rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications
Status: Not yet recruiting

To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18-65 years old  PATIENTS WHO WILL HAVE ENDOSCOPY AND OR COLONOSCOPY  Exclusion Criteria:  Chronic obstructive pulmonary disease Having low saturation Lung cancer - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)
Status: Not yet recruiting

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.

This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical diagnosis with Rheumatoid Arthritis or Spondylarthritis Treatment with biologic or targeted disease modifying antirheumatic drugs. Ability to use smartphone.  Exclusion Criteria:  only patients with conditions that hinder or prevent the use of a mobile application (blindness, mental retardation, dementia, digitalfilliteracy). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Initiating Pediatric Palliative Care in ACT Group 4
Status: Not yet recruiting

Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.

This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).

Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.

The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 0 to 25 Follow-ups at APHP Supported by a palliative care team from Ile de France (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022 Suffering from a serious non-progressive neurological disease (ACT-4) Information and absence of opposition from the holders of parental authority of the minor patient and the guardian or curator of the adult patient if he is under guardianship/curatorship;  Exclusion Criteria:  Other ACT category (1, 2, 3 or 5) of the classification of diseases by the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) during treatment Patients for whom there was no pediatric palliative care intervention Patients in palliative care without follow-up at the APHP - HealthyVolunteers: No - Gender: All - MaximumAge: 25 Years - StdAgeList: Child, Adult - StudyPopulation: AP-HP (Assistance Publique - Hôpitaux de Paris) patients followed by the pediatric palliative care teams of the greater metropolitan area of Paris "Ile de France" (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022 and suffering from a serious non-progressive neurological disease.  Robert Debré et Necker Hospitals are tertiary care hospitals. Paliped is a community based service for PPC. - SamplingMethod: Non-Probability Sample
Impact of Food Intake on Berberine Kinetics
Status: Not yet recruiting

The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.

In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.

As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.

24 heathy volunteers with an equal ratio of man and women will be enrolled.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  wildtype genotypes for CYP2D6 and OCT1 understands the study purpose and design contractually capable and provides signed informed consent form healthy condition or mild and/or well treated forms of allergies, asthma, hypertension and orthopedic diseases  Exclusion Criteria:  BMI ≤18,5kg/m2 and ≥29,9 kg/m2 only in women: known pregnancy or lactation period only in women: positive pregnancy test at screening or any other study visit danemia: Hb < 13 g/dl (8,07 mmol/l) in men or < 12 g/dl (7,45 mmol/l) in women elevated liver function tests (ALAT, ASAT, yGT, Bilirubin > 2xULN) reduced renal function (eGFRMDRD < 60ml/min/1,7m2) currently mentally unstable use of recreational drugs more than twice a week poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Ultrasound Monitoring of Muscle Thickness in Premature Patients
Status: Not yet recruiting

The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.

The main questions it aims to answer are:

To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.
Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.

Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.

Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).

Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  gestational age between 28and 35 weeks; day of life ≥ 7 (to ensure passing the transition phase); clinically stable infants, either in spontaneous breathing or ventilatory support invasive or noninvasive, with a good ability to regulate states and good stress management.  Exclusion Criteria:  Brain pathologies; Dysmorphisms; Clinically unstable patients requiring treatment with inotropes and/or nitric oxide nitric acid and/or drug therapy for closure of the ductus arteriosus of Botallo. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 28 Weeks - MaximumAge: 35 Weeks - StdAgeList: Child
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
Status: Recruiting

Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.

This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years and ≤90 years Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)19 The tumor is suitable for resection (according to neurosurgeon) Written informed consent  Exclusion Criteria:  Tumors of the cerebellum, brainstem, or midline Multifocal contrast-enhancing lesions Medical reasons precluding MRI (e.g., pacemaker) Inability to give written informed consent Secondary high-grade glioma due to malignant transformation from low-grade glioma Clinical data unavailable for the newly diagnosed setting - HealthyVolunteers: No - Gender: All - MaximumAge: 90 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients with recurrent glioblastoma will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium. - SamplingMethod: Non-Probability Sample
Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
Status: Recruiting

Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  18 years of age or older; ability to read, write, and speak English; ability to provide informed consent; greater than 10% GLP-1 Receptor Agonist induced weight loss less than 30-days since GLP-1 Receptor Agonist cessation; willing to participate.  Exclusion criteria:  major psychiatric illness or substance misuse that could impair ability to participate; presence of a medical condition or dietary restriction precluding eating study meals or weight loss (e.g., medical condition requiring liquid diet, pregnancy, eating disorder); participation in a study or program involving medically tailored meals or Noom® within the past 12-months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Positive Affect Treatment for Adolescents With Early Life Adversity
Status: Recruiting

Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  aged 12-16 exposed to 2 or more adverse childhood experiences (ACEs)  Exclusion Criteria:  currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies) current or past history of manic or psychotic symptoms parent-reported diagnosis of intellectual disability or autism spectrum disorder chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis), bleeding disorders such as hemophilia - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - MaximumAge: 16 Years - StdAgeList: Child
Topical Simvastatin for Treating Infantile Hemangioma
Status: Not yet recruiting

This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.

The primary objective:

To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.

The secondary objective:

1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS).

1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy children aged between 3 months and 5 years. Newly diagnosed superficial IH or experiencing rebound growth with a superficial component. Participants must possess at least one IH lesion with the longest diameter equal to or greater than 2 cm, located on any part of the body except the lips.  Participants must not have received any of the following treatments for their IH:  Topical medical therapy within the past 2 weeks. Systemic medical therapy within the past 3 months. Laser treatment within the past 6 weeks. Written informed consent from the parent(s)/guardian(s) of minor participants must be obtained before any study procedure is performed.  Exclusion Criteria:  IH is primarily characterized as subcutaneous, and deep, with minimal cutaneous involvement for evaluation. IH with active ulceration. IH to be treated involving the lips mainly. Participants with concurrent skin conditions that may impede accurate clinical assessment of the IH. Participants with hereditary or metabolic disorders requiring systemic statin therapy. Participants who are allergic to statins, or other ingredients present in the topical medication. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Months - MaximumAge: 5 Years - StdAgeList: Child
School-Based Bladder Health Intervention
Status: Not yet recruiting

The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  4th grade students from elementary schools that meet the historical criteria for >50% students receiving free school lunch.  Exclusion Criteria:  Not meet the inclusion criteria - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 5 Years - MaximumAge: 10 Years - StdAgeList: Child
Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction
Status: Recruiting

The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with Heart Failure reduced Ejection Fraction (EF≤40%) Age >18 years Able to consent for enrollment. Hospitalized at one of the Medstar facilities (Inpatient)  Exclusion Criteria:  Pregnancy Patient with stage D heart failure candidates for advanced therapies or on home inotropes or receiving hospice service Patients with advanced organ failure (End stage cancer, Advanced dementia, MELD (Model for End-Stage Liver Disease) score > 30, GFR (Glomerular filtration rate) <25) in whom GDMT is Futile Patients with Heart failure Collaboratory Score (HFCS) of 9 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
Status: Not yet recruiting

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Physician-diagnosed asthma on maintenance therapy Not well-controlled asthma (ACT score <20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months) Overweight or obesity: Body mass index ≥25kg/m2 Adult: Age ≥18  Exclusion Criteria:  Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis Active smoking or former smoker with ≥20 pack-year smoking history Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2 Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x the upper limit of normal or prior diagnosis of liver disease Anemia: hemoglobin < 13 g/dl in males and hemoglobin < 11 g/dl in females Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes) Participation in any other clinical trial (observational studies are permitted) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult