cyrilzakka/clinical-trials huggingface dataset:
Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury

The objective of the study will be to investigate the effect of low-level diode laser therapy (LLLT) and steroid on facial nerve injury. Thirty five male Wistar rat will randomly be divided into five groups: healthy control (HCG); damage control (DC); laser (LG); steroid (SG); and combined laser and steroid group (LSG). Right facial nerve electromyography (EMG) data will record after facial nerve damage done and before sacrification at 4th week.The results will be evaluated histopathologically, electrophysiologically and biochemically.

The animals will be randomly divided into two control groups, a healthy control group and a damaged control group, and three experimental groups; 7 rats were assigned to each group as follows;

1. Healthy Control Group (HCG): Seven rats will be included randomly in this group. No surgical/medical approach will be applied. EMG measurements will betaken over the right facial nerve.
2. Damaged Control Group (DCG): Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
3. Laser Group (LG): Facial nerve injury will be created on the right facial nerve. LLLT (Low-Intensity et al.) will be applied 3 times a week for 4 weeks postoperatively, at 830 nm with an optical power output of 30 mW, an energy density of 4 J/cm2, an irradiation area of 0.116 cm2 and an exposure time of 16 s per spot. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
4. Steroid group (SG): Facial nerve injury will be created on the right facial nerve. Intraperitoneal methylprednisolone (1mg/kg/day) will be administered every day for 1 week postoperatively. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
5. Laser+Steroid Group (LSG): Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

-Thirty-five male Sprague-Dawley rats weighing 200-300 g will be included the study

Exclusion Criteria:

-Rats that are older than 6 months and are not healthy and have impaired facial motor functions will be excluded from the study.
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin

The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

Rational and background :

The care for low back pain associated with neuropathic pain is a problem often encountered in daily outpatient.

And the care effectiveness has been frequently evaluated by the patients directly, because the pain would be felt by patients themselves.

On the view of those, we decided to investigate the clinical treatment outcome of pregabalin or other analgesics medication for relief of pain and improvement of sleep interference and QOLs by Patient-reported outcomes.

Research question and objectives :

To evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

Study design:

This is an 8-week, multicenter prospective observational study. Subjects who have chronic low back pain patients with accompanying lower limb pain (with a neuropathic component) and meet all other entry criteria are enrolled at baseline in the duration of study. The analgesic treatment is determined by the clinical judgment of the physician in charge of patient management. This therapeutic choice is not related to the decision to take part in the study. All enrolled subjects will be received with analgesic treatment. The study requires 3 visits at least, baseline/enrollment visit, Week 4 visit and Week 8 visit (or discontinuation).

Eligibility Criteria:
Inclusion Criteria:

1. Subject who received the enough study information and signed informed consent form.
2. Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
3. Subject is male or female patient ≥18 years old.
4. Subject who has complained low back pain for 3 months or more before Visit 1.
5. Subject who is refractory to prior analgesics for 3 months and more.
6. Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.
7. Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)

Exclusion Criteria:

1. Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
2. Subject who has been already treated by pregabalin
Kinetics of Extracellular Vesicles in Hemodialysis

The aim of this observational study is to gain insight into the kinetics of extracellular vesicles (EVs), derived from both in- (i.e. bio-incompatibility) and outside (tissue-injury) the extracorporeal circuit (ECC), during standard hemodialysis (HD) in adult prevalent end-stage kidney disease (ESKD) patients treated with HD.

During a single HD session, blood samples for EV-assessment will be taken at several time points and at different sampling sites in the extracorporeal circuit (sampling point 1: before the rollerpump, arterial line; sampling point 2: after the rollerpump and before the dialyzer, sampling point 3: after the dialyzer, efferent line).

Hemodialysis (HD) is a lifesaving treatment for ESKD patients. Yet, apart from beneficial effects, HD has adverse consequences, which, apart from rapid osmolality and electrolyte shifts, results from the bio-incompatibility (BI) of the extra-corporeal circuit (ECC) and intradialytic hypotension (IDH) as well. While BI arises within the ECC due to the contact between circulating blood cells and the foreign materials of the lines and dialyzer, IDH-induced tissue injury (TI) originates within the body of the patients. Activated cells can be detected by upregulation of cell surface markers and release of degradation products. Substances which are smaller than the pores of dialyzer-membranes may pass this barrier and, thus, become undetectable in blood.

Various cell types shed small particles upon activation an/or injury, so called extracellular vesicles (EVs). These EVs, which are shed by various cell types upon activation and/or injury, contain various proteins and are too large to travers dialyzer membranes. Their assessment requires strict and standardized collection and handling of blood samples. In previous HD research, both pre-analytical circumstances and analytic methods were insufficiently standardized, precluding solid conclusions. Both the contact between circulating blood cells and the ECC, and recurrent IDH, predispose to micro-inflammation and cell activation, which are related to morbidity and mortality. Hence, when analysed properly, the measuring of EVs might be a valuable tool to assess dialysis-induced adverse side-effects, not only in the dialyzer but also in the body, which, when occurring repeatedly, may influence survival.

In a recent study, we found an increase in EVs during treatment with different dialysis modalities. However, EVs were only assessed before and after dialysis. Hence, in the present study, we aim to assess the kinetics of EVs in routine HD.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Stable clinical situation: free of infection, no recent admission
* HD \>3 months
* Haemoglobin level \>6,2 mmol/L
* Residual diuresis \<200mL/24h
* Willing and able to give written informed consent.

Exclusion Criteria:

* Active infection, malignancy, auto-immune disease, or treatment with immunosuppressive medication.
* Allergy to polysulfone dialysers
* Life expectancy \<3 months due to non-renal disease
* Access recirculation
Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy

The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL).

The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.

Investigator initiated single site prospective and randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* patients being orally intubated in the Operating Room as per standard anesthesia procedures

Exclusion Criteria:

* previous history of cervical spine injury or surgery
* craniofacial abnormalities
* airway congenital abnormalities
* airway prior to surgery
Remote Ischemic Preconditioning for Renal Protection in TAVI

Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.


Eligibility Criteria:
Inclusion Criteria:

- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention

Exclusion Criteria:

* Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes
* Systemic hypotension (systolic blood pressure \< 90mmHg)
* Patients currently on hemodialysis
* Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
* Patients enrolled in other active cardiovascular investigational studies
* Severe comorbidities with a life expectancy of less than 6 months
* Pregnant or lactating women
* Patients unable to provide consent
* Patients taking the medication glibenclamide for treatment of diabetes
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.


Eligibility Criteria:
Inclusion criteria:

* Liver transplantation performed at least 6 months and up to 5 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF criteria
* Immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization
* Diagnosis of HCV genotypes 1 or 4 infection prior to transplantationconfirmed at screening
* Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization.

Exclusion criteria:

* Serum creatinine \>150 μmol/L (1.6 7 mg/dL) or eGFR \< 50 ml/min (4-variable Modification of Diet in Renal Disease \[MDRD Cockcroft-Gault formula\])
* Multi-organ transplant recipients
* Recent episode of steroid-treated acute rejection (AR) within 3 months prior to randomization, or \>1 episode of steroid-treated AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia
* Evidence of conditions that could cause graft dysfunction other than HCV infection
* Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin \<3.5g/dL or, total direct bilirubin \>1.5mg/dL or, INR \>1.5)
* Co-infection with HIV or Hepatitis B (defined as HBsAg-positive) at screening
* Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening
* Antiviral treatment for HCV administered at any time after liver transplantation
* Patients on daily doses of corticosteroids higher than 5 mg/day
* Patients with fibrosing cholestatic hepatitis
* Patients with current diagnosis of malignancies, including lymphoproliferative disorders
* Patients with platelet count \<70,000/mm3 or neutrophiles \<1,500/mm3
* History of HCC outside Milan criteria based on radiology or UCSF criteria based on analysis of the explant
Evaluation of Interprofessional Relations Between Primary Care and Hospital Centers in the Experimentation of Medical Cannabis in France Carried Out by the ANSM (ECIPCanna)

An observational study to explore inter-professional relations and perceptions around the experimentation of medical cannabis, conducted by the French National Agency for Safety and Health. The study aims to identify the barriers and facilitators to prescribing and dispensing medical cannabis and to analyse healthcare professionals' perceptions of medical cannabis in France. Using a qualitative method based on semi-directed interviews and focus groups, the study will involve hospital physicians, general practitioners, and community and hospital pharmacists participating in the the French National Agency for Safety and Health experiment. The primary objective is to understand the dynamics between health professionals involved in the medical cannabis programme, while secondary objectives include proposing strategies to overcome barriers to the provision of medical cannabis.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professional participating in the experiment conducted by the the French National Agency for Safety and Health: Hospital doctor, general practitioner, community pharmacist, or hospital pharmacist
* Non-opposition

Exclusion Criteria:

* Refusal of participation by hospital doctor, general practitioner, community pharmacist, or hospital pharmacist
Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients.

In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with CPAP therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Patients often report this fact, but it has not been objectivated.

Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients. Sleep schemes and physical activity will be studied with actigraphy.

Study Design : prospective study. Number of patients supposed to be studied: 190

Methods:

Patients Ø OSA patients assessed by polysomnography, showing apnea-hypopnea index \> 20, and Epworth Sleepiness Scale Score(ESS) \>10 Ø Indication of CPAP therapy

Initial Evaluation :

* Phase 1

  * ESS
  * BMI
  * Questionnaire : Nottingham health profile
  * Comorbidities -medical therapy
  * Smoking/alcohol Consumption
  * Then, we give an Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days
* Phase 2

  * Actigraphy report
  * Start of CPAP therapy(pressure adjusted according to autoCPAP device report after minimum one night)

Second Evaluation, after 3 months under CPAP:

* Phase 1

  § ESS
* BMI
* CPAP observance report to calculate mean use/day
* Questionnaire : Nottingham health profile
* Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days
* Phase 2: after 1 week under CPAP and actigraphy

  * Actigraphy report
  * CPAP observance report
  * CPAP Tolerance Questionnaire Ø

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe OSA
* sleepy (sleepiness assessed by Epworth Sleepiness Scale)
* indication for CPAP therapy

Exclusion Criteria:

* narcolepsy
* age \< 18
* non sleepy Moderate to severe OSA
* no CPAP treatment required
Effects of Warm-up Intensity and Blood Flow Restriction

Introduction: warming up has the function of preparing the body structures for a given task to be performed during sports, increasing body and muscle temperature, focusing on improving performance. Therefore, the use of the blood flow restriction technique (BFR) can be seen as a promising alternative for promoting greater mechanical and muscular stress, thus providing a more efficient warm-up and optimizing performance. Objectives: to analyze the effects of RFS used during low-intensity warm-up compared with low-intensity and high-intensity warm-up without RFS on performance (jump test and 30-meter sprint test) and skin surface temperature. In addition to analyzing and comparing, after the warm-up protocols with and without RFS, the acute responses on perceptual outcomes (perception of pain, change in sensitivity, subjective perception of exertion and perception of discomfort in relation to RFS) and muscle outcomes (tonus , muscle stiffness and elasticity). Methods: a randomized controlled clinical trial will be carried out, with 33 amateur soccer players aged between 18 and 35 years who will be randomly divided into three groups: low-intensity warm-up without RFS (30% VO2max), high-intensity warm-up without RFS ( 80% VO2max) and low-intensity warm-up associated with BFR (80% of total occlusion pressure) \[30% VO2max-BFR\]. All groups will carry out the heating protocol and the outcomes will be evaluated at baseline and immediately after the end of the heating, as well as 10 and 20 minutes after its completion, namely: skin surface temperature through thermography; tone, stiffness and muscle elasticity by myotometry, subjective perception of pain (VAS); pain threshold through the pressure algometer; subjective perception of exertion (BORG scale); perception of discomfort in relation to RFS (LIKERT-CR-10 scale); 30-meter sprints measured through photocells and vertical jump, measured through the force platform. Descriptive statistics will be used and comparisons will be made using the generalized linear mixed model, assuming a significance level of p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* male
* healthy
* amateur soccer player
* aged between 18 and 35 years

Exclusion Criteria:

* smokers;
* alcoholics;
* use drugs that influenced cardiac autonomic activity;
* cardiovascular, metabolic or endocrine diseases;
* having one or more predisposing risk factors for thromboembolism;
* history of lower extremity surgery or musculoskeletal injury within the last six months that may impair your performance during testing or warm-up (e.g., meniscal repair, ligament reconstruction, muscle injury, tendinopathy, lower extremity patellofemoral pain, and/or back pain);
A Study of Acute Myocardial Infarction Using FDY-5301

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA).

A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury".

FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug.

Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 year old male subjects
2. 18 to 80 year old female subjects who are not of child-bearing potential.
3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads), within 12 hours of symptom onset.

Written informed consent prior to study participation (either by the subject or a legally authorized representative of the subject)

Exclusion Criteria:

1. Previous myocardial infarction
2. Left bundle branch block (LBBB)
3. Previous coronary artery bypass graft surgery (CABG)
4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
5. Known contraindication to CMR
6. Patients with known thyroid disease
7. Subjects with past or current renal impairment requiring dialysis
8. Pregnant or females of child bearing potential
9. Body weight \> 120 kg or Body Mass Index (BMI) \> 35 kg/m2
10. Use of investigational drugs or devices within 30 days prior to enrollment into the study.
11. Life expectancy of less than 1 year due to non-cardiac pathology
12. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study
Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee Arthroscope Surgery

Knee MRI is difficult for patients to understand as the image offers a single plane image. Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality system by Mesh rendering technique.

The primary outcome of the study is APAIS score assessed at 24 hours postoperation. Experimental VR group will be applied with virtual reality transformed knee MRI whereas no interverntion group will be applied with traditional knee MRI. MRI will be transformed to virtual reality images by Mesh rendering technique.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective knee arthroscopy surgery

Exclusion Criteria:

* Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)