cyrilzakka/clinical-trials huggingface dataset:
The Effect of Energy Drinks Consumption on Acute Physiological and Psychological Responses of Israeli Arab Adolescents

Quasi-experiment and Cross-sectional study, six-arm design protocol will be carried out. The study will be conducted under the Declaration of Helsinki.

The current study will assess the effects of EDs consumption on the physiological and psychological responses of Israeli Arab adolescents. These effects will also be examined in association with the adolescent's plasma metabolite profiles.

The study has five specific aims: (1) to assess the effects of ED consumption with or without a meal, on Israeli Arab adolescents glucose levels by using mixed meal tolerance test (MMTT) (2) to assess the effect of ED consumption with or without a meal on their blood pressure (3) to evaluate the association between ED consumption per day by the Israeli Arab adolescents and their nutritional status and habits (4) to examine for possible associations between Israeli Arab adolescents psychological status (i.e. mood and anxiety) and ED consumption per day (5) to examine for possible associations between ED and caffeine consumption and plasma metabolite profiles and, the subject's psychological status.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Israeli Arab adolescents
* aged 14.5-17.5 years

Exclusion Criteria:

* diabetes
* hypoglycemic episodes
* coronary heart disease, cardiac arrhythmia, secondary hypertension, structural heart lesions
* hepatic or renal disorders
* autonomic neuropathy
* epilepsy
* obstructive sleep apnea
* migraines
* caffeine intolerance
* eating disorders or other mental disorders or those with prescribed psychiatric medications
School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and school performance/attendance among in-school adolescents in Zanzibar, Tanzania.

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Zanzibar. Findings from this study will clarify the optimal supplementation strategy (iron and folic acid alone or adding other essential nutrients) and provide a basis for scale up of national micronutrient supplementation programs to benefit the adolescent population as a whole in Zanzibar.

This will be a cluster randomized study with 3 arms. At the beginning of the academic year, 42 schools will be enrolled (14 schools per arm) to receive either 1) supplementation with weekly iron and folic acid (IFA); 2) supplementation with daily multiple micronutrient supplements (MMS) (including iron and folic acid as components); or 3) to serve as controls. Students in intervention schools will receive supplementation and students in control schools will receive the usual care (which does not include supplementation but does include existing curriculum on nutrition and water, sanitation and hygiene \[WASH\]). The program will be evaluated at the end of year 1, comparing effects of weekly IFA and daily MMS on anemia status and school attendance/performance. The more effective strategy (MMS or IFA) will be scaled up to all the study schools for year 2 of the intervention, and the outcomes will be re-assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 10-17 years
* Enrolled in secondary school form 1 at study initiation
* Member of one of the selected classes in a participating school
* Consent provided by the parent
* Assent provided by the adolescent
* Fluency in Swahili and/or English

Exclusion Criteria:

* No informed consent from parent or assent from adolescent
* Self-reported pregnancy
Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan

This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
* Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
* Pre-treatment cycle assessed as ovulatory and not longer than 44 days

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
* Known or suspected liver disorders
* Amenorrhea for more than 3 months within the last 6 months before the first screening examination
* Clinically relevant findings (e.g. blood pressure, electrocardiogram \[ECG\], physical and gynecological examination, laboratory examination)
* Positive urine pregnancy test
* Regular use of medicines
A Study of Bumetanide for the Treatment of Autism Spectrum Disorders

The investigators are going to carry out a randomized double-blind placebo-controlled trial to study the efficiency and mechanism of bumetanide on the treatment of children with Autism Spectrum Disorder.

In consideration of the increasing number of autistic children and poor intervention effect in China, it is an urgent to find some effective medicine. Some studies have reported bumetanide, a classic diuretic, could improve autistic behaviors in both animal model and humans; while the efficiency of bumetanide on Chinese autistic chilren is unkonwn and the underlying mechanisms remain unfolding. The investigators aim at investigating whether bumetanide would improve the clinical symptoms in Chinese children with autism within a safe dosage and further study the physiological mechanism beneath.The investigators will regularly assess the participants' autism-related symptoms during medication, as well as the adverse effects of each patient. The investigators will carry out genome-wide association analysis (GWAS) from blood sample, related metabolites in nervous system and compare the concentration of the neurotransmitter in autistic brain before and after 3 months' treatmeat,and also will collect the EEG signal in autistic chilldren when the participants performing certain tasks before and after 3 months' treatment.

Eligibility Criteria:
Inclusion Criteria:

The patients, aged from 3 to 6 years old, were given the diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) , by a team of autism experts; Scores for Children Autism Rating Scale (CARS) were more than 30; Signed Informed Consents were provided by parents.

Exclusion Criteria:

Liver and kidney dysfunction; With a history of allergy to sulfa drugs; abnormal ECG; chromosomal abnormality; suffering from nervous system diseases (such as epilepsy, schizophrenia, and so on); using the melatonin treatment for sleep disorders or withdrawal less than three weeks.
Potential Biomarkers for Early Diagnosis of Acute Aortic Dissection

Acute aortic dissection (AAD) is an acute vascular lesions with high early misdiagnosis rate(31.8%), and mortality rate was 38%. In recent years, the incidence is rising and serious threat to human health. At present, the clinical diagnosis of AAD commonly used imaging methods, including chest X-ray, B ultrasound, CT, MRI and aortic angiography. Chest X-ray and two-dimensional ultrasound is limited in diagnosis of AAD, esophageal ultrasonography can display the intimal, identify the true and false lumen, but greater risk. CT, MRI and aortic angiography can be used as diagnosis method, but time-consuming, expensive and requires handling patients in emergency situations, should not be used as the preferred. Therefore, it is significance that biomarkers with high specificity and sensitivity for clinical fast diagnosis of AAD.

Parts small sample tests found that single serum α-smooth muscle actin (α-SMA), myosin heavy chain(MHC) and human soluble elastin fragments (sELAF) levels in patients with AAD were significantly higher than that of others (normal people, acute myocardial infarction patients). But because of the small study sample, limited control risk factors and incomplete comparison, their conclusions were questionable. In our previous studies also found that serum α-SMA, MHC and sELAF levels and the pathogenesis of AAD and prognosis are closely related. Therefore, on the basis, a prospective study is needed. We observe all the three biomarkers in enrolled patients with acute chest pain in emergency department, levels in healthy volunteers as the blank control. Then make definite diagnosis of the enrolled patients, and further observe the biomarkers dynamic change in AAD. Lastly, evaluate the early diagnostic value of combination serum α-SMA, MHC and sELAF level on patients with AAD.

This is a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected AAD.

Subjects enrolled in this study will sign and informed consent and have 3 blood samples drawn at different time points during their emergency department visit. In addition, data will be collected about the patient's health history, hospital procedures, and final diagnosis.

Blood samples collected in this study will be sent to laboratory for long-term storage and analysis in the future for these blood markers as they become available. No genetic testing will be conducted on these samples.

Eligibility Criteria:
Inclusion Criteria:

* chest pain without diagnosis confirmed
* symptom occurred in 2 hours
* ≥18 years old
* Can complete the base information
* Able and willing to give written consent

Exclusion Criteria:

* known AAD
* known causes of acute chest pain such as tumour and trauma
* pregnant or lactating female
* Associated chronic inflammatory diseases
Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial

This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. The investigators want to see if in pediatric patients, giving Zofran prior to propofol, reduces the pain that patients often experience when propofol is injected through an IV. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. The investigators hope to show a means of improving pain control in their patients undergoing anesthesia.

Propofol is a drug commonly used at the beginning of anesthesia (induction). Patients often experience discomfort when propofol is injected through an IV. Ondansetron (Zofran) is a drug that is commonly used to treat nausea after anesthesia. In adult studies, it has been shown that there is significantly less pain when Zofran is given just before propofol is given. The investigators want to see if giving Zofran prior to propofol reduces the pain and discomfort experienced by pediatric patients.

This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. During induction the treating anesthesiologist will be blinded to the study arm, however they will be unblinded at the end of induction. All subjects will receive Zofran at some point during the surgery - for patients not in the Zofran arm, they will receive it at the end of the case as usual. A blinded observer will score the subject's pain during propofol injection and vital signs will be recorded.

Subjects will be identified by the study team from the surgery schedule. Patients ages 2-17 undergoing surgery with peripheral vascular access (an IV) will be approached. Consent and assent (when appropriate) will be obtained. Subjects will not be compensated. Participation will consist only of the single duration of the surgery.

In this study the investigators hope to show a means of improving pain control in their patients undergoing anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients 2 years old through 17 years of age
* Children undergoing surgery at Children's Healthcare of Atlanta Egleston location
* Patient with existing peripheral vascular access in the arm below the antecubital fossa
* Patients with an American Society of Anesthesiologists (ASA) physical status category score of 1, 2 or 3
* Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
* No known chronic pain syndrome

Exclusion Criteria:

* Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
* Patients presenting for endoscopy procedures
* Known chronic pain syndrome
* Patient diagnosed with long QT syndrome
* Patient weighing \>40kg
* Documented allergy to study medications
* Pain on injection of pre-operative normal saline flush
* Patient has received an opioid within 30 minutes prior to anesthesia induction
Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this condition, however intravitreal injection of corticosteroids, in conjunction with oral steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the treatment of neovascular age-related macular degeneration.

This is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. Since it is common clinical practice to perform regional periocular injections of steroids in patients with uveitic macular edema, only patients who are refractory to periocular steroids will be enrolled in the study. The 0.5 mg dose of ranibizumab will be given intravitreally since this dose and route has been found to be safe and efficacious in prior studies. A dosing regimen has not been established for ranibizumab in patients with uveitis, so patients will be assessed and treated monthly as needed. Triamcinolone 4mg intravitreal injection will be the steroid treatment, and patients will also be assessed monthly and retreated every three months as needed.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* History of non-infectious uveitis w chronic cystoid macular edema
* Refractory to therapy w periocular steroids; Last periocular steroid injection a minimum of 3 months prior to study enrollment
* Currently using oral steroids (\< or = 10 mg/day) and/or steroid sparing agents
* BCVA between 20/40 and 20/400
* IOP between 5 mmHg and 30 mmHg
* Media clarity sufficient for OCT measurement

Exclusion Criteria:

* Women known to be pregnant or have a positive urine pregnancy test; Pre-menopausal women not using adequate contraception during the study
* Prior treatment for CME with Macugen or Avastin in the study eye
* History of stroke
* Presence of vitreous hemorrhage or epiretinal membrane in the study eye
* Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
* Presence or history of uncontrolled glaucoma
* Known allergy or hypersensitivity to any component of the study drug
* Major surgery planned during the next 6 months
* Simultaneous participation in another clinical investigation
Post-stroke Neural Plasticity With Atomoxetine

This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.

Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients
* Single stroke
* Chronic (more than 6 months after from stroke)
* At least 21 years old, but there is no upper age range for this project.
* Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

Exclusion Criteria:

* History of head injury with loss of consciousness
* History of severe alcohol or drug abuse
* History of psychiatric illness
* Unstable cardiac dysrhythmia
* High blood pressure (systolic pressure \>160 mm Hg and/or diastolic pressure \>100 mm Hg)
* History of myocardial infarction or unstable angina
* Pregnancy
* Glaucoma, history of hypersensitivity or idiosyncrasy to sympathomimetic drugs.
* Subjects using drugs suspected of interfering with plasticity, such as MAOI, alpha-adrenergic antagonists, benzodiazepines, muscarinic receptor antagonists, dopaminergic antagonists, or other neuroleptics within 3 months of recruitment.
An Acute Human Intervention With Flavonoid to Investigate Absorption, Metabolism and Excretion

The era of general dietary recommendations for the whole population may be coming to an end, as it is becoming apparent that we are all unique and do not respond in the same way to the same foods. Within a decade it is believed that doctors will be able to take profiles of their patients, identify specific diseases for which they are at risk and create personalised nutrition plans accordingly. At the University of East Anglia, UK the investigators are interested in particular food compounds known as flavonoids which can be found in foods such as chocolate, orange juice and blackberries (COB). The study will determine if factors such as age, gender, genetics and the bacteria present in our guts contribute to variability between individuals in their absorption, metabolism and excretion of flavonoids.

The study will recruit men and women who are aged either 18-30 or 65-77 years and are generally healthy.On arriving at the study day we will collect a blood sample. Breakfast will then be supplied in the form of a food or drink that will contain freezedried powder from orange juice, chocolate and blackberry. After breakfast further blood samples will be taken at several time points throughout the day. Urine and faeces samples will also be collected. These biological samples will be tested for flavonoid absorption, metabolism and excretion as well as influence of genetic make-up of individuals and the gut microflora harboured in faecal samples.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Caucasian of European origin
* Age either between 18-30 years or between 65-77 years

Exclusion Criteria:

* BMI \< 18.5 kg/m2 or BMI \> 30 kg/m2
* Smokers or nicotine users
* High (above 140/90 mmHg ) or low (less than 90/60 mmHg) blood pressure
* Having any existing medical conditions or significant past medical history likely to affect study measurements e.g., type 2 diabetes, cardiovascular, renal, liver or gastrointestinal diseases
* Unsatisfactory biochemical, haematological or urinary assessment, indicating abnormal; renal or liver function, full blood profile, impaired glucose handling, deranged lipids or measurements considered to be counter indicative of the study by the clinical advisor
* Taking any prescribed medication that could interact with the enzymes involved in the metabolism of flavonoids
* Taking flavonoid containing supplements or other dietary supplements for one month prior to the study (and duration of the study intervention)
* Known allergies to the intervention foods
* Consume more alcoholic beverages on average than 21 units/wk for men, or 14 units/wk for women (The UK Department of Health recommendations)
* Pregnant, breast feeding, or planning a pregnancy (or having fertility treatment)
* Unable to provide informed consent to participate in the study
High Risk Screening Breast MR Using a Rapid Imaging Exam

This study is being done to find out if breast cancer detection will be improved using a short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are at an increased risk of developing breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. High risk for the development of breast cancer. For the purposes of this study high risk women will be defined as those having one of the following:

   1. One or more first degree blood relative(s), maternal or paternal, with known primary breast cancer, PLUS a Gail model calculated 5 year risk of greater than or equal to 1.67%
   2. First, and/or second degree blood relative(s) with a family history suggestive of a BRCA mutation (those families having a member(s) with primary breast cancer diagnosed at or before the age of 40, primary breast cancer and ovarian cancer within the same family or family member, male relative with primary breast cancer, a relative with bilateral breast cancer, or multiple generations of family members with primary breast and/or ovarian cancer)
   3. A known BRCA mutation
   4. A family member carrying a known BRCA mutation
   5. A personal history of a high risk breast lesion, including lobular carcinoma in situ and atypical hyperplasia
   6. A personal history of primary breast cancer (invasive or in-situ) treated with unilateral mastectomy
2. Patients must have a mammogram performed within the last 6 months, and the mammography images must be available for review at the time of the MR interpretation.
3. Age 25-75
4. Female

Exclusion Criteria:

1. They are unable to return in one year for follow-up exam
2. Medical history includes:

   1. Previous breast cancer treated with breast conservation
   2. History of benign excisional biopsy in the previous 24 months
   3. History of a benign core needle biopsy or FNA in the previous 12 months
   4. History of metastatic cancer
3. 45 minute prone scan cannot be tolerated
4. Pregnant, as a mammogram for correlation with MR is required
5. History of breast MR in the last 6 months
Effect of a Health Pathway for People With Persistent Symptoms Covid-19

People with persistent symptoms of covid-19 have increased needs for needs for management of their overall health (physical, psychological and social). Persistent covid-19 symptoms have a negative impact on quality of life. By proposing a follow-up and an intervention on the reduction of these symptoms, the symptoms, the study will improve quality of life.


Eligibility Criteria:
Inclusion Criteria

* Persons who have been infected with Covid-19.
* Person with persistent clinical signs of Covid-19 for more than 12 weeks, referred by one of the partner structures of the project. The persistent signs of Covid-19 are: fatigue which can be severe, neurological disorders neurological disorders (cognitive, sensory, headaches), cardio-thoracic disorders (pain and chest tightness, tachycardia, dyspnea, cough) and disorders of smell and taste. Pain, digestive disorders and skin disorders are also common.
* Person who has agreed to participate and has given informed consent to participate in the study

Exclusion Criteria:

* Refused to participate in the study
* Person under legal protection
* Person with severe cognitive impairment