cyrilzakka/clinical-trials huggingface dataset:
Ambulatory Prolapse Surgery

Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized.

Day-care surgery for prolapse has been little studied. The present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. The secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence.

The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the Lyon hospitals board (Hospices Civils de Lyon).


Eligibility Criteria:
Inclusion Criteria:

* Stage III or IV anterior genital prolapse (cystocele) on the Pelvic Organ Prolapse Quantification (POP-Q) classification and/or vaginal floor prolapse
* Vaginal approach with prosthetic reinforcement planned
* Patient eligible for day-surgery
* Patient consenting to participate
* Informed and signed consent

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, progressive disease, etc.
* Patient with ≥1 ineligibility criterion for day-surgery
* Impaired lower-limb range of motion preventing positioning for surgery
* Pregnancy, ongoing or planned during the study period
* Progressive or latent infection or signs of tissue necrosis on clinical examination
* Non-controlled diabetes (glycated hemoglobin \>8%)
* Treatment impacting immune response (immunomodulators), ongoing or within previous month
* History of pelvic region radiation therapy, at any time
* History of pelvic cancer
* Non-controlled progressive spinal pathology
* Known hypersensitivity to one of the implant components (polypropylene)
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision.
Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques

Children fear having an intravenous (IV) needle placed because of the pain that they will experience. The more needle punctures that a child has to endure before the IV is successfully placed, the greater the pain experienced and anxiety suffered. In addition, false starts increase the demands on medical staff and can increase the length of the emergency department stay. Often, veins are difficult to see or feel, particularly in an unwell, dehydrated child or in young infants who have more fat below the skin surface. Also, the venous pattern below the skin surface naturally varies from person to person and therefore success in placing IVs leaves room for improvement. Technology may be able to play an important role is improving the rates of success. The investigators wish to investigate whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to the current standard approach.

Peripheral IV line placement is one of the most common and challenging painful procedures performed in the pediatric emergency department (PED). The lack of a clear visual guide for IV placement often leads to multiple painful attempts; delays in urgent treatment; increased use of human resources; increased costs; and increased anxiety in the patient, the parents and the staff. The research plan is a randomized controlled trial (RCT) to compare the use of two new technologies with the current standard method for vein location and IV placement in children.We would like to know if either of these technologies improve rates of successful IV placement on first attempt. Furthermore we would like to know if either technology leads to decreased time spent by staff on the procedure or decreased overall number of painful attempts. Information on nursing satisfaction, parental satisfaction and cost analysis will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-16 presenting to the Pediatric Emergency Department (PED)
* Require IV as part of routine care
* Knowledge of English language

Exclusion Criteria:

* Child in critical condition
* Child requires urgent IV placement
* Central line available
Training Concepts in Emergency Ultrasonography

Emergency ultrasound examinations are increasingly important diagnostic tools in emergency and critical care medicine. This study wants to analyze different types of education for undergraduate students. Any method of medical training will be proved theoretical and in clinical practice.

This prospective educational study wants to analyze different methods of education for undergraduate medical students.

Method A: Theoretical training will be scheduled for 2 hours with lectures in basics of emergency ultrasound. After the theoretical education the students will obtain a bedside-teaching on intensive care unit for 4 hours.

Method B: Theoretical training will be scheduled for 3 hours and included lectures in echocardiography, lung ultrasound and abdominal ultrasound. After the theoretical education the students will obtain a bedside-teaching on intensive care unit for 3 hours.

Method C: Theoretical training will be scheduled for 3 hours and included lectures in echocardiography, lung ultrasound and abdominal ultrasound. After the theoretical education the students will obtain a hands-on-training in healthy volunteers for 3 hours. The acquired knowledge and practical skills will be analyzed by a multiple-choice exam (5 MC-questions, 5 video sequences) and a practical exam (five tasks).

Any method of training will be proved at the end theoretical and in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Medical students

Exclusion Criteria:

* No
SMAS: a Prospective Study in a Single Institution

Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008 and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of SMAS were prospectively included in the study, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.


Eligibility Criteria:
Inclusion Criteria (at least 2 of the following):

* severe and frequent upper digestive symptoms (occurring at least once a week), associated to poor quality of life and refractory response to medical treatment;
* a condition of underweight (BMI \<18.5 kg/m2) associated with difficulty eating;
* severe complications of SMAS (e.g. gastric perforation, acute pancreatitis, aspiration pneumonia);
* suggestive findings of SMAS at barium swallow;
* diagnostic aortomesenteric angle and distance at CT/MR angiography.

Exclusion Criteria:

* inability to provide the informed consent;
* malignancies;
* bowel motility disorders;
* severe psychiatric illness;
* pregnancy;
* impossibility to perform the required diagnostic workup.
Ultrasound Capsule Endoscopy for Esophagus Examination

The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

Wireless capsule endoscopy has opened a new era by enabling remote diagnostic assessment of the gastrointestinal tract in a painless procedure. However, most commercially available devices only utilise optical imaging to examine the GI wall surface. Using this sensing modality, pathology within the GI wall cannot be detected. Micro-ultrasound (mUS) using high-frequency (\>20 MHz) ultrasound can provide a means of transmural or cross-sectional image of the GI tract. Depth of imaging is approximately 10 mm with a resolution of between 40-120 μm that is sufficient to differentiate between subsurface histologic layers of the various regions of the GI tract. Ultrasound capsule endoscopy (USCE) uses a capsule equipped with mUS transducers that are capable of imaging below the GI wall surface, offering thereby a complementary sensing technique to optical imaging capsule endoscopy. In this work, a USCE device integrated with a 40 MHz ultrasonic transducer was developed to capture a full 360˚ image of the lumen. Previous animal studies of two anaesthetised Landrace pigs have demonstrated the effectiveness of the device. The reconstructed images demonstrate clear layer differentiation of the lumen wall. The tissue thicknesses measured from the B-scan images show good agreement with ex vivo images from the literature. The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 18 years or older.
2. Both inpatients and outpatients.
3. Healthy volunteers or patients with suspected esophageal disease
4. Able to provide informed consent.

Exclusion Criteria:

1. known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
2. dysphagia.
3. known or suspected possibility of active bleeding of digestive tract.
4. Pregnancy or suspected pregnancy..
5. Patients who have participated in or are participating in other clinical trials within three months.
6. Life-threatening conditions.
7. other circumstances that doctors consider inappropriate for the study.
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.

To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101combined with standard of care (SOC) compared with standard care alone in hospitalized adults with moderate COVID 19.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to comprehend and willingness to provide a written ICF before enter the study;
2. Male or non-pregnant female patients, ≥ 20 years of age at the time of enrolment;
3. Hospitalized patient with a diagnosis of COVID-19 on the basis of a positive# reverse transcriptase polymerase chain reaction (RT-PCR) with moderate## disease on admission###. #: Ct value \<30. ##:Disease severity as defined by the treatment guidance of Taiwan Centers for Disease Control (CDC):

   \> Moderate: Pneumonia patients without severe symptoms, blood oxygen saturation ≥93% without supplemental oxygen equipment (on room air); ###: Confirmed positive RT-PCR result ≤ 4 days prior to screening visit is eligible
4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.

Exclusion Criteria:

1. Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry.
2. Patients with intubation, respiratory failure, septic shock, multiple organ dysfunction or need additional organ support (e.g. vasopressors or ECMO).
3. Patients who have SpO2 \<93% on room air, respiratory frequency \>30 breaths/min.
4. Patients treated by dexamethasone before Day 1.
5. Patients treated by supplemental oxygen (FiO2 \>40%) before Day 1.
6. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<15 mL/min/1.73 m2).
7. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
8. Known history of severe allergic or hypersensitivity reactions, e.g. hypersensitivity to the active substance or to any of the excipients of ropeginterferon alfa-2b.
9. Known history or presence of poorly controlled or clinically significant medical conditions that are not suitable to be enrolled, at the discretion of the investigator: major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt).

11. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs.

12. Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening.

13.Therapy with any anti-neoplastic, or immunomodulatory treatment within 1 month prior to screening.

14. Patient who have been vaccinated with any live attenuated vaccine or COVID- 19 vaccine within 1 month prior to screening.

15. Use of an investigational medical product within 1 month prior to screening.
Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging (MonaLisaPredor)

Aging is a long term process, starting early in life, and progressively affecting various functions and organs. Cardiovascular diseases and cognitive impairment are two conditions related to advancing age and sharing common risk factors. The Mona Lisa- PREDOR study is a population-based prospective cohort study carried out to develop risk prediction algorithms aimed at identifying people who are the most likely to develop impaired psychometric and cognitive functioning and impaired cardiovascular risk, in the coming years.

The study is aimed at identifying predictors of impaired changes in psychometric and cognitive performances and level of cardiovascular risk, over a seven-year period, and to develop risk prediction algorithms. Main secondary objectives are to study response to psychometric and cognitive tests according to age, and to estimate the prevalence of the frailty syndrome according to age.

The design is a prospective cohort study carried out among 1500 men and women from the general population, aged 42-89 years, and living in South-western France. Except for participants aged 80-89 years, all participants have been previously assessed in 2005-2007, as regard to their psychometric and cognitive performances and level of cardiovascular risk, as part of the Mona Lisa study.

Data collection includes a detailed questionnaire on previous medical history, drug intake, education level, and life habits; a standardised clinical examination; psychometric tests (word list learning test, digit symbol substitution test, word fluency test and Stroop test), and a fasting blood sample. Level of cardiovascular risk and frailty syndrome were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 42-79 years, living in South-western France, who participated in the Mona Lisa Study (2005-2007) (in the Mona Lisa study, participants were selected by drawing on polling lists)
* Men and women aged 80-89 years, living in South-western France, selected by drawing on polling lists.

Exclusion Criteria:

* Subject who refuses to participate (who refuses to sign the inform consent)
* Subject not affiliated to a health assurance system
* Subject with altered cognitive functioning compromising the understanding of the information on the study, and not accompanied by a trusted third party.
Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy

An adequate bowel preparation has been well established to lead to a successful colonoscopy. Research has consistently demonstrated inadequate bowel preparation with lower adenoma detection rates. Over the years, endoscopy centers have changed the constituents of bowel preparation in light of new research. In 2006, 3 medical organizations recommended the use of polyethylene glycol (PEG) solution for bowel preparation. Initially, a 4 liter PEG solution was commonly used using a split dose regimen for bowel prep. However, many patients found that this large volume gave them side effects including bloating and cramping. Other studies showed that a low volume PEG solution with oral bisacodyl fared equally in terms of adequacy of bowel preparation. With the institution of lower volume PEG preparation our offices noted improved patient toleration, satisfaction, and clinical outcomes. However, multiple endoscopists have noticed an increased in intraluminal bubbles and foam with the low volume preparation. This can impair proper visualization of the bowel wall even with an adequate bowel preparation. The current standard of practice includes irrigation, lavage, and suctioning using a simethicone infused saline during the colonoscopy. Its property of reducing surface tension to help dissolve bubbles and clear the field of view is vital during the procedure. Furthermore, it does not dissolve into the blood stream and thereby, is considered rather safe.

This study evaluates whether the addition of oral simethicone with the colonoscopy bowel preparation reduces bubbles and foam during the procedure using a randomized and controlled interventional study.

This prospective, multi-center, randomized, controlled, double (patient and endoscopist) blinded study is conducted at the Gastroenterology Consultants outpatient clinics and endoscopy centers in association with the University of Nevada-Reno School of Medicine. After obtaining signed informed consent, outpatients are recruited and randomized into 1 of 2 treatment groups; PEG3350-Bisacodyl with 200 mg liquid simethicone treatment and PEG3350-Bisacodyl treatment with inert placebo (water).

The primary outcome includes reduction of bubbles using the intraluminal bubbles scale. Secondary outcomes include the evaluations of the numbers and types of polyps, numbers and types of masses detected, cecal insertion time, withdrawal time, adverse effects, and the adequacy of bowel prep using the Boston Bowel Prep scale.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for outpatient elective colonoscopy
* Adult 18-80 years of age able to give consent.
* English speaking adults.

Exclusion Criteria:

* History of bowel resection
* Uncontrolled hypertension
* Suspected bowel perforation
* Suspected bowel obstruction
* Indications for emergent/urgent colonoscopy
* Non-english speaking individuals
A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris

The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6 months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3; Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal lesions.
* Disease progression after treatment with standard therapies that are known to confer clinical benefit, or intolerant to treatment; there is no limit to the number of prior treatment regimens.
* Willingness to avoid pregnancy or fathering children.
* If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during the study period.

Exclusion Criteria:

* Pregnant or breast-feeding female.
* Participants with pemphigus vulgaris who are treatment-naive.
* Use of protocol-specified medications within defined periods before baseline.
* Evidence or history of clinically significant infection or protocol-defined medical conditions
* Laboratory values outside the protocol-defined range at screening.
* Known or suspected allergy to parsaclisib or any component of the study drug.
* Known history of clinically significant drug or alcohol abuse in the last year before baseline.
* Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer

Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.

The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patient (age ≥ 18 years);
* Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and:

  * previously treated by compassionate trastuzumab deruxtecan (ATU group), or
  * previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group);
* Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive.

Exclusion Criteria:

- Previous participation in an interventional clinical trial with trastuzumab deruxtecan
Investigation of the Effects of the Technology-based Cardiac Rehabilitation Program in Coronary Artery Patients

This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

Cardiovascular diseases constitute one of the most critical health problems of today's society due to the loss of workforce, morbidity, mortality, and high hospital expenses.

This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease
* Access to the online program
* Volunteering to participate in the research
* Having an iOS or Android operating system compatible phone

Exclusion Criteria:

* Having a musculoskeletal problem
* Having uncontrolled hypertension
* Having chronic heart failure (NYHA III-IV)
* A history of acute coronary syndrome or surgical revascularization less than 12 months ago
* More than 50% occlusion on the main coronary artery
* Having arrhythmia
Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

See Synopsis

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of rectum measurable (RECIST), locally advanced (defined by MRI - Tumour beyond mesorectal fascia (T4) or Tumour ≤ 2 mm from mesorectal fascia or T3 tumour \< 5 cm from anal verge
* Patient is at least 18 years of age
* Good organ function

Exclusion Criteria:

* Evidence of distant metastases
* Contraindication for bevacizumab
* Pregnant or breastfeeding women.