cyrilzakka/clinical-trials huggingface dataset:
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection

The study primarily aims to collect standard of care clinical data in a wide spectrum of simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys).

Investigator does not intervene in the care of the patient, but simply collects standard of care images and measurements that are needed for the validation of the investigational software.


Eligibility Criteria:
Inclusion Criteria:

* both genders
* age between 18 and 85 years old (adult, senior)
* sinus rhythm
* hHemodynamic stable
* mitral valve regurgitation (MVR) of any grade i.e., from mild to severe as determined by assessment of a qualifying TransThoracic Echocardiography (TTE) exam at Saint-Luc University Hospital
* scheduled for TransEsophageal Echocardiography (TEE) at Saint-Luc University Hospital, as part of the subject's routine standard of care
* subjects has functional capacity to give written informed consent

Exclusion Criteria:

* pregnancy
* subject lacks functional capacity to give written informed consent belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures

Among the120 subjects, there will be three (3) sub-groups as follows:

* a first sub-group (A) of 50 subjects with all inclusion criteria and none of the exclusion criteria
* a second sub-group (B) of 50 subjects with additional inclusion criterion: scheduled for cardiac Magnetic Resonance (cMR), as part of the subject's routine standard of care
* a third sub-group (C) of 20 subjects with additional inclusion criterion: scheduled for MitraClip transcatheter mitral valve repair (MitraClip) procedure as part of the subject's routine standard of care
Severe Hypoxemia : Prevalence, Treatment and Outcome

Hypoxemia is usually observed during ICU stay. Nevertheless, the prevalence of hypoxemia among patients admitted in ICU is not well known, in partly due to a lack of a consensual definition. Some of these patients meet the criteria of Acute Respiratory Distress Syndrome whom the definition has been recently modified in 2011. Many uncertainties are remaining in considering the patients with ARDS: prevalence of the category of "mild ARDS", the proportion of patients with invasive mechanical ventilation, the therapeutic modalities and the prognosis, in particular, the move towards a more severe ARDS category. Finally, many patients with hypoxemia do not meet ARDS definition. The prevalence of this population in ICU is unknown, likewise its prognosis. In this way, it would be interesting to compare, for each levels of hypoxemia (mild, moderate and severe) the prognosis of the patients with and without ARDS.

The main objective of the SPECTRUM study is to assess the prevalence of hypoxemia in French-speaking Intensive Care Unit in 2016 in using a single-day point-prevalence study design. Two periods of inclusion have been, actually, planned: from the 29th Mars to the 31st Mars and from the 5th to the 7th April. In each participating center, the day of the study will be chosen among these periods.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Hospitalized in ICU during the 24 hours of the study
* Information provided to the patient or proxy

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Patient under guardianship or curators
* Lack of social insurance
Infraclavicular Perineural Dexmedetomidine

Infraclavicular block is one of the peripheral nerve block used in upper extremity surgery. Adjuvant agents are used in peripheral nerve blocks to increase the duration and block quality. We investigated that the effects of patient-controlled perineural dexmedetomidine application on postoperative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* be undergoing distal upper extremity surgery
* Be between 18-65 years
* to agree to participate in research

Exclusion Criteria:

* allergy to dexmedetomidine
* AV block or bradycardia
* being serious cardiac - liver - kidney function disorders
* Being coagulopathy
* neuropathy in the upper extremity
* adrenoceptor agonists or antagonists use
A Study of AZD4901 in Females With Polycystic Ovary Syndrome

To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome


Eligibility Criteria:
Inclusion Criteria:

Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined as ≤ 6 menses per year). Negative serum pregnancy test at screening. Negative urine pregnancy test before randomisation. Not be breast-feeding. Not have been pregnant within the 6 months prior to screening.

Exclusion Criteria:

Perimenopausal or reached natural menopause, defined as FSH \> 10 IU/L. Menstruated within the month prior to the baseline visit. Hysterectomy or bilateral oophorectomy or both. Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding.

Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit.
Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

RATIONALE: Understanding how oxaliplatin affects hearing loss, dizziness, and peripheral neuropathy may improve the ability to plan effective treatment for patients receiving oxaliplatin for solid tumors.

PURPOSE: This clinical trial is studying hearing loss and dizziness in patients receiving oxaliplatin for solid tumors.

OBJECTIVES:

* Define the prevalence of audiometrically detectable hearing loss in patients with solid tumors treated with oxaliplatin.
* Describe the association of chemotherapy-induced peripheral neuropathy (CIPN) and audiometrically detectable hearing loss in these patients.
* Describe the association of CIPN and patient self-reported scales including, Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory.

OUTLINE: This is an exploratory study.

Patients will complete three self-reported questionnaires including the Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. Patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. Patients will also undergo a hearing test.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of solid tumor

  * Received an oxaliplatin-containing chemotherapy regimen within the past 15 months\* NOTE: \*If oxaliplatin was omitted from the patient's most recent chemotherapy regimen due to ototoxicity, the patient is still eligible for participation in this study
* No known CNS metastases

PATIENT CHARACTERISTICS:

* No history of spinal injuries
* ECOG performance status 0-3
* No history of chronic renal failure
* No known HIV/AIDS

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Trial of ZL-1201 in Subjects With Advanced Cancer

First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer

This is a first-in-human, dose escalation trial of ZL-1201. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists.
* Adequate hematologic status
* Adequate coagulation function
* Adequate hepatic function
* Adequate renal function

Exclusion Criteria:

* Known active brain metastases
* Red blood cells transfusion dependence
* Known cardiopulmonary disease
* Pregnant or breast-feeding females
* Any other serious underlying medical
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
* Subjects with treatment-naïve ROP classified according to the International Classification for ROP in at least one eye as:

  * Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
  * Zone II Stage 2 plus or 3 plus, or
  * Aggressive posterior retinopathy of prematurity (AP-ROP)
* Weight at baseline (day of treatment) ≥ 800 g
* Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Known or suspected chromosomal abnormality, genetic disorder or syndrome
* Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
* Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure)
* Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist
* Presence of active ocular infection within 5 days of the first treatment
* Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
* ROP involving only Zone III
* Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
* Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone ≥ 1 mg/kg/day for \> 2 weeks within 14 days of the first study intervention
* Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
* Participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer
An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive Disorder

The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression Rating Scale.

To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

* Total score of less than 24 on the MADRS.
* HAM-D total score less than 18.
* Duration of the current depressive episode less than 1 month or greater than 2 years.
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, MAOIs within 2 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate
A Novel Transition Program to Reduce Disability After Stroke

This study evaluates a program designed to help individuals transition home from inpatient rehabilitation following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.

A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity. The proposed study investigates the efficacy and safety of a novel enhanced rehabilitation-transition program to reduce environmental barriers and improve daily activity performance and community participation.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥50 years
* acute ischemic or hemorrhagic stroke diagnosis
* independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤2)
* plan to discharge to home

Exclusion Criteria:

* severe terminal systemic disease that limits life expectancy to \< 6 months
* previous disorder (e.g. dementia) that makes interpretation of the self-rated scales difficult or Short Blessed Test (SBT) score of 10 or less (indicating significant cognitive impairment)
* moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
* reside in congregate living facility.
Effect of 5% Aqueous Propolis in Salivary and Dental Plaque pH in Children

This study aims to investigate the changes in saliva and dental plaque pH after consuming sugar-free chewing gum containing 5% of aqueous propolis in children aged between 8-11 years. The studied sample will be divided into two groups: Group A (Control group) placebo chewing gum, and Group B (Experimental group) aqueous propolis chewing gum. All children will experience both types of chewing gum with an interval of 1 week between the two studied groups.

This study will evaluate saliva and dental plaque pH after consuming 10% sucrose solution and then each child will test each of the two types of gum (aqueous propolis 5% and placebo gum) so that the child himself is the control and tested sample together, according to the following order:

* In the first visit: the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing one of the two types of gum, and after giving the sucrose solution).
* In the second visit: after a week, the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing the other types of gum, and after giving the sucrose solution).)

Eligibility Criteria:
Inclusion Criteria:

1. Children have mixed occlusion.
2. Integrity of the buccal surfaces of the reference teeth (16, 21, 26, 36, 41, 46) from caries and developmental disorders
3. Children with DMFS ≥5 according to WHO guidelines and standards.

Exclusion Criteria:

1. Systematic or mental disorders
2. Medications that may affect the salivary flow rate or composition.
3. Allergy to natural sugar substitutes.
4. Children who wear fixed or removable orthodontic appliances.
5. Children who have the habit of daily use of sugar substitute products.
Safety of EUS-FNA for Pancreatic Solid-Pseudopapillary Neoplasm (SPN) Before Surgical Resection: the SPN-GRAPHE Series

Solid-pseudopapillary neoplasm (SPN) is a rare type of pancreatic neoplasm. A cytopathological diagnosis is often mandatory before performing surgical resection. Endo-ultrasonography with fine needle aspiration (EUS-FNA) improve significantly pre-operative SPN diagnosis accuracy. So far, few EUS-FNA performed for SPN were published, and safety of EUS-FNA for SPN has never been investigated. This retrospective European multicenter case-control study compared the recurrence rate in patients with and without EUS-FNA performed before primary tumor resection.

This European multicenter study was conducted in 22 digestive units from the GRAPHE (French taskforce of gastroenterologists working on digestive endoscopy: Groupe de Réflexion et d'Action des Praticiens Hépatogastroentérologues en Endoscopie Digestive), and retrospectively included all patients who have undergone complete resection of their pancreatic SPN from 2000 to 2018. The use of the diagnostic filing software of each unit of cytopathology, endoscopy and digestive surgery allowed the completeness of the prospection in each center.

The data were retrospectively collected by extraction from our medical patient management softwares.

The following data were collected: age, gender, symptoms, tumor size, tumor location (uncus, head, isthmus, body or tail of the pancreas), presence of tumor calcifications, performing of a EUS-FNA for diagnostic purposes before surgical resection, follow-up, and diagnosis of recurrence of the SPN during follow-up. Other data were collected in case of EUS-FNA: path of the needle puncture (transgastric or transduodenal), diameter of the needle, number of passes, immediate EUS-FNA morbidity, and EUS-FNA diagnosis of SPN (certain, probable, false or absent).

Patients with and without initial EUS-FNA were compared and the main criteria of this study was determinate: the presence of recurrence of the SPN during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients who have undergone complete resection of their pancreatic SPN were included. Inclusion criterion was the definite diagnosis of SPN on the pathological examination of the complete tumor resection specimen.

Exclusion Criteria:

* No
Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.

The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400 mg.

In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.

Eligibility Criteria:
Inclusion Criteria

Blinded study:

* Women age 18 and over
* Diagnosed with Interstitial Cystitis as defined by protocol
* Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
* Able to comply with visit schedule and diary completion at home

Open-label Extension:

* Must have completed the blinded study prior to screening for the Open-label extension

Exclusion Criteria (Blinded and Open-Label Extension):

* Pregnant or lactating women
* History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
* Bladder or urethral abnormality that would prevent safe insertion of investigational product
* Requiring medication not allowed per study protocol
Warning Labels and College Students' Sugar-Sweetened Beverage Intake

Sugar-sweetened beverages (SSBs) are one of the few dietary items causally linked to the development of obesity and chronic disease. SSB consumption among young adults are particularly concerning, because of the high levels of consumption and the influence of disease risk in later life. College students, particularly freshmen, are a captive audience when it comes to dietary consumption because many of them consume their meals in residential dining halls. We are currently working with Michigan Dining to implement warning labels on SSB fountain dispensers to examine whether carefully tailored signage could alter beverage choices of college students. The current study aims to assess changes in dietary intake before and after the labels are posted, in a representative sample of University of Michigan students who eat at residential dining halls.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled student at the University
* Visited one of three large dining halls at least 100 times in the first 1.5 months of the academic year

Exclusion Criteria:

-
Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries

This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.

Pneumonia is the leading infectious cause of death in children under five. World Health Organization guidelines recommend measurement of peripheral oxygen saturation (SpO2) in children with pneumonia to guide treatment. This project focuses on the design of a new 'Lifebox' pulse oximeter probe for use in children 0-5 years of age.

A new oximeter probe compatible with the Lifebox oximeter has been designed to be used for children 0-5 years in all settings.

The aims of the study are to:

1. to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user
2. to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications.
3. to compare the usability of the redesigned oximeter probe to a market leading probe

Eligibility Criteria:
Inclusion Criteria:

Patient participants:

* Inpatients (or child awaiting surgery on pre-operative ward) in Great Ormond Street Hospital, or government facilities in Malawi and Bangladesh
* Aged 0 - 59 months
* Clinically stable (as judged by the ward sister and medical team)
* Parent (or adult with parental responsibility) present
* Informed consent from the parent (or adult with parental responsibility)

Healthcare worker participants:

* Nursing staff employed at Great Ormond Street Hospital who are trained in the use of pulse oximetry or government healthcare providers working in Malawi and Bangladesh
* Written informed consent from the healthcare worker

Exclusion Criteria:

Patient participants:

* Unstable or critically unwell patients (as judged by their medical team)
* Parents (or adult with parental responsibility) who are not able or willing to give informed consent
* Parents (or adult with parental responsibility) unable to speak English well enough to understand study methods or consent form (UK only)
* For part of the study assessing usability of the probe by healthcare workers, patients with oxygen saturation 95% or below will be excluded

Healthcare worker participants:

* Healthcare providers who are not trained to use a pulse oximeter
* Healthcare providers who have not given written informed consent