cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Exercise Plus Pain Neuroscience Education on Brain Function in Knee Osteoarthritis

A three-arm randomized controlled trial will be conducted. Fifty-nine participants with KOA will be recruited in a 1:1:1 ratio. Assessor, and statistician will be blinded to group allocation. One experimental group (n=19) will receive NME plus PNE, the other experimental group (n=19) will receive isolated NME and the control group (n=19) will continue with usual care. The PNE will be adapted to the context of the participants. Outcome measures will be brain activity, pressure pain threshold, pain intensity, disability, fear-avoidance beliefs, self-efficacy, and pain catastrophizing. Outcome measures will be evaluated pre-intervention, immediately post-intervention, and four-month post-intervention.

The investigators hypothesize that there will be significant differences in favor of the NME plus PNE intervention group.


Eligibility Criteria:
Inclusion Criteria:

* women and men at least 45 years old radiologically diagnosed with unilateral or bilateral KOA (Kellgren-Lawrence 1-3 grading scale)
* pain duration greater than three months

Exclusion Criteria:

* Patients who have received physical therapy or other conservative therapy in the previous three months and those who have a history of major knee trauma and surgery in the last six months
* cardiac pathology
* structural use of psychoactive medications, such as antipsychotics, antidepressants, antiepileptics, and anxiolytics, during the past year
* neurological diseases
* other musculoskeletal clinical conditions that generate pain
Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis

One thousand patients with LHD who have no history of exposure to lead will be observed for 18 months. Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high sensitivity C-reactive protein (HsCRP), and blood cell counts are assessed at baseline. The morbidity and mortality are recorded in detail. Then, one hundred subjects with high BLL (\>20μg/dl) will be randomly assigned to the study and control groups. For 3-6 months, the 50 patients in the study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the BLB falls below BLL\< 5 μg/dl, and the 50 control group patients receive weekly placebo for 12 weeks. During the ensuing 18 months, the BLL, biochemical data will be regularly followed up every 3 months. BLL is measured every 6 months. If BLL of the study group patients increase \>10 μg/dl, the chelation therapy will be performed again until their BLL is \<5 μg/dl. The primary end point is morbidity or mortality during the observation and follow-up period. A secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP during the follow up period.


Eligibility Criteria:
Inclusion Criteria:

* MHD patients have dialyzed for more than 6 months and age \>18 and \< 90 year-old

Exclusion Criteria:

* Patients with malignancies and obvious infectious diseases as well as those who are hospitalized or underwent surgery or renal transplantation within the 3 months preceding the investigation;Patients with a history of occupational exposure to heavy metals, metal intoxication, living in metal-contaminated areas were also excluded.
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.


Eligibility Criteria:
Inclusion Criteria:

* A planned elective, abdominal hysterectomy
* Patients suitable for general anaesthesia

Exclusion Criteria:

* Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
* Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)
* Abnormal ECG
* Prolonged QT syndrome
* Current or regular use of analgesic medication for other indication(s)
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure

To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.


Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure of non-ischemic origin
* Age ≥18 years
* NYHA functional class III-IV
* LVEF \< 35 %
* Optimized heart failure therapy
* plasma NT-BNP \>2000pg/ml

Exclusion Criteria:

* Current treatment with Omacor or other fish oil products
* Known hypersensitivity to the study drug
* Ischemic cardiomyopathy
* Uncorrected significant valvular heart disease
* Heart failure due to congenital heart disease
* Restrictive cardiomyopathy
* Alcoholic heart disease
* Acute myocarditis
* Continuous i.v. therapy for heart failure
* Mechanical assist device
* Life expectancy \<1 year due to non-cardiac causes
* Inability to perform bicycle testing
* Women of childbearing potential not practicing a save contraception method
* Current participation in another intervention study
* Participation in another study with an intervention within the last 3 months.
Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy

Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.

Goal is:

Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function

Eligibility Criteria:
Inclusion Criteria:

* Patients with distal symmetrical diabetic neuropathy of the legs
* Type 1 or Type 2 Diabetes
* Stable Glucose control over last 3 months (Hba1c \<7.5)
* Written informed consent

Exclusion Criteria:

* Patients with peripheral arterial disease (ABI \<0.9)
* Neuropathy of other origin
* Myopathy
* Asymmetrical neuropathy
* Active infection oder fever
* Chronic inflammatory disease (z.B M. Crohn, Rheumatoid Arthritis)
* HIV or hepatitis
* Neoplastic disease without complete remission within last 5 y
* Stroke or myocardial infarction within last 3 months
* Renal failure (creatinine \> 2 mg/dl)
* Liver disease (GOT \> 2 upper limit or spontaneous INR \> 1,5).
* Anemia (hemoglobine \< 8.5 mg/dl)
* Platelets \<100.000/µl
* HbA1c \>7,5 %
* Allergies to Aspirin, Clopidogrel, Heparin
* Bleeding disorder
* Surgery or trauma within the last 2 months
* Pregnancy
* Mental retardation
* Participation in another study within 30 days
Renal Effects of RIPC in Patients After Total Arch Replacement

The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for total arch replacement
* written informed consent

Exclusion Criteria:

* pre-existing AKI
* peripheral vascular disease affecting the upper limbs
* hybrid total arch replacement
* the history of kidney transplantation
The Effect of Aerobic Endurance Training in Patients With Drug Addiction

Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. There are today few studies that provide information about SUD patients' physical health. One of the project's aims is to document the physical health of SUD patients in treatment, using objective measures. After completion of various physical tests, an 8 week period of high intensity aerobic training intervention will follow. It will be investigated if the SUD patients are able to engage and participate throughout the whole training intervention, to what degree the participants improve their physical health and the effect of physical health improvement on substance abuse treatment.


Eligibility Criteria:
Inclusion Criteria:

* substance use disorder diagnosed ICD10
* written informed consent
* "residential treatment"

Exclusion Criteria:

* not been using drugs the last six months
Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.

This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are to be treated with a Surpass Flow Diverter(s) will be eligible to participate in this registry. Patients will be enrolled on a consecutive basis.

Exclusion Criteria:

* This is a standard of care registry. Patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a Surpass Flow Diverter(s).
Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy

Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.

Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).

Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid hemorrhage
* Traumatic brain injury
* Intracranial hemorrhage
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study

According to the results Ciloğlu et al., CSC is related to elevated total testosterone levels. Testosterone may play a role in predisposing males to CSC. Thus, we aimed to investigate the possible effect of external testosteron intake over choroidal parameters; such as choroidal thickness, choroidal vascularity index, choroidal stromal ve luminal areas,ect.

In the study, we have two group: First group consists of patients with testosteron deficiency and there are sex and age-matched healthy control subjects in the second group. We will measure the parameters of both groups at baseline. And first month and 3rd month we will remeasure the values of the parameters by enhance depth optical coherence tomography. The results will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

for androgen deficient group: no other ocular and systemic disease except androgen deficiency. no history of ocular surgery or disease no medicine use for healthy controls :no other ocular and systemic disease. no history of ocular surgery or disease no medicine use, no smoking or any tobocco use

Exclusion Criteria:having any ocular and systemic disease. history of ocular surgery or disease,medicine use, smoking or any tobocco use

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Personality Characteristics and Compliance With Antiglaucoma Medication

Personality traits may influence to the drug compliance in glaucoma patients.

In chronic diseases, especially asymptomatic at early stage, drug compliance has been reported as an important factor to control them. And personality traits are associated with the drug compliance. However, there was few study to consider this relationship. We want to find the association the personality characteristics and drug compliance in glaucoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic glaucoma
* Topical anti-glaucoma medications

Exclusion Criteria:

* Oral glaucoma medications
Retinal Microvascularization and Cardiovascular Disease

The main objective of this study is to investigate whether there are links between the blood vessels of the retina as a whole and heart and/or vascular diseases (cardiovascular diseases).

The arteries and veins of the retina are, like the large vessels of the human body (aorta, coronary, cerebral arteries), exposed to the complications of hypertension, diabetes, obesity, dyslipidemia (abnormal blood lipid profile) or tobacco. Several studies have shown that changes in retinal vessels (microvascularization) generally occur several years before damage to large peripheral vessels (macrovascularization). The study of the vessels of the retina is now possible thanks to simple and non-invasive examinations of photographs (not creating any lesion). They allow a painless evaluation of the vessels in the retina.

Ultimately, if this study is conclusive, the patient's cardiovascular risk could be evaluated simply by analysis of the vessels of the retina.

The study is being conducted in the ophthalmology and cardiology departments of Dijon University Hospital. In total, the investigators wish to include approximately 510 patients who present cardiovascular risk factors (255 low risk patients recruited in the ophthalmology department and 255 high risk patients hospitalized in the cardiology department).

All patients participating in the study will be asked to visit the ophthalmology department for a complete examination of the retina.


Eligibility Criteria:
Inclusion Criteria:

* Person who gave oral consent
* High cardiovascular risk group: Adult patients hospitalized in the Cardiology Department of the University Hospital of Dijon Burgundy for acute coronary syndrome, patients between D1 and D5 of acute coronary syndrome, who can be moved for an ophthalmology consultation where the retinal imaging is done (heart monitoring in the presence of an experienced cardiologist if necessary)
* Low cardiovascular risk group: Adult patients over 40 years of age recruited in the Ophthalmology Department of the University Hospital of Dijon Burgundy following a standard consultation for cataract surgery, ocular surface pathologies and optical correction.

Exclusion Criteria:

* Person not affiliated to national health insurance
* Patient refusal
* Minor patient
* Protected patient
* Ophthalmological history (macular vascular or degenerative disorders)
Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle Toning

Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand and voluntarily provide written informed consent.
2. Healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved muscle strength and muscle toning in their core and extremities.
3. Subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during the study.
4. Able and willing to comply with the treatment/follow-up schedule and requirements.
5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study as well as have a negative Urine Pregnancy test at baseline.

Exclusion Criteria:

1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the study.
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
5. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions.
6. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone in the treatment area.
7. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections.
8. Poor skin quality (severe laxity).
9. Abdominal wall, muscular abnormality or hernia on physical examination.
10. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
11. Subjects unwilling or unable to adhere to all study requirements for treatment and follow-up.
12. Investigator may exclude any subject at any time at his/her discretion.
Pilot Study of a Tailored Model for Implementation of Injury Prevention Training in Youth Handball (the I-PROTECT Model)

This pilot study aims to test a tailored model (the I-PROTECT model) for implementation of injury prevention training in youth handball compared with current practice.

Injury prevention training is effective in reducing musculoskeletal injuries in youth athletes but has had limited public health impact because it is not widely or properly implemented. The lack of involving end-users at the individual and organizational levels is a main contributor to insufficient implementation.

This is a non-randomized pilot study included in the "Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)" project. The overall aim of I-PROTECT is to achieve wide-spread, sustained and high-fidelity use of evidence-based injury prevention training in youth handball through behavior change at multiple levels within the sports delivery system (individual and organizational levels). The I-PROTECT model is evidence-based, theory-informed, and context-specific injury prevention training specifically tailored for youth handball players, incorporating physical and psychological components and an associated implementation strategy. The process of developing the I-PROTECT model has been described.

In a prospective single-case study (ClinicalTrials.gov registration number: NCT04481958), the I-PROTECT model was implemented and tested in all youth teams (n=19) of two clubs during the 2020/2021 handball season. Due to Covid pandemic restrictions, handball training was only performed for about 2 months, thus, affecting intervention implementation and data collection. To further evaluate, develop, and finalize the I-PROTECT model, we will in the current study conduct pilot testing in clubs not involved in developing the model, before testing the model in a larger scale study.

Two clubs in Sweden offering handball for youth players will be recruited by convenience sampling. One club will use the I-PROTECT model (experimental) and one club will use current practice (control). Intervention will be approx. 6 weeks. Data will be collected among stakeholders (players, coaches, club administrators, caregivers) before, during and after the intervention. Parametric, or non-parametric, tests will be used as appropriate for main and secondary outcomes. Data will be used to calculate sample size in the main outcome for a larger scale study as well as to assess implementation determinants.

Eligibility Criteria:
Stakeholders (players, coaches, caregivers, club administrators) of all youth teams (13-17 years) in two community handball clubs will be eligible for participation.

Inclusion Criteria:

* Players: ages 13-17 years and training ≥2 times/week in a team
* Coaches: leading ≥1 training session/week
* Caregivers: directly associated with the eligible players
* Club administrators: engagement in the issues of sports injury, coach education or policy development for youth players

Exclusion Criteria:

* Employed/paid players
* Stakeholder other than the groups listed in inclusion criteria
Atorvastatin in Perioperative Vascular Surgery - Pilot Study

This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative period of major vascular surgery.

Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs


Eligibility Criteria:
Inclusion Criteria:

* Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs revascularization)

Exclusion Criteria:

* Pregnant or lactating women
* Patient with sensitivity to atorvastatin
* Patient has elevations in certain laboratory values (CK, AST, ALT)
* Known history of active hepatic disease or known hepatic insufficiency
* Patients participating in another clinical trial
* Prior statin therapy to include: \>10 mg of atorvastatin (Lipitor) or \>20 mg of other HMG-CoA Reductase Inhibitors (statins) or use rosuvastatin
* Serious infectious disease after surgery
* Known history of cancer
Uses of Immunosuppression Therapy in Patients With Liver Transplantation

Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.

Specific aims are proposed to achieve in this study:

1. To compare graft and patient survival rate, incidence of treatment-related adverse effects between different patterns of immunosuppression combination among patients received post-liver transplant care in Kaohsiung Chang Gung Memorial Hospital (KCGMH), Taiwan.
2. To quantify the long-term health impacts of immunosuppressive regimens on quality-adjusted life expectancy (QALE), the loss-of-QALE relating to immunosuppression therapy, and types of transplantation.

Eligibility Criteria:
Aim 1:

Inclusion Criteria:

* age at liver transplantation is at least 20 years

Aim 2:

Inclusion Criteria:

* age at liver transplantation is at least 20 years

Exclusion Criteria:

* deceased patient
* cannot obtain inform consent
* age \<20 years