cyrilzakka/clinical-trials huggingface dataset:
Extending Veteran Participation in the Validation of the SCI-QOL/CAT

The field of spinal cord injury rehabilitation medicine lacks a reliable, patient reported, health-related quality of life measurement tool. The National Institute of Health has provided funding to develop a spinal cord injury-specific, quality of life survey tool in non-Veterans with spinal cord injury called the spinal cord injury-quality of life (SCI-QOL). This quality of life survey asks questions regarding physical/medical, emotional, and social health as it relates to individuals with spinal cord injury.

The purpose of this study is to include a Veteran population in the making of the quality of life survey. Each participant will be asked to complete a packet of quality of life questions. Participants will be given the opportunity to take the survey a second time, either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow the research team to test the reliability of the survey. Comparing the SCI-QOL with other legacy measures will allow the investigators to test the validity of the survey.

Additionally, the investigators will be testing the SCI-QOL between Veterans and non-Veterans with SCI to determine if there are differences in their self-reported quality of life.

This study will be recruiting participants at the James J. Peters Veterans Affairs Medical Center, Bronx, New York and the James A. Haley Veterans Affairs Hospital, Tampa, Florida.


Eligibility Criteria:
Inclusion Criteria:

* Male and female Veterans with traumatic spinal cord injury
* At least 18 years old
* Persons judged by their primary care doctor to be competent
* Able to read
* Fluent in English.

Exclusion Criteria:

* Veterans with non-traumatic spinal cord injury ("non-traumatic" is defined as any injury from a chronic condition that resulted in decline of function due to the paralysis. These conditions include, but are not limited to: multiple sclerosis, arteriole-venous malformation, nerve impingement syndromes, congenital birth defects, or other)
* Diagnosis of a cognitive impairment (in the clinical chart) such that it limit the subject's ability to read, understand, and respond to statements about quality of life
* Not fluent in English.
Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement

This study aims to investigate levels of circulating cell free DNA (cfDNA), circulating tumor DNA (ctDNA), circulating tumor cells (CTC) and immunological changes after self-expanding metal stent (SEMS) placement for malignant obstruction in the colon, and interpret these levels in relation to overall- and disease-free survival.

Furthermore, we intend to study the opportunity to identify patients with a higher risk of recurrence due to the SEMS placement by monitoring cfDNA and ctDNA-levels, as it may be a potential biomarker to initiate or optimize chemotherapy and thereby ensure a better prognosis for the patients.

Study design This prospective study will include 20 patients undergoing SEMS placement as a bridge to elective surgery at Koege- and Slagelse Hospital. Baseline blood samples will be collected before the procedure. After the procedure blood samples will be collected 1, 4, 12 and 24 hours after SEMS placement. After elective surgery a tumor sample will be collected.

Prior to SEMS placement:

When potential candidates are admitted to the hospital they will be presented to the study by the relevant surgeon. The investigators will be contacted, when the patient is admitted to hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 to 95 years
* Patients with acute malignant obstruction in the colon.
* ASA class I-III (Classification of the American Society of Anesthesiology)
* Signed informed consent

Exclusion Criteria:

* Known immune-defects
* Withdrawal of informed consent
* Bloodtransfusion 24 hours prior to stent-placement until 24 hours after stent-placement.
* Surgery within 24 hours after stent-placement
* Known inflammatory bowel disease
Evaluation of Outcome of Adult Pulmonary Langerhans Cell Histiocytosis Based on Lung HRCT and Lung Function

this is a multicenter retrospective study on patients with pulmonary LCH who were sequentially evaluated by concomitant lung HRCT and lung function testing. The objectives of this study were: 1) to determine the changes over time of lung function parameters in patients with pulmonary LCH; 2) to compare the variations of HRCT and lung function results during follow-up; 3) to address the respective interest of these investigations for identifying the patients who eventually will experience a progression of their disease.

Pulmonary Langerhans cell histiocytosis (pulmonary LCH) is an uncommon disorder, characterized by the accumulation of CD1a+ Langerhans cells (LCs) organized in granulomas that develop in, and destroy the wall of distal bronchioles. In adults the disease occurs predominantly in young smokers from both genders, with a peak incidence at 20-40 yrs of age, although female may be slightly older. High resolution computed tomography (HRCT) of the lung has provided a considerable input for the diagnosis of pulmonary LCH.

We conducted a multicenter retrospective study on patients with pulmonary LCH who were sequentially evaluated by concomitant lung HRCT and lung function testing. The objectives of this study were: 1) to determine the changes over time of lung function parameters in patients with pulmonary LCH; 2) to compare the variations of HRCT and lung function results during follow-up; 3) to address the respective interest of these investigations for identifying the patients who eventually will experience a progression of their disease. Results of this study may help to improve the management of patients with adult pulmonary LCH.

Eligibility Criteria:
Inclusion Criteria:

* pulmonary HLP diagnosed between June 1989 and February 2005

Exclusion Criteria:

* followed up for less than 6 months
* with less than 2 lung HRCT and lung function tests at the same time or within a 2 month period
Translation, Cross Cultural Adaptation and Validation of the Italian Version of the Forgotten Joint Score in Total Knee Arthroplasty

This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS)

This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS) as described by Behrend and Giesinger in 2012. Patients will be given two self-assessment questionnaires (WOMAC and FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery.

Comparison of data will be done for each patient by evaluating the evolution of the postoperative period, comparing the results obtained with a well known validated score (WOMAC).

Questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age range between 55 and 85 years
* Italian mother-tongue
* Patients with unilateral gonarthrosis who need total knee prosthesis

Exclusion Criteria:

* Patients with orthopedic pathologies of other origin
* Patients with history of previous articular prosthetic replacement surgery on joints of the lower limb.
* Patients with history of previous major cardiovascular events
* Patients who need aids for walking
* Patients claiming that they can not submit to follow-up and therefore can not complete the study
Effect of Angulus on Patient-elevation Compliance

Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in critically ill patients by up to 50%, while simultaneously increasing cost of care. C

Best-practice guidelines state that positioning ventilated patients at an angle between 30-45 degrees significantly reduces the potential for VAP and other VAE to develop. While the intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to accurately measure patient elevation requires that nurses rely on the head-of-bed (HOB) protractor - a tool which reflects the angle of the bed, not the patient - to measure compliance. Depending upon the position and posture of the patient in the bed, a patient's elevation angle may be significantly different from the HOB angle. Critical care teams currently rely on built-in HOB protractors and digital inclinometers that measure the angle of the bed not the patient.

Angulus, LLC has developed a dual-component Angulus sensor to fill this gap in critical care technology. Angulus enables critical care practitioners to instantaneously understand a patient's elevation, identify when the patient is outside of the desired 30-45 degree recumbency scope, and efficiently correct the patient's orientation with immediate feedback. Angulus supports real-time minute-to-minute data display as well as longitudinal aggregation of data.


Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
* Age between 18 and 75 years

Exclusion Criteria:

* Patients with a known allergy to the encasing materials
* Patients who are advised to be positioned outside of the 30-45 degree scope.
* Patients with any major chest wall abnormalities, or defects, including but not limited to:

  * post-cardiac surgical patients
  * pectus excavatum (or any congenital chest wall deformity)
  * complicated skin and soft tissue infections on the chest wall
  * heart-lung machine systems
Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status

BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥18 years of age
* The study enrolls healthy participants and participants at different stages of renal impairment (mild to severe renal impairment).
* Race: White
* BMI (body mass index): above or equal 18.5 and below or equal 35 kg/m\*2 at the first screening visit.
* Male or female.
* Participants with renal impairment must have an eGFR (estimated glomerular filtration rate) \<90 mL/min/1.73 m\*2 determined from serum creatinine 21-3 days prior to dosing using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation (eGFR has to be repeated if screening period \>10 days before dosing).

Stable renal function, e.g. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit confirmed by nephrologist or general practitioner the patient is under care.

Exclusion Criteria:

* Clinically relevant findings in the physical examination affecting the objectives of the study.
* Systemic use of the following co-medications from 2 weeks before administration until end of follow-up:

  * Moderate and strong inhibitors of CYP3A;
  * Moderate and strong CYP3A inducers;
  * Moderate and strong inhibitors of P-gp transport;
  * UDP-glucuronosyltransferase (UGT) inhibitors probenecid and valproic acid.
* Regular daily consumption of more than 10 cigarettes.
* Acute renal failure.
* Active nephritis.
* Impairment of any other major organ system other than the kidney.
* Change in chronic medications for renal disease (or its consequences) less than 4 weeks prior to dosing.
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial

This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.

Postoperative complications occur in up to 50% of patients and major surgery is associated with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery 4 times more often than the rest of the population, thus in the future a major proportion of patients presenting for surgery will be older than 65 years. Elderly patients have more postoperative complications, a longer convalescence and higher surgical morbidity and mortality. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Another population most probably to benefit from such a program are cancer patients with decreased functional health after cancer treatment. Cancer prehabilitation affords an opportunity for the patient to improve functional status while waiting to begin treatment. This is a patient group expected to grow in the future.

This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e. prehabilitation, n=233), randomised controlled trial (RCT).

The prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation.

This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, morbid patients.

The primary outcome is measured by the comprehensive complication index (CCI). Secondary outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior, haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15 (QoR15).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* comorbid (≥ASA 3)
* pre-existing fitness deficit: AT\<11ml/kg/min respectively VO2peak\<14ml/kg/min if AT unavailable or VE/VCO2 slope \> 33
* scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery
* screening at least 2 weeks prior to surgery

Exclusion Criteria:

* Paralysis or patients with mobility problems (who are unable to exercise),
* Premorbid conditions or orthopaedic impairments that contraindicate exercise,
* Cognitive disabilities,
* Chronic renal failure (need for dialysis)
* Emergency procedures.
Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy

The aim of this study is to evaluate the evolution of quality of sex life of women with POI after introduction hormone replacement therapy through the FSFI scale

Premature ovarian failure (POI) is a pathology that affects about 1-2% of women before the age of 40. The resulting estrogen deficiency is the cause of multiple repercussions. Clinically, sexual disorders may appear in the short term, such as a decrease in libido, vaginal dryness, an increase in dyspareunia, resulting in less frequent sexual intercourse and less satisfaction with sexual life. The quality of life of these patients also appears to be reduced compared to women with normal ovarian reserve. A 2008 study showed that the sexual function of patients with POI treated with hormone replacement therapy (HRT) was normal but remained significantly lower than that of patients with normal ovarian function. However, no study has attempted to assess the evolution of the symptomatology of these patients before and after the introduction of HRT. Evidence of improvement in sexual disorders under treatment could be an additional argument to improve patient adherence and treatment compliance; as well as information for health professionals

Eligibility Criteria:
Inclusion Criteria:

* positive diagnosis of POI (amenorrhea \> 4 months or spaniomenorrhea \> 4 months and FSH \> 25 IU/L checked twice, more than 4 weeks apart)
* absence of hormonal treatment,
* patient's oral consent,
* affiliated or beneficiary of health insurance

Exclusion Criteria:

* contraindication to hormonal treatment (history of hormone-dependent cancer, history of ischemic arterial stroke),
* inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
* patient under legal protection
18F-FAPI PET/MRI Imaging in Myelofibrosis: a Prospective Observational Study.

This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.

Myelofibrosis (MF) is a pathological process characterized by dysplasia of bone marrow fibrous tissue, clonal proliferation of potential stem cells, inflammatory changes in the bone marrow microenvironment, and extramedullary hematopoiesis. Bone marrow histopathology is the gold standard for diagnosis, but because of the invasive nature of the puncture, repeated examination is not possible to dynamically monitor the disease process. In addition, due to the focal nature of puncture biopsy, it can not accurately reflect the systemic disease. 18F-FDG PET/CT provides visual assessment of MF, but its diagnostic effectiveness decreases as MF progresses. 18F-FAPI PET/MRI characterizes fiber activation processes in a variety of diseases. This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary myelofibrosis or myelofibrosis secondary to myeloid tumors were diagnosed according to the diagnostic criteria of who 2022.
* Stable vital signs, ECOG score ≥ 2 points, tolerate and cooperate to complete 18F-FDG PET/CT and 18F-FAPI PET/MRI examination.
* The interval between imaging ,hematologic, cytogenetic and pathology was \< 2 weeks.
* Willing to accept 18F-FDG PET/CT and 18F-FAPI PET/MRI , sign the informed consent.

Exclusion Criteria:

* Inability or unwillingness to provide informed consent.
* Other malignancies, autoimmune diseases, or chronic active infections were diagnosed within 1 year before the diagnosis of myelofibrosis.
* Current infection was present within 1 week before PET examination.
* Pregnant or lactation.
* Unable to follow protocol to complete follow-up.
* Have received glucocorticoid therapy within 2 weeks before PET imaging examination.
* Using granulocyte colony-stimulating factor (G-CSF) within 4 weeks prior to PET imaging.
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma

The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy with WST11 in patients with non-resectable or inoperable biliary carcinoma.

This is an open-label, prospective, multicentre, phase IIa study, evaluating a new therapeutic agent in the management of patients suffering from inoperable or non resectable biliary carcinoma. The patients will receive the dose of WST11 according to order of inclusion. The first 3 patients will receive 2.5 mg/kg. In the absence of toxicity, the following 9 patients will receive the dose of 5 mg/kg.

The patient is to receive anesthesia. WST11-mediated therapy will consist of the combination of single IV administration of WST11 at doses of 2.5mg/kg or 5mg/kg, using 753nm laser light at a fixed power of (150mW/cm) and light energy (200 J/cm) delivered through a diffusing fiber. The fiber is introduced in a transparent standard ERCP catheter and positioned under radioscopy in front of the lesion.

Eligibility Criteria:
Inclusion Criteria:

* Patient having signed the consent form to take part in the study
* Patient aged over 18 years, with no upper age limit
* Patient with histologically proven cholangiocarcinoma
* Patient with cholangiocarcinoma, inoperable or non resectable owing to extension, age or concomitant diseases
* Bilirubin level decrease of more than 50% after stent insertion compared to base level
* Patient with a WHO Performance Scale ≤ 2
* Patient in whom efficient drainage is performed by means of a plastic biliary stent endoscopically or radiologically
* Patient capable of completing the quality of life questionnaires
* Women of child-bearing potential must have a negative pregnancy test, and must thereafter prove to be using acceptable contraception (oral contraceptive pill, hormone patches, or IUD)

Exclusion Criteria:

* Absence of consent to take part in the study
* Patient with operable biliary carcinoma
* Class ASA IV patients
* Patients presenting clinical and laboratory signs of biliary infection
* Absence of bilirubin decrease after stent insertion
* Patients with extrinsic biliary compression
* Patients already having received or currently receiving radiotherapy or chemotherapy for cholangiocarcinoma or needing to be treated during the first month of the follow-up
* Known metastatic lesions
* Patients having received immediate treatment by insertion of a metal stent
* Patients with porphyria or known hypersensitivity to porphyrins (contraindication to WST11)
* Patient receiving prohibited treatment at the time of inclusion in the study
* Pregnant or breast-feeding women
* Non-menopausal women not using effective contraception
* Majors under protection as per the French Public Health Code
* Persons not registered with or covered by a social security system
* Persons in an exclusion period relative to other biomedical study