cyrilzakka/clinical-trials huggingface dataset:
Functional Training Improves the Functional Capacity and Physical Fitness of People Whit Spinal Cord Injury

The aim of this study is to understand the effect of adapted functional training on the physical fitness, functionality and quality of life of individuals with SCI after social distancing due to COVID-19. The main question\[s\] it aims to answer are:

* Are the participants of the functional training program adapted for people with spinal cord injury show better results in functional capacity in post-test evaluations training period, when compared to your results in the functional training pré-period?
* Is adapted functional training capable of improving cardiorespiratory fitness, muscular strength and body composition?
* Can the perception of quality of life be influenced by functional training?

Participants will be evaluated through questionnaires and field tests, such as:

* Functional Capacity (battery of motor tests related to functional independence and Motor Assessment Scale),
* Physical fitness (handgrip test; medicine ball throw; Illinois agility and 12-minute displacement) and Quality of Life (WHOQOL-DIS).

The spinal cord is an important component of the central nervous system, whose function is to transmit motor nerve impulses from the brain to other parts of the body, and to transmit sensory impulses from other systems of the body to the brain. Among adults living with SCI, studies show that participation in physical exercise programs, such as functional training, is associated with numerous health-related benefits, including improvements in cardiorespiratory fitness, energy production, and muscle strength, reduced the risk of cardiometabolic diseases and osteoporosis, in addition to psychosocial and quality of life benefits. However, high rates of physical inactivity among people with SCI are still a reality and, therefore, a cause for medical and health concern. In the recent scenario, measures to prevent and contain COVID-19 further contributed to the increase in sedentary time and behavior among individuals with spinal cord injury. Considering that TF aims to enhance specific actions in activities of daily living, the hypothesis of the cohort study is that a positive effect will be observed on functional capacity, on elements of physical fitness of these individuals and on quality of life after 8 weeks of training functional. Participants will be recruited by convenience and will undergo assessments of body composition, functional capacity, physical fitness and quality of life pre and post eight weeks of functional training, three times a week.

Eligibility Criteria:
Inclusion Criteria:

* Men and women;
* Aged 18 or over
* Have had Spinal Cord Injury for at least two years
* Wheelchair users

Exclusion Criteria:

* Individuals who had clinical or physical conditions that prevented them from carrying out the proposed tests
Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin

Some aspirin-treated patients have a blunted pharmacological response predisposing to clinical failure. The investigators hypothesize that the blunted response often results from increased rate of platelet production and some failures will be prevented by administering aspirin twice daily. The overall objective is to develop a valid method to quantify platelet production (without the use of radioactive isotopes) in order to examine the hypothesis that enhanced platelet production is a common cause of poor aspirin responsiveness in patients with atherothrombosis.

The specific objective of this study is to validate the Cayman Chemical serum thromboxane immunoassay as a measure of platelet production in healthy subjects who are treated with aspirin by demonstrating that the recovery of their serum thromboxane B2 levels occurs at a rate of about 10% per day after aspirin cessation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking volunteers;
* Age ≥ 18 years;

Exclusion Criteria:

* Allergy or intolerance to aspirin;
* Current pregnancy;
* Use of aspirin or drugs interfering with platelet function (NSAIDs, anticoagulants) within one week of study enrolment.
Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study

immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.

In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.

One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).

Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study.


Eligibility Criteria:
Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* With biopsy proven IgA nephropathy (any vintage)
* With urine albumin/creatinine \> 300mg/g,
* under maximal tolerated labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors for at least 3 months
* With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy
* With estimate GFR above 15 mL/min/1,73m² (Chronic Kidney Disease - EPIdemiology collaboration CKD-EPI formula)
* With at least one contraceptive method for women of childbearing age

Exclusion Criteria:

* Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)
* Corticosteroid or immunosuppressive therapies in the past year before screening
* Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to hydroxychloroquine...)
* Uncontrolled hypertension (systolic blood pression\> 160 mmHg and/or diastolic blood pression \>110 mmHg )
* Long QT interval and/or QT prolonging medicines
* Pregnancy or lactation
Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke

Stroke is a leading cause of chronic disability here in Nova Scotia and globally. Aerobic exercise is known to improve health by increasing energy levels, physical mobility, balance, bone health, cardiovascular risk reduction, mental well-being, cognition, sleep, and quality of life. Nonetheless, people remain woefully inactive after stroke, regardless if they are in hospital or at home. The current investigative team and others have shown that even during physiotherapy, exercise intensity is not adequate to increase physical fitness. Consequently, patients are often deprived of a treatment that could improve their recovery. Why does this gap between evidence and clinical practice persist? Through a national survey the current team found that an important contributing factor is lack of appropriate screening (especially stress tests) to ensure that patients are safe to engage in aerobic exercise. This project is designed to close this evidence-practice gap by establishing a state-of-the-art aerobic exercise screening and prescription clinic at the Nova Scotia Rehabilitation Centre (NSRC). The intent is to compare outcomes of stroke rehabilitation participants before and after the clinic is underway and determine if the clinic has a positive effect on the confidence of NSRC physiotherapists to use aerobic exercise safely and effectively in stroke rehabilitation.

Research question: To what extent does an on-site aerobic exercise screening and prescription clinic effect uptake of aerobic exercise and patient outcomes in in-patient stroke rehabilitation?

Design: Pre-post cohort design to explore real-world application and feasibility

Aim 1. Establish an aerobic exercise screening and prescription clinic (herein 'Aerobics Clinic') at the NSRC.

Aim 2. Assess the potential impact of the Aerobics Clinic on the self-efficacy of physiotherapists at NSRC regarding clinical utilization of aerobic exercise in in-patient stroke rehabilitation.

Method: An assessment of the physiotherapy participants' self-efficacy regarding the clinical utilization of aerobic exercise post-stroke will be conducted prior to, and after, implementation of the Clinic.

Aim 3: Assess the potential impact of the Aerobics Clinic on prescription and treatment practices regarding aerobic exercise among patients in stroke rehabilitation at the NSRC.

Method: Prior to, and after, implementation of the Clinic the actual utilization of aerobic exercise in the practices of the physiotherapy participants will be assessed using heart rate monitoring, activity monitoring, and health record review.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults
* Diagnosed with ischemic or hemorrhagic stroke
* Referred to NSRC for stroke rehabilitation

Exclusion Criteria:

* Have contraindications to exercise testing using American College of Sports Medicine guidelines
Behavior Management Techniques Adopted by Pediatric Dentists in Egypt

A cross-sectional study to investigate behavior management techniques used by pediatric dentists in Egypt according to AAPD clinical guidelines.

Observational study to investigate behavior management techniques adopted by pediatric dentists in Egypts for different patients ages, by distributing questionnaires in Egyptian govermental universities consisting of participant's demographic information, behavior management techniques used for each age group and their opinion or comments.

Eligibility Criteria:
Inclusion Criteria:

* pediatric dentist and holding at least a master degree

Exclusion Criteria:

* refusal to participate
Optimizing the Ocular Surface Prior to Cataract Surgery

Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with significant EBMD that are contemplating cataract surgery.
2. Age range: 50 years and older.
3. Both Genders and all ethnic groups comparable with the local community.
4. Subjects able to understand and willing to sign a written informed consent.
5. Subjects able and willing to cooperate with the investigational plan.
6. Subjects able and willing to complete postoperative follow-up.

Exclusion Criteria:

1. Subjects with known intolerance to PKS or known allergy to its preservative media.
2. Subjects with symblepharon or lid abnormality preventing PKS placement.
3. Ocular infection within 14 days prior to study entry.
4. Previous ocular surgery or injury within 3 months before enrollment.
5. Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
6. Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
Clinical Investigation of the Nucleus® CI532 Cochlear Implant

The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.

Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older at the time of implantation
* Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the exclusion criteria that follow)
* Native speaker in the local language used to assess clinical performance

Exclusion Criteria:

* Evidence of hearing loss prior to 5 years of age
* Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear
* Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery
* Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination
* Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway
* Active middle-ear infection
* Tympanic membrane perforation
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
* Unwillingness or inability of the candidate to comply with all investigational requirements such as undergoing a post-operative digital volume tomography/ConeBeam scan
* Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak
* Patients with recurrent episodes of bacterial meningitis
* Pregnancy or breast-feeding
* Known allergies to components of the implant
* Wearing other active implants with known interference with cochlear implants
Role of Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response

The goal of this clinical trial study is to investigate the role of anthropometric indices and Vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals infected with COVID-19.

The main question\[s\] it aims to answer are:

1. BMI has role in reduce BioNTech, Pfizer vaccine side effect
2. BMI has role in improve IgG titer
3. Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
4. Vit-D supplementation has role in improve IgG titer

The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast, for 14-16 weeks. The control group took a placebo prepared with the same shape and size of supplements. The supplement was given to the patients by someone other than the researcher, to ensure that the researchers did not know which group receiving the supplement/placebo (given the double-blindness of the study). Also, in this study, the person who did the data analysis did not aware of randomization. at first, a 3-day recall food questionnaire was taken from two groups. From the day, the subjects tested positive, they were asked to start supplementation for 4 weeks and return after that to take the first dose of the vaccine. Subjects were asked to continue to use supplements after the first vaccination. After 6 to 8 weeks, patients came back for another vaccination dose and were again asked to use the supplement for 4 weeks again, after that subjects were asked to come for a blood test.

Eligibility Criteria:
Inclusion criteria:

participants with COVID-19 positive tests.

Exclusion criteria:

1. Who did not take the vaccine
2. who take one dose of the vaccine
3. who did not come back for another dose
4. subjects who in the last 6 months received vitamin or mineral supplementation
5. those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.
Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. In the foreign literature, many studies bring to light in children and adolescents the negative impact of ADHD on overall quality of life. Some of these studies were able to identify the fact that the higher the age of ADHD children or adolescents, the lower the quality of life. Currently, to our knowledge, only a few European studies have demonstrated the negative impact of ADHD on the quality of life of children and adolescents. In addition, these studies used only questionnaires intended for parents and not for children or adolescents.

During a regular follow-up consultation with their referent child psychiatrist, adolescents accompanied by at least one of their parents will be informed of the modalities of our study. A newsletter will be delivered to parents and one to the adolescent. If neither the adolescent nor the parents is opposed to participate, the child psychiatrist will register the patient on the list of study participants. He will also fill out a medico-social information sheet about the adolescent as to summarize the data in the medical record. At the end of this consultation, in the waiting room, adolescents will answer questionnaires KIDSCREEN-27 and MSPSS; their parents will complete the CBCL questionnaire. These questionnaires will be handed to the secretary who will put them back in the patient's record. The KIDSCREEN-27, MSPSS and CBCL questionnaires as well as the medico-social information sheet will be source documents. The principal investigator or one of the associates investigators will complete the case report form from these source documents. For this purpose the data will be entered anonymously into a data entry software on a computer server secured by the Centre Psychothérapique de Nancy (CPN). Then, anonymous data from the software will be forwarded to Dr. Epstein of the Clinical Investigation Center for statistical analysis. The study will begin when the favourable opinion of the Ethical Research Comittees will be obtained and the study will last one year.

Cross-sectional, descriptive epidemiological study based on single-centre trials

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 12 to 18 years
* Diagnosis of ADHD (f 90.0) ascertained by a child psychiatry according to CIM-10 criteria
* Seen by a child psychiatrist in consultation and accompanied by at least one of their parents
* Adolescents and at least one parent who has received enlightened information about the study
* Non-opposition to participate in the study gathered from at least one of their parents
* Patient affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Illiteracy of the parents or the adolescents
* Difficulties to understand french for the parents or the adolescents
A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer

This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the \[131I\]/\[18F\]/\[68Ga\]ZT-111 in patients with PSMA positive metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years old.
2. Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
3. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
4. Willing and able to comply with all aspects of this study.

Exclusion Criteria:

1. Severe hepatic or renal impairment.
2. History of major surgery within the last month.
3. Participation in another concurrent clinical trial.
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer

This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy.

Epidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* 1. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
* 2. female ≥ 18 years of age
* 3. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \< age ≤ 60 years old with 1 year of menopause. d) Age \<60 years and receiving ovarian suppression therapy.
* 4. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
* 5. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
* 6. have normal organ function (as assessed by the investigator).

Exclusion Criteria:

* 1. women who are pregnant or breastfeeding
* 2. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
* 3. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator