Fibrosis and IBS.
* people who have a chronic illness which harms Vitamin D metabolism, such as chronic hepatitis, kidney insufficiency and Nephrotic Syndrome.
* pregnant women.
* people who require prescribed medicine like steroids, anti-convulsion, and HIV treatments.
Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study

The burden of cardiovascular disease (CVD) is considerable, despite many advances in diagnosis, clinical management and drug therapy. The World Health Organization estimates 30% of global deaths are attributable to CVD and whilst mortality rates in developed countries are falling, it remains the largest single cause of death (WHO, 2007). Nineteen out of every 100 deaths in Australia are attributed to CVD, with an annual cost of $1.47 billion (AIHW, 2006).

Assessing the risk of future cardiovascular events is traditionally based on a number of 'risk-factors' determined by observational clinical studies such as the Framingham cohort. Recent evidence however invalidates their use in both the highest and lowest risk groups and raises questions about applying such methods in changing risk-behaviour. A considerable number of new risk markers have surfaced in recent years (including various biomarkers, pulse wave velocity and measures of arterial function). Unfortunately their long-term predictive capacity is largely unknown, particularly when compared with existing risk factors.

The aims of this study are to provide objective longitudinal data for a wide variety of risk markers both in current use and in development. Participants of current on-going clinical studies at will be approached to lengthen their observation period for the purposes of determining long-term clinical outcomes.

Standard clinical observations and data obtained within the participant's enrolled studies will be collated into an electronic database. All existing and future studies must have individual approval from an appropriate ethics committee with signed consent. The baseline studies and follow-up assessments of this cohort will be correlated with cardiovascular events, hospitalizations and mortality. In addition, volunteers can be directed to appropriate clinical studies in CVD, thereby enhancing recruitment, encouraging good quality clinical studies and advancing knowledge of cardiovascular disease prevention.

Design: Longitudinal cohort study

Objectives:

* Establish a database of cardiovascular risk factors
* Correlate with long-term cardiovascular outcomes
* Assign suitable volunteers to appropriate clinical studies

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years of age

Exclusion Criteria:

* Risk assessment would constitute harm to patient
* Informed consent not obtainable
Chronic Post Surgical Pain-Cardiac

The CPSP-Cardiac is a large, multi-center, observational study with the aim to investigate the incidence of chronic pain in the 3rd month postoperatively in cardiac surgery and its affecting factors.

Cardiovascular diseases pose a significant global health concern, particularly among the elderly population, leading to a surge in surgical interventions. Enhanced Recovery After Surgery (ERAS®) protocols, specifically ERAS® Cardiac, target improved perioperative pain management to optimize patient outcomes. Effective pain control aims to alleviate acute discomfort, prevent chronic pain development, facilitate early mobilization, reduce hospital stays, and enhance patient satisfaction and functional recovery. While pain intensity peaks within the initial days following cardiac surgery and gradually subsides, inadequate acute pain management can predispose patients to chronic pain, impairing their quality of life. Multimodal opioid-sparing analgesia strategies are recommended, with recent advancements in ultrasound-guided regional anesthesia techniques showing promise in enhancing acute pain relief and reducing opioid consumption, particularly through truncal fascial plane blocks and parasternal blocks. However, the impact of these techniques on chronic postsurgical pain remains incompletely understood. This multicenter study aims to investigate the incidence of chronic postsurgical pain following cardiac surgery, exploring the influence of various factors and their implications on patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* patients will be undergoing a first-time cardiac surgery involving a median sternotomy, including coronary artery bypass grafting (CABG) and all open-heart procedures, such as valvular repairs/replacement.
* patients between the ages of 18-80 years
* American Society of Anesthesiologists (ASA) Physical Status score of II-III
* patients will also sign the written informed consent form

Exclusion Criteria:

* patients scheduled for minimally invasive cardiac surgery,
* patients with BMI\>40,
* patients who undergone thoracotomy,
* patients with alcohol and drug addiction,
* patients with severe dysfunction in a significant organ (e.g., presence of severe hepatic and renal disease),
* patients who undergone emergency and redo surgeries,
* patients who cannot be extubated within the first 8 hours postoperatively,
* patients have a severe psychiatric diseases such as psychosis or dementia that restrict cooperation with the patient (patients who cannot evaluate verbal numerical pain scales),
* patients who are pregnant and breastfeeding,
* patients who cannot be reached by phone during the postoperative follow-up periods
* patients who cannot communicate in the native language.
Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?

Prospective multicenter study in which all patients with borderline or locally advanced pancreatic adenocarcioma undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. Preoperative images by traditional CT and 3D-MSP technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis).

Neoadjuvant chemotherapy followed by surgery represents the treatment of choice for patients with borderline and locally advanced pancreatic adenocarcinoma (PAC). Despite being the diagnostic technique of choice for PAC staging, computed tomography (CT) has a very low accuracy in detecting those patients who may benefit from surgical resection after neoadjuvant chemotherapy. Consequently, the study of computerized image processing technologies is gaining importance. However, there are no prospective validation studies of these technologies to determine their usefulness in the preoperative evaluation of PCA patients undergoing neoadjuvant therapy.

A prospective multicenter study in which all patients with borderline or locally advanced PAC undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. Preoperative images by traditional CT and 3D-MSP technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis).

A prospective, multicenter study with control group will be performed. Since this is the evaluation of a diagnostic test, it will not be necessary to randomize the patients included, since each patient will be evaluated by means of both techniques under study, thus serving as his or her own control.

Eligibility Criteria:
Inclusion Criteria:

- Patients with a diagnosis of borderline or locally advanced PAC of the head of the pancreas, as defined by the National Comprehensive Cancer Network (NCCN), who have received neoadjuvant treatment and who undergo surgical exploration with resective intent.

Exclusion Criteria:

* Patients younger than 18 years of age.
* Patients under 18 years of age.
* Disease progression during neoadjuvant treatment.
* No preoperative CT scan.
* Refusal to participate in the study.
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin

Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the management of neuropathic pain in the short term - up to six hours.

This study will examine the role of intravenous lidocaine in the relief of neuropathic pain over four weeks following infusion compared to an active placebo infusion of diphenhydramine(Benadryl) in normal saline. If we can show that intravenous lidocaine provides sustained benefit for up to one month, this will be a major advance in the management of individuals suffering from neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Chronic neuropathic pain due to diabetes mellitus or herpes zoster and a score of 4/10 or greater on the DN4 questionnaire.
* Moderate to severe pain as defined by screening average pain intensity of 5 or greater on a 0-10 numerical rating scale.
* Neuropathic pain duration of at least 6 months.

Exclusion Criteria:

* Presence of clinically significant cardiac disease.
* Poorly controlled seizure disorder.
* Significant psychiatric disorder.
* History of allergy to lidocaine or any other amide local anesthetic
* History of allergy to diphenhydramine.
* Prior treatment with a local anesthetic infusion.
* Neuropathic pain due to cancer or complex regional pain syndrome
* Language barrier or cognitive impairment that would preclude understanding of the study and filling out of questionnaires
* Lack of a driver to transport the patient to and from the pain clinic.
Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose

Patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular complications. Statins have shown to lower cholesterol levels and reduce cardiovascular events in other scenarios. The objective of this study is to explore the effects of atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo noncardiac surgery.

Cardiovascular complications, such as myocardial infarction (MI) and stroke are common in the perioperative period of noncardiac surgeries. To the moment there are no safe and effective interventions to reduce vascular events in this scenario. Data from observational studies and small-sized randomized controlled trials (RCTs) have shown promising results in terms of risk reduction. In addition, experimental data have indicated that statins have acute anti-inflammatory properties, which promote the stabilization of atherosclerotic lesions and, therefore, might reduce the risk of MI, even in the short term. This study was designed to explore the effects of atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo noncardiac surgery.

The study was conducted in accordance with the prespecified protocol and reached successful enrollment rates when, by the end of 2014 the steering committee was invited to join an international initiative and participate in a much larger clinical trial to investigate this relevant question. Due to this outstanding possibility, the steering committee decided to redesign the study which is now formatted as an exploratory trial. As described, the study was completed with the inclusion of 648 participants in June, 2015.

Eligibility Criteria:
Inclusion Criteria:

Patients older than 40 years-old undergoing non-cardiac surgery with an expected hospital stay of at least 24hs and that fulfills any one of the following criteria:

A) Established vascular disease:

i) Major vascular surgery ii) All types of surgery in patients with overt atherosclerosis (any significant or symptomatic coronary, cerebral or peripheral artery disease)

B) Without established vascular disease:

At least 3 risk factors for cardiovascular complications:

1. Major surgery;
2. Emergency surgery;
3. Previous history of heart failure;
4. diabetes;
5. Arterial hypertension;
6. Smoking habit along the last two years;
7. chronic kidney disease (creatinine greater than 2mg/dl);
8. Patients older than 70 years.

Exclusion Criteria:

* Previous intolerance to statins
* Current rhabdomyolysis
* Current use of statins
* Severe Liver Failure (CHILD-PUGH SCORE C)
* Breast-feeding or pregnancy
* Low-risk surgeries
Pain in Competitive Athletes With Physical Disabilities and Techniques for Its Management

There are psychosocial factors that affect pain, and therefore, psychological intervention techniques have been added to its usual pharmacological and physiotherapeutic treatment. Despite the abundant evidence that addresses psychosocial factors as clear mediators in the perception of pain, the use of psychological techniques for pain management in competitive athletes, and more especially in competitive athletes with physical disabilities, is scarce. The purpose of this study was to ascertain the perception of high-level competitive athletes with physical disability and sports agents (coaches, physiotherapists and psychologists).

Qualitative study with in-depth interviews to find out the perception of sports agents (coaches, physiotherapists and psychologists) and athletes on how pain can affect the development of the sports career and to determine what techniques are known and/or implemented by sports agents (coaches, physiotherapists and psychologists) and athletes to manage pain.

Eligibility Criteria:
Inclusion Criteria:

For the athlete:

* Physical disability.
* Participate in high performance competition
* Aged between 15 and 55 years old;

For the sports agents:

* To exercise their profession with high performance athletes with physical disabilities

Exclusion Criteria:

* Not meeting the above requirements
Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery

SGLT2 inhibitors are oral anti-diabetic medications that were found to improve cardiorenal outcomes in patients with type 2 diabetes mellitus (DM), chronic heart failure with reduced and preserved ejection fraction, and chronic kidney disease. Recent evidence suggested that the use of SGLT2 inhibitors resulted in a significant reduction in atrial fibrillation (AF) over a mean follow-up duration of 2.6 years. Given the possible AF protective benefit with SGLT2 inhibitors use.

we aim to conduct a retrospective cohort study to evaluate the impact of SGLT2 inhibitors use on post-operative AF (POAF) among patients undergoing cardiothoracic surgery, including coronary artery bypass grafting (CABG), valve replacement, and valve repair over a 6-year period (from 1/06/2017 to 1/07/2023). The follow-up period will be the post-operative hospital stay or 30-days, whichever is shorter, and the data will be obtained from the electronic medical records. The study outcomes will include effectiveness outcomes of incidence of POAF regardless of frequency, duration, or intervention used for termination, incidence of paroxysmal POAF, incidence of paroxysmal POAF requiring pharmacological cardioversion, incidence of hemodynamically unstable POAF requiring electrical cardioversion, incidence of persistent POAF (sustained beyond 7 days), incidence of POAF requiring anticoagulation, ischemic stroke, and safety outcomes of euglycemic diabetic ketoacidosis and urinary tract infections (UTI).

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years undergoing cardiothoracic surgery, including CABG, mechanical valve replacement, bioprosthetic valve replacement, or valve repair.
* Use of SGLT2 inhibitors for a minimum of 1 week prior to surgery regardless of DM status.
* Resumption of SGLT2 inhibitor after stepping down from the intensive care unit.

Exclusion Criteria:

* Known AF on anticoagulation.
* Chronic kidney disease with CrCl \< 25 mL/min.
Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section

This cross-sectional observational study was conducted to compare breastfeeding success and breastfeeding self-efficacy levels of mothers who gave birth via vaginal delivery (spontaneous or via epidural analgesia) or cesarean section (under general or spinal anesthesia).

This study was conducted by including women, who gave birth via VD or CS in the gynecology clinics of a training and research hospital and a city hospital and were in the postpartum period (after 24 hours).

It compared the breastfeeding self-efficacy and breastfeeding success of mothers who gave birth via CS (under spinal anesthesia or general anesthesia) with those of mothers who gave birth via vaginal delivery (under epidural analgesia or via spontaneous vaginal delivery).

Eligibility Criteria:
Inclusion Criteria:

1. being aged \>18 years old;
2. being literate;
3. having a baby of weight between 2500-4000 g, with 5th minute APGAR score of ≥7, and without congenital diseases and sucking and swallowing problems;
4. not having a disease that prevents breastfeeding;
5. having a full-term (37-42 weeks) VD or CS,
6. agreeing to participate in the study

Exclusion Criteria:

1. a history of psychological or mental health problems
2. any condition in the mother or infant that was a barrier to breastfeeding
3. baby's admission into the neonatal unit
4. baby's separation from the mother for any reason