cyrilzakka/clinical-trials huggingface dataset:
Stretching and Musculoskeletal Pain

The purpose of this study is to assess whether a daily, 15-minute stretching routine for one year reduces musculoskeletal pain and improves quality of life in personnel working in the radiology and cardiology departments at Mayo Clinics and Mayo Clinic Health System sites.


Eligibility Criteria:
Inclusion Criteria:

* A 15-minute daily stretching program will be implemented for 1 year.
* Personnel working in the departments of Cardiology and Radiology at Mayo Rochester, - Mayo Scottsdale, and Mayo Jacksonville and Mayo Clinic Health System.
* Willing to complete standardized questionnaires (DASH, ODI) to assess work-related pain at baseline and at 1 year.
* Employees who respond to questionnaires at baseline and 1 year but don't participate in the stretching exercises will be controls for the study.
* Willing and able to provide written, informed consent.

Exclusion Criteria:

* Pregnancy.
* Inability to participate in the stretching exercises for any reason.
* Preexisting musculoskeletal problems that has required employees to seek active medical or orthopedic treatment.
Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis

The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient.

Hemodynamic instability due to high block largely limits the use of conventional dose spinal anesthesia in high-risk septic patients. Hypotension is more common, and also more hazardous, in septic patients, as they may have decreased physiological reserve and compromised blood supply to various vital organs. A smaller dose of local anesthetic reduces the severity and incidence of hypotension during spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 21 years old
* American Society of Anesthesiologists (III, IV) diagnosed with sepsis (Sequential Organ Failure Assessment (SOFA) score ≥ 7)
* Hemodynamically stable and not on vasopressor due to lower limb pathology candidate for spinal anesthesia to drain source of infection.

Exclusion Criteria:

* Patients with known hypersensitivity to local anesthesia.
* Infection at the site of injection.
* Coagulopathy.
* Septic shock.
* Increase of intracranial pressure.
* Severe deformity of the spinal column.
Treatment of Adolescent Anorexia Nervosa

VISAN is a naturalistic study of family based treatment of Anorexia nervosa in adolescnet girls.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with f500 or f501 and being planned for family based therapy at the unit.

Exclusion Criteria:

* being subjected to care by the social welfare system
Effect of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals

The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals.

The duration of the study will be 6 months during which the investigational product or placebo will be consumed according to the assignment.

Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).

Eligibility Criteria:
Inclusion Criteria:

* Adults (age: 30 - 70 YO)
* BMI over 25 kg/m2.
* Subjects who are smokers or non-smokers, but in any case who do not modify their nicotinic habits during their participation in the study.

Exclusion Criteria:

* Subjects with eating disorders.
* BMI less than 25 Kg/m2.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Participation in another clinical trial in the three months prior to the study.
* Unwillingness or inability to comply with clinical trial procedures.
* Pregnant woman.
* Participants with an active daily exercise activity.
* Subjects whose condition makes them ineligible for the study at the investigator's discretion.
Effect of Fistula Training in Hemodialysis Patients

It was planned to examine the effect of fistula-related education given to patients receiving hemodialysis treatment on their self-care behaviors.

Nurse-led education about fistula for hemodialysis patients affects fistula self-care behaviors.

Nurse-led training regarding fistula to hemodialysis patients does not affect fistula self-care behaviors.

Hemodialysis patients in the experimental group will be given face-to-face training in 2 sessions. Patients will also receive an educational brochure on fistula self-care. Simultaneously, patients will receive routine treatment and care.

No intervention will be performed on patients in the control group. These patients will receive normal treatment and care.

A pre-test will be applied to both groups at the first meeting and their self-care behaviors related to fistula will be examined. Three months later, fistula-related self-care behaviors will be evaluated again with the relevant scale.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,with chronic kidney disease
* Having a fistula as a vascular access route
* Receiving hemodialysis treatment for at least 6 months

Exclusion Criteria:

* Those with acute renal failure,
* Having a graft and catheter as a vascular access route,
* Not volunteering to participate in the research
* Those with communication problems (hearing, language, understanding, etc.)
Home Treatment for Individuals Suffering From Severe Addictive Disorders

Home Treatment (HT) has been successfully implemented in adult psychiatry in several countries including Switzerland. Patients with addiction problems were generally excluded even if the latter was not the main diagnosis. On the other hand, community treatments have successfully been established for these individuals. The investigators have recently offered HT to persons with severe addictive disorders which was well accepted.

The investigators intend to conduct a pilot study to prepare a large-scale study if successful. The investigators intend to compare HT to treatment as usual (regular inpatient treatment) on a specialized ward with respect to readmission rates during 6 months after discharge. The data show that 70.8% of all readmissions occur during the first 6 months. Therefore, a period of 6 months is considered an adequate time interval to sufficiently answer this pilot study's question.


Eligibility Criteria:
Inclusion Criteria:

* Substance use disorder
* age 18 or above
* sufficient french language skills
* competent subjects
* consent to randomization progress

Exclusion Criteria:

* organic brain disease or developmental disorder
* non voluntary admission
* severe somatic comorbidity
* History of complicated substance withdrawal
* acute suicidal ideation
* aggressive behavior
* acute psychiatric disease such as mania or psychosis
* distance to center (must be reachable within 60 minutes)
Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Men or women aged 18 years of age or older of Chinese origin
3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
4. Subjects seeking augmentation therapy for the midface
5. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
2. Previous surgery or tattoo in the area to be treated
3. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
4. Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 9 months before treatment.
5. Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated.
6. Other condition preventing the subject from entering the study in the Investigator's opinion.
Epileptogenic Network Visualisation With Advanced MRI

The goal of this clinical trial is to improve non-invasive identification of epileptogenic networks in drug-resistant epileptic patient.

The investigators aim to compare epileptogenic network identification with stereo-EEG (used as glod standard) with the identification of the same network using advanced MRI (rs-fMRI, microstructural analysis of white matter, ...). The main goals are to:

1. Compare the accuracy of network identification.
2. Analyse the effect of the MRI sequences on candidates selection and target identification.

Participants will already have been selected for stereoEEG and will undergo a supplementary MRI (about 1h) with the additional MRI sequences. Follow-up MRI are scheduled for patient undergoing a second, therapeutic epileptic surgery.

Patient identified for SEEG will undergo, prior to the implantation procedure an MRI with the following sequences:

* 3D T1
* rsfMRI
* multishell diffusion

The rsfMRI will be post-processed to delineate the epileptogenic networks based on an Independant Component Analysis (ICA) methods. Once the epileptogenic network(s) has/have been identified, connexion between the different regions will be identified through post-processing of the diffusion using a MSMT-CSD algorithm. Finally, the identified tract between the different region will be quantitatively analysed using different algorithms (NODDI, DIAMOND, MF) to better grasp there integrity.

In a follow-up study, the patients that will later on benefit from a resection or disconnection (i.e. curative surgery) will also have an identical MRI 3 months after the said procedure to evaluate the evolution on the network(s) based on the same criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from drug-resistant epilepsy
* Patient already selected for SEEG implantation as part of their epileptic networks

Exclusion Criteria:

* Patient excluded from SEEG (pregnant women, children too young for the procedure, patient unable to undergo the procedure)
* Contra-indication for MRI
Extubation Readiness Study in Very Low Birthweight Infants

The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for \>48 hours and have not yet been successfully extubated (extubated \>7 days).


Eligibility Criteria:
Inclusion Criteria:

* Birthweight \>500g and\<1500g.
* Postmenstrual age \<34 weeks
* Mechanically ventilated \>48 hours
* Never successfully extubated

Exclusion Criteria:

* Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
* Known or suspected airway anomalies
* Severe congenital malformations
* Need to remain intubated for other reasons (i.e. having surgery)
* Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers

Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present clinically with symptoms of cardiac failure although this is often a subclinical disease. Various imaging modalities and collagen biomarkers have been used as surrogate markers to assess the presence, extent, and turnover of myocardial fibrosis. Techniques using echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to detect early features of systolic and diastolic left ventricular dysfunction and impaired contractile reserve. Further identification of diffuse reactive fibrosis may be possible with evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol is to validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification against histology as standard of reference.


Eligibility Criteria:
Inclusion Criteria:

* All patients who require surgical aortic valve replacement , which will benefit from an MRI to measure fibrosis in the months preceding the surgery.
* Patient submitted to the social security scheme
* Patient agreeing to participate in the study and who signed the informed consent.

Exclusion Criteria:

* A history of myocardial
* Unstable Patients requiring treatment with catecholamines.
* hepatocellular insufficiency of alcoholic origin
* Severe renal impairment
* Appearance before examining coronary syndrome at high risk, defined according to international recommendations.
* History of known allergy to gadolinium at diagnosis
* Pregnant or lactating
* Patient \< 18 years
Effect of Wound Infiltration by Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress

This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower abdominal cancer surgery.

Patients will be randomly assigned using an online research randomizer into three groups, 30 patients in each group:

Group C:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).

Group K:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.

Group D:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I-II Body weight of 50 - 90 kg

Exclusion Criteria:

* History of bleeding diathesis
* Relevant drug allergy, opioid dependence
* Morbid obesity, sepsis
A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
* Palpable spleen of \> 10 cm below the left subcostal margin on physical examination at the screening visit OR
* Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

* Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better
* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
* Unwillingness to be transfused with blood components
* Recent history of inadequate bone marrow reserve as demonstrated by the following:

  * Platelet count \< 50 × 10\^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
  * Absolute neutrophil count levels \< 0.5 × 10\^9/L in the 4 weeks before screening
  * Subjects with peripheral blood blast count of \> 10% at the screening or baseline hematology assessments
  * Subjects who are not willing to receive red blood cell (RBC) transfusions to treat low hemoglobin levels
* Inadequate liver function at screening as demonstrated by the following:

  * Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN)
  * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × ULN
* Inadequate renal function at screening as demonstrated by creatinine clearance \< 50 mL/min or glomerular filtration rate \< 50 mL/min/1.73 m\^2
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone

The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine when co-administered with methadone. Symptoms of methadone withdrawal will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history except drug abuse), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Receiving stable methadone maintenance treatment for at least 3 months (dose range 50-150 mg QD).

Exclusion Criteria:

* Subjects on therapy for Hepatitis B and/or Hepatitis C; Evidence of impaired liver function (ie, AST and/or ALT greater than 3 times the upper limit of normal, total bilirubin \>1.5 times the upper limit of normal, albumin \<3.5 g/dL).
* 12-lead ECG demonstrating QTc \>450 msec for males and QTc \>470 msec for females or any other clinically significant abnormalities at screening.
Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese Patients

The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study should represent the differences between the two techniques.

Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional.

The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy.

It is recognized that regional anesthesia is more difficult to perform in obese patients. Anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. The complication rate of regional techniques is also reported to be higher in the obese patient population.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* BMI\>30
* Forearm- Hand surgery

Exclusion Criteria:

* \<18 years
* Local infection
* Coagulopaty
Effect of Antioxidants on Oxygen Induced Vasoconstriction in Lipopolysaccharide (LPS) Induced Inflammatory Model in Humans

Oxidative stress has been implicated in playing a pathogenic role in many disease processes, especially in age-related disorders. It has been hypothesized that antioxidative agents such as vitamins and minerals, which are capable of scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for patients with age-related disorders. Based on this hypothesis, several different combinations of vitamins have been introduced, all targeting at reducing oxidative stress. However, the in-vivo determination of the antioxidative properties of a certain drug or vitamin combination are hard to determine. In the current study, the researchers propose to investigate the effect of VITAMAC®, a combination of vitamins and minerals, in a systemic in-vivo inflammation model.

In the present study, the infusion of LPS, which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammation in humans. Given that inflammation is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS model is well suitable for determination of the antioxidative effects of VITAMAC®. As a main outcome parameter, the vascular reactivity of retinal vessels to systemic hyperoxia (induced by breathing 100% oxygen) will be tested in presence or absence of the antioxidant combination.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as well
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks