cyrilzakka/clinical-trials huggingface dataset:
Combination of Neck Muscle Vibration and tDCS With Conventional Rehabilitation in Neglect Patients

BACKGROUND: Unilateral spatial neglect (USN) rehabilitation remains a challenge and requires the development of new methods that can be easily integrated into conventional practice. The aim of the HEMISTIM protocol is to assess immediate and long-term functional outcomes and neuropsychological aspects of recovery, induced by an innovative association of left-side neck-muscle vibration (NMV) and anodal transcranial Direct Current Stimulation (tDCS) on the ipsilesional posterior parietal cortex during occupational therapy sessions in patients with left USN.

METHODS: Participants will be randomly assigned to 4 groups: control, Left-NMV, Left-NMV + sham-tDCS or Left-NMV + anodal-tDCS. NMV will be applied during the first 15 minutes of occupational therapy and tDCS will be applied for 20 minutes, starting 5 minutes before, three days a week for three weeks. USN will be assessed at baseline, just at the end of the first experimental session, after the first and third weeks of the protocol and three weeks after its ending.

DISCUSSION: Left NMV, by activating multisensory integration neuronal networks, might enhance beneficial effects obtained by conventional occupational therapy sessions since interesting post-effects were shown when it was combined with voluntary upper limb movements. The investigators expect to reinforce lasting intermodal recalibration through LTP-like plasticity induced by anodal tDCS. The HEMISTIM protocol represents a therapeutic innovation associated to conventional practice that could provide a partial solution to the rehabilitation challenges of the USN syndrome and some insights to its underlying mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* admitted in a post-stroke rehabilitation unit in the sub-acute phase (15 days to 6 months from the onset of stroke symptoms)
* at least 18 years old
* a first unilateral right hemispheric stroke
* diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
* Behavioral Inattention Test (c-BIT), inferior or equal to 129

Exclusion Criteria:

* unable to give informed consent
* pregnant women
* patients with skin lesions on the areas for electrode placement
* having history of metal-in-cranial injury
* epilepsy
* vestibulo-cochlear illness
* cardiac pacemaker
A Real-world Comparison of FNB and FNA in IHC-required Lesions.

Endoscopic ultrasound (EUS)-guided fine needles with side fenestrations are used to collect aspirates for cytology analysis and biopsy samples for histologic analysis. The investigators conducted a large, multicenter study to compare the accuracy of diagnosis via specimens collected with fine-needle biopsy (FNB) versus fine-needle aspiration (FNA) for patients with lesions requiring immunohistochemistry (IHC) pathological diagnosis.

Current guidelines recommend FNA and FNB needles equally for pancreatic and other deep-seated lesions. However, some studies indicate that the sample adequacy for histologic evaluation is higher when using FNB compared with FNA needles. The diagnosis of neuroendocrine tumor (NET), autoimmune pancreatitis (AIP), and other gastrointestinal stromal tumors require high-quality tissue sampling for IHC diagnosis. Whether FNB is superior to FNA in these IHC-required lesions remains unclear.

The investigators performed this at 2 tertiary care centers in China. The study prospectively collected patients undergoing EUS for a solid mass (\>1 cm) in the pancreas, abdomen, mediastinum, or pelvic cavity from December 2014 diagnosed with AIP, NET, mesenchymal tumors, and Lymphoma. Patients accepted FNB or FNA according to doctors' and patients' willingness in a real-world setting. All procedures were performed by experienced endosonographers; cytologists and pathologists were blinded to the sample collection method. Patients were followed for at least 48 weeks, and final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion. The primary aim was to compare diagnostic yields of EUS-FNA with EUS-FNB for all solid masses, then separately as AIP, NET, mesenchymal tumors, and lymphoma. The secondary endpoint was the quality of the histologic specimen.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years;
* presence of a solid mass lesion was confirmed by at least 1 imaging modality and it was located within pancreas, abdomen, mediastinum, or pelvic cavity;
* mass size \>1 cm;
* final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion, including AIP, NET, mesenchymal tumors, and lymphoma.

Exclusion Criteria:

* coagulopathy (international normalized ratio, 1.5);
* thrombocytopenia (platelet count \<50,000/mm3);
* acute pancreatitis within the previous 2 weeks;
* inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction);
* refusal or inability to provide an informed consent.
Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network (HEKATE)

This is a cross-sectional retrospective study of laboratory records of patients who take electrolytes blood tests containing the data of the serum potassium level. This study is an observational one, and there is no intervention into routine clinical practice either in terms of therapy, or special examinations.


Eligibility Criteria:
Inclusion Criteria:

* Males and females tested in the Russian centres of INVITRO laboratory from 01.01.2015 till 31.12.2016;
* 18 years and older;
* Available electrolytes blood test containing of the serum potassium level of the unique patient fits for interpretation.

Exclusion Criteria:

* Blood test cannot be interpreted due to various reasons.
* Blood samples with sing of hemolysis
Dietary Treatment Study of Pediatric NAFLD

This is an investigator initiated study being conducted in equal numbers at two sites, University of California, San Diego (UC San Diego) and Emory University (EU). The purpose of this study is to understand the potential of a low sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children. Forty boys with NAFLD will be randomly assigned to either an intervention group or a habitual diet control group. The intervention will be a low sugar diet for a period of 8 weeks. The effect of this dietary change will be assessed using advanced magnetic resonance imaging (MRI) testing to measure liver fat.


Eligibility Criteria:
Inclusion Criteria:

* Boys age 11-16 years inclusive.
* Clinical history consistent with NAFLD.
* Biopsy-proven NAFLD
* MRI measured Liver Proton Density Fat Fraction ≥10%
* alanine aminotransferase (ALT) ≥ 45 u/L
* No evidence of any other liver disease by clinical history or histological evaluation.
* Written informed consent from parent or legal guardian.
* Written informed assent from the child or adolescent.

Exclusion Criteria:

Exclusions will not be based upon gender, race, or ethnicity. Participants with a current history of the following conditions or any other health issues that make it unsafe for them to participate in the opinion of the Investigators will be excluded from the study:

* History of significant alcohol intake (Alcohol Use Disorders Identification Test \[AUDIT\]) or inability to quantify alcohol consumption
* Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic steatosis or steatohepatitis in the past year.
* The use of other known hepatotoxins within 120 days of baseline
* History of total parenteral nutrition (TPN) use in the year prior to screening
* History of bariatric surgery or planning to undergo bariatric surgery during the study duration
* Significant depression
* Non-compensated liver disease with any one of the following hematologic, biochemical, and serological criteria on entry into protocol:
* Hemoglobin \< 10 g/dL
* White blood cell \< 3,500 cells/mm
* Neutrophil count \< 1,500 cells/mm3 of blood
* Platelets \< 130,000 cells/mm3 of blood
* Direct bilirubin \> 1.0 mg/dL
* Total bilirubin \> 3 mg/dL
* Albumin \< 3.2 g/dL
* International normalized ratio (INR) \> 1.4
* Evidence of other chronic liver disease
* Children who are currently enrolled in a clinical trial or who received an investigational study drug or a medication with the intent to treat NAFLD/NASH in the past 60 days
* Contraindications to MRI, e.g. metal in the eyes, implanted electronic devices, aneurysm clips, pacemaker, cochlear implants
* Unable to have or complete the MRI exam due to body weight exceeding scanner table limit or girth exceeding scanner bore diameter
* Subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
* Families with \> 5 individuals
* Failure to give informed consent
Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris

Subject of interest is to evaluate serum level of asprosin in male patients with acne vulgaris, demonstrate the relation between acne vulgaris severity and level of asprosin in these patients \& the relation between metabolic syndrome in acne vulgaris and level of asprosin.


Eligibility Criteria:
Inclusion Criteria:

* Acne vulgaris male patients (\>18 years) will be included.

Exclusion Criteria:

* Age \<18 years.
* Females.
* Patients with other inflammatory skin disorders.
* Patients with associated systemic diseases.
* Current or previous treatment with isotretinoin in the last 3 month ,anti-inflammatory drugs, systemic antibiotics, androgen or anti androgen therapy, and steroid therapy).
* Patients known on treatment of diabetes, hypertension and dyslipidemia.
* Athletes.
* Patient refusal.
Effect of Melatonin on Multiple Sclerosis Related Fatigue

The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment of fatigue and Quality of Life of MS patients.

Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Eligibility Criteria:
Inclusion Criteria:

1. definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria
2. a baseline of Expanded Disability Status Score (EDSS)of less than 5.0
3. aged between 18 and 55 years of either sex
4. treated with one type of interferon beta-1a (IFNB-1a);
5. signed an informed consent

Exclusion Criteria:

1. clinical relapsing of MS during past 30 days;
2. use of melatonin and warfarin within 30 days prior to participation;
3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ;
4. working more than one nighttime shift per month;
5. Pregnancy or lactation;
6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ;
7. failure to adhere to the study protocol
A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk

This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.

Mitral annular disjunction is a structural defect of the mitral annulus fibrous commonly associated with mitral leaflet prolapse. However, there have been few cases of mitral annular disjunction in mitral valve prolapse (MVP).

Mitral annular disjunction (MAD) is a structural defect characterized by a clear separation between the mitral valve annulus, the left atrium wall, and the myocardial continuity. This condition can be seen in a 360-degree circle around the mitral valve annulus. However, it is most typically seen in the inferolateral myocardium, right behind the posterior mitral valve leaflet. It is generally present in the P1 and P2 mitral valve scallops.

Mitral valve prolapse (MVP) occurs in 3% of the population and is the most common reason for mitral valve replacement\[1\]. According to population and cohort studies, the patient's age significantly influences mitral valve prolapse (MVP) outcomes, left ventricular ejection fraction, and the severity of mitral regurgitation. Mitral regurgitation has little influence if it is not severe. While the link between MVP and sudden cardiac death was first discovered many years ago, it was once assumed to be extremely low risk. Recent observational studies have found a link between MVP and malignant ventricular arrhythmias, as well as sudden cardiac death, in a particular population of young and middle-aged people. This raise worries regarding the existence of an arrhythmic MVP variation. Recent research has led to a better knowledge of the aberrant physiological processes and circumstances that enhance the likelihood of developing irregular heart rhythms in people with mitral valve prolapse.

The diagnosis of mitral valve regurgitation can be accurately determined by non-invasive imaging techniques such as transthoracic echocardiography, Transesophageal echocardiography, and cardiac magnetic resonance imaging.

This study tries to improve patient risk assessment

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients \> 18 years of age presenting to Assiut University Heart Hospital with MVP and more than moderate MR.

Exclusion Criteria:

* Previous mitral valve surgery.

  * MVP due to infective endocarditis.
  * Moderate or more significant aortic stenosis, aortic regurgitation or mitral stenosis.
  * Congenital heart disease and poor image quality precluding accurate assessment of the mitral valve.
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
* Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
* Subject is 18 years of age or over at the time of transplant.
* If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

* Recipients of a kidney from a donor 60 years of age or older
* Recipients of donation after cardiac death (DCD) donors
* Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
* Subjects with a second renal allograft who had their original graft for \< 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
* Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) \>20
* Subjects with hepatitis B \& C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
* Subjects receiving an allograft with cold ischemia time 24 hours or greater
* Subjects who have received an investigational drug within three months prior to randomization
* Subjects who are breastfeeding
* Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
* Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol
Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries

• Anterior cervical discectomy and fusion (ACDF) is a highly effective and safe method for spinal cord and cervical root decompression. Vocal cord paralysis secondary to recurrent laryngeal nerve injury is a common complication after ACDF. The incidence reported as high as 22%. The standard technique for vocal cord evaluation and the most commonly used tool is direct laryngoscopy. Laryngoscopy causes patients annoyance and could potentially contribute to poor patient compliance. Ultrasonography is a non-invasive technique that is used as an alternative tool.

1. Design: A prospective cohort study.
2. Sample size: Assuming that the target population is 240 and positive predictive value of transcutaneous laryngeal ultrasonography is 89.4%. So, the sample size is 91 cases using OPEN Source Epidemiologic Statistics for Public Health (OPENEPI) with confidence interval 95% and power of test is 80%.

All patients underwent transcutaneous laryngeal ultrasonography examination by both anterior and lateral approach of the Vocal Cords (VCs) before the surgery, immediately after extubation, 2 h, 12h, 24 and 48hour postoperatively by an anesthesiologist with an experience of at least three years in ultrasonography scan.

Eligibility Criteria:
Inclusion Criteria:

* Patient acceptance.
* Both sex
* Age (21-60) years old.
* American Society of Anesthesiologist I / II
* Elective anterior cervical spine surgeries
* patient With Body Mass index (25-35 kg/m²)

Exclusion Criteria:

* Patient refusal.
* Altered mental status.
* Patients with per-existing neurological or thyroid disease affecting vocal cord function.
* Patients with a diagnosis of primary untreated laryngeal/hypopharyngeal cancer.
* Patient with a history of thyroidectomy affecting recurrent laryngeal nerve.
* Patient with a history of laryngeal trauma.
* Pre-operative voice abnormalities.
Alive & Thrive Nigeria Breastfeeding Promotion in Urban Private Facilities Study

The purpose of this study was to evaluate the effect of a breastfeeding promotion intervention on breastfeeding intentions, early initiation of breastfeeding, and exclusive breastfeeding among clients in private health facilities in Lagos, Nigeria.

This was a longitudinal cohort study designed to evaluate and measure the implementation processes of a breastfeeding counseling and support intervention offered to pregnant and postpartum women in private health facilities in Lagos State, Nigeria. This study was conducted as part of the Alive \& Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design, implementation, and analysis for the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study took place in 20 private health facilities. Ten facilities were assigned to intervention and 10 to comparison based on their location within the existing intervention and comparison local government areas (LGAs) for our overall impact evaluation of the Alive \& Thrive program in Nigeria (NCT02975063). To be included in the study, facilities had to provide maternity and pediatric services, such as antenatal care, postnatal care, and immunizations, and be registered with the Association of General and Private Medical Practitioners of Nigeria and the Health Facility Monitoring and Accreditation Agency. To ensure that the investigators would achieve their sample size, selected facilities with a monthly average of ≥40 antenatal clients and ≥20 deliveries over 3 months. All eligible women attending antenatal care on the days of data collection were invited to participate until the target enrollment at each facility was achieved. The investigators collected survey data from a cohort of 1,200 women (600 per study arm) during the third trimester of pregnancy and when their child was 6 weeks and 24 weeks. The purpose of the surveys were to obtain data on the women's breastfeeding intentions (third trimester) and practices (6 weeks and 24 weeks), their breastfeeding knowledge and attitudes, and their exposure to the intervention. To measure implementation outcomes, the investigators conducted 180 observations of client-provider interactions among a subset of women enrolled in the study and then completed a short exit interview with the women immediately after their facility visit. In addition, the investigators conducted qualitative interviews with 20 health providers and facility managers/owners in the intervention facilities at the end of the intervention to learn about the facilitators and barriers to implementation.

Eligibility Criteria:
Inclusion:

* Women ≥18 years old, third trimester
* Current Client of a private health facility
* Infant alive at 6 and 24 weeks postpartum

Exclusion:

* Infant died
* Infant unable to breastfeed
The Incidence of Gallstones After Gastric Cancer Surgery

Through previous clinical observations and literature, we found that the incidence of gallstones in patients after gastric cancer radical resection was significantly higher than that in the normal population (4%). However, its pathogenesis has not been clarified. We compare the risk of gallbladder stones after four different radical gastric cancer surgical methods, in order to provide prevention and treatment strategies for people with gallstones after gastric cancer.

A large number of clinical studies have found that the incidence of gallstones in patients with radical gastric cancer is higher than that in the normal population. However, its pathogenesis has not been clarified, and there is still controversy about the prophylactic removal of gallbladder in patients with gastric cancer. The investigator's previous study found that there was no statistical difference in the incidence of gallstones after laparoscopic distal gastrectomy (LDG), laparoscopic total gastrectomy (LTG) and laparoscopic proximal gastrectomy (LPG). A common feature of the three surgical methods is that the vagus nerve were more or less cut during the operation. Therefore, we plan to further collect gastric cancer patients undergoing endoscopic submucosal dissection (ESD) surgery in order to answer whether the vagus nerve cut during surgery will increase the incidence of gallstones.

Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer patients
* Age from over 18 to under 75 years

Exclusion Criteria:

* Gallbladder disease before surgery
* Gallbladder has been remove
* History of previous upper abdominal surgery
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* Pregnant women or breastfeeding
* Unwillingness or inability to consent for the study
* Severe mental disorder
* Unstable vital signs Coagulation dysfunction (INR\>1.5)
* Low peripheral blood platelet count (\<50×10 \^9 / L) or using anti- coagulation drugs
Accuracy of Teledentistry for Diagnosis and Treatment Need in Dental Caries Detection Versus Clinical Examination on a Group of Egyptian Children: A Diagnostic Accuracy Study

The aim of this study is to assess the accuracy of teledentistry for diagnosis and treatment need in dental caries detection versus clinical examination on a group of Egyptian children.

The objective of this study is to assess the precision of using the mobile photographic method of teledentistry for dental caries diagnosis and treatment need of pediatric Egyptian children. This will be assessed by measuring the diagnostic accuracy of the mobile photographic method versus direct clinical oral examination for the same group of participants.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian pediatric patients aged 4 to 12 years with a chief complaint of dental caries with or without pain.
* Both genders are included.

Exclusion Criteria:

* Egyptian pediatric patients with systemic conditions that will affect their treatment needs.
* Refusal of participation.
* Refusal to sign the informed consent.