cyrilzakka/clinical-trials huggingface dataset:
Effect of Sport Education on Physical Fitness and Learning Attitude Among Junior High School Students

Since the outbreak of COVID-19, students; sports environment and time have been severely compressed, which has had an unprecedented impact on their physical fitness and sports learning attitude. Therefore, it is urgent to adopt an effective teaching mode that aligns with curriculum reform to improve students; physical quality and learning attitude. The Sports Education Model is one of the most popular teaching models in Western developed countries, but the application in China and the related evidence of improving students; physical quality and learning attitude towards sports are relatively scarce. This study compares and analyzes the influence of the Sports Education Model and Traditional Teaching on junior middle school students; physical fitness and learning attitude, aiming to provide theoretical support for improving students; physical fitness and learning attitude and promoting the Sports Education Model in China. Promote the healthy development of junior middle school students.

In the study, the experimental group underwent a 12-week soccer program based on the Sport Education Model instructional intervention designed for this research. In contrast, the control group discussed and studied traditional soccer teaching content for 12 weeks with their teachers. Employing a Cluster randomized controlled experiment design, the experimental and control groups were randomly assigned to two different schools. Students participated in the Sport Education Model (experimental group) and traditional teaching (control group) sessions three times a week, each lasting 40 minutes (totaling 120 minutes per week). Physical fitness tests and responses to the Students' Attitudes Toward Physical Education Scale (SPEA) were conducted for both groups before the start of the first week. After 12 weeks of instruction, both groups were required to undergo physical fitness tests and respond to the Students' Attitudes Toward Physical Education Scale once again.

Eligibility Criteria:
Inclusion Criteria:

The experimental subjects were students from two junior high schools in Haigang District, Qinhuangdao City, Hebei province. Before enrolling subjects, researchers need to inform them of the proposed study and what they need to participate in. After the subject is informed, the subject is allowed to ask questions. The various criteria and requirements for participation in this study were explained during the meeting. The criteria for inclusion of potential participants are as follows:

1. Participants must be enrolled in junior high school and mixed gender.
2. Participants must be in good health and capable of engaging in regular physical education activities.
3. All participants and their parents have provided written informed consent for their involvement in the study.

Exclusion Criteria:

1. Participants failing to complete all tests due to attendance-related issues (25%) or illness during experimental teaching or testing will be excluded.
2. Participants who have already participated in the Sport Education Model will be excluded.
Human Placental-Derived Stem Cell Transplantation

The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and HPDSC.


Eligibility Criteria:
Inclusion Criteria:

* \< 55 years of age
* Life expectancy greater than 3 months
* Lansky performance status ≥ 50% (children) or Karnofsky performance status ≥ 70% (adults) or ECOG performance status 0-2 (adults)
* DLCO \> 50 percent predicted
* Left ventricular ejection fraction \> 40% estimated
* Creatinine clearance or estimated GFR . 60 mL/min/1.73m2
* Serum bilirubin \< 1.5x upper limit of normal
* Transaminases \< 3x upper limit of normal
* Absence of uncontrolled infection
* HIV negative

Exclusion Criteria:

* Fanconi Anemia
* Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Uncontrolled infection
* Pregnant or breast-feeding females
* Received other investigational agents within 30 days prior to the start of the conditioning regimen
Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation

Liver transplantation (LT) is a live-saving therapy for patients with complicated chronic liver diseases and acute liver failure .Even though many complications can occur after LT, biliary complications (BC) are both common and potentially severe .

a prospective study and retrospective part from hospital records.

Aim of the study:

1. Detect frequency, risk factors for development of biliary complications post living donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone, cholangitis etc....).
2. Evaluate outcomes of different biliary complications


Eligibility Criteria:
Inclusion Criteria:

* Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital , Assiut university,Egypt

Exclusion Criteria:

* pediatric liver transplantation
* cadaveric liver transplantation
Effect of Radiation on Tissue for Delayed Breast Reconstruction

The purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation.

In the setting of post-mastectomy radiation therapy delayed autologous reconstruction, favored by many attempts to avoid complications encountered with radiating the immediately reconstructed breast. The timing of delayed reconstruction is however not known. The goal of this proposal is to study the gross, structural and vascular changes in radiated mastectomy skin in addition to possible structural and flow changes of the underlying internal mammary vessels over time. We plan to use these objective findings as a basis for determining an ideal time frame for delayed autologous breast reconstruction.

Sequential mastectomy skin specimens will be obtained from 20 patients undergoing post-mastectomy radiation therapy over a 24 month period and these specimens will be evaluated histologically. These same patients will also undergo serial examinations and photographic documentation of gross skin changes. Skin perfusion will be assessed by laser Doppler imaging and internal mammary vessel structure, and flow characteristics will be assessed by color Doppler sonography.

Based on these studies, we will elucidate short and long term changes in radiated breast skin, showing inflammatory, structural and perfusion patterns that can be correlated with optimal conditions for reconstruction. This has the potential to dramatically change practice patterns of delayed reconstruction for many reconstructive surgeons and more importantly restore what patients loose with mastectomy in a consistent, timely fashion. There is also potential for improved outcomes of delayed breast reconstruction by decreasing the number of reconstructions performed too soon after completion of radiation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
2. Patients who meet criteria 1, who plan on postmastectomy breast reconstruction

Exclusion Criteria:

1. Male patients
2. Patients under the age of 18
3. Patients of advanced age (greater than 75)
4. Patients with comorbidities that affect wound healing.
Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis

The aim of the study is to investigate the long-term effect of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in people with allergic rhinoconjunctivitis caused by house dust mites and the associated symptoms (symptom type and severity) during exposure to house dust mites in an Allergen Exposure Chamber (AEC).

In particular, the study aims to evaluate whether the improvements in symptoms of house dust mite-induced rhinoconjunctivitis observed after 3 months of supplementation with holo-BLG can still be detected 7 to 8 months after the last intake.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the predecessor study including complete intake of the holo-BLG lozenge for 3 months; inclusion in the final analysis set of the predecessor study
* patients with allergic rhinoconjunctivitis caused by house dust mites of any gender, aged 18-65 years
* Verbal and written informed consent

Exclusion Criteria:

* Persons \<18 years
* lack of verbal and written consent
* persons who do not speak German
* seriously ill persons
* Persons with immunosuppressive medication such as systemic corticosteroids, cyclosporine
* Pregnancy and breastfeeding
* psychiatric illness
* Persons who have received or have started sublingual or subcutaneous immunotherapy (SLIT/SCIT) against house dust mites in the last 2 years before screening
* Contraindications and/or history of adrenaline intolerance and/or emergency medication.
* Concurrent use of anti-allergic medications and/or inadequate washout period of these anti-allergic medications prior to the selection process and exposure in the exposure chamber
* Use of an investigational drug 30 days/5 half-lives of the drug (whichever is longer) prior to screening
* Use of certain drugs prior to V5: Systemic corticosteroids within 3 weeks; Topical nasal corticosteroids within 2 weeks; Chromones within 7 days; Antihistamines within 72h; Antibiotics within 3 months; Pro-, Pre- and Synbiotics 1 month
Effects of Footwear Suitability on Functional Performance and Balance in Elderly

Proper footwear serves to protect the foot against external factors. Balance and functional performance are affected by the level of footwear suitability. This study was designed to investigate the effects of footwear suitability on functional performance levels and balance in the elderly.

The function of proper a footwear is to protect the foot against external factors. Balance and functional performance are affected by the level of footwear suitability. Particularly in elderly who have generally balance disorders and falling, footwear suitability is very important. Thus this study was designed to investigate the effects of footwear suitability on functional performance level and balance in elderly. The Footwear Assessment Score was used to assess parameters such as the design materials for footwear (upper and base), bending point, width, height of the toe box, getting out of the foot when walking, heel height, footwear style, wearing of the heel, and the distance between the longest toe and the end of the footwear. Thus, footwear was evaluated in many parameters.

In the literature, there are studies in which footwear was evaluated in only parameter such as height of heel.

Eligibility Criteria:
Inclusion Criteria:

* Subject has not musculoskeletal injury within the last year.
* Subject has not needed gait assistance for ambulation.

Exclusion Criteria:

* History of psychiatric, neurological and cognitive diseases.
* history of visual and hearing problems.
* Has poor coordination.
* History of chronic diseases and acute pain.
* has diabetic foot.
Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine the intraocular Pressure (IOP) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age at Visit 1 (Screening), of either sex and any race
* Be willing and able to provide written informed consent prior to any study procedures being performed.
* Be willing and able to follow all instructions and attend all study visits.
* Be willing to discontinue use of disallowed medication
* Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications.
* Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.
The Use of Hospital and Emergency Department of Refugee Patients

After Middle Eastern crisis, millions people were forced to migrate to European countries and especially neighboring countries. In Turkey, cities which are closed to east of border, face to cope more refugees' health care than those of other cities. The incidence of admission of hospital outpatient clinics and emergency department by refugee patients is not known clearly in our city, Nevsehir. In this study, we wanted to investigate use of health care among these patients in Nevsehir in Turkey.


Eligibility Criteria:
Inclusion Criteria:

All patients who visited an outpatient clinic and emergency department.

Exclusion Criteria:

Patients who have missing records.
Ear Drops for Children With Otitis Media

The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to participating clinic with otitis media
* Diagnosed with acute otitis media
* Parents rate symptoms as a "moderate problem" or more

Exclusion Criteria:

* Diagnosis of otitis media within preceding 30 days
* Receipt of antibiotics within 2 days
* Perforated ear drum or bullous lesion
* Receipt of homeopathic treatment within 30 days
Longitudinal One Year Vs Single Day NRP Training.

The Neonatal Resuscitation Program (NRP) recommends providers renew their certification every 2 years. However, many Neonatal Intensive Care Units (NICUs) in Canada face challenges of significant budget cuts in training and a large number of caregivers to train with a high turnover rate. This situation makes it difficult for managers and nurse educators to ensure up-to-date certification and competence for all clinical staff. In addition, considering that only 0.1% of newborns will require cardiac massage and/or epinephrine, health care professionals' exposure to critical events is low to insure maintenance of expertise. Furthermore, it is shown that there is a significant decrease in knowledge among learners who have undergone specific training after only 3 months. This is worrisome considering that some nurses will not renew their certification if the course is not paid for by the employer, or if they are not released from clinical duties to attend. While keeping in mind the various required components of NRP training: book reading, online exam, performance stations, Integrated Skills Station Assessment (ISSA) and simulations, we would like to assess the educational and financial impact of a new educational strategy developed as to allow more nurses to be retrained thus ensuring maintenance of their neonatal resuscitation expertise.


Eligibility Criteria:
Inclusion Criteria:

* Newly recruited ( in the last 3 months) neonatal and delivery room registered nurses from level 2 and 3 perinatal centers

Exclusion Criteria:

* Registered nurses that have already completed a NRP training in the past.
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.


Eligibility Criteria:
Inclusion Criteria:

-First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302

Exclusion Criteria:

* Other protocol-defined inclusion/exclusion criteria may apply.
Breast Cancer Women on Aromatase Inhibitors Treatment

The main objective of the study is to improve the life quality of women treated with AI. Cohort B-ABLE is designed to evaluate musculoskeletal events derived of using AI in breast cancer women. The project objectives are the analysis of the AI deleterious effect on bone microarchitecture and early determination of the risk of fragility fracture with dual energy x-ray absorptiometry (DEXA), lumbar spine Rx, Trabecular Bone Score (TBS) and microindentation. Determination of physiological causes of the AI-related arthralgia by analyzing joint degradation markers, steroid hormone levels remaining in blood and functional magnetic resonance, before and after three months of AI treatment

Postmenopausal women with breast cancer treated with aromatase inhibitors (AI) have a higher incidence of osteoporosis, fractures and other musculoskeletal symptoms, particularly pain and stiffness. B-ABLE is a clinical, prospective cohort study carried out in both Breast Cancer and Bone Metabolism Units of the Hospital del Mar in Barcelona. Currently, 780 postmenopausal Caucasian women with early breast cancer and candidates for adjuvant AI treatment were included and predicted to reach more than 1000 patients. The main objective of the study is to improve the life quality of women treated with AI. Cohort B-ABLE is designed to evaluate musculoskeletal events derived of using AI in breast cancer women. The project objectives are the analysis of the AI deleterious effect on bone microarchitecture and early determination of the risk of fragility fracture with DEXA, lumbar spine Rx, TBS and microindentation. Determination of physiological causes of the AI-related arthralgia by analyzing joint degradation markers, steroid hormone levels remaining in blood and functional magnetic resonance, before and after three months of AI treatment. The study results will help to decide the most appropriate treatment for each patient in order to minimize AI-related side effects and hence avoid discontinuation of adjuvant therapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with early breast cancer estrogen receptor with aromatase inhibitors treatment

Exclusion Criteria:

* Previous treatment with antiresorptive treatment for osteoporosis secondary osteoporosis, as corticosteroids, Hyperparathyroidism, Kidney Chronic disease, previous treatment with aromatase inhibitors Diabetes mellitus type 1 Fibromyalgia
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an adult (18 years of age or more )
* Subject with epilepsy who has completed 1 of the previous Padsevonil (PSL) studies which allow access to the present study
* Female subjects of child bearing potential must have a serum negative pregnancy test at the Entry Visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. Subjects will be withdrawn from the study as soon as pregnancy is known. Female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of PSL.

Exclusion Criteria:

* Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject
* Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has \>2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (\>= l.5x ULN total bilirubin if known Gilbert's syndrome) at the Entry Visit
* Subject has a clinically-significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a Grade 2\* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (\*according to the ASE Guidelines, 2017; Zoghbi et al 2017)
* Female subject who plans to be pregnant or is breastfeeding
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Postoperative pain control is a signiﬁcant challenge in medical practice. Inadequate pain control could decrease patient's satisfaction, delay postoperative ambulation, increase the incidence of pulmonary and cardiac complications and cause the development of chronic postoperative pain. Laparoscopic surgical techniques could decrease postoperative pain and opioid consumption.

The addition of regional techniques to general anesthesia showed better pain management and less consumption of opioids compared to the traditional techniques.

The aim of this study is to compare the effectiveness of ultrasound guided erector spinae plane block versus quadratus lumborum block regarding postoperative analgesia in patients undergoing laparoscopic sleeve gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
* BMI \> 35 kg/ m2

Exclusion Criteria:

* Patients unfit for surgery or refuse to sign the consent of regional block.
* Patients with known coagulation defects.
* Patients with known hypersensitivity to bupivacaine.
* Patients with infection at the site of injection.
* Conversion of laparoscopic surgery to laparotomy