cyrilzakka/clinical-trials huggingface dataset:
Healing of Burns and the Effect of Shockwave Therapy on the Recovery of Skin Grafts

The study is to review whether musculoskeletal shockwave therapy (ESWT) can speed up the healing of second-degree burns as well as skin-graft donor sites.

In both cases, the primary hypothesis is the shortened period leading up to the complete healing of the wound (reepithelization).

The secondary hypothesis in the course of the study assesses:

the rare manifestation of undesirable local events (e.g. reddening, swelling, hematoma).

ESWT is administered as a one-off treatment on the wound surfaces within 24 hours of a 2nd degree burn trauma and immediately after an intraoperative skin graft excision procedure. A defocused sound head is orthogradely applied to the burn wound or the donor site. 100 impulses/cm² is administered at 20 seconds per cm². The defocused sound head is placed on the wound along with a sterile gel (Lavaseptgel®, Octenidingel®) and a sterile protection foil. The shockwaves deployed are not at an energy density that is painful. This single application of ESWT is followed by routine dressing using Mepitel® in combination with Polyhexanid/Octenidin®.

Eligibility Criteria:
Inclusion Criteria:

Group A (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of age who have sustained a superficial 2nd degree burn on ≥1% and ≤30% of the surface of the body.

Group B (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of age who have sustained a deep 2nd degree burn on ≥1% and ≤30% of the surface of the body.

Group C (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of BBS.

Exclusion Criteria:

General exclusion criteria

1. pregnancy
2. below 18 or above 80 years of age
3. burns requiring artificial respiration, since consent for the study participation is unobtainable
4. extent of burns ≤1% to ≥30% of the body surface

Anamnestic exclusion criteria

1. diabetes mellitus requiring insulin
2. dialysis-dependent
3. ongoing chemotherapy treatment
4. drug abuse
5. systemic skin diseases
6. systemic and local cortisone therapy

Local exclusion criteria

Excluded from the study are those with burns in the regions:

1. head, face, neck
2. proximal ventral and dorsal thorax
Effectiveness of Conventional Therapy Plus Pulsed-Radiofrequency for Herniated Nucleus Pulposus

The purpose of this research was to study whether the additional application of a certain medical intervention making use of radiofrequencies (pulsed-radiofrequency) would reduce pain in patients with herniated disk.

Pain is an uncomfortable sensory and emotional experience that can affect quality of life. Low back pain (LBP) is one of the most common causes of pain, with herniated nucleus pulposus (HNP) being a common etiology. Pulsed radiofrequency (PRF) is a relatively novel technique that has shown promising results in many applications, including spinal pain conditions.

This quasi-experimental study aimed to compare pain levels between patients who underwent conventional therapy (CT) alone and CT plus PRF as management in patients with HNP. Pain severity was measured in the numeric rating scale before and 1 month after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Having an established diagnosis of HNP
* Complaint present for at least the pas 3 months
* Experiencing pain intensity of 4 or greater on the numeric rating scale
* Capable of giving informed consent

Exclusion Criteria:

* Pregnant patients
* Presence of infection at the site of pulsed radiofrequency
* HNP with red flags.
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis

Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis knee

Exclusion Criteria:

* coaguloapthy
* patient refusal
Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis

Randomized, double-blind, placebo-controlled, parallel group study where subjects will receive velmanase alfa or placebo for 24 weeks.

Each subject undergoes to 8 complete visits at the clinic for clinical, laboratory and functional assessments. Study treatment is administered weekly through i.v. infusions

A Screening visit (V1) will take place 7±3 days prior to randomization in order to give the subject enough time to consider their participation in the study, to plan the next visits including the long-stay visits at V2, V5 and V8 (long-stay visits as PK and certain tests are performed over more than one day), and to allow the clinic center to complete the evaluation of the eligibility criteria.

Upon confirmation of eligibility, subjects will be randomized to receive weekly i.v. administration of either velmanase alfa 1 mg/kg or placebo.

Thereafter, subjects will undergo weekly visits for administration of study treatment and safety data collection. Clinical, laboratory and functional assessments will be performed at the 4-weekly assessment visits with each subject undergoing a minimum of 8 assessment visits (V1 to V8).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of alpha-mannosidosis based on alpha mannosidase activity \<10% of normal in leukocytes or fibroblasts or through genetic testing;
* Capability to comply with the protocol;
* Evidence of informed consent provided by subject or legally authorized guardian(s) prior to performance of any trial-related activities.

Exclusion Criteria:

* Previous hematopoietic stem cells transplantation (HSCT) with positive outcome;
* Major surgery planned within 3 months prior to study entry or planned during the study that, in the opinion of the Investigator, would preclude participation in the trial;
* Known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition that would preclude participation in the study in the Investigator's judgment;
* Pregnant (as evident by a positive urine hCG or serum-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential \[WOCBP\]) UNLESS they are willing to use highly effective birth control methods;
* Participation in other interventional trials testing investigational medicinal products (IMPs) within the last 6 months;
* Total IgE \>800 IU/ml;
* Any hypersensitivity to velmanase alfa or its excipients that, in the judgment of the Investigator, places the subject at an increased risk for adverse reactions
* Clinically active infection and recent vaccinations (within the last month before screening).
Comparison of Coconut and Sunflower Oil Application in Preserving Babies' Skin Integrity

This study was planned to examine the effects of coconut and sunflower oils applied to the skin of newborns on the daily fluid intake and output of the baby, the weight gain/decrease status and skin integrity.

Although there is no consensus on the use of products in daily skin care to maintain the skin integrity of newborns, many products are used. These products; mustard, sunflower, sesame, coconut, olive, soybean, palm oils, ointment (Auqophor), cream (Eucerin) and moisturizers. It is stated that these products prevent skin drying and fissures, maintain skin integrity, and reduce transepidermal fluid loss (Vaseline).

Sunflower oil accelerates the maturation of the skin barrier, there is less weight loss in newborns younger than 35 weeks of gestation who are massaged with sunflower oil compared to the control group, the incidence of nosocomial infections in newborns who receive skin care with sunflower oil is lower than the control group, sunflower oil protects the newborn from infections, olive oil, more effective than oils such as soybean oil and mustard oil; In another study, it was determined that skin care applied to preterm newborns with sunflower oil reduced mortality by 26%, the duration of hospitalization was shorter in newborns treated with sunflower oil than the control group, and regular use of moisturizers had no effect on the incidence of infection. Recently, it has been reported that topical application of coconut oil is safe and feasible in very preterm infants and has beneficial effects on skin condition and recovery of infants. In a systematic review of randomized studies evaluating the effects of topical coconut oil in preterm infants, it was emphasized that in general, transepidermal fluid loss and infection rate were reduced in infants in the coconut oil group, the growth and skin integrity of the infants were better, and no significant side effects were experienced. In a study comparing coconut and carrot oils, it was stated that the skin flora and barrier function were better in babies using coconut oil.

Comparison of the application of Coconut and Sunflower Oil in the preservation of skin integrity, the amount of fluid ingested/extracted daily, and weight gain/decrease in infants hospitalized in the Neonatal Intensive Care Unit.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary verbal and written consent of the parents of the newborn,
* The gestational week of the newborn is 34 and above,
* The birth weight of the newborn is 2000 g and above,
* The hospitalization of the newborn is the first day of birth.

Exclusion Criteria:

* Unstable clinical condition and vital signs,
* Having a major congenital anomaly,
* High risk of infection due to surgery,
* More than 5% of the body surface is a skin disease,
* External application of medication to the skin in its treatment.
Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures

Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates.

The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.

: Proximal humerus fractures have a higher occurrence in elderly patients and therefore represent a public health problem.

Prognosis depends on greater and lesser tuberosity status, where rotator tendons of the shoulder have their insertion site.

Surgical treatment is recommended in case of tuberosities displacement. Goals are their anatomic reduction and stable primary fixation that will allow good bone healing and early mobilization. It has been demonstrated that an extended immobilization can result in stiffness by capsular retraction. On the contrary a too early mobilization can lead to secondary displacement of tuberosities and malunion.

These sequelae can be responsible for real disability when occuring in active patients, in particular when dominant limb is affected.

Internal fixation by locking intramedullary nails is currently the first choice technique because less invasive. However it doesn't always provide a good bone fixation, leading to tuberosities displacement or longer immobilization that decrease shoulder function prognosis. Locking plates represent a good alternative to avoid these complications by offering a better fixation of tuberosities in osteoporotic bone.

Though there is no existing randomised study comparing these techniques regarding functional outcomes, complications rates, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* patients between 40 and 85-years-old, who didn't expressed opposition to inclusion, with type III or IV displaced CEPHALOTUBEROSITY fracture( classification of Neer and DUPARC).

Exclusion Criteria:

* CEPHALOTUBEROSITY fractures type IV - CT4 will not be included because it can correspond to posterior or anterior fracture-dislocation of humeral head and therefore be associated to very high risk level of avascular necrosis . In this case a surgical treatment by arthroplasty is recommended.

Dislocated fracture Patient who express opposition to inclusion polytrauma
Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)

Amifampridine may also be effective in treating the sequelae of botulinum toxin injections and this study will determine if neuromuscular transmission as measured by single fiber electromyography is improved in patients treated with BTX-A following administration of amifampridine

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years of either gender and of any racial background
* Underwent BTX-A injection of facial muscles including frontalis with a total dose between 100-200 units between 80 and 150 days prior to study
* Have decision-making capacity to provide informed consent to study drug dosing and Single Fiber Electromyography (SFEMG)

Exclusion Criteria:

* History of cardiac arrhythmia
* History of seizures or uncontrolled asthma
* History of renal or hepatic disease
* History of any generalized neuromuscular disease
* History of Bell's Palsy or facial nerve trauma
* History of treatment with or sensitivity to amifampridine, 3,4 diaminopyridine (DAP) or 4-aminopyridine (Ampyra®)
* Currently experiencing sequelae of previous BTX-A treatment
* Current use of pyridostigmine (known to alter neuromuscular transmission)
* Use of any investigational drug or device within 30 days of enrollment
Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study

A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.

Background: Rectus sheath plication within abdominoplasty is a standard treatment for diastasis of the recti muscles. Previous studies assessing the efficacy and endurance of the correction of recti diastasis have mostly been performed with small groups of patients, short follow-up periods and/or with questionable methodology

Methods: A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture. The investigators assess the outcomes by physical and ultrasonographic examinations and a patient questionnaire, which asks about the number of pregnancies and the types of deliveries, other abdominal surgeries before or after the abdominoplasty, the interval of time required to return to full activity, postoperative pain, and the overall satisfaction with the final result. During the examination, the inter-recti distances are measured at 3 levels: halfway between the xyphoid and umbilicus, just above the umbilicus and halfway between the umbilicus and pubis. The same examination is done on a control group of nulliparous women.

Eligibility Criteria:
Inclusion Criteria:

Women after rectus sheath plication for diastasis recti

Exclusion Criteria:

Abdominal wall defect other then umbilical hernia
Online Diabetic Foot Support Program- Care Kit

The aim of this project is to examine the effects of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who have previously had a diabetic foot ulcer on diabetic foot outcomes (diabetic foot knowledge level, foot care behavior level, foot care self-efficacy level, HbA1c, etc.).

It was planned as a randomized controlled study to determine the effect of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who had previously had diabetic foot ulcers on diabetic foot outcomes. The sample calculation of the study was based on determining the difference between two independent groups and the sample size for the experimental and control groups was taken as experimental: 31-control: 31 people using the G\*Power 3.1.9.6 program. The experimental group was given a foot care kit developed by the researcher, which included special foot care products. Pre-test data for the experimental and control groups are collected from the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Online diabetic foot care training consisting of 5 modules is given individually to the patients in the experimental group. After the training, motivational messages and informative videos are sent once a week for 3 months. Patients are also asked to send photos while doing foot care. The post-test data of the experimental and control groups will be collected at the end of 3 months with the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Training videos will be delivered to the control group at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, Individuals diagnosed with type 2 diabetes, Patients who have had diabetic foot ulcers and have healed, Can read and write Turkish, No visual, hearing, perception and any physical disability, Physical, mental and cognitive competence to participate in self-care activities, Able to use technological products (able to use computers, tablets and smartphones), Individuals who voluntarily agree to participate in the study will constitute the sample

Exclusion Criteria:

* Patients with active diabetic foot ulcers, Individuals who cannot read or write, Individuals who cannot use technological devices, Individuals who do not want to participate in the study
Cybersickness imAgiNg Olfactory Evocation

The aim of this study is to, using fMRI, compare brain activations during olfactory imagery induced by different visual supports (words, pictures, colors and colored arrangements) in healthy subjects.

This will allow us to choose the best olfactory imagery facilitator and to assess its effect on cybersickness.


Eligibility Criteria:
Inclusion Criteria:

* to be of French nationality who has always lived in metropolitan France;
* to be right-handed person;
* to be enrolled in a social security plan;
* to be able to understand the instructions given;
* to have underwent a pre-inclusion medical examination;
* to give a written consent;
* Person with a strong capacity for olfactory imagination: having obtained a score strictly below 2.5 on the fVOIQ olfactory imagination questionnaire.

Exclusion Criteria:

* to have an inability to read French;
* to be recognized as a synesthete;
* to have a professional activity requires intense olfactory activity;
* to have a partial or total loss of smell (hyposmia, anosmia);
* to have qualitative smell disorders (carcosomia, hyperosmia, phantosmia, parosmia);
* to have smell disorders of neurological, post-traumatic or neurodegenerative origin;
* to have uncorrected or poorly corrected visual disturbances;
* to have vestibular disorder diagnosed;
* any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... );
* subject under a measure of legal protection.
Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy

To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine 0.2% in preventing intraocular pressure (IOP) elevations after neodymium: yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.

In this prospective, randomized, double masked clinical trial, patients scheduled to undergo Nd:YAG laser posterior capsulotomy for posterior capsule opacification are randomized in 3 groups. The Brimonidine group receives 1 drop of Brimonidine 0.2%. The Brinzolamide/Brimonidine group receives 1 drop of Brinzolamide 1%/Brimonidine 0.2% fixed combination. The Control group receives artificial tears. All groups are administered a single drop instillation, approximately one hour before Nd:YAG application. Intraocular pressure measurements are performed before treatment (baseline) and at the 1, 3, 24 hours and 1 week post treatment.

Dexamethasone ophthalmic drops are prescribed q.i.d. for one week after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo laser posterior capsulotomy due to posterior capsule opacification (PCO) after uneventful phacoemulsification cataract extraction with implantation of posterior chamber intraocular lenses (IOL/PC).

Exclusion Criteria:

* baseline IOP greater than 21mmHg
* glaucomatous eyes, already under treatment with anti glaucomatic medications
* intraocular surgery except for uncomplicated cataract surgery
* previous photorefractive surgery
* active ocular inflammation or infection
* patients under systemic administration of medications known to affect IOP
* patients with severe respiratory or cardiovascular disease
* pregnant or breast feeding women, and individuals with known hypersensitivity or contraindication for administration of the medications tested
* a measurement of IOP \> 30 mmHg at any time point of the study, or an increase from baseline \>20 mmHg
Nutrients to Enhance Sleep Quality and Quantity

Identifying non-pharmacological means of enhancing sleep is an important area of research for elite athletes. Research completed at the AIS has identified that some athletes have difficulties falling and staying asleep during both training and competition.

There are a number of dietary components such as nutrients and certain dietary supplements that are purported to decrease sleep latency and increase quality of sleep. While many of these interventions have been investigated in isolation, no research has examined different combinations and/or amounts of these substances to determine the resultant effects on sleep. The results of such a systematic investigation could produce an effective diet based sleep product ("Sleep Drink').

The optimal components, amounts, and timing of intake of such a Sleep Drink will be explored. Additionally, the effects on sleep will be evaluated using the gold standard of sleep measurement: polysomnography.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 year old males

Exclusion Criteria:

* Exclusion: Exclusion criteria will include any observed or disclosed injury, illness, sleep or health issue which may disrupt the subject's performance or endanger their health. Participants will need to complete an adult screening tool, as recommended by Exercise and Sports Science Australia (ESSA), to assess this.
* Blood samples will also be collected to screen for magnesium, zinc and B12 which may influence nutritional impact on sleep. If subjects score above the reference ranges for these measures, they will be excluded.
* The Pittsburg Sleep Quality Index (PSQI) and Stanford Sleepiness Scale (SSS) will be used to screen for sleep disturbances. If subjects score outside the reference ranges for these questionnaires, they will be excluded.