cyrilzakka/clinical-trials huggingface dataset:
Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of ramucirumab plus paclitaxel in gastric or gastroesophageal junction adenocarcinoma as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review \& Assessment Service (HIRA). The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy will be collected.

Ramucirumab plus paclitaxel combination therapy has shown a survival benefit in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. However, the real-world efficacy and safety of ramucirumab plus paclitaxel combination therapy in Korea have only been evaluated once outside of controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of ramucirumab plus paclitaxel under the Korea National Health Insurance System. The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, locally advanced unresectable or metastatic disease, and previous first-line systemic therapy including fluoropyrimidine and platinum. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, and duration of response. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with ramucirumab plus paclitaxel combination therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥19 years at the time of study registration
2. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
3. Locally advanced unresectable or metastatic disease
4. Patients who have received previous palliative first-line systemic therapy including fluoropyrimidine and platinum for advanced gastric or gastroesophageal junction adenocarcinoma
5. Patients who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 under the Korea National Health Insurance System

Exclusion Criteria:

1. Patients who have received ramucirumab plus paclitaxel combination therapy outside of the Korea National Health Insurance System
2. Patients who have received ramucirumab monotherapy
Natrecor for Pulmonary Hypertension in Lung Transplants

This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will decrease the otherwise historically mandated use of iNO by 50%, as compared to the necessity of iNO use by matched historical controls.

A condition called ischemic reperfusion injury (IRI) occurs in all lung transplants. The amount of reperfusion injury varies from person to person. IRI occurs when the blood supply to tissue (in this case, transplanted lung(s)) is decreased and then is restored. IRI can cause a decrease in function in a newly transplanted lung. When this occurs, or when people have pulmonary hypertension (high blood pressure in your lungs), doctors use Nitric Oxide to improve the pressure and blood supply to the transplanted lung. Nitric Oxide (NO) is given by inhalation while patients are on a ventilator (breathing machine). Because NO must be given by a ventilator and because patients on ventilators must be in an intensive care unit, the cost of treating people with NO is very high. NO can also cause rebound pulmonary hypertension (high blood pressure in the lungs that reoccurs) when it is stopped. Because of these reasons, doctors are looking for other treatments for IRI and pulmonary hypertension. A drug called Natrecor has been shown to reduce pulmonary pressures in heart transplant patients. Doctors believe it may be helpful to lung transplant patients as well.

Eligibility Criteria:
Inclusion Criteria:

* Single or double lung transplant or heart/lung transplant recipient
* Planned use of Natrecor
* Pulmonary artery (PA) systolic pressures \> 35

Exclusion Criteria:

* Previous lung transplant
* Use of Prolastin after pneumonectomy
* Mean arterial pressure of \< 55
* Known allergy or sensitivity to nesiritide
* Females of childbearing potential with a positive pregnancy test or women who are breast feeding
* Use of nesiritide, for any reason, within 30 days prior to transplant
Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment

Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.

Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.

Secondary objectives:

* To demonstrate that the use of high performance dressing decrease the rate of unstuck dressing and the rate of catheter infections.
* To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).
* To calculate the cost saving of each dressings

Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours

Exclusion Criteria:

* pulmonary arterial catheter
* antiseptic-impregnated catheter
* hemodialysis catheter
* chlorhexidine allergy
* emergency catheter without surgical asepsis
Clinical Analysis of Two Toric Intraocular Lenses

Purpose: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract.

Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after surgery visual acuity, rotation stability and astigmatism correction were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age related cataract on both eyes
* Corneal astigmatism 1,0- 4,0 D
* Potential postoperative visus 1,0
* No other ocular pathology as cataract
* Age 18 - 80
* Written informed consent to surgery and participation in the study

Exclusion Criteria:

* Pregnancy, breastfeeding
* Amblyopy, diabetic retinopathy, uveitis or other relevant ophthalmologic diseases
* Optical media disturbances due to: corneal and vitreal opacity, PEX
* Irregular astigmatism measured with corneal topography (Visante-omni), keratoconus
* ≥ 10 degrees difference between the axis of keratometry measurement of the IOL Master and the simulated K reading of the corneal topograph (Visante-omni)
* Trauma, ocular surgery performed within 6 months
* Traumatic cataract
* Potential postoperative visus under 1,0
A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on abdominal distension in IBS patients with constipation (IBS-C).


Eligibility Criteria:
Inclusion Criteria:

* female
* Age: 18-70

Exclusion Criteria:

* NA
Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)

This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.


Eligibility Criteria:
Inclusion Criteria:

* Need for ventilation in the delivery room

Exclusion Criteria:

* Tracheal suctioning for meconium
* Congenital Diaphragmatic Hernia
* Suspected hypoplasia of the lungs
* Oligohydramnios \<28 weeks gestation or AFI\<5
* Known or suspected airway anomaly
* Mother not speaking English or Spanish
* Refusal of consent
Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese

Introduction:

The pregnancy brings about physiological and hormonal modifications which cause sleep disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The limited airflow causes micro-awakenings that enter in the frame of the high resistances airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at pregnant women.

Objectives:

To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman with or without gestational diabetes

Methods :

It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going to compare the breathing disorder during sleep of a control group with a group of women with gestational diabetes. A polysomnograph will be run at the included patients' home.

Expected results :

The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that limited airflow in association with micro-awakenings in the RERA have a negative impact on the glucose metabolism and favor the gestational diabetes.


Eligibility Criteria:
Inclusion Criteria:

Pregnant woman in the 3rd quarter of pregnancy (24 to 32 weeks amennorhea).

* Presenting a gestational diabetes ou not (=controle group)
* Written and signed consent.

Exclusion Criteria:

* Twin pregnancy
* High blood pressure before pregnancy
* Diabetes diagnosed before pregnancy
* Left ventricular ejection fraction below 40%
* Alcohol consumption (more than 7 glaces/day), drugs of type hypnotic, sedative, opioids
* History of gestational diabetes or glucose intolerance
* Severe cronical respiratory impairment (severe asthma)
* Creatinine clairance below 60 mL/min
Blended Learning in Future Physiotherapy Professionals

Blended Learning (BL) is proving to be an effective method of teaching within the health professions . However, there are still scarce studies on BL conducted with undergraduate physiotherapy students. Therefore, the aim of this study was to determine the effectiveness of a heart disease BL programme in knowledge, motivation, engagement, design of the programme instructions and learning behaviours in physiotherapy students.


Eligibility Criteria:
Inclusion Criteria:

* studying a Physiotherapy Degree at the aforementioned University
* to be willing to participate

Exclusion Criteria:

* none
Oral Fluoride Bioavailability by the Consumption of Meals Prepared With Fluoridated Water or Salt

This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian meals (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion, unstimulated saliva and dental biofilm will be collected for determination of fluoride concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of mastication) will be collected for determination of fluoride concentration. Dental biofilm will be collected immediately after the ingestion of the meal. Saliva will then be collected after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an ion-specific electrode. In order to standardize biofilm formation, during lead-in and wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2. refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each phase. Groups will be compared by ANOVA and Tukey test.


Eligibility Criteria:
Inclusion Criteria:

* good general health
* good oral health
* not having used topical fluorides in the last 2 months

Exclusion Criteria:

* poor general health
* poor oral health
* breastfeeding
* expecting mothers
Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults

The purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* First or Second-degree relative of someone with Alzheimer's Disease
* Not currently engaging in regular exercise
* Able to undergo an MRI
* Fluent in English

Exclusion Criteria:

* Neurological illnesses/conditions
* Medical illness/conditions that may affect brain function
* Any unstable or severe cardiovascular disease or asthmatic condition
* Severe depressive symptoms
* Inability to walk unassisted
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis

This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.


Eligibility Criteria:
Inclusion Criteria:

* Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis.
* Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study.

Exclusion Criteria:

* Subject is pregnant, lactating or is planning to become pregnant during the study.
* Subject requires any topical or systemic medications or is using topical inflammatory dermatoses therapies that could affect the course of their atopic dermatitis during the study period.
* Subject has used systemic corticosteroids, immunomodulators including leukotriene inhibitors, or antimetabolites within 30 days prior to study start.
* Subject has used Ultraviolet Light Therapy (PUVA, UVB, etc.) within 30 days prior to study start.
* Subject has used topical therapies for the treatment of (or may affect) their atopic dermatitis including but not limited to corticosteroids, immunomodulators (tacrolimus, pimecrolimus, etc.), tar, calcipotriene or other vitamin D preparations, retinoids, antihistamines (doxepin, diphenhydramine, etc.), antibiotics, among others, within 14 days prior to study start.
* Subject desires excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study.
* Subject has used systemic (oral, IV, etc.) antibiotic therapy within seven days prior to study start.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has used an investigational drug or investigational device treatment within 30 days prior to study start.
Development and Evaluation of an Artificial Intelligence Tool for Colposcopy Assistance

Project aiming to develop an algorithm to help the interpretation of colposcopy images, then to evaluate the effectiveness of this algorithm by using it on new cases and comparing the results obtained to the impression of expert clinicians

Due to the increase in the number of colposcopies following changes in recommendations regarding cervical cancer screening, the investigators wondered about the benefit of assistance provided by the computer tool. Several teams have already developed algorithms to aid in the interpretation of colposcopy, but the studies were carried out in countries that do not have the colposcopic expertise of French practitioners, and no algorithm has has demonstrated its effectiveness to our knowledge, the different results being inhomogeneous. The investigators therefore wanted to develop an algorithm to aid colposcopy based on clinical cases carried out by practitioners considered experts, then evaluate its effectiveness.

The investigators manually collect data concerning adult patients who underwent colposcopy by an expert doctor at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023, for whom the photographs of the colposcopic examination (without staining, after acid acetic and after Lugol) are available and usable and for which the clinical context is known. If a biopsy has been performed, the histological result is considered the gold standard. If this is not the case (normal and satisfactory colposcopy), the investigators consider by default that the histology is normal. The investigators excluded all patients for whom photographs were of poor quality or unavailable.

Development of the algorithm with the help of a computer science student, aiming to answer the following 2 questions:

* assumed histological result
* localization of the targeted biopsy if necessary

Evaluation of the algorithm: use of the algorithm for new cases, then comparison of the results obtained with the response given by expert clinicians (reading of images by 2 colposcopists). The aim will be to highlight the non-inferiority of the algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients who underwent colposcopy with directed biopsies at La Pitié-Salpêtrière between September 1, 2022 and December 31, 2023
2. Known clinical context (why the patient underwent colposcopy)
3. Histological results of cervical biopsies (+/- conization or even hysterectomy) known
4. Images available (photographs of the cervix without preparation, after application of acetic acid and after application of lugol)
5. Informed of the study and not opposing the use of their data

Exclusion Criteria:

* Patients who do not speak French
Blood Loss Measurement Using Electrical Impedance Tomography

The project focuses on the possibility of detecting blood loss using electrical impedance tomography. Based on previous animal experiments, it was found that the bolus of saline significantly affects the signal of chest bioimpedance. It is assumed that blood loss of a similar volume will cause a similar signal change with the opposite trend. The aim of this project is to determine whether there is a significant change in the thoracic electrical impedance tomography signal when blood loss is caused by voluntary blood donation.

Electrical impedance tomography is a bedside method of ventilation monitoring. The bioimpedance of the tissue depends, among other things, on its blood content. The area of the chest and especially the lungs is a heavily perfused tissue, which also serves as one of the reservoirs of blood in case of blood loss. It is therefore possible that blood loss will be visible on chest bioimpedance relatively soon.

The study will be performed on voluntary blood donors. Blood loss of 450 mL will be caused by the collection of donated blood. During blood collection at the transfusion department, thoracic bioimpedance will be measured using electrical impedance tomography. The resulting signal change will then be analyzed to determine the possibility of detecting and measuring blood loss using electrical impedance tomography.

Eligibility Criteria:
Inclusion Criteria:

* voluntary blood donation

Exclusion Criteria:

* standard exclusion criteria for voluntary blood donation based on the transfusion station protocol
* standard exclusion criteria for electrical impedance tomography according to the manufacturer
Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults

The purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at risk for acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

Male and females ≥ 22 years of age. Subjects must be admitted to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission.

Subjects must have at least one of the following leading to admission to the ICU, or occurring within 24 hours of admission to the ICU:

* Vasoactive medication administration
* Mechanical ventilation
* Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula
* Mean arterial pressure (MAP) less than 60 (within 12 hrs. of ICU admission only)
* Serum Lactate greater than 2.5 mmol/L
* History of solid organ transplantation, renal transplantation included only if more than 3 months prior
* History of bone marrow transplantation Subject with signed informed consent.

Exclusion Criteria:

Special populations including pregnant and lactating women, prisoners, or institutionalized individuals.

Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission.

Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling.

Subjects with a known history of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 and under the care of a nephrologist.

Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any urologic procedure or urologic surgery immediately prior to admission to the ICU.

Subjects that have had surgical nephrectomy less than 3 months prior to admission.

Subjects that have been previously enrolled in this study. Subjects that do not have a baseline sCR within 6 months prior to ICU admission available.

Subjects that did not sign the informed consent. Subjects enrolled in an interventional pharmaceutical or device clinical trial at time of ICU admission