cyrilzakka/clinical-trials huggingface dataset:
Mitochondrial Oxidation and Insulin Resistance in Burn Patients Treated With Fenofibrate

Major burn injury causes significant insulin resistance on glucose and protein metabolism that persists for up to 6 months after the acute injury

This project proposes to answer the following questions:

1. Will fenofibrate given to burn patients with insulin resistance restore their insulin sensitivity?
2. What is the relationship between mitochondrial dysfunction in muscle tissue as the causative mechanism of burn related insulin resistance?
3. To what extent will the restored insulin sensitivity affect glucose and protein metabolism in muscle, regenerating wounds and the liver, i.e. ameliorate burn related hyperglycemia and protein catabolism?

The following specific hypotheses will be investigated:

1. Following severe burn injury in human patients the mitochondrial fat oxidation capacity is decreased in muscle. This is associated with a corresponding progression in the severity of the resistance to the action of insulin on glucose disposal and protein synthesis and breakdown in muscle, regenerating wound and liver.
2. Fatty acids, or their active intracellular products (e.g., DAG, acyl-CoenzymeA (Co-A), or acylcarnitine), are the direct inhibitors of insulin action, rather than tissue triglycerides (TG) itself. In other words, impaired mitochondrial fatty acid oxidation is the mechanism that causes altered lipid metabolism that ultimately contributes to insulin resistance.
3. Accumulation of active fatty acid products, such as DAG, acyl-CoA, or acylcarnitine esters in muscle cells is due to the rate of uptake of plasma free fatty acid (FFA) exceeding the rate of oxidation within muscle due principally to a reduced capacity of mitochondria to oxidize fatty acids.
4. Decreased insulin sensitivity in muscle is related to impaired insulin signaling. This will be reflected by increased activity of protein kinase C (PKC). Because PKC is thought to exert its regulatory effect primarily on either tyrosine kinase activity on the insulin receptor or downstream kinase insulin receptor substrate (IRS) phosphorylation, these elements of the insulin signaling cascade will be decreased. In turn, elements of insulin signaling related to the response of muscle glucose (PI3 kinase) and protein (P70S6k) metabolism will be reduced. We propose that increased tissue PKC activity will be associated with increased tissue concentration of DAG, acyl-CoA, or acylcarnitine.
5. Treatment of patients with the peroxisome proliferator-activated receptor (PPAR) alpha agonist fenofibrate will improve mitochondrial capacity to oxidize fatty acids.
6. Insulin sensitivity in muscle, skin and liver in terms of both glucose and protein metabolism will be improved by fenofibrate treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 7 years old with burns covering 40% or more of body surface who are admitted to the Shriners Hospital for Children, Galveston, Texas

Exclusion Criteria:

* Abnormal liver and kidney function,
* Pregnancy,
* Diabetes mellitus,
The Application of Honey on Perineal Sutures

Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.


Eligibility Criteria:
Inclusion Criteria:

* Major women
* Giving birth vaginally in the maternity of Geneva university hospital
* First and second degree perineal tears or episiotomy
* French speaking women
* The day of the delivery

Exclusion Criteria:

* Allergic to honey and bees
* Drug use
* postpartum hemorrhage
The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department

The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.

Methods

* a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
* survey for the occurrence of vomiting at ED and after discharge

Primary outcome

* the number of vomiting at ED and at home

Secondary outcome

* parent's satisfaction and ED length of stay

Eligibility Criteria:
Inclusion Criteria:

* children under 18 years of age
* children who are planned to admit ketamine intramuscular injection
* children with ASA classification class I or II

Exclusion Criteria:

* don't want to enroll to study
* children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria)
* children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus)
* children under 3 months of age
* children whose weight are over 30 kg
* children managed by other drug with ketamine
Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19

The purpose of this trial is to assess the safety and toxicity profile of the combination of famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2 infection.

This is a phase I trial enrolling subjects with newly diagnosed SARS-CoV-2 infection who do not require hospitalization. Exclusion criteria have been written to exclude patients who would be expected to have increased risk from either medication alone. Subjects will be assigned a dose combination of famotidine and n-acetyl cysteine. In addition to assessing the safety and toxicities profiles of the combination of drugs we will be measuring certain endpoints to assess possible efficacy. These endpoint include the following: rates of hospitalization; time to complete remission of symptoms, e.g, fever, respiratory symptoms, etc.; severity of symptoms with validated survey instruments; cytokine values in serum and urine; and markers of inflammation and oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* performance of a SARS-CoV-2 test within 1 day of enrollment, N.B., must be positive to proceed to treatment phase of the trial

Exclusion Criteria:

* All patients under 18
* Known allergy to N-Acetyl Cysteine
* Known allergy to famotidine or other H2-receptor antagonists
* Pregnant or Nursing Mothers
* Laboratory Evidence or History of Renal Impairment (eGFR \< 30 mL/min/1.73 m2)
* Taking H2-receptor antagonists, hydroxychloroquine or chloroquine.
* Patient has been admitted to the hospital prior to study enrollment
Effect of Lavender on Sleep Quality and Insomnia Severity in Patients

Today, psychophysiological insomnia is the most common persistent insomnia. Lavender essential oil is frequently used in the literature as an aromatherapy method to improve sleep quality. Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature is reviewed, no studies examining the effects of lavender oil on patients with psychophysiological insomnia were found. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.

Today, psychophysiological insomnia is the most common persistent insomnia. The patient's inability to sleep occurs as a result of repetitive negative thoughts such as the thought that he will have difficulty sleeping before going to bed and/or past experiences involving the bedroom or the night. More effort to sleep causes more wakefulness and more difficulty falling asleep.

Numerous studies have shown that insomnia seriously affects health and quality of life and can cause various problems including memory problems, depression, irritability, cardiovascular and cerebrovascular diseases, etc. Therefore, looking for effective ways to improve sleep quality is important for individual and social health. Today, drug therapy, psychotherapy, physiotherapy and cognitive-behavioral therapy are widely used treatments for insomnia. Recently, more and more studies have found that aromatherapy is one of the non-drug treatments to improve sleep quality. Lavender essential oil appears in the literature as an aromatherapy method frequently used to improve sleep quality.

Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature was examined, no studies were found examining the effects of lavender oil on patients with psychophysiological insomnia. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older,
* Being over 65 years old
* Being diagnosed with psychophysiological insomnia,
* Knowing Turkish at a level that will allow you to read and understand the survey questions,
* Accepting to participate in the study

Exclusion Criteria:

* Having a serious physical or cognitive disability that would prevent him/her from answering the survey,
* Being under the age of 18,
* Not accepting to participate in the study,
* Being allergic to lavender,
* Having a chronic additional disease related to the respiratory system,
* Having a psychiatric or neurological additional disease,
* Using medication(s) that may affect sleep,
* Experiencing a physical activity limitation that causes bedriddenness,
* Having or contracting a disease that will affect the ability to smell.
Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the CAP Questionnaire

The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described. The "CAP questionnaire" is used in people with musculoskeletal pain and diagnostic subgroups of osteoarthritis, back pain, and fibromyalgia. There is no Turkish version of the CAP questionnaire. This study aims to investigate the cultural adaptation, validity, and reliability of the Turkish version of the "CAP questionnaire."

Chronic pain is a symptom shared by many musculoskeletal conditions, even when disease management is optimized. Musculoskeletal pathologies are reported to be an essential therapeutic target in pain management. However, these pathologies often do not adequately explain the pain or the reason for its persistence.

Central sensitization is the increased sensitivity of Central Nervous System (CNS) neurons to a standard nociceptive input. Pain that increases in intensity and distribution beyond that explained by musculoskeletal pathology has been termed "nociplastic pain." Measuring these CNS aspects of pain is a prerequisite for understanding their mechanistic basis and predicting future pain and responses to treatment. Chronic pain is associated with CNS dysfunction in several areas, including depression, anxiety, pain catastrophizing, cognitive dysfunction, sleep disturbance, and fatigue. Considering the increasing importance of assessing mood-related pain (nociplastic pain) The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described.

Eligibility Criteria:
Inclusion Criteria:

* People with musculoskeletal pain and in diagnoses with OA, back pain, or FM
* Above 18 years of age
* Informed consent of the participant

Exclusion Criteria:

* Diagnosis of uncontrolled/other clinically significant diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.)
* Pregnant women
Comparison of Lumbar Muscle Thickness Measurements in Osteoporotic and Osteopenic Patients

In osteoporosis, sarcopenia is a common condition. Sarcopenic measurements can be made by evaluating muscle thickness in different regions. We aim to evaluate lumbar muscle losses in patients with osteoporosis in the lumbar region and to examine whether these muscle losses are correlated with the level of osteoporosis. The patients will be divided into 3 groups as healthy, osteopenic and osteoporotic according to DEXA measurements. Demographic values, comorbidities, osteoporosis drugs used, fracture histories, L1-4, L2-4, femoral neck and total BMD and t values of the patients, psoas and multifidus muscle measurements will be made at L2-L3 level in Lumbar MR imaging. Lumbar MR muscle measurements will be made by 1 physician blind to the DEXA values of the patients.


Eligibility Criteria:
Inclusion Criteria:

* 50-90 years old
* 2. Recent MRI of the lumbar region with DEXA evaluation

Exclusion Criteria:

* Have had previous lumbar surgery
* Any previous lumbar injection
* Stage 3-4 Lumbar Listesis
* Presence of Lumbar Discopathy accompanied by neurological deficit
Glucagon-like Peptide-1 Receptor PET/CT in GLP-1R Related Disease

To evaluate the potential usefulness of 68Ga/18F-Exendin 4 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various GLP-1R-related disease patients.

Subjects with various GLP1-R-related disease patients underwent 68Ga/18F-Exendin 4 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Exendin 4 PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Exendin 4 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Neoadjuvant Treatment Modalities in Esophageal Cancer

Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years；
* Esophageal or Esophagogastric cancer；
* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；
* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；
* ECOG PS score: 0\~1；
* Estimated survival time ≥3 months；
* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；
* Informed consent；

Exclusion Criteria:

* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；
* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；
* Existing active infection such as active tuberculosis and hepatitis；
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；
* Participation in other clinical trials currently or within 4 weeks of selection；
* Pregnant or lactating females；
* Absence of medical records.
Study of New Implantable Loop Recorder

The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias
* Patients who experience transient symptoms that may suggest a cardiac arrhythmia
* Patients who have been previously diagnosed with atrial fibrillation
* Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented
* Patients who have provided written informed consent to participate in the study.

Exclusion Criteria:

* Patients who are under the age of 18 years
* Patients who have a life expectancy less than 1 year
* Patients who are unable to comply with the follow-up schedule
* Patients who are currently implanted with a pacemaker or defibrillator
* Patients who the physician deems inappropriate for the study
Follow-up of Migraine Patients on Eptinezumab

The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.

Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients suffering from severe migraine with at least 8 migraine days per month

  * Patients who have failed at least 2 disease-modifying treatments,
  * Patients treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at Saint-Denis Hospital and Nîmes University Hospital.

Exclusion Criteria:

* Patient refusing to participate
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus

Device under Test: The Viacor® Percutaneous Transvenous Mitral Annuloplasty (PTMA) system comprises a sterile implantable cardiac device and associated custom accessories to assist implantation. The PTMA system is intended to treat functional mitral regurgitation (MR) in a heart failure patient by a less invasive method than surgical annuloplasty with greater relief of symptoms than medical management alone.

Study Objective: Functional mitral regurgitation is associated with an adverse prognosis in the heart failure patient. The objective of this study is to evaluate whether PTMA is effective in reducing mitral regurgitation in heart failure patients and whether this reduction is associated with a moderation in the adverse progression of heart failure symptoms.

Hypothesis under Test: Reduction of the severity of functional mitral regurgitation from baseline, as defined by a composite improvement of quantitative echocardiographic metrics, can be achieved safely with the PTMA device and will be associated with a measurable moderation of adverse progression of heart failure symptoms and a moderation of the deterioration of exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* Patient has moderate functional MR: regurgitant orifice area \>/= 0.20cm2 or regurgitant volume \>/= 30 mL/beat or regurgitant fraction \>/= 30%
* Symptomatic heart failure NYHA Class II to IV
* LV dysfunction (25% \< LVEF \< 50% by echocardiography) OR dilated mitral annulus \> 30mm

Exclusion Criteria:

* MR of organic origin
* Severe mitral leaflet tethering
* History of MI or PCI within 60 days of study procedure
* Inability to walk a minimum of 100 meters in 6 minutes
* Significant left main stenosis or proximal circumflex stent
* Indication of non-patent CSO or discontinuous CS-GCV-AIV
* Bi-ventricular with leads in CS or other devices impeding device placement
* Severe aortic valvular disease
* Chronic corticosteroid use other than \< 20mg prednisone for arthritis
* Significant co-morbidities
Outcome Following Vitamin C Administration in Sepsis

This study is designed to determine if Vitamin C administration to septic patients will result in an improvement in organ dysfunction which occurs during a septic illness.

Hypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce the length of time on a ventilator, length of stay in the intensive care unit and in hospital.

This study will measure biomarkers of inflammation, coagulation and oxidative stress. These biomarkers have been shown to be increased during periods of oxidative stress eg post-operative, trauma, sepsis. The investigators will determine if Vitamin C administration decreases oxidative stress and as a result, a decrease in the markers of organ dysfunction eg SOFA Scores. Ultimately, if the investigators show a decrease in injury to organs, will this result in a better outcome for patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of severe sepsis
* admitted to the intensive care unit

Exclusion Criteria:

* allergy to Vitamin C
* history of kidney stones
* glucose-6-phosphate dehydrogenase deficiency
* history of iron overload/hemochromatosis