rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Novel Iron-Based Supplement for Athletes: Phase II
Status: Not yet recruiting

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  cis-gendered female 14-25years old sub-optimal iron status (ferritin ≤45mcg/ L) At least 1 year past the age of menarche Engage in moderate to vigorous endurance activity for at least 3 hours a week  Exclusion Criteria:  Supplemented with iron iron (>5mg/day), prebiotics, or probiotics in last 3 months antibiotic use in last 3 months - Energy availability >30 kcal/kg lean body mass - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 14 Years - MaximumAge: 25 Years - StdAgeList: Child, Adult
Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
Status: Not yet recruiting

Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two clinical criteria (body temperature > 38°C and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (Sputum, AET, BAL, mini-BAL or blind BAL) collected for bacteriological diagnosis (results can be pending at inclusion). The diagnosis of HAP can have been made outside of ICU but at least 48 hours after hospital admission. Severity defined as a PaO2/FiO2 ratio < 200 under invasive mechanical ventilation. Biological systemic inflammatory response defined as CPR> 150 mg/L (15 mg/dL)* Receiving curative antimicrobial therapy for the current episode of HAP pneumonia for less than 48 hours. Informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). If it is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible. Person insured under a health insurance scheme. Female of childbearing age who agree and who are able to comply with effective contraception for the 28 first days of the study:  Exclusion Criteria:  Pregnant women (serum or urine test), breastfeeding women. Patient under legal protection (incl. under guardianship or trusteeship). Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients Ongoing administration of glucocorticoid at the time of randomisation, such as for COVID-19 infection requiring supplemental oxygen therapy a Severe septic shock (norepinephrine > 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) at the time of randomisation a Prolonged use of corticosteroids at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for >3 weeks in the past 60 days Uncontrolled viral (hepatitis, zona, varicella) or systemic fungal infectionb Immunosuppression (severe lymphopenia < 750 lymphocytes/mm3, hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug). Uncontrolled psychotic disorder (acute or chronical) Patients not expected to survive for more than 48 hours. Participation in another drug clinical trial - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Dominant Non-Dominant Upper Extremity in Gender
Status: Recruiting

There are strength and functional differences between non-dominant and dominant extremities. This is important in the hand and extremity rehabilitation process. This situation also differs between genders. Comparison of the dominant and non-dominant limb can provide important clinical or rehabilitation field-related information. It is reported in the literature that manual dexterity, grip strength and joint position sense may differ between extremities. However, the relationship between this situation and the difference between genders has not been explained. It is thought that examining this difference can be extremely useful in determining achievable goals in hand rehabilitation and in customizing care for different groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being between the ages of 18-25 Volunteering to participate in the study  Exclusion Criteria:  Having trauma (fracture, dislocation) in the last year Doing sports or activities that require bilateral activity (playing music, knitting, sports, etc.) Being diagnosed with any neurological or orthopedic disease that will affect hand-eye coordination Having had upper extremity surgery Having any Botox injection in the last 6 months Those who did not agree to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult - StudyPopulation: Healthy young adult individuals will be included in the study. - SamplingMethod: Non-Probability Sample
Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment
Status: Not yet recruiting

The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.

Goals of this study are:

Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.
Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).
Time required for IMR measurements

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Chronic coronary syndrome (including patients with anginal equivalents). Indication to cardiac catheterization; Indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication) Willingness to participate and ability to understand, read and sign the informed consent Age>18 years  Exclusion Criteria:  Age <18 years Bronchial asthma, COPD (chronic obstructive pulmonary disease) Secondary or tertiary atrioventricular block without prior pacemaker implantation Previous CABG (coronary artery bypass graft) with patent grafts to the left anterior descending coronary Epicardial coronary disease (FFR <0.80 with evidence of a focal stenosis) in the left anterior descending territory Inability to provide informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparison of Body Weights Via Visual Estimation, Anthropometric Calculation, and Actual Measured in Critically Ill Patients
Status: Recruiting

Rapid and accurate determination of body weight in adult intensive care patients is very important for both calculating target tidal volume during invasive mechanical ventilation support and dose dependent drug administration. In this patient group, measuring actual body weight with a calibrated scale by standing the patient up is often impossible due to acute illness. Instead, estimated body weight determined by health care personnel or estimated body weights calculated according to anthropometric measurements are used. These calculations have some limitations in showing actual body weight, and there is some controversial information in current literature regarding their validity in critically ill patients. There is newly developed patient transfer scale called Marsden M-999® manufactured by Marsden Weighing Machine Group Ltd, which has the advantage of being used in patients who are unable to stand up, in rapidly and accurately measuring the current body weight in critically ill patients. This study aimed to evaluate the validity of these methods by comparing the body weights calculated by visual estimation and various anthropometric methods in critically ill Turkish patients with the actual weight measured by the mentioned scale.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who can stand without assistance are admitted to the inward of the internal disease department. Patients who are admitted to the medical intensive care units  Exclusion Criteria:  Patient or control group under the age of 18 years Patients died within the first 8 hours after hospital admission Patients who did not sign informed consent Refusal of legal representative to participate in the study in unconscious patients Patients with anatomical defects or limb instruments that would prevent performing anthropometric measurements - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia
Status: Recruiting

This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation; age<1 year; diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy; with a nasogastric tube inserted at admission; enteral nutrition support is required and feasible.  Exclusion Criteria:  with dysphagia caused by other diseases or factors; with progressive neurological disease or degenerative neurological disease; with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms; with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract; with poor compliance. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 12 Months - StdAgeList: Child
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Status: Recruiting

This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants eligible for inclusion in this Trial must meet all of the following criteria:  Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. Female Age: 18-50 years Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas.  Exclusion Criteria:  Participants eligible for this Trial must not meet any of the following criteria:  Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial Participation in an interventional Trial with an investigational medicinal product (IMP) or device Patient refusal to participate in the Trial (Possible) malignancy any contra indication for a laparoscopic or robotic surgery - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis
Status: Recruiting

The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Previous diagnosis of symptomatic kidney stone in the past 5 years, Age 18 or older, Own an iOS or Android smart phone, Proficient in English, Capable of providing informed consent, Willing to use the water bottle and companion app & receive text message reminders for 3 months, Live in continental US.  Exclusion Criteria:  Pregnant or planning to become pregnant during the next 6 months, Concurrently participating in other study involving fluid intake or diet, Plan to have surgery in the next 6 months, Co-morbidities that preclude high fluid intake (congestive heart failure, end-stage renal disease, chronic hyponatremia), or Active medical treatments that would impair protocol compliance. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Tapentadol vs Tramadol in Total Knee Arthroplasty
Status: Recruiting

Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients for elective TKR ASA PS I - III  Exclusion Criteria:  Patient refusal Cognitive disfunction Severe psychiatric disease Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors Not speaking Greek Known allergy to the study drugs Contraindications for any of the study drugs Chronic renal failure (GFR < 50 ml/h) Liver failure Known regular use or misuse of opioids Pregnant women Patients undergoing general anesthesia - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Exercise Program for ITB Syndrome
Status: Not yet recruiting

Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical diagnosis of ITB syndrome Age 18-65 Ability to comply with a standardized physical therapy protocol Willing and able to provide consent  Exclusion Criteria:  Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist Patients who are pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Proactive Outreach With FIT
Status: Not yet recruiting

The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients  Men and women aged 45-75 Receiving medical care at NYULH Flatbush FHC and CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites. Due or overdue for CRC screening. Medical visit of any type at clinic in past year.  Providers  Physicians or primary care givers at Flatbush FHC or CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites (CHN employees) Provide care to CRC screen-eligible patients  Exclusion Criteria:  Age younger than 45 years old or greater than 75 years old Up-to-date with colorectal cancer screening: History of colorectal cancer, inflammatory bowel disease, colorectal polyps, or total colectomy In hospice care Patients 66 years or older living long-term in an institution or with advanced illness No address or phone number on file  Providers  • No longer employed at an included clinic site - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 45 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Anxiety & Depression in Thyroid Cancer Patients
Status: Not yet recruiting

To identify the prevalence of both anxiety and depression in thyroid cancer patients
To assess quality of life in thyroid cancer patients

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age at or more than 18 years old None of the patients had history of other psychiatric illness Both sex Accept to participate in the study  Exclusion Criteria:  Age less than 18 years old Previous history of other psychiatric illness substance abuser or dependence Refuse to participate in the study - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: thyroid cancer patients - SamplingMethod: Non-Probability Sample
The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia
Status: Recruiting

The aims of this study are:

Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function
To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.
To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Stroke patients with hemiplegia that are diagnosed with or without dysphagia (FOIS1-7) The duration since the onset of stroke should be within 6 months. The ages of participants should be from 18 to 80 years old.  Exclusion Criteria:  The stroke duration is more than 6 months after stroke Aged younger than 18 or older than 80 years old Any cognitive deficit that leads to communicative difficulty. Any other history of systemic diseases that are associated with swallowing difficulty. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Status: Not yet recruiting

Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).

Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age > 18 years; Patients with a LVEF≤35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction; Left ventricular systolic impairment as defined by LVEF≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months; Able and willing to comply with all pre-, post- and follow-up testing, and requirements; Use of maximum tolerated doses of ACE inhibitors (or Angiotensin II Receptor Blockers if intolerant of ACE) and Beta Blockers and MRA as per ESC guidelines; Person affiliated to or beneficiary of a social security plan Person informed about study organization and having signed the informed consent  Exclusion Criteria:  History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction; Standard contraindications for cardiac LGE-MRI; Hypersensitivity to gadolinium-based contrast agent; Currently implanted permanent pacemaker and/or ICD; Patient refusal of ICD/ILR implantation; Currently implanted permanent pacemaker and/or ICD; Clinical indication for or Cardiac Resynchronization Therapy (CRT); Severe renal insufficiency defined by a glomerular filtration rate (GFR) < 30 mL/min/1.73m²; Recent PTCA (within 30 days) or CABG (within 90 days); Baseline NYHA functional class IV; Contraindication for ICD implantation according to current guidelines; Woman of childbearing age without effective contraception; Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult