cyrilzakka/clinical-trials huggingface dataset:
Effects of Ritalin on Postural Stability of Hyper Active Children

Experimental design overview The proposed project is a prospective experimental study design. Children (age \<15) suffer from attention deficit hyperactivity disorder (ADHD) that their Parents willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 1 hour after taking of Methylphenidate (Ritalin) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years old
* Diagnosed as ADHD childrens by a neurologist
* Taking methylphenidate (Ritalin)

Exclusion Criteria:

* Children who suffer from CP, or other neurological disease
* Children who suffer from psychiatric state
* Children who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients

Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head / Neck Cancer patients undergoing chemo-radiation therapy.

Swallowing deficits resulting from oropharyngeal cancer and the ablative therapies used to control the disease are often devastating to the functional feeding outcome in these patients. Most patients will experience some degree of dysphagia along with nutritional decline. In particular, the swallowing outcome of those patients treated with external beam radiation is suggested to be poorer than those patients treated by surgical interventions alone. It has also been postulated that the formation of radiation-induced fibrotic tissue, along with the acute radiation effects (edema, mucositis, xerostomia) may act collectively to promote muscular disuse or atrophy, and the noted decline in swallowing function. We therefore suggest that a program of swallowing exercises may help facilitate and maintain muscle function in the oral cavity and pharynx during radiotherapy, thus preserving or supporting swallowing function in these patients.

This study will follow a randomized controlled trial design. Patients with confirmed head / neck cancer identified for planned radiotherapy will undergo a baseline evaluation including clinical and instrumental swallowing assessment, nutritional examination, and MRI prior to CRT. Subjects will then be randomized to one of three intervention arms representing control, placebo and intervention groups. Patients will be treated for 6 weeks and progress reassessed at 6 months. Outcome assessment will be completed by a blinded observer. Primary outcomes include; I)Oropharyngeal active muscle volume, signal intensity, and tissue composition over time as identified by T2 weighted MRI, II)Level of functional swallowing ability,III)Patient perception of swallowing function and quality of life.The results of the study will provide information on the efficacy (or lack of efficacy) of isometric / isotonic exercises for the maintenance of swallowing function post radiotherapy for Head /Neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Head / neck cancer of the oropharyngeal or adjacent regions, confirmed by clinical history and exam, with positive cross sectional imaging studies and histopathological biopsy excluding other pathology.
* Planned to undergo external beam radiation therapy,
* No previous history of nonoral feeding for cancer related illness,
* Able to undergo MRI procedures.
* Physician / patient agreement to participate

Exclusion Criteria:

* Planned surgical intervention
* Existence of a co-existing neurological or medical disorder known to cause dysphagia
* Prior radiotherapy or surgery to the head / neck region that could contribute to dysphagia.
* Previous swallowing therapy within four weeks of randomization
Swiss Dermatology Network of Targeted Therapies (SDNTT)

The purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A patient will be included at first initiation of the treatment and will remain in the registry for 10 years, regardless of subsequent therapy.

The registry will also evaluate safety clinical outcomes and health related quality of life.

Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland is largely performed with systemic therapies. This includes conventional systemic therapy such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and biological treatments such as etanercept, infliximab, adalimumab and within a pre-registration program ustekinumab. While short- and middle-term efficacy of most systemic treatments has been shown in clinical studies (and is incorporated in international guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under real-world conditions is still missing. SDNTT, the Swiss registry on the treatment of moderate to severe Pso and PsA documents the long-term course of patients being administered a defined biologic or conventional systemic drug. Following outcomes are observed: Effectiveness on the long-term, of combined/alternating treatments and under comorbidity conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of response and safety.

The study evaluates the long-term course of patients with Pso and PsA in systemic treatments. A patient will be included at first initiation of the treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment will consecutively enroll patients. Follow-ups will be every 3 months, comprising patient and treatment characteristics, clinical parameters, patient-defined benefit, quality of life and adverse events. Standardized questionnaires will be addressed to the patient and to the dermatologist 12 times at the dermatologic centres. In interim intervals, patients are directly contacted another 9 times by mail.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist,
* age ≥ 18,
* Being administered a specific biologic/conventional systemic drug for the first time
* Sufficient language skills (German, French, Italian and English) for the informed consent to participate
* Informed consent to participate

Exclusion Criteria:

* Lack of informed consent
* Patients being participants of clinical trials at the day of registration to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analyzed separately)
Low Intensity Pulsed Ultrasound Versus Low Level Laser Therapy Post Dental Implant

The purpose of the study is to investigate the significance difference between low intensity pulsed ultrasound (LIPUS) versus low-level laser therapy (LLLT) on osseointegration, soft tissue healing, pain pressure threshold and oral health related quality of life in patients post dental implant surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult Patients.
2. Both sexes will be contributed in the study.
3. Non-smokers.
4. Patients who needed dental implant in the maxillary or in the mandible.
5. Bone height and width no less than Class III bone quality assessed clinically and radiologically.

Exclusion Criteria:

1. Medically compromised patients as Uncontrolled diabetes mellitus.
2. Patients indicated for bone graft at the implant site.
3. Patients under chemotherapy or radiotherapy in facial region.
4. Poor oral hygiene.
5. Patients with any history of temporomandibular joint disorders.
6. Patients with any other periodontal and oral surgeries
Prevalence , Risk Factors and Outcomes of AKI in ICU Patients

Early recognition of AKI is essential to ensure prompt and appropriate management, and to avoid progression to late stages of the disease (2) AKI requiring renal replacement therapy occurs in 5-6% of ICU patients, with an extremely high in hospital mortality rate of 60%.6 It is estimated that about 2 million people die of AKI every year. Those who survive AKI have a higher risk for later development of CKD(3). Epidemiology of AKI is understudied in developing countries so further studies are needed to estimate the burden of AKI among ICU patients.

Few studies about the epidemiology of AKI in Egypt were done;

Acute kidney injury is a sudden episode of kidney failure or damage that happens within a few hours or days. According to KDIGO (kidney disease improving global outcomes) criteria: AKI is defined as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or. Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or. Urine output less than 0.5 mL/kg/h for 6 hours(1). Kidney Injury (AKI) affects over 13 million people per year globally and results in 1.7 million deaths. Recent hospital studies in the developed world report AKI in 3.2-9.6% of admissions, with overall in-hospital mortality around 20%, and up to 50% in ICU patients.

Early recognition of AKI is essential to ensure prompt and appropriate management, and to avoid progression to late stages of the disease (2) AKI requiring renal replacement therapy occurs in 5-6% of ICU patients, with an extremely high in hospital mortality rate of 60%.6 It is estimated that about 2 million people die of AKI every year. Those who survive AKI have a higher risk for later development of CKD(3). Epidemiology of AKI is understudied in developing countries so further studies are needed to estimate the burden of AKI among ICU patients.

Few studies about the epidemiology of AKI in Egypt were done; Samar Abd ElHafeez e,tal 2017 found in a multicenter study of over 500 consecutive patients admitted to ICUs in Alexandria Teaching Hospitals in Egypt, that about 40% of patients admitted to ICU had AKI at presentation, and a similar proportion of those who were AKI-free on admission developed AKI during their ICU stay (4) .

Up to our knowledge, there are no sufficient data about the epidemiology of AKI in upper Egypt

Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years admitted to medical ICU in Internal Medicine Department with critical medical conditions who develop AKI during hospital admission or presented with AKI

Exclusion Criteria:

* Patients with ESRD on regular dialysis ,Patients with stage 4 or 5 non-dialysis if the condition proven to be progression of the already known diagnosis.
Role of Perfusion CT in Pancreatic Cancer

The purpose of this study is

1. to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT
2. to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD, PD according to RECIST 1.1).

1. Performance of preoperative perfusion CT for preoperative staging is assessed by comparing with operative finding and histologic disease staging
2. Estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma

Eligibility Criteria:
Inclusion Criteria:

* patients who are older than eighteen years
* patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor
* patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma
* patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup
* patients who agree with the study and whose informed consent is obtained.

Exclusion Criteria:

* patients who are younger than eighteen years old
* patients in whom previously radiation therapy was performed and the RTx field includes pancreas
* patients with recurred pancreas adenocarcinoma
* patient who are pregnant or nursing patients
* patients with renal failure (GFR\<30mL/min)
* patients with history of malignancy, except malignancy is in complete remission after operation or iodine therapy for at least five years)
* patients with hypersensitivity for iodine or contrast media or other causes of contraindication of contrast-media enhanced CT scan
* Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.
A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture Treatment

The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by a single implant. The study hypothesis is that SIMO is more effective but more costly than the conventional denture, though this incremental cost is relatively low for the offered effectiveness in terms of clinical and patient-reported outcomes.

This randomized clinical trial alongside a cost-effectiveness analysis will include twenty-eight edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. Each participant allocated to the overdenture group will then receive a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline. A healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. Then, a 3.4mm retentive titanium anchor abutment (Straumann 048.439, Institute Straumann AG, Basel, Switzerland) will be connected and tightened to 35 N.cm with a torque wrench. The matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Eligibility Criteria:
Inclusion Criteria:

* No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
* Present enough bone volume in the mandibular midline area for implant placement without the need of bone augmentation procedures.
* Be able to understand and answer the questionnaires used in the study
* Agree to participate by providing a written informed consent.

Exclusion Criteria:

* Noncompliant participants
* Individuals who do not agree to be randomly allocated to the treatment study group
* Presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments
The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children

This study aims to Evaluate and compare the role of Damask rose essential oils in reducing a child's dental anxiety and pain undergoing local anesthesia administration

Dental anxiety is recognized as one of the major public health problems. It can lead to avoidance of necessary dental care, which affects oral health negatively, especially in children where dental care providers face a challenge to control dental anxiety to manage the child in the dental visit. Overall prevalence of dental anxiety was 23.9% with less prevalent in adolescents (13.3%), more prevalent in preschoolers (36.5%), and schoolchildren (25.8%).

Methods for managing anxiety in dentistry are both pharmacological and non-pharmacological. Aromatherapy is one of the non-pharmacological methods, it is a Simple, inexpensive, non-invasive method introduced by the use of aromatic essential oils through the sense of smell to produce positive physiological effects, relaxation and relieve anxiety symptoms. Aromatherapy can also decrease pain perception during local anesthetic injections in children.

Rosa damascene is commonly known as Damask roses, a plant belonging to the Rosaceae family. The flowers of this plant are large, showy and colorful. for its scent, it is also used in the production of essential oil and rose water. The R. damascena plant has also been used for medicinal applications it has analgesic, anti-inflammatory, anti-headache, and muscle-relaxing effects, and due to its strong depressing effect on the central nervous system it has hypnotic, anticonvulsant, antidepressant, and ant anxiety, effects.

The effect of rose oil in reducing pain has been conducted in children who are hospitalized for surgery, measuring the effect on post-operative pain intensity. Also, the effect of rose oil in the reduction of dental anxiety has already been studied but has been conducted on adults orthodontic patients.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian children from 7 to 12 years old require local anesthesia administration.
* Absence of any systemic problems, physical and mental disabilities.
* Children intellectually sufficient to complete the anxiety scale and those whose parents were willing to participate in the study.
* Frankel rating 3 in cooperation

Exclusion Criteria:

* Presence of dental or medical emergency and systemic disorders.
* Special needs children.
* Children with any respiratory tract illnesses, common, cold or allergy.
Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

Objective:

* To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
* To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* males of females
* any ethnic origin
* Age 18-55 years
* BMI 18.0 - 33.0 kg/m2
* generally in good health
* signed informed consent

Exclusion Criteria:

* males or females not willing to use appropriate contraception
* recent blood donation
* recent blood received
* high consumption of alcohol
* high consumption of tobacco
* subjects who have engaged in heavy exercise last two weeks
* prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
* other medication know to alter drug absorption or elimination
* abnormal heart rate or blood pressure or 12-lead ECG
* significant history of drug allergy, or hypersensitivity to treatment ingredients
* ocular disorder requiring topical ocular therapy, or recent allergic eye disease
* other significant medical history or physical findings
Safety and Efficacy Evaluation of Erbium Treatment

The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.

The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures.

Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Adults (18 years or older).
* Subjects who can read, understand, and sign the Informed Consent Form.
* Subjects willing and able to comply with all study requirements.

Exclusion Criteria:

* Subjects with active localized or systemic infections.
* Immunocompromised subjects.
* Subjects with coagulation disorder.
* History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
* Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
* In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
* Use of Accutane® within the past 6 months.
* Subjects with a history of radiation therapy to the treatment area.
* Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
* Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.