cyrilzakka/clinical-trials huggingface dataset:
A Comparative Study Between TMJ Discopexy to External Ear Cartilage Versus to Temporal Fascia

Discopexy is a surgical procedure aimed at stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD). The TMJ is a complex joint responsible for jaw movement, and its proper function relies on the alignment and stability of the articular disc, a fibrocartilaginous structure that cushions the joint. In cases of disc displacement or dysfunction, patients may experience pain, clicking, limited jaw movement, and other symptoms.

Discopexy involves repositioning and securing the displaced disc to its anatomical position, often using sutures or anchors, to restore normal joint mechanics and alleviate symptoms. This procedure is typically considered when conservative treatments, such as physical therapy or splints, have failed to provide relief. Discopexy aims to improve joint function, reduce pain, and prevent further degenerative changes in the TMJ. The aim of the present study is to compare between new surgical techniques of discopexy of TMJ disc either to external ear cartilage or to temporal fascia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary TMD with complete anterior disc displacement without reduction with no or minimal osteoarthritic changes

Exclusion Criteria:

* osteoarthritis
Inflammatory Markers in Sputum After LPS Inhalation

The purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as particles of different sizes.

Endotoxins are inflammatory substances present in the environment. In man, the inhalation of the lipopolysaccharride moiety (LPS) induces measurable immune responses. With an inhaled single dose of 20 micron, the inflammatory response in man is sub-clinical. During bronchoprovocation tests with allergens, the particle size determines to a large extent the intensity of the response. the response to LPS as a function of particle size is not known and will be studied in this study.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer, non-smoking or ex-smoker \>1mth and \<10packs/year
* normal ECG
* normal lab values for hematology, ionogram, AST, ALT, alk phosphatases, urea, creatinine and CRP
* FEV1/forced vital capacity \>0.7 and FEV1\>80% of predicted value
* able to produce valid sputum following induction (\>=50% viable cells, \<50% squamous cells and \<60% neutrophils)
* females must be using contraception
* written informed consent

Exclusion Criteria:

* infection within 14 days
* history of bronchial asthma
* obstructive respiratory condition with FEV1 \<70% of theoretical value
Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal Women

Postmenopausal women suffer from a series of negative health factors, such as decreased bone and muscle mass and physical performance, increasing the risk of falls and decreasing quality of life. Therefore, intervention strategies aimed at mitigating these factors are essential. A technique that has been studied and can reverse these factors is whole-body vibration (WBV), however studies present contradictory results and the main confounding factor appears to be related to the type of vibration (synchronous or side-alternating). Therefore, the primary objective of this project is to verify the effects of 12 months of whole-body vibration on different devices on bone mineral density measurements in postmenopausal women. As a secondary objective, the effects on muscle mass, physical performance, quality of life and falls will be verified. 228 postmenopausal women will participate in the study and will be randomized to: triplanar vibration (synchronous); side-alternating vibration; or false vibration. The interventions will last 12 months and will occur three times a week on non-consecutive days. The following assessments will be carried out at baseline, 6-months and 12-months: bone mineral density and muscle mass by DXA equipment, muscle thickness by ultrasound, peak torque of the knee extensor and flexor muscles by an isokinetic dynamometer, hand grip, balance static postural and vertical jump on a force platform, dynamic balance using the Timed Up and Go test, SPPB battery, fear (FES-I) and incidence of falls and quality of life (SF-36).


Eligibility Criteria:
Inclusion Criteria:

* Being postmenopausal (without menstruating for at least 12 months);
* Not performing physical exercise systematically for at least 6 months;
* Not needing assistance to carry out daily tasks;
* Do not present serious cognitive problems that make it impossible to understand simple commands;
* Do not have serious dysfunctions or implants in the spine, hips or lower limbs;
* Not have neurological diseases or diseases that affect bone metabolism;
* Do not have vascular diseases, arrhythmia, use a pacemaker, suffer from epilepsy or seizures;
* No diseases/problems that affect the retina;
* Do not present severe labyrinthitis or vertigo;
* Not using medication/supplements to increase bone and/or muscle mass for at least 6 months;
* Have not undergone cancer treatment in the last 5 years.

Exclusion Criteria:

* Withdraw from participating in the study for any reason;
* Present adverse events during interventions that cannot be controlled.
Comparison of Erector Spinae Plane Block and Rectus Sheath Block

In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.

Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years
* American Society of Anesthesiologists (ASA) classes I-III

Exclusion Criteria:

* Local anesthetic allergy
* Coagulopathy
* Injection site infection
* History of abdominal surgery
* Severe neurological or psychiatric disorder
* Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate \<15 ml/min/1.73 m2)
* chronic opioid use
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery

Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery

A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery. Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery. Opioids have well established side effects like nausea, vomiting, respiratory depression, urinary retention. Regional anesthetic techniques in anti coagulated patients may result in potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events, renal dysfunction, sternal wound infections. These make alternative therapies, including non pharmacological modalities, attractive options for optimal analgesic therapy during the post operative period.

Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium, Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in cardiac surgery. A somatotopic relationship has been described between the auricle and the other anatomical regions of the body. When specific points are accurately identified along the meridians of the ear and stimulated electrically, analgesic effects are known to occur. Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in management of post midline sternotomy pain has not been evaluated previously. Primary Relief v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative pain management.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery patient with midline sternotomy incision

Exclusion Criteria:

1. Thoracotomy incisions
2. Patients with pacemakers,
3. Post operative cognitive dysfunction
4. Anticipated ventilation \> 24 hrs
5. Pre operative opioid therapy
6. Ear infections
7. Skin lesions / allergy to adhesive materials
8. Re-exploration for any reason
The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients

Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance

Ultrasound-guided cannulation of central veins is successful in \>95% of the cases, according to the largest study so far. However, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. Critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. These changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. Supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. Based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.

Eligibility Criteria:
Inclusion Criteria:

* Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins

Exclusion Criteria:

* Less than 18 years-old

  * Patients with previous failed attempts with non-ultrasound guided technique
  * Non-resolved pneumothorax/hemothorax at enrollment
  * Refusal to sign informed consent
Comparison of Sevoflurane and Propofol on ANI

The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane.

Patients will be allocated to either propofol or sevoflurane group. Nociceptive event will be defined as long-lasting tetanic stimulation, square-wave, duration of 30 seconds , amplitude of 50mA, frequency of 50 Hz. analgesia nociception index value and hemodynamic parameters will be recorded 1-minute before and after nociceptive event.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists physical status class I or II

Exclusion Criteria:

* history of drugs that can affect the central nervous system and autonomic nervous system, such as anticholinergics, betablockers, antidepressants..etc.
* history of allergic reaction to sevoflurane and/or propofol
* history of and/or family history of malignant hyperthermia
* neurodegenerative disorder
* psychiatric disorder
* arrhythmia
* diabetes mellitus
* drug abuse history
Multimodal Neuroimaging of Stress and Reward Cues to Assess Alcoholism Risk and Relapse

Extending previous findings, and applying a novel multi-method translational approach, this project hypothesizes that there are alcohol-related neuroendocrine and neural changes observable in acute and protracted abstinence, and which can accurately classify future relapse and treatment outcome in separate alcohol dependent (AD) patient samples, thereby validating them as biomarkers of relapse, with potential clinical utility as prognostic markers in identifying and treating those most susceptible to relapse.


Eligibility Criteria:
Inclusion Criteria:

* Male and females, aged 18-60 years;
* Good health as verified by screening examination;
* Able to read English and complete study evaluations;
* Able to provide informed written and verbal consent;
* AD sample must meet DSM-5 criteria for AUD as assessed using SCID-I and have positive alcohol urine toxicology screens on admission to study; while HC group must never have met criteria for AUD, with non-binging and nonhazardous alcohol intake levels( men: below15 drinks/week; women: less than 8 drinks/week); and with negative alcohol urine toxicology screens; Page

Exclusion Criteria:

* Meet current criteria for dependence on another psychoactive substance, excluding nicotine; (ii) Current use of opiates or past history of opiate abuse/dependence;
* Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, other antihypertensives, anti-arrhythmics, antiretroviral medications, SSRI's naltrexone, antabuse;
* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
* Significant underlying medical conditions such as a history of seizure disorder, cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude subjects from fully cooperating or be of potential harm during the course of the study;
* Any psychotic disorder or current Axis I psychiatric symptoms (excluding anxiety disorders) requiring specific attention, including need for psychiatric medications;
* hypotensive individuals with sitting blood pressure below 90/50 mmHG;
* Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study); and
* those with metal in their body excluded from MRI due to safety.
Fish Oil T Cell Function

The purpose of the study is to examine the effect of dietary n-3 polyunsaturated fatty acid supplementation on subjects' pan CD4+ T cell function, cognition, and muscle function. Half of the participants will receive fish oil, while the other half will receive a placebo (olive oil).

Generalized inflammation has been consistently associated with aging and metabolic diseases, often characterized by reduced muscle and cognitive function. Although much of the aging-associated inflammation has been attributed to chronic activation of the innate host defense system, activated CD4+ T cells have been shown to contribute directly to the pathogenesis of several other inflammatory diseases. In humans, dietary n-3 polyunsaturated fatty acids (PUFA), particularly docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), have anti-inflammatory properties and reduce disease symptoms, in part, through suppression of CD4+ T cell activation. Therefore, the Researchers' overall hypothesis is that dietary supplementation with DHA and EPA in humans will ameliorate inflammatory symptoms, in part, by suppressing CD4+ T cell activation, positively affecting muscle and cognitive function.

Eligibility Criteria:
Inclusion criteria:

1. Healthy male or female according to the investigator/appointed staff judgment
2. 55 years and older
3. Stable body weight for the past 3 months (\< 5% change)

Exclusion criteria:

1. History of cardiovascular disease
2. Metabolic diseases, including hepatic or renal disorders
3. Presence of acute illness or metabolically unstable chronic illness (including diagnosis of Insulin Dependent Diabetes Mellitus)
4. Unwilling to stop taking nutritional supplements containing proteins or free amino acids within 5 days of the first study day until study completion
5. Participated in a nutritional supplement study program within the past 4 weeks
6. Any other condition according to the PI or nurse that would interfere with the study or safety of the subject or influence the results
7. Daily use of supplements containing \> 1000 mg EPA+DHA 3 months prior to the first test day
8. Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or any of its ingredients
9. Presence of fever within the last 3 days
10. Failure to give informed consent
11. (Possible) Pregnancy
12. Unwilling to comply with any other rules set forth in the Informed Consent Form
Choose the Best Concentration of Ropivacaine on TAP Block for Open Appendectomy in Children

Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall and the parietal peritoneum. The TAP block could advange the postoperative pain of Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s concentration to improve postoperative pain in Appendectomy in children. We propose a randomized trial that compares 3 groups children submitted Appendectomy in children between 6 and 16 years. The control group has received no blockade, the other two groups have received TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.

Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall and the parietal peritoneum. The meta-analyzes in adults demonstrate improved of postoperative pain and analgesic´s consumption. There are few studies on TAP block in open appendectomies and laparoscopic in pediatrics, they show good results. There is a consensus of the best anesthetic volume for good infiltration of the TAP block, but there are still doubts in the literature about the best concentration of local anesthetics of long duration. The main objective of this prospective, randomly distributed and double-blind clinical trial is to evaluate two concentrations of 0.25% and 0.5% ropivacaine with a volume of 0.4 ml / kg in pain control and the analgesic consumption through 24 hours observation in open Appendectomy in children between 6 and 16 years. 3 groups were being compared: the control group has received no blockade, the other two groups have received TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg. All pacients patients received the same protocols (anesthesia and analgesia). The provided analgesia was dipyrone every 6 hours and ketoprofen every 8 hours, and rescue analgesia was tramadol every 4hours if it were required. The FACE pain scale was used to evaluate the postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Children between 6 and 16 years who were previously healthy submitted to appendectomy.

Exclusion Criteria:

* Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.
Evaluation of the Medical Service by Socio-aesthetics in Oncology

the 3-year randomized controlled RCT-SE study aims to investigate Socio-aesthetics well being care on quality of life, pain and anxiety.

The primary objective is to show that socio-aesthetics well being care improves quality of life during cancer treatment, compared to self care administration of dermo-cosmetics products

The secondary objectives are to show that socio-aesthetics well being care significantly reduced anxiety and pain compared to self care administration of dermo-cosmetics products

Socio-aesthetics care is the delivery appropriate beauty care in a population weakened by a physical, psychological and/or social attack.

this well-being care is imperfectly assessed with few data from randomized controlled trials.

The RCT-STudy is a randomized, controlled, multicenter, open label, intervention study that will be conducted among 400 patients treated with chemotherapy for breast, prostate, colon and lung cancer.

Patients will be randomly assigned to one of the two arms of the study according to a 1:1 ratio:

* Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetic person, with dermo-cosmetics product defined, during 4 consecutive chemotherapy administrations .
* Group B (control) will apply the same dermo-cosmetics products themselves (self-care) without intervention of socio-aesthetic, during 4 consecutive chemotherapy administrations

  12 Evaluations will be conducted between chemotherapy cure N° 2 and chemotherapy cure N°5:
* Pain assessed by Eva
* Anxiety assessed by HADS
* impact of socio-aesthetics care care , assessed by Patient Centricity Questionnaire (PCQ) (0 -110)

Data will be recorded using an e-CRF. patient will be recruited over 3 years and will be followed up for 3 months.

Hypothesis:

Socio-aesthetics session significantly improves quality of life and reduced pain and anxiety compared to self care administration of dermo-cosmetics products

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* treated with chemotherapy for lung , breast, colon or prostate cancer
* Able to understand, read, and write French,
* Affiliated with a social security scheme,
* Having dated and signed an informed consent.

Exclusion Criteria:

* Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,
* Deprived of their liberty by court or administrative decision,