cyrilzakka/clinical-trials huggingface dataset:
High Throughput Screening Device Based on 3D Nano-matrices and 3D Tumors With Functional Vascularization

Almost 85% of new therapeutic molecules are abandoned before the clinical trial stage. Most of these failures currently concern cancer therapies.

In order to optimize the development of these molecules and allow the development of precision medicine, an innovative screening device that is as close as possible to in vivo is necessary.

For this reason, the platform the investigators are setting up takes into account tumor vascularization as well as the 3D microenvironment.

The platform the investigators intend to set up is based on 4 cornerstones:

* the formation of patient-derived organoids seems to be the best option to take into account the microenvironment and cellular interactions.
* the vascular network: the formation of a peri-tumoral vascular network, either by using HUVECS cells or by using endothelial cells from the patient.
* the extracellular matrix, and the set of proteins it contains, is a major element of in vivo interaction. Moreover, the presence of a matrix is a key element for the development of vascularization in vitro.
* Functional tumor microenvironment: peri-tumor vascularization is necessary but not sufficient to claim to recreate a tumor microenvironment. It must be functionalized, and this implies the use of a microfluidic system.

This ready-to-use platform will be used on tumor biopsies of the patient, to constitute a tool for personalized medicine. This could even be a future component of decision at multidisciplinary board meetings.

The main objective of our research is the constitution of organoids derived from the patient in order to select, via a screening device, the best anti-tumor therapy to administer to the patient.

A secondary objective is to collect lymphocytes from the patient's blood in order to test the effectiveness of therapies mediated by the immune system (immunotherapy).


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years old
* Patient with non-small cell bronchopulmonary cancer (NSCLC), at any stage, undergoing surgery in the Thoracic Surgery Department of the New Civil Hospital, Strasbourg.
* Patient who agreed to participate in this observational study.
* Patient affiliated to a social security system

Exclusion Criteria:

* Refusal to participate in the study
* Known hepatitis, known HIV
* Subject under safeguard of justice
* Subject under guardianship or trusteeship
* Inability to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject)
* Pregnant Women
Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.

This pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environments. The treatment intervention duration is 42 days during which time supplemental analgesic medication (usual analgesic care) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility Criteria:
Inclusion Criteria:

* residing in a nursing home, assisted living environment, or any type of supervised living situation in which the principal investigator maintained primary responsibility for the analgesic management of the resident.
* chronic pain of musculoskeletal origin who had been managed with short-acting opioids.

Exclusion Criteria:

* taking \>90 mg oral morphine sulfate per day (during any single day) or \>50 mcg/hr of transdermal fentanyl or its equivalent.
* activity restricted totally to bed rest.
* have cancer-related pain.

Other protocol-specific exclusion/inclusion criteria may apply.
Supportive Care for Patients Newly Diagnosed With Lung Cancer

The aims of this project are to assess the feasibility of recruiting patients and delivering a nurse-led telephone based palliative care intervention for patients with newly diagnosed lung cancer and to assess if among patients with newly diagnosed lung cancer, the investigators can estimate the effect of a nurse-led telephone based palliative care intervention on quality-of-life, symptom burden and patient satisfaction.

Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcomes measures will be collected at baseline, and 3 months.

The study will be performed at the VA Puget Sound Health Care System. The investigators will recruit individuals (n=40) with lung cancer over 1 year. The primary objective is to test the feasibility and acceptability of the intervention, and recruitment of subjects. The investigators will estimate the effect of a nurse-led telephone based palliative care intervention to improve quality-of-life, symptom burden and patient satisfaction. In addition, using validated instruments, the investigators will assess the potential effect size of the intervention on quality of provider communication and on clinician knowledge of patient preferences for life sustaining therapies. The results of this pilot study will inform a future randomized clinical trial to test the efficacy of the intervention on a larger scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed at the Puget Sound Health Care System with a primary diagnosis of lung cancer,
* any cell type or stage,
* diagnosed within 8 weeks of study enrollment.
* Must have telephone access,
* ability of understand English and
* provide informed consent.

Exclusion Criteria:

* Patients not eligible to participate in the study include those who are inpatients prior to randomization,
* those who are under the care of palliative care or hospice at the time of randomization,
* those who have severe mental health disorders,
* those who are unable to speak directly with the nurse over the telephone,
* or those that have the inability to provide informed consent. Investigators will recruit individuals (n=40) with lung cancer over a 12 month period.
Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior

To evaluate the effectiveness of an online educational course on Alzheimer's disease (AD) prevention, treatment and caregiving.

Alzheimer's Universe (www.AlzU.org) was created to provide online education about Alzheimer's disease (AD), with a focus on family members of people with AD, people with mild cognitive impairment due to AD and mild AD, caregivers, healthcare providers, medical students, college students and high school students. The website provides evidence-based courses with interactive lessons and activities that have been shown to increase knowledge about AD, willingness to participate in an AD prevention clinical trial, and intent to make specific lifestyle changes in effort to reduce AD risk.

Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 14 years old with a friend, family member or acquaintance with Alzheimer's disease or memory loss, OR a person diagnosed with mild memory loss (including mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease), OR an AD caregiver, OR healthcare providers, OR a medical student, college student or high school student.

Exclusion Criteria:

* \< 14 years old, OR diagnosis of moderate or severe Alzheimer's disease
Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage

Objective: To explore the predictive value of characteristic disorder of intestinal flora for clinical prognosis in patients with intracerebral hemorrhage. Secondary objectives: 1) To investigate the correlation of gut microbiota and its serological indicators with imaging features and clinical neurological deficits in ICH; 2) Dynamically observe the changes of human microbiome and its serological indicators after ICH, and explore the biomarkers based on human microbiome related to disease changes.

Spontaneous intracerebral hemorrhage has brought a heavy burden to society and families. Finding biomarkers closely related to the condition of intracerebral hemorrhage is an important research direction for the prevention and treatment of intracerebral hemorrhage. However, there are few studies on the correlation between cerebral hemorrhage and microbiota. Our previous small sample study found that there were intestinal flora and SCFAs metabolism disorders in patients with hypertensive cerebral hemorrhage, and the latter was significantly related to poor prognosis. These results suggest that gut microbiota and its metabolites may become prognostic predictors and therapeutic targets for patients with intracerebral hemorrhage. However, more research evidence is still needed to confirm. Therefore, this study hypothesized that oral or intestinal flora in patients with acute cerebral hemorrhage has a certain degree of disorder and dynamic changes, accompanied by changes in serum markers, and there is a potential relationship between the changes of some microbiota-related markers and the severity and outcome of cerebral hemorrhage. Therefore, this topic proposed collection in patients with acute cerebral hemorrhage oral swabs, blood and feces or anal swab specimens, evaluate the neurological function score, imaging features and clinical outcomes, and to establish a follow-up queue, the dynamic change of cerebral hemorrhage patients after intestinal bacterial flora and condition and poor prognosis, the correlation of biomarkers new prediction and prevention of brain hemorrhage, To improve the effectiveness of prevention and treatment of cerebral hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

1. It meets the diagnostic criteria for acute ischemic stroke
2. Age ≥ 18 years
3. The onset time is less than or equal to 2 weeks
4. Diagnosis of cancer before stroke onset or during hospitalization and active cancer (failure to meet clinical criteria for cure, or discovery of recurrence or metastasis)
5. Sign an informed consent form, provide relevant medical history information and provide biological specimens

Exclusion Criteria:

1. Previous history of disabling stroke (pre-onset mRS ≥2)
2. Primary central nervous system tumor or hematologic system tumor
3. The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
4. Antibiotics, prebiotics/probiotics taken within 1 month
5. Patients who cannot have stool specimens within 4 days of admission
Treatment Outcomes of Vaginal Prolapse Repair

Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital.

Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital. Preoperative, intraoperative and post-operative data will be collected from the hospital and physician medical records. A questionnaire will be mailed to patients whose charts have been reviewed to assess urinary and bowel function, satisfaction with treatment and changes in sexual function. Completion of the questionnaire is voluntary.

Eligibility Criteria:
Inclusion Criteria:

* Women having Prolift repair at William Beaumont Hospital

Exclusion Criteria:

* None
Optimizing the Obstetrician's Movement During a Simulated Forceps Operative Vaginal Delivery (PERFORMAC)

Operative vaginal delivery is the main risk factor for pelvic floor trauma occurrence and especially for obstetric anal sphincter injuries. These complications are strongly and negatively impact women's health: fecal incontinence, perineal pain, sexual dysfunction.

The risk appears higher in case of operative vaginal delivery assisted by forceps compared to a vacuum delivery. This considered it is likely that optimizing the performance of the operator that perform the operative vaginal delivery will reduce the morbidity associated with this intervention. There are data bout how to optimize the placement of the forceps on the fetal head before performing the delivery but there are no data about the movement of the obstetrician during this intervention.

The objective is to analyse the posture and the movement of the obstetrician during a simulated forceps operative vaginal delivery using a 3D cinematic analysis. Secondary objectives are to analyse the traction force applied on the forceps during the delivery, to describe the different postures in terms of stability and last to compare the self-declared practice to the objectively observed.

This is a prospective study including 40 volunteers (medical doctors and registrars).

Each volunteer will perform a simulated operative vaginal delivery using a Suzor's Forceps on a high fidelity mannequin. Postures and movement will be assessed using optometric analysis. The force of traction will be assessed during the operative delivery thank to a force sensor on the forceps. The self declared practice collected thanks to individual questionnaires will be compared to the observed practice during the simulation.

The prospects are to identify the best posture and movement for performing an operative vaginal delivery and to promote tools for simulation of medical students.


Eligibility Criteria:
Inclusion Criteria:

* Medical doctor or registrar that have an experience of operative vaginal delivery using forceps in their clinical activity

Exclusion Criteria:

* No practice of the forceps at all
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.

In the VIVALL.2 study, 104 patients with severely degenerated biological aortic surgical valve accepted for vave-in-valve procedure (transcatheter aortic valve implantation) will be randomized to be treated with the self-expandable supra-annular Allegra or the balloon-expandable intra-annular Edwards systems. The primary end-point will be trans-aortic mean gradient determined by trans-thoracic echocardiography at 30 days. The proportion of patients with moderate or severe prosthesis mismatch at 30 days will be a secondary end-.point. Different countries will participate in the study.

Eligibility Criteria:
Inclusion Criteria:

Patients meeting ALL the following criteria will be included:

* Patients aged ≥ 18 years.
* Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \< 1.0 cm2) and/or severe valve regurgitation.
* The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease.
* Heart team decision of VIV procedure.
* Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.

Exclusion Criteria:

Patients meeting, at least, 1 of the following criteria will be excluded:

* Patients who openly express their refusal to participate in the study.
* Female patients in gestational age.
* Presence or suspicious of biological aortic valve thrombosis.
* Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
* Ongoing sepsis and/or suspicious or diagnosis of endocarditis.
* Patients whose life expectancy is \< 1 year due to non-cardiac comorbid conditions.
* Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.
* True inner diameter of the prosthetic valve \> 27 mm.
* Transfemoral access inadequate to accommodate an 18F sheath.
* Patients included in other clinical trials (excluding registries).
Spine Patient Outcomes Registry for Biomet/EBI (Electro-Biology, Inc)

The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.

A patient registry to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.

Eligibility Criteria:
Inclusion Criteria:

N/A

Exclusion Criteria:

N/A
Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

The aim of this controlled randomized crossover study is to compare the physiological effects of nasal high flow therapy (NHF) with 2 different nasal cannulas in patients with exacerbated chronic obstructive pulmonary disease (ECOPD) and chronic respiratory failure.

20 patients will be treated with NHF therapy (Airvo, Fisher\&Paykel Healthcare, NZ) during wakefulness. Physiological measuremends will take place over three perdiods (visits). One period without NHF, one with NHF via standard cannula (Optiflow M) and one with asymmetrical cannula (Optiflow Duet) in randomised order.

Background: Nasal High Flow (NHF) therapy had shown to increase airway pressure, reduce dead space, and improve mucociliary clearance and gas exchange in patients suffering from chronic obstructive pulmonary disease (COPD). The long-term and short-term physiological aspects of NHF are subject of ongoing research. Different flow rates and cannula sizes have been studied and found to yield different therapeutic effects. Larger sized cannulas tend to seal the nares and produce increased positive airway pressure, while smaller cannulas increase the washout effect. Currently, a new cannula is available, with one smaller and one larger opening (Optiflow+ Duet, Fisher\&Paykel Healthcare, NZ).

Procedure: Following a baseline period without high flow therapy, NHF (35L/min) will be applied via the nasal cannula (Duet or Standard in randomized order). After a wash out phase, the NHF interface will be replaced for another measurement with the respective other cannula (Standard or Duet).

Respiratory rate, tidal volume, minute ventilation, inhalation to exhalation ratio (Ti/Te), transcutaneous pCO2 and intercostal EMG will be recorded during each partial measurement.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with COPD GOLD 3 and 4 in stable phase after acute exacerbation
* Inpatients with COPD GOLD (2, 3 and 4)
* Informed Consent

Exclusion Criteria:

* Acute respiratory insuffiency with respiratory acidosis (pH\<7.35)
* Severe acute physical disease, that do not allow the subject to participate in a clinical trial
* Language, cognitive, or other barriers that make study participation impossible
* Pregnancy or Nursing
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
* At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL
* Intact Uterus

Exclusion Criteria:

* Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
* A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.
Impact of Platinum-based Cancer Treatment on Endothelial Function

In this research we investigate endothelial function in cancer patients who received platinum based chemotherapy.

The goal of the study is to evaluate endothelial function in patients with platinum-based versus non-platinum-based chemotherapy.

Endothelial function was evaluated via Angioscan( the apparatus that evaluate the stiffness of vessels by pulse wave velocity) and serum levels of endothelial nitric oxide synthase (ENOS),endothelin1.

Patients with gastrointestinal, ovarian, bladder and brest cancer would be included.

Patients with malignancies were followed-up from 2 weeks to 3 month after start of chemotherapy, Medical records and hospital databases were searched for all the patients treated with different chemotherapy treatment for any kind of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subject has solid cancer
* Subject is expected to start chemotherapy

Exclusion Criteria:

* Pregnancy and lactation
* Severe impaired kidney function
* Severe hepatic impairment
* Mental disease
* Acute myocardial infarction 28 days ago or earlier
* Acute Cerebrovascular Event 1 month ago or earlier
* Rhythm disturbance that complicate pulse wave velocity evaluation
Non Invasive Breath Based Acetone-meter- Easy Check

Segment 1- this segment will include two main steps:

Step 1-Calibration: During this step we plan to collect paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary blood glucose will be measured using the invasive reference method. The paired reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will convert the acetone values measured by study device to blood glucose values.

step 2-Validation: During this segment the second step of this segment we plan to evaluate the validity and reliability of the non-invasive breath-based glucometer compared to standard invasive reference glucometer. Results will be compared using a Clark error grid.

Segment 2- During this segment we plan to collect paired measurements of capillary blood glucose beta Hydroxybutyrate using reference method and acetone values generated by the non invasive breath based study device. Samples will be obtained at specific time points during 4 hours after overnight fasting, while basal insulin will be suspended, which is accepted to produce ketosis.


Eligibility Criteria:
Inclusion Criteria:

* Signing an inform consent form
* Type 1 diabetes diagnosed at least 12 months prior to study inclusion
* Males aged \> 18 years old
* 23\< BMI \< 28 (segment 1 only)
* Treatment with insulin pump (segment 2 only)
* Willing to perform all study related procedures

Exclusion Criteria:

* Psychiatric disorder
* Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
* Patients who are not willing or are not capable of performing the protocol requirements
* Participating in another study that includes investigational drug or investigational equipment
* Patients who are under low carbohydrate diet
* Patients who are known as heavy alcohol drinkers