cyrilzakka/clinical-trials huggingface dataset:
Split-face Study: Cosmetic Botulinum Toxin Type A Injection Under Electromyography-guidance Versus Conventional Palpation Technique

The aim of this study was to compare between the conventional palpation method of botulinum toxin type A injection and the electromyography-guided method using clinical parameters and electromyography analysis.

The study was conducted on 15 healthy-looking female subjects with visible glabellar rhytids when frowning. All participants were recruited from the outpatient clinic of Dermatology Department, Main University Hospital, Faculty of Medicine, Alexandria University. The mean age was 46.27 ± 6.31 with a range from 33 to 59 years. All 15 subjects completed the study.

Each subject provided a right and left corrugator supercilii muscles to the study. Each muscle was divided into a body and a tail, each part injected separately (n=60).

Neurotoxin injection into the corrugator body and tail by palpation method on one side and under EMG-guidance on the other.

Photographs were taken both at rest, and while frowning at each visit: pre-operatively, after 2 weeks and after 3 months.

Clinical grading according to static and dynamic Merz glabellar frown line scales and EMG analysis was done at each visit: pre-operatively, after 2 weeks and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Consent.
* Patients within age range of 25 - 60 years.
* Visible corrugator muscle rhytids when frowning by examination.

Exclusion Criteria:

* Patients with no, or minimal wrinkles on the studied area.
* Previous use of botulinum toxin in the previous 6 months.
* Patients on regular or very occasional antispasmodics.
* Patients with any neuromuscular disorders, infections or skin problems at the injection site.
* Patients with any known neurological disease.
* Patients who undergone surgery involving the glabellar area.
Direct Portal Pressure Measurement Via Endoscopic Ultrasound in Advanced Chronic Liver Disease (EVADIPP)

A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement.

Specific Aim 1 To explore the correlation between endoscopic ultrasound (EUS)-guided portal pressure gradient (PPG) and hepatic venous pressure gradient (HVPG) in evaluation of hemodynamic response to non-selective beta blockers (NSBBs) in patients with advanced chronic liver disease and high risk varices. The investigators will perform EUS-PPG measurement and HVPG measurement at baseline and after NSBBs titration in enrolled patients. Hemodynamic response to medical therapy is defined as either a decrease in HVPG by \>20% of the baseline value or an absolute value of HVPG \< 12 mmHg after dose titration.

Correlation between PPG/HVPG values and development of portal hypertension-related gastrointestinal bleeding or liver- related events (ascites, spontaneous bacterial peritonitis, and hepatic encephalopathy) will be clinically assessed during follow-up with outpatients visits every 2-3 months.

Specific Aim 2 Identification of other markers of hemodynamic response to non selective beta blockers (NSBBs), with focus on elastography modifications and gut microbiota composition. To identify predictors of hemodynamic response, splenic and hepatic elastography measurement will performed at baseline and after NSBBs titration. In the same way the investigators will evaluate the gut microbiota before and after the start of therapy with NSBBs.

Specific Aim 3 Identification of factors potentially affecting the accuracy of PPG measurement. It is well-known that deep sedation may cause inaccurate HVPG values, while mild sedation with low dose midazolam does not modify the HVPG. In a subgroup of enrolled patients the investigators will perform PPG measurement with deep and mild sedation in order to investigate influence of deep sedation on PPG measurement accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests (porto- systemic collaterals at imaging, platelet count \<150.000 x mm3, spleen size \>13 cm in the largest axis, alteration of elastography parameters of the liver or spleen)
* naïve to treatment with NSBBs,

Exclusion Criteria:

* Child Pugh \>A6
* Hepatocellular carcinoma
* Portal vein thrombosis
Telerehabilitation to Improve Balance and Mobility in Patients After Stroke

Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions.

Patients in the chronic post-stroke phase will be assessed for balance and mobility before and after remotely conducted group training. The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate. The participants's balance and weight-bearing symmetry will be comprehensive assessed, as well their sit-to-stand ability, walking speed, and satisfaction with the remote training. Detailed inclusion and exclusion criteria are specified in the appropriate section.

Eligibility Criteria:
Inclusion Criteria:

* chronic phase of ischemic or haemorrhagic stroke (\>6 months after stroke)
* ability to walk independently on level ground or on all surfaces with or without a walking aid
* mild balance deficit
* sufficient cognitive and communicative abilities for participation
* access to a personal computer with a camera, connected to the Internet

Exclusion Criteria:

* stroke in the brainstem or cerebellum
* additional neurological condition
* musculoskeletal impairments that would interfere with the training
* advanced heart failure
MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users

This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.

This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.

Eligibility Criteria:
Inclusion Criteria:

* HIV+, Viral load \>200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics

Exclusion Criteria:

* Severe renal or hepatic disease
* Hypersensitivity to silver, magnesium, or zinc following oral use
* Pregnancy
* non-English speaking
* History of Crohn's disease or Ulcerative Colitis
* History of bowel surgery, gastric bypass, or bowel stricture
* History of gastrointestinal malignancy or radiation to the abdomen.
Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors

This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Obesity has been linked to increased risk for certain kinds of cancer and is the second highest modifiable risk factor for cancer. It is also well documented that having a cancer diagnosis and treatment is a stressful experience. It is hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the virtual positive health habits group focused on weight management can improve wellbeing and distress. Virtual care options continue to extend the reach of medical providers to cancer survivors, particularly those in the rural setting. A virtual behavioral weight management program with an integrated mindfulness component may improve mood, coping strategies, stress management, and weight loss among community practice and rural obese cancer survivors.

PRIMARY OBJECTIVES:

I. To assess if a 12-week virtual weight management program with a mindfulness component will improve well-being of obese cancer patients with a specific focus on self-reported measures of depression and anxiety.

II. To assess if a mindfulness component added to the virtual behavioral weight management will promote weight loss, improve mood, and increase physical activity.

OUTLINE:

Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.

Eligibility Criteria:
Inclusion Criteria:

* 18 or over
* Identified stage I, II, or III cancer in remission
* Body mass index (BMI) of 30 or greater
* English as a primary language
* Has access to a device with a camera (computer, tablet, or video capable phone) that has wifi and reliable internet access

Exclusion Criteria:

* Unable to provide consent
* Eastern Cooperative Oncology Group (ECOG) performance status scale score of 3 or above
Retorna Facial Cream in the Treatment of Facial Wrinkles

The purpose of the study is to assess the efficacy of Retorna facial cream usage in the reduction or total correction of facial wrinkles. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be recruited and randomized for the study is 148. Occurrence of adverse effects will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Facial wrinkles
* Signed informed consent
* Given verbal agreement on solar exposure prevention within hours of intense solar radiation (10 am - 4 pm) by the usage of physical protection methods such as umbrellas, caps and hats.

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Use of steroids within 6 months.
* Patients under other experimental treatment
* Decompensated concomitant diseases
* Malignant neoplastic conditions.
* Alcoholism
* Handicap and/or psychiatric condition preventing treatment accomplishment.
Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection

Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.

The void in the literature is that while multimodal pain management reduces postoperative pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15. Additionally, postoperative falls are greater with femoral nerve blocks16, and new neurological symptoms are associated with the block17. Bupivacaine liposome suspension periarticular injection has large scale national anecdotal support for TKA pain control with avoidance of regional block adversity. There is one recent randomized control trial in TKA patients favorably comparing periarticular injection with bupivacaine liposome suspension versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint arthroplasty, a more effective and better tolerated pain management solution is needed.

Hypothesis Statement:

Hospitalized TKA patients without a pre-operative femoral nerve block will experience improved postoperative pain control and less MSO4 equivalence consumption when receiving an injection of bupivacaine liposome suspension versus concentrated multi drug.

Eligibility Criteria:
Inclusion Criteria:

* TKA candidacy
* Osteoarthritis
* Failure of non-operative treatments to control knee pain
* Patients able to understand and agree to study inclusion

Exclusion Criteria:

* Subjects have orthopaedic and medical co-morbidities that would thwart postoperative pain control such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy,ipsilateral hip disease)
* Severe knee deformity
* Post-traumatic and inflammatory arthritis
* BMI above 40
* Patients unable to receive multimodal pain remitting agents
* Active knee sepsis
* Remote sites of active infection
* Diabetes with A1C \> 7
* ASA class \> lll
* Cardiac disease failing medical clearance
* Severe liver disease
* PAD with AAI \< 0.75
* Seizure disorder
* Allergic to any pain remitting agent
* Alcohol abuse
* Smoking abuse
The Effectiveness of a Topical Palmitoylethanolamide (PEA) Formulation (Levagen+) for Reducing Symptoms of Eczema

This is a double blind, randomised, non-clinical study with 2 groups (1 investigational group and 1 comparator group) aiming to assess the effectiveness of PEA for reducing eczema severity compared to a base comparator moisturiser in healthy adults aged over 18 years.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18)
* Suffering from atopic eczema with symptoms of redness, dry skin, scaling and/or itchiness on hands or arms
* Otherwise healthy
* Able to provide informed consent

Exclusion Criteria:

* Active allergic skin responses
* Unstable or serious illness (eg kidney, liver, GIT, heart conditions, diabetes, mood disorders, cancer)
* Use of immunosuppressive medication within the last 3 months
* Pregnant or lactating women
* Smokers
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in active or comparator formula

  * An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
New Rehabilitation Protocol for Patients With PPPD

The investigators will test a new rehabilitation protocol on patients with persistent postural perceptual dizziness (PPPD). The investigators hypothesize that patients with PPPD, in the absence of vestibular deficits, do not benefit from standard vestibular rehabilitation but instead need a rehabilitation that acts on visual and postural stability, through training of saccadic movements in dynamic contexts of cognitive-motor dual-task and rehabilitation of postural stability.

Persistent postural-perceptual dizziness (PPPD) is a chronic functional vestibular disorder that manifests as a sensation of non-vertiginous dizziness and instability.

The most common triggers of PPPD are peripheral vestibular conditions such as vestibular neuritis (VN) and benign paroxysmal positional vertigo (BPPV), although vestibular migraine, central vestibular disorders and non-vestibular conditions such as panic attacks, minor injuries traumatic brain injury and also orthostatic intolerance have been reported as precipitants of PPPD. PPPD persists after the triggering events have resolved.

The diagnostic criteria for PPPD were established by the Barany Society. Once the negativity of the routine vestibular tests has been ascertained, the diagnosis is based on additional criteria such as the persistence of the symptom of dizziness for most of the time for at least 3 months, the worsening of the symptoms when standing, during active movement or passive, during exposure to moving visual stimulation or to visual stimuli with complex textures.

Existing treatments (e.g., selective serotonin reuptake inhibitors, vestibular habituation) are only partially successful in PPPD.

Methods. Experimental design. Single-blind randomized controlled trial. 40 individuals affected by PPPD will be recruited.

The patients will be randomly divided into 2 groups and evaluated before the rehabilitation training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3). All patients will undergo 5 rehabilitation sessions supervised by a physiotherapist with experience in rehabilitation of balance disorders. The experimental group will carry out a interactive visuo-vestibular training (IVV) in order to facilitate postural visual stability and the control group will carry out a conventional vestibular rehabilitation training aimed at training the vestibular reflexes.

The rehabilitation protocols (IVV and vestibular) will consist of 1 session of 40 minutes per week, for a total of 5 sessions.

IVV training consists of exercises that stimulate saccadic movements during motor activities on the treadmill and walking on the treadmill blindfolded with the support and supervision of the physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted

Exclusion Criteria:

* Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.
The Effect of Pilates exercıses on Engine Performance and Body Composition ın Primary School Children

In thıs study, planned for prımary chıldren between 7-11 years, pılates exercıses wıll be done wıth the chıldren who accept to partıcıpate ın the study wıth the accountance of the researcher and compared wıth the control group. Evaluatıon; parameters; engıne performance tests and body composıtıon analysıs.

It is a fact that there are disadvantages as well as advantages brought by the development of technology. With this development, individuals adopt a more sedentary lifestyle and daily physical activity and mobility are gradually decreasing. These deficiencies have affected the child population as much as adults. This lack of physical activity in childhood negatively affects the child's growth, development, mood and school success, and increases the risk of chronic diseases in adulthood by preparing the ground for obesity.

The positive effects of physical activity on human health are multifaceted. Physical, mental, social and cognitive well-being is among its well-known benefits. Especially the physical activity and exercise habits gained in childhood contribute greatly to the mental, physical and emotional development of children.

The positive effects of the Pilates method on individuals' muscular strength and endurance, motor performance and body composition have been reported in many studies. Pilates exercise method is a suitable and reliable type of physical activity that can be done for children, and it has positive contributions to the growth, development and postural development of children .

Our aim in this study, which we will do with 7-11 age group primary school children, is to investigate the effects of regular physical activity and exercise, such as pilates, on both motor ability and body composition.

Our hypotheses in our study;

H1: Pilates exercises improve motor ability in primary school children. H2: Pilates exercises positively affect body composition in primary school children H3: Pilates exercises do not affect motor ability in primary school children. H4: Pilates exercises do not affect body composition in primary school children.

Pilates studies with healthy children are not common in our country. Therefore, our study is the first long-term planned (12 weeks 36 sessions) pilates study to be carried out with healthy children at primary school age.

Apart from this, when looking at the evaluation parameters, criteria such as pain, physical fitness, balance were frequently investigated with pilates.

Apart from these, motor ability tests and body composition analysis with a bioimpedance body analyzer will be evaluated in our study, and in this sense, it is one of the first pilates studies conducted with healthy children with these parameters.

Eligibility Criteria:
Inclusion Criteria:

* AGREEING TO PARTICIPATE IN THE STUDY,
* NO CHRONIC DISEASE,
* NO SPORTS HISTORY

Exclusion Criteria:

* Failing to COMPLETE SESSIONS
* PRESENCE OF CHRONIC DISEASE
* Engaging in SPORTS ACTIVITIES
The Biomechanical Effects of Flaccid Paralysis Induced by Botulinum Toxin a After Damage Control Laparotomy

Damage control laparotomy (DCL) is a life saving maneuver used with success in trauma and acute general surgery patients. The technique involves source control of sepsis and hemorrhage with an abbreviated laparotomy. In other words, the surgical procedure is cut short to allow for resuscitation in the ICU after the immediately life threatening pathology is treated. Planned re-exploration is then performed within 24-48 hours. It is at this procedure that the injuries are reconstructed. This technique, unfortunately, has several complications implicit with its use including wound infection, enterocutaneous fistula formation, and intra-abdominal abscess development.\[1\] Additionally, in patients whom primary fascial closure is not achieved, extensive abdominal wall reconstruction will be required in 6-12 months. The key for preventing these complications is definitive closure of the abdominal fascia, however, 10-50% of patients will have a planned ventral hernia with an open abdominal wound at dismissal \[1,2\] Proven methods for decreasing the rate of planned ventral hernia utilize tension in the midline to counter the effects of lateral abdominal muscular retraction.\[3,4,5\] Despite these improvements, however, the planned ventral hernia rate continues to be substantial.\[2\] Botulinum toxin a (BTX) is an FDA approved neuron modulating agent which has been used extensively in cosmetic, motor and pain disorders over the past 20 years \[6,7\]. The toxin blocks acetylcholine and pain modulator release (calcitonin gene related peptide and substance P) from the pre-synaptic cholinergic nerve terminal. The peptides are unable to bind at their motor end plate receptors through a process that cleaves proteins involved in the transport protein cascade. This results in flaccid paralysis and neuromodulation of the abdominal wall muscles resulting in reduced lateral tension and pain. Theoretically, this could increase the rates of primary fascial closure, improve pain sensation, decrease the rate of complications associated with open abdomens all while lowering the costs and need for future abdominal wall reconstruction.


Eligibility Criteria:
Inclusion Criteria

* male or female, aged ≥ 18 years or older
* signed Informed Consent form by appropriate patient representative
* undergone a DCL for trauma or acute general surgery

Exclusion Criteria

* death prior to BTX injection
* failure to achieve hemodynamic stability within 24 hours (stable or decreasing vasopressor support within 6 hours in combination with a stable or improving base deficit or lactate level)
* Viable pregnancy
* At risk populations (\<18 years of age, prisoners)
* BMI \> 50
* Pre-existing pareses (Amyotrophic Lateral Sclerosis, myopathies, motor polyneuropathies
* impaired neuromuscular transmission (Myasthenia Gravis, Lambert-Eaton Syndrome)
* concurrent aminoglycoside use
* chronic obstructive pulmonary disease
* known metastatic malignancy
* pre-existing cirrhosis
* necrotizing fasciitis of the trunk
* hypocoagulable state (INR \>1.5)