rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation
Status: Not yet recruiting

In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.

After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.

Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.

In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient over the age of 18 Patient registered on the lung transplant list at Hôpital Foch for a single or double-lung transplant Patient who did not object to inclusion in the study Patient affiliated to a French health insurance plan  Exclusion Criteria:  Patient listed for a combined transplant (heart-lung, liver-lung, lung-kidney) Patient on national priority list (super-emergency) Pregnant or breast-feeding patient Patient under guardianship - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Lung transplant patients at Hôpital Foch - SamplingMethod: Non-Probability Sample
The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit
Status: Recruiting

After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study will be conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.

It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.

During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, will be used.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Those who have had abdominal surgery Those who volunteer to participate in the research Those who are over 18 years old Richmond Agitation-Sedation Scale -1, 0, +1 Those who have been in intensive care for at least 3 days No communication problems (language, hearing impairment, etc.) No mental problems Patients who do not use sleeping pills or sedating drugs and who do not have alcohol or substance addiction will be included in the study.  Exclusion Criteria:  Those who experience blood loss and fluid electrolyte imbalance after surgery There are contraindications to the use of eye masks (for example, head trauma), Patients with delirium before or after surgery will not be included in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
ECC5004 RBA FE Study in Healthy Participants
Status: Recruiting

This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy male and female participants of non-childbearing potential Age of 18 to 65 years BMI of 18.0 to 32.0 kg/m2 Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence Male participants agree to use contraception, or agree to practice true abstinence No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history Able to understand and sign and date informed consent  Exclusion Criteria:  Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study. Concomitant participation in any investigational study of any nature Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing Serum calcitonin > 20 ng/L Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC History of pancreatitis Significant allergic reaction to active ingredients or excipients of the study drug Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Longevity in Russia
Status: Recruiting

This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.

The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.

The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Informed consent 90 years of age or above  Exclusion Criteria:  Refusal to participate or to provide informed consent; Any other criteria deemed reasons for exclusion by the Principal Investigator. - Gender: All - MinimumAge: 90 Years - StdAgeList: Older Adult - StudyPopulation: The inclusion of participants will be carried out with the involvement of social services, boarding houses for labor veterans, geriatric centers and other geriatric services in the central region of Russia - SamplingMethod: Non-Probability Sample
Graphic Novel for Patients Undergoing EUS-FNB
Status: Not yet recruiting

Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety.

This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels.

Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels.

This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  age ≥ 18 years pancreatic solid mass or partially solid in case of cystic component agree to participate in the study by signing the informed consent, and the ability to read and understand informed consent patients not affected by any known psychological disorder.  Exclusion criteria:  patients with cognitive deficits, such that they cannot adequately complete the questionnaire and the visually impaired suspected or obvious pregnancy status in female subjects patients using benzodiazepines or other psychotropic medications patients with previous diagnosis of cancer. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Therapeutic Effect of Thalidomide in Syringomyelia
Status: Recruiting

Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.

Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects, or non-effective response to duraplasty and shunting treatment in 12 months prior to study entry. Estimated life expectancy must be greater than 12 months. Routine laboratory studies: bilirubin </=1.0 * upper limits of normal (ULN); aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)< 1.0 * ULN; creatinine <1.0 * ULN; white-cell count >/= 4,000 per cubic millimeter; neutrophils count >/=1500 per cubic millimeter platelets >/= 100,000 per cubic millimeter; Hb >/=110 gram per millilitres; PT, APTT, INR in a normal range. Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document. Must be able to swallow tablets  Exclusion Criteria:  Evidence of tumor metastasis, recurrence, or invasion; History of psychiatric diseases ; History of seizures; History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infaction, unstable angina, within 6 months; New York Heart Association Grade II or greater congestive heart failure; Serious and inadequately controlled cardiac arrhythmia; Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, history of aortic dissection; Severe infection; History of allergy to relevant drugs; Pregnancy, lactation, or fertility program in the following 12 months; History or current diagnosis of peripheral nerve disease; Abnormal in liver and renal function; Active tuberculosis; Transplanted organs; Human immunodeficiency virus; Participation in other experimental studies. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery
Status: Not yet recruiting

The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery.

Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time.

Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured.

If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged ≥ 65 years, and Māori, Pacific or Indigenous participants aged ≥ 55 years who are undergoing major elective or non-elective surgery with expected surgical duration ≥ 2 hours and postoperative hospital stay ≥ 2 nights. Having general anesthesia using total intravenous anesthesia (TIVA) with pEEG monitoring Able to provide informed consent (including patients with mild preoperative neurocognitive disorders)  Exclusion Criteria:  Intracranial or cardiac surgery Undergoing surgery with 'wake up' test Previous enrollment in Balanced-2 study Terminal illness with expected survival <3 months Emergency surgery within 6 hours of presentation to hospital Cognitive impairment with no capacity to consent or activated enduring power of attorney Clinically impaired and unable to consent due to acute pathology or preoperative delirium - HealthyVolunteers: No - Gender: All - MinimumAge: 55 Years - StdAgeList: Adult, Older Adult
Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status
Status: Not yet recruiting

Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients undergoing PET/CT examination for oncologic or non-oncologic purposes.  Exclusion Criteria:  Patients underwent PET/CT examination with age under 18 years. Presence of pathological conditions affecting kidneys (e.g., cancers, inflammation, polycystic kidney disease) Inability to stay still for the duration of the scan. Claustrophobia. Patients with uncontrolled diabetics (blood glucose >200 mg/dl immediately before PET/CT scan) Pregnant females. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients undergoing PET/CT examination for oncologic or non-oncologic purposes.  For all the patients included in this study, data about serum Cr levels and estimated glomerular filtration rate (EGFR) calculated with the CKD-EPI formula. - SamplingMethod: Non-Probability Sample
The Effectiveness of Early Intervention to Correct the Position of PDC:s
Status: Recruiting

Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008).

It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews.

Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  One or both upper permanent canine teeth are not palpable or there is a pronounced difference in the eruption between the left and right side. Dental radiographs will be taken to confirm that the permanent tooth is displaced. Canines in sector 5 are going to be excluded from this trial.  Exclusion Criteria:  Buccal displacement of the canine(s), missing permanent lateral incisors; severe upper arch dental crowding (>2mm in each affected quadrant) or associated pathology. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 10 Years - MaximumAge: 12 Years - StdAgeList: Child
Validation of the ProSomnus® RPMO2 Device
Status: Not yet recruiting

The purpose of the study is to:

Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.
Evaluate the pulse rate performance simultaneously collected over the SpO2 range.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female, aged ≥ 18 and < 50 years. In good health with no evidence of medical problems. Ability to provide informed consent and willingness to comply with the study procedures. Ability to undergo controlled hypoxemia to the levels outlined in the desaturation profile. Adequate dentition for an oral appliance. Ability to breathe through the nose comfortably.  Exclusion Criteria:  Obesity (BMI > 40 kg/m2). Known history of heart, lung, kidney, or liver disease. Diagnosis of asthma or sleep apnea. Diagnosis of diabetes. Presence of a clotting disorder. Presence of hemoglobinopathy or history of anemia that, in the opinion of the PI, makes the individual unsuitable for participation. Current smoker. History of fainting or vasovagal response. History of sensitivity to local anesthesia. Unacceptable collateral circulation based on exam (Allen's test). Pregnancy or lactation. Resting heart rate > 120 bpm. Systolic BP > 150, diastolic BP > 90. Carboxyhemoglobin level > 3%. Presence of any other condition that, in the opinion of the PI, makes the individual unsuitable for participation. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: The study will include volunteers who have previously been determined to be healthy enough for the study and who have signed an informed consent form and met the eligibility criteria.  A minimum of 10 healthy participants will be recruited to complete the test protocol. A minimum of two participants or 15% of the participant pool (whichever is larger) will have Fitzpatrick Skin type IV, V, or VI (i.e., darkly pigmented skin). - SamplingMethod: Non-Probability Sample
Effect of Oral Feeding in Infants With Pierre Robin Syndrome
Status: Recruiting

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  meeting the diagnostic criteria for Pierre Robin sequence based on CT and X-ray examinations, combined with clinical manifestations and physical signs. with spontaneous vaginal birth, aged 1 to 12 months. with dysphagia screened by the water drinking test and further confirmed by the assessment of Dysphagia Disorders Survey (DDS), Dysphagia Severity Scale (DSS), or Schedule for Oral Motor Assessment (SOMA) before the treatment, the tube feeding was required and feasible after evaluation. stable vital signs. with nasogastric tubes placed before the treatment. sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device).  Exclusion Criteria:  abnormalities in brain development or other neurological lesions revealed by CT or MRI scans. dysphagia caused by other diseases. other congenital malformations, such as Down syndrome, cleft lip, and palate, etc. severe systemic disease (such as severe infection, severe hepatic and renal dysfunction). participants who need to receive other therapy which would potentially affect the result of this study - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Month - MaximumAge: 12 Months - StdAgeList: Child
Fixation of Fracture Neck of Femur in Children
Status: Not yet recruiting

Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  clinical diagnosis of fracture neck of femur children with age less than 14 years old  Exclusion Criteria:  pathological fracture patients with cerebral palsy Associated ipsilateral femoral shaft fracture comminuted fractures old fracture ( > 2 weeks) - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 14 Years - StdAgeList: Child