cyrilzakka/clinical-trials huggingface dataset:
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Down syndrome (established during study E2020-A001-220).
* Completion of study E2020-A001-219 (NCT00570128 \[also known as A2501059\]) with no ongoing seroius adverse events and no severe drug reactions.

Exclusion Criteria:

* Weight less than 20 kg.
* Clinically significant conditions affecting absorption, distribution or metabolism of the study medication.
* No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study.
* Females of childbearing potential who are not practicing an effective means of birth control.
MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

As efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-Saharan Africa, with areas of moderate-to-high transmissions, to implement Perennial Malaria Chemoprevention (PMC) delivered through the Expanded Program on Immunization (EPI), which is the only feasible, sustainable and cost-effective strategy to reach this high-risk group. PMC is a full therapeutic course of antimalarial medicine (with sulfadoxine-pyrimethamine, SP) delivered to infants in the context of routine immunisation services during the first two year of life.

PMC has been shown to be safe, efficacious in reducing clinical malaria, anaemia and hospital admissions, and to be highly cost-effective; for all these reasons, the World Health Organization (WHO) recommended in 2010 Intermittent Preventive Treatment for Infants (IPTi) for malaria prevention. Only one African country - Sierra Leone -put IPTi into policy and practice. Concerned with this slow adoption, WHO in 2019 recommended adaptations be urgently tested through pilots assessing impact, operational feasibility and cost effectiveness. In 2022, WHO expanded that recommendation to cover children through the age of two because of studies documenting the value in children aged 12 to 24 months. The name for this preventive treatment has consequently changed to Perennial Malaria Chemoprevention (PMC) as the updated recommendation is no longer just for infants.

MULTIPLY is the pilot implementation of PMC in selected districts in Mozambique, Sierra Leone and Togo to maximise the delivery and uptake of PMC, to achieve the full potential of this intervention. Working with the ministries of health in Mozambique, Sierra Leone and Togo, MULTIPLY will give up to 6 doses of PMC in the first two years of life. PMC will be given at health facilities and EPI mobile outreach clinics using a paediatric dispersible formulation of SP, alongside routine vaccinations and vitamin A supplementation.

The study will be conducted in 3 sub-Saharan African countries; Sierra Leone, Mozambique and Togo.

Sample size; Assuming an average population of a district/project area of 150,000 inhabitants and a percentage of U2 children of 5%, the project intervention will target approximately 45,000 U2 children in total (i.e. 7,500 children per country and per year for 2 years).

Study population; Children U2 who are eligible for IPTi in the selected MULTIPLY district of each country.

Eligibility Criteria:
Inclusion Criteria:

All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.

Exclusion Criteria:

Infants/children; with acute malaria; known to have sulfa allergies; who have taken SP in the past 4 weeks; who are HIV-exposed or HIV-infected
Curative Chemoradiation of Low Rectal Cancer

The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies.

Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically verified adenocarcinoma of the rectum
* Planned abdominoperineal resection (APR) or ultralow resection
* Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor.
* Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope
* Performance status 0-2
* Patient acceptance to collection of biopsies and blood samples for translational research
* Age ≥ 18 years
* Normal function of bone marrow as evaluated by

  * neutrophils ≥ 1.5 x 10\^9/l
  * thrombocytes ≥ 100
* Normal function of liver

  * alanine aminotransferase (ALAT) \< 2.5 x upper limit of normal
  * bilirubin \< 2.5 x upper limit of normal
* Kidney function

  - Serum creatinine \< 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) \> 30 ml/min
* Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
* Written and orally informed consent

Exclusion Criteria:

* Previous surgical treatment of the present cancer, including transanal excision of tumor.
* Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri
* Distant metastases verified by imaging or biopsy
* Previous radiation treatment of the pelvis
* Pregnant or breastfeeding women
Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer

Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and alternative therapeutic approaches to the treatment of advanced prostate cancer during normal clinical practice and in accordance with the terms of the Belgian marketing authorization and reimbursement conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced prostate cancer who have been prescribed Lucrin/ Lucrin-Tri-depot or any other treatment with local reimbursement guidelines; Patients willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

* Contraindications according to the Summary of Product Characteristics (SPC).
Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using different methods of irrigation activation.

Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using different methods of irrigation activation.

Methodology: In this prospective clinical trial, root-canal treatment was performed on 162 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to one of 3 treatment groups, each of which was treated using a different activation protocol during the final irrigation \[manual dynamic irrigation (MDI), passive ultrasonic irrigation (PUI), sonic irrigation (SI)\]. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 24h, 48h and 7 days using a modified 4-step visual analogue scale (VAS). Patients were recalled at 12 months for clinical and radiographic examinations. Periodontal healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P \< 0.05 considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* a non-contributory medical history
* must have an asymptomatic, necrotic premolar or molar with periapical lesions of \> 2.0 x 2.0 mm around one or both roots
* must be diagnosed as chronic apical periodontitis

Exclusion Criteria:

* Those with clinical symptoms (acute pain)
* have periapical radiolucency of \>5 mm
* no previous endodontic treatment
* no severe periodontal disease in the related tooth
* non-restorable tooth
* use of any analgesics within the previous 3 days or antibiotics within the previous month
Vestibular Disorder and Visuo-spatial Functions

The purpose of these studies is to determine whether vestibular disorders could affect visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire and a new computerized test using a digital tablet in different studies.


Eligibility Criteria:
For participants of the questionnaire study :

Participants with vertigo complaints versus participants without vertigo complaints.

For patients of the behavioural study :

Inclusion Criteria:

* Vestibular disorder (with or without vertigo)
* Deafness / hard of hearing

Exclusion Criteria:

* Neurological or psychiatric conditions
* Cochlear Implant (for functional magnetic resonance imaging study)
Change in Permeability of the Small Intestine After Treatment With Gluten

The overall hypothesis of this research study is that gluten intake alters intestinal barrier function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac gluten sensitivity (NCGS).

The specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of a coin) patients who have Non Celiac Gluten Sensitivity to a 4-week Gluten-containing diet (GCD) or to a Gluten free diet (GFD). The study will evaluate small bowel (SB) permeability functionally (2-sugar differential excretion), morphologically, using probe-based confocal laser to evaluate the small intestinal, as well as molecularly, using tight junction (TJ) messenger RNA (mRNA) expression in small bowel mucosa in response to the different diets.

Eligibility Criteria:
Inclusion Criteria:

1. Non celiac gluten sensitive patients with a functional bowel disorder
2. Age 18 to 70 years.

Exclusion Criteria:

1. Positive serum tissue transglutaminase (TTG) Immunoglobulin A (IgA) positive or medical record of small bowel biopsy suggestive of celiac disease.
2. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability).
3. Abdominal surgeries (except appendectomy, cholecystectomy and vaginal hysterectomy or tubal ligation)
4. Use of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or aspirin within the past week (since Nonsteroidal Anti-inflammatory Drugs (NSAIDs) affect intestinal permeability).
5. Use of oral corticosteroids within the previous 6 weeks.
6. Ingestion of artificial sweeteners such as Sucralose, Nutrasweet ™ (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g., foods to be avoided are sugarless gums or mints and diet soda.
7. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
8. High anxiety or depression score (\>11 on each subscale) on the Hospital Anxiety Depression Score questionnaire.
9. Known allergy to fluorescein.
Simplified Tai Chi for Reducing Fibromyalgia Pain

Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a larger randomized, controlled clinical trial in a community-based setting. We also sought to extend this line of inquiry by closely examining Tai chi's effect on physical function, specifically postural stability. Towards these ends, we conducted a single-blind, randomized controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to standard education. Subjects in both conditions meet in small groups two times weekly for 60 minutes over 12 weeks.

120 males and females with fibromyalgia were randomized to participate in a modified 8 form Yang-Style Tai Chi program or a standard group education program. Both programs met in a small group format for twice weekly 60 minute sessions lasting for 12 weeks. 99 subjects completed the protocol. Primary outcomes from the Fibromyalgia Impact Questionnaire were assessed at baseline and 12 weeks. Secondary measures included pain intensity and interference, sleep, coping, and fitness tests.

Eligibility Criteria:
Inclusion Criteria:

* Subjects included adults over 40 years of age or older who met 1990 ACR criteria for the classification of FM. Those criteria include pain in three or more body quadrants (above the waist, below the waist, left of midline and right of midline) including axial pain by self-report for a minimum of three consecutive months.
* Additionally at least 11 of 18 muscle/tendon junction tender points were found to be painful via digital palpation of 4kg over 4 seconds by a trained examiner (Wolfe 1990).

Exclusion Criteria:

* Individuals were excluded if they practiced Tai chi within the past 6 months; - were exercising more than 30 minutes, three times weekly for past 3 months;
* could not independently ambulate without assistive devices;
* were unable to attain MD clearance for exercise within past 3 months;
* were unwilling to undergo random assignment; had cognitive impairment based on score \>3 Pfeiffer Mental Status;
* had significant depressive symptoms based on a score of \>27 on Beck Depression Inventory;
* had BPI pain severity scores less than 3/10, had planned elective surgery during the study period;
* were unwilling to keep all treatments/medications steady throughout the study period;
* were currently enrolled in another study.
Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke

Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.

This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Cryptogenic TIA/Minor stroke
* Age \> 18 years
* Medical care in Neuro Vascular Unit of CH Versailles
* Holter 21 days performed

Exclusion Criteria:

1. ACFA history
2. ECG or telemetry who showed ACFA before the Holter initializing
3. Carotid Stenosis / symptomatic vertebral
4. Arterial dissection
5. Prothrombotic state demonstrated by laboratory tests
6. Infective endocarditis
Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

The purpose of this study is to determine wether topical rapamycin is more efficient than topical steroids in the treatment of chronic erosive lichen planus.


Eligibility Criteria:
Inclusion Criteria:

* Oral Lichen Planus
* Oral Erosive Area More Than 1cm²
* Lichen Planus Pathologically Proven

Exclusion Criteria:

* No Previous Treatment by Rapamycin
* Non Child Bearing Or Breast Feeding Woman
* Patient Who Cannot Be Treated By Rapamycin Or Betamethasone
* Chronic Renal Insufficiency (Creatinin Clearance \< 40ml/Mn)
* Ongoing Treatment By Topical Calcineurin Inhibitors Or Systemic Steroids Or Retinoids Or Systemic Immunosuppressors Or Thalidomide Or Griseofulvin Or Antimalarials
* Cholesterolemia \>7.8 Mmol/L Or Hypertriglyceridemia \>3.95mmol/L Non Responsive To Medical Treatments
* Leucopenia (\<3000/Mm3)
* Thrombopenia (\<100 000/Mm3)
* Hypertransaminasemia (\>3n)
* Hypersensitivity To Macrolides
Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly

The investigators aim to examine target-controlled propofol infusion as a technique of anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which regional anesthesia was more sufficient for the old.

Eighty patients with American Society of Anesthesiologists（ASA） Ⅰ-Ⅲ older than 80 years are randomly assigned to 2 groups: a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus; a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1). The target-controlled propofol infusion is started immediately after positioning the patient on the operating table. The initial target concentration was 0.5μg/mL. The infusion rate is adjusted every 5min by increasing or decreasing the target concentration by 0.2μg/mL steps based on the patients' respiratory rate(RR), blood pressure(BP), heart rate(HR), and level of sedation(score of 5 on Ramsay Sedation Scale ). The minimal, maximal, optimal target concentration, cumulative propofol dose, frequency of spontaneous movement and incidences of associated complications are recorded. Patients were phoned for followup and questioned for activity status in one year. If the patients were dead, date of death; if they survived, daily living activity questioned.

Eligibility Criteria:
Inclusion Criteria:

* ASA Ⅰ-Ⅲ
* hip fracture need surgery

Exclusion Criteria:

* patient refusal
* chronic use of opioids
* coagulation disorders
* preexisting neurological disorders
Usage of Stainless Steel Crown on Primary Molars Using Hall Technique

Rationale: Gaining information about the knowledge, practice and attitude regarding hall technique and find out how much the Egyptian dentists use this method for treatment the carious primary teeth.

Aim of the study: To assess the knowledge, practice and attitude of Egyptian dentists regarding non invasive restorative approach.

The first study on the Hall Technique was published in 2006 . It was a retrospective study which analysed the practice records of a general dental practitioner from Scotland, Dr. Norna Hall. Dr. Hall simplified the standard technique to restore primary teeth using preformed SSCs and used it with her patients. This retrospective study involved a total of 978 crowns fitted in 259 children using her novel technique (today known as the Hall Technique). Most crowns were placed when there was clinical evidence of a proximal carious lesion into dentine and marginal ridge breakdown. This study showed the Hall Technique to have comparable outcomes to those achieved with other more conventional restorations.

Since then, growing understanding that caries is essentially a biofilm driven disease rather than an infectious disease, explains why the Hall Technique, and other 'sealing in' carious lesion techniques, are successful. The intervening ten years has seen robust evidence from several randomised control trials that are either completed or underway. These have found the Hall Technique superior to comparator treatments, with success rates (no pain or infection) of 99% (UK study) and 100% (Germany) at one year, 98% and 93% over two years (UK and Germany) and 97% over five years (UK). The Hall Technique is now regarded as one of several biological management options for carious lesions in primary molars.

Eligibility Criteria:
Inclusion Criteria:

1. Egyptian dentists.
2. Pediatric dentists ( having PhD).
3. Pediatric dentists (having Master degree or studying master degree) .

Exclusion Criteria:

1. dentists in other dental speciality.
2. dental students.
3. pediatric dentists who have not enough knowledge about hall technique.
Aggressive Prostate Cancers in Elderly Patients

Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.

Patients aged 70 years or older had a higher risk of advanced prostate cancer and shorter BCR-free survival than younger ones. Definite treatment of clinically localized prostate cancer should be actively considered in well-selected healthy patients older than 70 years.

Eligibility Criteria:
Inclusion Criteria:

* clinically localized prostate cancer
* good health status
* follow-up period more than 12 months

Exclusion Criteria:

* insufficient clinical data
* poor health status
* clinically advanced prostate cancer
The Effects of Omega-3 Status and Supplementation on Tendon Structure in Competitive Athletes

The study will examine the association between omega-3 status and the effects of omega-3 supplementation on changes in tendon structure and recovery from tendon injuries and inflammatory markers in competitive athletes. Half of the participants will receive omega-3 in combination with vitamin E, while the other half will receive a placebo and vitamin E.

Sports injuries are common among athletes, while injury prevention received much clinical attention, there is no consensus among clinicians and researchers as to which injury-causing factors are dominant. It has been suggested that increased training load may be the leading cause of sports injuries, since tendons are sensitive to changes in load, making them vulnerable to injury. Inflammation is one of the reversible risk factors to sports injuries, and there are numerous methods which are used to treat inflammation. It has been recently suggested that inflammation reactions are affected by Omega-3 status and that omega-3 deficiency may increase the risk of sports and tendon injuries. The omega-3 fatty acid may act as a regulator of membrane structure and function, intracellular signaling pathways, transcription factor activity, and gene expression and reducing inflammation. Due to these functions, omega-3 may influence exercise-induced injuries/inflammation in athletes, thus, may influence their health and allowing training.

Eligibility Criteria:
Inclusion Criteria:

Part one:

* Training for at least 5 hours per week.
* No complaints about lower extremities pains during the last 12 months.

Part two:

* Training for at least 5 hours per week.
* Diagnosed with patellar and Achilles tendinitis.

Exclusion Criteria:

* Underwent lower extremities surgeries.
* Allergic to Fish products.
* Athletes who use anti-inflammatory drugs and/or omega-3 supplements.
* Pregnant and/or nursing mothers.