cyrilzakka/clinical-trials huggingface dataset:
Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?

According perinatal surveys, induction of labor is performed at more than 20% of pregnant women.

According to a survey on the trigger practices in France, prostaglandins are widely used to initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®).

The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal deliveries.

Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone limits the use of oxytocin (Syntocinon®) or in lower doses.

Using a second Propess® is carried out in several maternity hospitals, as reported by the survey on the cervical ripening practices in France. This second administration could be the solution to reduce the rate of caesarean in France which amounted to 20.8%.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is \>=18 years.
* Term pregnancy \> 37 weeks
* Induction of labor in progress, medically indicated
* Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
* Cephalic presentation
* Unfavorable cervical conditions (Bishop score \<6) 1 hour prior to inclusion
* Intact Membranes
* Affiliated with a social security system
* Having signed the consent form.

Exclusion Criteria:

* Multiple pregnancy
* Uterus scar
* Contraindications to epidural anesthesia
* Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins Adverse effects appeared in the first Propess®: anaphylactic shock, disseminated intravascular coagulation (DIC).
* Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
* Contraindications to vaginal delivery (placenta previa, previa obstacle ...)
* Premature Rupture of Membranes (PROM)
* Intra Uterine Growth Retardation (IUGR) \<3rd percentile
* Macrosomia\> 97th percentile
* Severe Impaired fetal heart rate
* In Utero Fetal Death (IUFD)
* Medical Termination of pregnancy or lethal fetal pathology
* Patient under guardianship or trusteeship safeguard justice
Acceptance of Telemedicine During the COVID-19 Pandemic

Currently, due to the effects of COVID-19 pandemic, there is an imperative need to change the healthcare model. In this regard, telemedicine has proved very useful in health crises, in which there is a possibility of infection between people, offering remote access to medical care. Telemedicine has been used in many chronic diseases such as asthma and chronic obstructive pulmonary disease, diabetes mellitus, and appears to be well accepted by patients. However, few studies have been conducted in surgical services and in other diseases. Therefore, the aim of this study is to assess the level of acceptance of the patients, in this pandemic situation, to a telemedicine follow-up in different departments.

This is an observational, cross-sectional, multicenter and international study with prospective and retrospective data collection. To evaluate patients' acceptance, we used the validated questionnaire Telehealth usability questionnaire (TUQ). In addition, all patients will provide an overall satisfaction score for telemedicine on a scale from 1 to 5 (1=lowest; 5=highest satisfaction).


Eligibility Criteria:
Inclusion Criteria:

* Patients contacted by telemedicine (phone and/or video call) during the COVID-19 pandemic in outpatient clinics
* Follow-up of patients with any chronic disease and postoperative patients, preoperative and urgent consultation
* Age greater than or equal to 18 years

Exclusion Criteria:

* Patients with cognitive or sensory difficulties or with insufficient comprehension of the language in which the survey is conducted
* Patients who decline to take part in the telephone survey
Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer.

Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer

Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.

The study included:

* A Thirty (30)-day screening phase
* The double blind treatment period for a minimum of 60 days. Day 1 of the double-blind treatment period was defined as the date of the qualifying paracentesis (ie, withdrawal of \>= 1 Liter of ascitic fluid). Participants were randomized after adequate recovery from the qualifying paracentesis (The first dose was administered on Day 1 or Day 2).
* The optional open-label extension (until treatment discontinuation criteria were met)
* A posttreatment follow-up phase lasting 60 days.

Criteria for discontinuation included:

1. Participant or his legally authorized representative request discontinuation
2. In the Investigator's opinion, continuation of treatment would be detrimental to the participant's well being, such as disease progression, unacceptable toxicity, noncompliance, or logistical considerations
3. Sponsor request
4. Intercurrent illness that prevented further administration of investigational product(IP)
5. More than 2 IP dose reductions
6. Unacceptable adverse events (AE) not manageable by symptomatic therapy, dose delay, or dose modification
7. Arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset or worsening of preexisting angina
8. Radiographic evidence of intestinal obstruction (for example, dilated loops of bowel accompanied by air-fluid levels) or gastrointestinal perforation (for example, presence of extraluminal gas) requiring surgical intervention

Eligibility Criteria:
Participants who met the following criteria were eligible to participate in this study.

Inclusion Criteria:

* Advanced ovarian epithelial cancer, treated with paracentesis
* Platinum-resistant, and topotecan-resistant and/or liposomal doxorubicin-resistant disease;
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.

Exclusion Criteria:

* Pseudomyxoma peritonei or peritoneal mesothelioma;
* Transudative ascites;
* Peritoneovenous or other shunt placed for malignant ascites management;
* Recent (\<6 months) cardiovascular event (pulmonary embolus, myocardial infarction, stroke) or gastrointestinal disease (ulcer, hepatic cirrhosis);
* Known brain metastases;
* Uncontrolled hypertension;
* Recent treatment with chemotherapy, surgery or radiotherapy;
* Prior treatment with VEGF or VEGFR inhibitor.

The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Study on the Relationship Between Maternal Exposure to Environmental Factors and Fetal Congenital Heart Disease

The objective of this study is to research the relationship between maternal exposure to environmental factors and fetal congenital heart disease in a community-based case-control study.

This is a community-based case-control study in SHANGHAI,a municipality in CHINA. Cases will be identified from maternity centers. Matched controls will be accrued from the same region as the case came from. Pregnant cases and their controls are women (18-45 years). Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-29nd of gestational weeks. Controls are pregnant women without fetal congenital heart disease diagnosis. Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. About 2 controls matched by year of birth and region will be allocated to each case. A standardized questionnaire will be used for all cases and controls. Field investigations are also conducted for them by quantitative measurement of some chemical, physical and nutritional factors related indicators may affect fetal cardiovascular development. Study participants will be asked for their informed consent.

Eligibility Criteria:
Inclusion Criteria:

1. Gravida with singleton pregnancy taking fetal echocardiography in 16th-29nd of gestational weeks.
2. Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
3. On the basis of informed consent，willing to cooperate with our group.

Exclusion Criteria:

1. Pregnant women with serious pregnancy complications .
2. Pregnant women suffering from mental illness, can't take care of themselves. 3) Fetus diagnosed with chromosomal abnormalities in pregnant women .

4）Repeated explanation does not cooperate in pregnant women.
Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density

The purpose of this study is to test the ability of a technique called Transillumination Breast Spectroscopy (TIBS) to monitor an individual's breast density changes over time.

Breast density is an established physical risk factor for breast cancer, applicable to the entire female population in a pre-breast-screening program and, unlike other risk factors, was shown to be affected by an intervention treatment. High breast tissue density is associated with increased risk of breast cancer. Transillumination Breast Spectroscopy (TIBS) uses a white light to provide spectral information on breast tissue density and composition (e.g. water, lipid, hemoglobin and other biomolecules). The overall goal of the TIBS program is to develop a technique that can identify individuals at high risk for breast cancer who would benefit most from improved screening methods and a risk reducing intervention (e.g. diet and lifestyle changes) and can monitor the efficacy of the risk reducing intervention itself in an individual. In a previous study, we demonstrated a high correlation between breast density assessed by TIBS and density identified by x-ray mammography. The current study is testing TIBS ability to monitor changes in an individual's breast density over time

Eligibility Criteria:
Inclusion Criteria:

* Be in good health and able to provide consent
* Be between 25 and 45 years of age
* Be pre-menopausal
* Are willing to come in to Princess Margaret Hospital (Toronto, Ontario, Canada) for up to 12 visits at intervals of about three months

Exclusion Criteria:

* Have had a full term pregnancy
* Have had breast biopsy
* Have had breast augmentation or reduction
IMPACT of an Instrumented Measurement on a Performance Assessment in Cerebral Palsy Treatment

The goal of this study is to assess the impact of passive reflective markers on bimanual performance assessment scores in children with unilateral cerebral palsy.

The main questions it aims to answer are:

* Is it possible to instrument performance assessment without changing the functionnal behaviour of the patient ?
* How is this behavious modified ?

During their usual occupational therpy assessment at the CMCR Massues, participants will do a second bimanual performance assessment with passive reflection markers taped on their trunk, humerus and forearm.

The glocal scores and sub items scors of both instrumented and non instrumented assessment will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral cerebral palsy
* With an Occupational therapy assessment planed with the duration of the study

Exclusion Criteria:

* Severe cognitive impairment
Effects of Cardiovascular and Pulmonary Optimization on Cerebral Oxygenation in COVID-19 Patients With Severe ARDS

The aim of the present study is to examine whether cerebral oxygenation could be a more useful parameter than peripheral oxygen saturation to guide clinical titration of permissive hypoxemia in COVID-19 ARDS patients

Mechanical ventilation is the cornerstone of supportive management for most ARDS patients to prevent life-threatening hypoxemia. Arterial oxygenation can be improved via ventilator by increasing fractional inspired oxygen (FiO2) and/or increasing mean airway pressure. When treating mechanically ventilated ARDS patients, the benefit of improved arterial oxygenation must be balanced against the potential risk of ventilator-induced lung injury (VILI), oxygen toxicity occurring with high FiO2 and development of right heart failure.

Arterial oxygen saturation target of 88-95 % and partial oxygen pressure (PaO2) target of 7.3-10.6 are advocated in the management of patients with ARDS. Surprisingly little randomized evidence exists to support these values and current recommendations are thus arbitrary and largely based on normal physiologic values.

Given the lack of evidence of strategies in oxygenating critically ill patients to an oxygen saturation and partial oxygen pressure that is generally accepted to be 'normal,' permissive hypoxemia may offer an alternative that has the potential to improve patient outcomes by avoiding unnecessary harm. Permissive hypoxemia is a concept in which a lower level of arterial oxygenation than usual is accepted in order to avoid the potentially detrimental effects of high fractional inspired oxygen and invasive mechanical ventilation with high pressures, while maintaining adequate oxygen delivery by optimizing cardiac output.

Pulse oximetry is a simple, non-invasive and universally used method to monitor peripheral oxygen saturation of hemoglobin in a variety of clinical settings. Pulse oximetry depends on pulsatile blood flow and only measures the oxyhemoglobin in arterial blood as it leaves the heart. However, this measure does not provide information regarding organ or tissue oxygenation, which reflects the important local balance between oxygen supply and demand.

Near-infrared spectroscopy (NIRS) allows for continuous measurement of regional tissue oxygenation which reflects perfusion status and enables clinicians to directly monitor fluctuations in real time. NIRS reflects the balance of oxygen that is delivered minus what is extracted at tissue level and is an indicator of the tissue oxygen uptake.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Verified COVID-19 infection (throat swab or tracheal aspirate positive for SARS-CoV-2)
* Severe ARDS according to Berlin definition
* Ventilator settings: Controlled IPPV, FiO2 \> 0.70, PEEP \> 10
* Norepinephrine infusion
* SVV \< 10% measured by LiDCO
* RASS - 5

Exclusion Criteria:

* Any of the following contraindications to lung recruitment: pneumothorax, patients on ventilator \> 1 week
* Patients with dark pigmented skin
Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing patients in the emergency department (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy. Eligible patients will be approached when patients will be scheduled and waiting for receiving percutaneous cholecystostomy in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age or older
* scheduled to receive the percutaneous cholecystostomy

Exclusion Criteria:

* clinically unstable
* refuse to participate
* are unable to understand the study process
Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women

The overall goal of this education program is to increase breast and cervical cancer screening in low-income women in Puerto Rico through implementation of an evidence-based educational program that addresses both health professionals (promotoras or community health workers) and public audiences of low-income women living in Canóvanas, Puerto Rico who have either never been screened for breast and/or cervical cancer, or are under-screened according recommended guidelines. To evaluate promotoras' delivery of the CLS screening education program we used a randomized pre-post comparison group study design that will provide data to determine the effectiveness of the CLS intervention program compared with usual practice (no intervention).

The proposed promotora and community based breast and cervical screening education program includes the following specific aims:

Aim 1. To train community health workers (promotoras) from Taller Salud to implement the CLS breast and cervical cancer screening program. Taller Salud staff train and build capacity of promotoras to implement the CLS community-based education and navigation program.

Aim 2. To deliver the CLS intervention program to at least 600 women in Canóvanas municipality, Puerto Rico.

Aim 3. To evaluate the impact of the program on increasing mammography and cervical cancer screening among participating women in Canóvanas, Puerto Rico.

Aim 4. To adapt and update intervention materials

Eligibility Criteria:
Inclusion Criteria:

* Women aged 21 and older for Pap cohort
* Women aged 40 and older for Mammography cohort

Exclusion Criteria:

* Having completed a Papanicolau test in the past 3 years if participant is between the ages of 21-65.
* Having completed a Mammography screening in the past year if participant is aged 40 or older
* Have a hysterectomy
* Currently pregnant
* History of any type of cancer
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Migraine Headaches

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Migraine Headaches.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages.
3. Diagnosis of migraine headaches by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
Prospective Observational Trial of IAPA

A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza.

Invasive pulmonary aspergillosis was shown to be a complication of severe influenza infections in immunocompromised patients as well as in immunocompetent patients and is associated with a high mortality. Antifungal prophylaxis might prevent influenza-associated pulmonary aspergillosis (IAPA) and thus might improve the outcome in patients with severe influenza. However, clinical related risk factors should be identified to assess whether a patient will benefit from antifungal prophylaxis. This prospective multi-center observational study will assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients in 12 ICUs in The Netherlands, Belgium and France over 4 influenza seasons. The secondary objective of this study is to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza. Patients aged 18 or older admitted to the intensive care unit (ICU) during the inclusion period due severe influenza without classic risk factors defined by the EORTC will be included.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a PCR-positive respiratory virus panel (RVP) result for influenza within 96 hours before or 48 hours after ICU admission.
* Patients who require ICU admission for more than 24 hours for severe influenza.
* Patients who have respiratory distress (respiratory rate \>= 25x/minute and paO2/fiO2 \< 300 with or without bilateral infiltrates) as the main reason for ICU admission.
* Patients who do not have an EORTC host factor.
* Patients who are at least 18 years of age.

Exclusion Criteria:

* Patients with age \< 18 years as extensive sampling is required
* Expected survival on ICU admission ≤ 48h
* Patients that are being treated actively with antifungal agents for invasive aspergillosis.
* Patients or their legal representatives who did not sign the informed consent form
Effects of Prior Induced Termination of Pregnancy on Complications and Pregnancy Outcomes.

A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.

A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* women have induced abortion in early pregnancy (\<12 weeks of gestation).
* permanent population and no tendency to move.
* normal language expression and understanding ability, able to understand research content.
* be able and willing to provide written informed consent and effective contact information, and be willing to cooperate with follow-up investigations.

Exclusion Criteria:

* above the age of 40
* with history of adverse pregnancy and childbirth
Measuring the Impact of an Interdisciplinary Polypharmacy Clinic Within a Patient-centered Medical Home

Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a patient-centered medical home

Objectives:

The primary objective of this project will be to track the types of interventions made in an interdisciplinary polypharmacy clinic to improve medication regimens and medication burden. Polypharmacy has been well documented in the literature as a risk for medication errors, adverse drug events, and morbidity. Team visits, including complete medication reviews, by pharmacists and physicians within a National Committee for Quality Assurance (NCQA) tier 3 patient-centered medical home (PCMH) at an academic medical center, can improve medication regimens. Secondary objectives include (1) measuring each patient's quality of life at baseline and one month post-intervention and (2) tracking the cost of medication additions and discontinuations.

Methods:

Patients taking ten or more chronic medications will be identified for referral to the polypharmacy clinic from a report generated from the electronic medical record. The polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from an attending physician who specializes in geriatrics. Drug-related problems identified during the visit will be resolved and categorized based upon indication, efficacy, cost, safety, and compliance. The numbers and types of interventions made, both during the primary visit and anticipated in the future, will be tracked. The 12-item short form (SF-12) survey will also be administered at baseline and one month post intervention. The increase or decrease in cost for medications added and removed during these visits will be captured using the average wholesale prices.

Preliminary Results Using descriptive statistics, the types of drug-related problems identified and interventions made will be reported. Changes in quality of life and monthly medication costs will also be described.


Eligibility Criteria:
Inclusion Criteria:

* Patients on 10 or more chronic medications
* Age 18 or older

Exclusion Criteria:

* Non-English speaking patients