cyrilzakka/clinical-trials huggingface dataset:
Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players

Background: Soccer is a prevalent sport worldwide; most soccer players are under 18. Soccer has benefits for your health, but there is also a chance that you could get injuries occasionally. High injury rates have been observed in both adult and young players, which has prompted the development of various preventive measures. FIFA recently introduced the FIFA 11+ Kids program for children under 14 to prevent soccer injuries and enhance kids' performance. To date, no studies have been done to determine whether adding the FIFA 11 + kids program for young players under 14 will enhance soccer-specific skills.

Objective: To investigate the efficacy of FIFA 11+ Kids on soccer-specific skills among young soccer players.

Methods: Thirty six young soccer players (aged 7-13) will be assigned randomly to the following groups: the control group (n =18) and the FIFA 11+ Kids program (n = 18). The experimental group will perform eight weeks of FIFA 11+ kids program (3/week). The control group will be instructed to continue their regular training . Three soccer specific skills tests : the Slalom dribble test, Harre circuit test, and Loughborough soccer passing test, will be done before and after eight weeks of training.

Statistical analysis: IBM SPSS software (version 20) will be used for all statistical analyses. Data will be summarized in terms of mean and SD. Normality is checked with the Shapiro-Wilk test and homogeneity with Levene's tests. If the data are normally distributed, a paired t-test will be used for within-group difference comparison, and an independent t-test will be used for between-group comparison. If the data are not normally distributed, the Wilcoxon-Signed rank and Mann-Whitney U tests will be used.


Eligibility Criteria:
The inclusion criteria are

1. Healthy male young soccer players between the ages of 7-13 (al Attar et al., 2022).
2. Playing experience of at least one year.
3. Participating in a training session at least three times per week (Teixeira et al., 2021).
4. Participating in training at least 4.5 hours a week.

The exclusion criteria:

1. Upper or lower limb injuries require medical attention within the last six months (al Attar et al., 2022).
2. Any systemic disease, cardiovascular, neurological disorders, or surgery may affect the measurement and participation as reported by the participants (al-Attar et al., 2022).
3. Any medication which may affect the training or measurement as reported by the participants.
4. Any biomechanical abnormalities as reported by the participants.
5. Missed two consecutive training sessions or three separate ones (Mirwald et al., 2002).
6. Missing one of the testing sessions (Mirwald et al., 2002).

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A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP\[s\]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR
* Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
* First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
* Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator
* Ability to comply with the extension study protocol, per Investigator's judgement

Exclusion Criteria:

* Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
* Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant
* Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
* Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
* Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
* Concurrent participation in any therapeutic clinical trial (other than the parent study)
The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.

The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.

The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.

The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up

Exclusion Criteria:

* Patients unwilling to participate
* Patients unfit for EUS and ERCP
How Much Reliable iv Calcium for the Treatment of Hyperkalemia?

Hyperkalemia is a common problem in the emergency services and one of the life threatening metabolic emergencies. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics, sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially, avoiding evolution of serious arrythmias and iv calcium using in the treatment of occured electrocardiogram (ECG) abnormalities, there is not sufficient level of survey in the literature. So the aim of this study was to evaluate administration of iv calcium efficiency on vital signs and ECG.

Hyperkalemia is a common problem in the emergency services and one of the life threatening metabolic emergencies. Serious hyperkalemia is mostly seen in patients who have known chronic renal failure or end stage renal disease, and also new diagnosis of acute renal failure can be appear with serious hyperkalemia. Paresthesia and weakness which is proceeded to flask paralysis can be observable, sharp ''T'' waves (the repolarization and relaxation of the ventricles), diminution of ''P'' waves (atrial depolarisation and contraction), long ''PR'' intervals (time frame from the beginning of atrial depolarization to the beginning of ventricular depolarization), or elongated ''QRS'' complexes (depolarisation and contraction of the ventricles), ''ST'' segment (end of the QRS complex to the beginning of the T wave) elevation, and serious ventricular arrythmias can be seen in electrocardiography. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics, sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially, avoiding evolution of serious arrythmias and İv calcium using in the treatment of occured ''ECG'' abnormalities, there is not sufficient level of survey in the literature. The group of Cochrane stated in systematic assessment report, which is published in 2005 about IV calcium administration, available dates are based on anecdotal and animal experiments. And in the researches that we have done, we did not find clinical human studies showing the benefits of calcium administration beyond the delivery of case reports . The aim of this study was to evaluate administration of İv calcium efficiency on vital signs and ECG.

Eligibility Criteria:
Inclusion Criteria:

* All patients who had ECG changes due to hyperpotassemia (K\>5.5 mmol/l)

Exclusion Criteria:

* Arrest patients
* Patients needed antiarrhythmic interventions
* Patients need inotropic that may cause ECG changes
* Patients need atropine during emergency treatment prior to Ca-gluconate
* Patients needed cardioversion or defibrillation
* Hyperpotassemia with myocardial infarction
* In the presence of other situations which changes ECG for example pericarditis
* Unstabile patients for ideal ECG
* Digoxin usage
* Trauma
* blood calcium level of \> 10.5 mg/dl
Cardiac Amyloidosis Registry Study

This registry is a observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025.

Amyloidosis is a rare, multisystem disorder in which an insoluble protein is deposited in tissues, leading to organ dysfunction. Several proteins have been identified to potentially lead to amyloid cardiomyopathy (AC). Given the rare nature of these diseases, a large, multi-center effort to describe the characteristics of these patients and their outcomes with novel treatment modalities has not been established. (TBD) academic medical centers from the US and internationally will compile demographic, hemodynamic and organ-involvement data, as well as treatment strategies for AL and TTR amyloidosis.

This registry is an observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025. It is expected that the total patient population will be approximately 5000 patients.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of AL or TTR cardiomyopathy identified or treated within the timeframe
* Specific to CSMC: If the individual provided consent while they were alive, and if sufficient information exists in their chart, their data will be included.
* Information on deceased individuals may be included, but only with the appropriate approval from the external site IRB and/or according to the federal regulations for the protection of human subjects.

Exclusion Criteria:

* At Cedars-Sinai, records that specifically state not to be used in research will not be accessed. Patients who have enacted a No Research Flag or are noted as "Break the Glass" will not be included. For external sites, records that indicate No Research Flag or are noted as "Break the Glass" may be included based on institutional policies and appropriate approvals, as applicable.
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients with Cystic Fibrosis

The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation.

The purpose of this research study is to:

* test the safety and effectiveness of multiple doses of the study drug, SPL84
* test how multiple doses of the drug are processed by the body

Researchers will compare drug SPL84 to a placebo (a look-alike substance that contains no drug) to see if drug SPL84 is safe and if it works to treat CF.

Participants will:

Take drug SPL84 or a placebo by inhalation every week for 9 weeks months Visit the clinic approximately 14 times over 17.5 weeks for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF and two CF causing mutations; 3849+10 Kb C-\>T mutation on one allele in the CF transmembrane conductance regulator (CFTR) gene (homozygote or compound heterozygote). Source documentation from a certified genetic laboratory is required.
* Body mass index (BMI) of ≥ 17 kg/m2.
* FEV1 40-90% predicted at screening.
* Non-smokers or vapers for at least 180 days (6 months) prior to screening, per participant report.

Exclusion Criteria:

* Use of Kalydeco, Orkambi, Symdeko/Symkevi or Trikafta/Kaftrio within 30 days of first dose with study intervention.
* Use of any investigational drug (other than SPL84) or device within 30 days of first dose with study intervention.
* Use of systemic steroids over 3 consecutive months in the last 6 months prior to screening, or use of systemic steroids in the last month prior to screening. Use of inhaled steroids above 1 mg.
* Use of CF medications, e.g. inhaled antibiotics, dornase alfa (Pulmozyme), hypertonic saline and physiotherapy should be on stable regimen for the period 28 days prior to screening; those participants taking inhaled antibiotics for prophylaxis must be on a stable regimen of these drugs for at least 90 days prior to first dose with study intervention.
* Any acute infection including acute upper respiratory or lower respiratory infections, pulmonary exacerbation, changes in therapy for pulmonary disease, or any non CF-related illness which results in the initiation of any new therapy within 14 days prior to first dose with study intervention.
* Hemoptysis of greater than 30 mL within 90 days prior to Day 1, or hospitalization for hemoptysis within 6 months of first dose with study intervention.
* Liver disease characterized by clinically significant cirrhosis and/or documented portal hypertension.
* History of any organ transplantation.
* Documented coronavirus disease (COVID-19) infection within 4 weeks prior to dosing.
Telemedically Supported Analgesia in the Emergency Medical Service

The aim of the study is to evaluate the safety and efficacy of telemedically supported and delegated pain therapy in the Emergency Medical Service (EMS).

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team and can delegate the application of morphine and other analgesics. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene.

All regular ambulances of the five districts are not allowed to administer analgesics without an physician on-scene. They have to call an Advanced Life Support response unit, staffed with an EMS physician, who carries out all kinds of ALS interventions.

The safety, efficacy and the quality of analgesia should be compared with regular EMS.

Eligibility Criteria:
Inclusion Criteria:

* Verbal consent obtained or patient is unable to consent due to the severity of the emergency
* Indication for analgesia

Exclusion Criteria:

* Refused consent
* No indication for analgesia
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.

This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject 6 months through to 59 months of age at the time of first vaccination and born between 36 and 42 weeks of gestation;
* Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws.
* Subject is in generally good health as per the Investigator's medical judgment

Exclusion Criteria:

* History of allergic reactions to egg proteins or any components of the Study Vaccines;
* History of serious adverse reactions to any influenza vaccines;
* History of Guillain-Barré syndrome or other demyelinating disease such as encephalomyelitis and transverse myelitis;
* History of licensed or investigational influenza vaccination in the last 6 months;
* Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥ 37.5 °C) on the day of vaccination or within 48 hours preceding vaccination.
* Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable
* History of any seizures, with the exception of a single febrile seizure;
* Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C;
* Known or suspected congenital or acquired immunosuppressive conditions;
* Current or recent immunosuppressive or immunomodulatory therapy
* Current or medical history of malignant neoplasms;
* Administration of immunoglobulin and/or any blood products within the previous 90 days preceding the administration of the Study Vaccine or planned administration during the study;
* Participation in a clinical trial or use of an investigational compound within 28 days prior to or 28 days after receiving the Study Vaccine, or plans to enter a study during this period;
* Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
* Medical conditions or treatment contraindicating intramuscular vaccination due to increased risk of bleeding.
* Family members of the employees of the Investigator or study center with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study center.
Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).


Eligibility Criteria:
Inclusion Criteria:

* Individuals who were or are being treated for refractory Follicular Lymphoma (FL) according to the product information for idelalisib and treatment guidelines in routine clinical practice.

Exclusion Criteria:

* Individuals included in clinical trials on idelalisib within the timeframe of this study.
Eosinophilic Esophagitis Steroid Safety Study

This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.


Eligibility Criteria:
Inclusion Criteria:

1. Age \<18 years at the time of enrollment.
2. Males and Females are included.
3. Patients diagnosed with EoE as defined by age appropriate signs of esophageal dysfunction (in older children and adolescents - dysphagia, impacted food bolus, foreign body impaction, vomiting, and GERD not responsive to high dose proton pump inhibitors. In infants and young children - failure to thrive, poor feeding, vomiting, food bolus impaction)
4. Histopathological finding of ≥15 eosinophils/high power field (X400) on at least one esophageal biopsy.
5. After discussing the available treatment options with the gastroenterologist, the patient has chosen oral topical steroid treatment (either as a first treatment or after failure of other dietary or medical treatment).

Exclusion Criteria:

1. Known alternative causes of esophageal eosinophilia.
2. Legal guardian unable or unwilling to sign informed consent..
3. Known allergy to topical steroids ingredients
4. Patient will not be available for follow-up for at least the 3 month assessment and ACTH test.
5. Known pregnancy
6. Use of oral systemic steroids in the 6 months prior to inclusion in the study. Use of systemic steroids once in the study will not lead to study termination, but such use will need to be reported in the medication changes and use page of the following visit.
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload

The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18-70 years at the time of signing informed consent.
2. Diagnosed as chronic heart failure at least 1 month prior to screening.
3. Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.

Exclusion Criteria:

1. Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
2. Hypovolemic hyponatremia.
Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.

In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.


Eligibility Criteria:
Inclusion Criteria:

* age: over 20 years
* diagnostic of normal pressure hydrocephalus
* ventricular dilation visible on radiological examination
* patients gave their written informed consent

Exclusion Criteria:

* age: less than 20 years
* MRI contra-indication
* pregnancy
* lumbar puncture within 48 hours before MRI
* cardiac arrhythmia
* cerebral/lacunar stroke