cyrilzakka/clinical-trials huggingface dataset:
Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.

The main objective of the CHF-COV Preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with preserved left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic acute heart failure with preserved ejection fraction admitted in hospital for scheduled day hospitalization or consultation
* Patient with preserved left ventricular ejection fraction (≥50%).
* Age ≥18 years
* Patients having received complete information regarding the study design and having signed their informed consent form.
* Patient affiliated to or beneficiary of a social security scheme

Exclusion Criteria:

* Comorbidity for which the life expectancy is ≤ 3 months
* Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion.
* History of lobectomy or pneumonectomy lung surgery
* Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
* Pregnant woman, parturient or nursing mother
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Adult person who is unable to give consent
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy

The purpose of this study is to compare two different techniques of performing a pancreatic anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces pancreatic remnant leak, post-operative complications and overall length of hospital stay.

This is a randomised controlled, phase III, double blinded, multicentre clinical trial comparing Cattell-Warren (CWA) versus. Blumgart (BA) methods of pancreaticojejunostomy following pancreaticduodenectomy for supected malignancy of the pancreatic head.

The primary objective of the trial is to establish if the Blumgart anastomosis reduces pancreatic remnant leak and in turn complications, hospital stay, cost and promote enhanced recorvery programs.

506 patients (253 patients per treatment arm) will be recruited from approximately 7 centres throughout the United Kingdom.

Patients recommended for resection who provide written informed consent will be randomised to one of the following treatment arms on the day of surgery by the surgeon:

Arm A: Blumgart method of panreaticojejunostomy. Arm B: CattellWarren method pf pancreaticojejunostomy.

Randomisation will be undertaken intra-operatively, following pancreatic head excision, just prior to pancreatic head remnant reconstruction.

Patients will be assessed post operatively on days 3 to 7 and on day of dishcharge from hospital. Patients will continue to be followed up in the outpatient setting at 3, 6 and 12 months post surgery.

All laboratory and physical assessments performed will be in line standard care.

Blood samples for the translational study will be taken subject to informed consent pre-operatively and post-operatively 5 days after surgery.

A histological (H\&E stained) slide of the pancreatic transection margin should be taken as routine. This will be requested from each patient for central pathology review to assess the amount of fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective pancreato-duodenectomy for presumed malignancy.
* Ability of the subject to understand the nature and consequences of the trial.
* Ability to rovide writen informed consent.
* Age 18 or greater.

Exclusion Criteria:

* Patients undergoing extended pancreato-duodenectomy
* Left, central or total pancreatectomy.
* Arterial resection or multi-visceral resection
* Previous pancreatic surgery
* Surgery for known chronic pancreatitis.
* Recruited to any other pancreatic resection trial.
* Pregnant women.
* Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from time of consent up to the day of surgery.
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge

Nipple discharge is one of the common symptoms of breast disease patients. Nipple discharge can be divided into physiological and pathological nipple discharge (PND). Among patients with PND symptoms who undergo biopsy, 5%-21% of them are malignant, and the risk of malignancy increases with age. The primary diagnostic imaging methods for PND patients include mammography and breast ultrasound. Nearly half of PND patients who undergo traditional mammography and ultrasound examination have negative findings, but this does not rule out the presence of malignant lesions. Central duct excision is the gold standard for PND diagnosis, but invasive surgery without imaging guidance can lead to some complications. Magnetic Resonance Ductography (MRD), which uses water imaging technology to visualize the inside of the duct without contrast injection, can show imaging features of ductal lesions such as filling defects, irregularities of duct walls, and ductal obstruction. However, previous studies have shown that the signal-to-noise ratio of MRD images needs to be improved. Microscopy coil has the characteristics of small voxels and high spatial resolution, making it suitable for high signal-to-noise ratio imaging of small superficial structures. This provides a hardware foundation for improving the quality of MRD images. Therefore, in this study, the investigators aim to use the 3T MR instrument and microscopy coil to perform non-invasive high-resolution Magnetic Resonance Ductography (HR-MRD) on PND patients to evaluate the ability of HR-MRD to detect PND causes and the imaging features of duct-related lesions on HR-MRD, to assist in the accurate diagnosis and treatment of PND.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 and 75 years old.
* Pathological nipple discharge patients who received treatment at Sun Yat-sen Memorial Hospital. The diagnostic criteria for pathological nipple discharge include unilateral, single duct orifice, and spontaneous discharge of serous or bloody fluid. Patients who meet any of the above criteria are considered as pathological discharge.
* Willing to sign an informed consent form for clinical research and undergo HR-MRD and MRD examination.

Exclusion Criteria:

* Patients who have undergone surgery on the nipple-areolar complex of the PND breast side within the past year.
* Patients who have claustrophobia or metal implants in their body, which are not suitable for MRI scans.
* Patients who are pregnant or breastfeeding.
High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery

This randomized clinical trial studies how well high volume washing of the abdomen works in increasing survival after surgery in patients with pancreatic cancer that can be removed by surgery. High volume washings may remove free floating cancers present after surgery and help prolong survival in patients with pancreatic cancer.

PRIMARY OBJECTIVES:

I. Overall survival (OS) (18 to 27 months after resection).

SECONDARY OBJECTIVES:

I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (EIPL-S): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage 10 times over 15 minutes.

ARM II (EIPL-D): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal distilled water (EIPL-D) lavage 10 times over 15 minutes.

ARM III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.

After completion of study treatment, patients are followed up every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy) as determined by the treating physician/surgeon
* A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively
* In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy
* Age ≥18 years of age.
* The subject is willing to consent to randomization of EAL-S vs. standard EAL-W vs. no extensive lavage. (SOC)

Exclusion Criteria:

* The subject does not have a surgical indication for pancreatectomy
* In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy
* Age \< 18 years of age
* The subject is not willing to consent to EAL-S vs. EAL-W vs. no extensive lavage (SOC)
* Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors) without possible risk of malignancy
* Other malignancy within five years, unless the probability of recurrence of the prior malignancy is \< 5% as determined by the principal investigator based on available information. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
* Evidence of metastatic disease preoperatively.
Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia

The investigators aim to investigate whether administration of a short-acting opioid (remifentanil) guided by a pain monitor (nociceptive level monitor) during anesthesia, can reduce pain in children after surgery.

The investigators hypothesize that pain monitor-guided administration of remifentanil can reduce pain postoperatively compared with standard care.

NOL-guided analgesia has not previously been assessed in children, and it is unknown whether this additional monitoring has any clinical benefits in a pediatric population.

In the present study the investigators aim to investigate whether administration of perioperative remifentanil guided by the CE-certified Pain Monitoring Device monitor-PMD200™, also called NOL-monitor, can reduce pain (primary endpoint), opioid consumption and agitation in children aged 3-16 years undergoing surgery with intravenous anesthesia.

The investigators hypothesize that NOL-guided perioperative remifentanil administration can reduce postoperative pain compared with standard clinical care (remifentanil dosing based on hemodynamic variables).

All patients will receive standard analgesia and antiemetic administered perioperatively:

* IV paracetamol 15 mg/kg
* IV Ibuprofen 10 mg/kg, unless contraindicated
* IV Morphine 25-100 μg/kg according to the extent of surgery and the departments' standard, administered 30 minutes before end of surgery (will not be included in the total perioperative or postoperative opioid consumption)
* In case of minor surgery, 1-2 μg/kg fentanyl, according to the department's standard, may be administered instead of morphine at the discretion of the anesthetist (will not be included in the total perioperative or postoperative opioid consumption)
* Regional anesthesia may be provided at the discretion of the anesthetist
* IV ondansetron 100 μg/kg

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) class of 1-3
* Scheduled surgery requiring intraoperative opioid administration
* Planned maintenance anesthesia with propofol and remifentanil
* The trial subject's custody holders' must be able to understand the trial protocol, risks, and benefits, and provide signed informed consent

Exclusion Criteria:

* Inability of the trial subject's custody holder to read or write Danish
* Children who cannot cooperate to the study assessments based on the investigators' evaluation. This may be children with mental disorders, visual disturbances, hearing or speech impairment etc. interfering with assessments.
* Arrythmias, either known arrythmias preoperatively or arrythmias detected within the first minutes perioperatively (in which case the patient will be excluded post- randomization).
* Allergy to the medicines used in the study
* Daily intake of opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
* Weight \< 10 kg
Comparison Between Oral and Enema of Chloral Hydrate

To compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.The patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).

To compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.The patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).One hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or enema chloral hydrate(80 mg×kg-1, n = 60). The primary endpoint was successful sedation to complete the examinations including slit-lamp photography, tonometry, anterior segment analysis, and refractive error inspection. The secondary endpoints included onset time, duration of examination, recovery time, discharge time, any side effects during examination, and within 48 h after discharge.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with congenital cataract aged from 3 to 36 months weight from 5 to 15 kg with American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion Criteria:

* with gastro-esophageal reflux, nausea and vomiting, apnea in the past 3 months recent pneumonia exacerbation of asthma, bronchitis and upper respiratory tract infection bradycardia, and facial abnormalities, allergy to chloral hydrate, weight \<2 or \>20 kg .
Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump

The study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. A before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention.

A before and after intervention study will be conducted with a control and intervention group, where data will be collected at the household (through questionnaire based interviews, floor and/or windowsill samples and soil samples collection) and individual level (through hand dust wipe sample collection). In phase one, both the control and intervention group will be interviewed, household floor and/or windowsill dust wipes will be taken, yard soil sample collected and hand dust wipe samples will be taken from children in participating households. After baseline data collection, participants will be allocated into either intervention or control group. The intervention group will participate in the domestic hygiene demonstration and educational discussion.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of one and five years

Exclusion Criteria:

* Children above 5 years
Lorlatinib Continuation Study

The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention


Eligibility Criteria:
Inclusion Criteria:

1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.

2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function

Exclusion Criteria:

1 - Female participants who are pregnant or breastfeeding. 2- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
French Adaptation of the California Card Sorting Task (CCST) in Multiple Sclerosis

Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially executive functions. The California Card Sorting Task (CCST) assesses specific components of problem-solving ability. There is currently no French version of this test. Reims neurological department in collaboration with Rothschild Foundation has developed a French adaptation of CCST. This version includes three cards packages with two alternate forms to control practice effects (test-retest). In order to assess "test-retest reliability" we have to verify the comparability of the three cards packages within one session in MS patients.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis patients
* age \> 18 years old

Exclusion Criteria:

* Montreal Cognitive Assessment (MOCA) ≤20
* psychiatric disease
* no proficiency in the French language
* opposition to participate in the study
* no medical insurance coverage
Seated Physical Activity in Ageing

This trial will take the form of a feasibility study; designed to assess the feasibility of a proposed future clinical trial in this setting. This proposed future clinical trial is proposed to assess the impact of physical activity, in the form of specialised chair based physical activity interventions, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a clinical hospital ward setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).


Eligibility Criteria:
Inclusion Criteria:

* Temporary residents within the Harborne 'living lab' ward of the Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom
* ≥ 65 years of age
* Frail according to the Fried Frailty criteria: meeting at least three of the five characteristics of frailty (Fried et al. 2001)
* Have the capacity to speak and read in English
* Anticipated by their care team to remain on the ward for approximately 14 days post enrolment into the study. This will be advised by the patient's care team.

Exclusion Criteria:

* Currently taking part in any other clinical trial which could potentially have an impact upon or influences the findings of the current study
* Currently terminally ill with life expectancy which is less than the duration of the study's interventions
* Severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.
LLLT Combined With CDT in Breast Cancer-Related Lymphedema

This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition of LLLT to CDT will result in statistically significant improvements and greater long-term benefits as measured by changes in arm volume and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
* stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)
* girth ≥ 2 cm circumferential difference and/or volume ≥ 200 mL compared to the uninvolved upper extremity at any 4 cm segment
* able to commit to a long term follow-up schedule

Exclusion Criteria:

* active cancer/metastatic cancer
* currently receiving or have plans for adjuvant radiation or chemotherapy
* pregnant
* presence of other extremity lymphedema (primary or secondary)
* pacemaker
* artificial joints in the upper quadrants
* renal failure
* arterial insufficiency
* congestive heart failure
* chronic inflammatory conditions
* history of deep vein thrombosis (DVT) in the lymphedematous upper extremity
* previous treatment with Low Level Laser (regardless of indication)
* medication(s) known to affect body fluid balance
* body mass index (BMI) \> 40 (morbid obesity)