cyrilzakka/clinical-trials huggingface dataset:
Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans. LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no longer functional. This can cause conditions known as high triglycerides in the blood and inflammation of the pancreas.

Investigational medications to treat LPLD are currently being developed. In order to see if these medications are effective, it is necessary to be able to accurately measure LPL activity in humans.

LPL activity has been successfully measured in animal models after giving heparin. Heparin is a blood thinner which is approved by the FDA. It is originally used to prevent blood clots. This study will administer heparin to healthy adults through intravenous infusion (IV). Blood samples will be collected before and after the infusion to test LDL levels.

The purpose of this study is to develop a cheap, more reliable standard for assessment of LPLD in patients


Eligibility Criteria:
Inclusion Criteria:

1. male and females between ages of 20-39

Exclusion Criteria:

1. Past history of LPL deficiency
2. Hypercholesterolemia (Cholesterol \>200, LDL \>160, HDL \<35) hypertriglyceridemia (TG\>150), any familial lipid disorder
3. Diabetes mellitus (type 1 or 2)
4. Uncontrolled hypertension SBP\>140, DBP\>90
5. History of hemorrhagic stroke
6. Current pregnancy
7. History of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study
8. Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening
9. History of allergy to heparin
10. History of heparin-induced thrombocytopenia
11. Current smoking
12. Active ulcerative or angiodysplastic GI diseases
13. Thrombocytopenia or platelet disorders (Platelet count \<100,000/UL)
14. Major health issues which may affect the safety of study subject, including but not limited to:

    * History of chronic kidney disease (eGFR\<60)
    * Long term use of medications which alter lipid metabolism
    * History of hepatic disease (ALT or AST more than 2 times the upper limit of normal)
    * History of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia
    * Chronic use of ASA, anticoagulants, platelet inhibitors
    * Use of NSAIDS for more than 2 weeks prior to screening
    * Anemia (hemoglobin \<13 g/dL)
Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia

Water vapor thermal therapy (Rezum) is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation.

For BPH, open or transurethral anatomical enucleation is recommended. Open prostatectomy has a higher risk of bleeding and slower postoperative recovery, with a higher probability of requiring blood transfusion. The incidence of urinary incontinence after transurethral enucleation ranges from 3.33% to 20%, possibly due to excessive traction and compression on the external urethral sphincter, leading to partial muscle fiber rupture. The rate of erectile dysfunction after enucleation is 8.82%, while retrograde ejaculation occurs in 6.37% of cases, especially for patients with larger prostates. Once these complications occur, they are often difficult to recover from and severely impact the patient's quality of life. In our center, the technique of Rezum has been further improved by incorporating ultrasound and MRI imaging guidance. The investigators design a reasonable and comprehensive ablation plan that ensures accurate positioning of enlarged prostate glands for complete and thorough ablation while ensuring efficacy and safety. The optimized methods mainly include ablation optimization and combined imaging techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects ≥ 45 years of age who have obstructive symptoms secondary to BPH requiring invasive intervention.
2. IPSS score of ≥ 13.
3. Qmax: Peak flow rate ≤ 15 ml/sec.
4. Post-void residual (PVR) \< 300 ml.
5. Prostate volume \> 30 ml.
6. Subject able to complete the study protocol in the opinion of the Principal Investigator.

Exclusion Criteria:

1. History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
2. Any prior minimally invasive intervention or surgical intervention for the symptoms of BPH.
3. Currently enrolled in another clinical trial.
4. Confirmed or suspected malignancy of prostate or bladder.
5. Documented active urinary tract infection by culture or bacterial prostatitis.
6. Neurogenic bladder or sphincter abnormalities.
7. Urethral strictures, bladder neck contracture or muscle spasms.
8. Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
9. Subjects who are interested in maintaining fertility.
10. Significant urge incontinence.
11. Unable or unwilling to sign the Informed Consent Form.
12. Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
Mindfulness-Based Stress Reduction for Metro Nashville Public School Employees

Stress, anxiety, and depression are common symptoms among public school teachers. Public school teachers are among the top professions reporting stress, anxiety, and depression. The causes are multifactorial and include work-related demands, challenges with students, limited resources, and compassion fatigue. Because of this, teachers are at risk of burnout and leaving or changing their profession. The COVID-19 pandemic has had a considerable impact on teachers due to disruptions in usual education delivery and ability to support students. Recent reports show poorer mental health and decreases in physical activity in teachers since the onset of the pandemic. Effective and implementable strategies are urgently needed to address poor mental health and to foster positive health characteristics in this population.

Mindfulness programs decrease feelings of stress, anxiety, and emotional exhaustion. Additionally, mindfulness can improve self-compassion, which may be an important mediating factor in a teacher population. Prior work has shown an inverse relationship between self-compassion and burnout. Currently, there are few studies investigating whether building self-compassion can reduce burnout in public school teachers. The investigators will explore therelationship between participation in a Mindfulness-Based Stress Reduction (MBSR) course and changes in burnout, self-compassion, and other whole person health measures in an educator population. The overall objective of this open pilot study is to examine the feasibility and acceptability of an 8-week remote, group-based MBSR program delivered over Zoom for Metro Nashville Public Schools (MNPS) personnel reporting elevated stress, anxiety, and/or depressive symptoms. Our pilot study results will contribute to the evidence on MBSR in a public-school employee population and inform strategies to optimize implementation of our remote MBSR program within the Vanderbilt Health at MNPS system.


Eligibility Criteria:
Inclusion Criteria:

* Working certificated Metro Nashville Public Schools (MNPS) employees who self-report stress, anxiety, and/or depressive symptoms

Exclusion Criteria:

* Unable to commit to the weekly MBSR schedule
* Have taken the MBSR course previously
* Participants who do not have reliable home internet
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

The purpose of this clinical trial is to determine the feasibility of the Y-90 plaque applicator. The Y-90 plaque application is designed to deliver high doses of radiation to tumors in the spine that involve dura (the tough outer layer of the spinal cord). Tumors in the spine need a high dose of radiation to kill cancer cells. The nearby spinal cord is a sensitive area which does not safely tolerate high doses of radiation. The Y-90 plaque applicator is a special technique used to deliver the radiation dose to the tumor cells and avoid the spinal cord.

* The surgeon will remove the participants tumor from the outer layer of the spinal cord (dura). The Y-90 applicator and a "dummy" applicator will be brought to the surgery table in a protected container. A "dummy" applicator is the same size and shape as the Y-90 plaque applicator but does not contain radioactive plaque. The "dummy" applicator will be placed on the participants dura to make sure it fits properly, then it will be removed. The working Y-90 applicator will be placed on the dura for 10-17 1/2 minutes and then be removed.
* External beam irradiation is a type of high-energy radiation used to kill cancer cells and shrink tumors. This radiation will be given to the participant only if they have not had it prior to the study.
* After the treatment, participants will be asked to return for a follow-up visit 6 weeks, 3 months, every 6 months thereafter for 4 years, then annually to year 10. At these visits, they will have the following: physical examination; recent medical history; MRI or CT scan (twice each year) and; chest x-ray or chest CT (twice each year).

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of malignant tumor involving spine with extraosseous extension or arising in paraspinal soft tissues with tumor involving or abutting the dura. Patients with a limited metastatic disease and tumor involving the spine or paraspinal soft tissues and who are judged to benefit from surgery will also be eligible.
* Lesion may be primary or recurrent after prior surgery
* No clinical, radiographic or other evidence of distant metastatic tumor
* Fit for receiving the planned radiation dose to the affected site. No known genetic disease or medical condition associated with an abnormal radiation sensitivity.
* 18 years of age or older
* KPS of 70 or greater (excluding consideration of poor function due to the local growth or systemic metabolic effects of the tumor

Exclusion Criteria:

* Disease/conditions characterized by high radiation sensitivity
* Pregnancy
* Evidence of cord/cauda malfunction for causes other than effect os local tumor growth or due to metabolic effects of tumor
Patient Activation Through Counseling, Exercise and Mobilization

PACE-Mobil-PBL is a prospective randomized controlled trial. The aim is to investigate the effect of a multimodal and exercise-based intervention among older patients with advanced pancreatic cancer, biliary tract cancer, or lung cancer during treatment with first-line palliative chemotherapy, immunotherapy or targeted therapy.

The hypotheses: That the multimodal intervention will increase or maintain physical function levels and strength, reduce symptoms and side-effects, improve quality of life, reduce treatment-related complications and hospital admissions, and reduce risk of cancer cachexia and sarcopenia.


Eligibility Criteria:
Inclusion Criteria, participants must:

* Be diagnosed with locally advanced or metastatic pancreatic cancer, OR locally advanced or metastatic biliary tract cancer, OR locally advanced or metastatic non-small cell lung cancer within 12 weeks.
* Have unresectable cancer.
* Be treated with first-line palliative chemotherapy, immunotherapy or targeted therapy at the Department of Oncology, Herlev and Gentofte Hospital.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Have the ability to speak and read Danish, and to provide a signed informed consent form.

Exclusion Criteria, patients with:

* Small-cell lung cancer.
* Any physical condition that hinder the execution of physical exercise training.
* Documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment.
* Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial.
* Unstable medical disease or history of serious or concurrent illness; any Medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class II-IV), unstable angina pectoris, implantable cardioverter defibrillator, or myocardial infarction within 6 months, based on the referring oncologist's assessment.

In patients with bone metastases:

- A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.
Determinants of the Vascular Response to Training in Chronic Obstructive Pulmonary Disease (COPD) Patients

Vascular comorbidities constitute a major burden in COPD patients. The atherosclerosis process is preceded by the onset of an endothelial dysfunction (assessed by the flow-mediated dilatation (FMD)), which is a risk factor for later ischemic vascular complications and death. In COPD, this endothelial dysfunction could be explained by intrinsic endothelial cell properties, or the effect of a pathogenic endothelial cell microenvironment (inflammation and/or oxidative stress). Exercise training constitue a powerful stimulus for the endothelial function, and could be mediated by the mobiliaztion and function of endothelial progenitors. While exercise training is an efficient intervention in COPD patients, its vascular effect appear blunted. The endothelial function response to training has appeared heterogeneous in COPD patients, and possibly linked to the endothelial cel lesion. Thus, endothelial function (assessed by the FMD) response to exercise training would be lower in COPD patients with a baseline impairment of the their FMD. In addition, of biological and functional factors could explained the magnitude of the FMD response in COPD patients.The aim of the study are thus :

To compare the FMD change in COPD patients with FMD above (FMD+) and under the median FMD (FMD-) after 4 weeks of exercise training in the whole study population.

To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects, the endothelial inflammation and senescence at baseline and the endothelial progenitor mobilization and function change induced by exercise (maximal exercise test and training).

To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects the effect of the endothelial microenvironment on the cellular pathways regulating the endothelial function in vitro at baseline and changes after exercise training.

To test in COPD patients the association between the magnitude of the FMD changes after training and biological, functional and clinical factors (inflammation oxidative stress markers, endothelial biomarkers, pulmonary impairment and phenotype, cardiovascular risks factors, vascular function, metabolic markers, physical activity level, ...)


Eligibility Criteria:
Inclusion Criteria:

A/ COPD patients

* age between 35 and 85 years old
* spirometry showing an FEV1/VC \< lower limit of normal
* with an indication for a pulmonary rehabilitation program
* written and informed consent for this study signed by the patient

B/ Healthy subjects

* age between 35 and 85 years old
* no cardiovascular or respiratory disease
* normal spirometry

Exclusion Criteria:

* Unstabilized comorbidity
* Subject in a period of exclusion relative to another protocol
* Major protected by law
* Subject participating in another research protocol
* Subject not affiliated to a social security scheme
* Pregnant or lactating woman
* Patient deprived of freedom by court or administrative order
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) in 4 arms.

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (Papilocare schedule C) Arm D (usual clinical practice-without treatment-).

Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment.

Patients will visit the site into a total of 5 visits throughout the study. Total study duration: 13 months.

Eligibility Criteria:
Inclusion Criteria:

1. Woman between the ages of 30 and 65 (both inclusive).
2. Able to read and understand the Patient Information Sheet and the Informed Consent form.
3. Acceptance in the participation of the essay and signature of the Informed Consent form.
4. ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit).
5. High risk HPV positive by PCR performed at screening visit.
6. Is able, at the discretion of the researcher, to comply with the requirements of the trial and without hindrance to follow the instructions and assessments throughout it.

Exclusion Criteria:

1. Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
2. Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
3. To had been vaccinated against HPV.
4. Other symptomatic vulvovaginal infections.
5. Surgical cervical excision in the last year or total hysterectomy.
6. Previous history of gynecological cancer.
7. Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial.
8. Any planned surgery that prevents the correct compliance with the guidelines.
9. Use of vaginal contraceptives or other vaginal hormonal treatments.
10. Contraindications for the use of Papilocare® gel or known allergies to any of its components.
11. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.
Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux

This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria :

* Digestive symptoms suggestive of GORD (heartburn, regurgitation, epigastric pain), or dyspeptic syndrome (nausea, belch, bloating, epigastric discomfort).
* Need of upper GI endoscopy and pH monitoring.
* Normal propagation of oesophageal persitaltic waves (manometry \< 6 months).
* Age 18 -70 yrs
* Signed informed consent
* Normal coagulation

Exclusion Criteria:

* Barrett's oesophagus
* Previous oesophageal bleeding
* Need of NSAID treatment.
* Previous sus mesocolic surgery
* Alcool consumption \> 40g/d, smoking \> 10 cig/j
* Pregnancy or lack of contraceptive disposal, breast feeding.
* Allergy to Xylocaïne
Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated for Giant Cells ARTEitis (Horton's Disease)

Giant cell arteritis (GCA) or Horton's disease: frequent large vessel vasculitis (cephalic) (incidence estimated at 9 per 100,000 in France), potentially responsible for blindness.

Treatment: corticosteroid therapy, which is effective in the vast majority of cases.

Clinical problem: relapse; 36% to 44% of patients have a relapse that occurs in the first year for many patients, requiring a re-escalation of corticosteroid therapy, with its consequences:

* Cumulative dose of corticosteroid therapy that causes cardiovascular and infectious morbidity.
* Requires additional immunosuppressive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 45 years or older
* Patients with giant cell arteritis according to ACR criteria or revised criteria incorporating imaging parameters,
* Patients managed at the University Hospital of Carémeau in Internal Medicine from 01/01/2011 to 01/01/2020.

Exclusion Criteria:

None
Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.

This aims to collect observational data that describe clinical (primary endpoint) and subclinical (secondary endpoint) cardiopulmonary toxicities from combined thoracic radiotherapy and immunotherapy up to 25 months after thoracic radiotherapy and 12 months after consolidation immunotherapy among patients with locally advanced lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years age
* Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curative radiotherapy (45Gy and above) and planned consolidation immunotherapy.

  * Patients who are not receiving concurrent chemotherapy and radiotherapy are eligible.
  * Patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study.
* ECOG performance status of 0-2
* Life expectancy of 6 months or longer
* Patient able to provide a written informed consent prior to study entry

Exclusion Criteria:

* Prior thoracic radiotherapy to chest.
* Patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy.
* Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

This study is a two-arm parallel group randomized double-blind placebo-controlled trial with the aim of Investigating pyridoxine effect on behavioral side effects of levetiracetam in adult patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* Patients with epilepsy
* Patients who are treated by levetiracetam (Levebel, Cobel darou) in recent month
* Complaint of behavioral problem
* Patient's consent for participation

Exclusion Criteria:

* History of known psychiatric disease
* Pregnancy
* Incidence of psychotic side effects including hallucination, psychosis, suicidal idea or attempt
* Treatment with psychiatric medications
* Alcohol or drug abuse
* Mental retardation to the degree that intervenes comprehension and response to questionnaire