rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA
Status: Recruiting

In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Premature newborn under 37 weeks of amenorrhea hospitalized in neonatal intensive care Prescription of a 10 to 20ml/kg fluid expansion (crystalloid, blood products or albumin) by the physician in charge, whose goal would be to increase cardiac output (based on clinical, biological and/or echographic criteria).  Exclusion Criteria:  Acute cardiogenic pulmonary edema Hemodynamic instability making the delay necessary for abdominal compression and ultrasonography dangerous for the patient Non corrected congenital cardiopathy, or inferior to 15 days postoperative. Intra-abdominal hypertension or painful abdominal palpation Abdominal surgery in the last 15 days Supine position contraindicated or deleterious No investigator available to assess ultrasonographic measures Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Minute - MaximumAge: 5 Months - StdAgeList: Child - StudyPopulation: As this is a pilot study in a population of premature infants (term bellow 37 weeks of amenorrhea), the projected number of patients included will be 20, based on the department's active patient file, in order to have a minimum of 40 fluid expansion required for the study. - SamplingMethod: Non-Probability Sample
Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis
Status: Recruiting

Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Acute respiratory tract infection due to community- or hospital-acquired pneumonia  Exclusion Criteria:  Consent card not signed Pregnancy Prisoners Aspiration pneumonitis Patients with ventilator-associated pneumonia - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Sepsis secondary to community- or hospital-acquired pneumonia - SamplingMethod: Non-Probability Sample
Colorectal Omics and ofCS Proteoglycans
Status: Not yet recruiting

This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.

The main questions to answer are:

can these biomarkers predict anastomotic leakages
can these biomarkers predict recurrence after colorectal cancer
can these biomarkers be used as diagnostic tests for colorectal cancer
can these biomarkers be identified in the tumor

Participants will undergo elective colorectal resection or stoma closure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed or with suspicion of colorectal cancer or adenoma, inflammatory bowel disease, late complications to colon diverticulosis, colostomy reversal or other diagnoses requiring colorectal resection. Patients planned to undergo elective surgical procedures coded as KJFB20-KJFB99, KJFG30-37 or KJGB00-97 according to the Danish modification of the NOMESCO Classification of Surgical Procedures Able to speak Danish, English, or other languages where professional interpretation is available Able to give informed consent  Exclusion Criteria:  Patients undergoing synchronous: liver resection (patients undergoing metastasectomies can be included); total gastrectomy or cardia resection; Whipple's procedure or another major pancreatic resection (resections of the pancreatic tail can be included); total or partial nephrectomies or cystectomy Patients previously included in the study Patients known to be pregnant (pregnancy test not required) Non-resident in Denmark - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients planned for elective colorectal surgery - SamplingMethod: Non-Probability Sample
The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence
Status: Not yet recruiting

This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Agreeing to participate in the study Having a complaint of urinary incontinence Being a woman between the ages of 45-55 Being communicable Having a device (phone, tablet, computer) that can participate in online conversations Being in the premenopausal period  Exclusion Criteria:  Women who do not complain of urinary incontinence Women in menopause Women who left unanswered questions on their scale forms - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 45 Years - MaximumAge: 55 Years - StdAgeList: Adult
Color Fundus Photograph With Experts Labelling
Status: Recruiting

This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with Type I or Type II Diabetes. Patients of age of 20 years or above  Exclusion Criteria:  The participant is unable or unwilling to comply with study procedures. Vulnerable participants (minors, legally detained individuals). Prisoners or subjects who are involuntarily incarcerated. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients visiting the diabetic eye care center at our collaborated hospital will be registered for this study. - SamplingMethod: Non-Probability Sample
CPAP in Patients With Severe Obesity After Anesthesia
Status: Not yet recruiting

The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:

Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia?
Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?

Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.

Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure
Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients (≥ 18 years old) scheduled for elective non-cardiothoracic surgery requiring general anesthesia with an endotracheal tube Planned admission to the post-anesthesia care unit (PACU) after surgery BMI ≥ 40 kg/m2  At the time of baseline measurements in the PACU, patients meet the following criteria:  Receiving ≤ 6 liters of supplemental nasal cannula oxygen Alert as defined by a Richmond Agitation Sedation Scale of 0 or -1 Oriented to person, place, and time  Exclusion Criteria:  Pregnancy, suspected pregnancy or less than six weeks postpartum Known or current pneumothorax  Hemodynamic instability at the time of study assessment in the PACU defined as:  systolic blood pressure <90 mmHg or >180 mmHg mean blood pressure <60 or >130 mmHg Any use of intravenous vasoactive agent heart rate < 50 or > 120 beats per minute  Respiratory insufficiency in PACU defined as:  Respiratory rate > 30 Oxygen saturation < 92% Receiving > 6 liters of supplemental oxygen Known chronic lung disease requiring supplemental oxygen at home Known systolic heart dysfunction (left ventricular ejection fraction ≤ 30%)  Contraindication for esophageal catheter placement:  Known esophageal varices Known bacterial sinusitis Recent esophageal, nasopharyngeal, or laryngeal trauma or surgery Known coagulopathy: including history of thrombocytopenia defined as platelet count <50,000; presence of hemophilia; known genetic disorder of coagulation (e.g.,deficits of protein C, protein S, von Willebrand factor) or oral and subcutaneous anticoagulation treatment (e.g., heparin, warfarin, and or other oral anticoagulants)  Contraindication for electrical impedance tomograph belt placement:  Pacemaker and/or internal cardiac defibrillator Chest skin injury Concern for study inclusion by the perioperative nurse or anesthesia team - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Status: Not yet recruiting

POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (CPB) and who meet all following criteria:  Age greater than 18 years old  Preoperative iron-deficiency anemia, defined as Hb <130 g/L with any one of:  ferritin < 30 μg/L; or ferritin 30-100 μg/L and transferrin saturation <20%; or reticulocyte Hb content < 29 pg, where available  Exclusion Criteria:  Patients who meet any of the following criteria are not eligible for the study:  specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)  established contraindications to IV iron:  hypersensitivity to the iron product history of >2 food and/or drug allergic reactions (excluding drug intolerance) non-iron deficiency anemias such as myelodysplastic syndrome history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis active infection preoperative unstable hemodynamics defined as the requirement for vasopressors or inotropes, or active bleeding (as noted in the clinical record and/or defined as a requirement for red blood cell transfusion for ongoing clinical bleeding) refusal of blood products for religious or other reasons known pregnancy already enrolled in this trial enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid) receipt of intravenous iron at any point in the 6 weeks prior to randomization - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC
Status: Not yet recruiting

This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients should voluntarily join this study and sign the informed consent form Patients diagnosed with resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2) NSCLC Patients with EGFR 19del or L858R mutations. Age from 18 to 75 years old, both male and female ECOG score 0-1 According to the RECIST v1.1 , patients should have at least one measurable lesion For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy  The function of important organs should meet the following requirements: absolute count of neutrophils ≥ 1.5 × 109/L# Platelets  ≥ 100 × 109/L# Hemoglobin ≥ 90g/L; Serum albumin ≥ 35g/L; Thyroid hormone (TSH) ≤ 1 × ULN# Serum bilirubin ≤ 1.5 × ULN# ALT and AST ≤ 3 × ULN# International standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN# Serum creatinine ≤ 1.5 × ULN  Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period  Exclusion Criteria:  Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ) Patients with active hepatitis B/C Patients with any active autoimmune diseases or a history of autoimmune diseases Patients who are using immunosuppressive agents or require systemic hormone therapy Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function Patients with abnormal coagulation function (INR>2.0, PT>16s) Arterial/venous thrombotic events occurred before screening within 6 months Patients with active infection Patients with congenital or acquired immune dysfunction (such as HIV infection) According to the judgment of the researchers, patients have other factors that may affect the results of the research or cause the research to be terminated - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults With Hypertension.
Status: Not yet recruiting

High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age ~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment.

It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment.

Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Older men and women with mild-to-moderate essential hypertension (60-85 years, clinic systolic BP 130-159 and/or diastolic BP 80-109 mmHg)  Exclusion Criteria:  Any evidence of cardiovascular or pulmonary disease by medical history or by physical examination Severe hypertension (systolic BP ≥160 and/or diastolic BP ≥110 mmHg; for safety reasons) or secondary hypertension Being on ≥3 antihypertensive agents Chronic kidney disease (an estimated glomerular filtration rate &gt;45 mL/min) or renal failure Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-hour oral glucose tolerance test, glucose level ≥200 mg/dL) or other systemic illness Any history of substance abuse (other than tobacco) Current cigarette smokers History of gouty arthritis Taking hormonal replacement therapy Endurance-trained athletes Diagnosed Alzheimer's disease and related dementias - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
Status: Recruiting

The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with NMIBC who have undergone initial TURBT and are scheduled for reTURBT surgery as recommended by guidelines or chosen by their physicians; Patients who have tested negative for urine biomarkers after the initial TURBT and before the second TURBT; Age ≥ 18 years; Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results; Willingness to sign informed consent.  Exclusion Criteria:  Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma); Patients previously diagnosed with muscle-invasive bladder cancer; Patients unable to undergo a second transurethral resection; Patients with incomplete sample pathology information; Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements; Patients unable to provide written informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
Status: Not yet recruiting

To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old on the day of signing informed consent and willing and able to sign a written informed consent. English fluency in order to complete PROs and neurocognitive assessment Pathologic or cytologic confirmation of malignancy. Poorly controlled intractable nociceptive or mixed pain limiting function or quality of life. Participants must have exhausted or not a candidate for standard of care pain control measures such as opioids, injections/ablations, conventional radiation therapy, or surgical intervention with a curative intent and pain limiting function that affects the participants quality of life in the judgment of the treating physician. Refractory status will require at least consultation and two follow-up visits with pain specialists (pain management or supportive care). ECOG performance status of 0-3. Life expectancy is greater than 4 weeks and less than 1 year in the treating physician's judgment.  Exclusion Criteria:  Participants with prior cranial or head/neck radiation where cumulative organ-at-risk dose constraints cannot be achieved (see section 4.2). Inability to have an MRI of the brain for reasons such as a non-compatible bioimplant that could be displaced during MRI, shrapnel embedded (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes). Expressions of pain due to depression, delirium or addictive behavior Participants who are pregnant. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study in the judgment of the Investigators. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult