cyrilzakka/clinical-trials huggingface dataset:
EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)

The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA).

NSCLC is a common cancer. Accurate and early staging has a significant impact on outcome. EBUS-TBNA of involved mediastinal lymph nodes is critical. Molecular markers could improve mediastinal staging.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Samples are collected before surgery or before any therapy
* ECOG 0 or 1
* Clinical stage I-II, T1-2, N0-1, M0)
* Surgically respectable
* Patient with enlarged med. lymphnodes (control group)

Exclusion Criteria:

* Previous RT/CHT
* Previous or current cancer of other entity
Effect of Four Exercises on the Inter-recti Distance in Women

Diastasis rectus abdominis (DRA) is defined as an excessive separation between the two abdominal rectus muscles. It is generally quantified by the inter-recti distance. In postpartum women, the prevalence of diastasis is 60% six weeks after delivery.

The increase in the inter-recti distance has been associated with a decrease in strength and endurance of the trunk flexors and rotators (p \< 0.05). Exercise during pregnancy has been shown to be helpful in the treatment of DRA. Nevertheless, there is still not strong evidence to establish what kind of exercise should be recommended during pregnancy and in postpartum.

The aim of this study is to compare the morphological and functional changes of the linea alba during four exercises.

Inter-recti distance, linea alba thickness and distortion index will be measured at rest, as well as during 4 exercises (draw in maneuver, crunch, pelvic floor muscle contraction and a "de Gasquet" exercise). Subgroup analysis will be performed to determine if the presence or absence of an abdominal diastasis has an influence on these outcomes.

A cross-sectional pilot study will be carried out. The main outcome measure will the inter-recti distance. Secondary outcomes will be the thickness of linea alba and distortion index.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Parous
* Women
* Accepting to participe in the research

Exclusion Criteria:

* Under curatorship
* Persons deprived of their liberty by judicial or administrative decision
* Having intellectual limitations that may limit the understanding of questionnaires or exercises
* With limitations in understanding the French language
* Pregnant women
* History of pelvic / spine fractures
* History of pelvic surgery
* History of spinal surgery
* History of abdominal surgery
* History of lower limbs weakness, changes in osteotendinous reflexes or loss of sensitivity
Patterns and Outcomes of Neurosurgery in England Over a Five-year Period

Neurosurgical practice has seen many important changes over several decades with advances in treatments and the types of patients treated. Neurosurgical procedures have evolved, and as outcomes have improved the number of patients being treated has increased.

There are no recent evaluations of national neurosurgical practice in the United Kingdom (UK), with the last prospective cohort studies being Safe Neurosurgery 1993 and Safe Neurosurgery 2000. More recent studies of neurosurgical services have been based on data from single institutions or surgeons and these may not give a representative picture of practice nationally.

Recent national quality improvement programmes for neurosurgery in England (such as the National Neurosurgical Audit Programme (NNAP) and Cranial Neurosurgery and Spinal Surgery Getting It Right First Time (GIRFT) Programmes) have focused on using national hospital administrative datasets. To be effective, quality improvement initiatives require robust outcome measures and quality (process) indicators. Currently, there is a lack of validated quality indicators for neurosurgery, with practice often being described using generic measures such as readmission and reoperation rates and length of stay. Many studies have been able to derive these common outcome measures, but it may also be possible to produce indicators specific to neurosurgery.

The aim of this observational study was firstly to describe the current pattern of neurosurgical admissions and procedures in England, and thereby given an overview of the epidemiology of neurosurgical patients. Secondly, it aims to investigate the range of outcome measures that might be produced from hospital administrative data and use these to assess the quality of care in neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

* All admissions to neurosurgical units in the National Health Service (NHS) in England.

Exclusion Criteria:

* Records with poor quality data (e.g. no data for clinical diagnoses).
* Patients under 18 years that were admitted to an adult neurosurgical unit.
Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food

The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects entered are planned to be included in this comparison.

The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison.

An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.


Eligibility Criteria:
Inclusion criteria:

healthy male and female subjects
Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry

A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set. Data will be compared with a similar population (weighting 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.

This study aims to compare patient outcomes after treatment with HF20 based CRRT to the historical ppCRRT registry. Data from eligible patient records will be collected, starting from January 2008 to most recent in Canada and from January 2020 to most recent in the US.

The ppCRRT registry used a prospective observational format whereby de-identified data on patients and CRRT circuits were collected from 13 participating centers across the US between 2001 JAN 01 and 2005 AUG 31. The registry's primary outcome measure was patient survival to ICU discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Patient weighed between 8 and 20 kg (17.6 - 44.1 lb).
2. Patient received medical care in an intensive care unit (ICU) and was treated with HF20 based CRRT.
3. Patient had a clinical diagnosis of AKI or ARF or fluid overload requiring CRRT.

Note: The cohort of patients treated with M60 sets from the ppCRRT registry (weighing 8 - 20 kg) are to meet inclusion criteria 1 and 3.

Exclusion Criteria:

There are no exclusion criteria for this study.
Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)

This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).


Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 45 years of age with uncontrolled systolic hypertension measured by office cuff and by an ambulatory blood pressure monitoring device
* Willingness to be taken off any current antihypertensive treatment to be placed on hydrochlorothiazide in combination with study medication.

Exclusion Criteria:

* Any significant history, systemic illnesses, or medical condition(s) that could lead to difficulty complying with the protocol or that could confound interpretation of the data.
Monitoring and Testing of Blood Pressure in Postpartum Women

The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high BP, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high BP can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote BP after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor BPs without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their BP remotely after delivery found out that this was both possible and acceptable.

This is a randomized control trial (RCT). All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, NC that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART- BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit". This nurse home visit occurs via phone call, telehealth visit, or an in person visit \~2 weeks after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Women that received prenatal care at one of the Atrium Health Wake Forest Baptist OB/MFM outpatient clinic locations in Forsyth County, NC
* Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist
* Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center
* Currently resides in Forsyth County, NC
* 18 years of age or older
* Able to read and understand either English or Spanish
* Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Exclusion Criteria:

* Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
* Resides outside of Forsyth County, NC
* Under 18 years of age
* Unable to read or understand either English or Spanish
* Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
Transgender Cohort Study of Gender Affirmation and HIV-related Health

This observational research study will evaluate medical gender affirmation delivered in primary care as an intervention to reduce disparities in HIV-related outcomes (e.g., low rates of PrEP uptake for HIV-uninfected patients, high rates of viral suppression for HIV-infected patients) for transgender patients in two urban federally-qualified community health centers.

This observational, longitudinal prospective cohort study will evaluate whether medical gender affirmation delivered in primary care improves HIV-related outcomes for transgender patients. Medical gender affirmation therapies-hormones and surgical interventions-are medically necessary treatments shown to improve psychological functioning and quality of life for transgender patients. It is not yet known whether these treatments improve HIV-related outcomes over time because studies providing the best evidence of medical gender affirmation's clinical effectiveness do not examine HIV-related outcomes in transgender adult patients. To fill this gap, the proposed study will prospectively evaluate the effects of medical gender affirmation delivered in primary care on HIV-related outcomes in a multi-site clinic-based cohort of 4,500 diverse transgender patients from two urban U.S. health centers who are leaders in transgender healthcare. Transgender adult primary care patients at Fenway Health in Boston, MA and Callen-Lorde Community Health Center in New York City, NY will be enrolled over 12 months and followed prospectively for 12 months. Bio-behavioral data will be linked, including electronic patient-reported outcomes (baseline, 6-month, 12-month assessments), and electronic health record (EHR) data.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Have a gender identity differing from their assigned sex at birth (verified at screening via two-step method cross-categorizing natal sex and gender identity);
* Current or new primary care patient at Fenway Health or Callen-Lorde Community Health Center (primary care patients are defined as those who had at least one medical visit in a 12-month period);
* Able to read, speak, and understand English and/or Spanish;
* Willing and able to provide informed consent.

Exclusion Criteria:

* Under 18 years of age;
* Unable to read, speak, and understand English and/or Spanish;
* Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of consent.
Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer

A biobank of Serum, plasma, DNA samples together with clinical information including specific questionnaires, complete pulmonary function and chest CT-scan, is prospectively collected in patients seen at the investigators' clinical service.

The objective is to study candidate gene pathways in COPD and or lung cancer and to associate them with the clinical characteristics and phenotypes of COPD/emphysema and lung cancer.

In subgroups of well characterised patients, other biological materials are also collected (lung tissue biopsies, peripheral blood mononuclear cells).

All patients with a smoking history of at least 15 pack years, an minimal age of 50 years and an recent available CT scan are enrolled.

All subjects with a diagnosis of lung cancer are also collected (irrespective of age and smoking behavior).

In addition the investigators collect:

* specific questionnaires (MRC, CCQ and smoking history)
* medical and professional history
* complete pulmonary function (spirometry, bodyplethysmography and diffusing capacity)
* serum, plasma and DNA samples.

In specific subgroups the investigators also collect:

* Peripheral blood mononuclear cells
* Lung tissue - if available - from a surgical procedure (lung transplantation or lobectomy)

Eligibility Criteria:
Inclusion Criteria for smokers:

* A smoking history of at least 15 pack years and age of 50 years or older
* Complete pulmonary function on day of visit
* Chest CT-scan within one year of enrollment
* 4 weeks from exacerbation

Exclusion Criteria for smokers:

* Less than 15 pack years
* Younger than 50 year
* Other pulmonary diseases interfering with CT or pulmonary function
* Asthma

Inclusion Criteria for lung cancer patients:

* new diagnosis of proven lung cancer
* chest CT scan within 2 months of enrollment
* Complete pulmonary function

Exclusion Criteria for lung cancer patients

* not able to perform pulmonary function
* Absence of histological diagnosis of lung cancer
Medico-economic Evaluation of Management Strategies for Severe Epistaxis

Current recommendations consider surgical ligation and supra-selective embolization as equivalent in terms of efficacy and there is no clear consensus to choose between one and the other technique. In the absence of medico-economic studies, these recommendations could not be based on any differences in efficiency between the two techniques. The management of patients with severe non-traumatic epistaxis remains controversial and varies according to the hospital and/or university centers. In practice, the use of one or the other technique depends on the habits of each reference center.

The hypothesis is that early ligation of the sphenopalatine arteries would reduce the costs of care for the community while improving the quality of life of patients compared to supra-elective embolization.

This medico-economic superiority could go through:

* reduction in the number of recurrences
* reduction in the length of hospital stays.
* reduction in the cost of postoperative care.
* reduction of iatrogenic complications
* improvement of functional suites upon return home.
* Tertiary prevention of dependency, particularly among the elderly

Eligibility Criteria:
Inclusion Criteria:

* Patient with severe epistaxis who failed treatment with double tamponade for more than 48 hours.
* Patient over 18 years old
* Affiliated patient or beneficiary of a social security scheme.
* Patient accepting the principle of randomization
* Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patient with epistaxis secondary to facial and/or surgical trauma.
* Patient with epistaxis related to a malignant tumor cause
* Patient with a history of ligation or embolization
* Patient under legal protection and/or curatorship and/or guardianship.
* Impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health.
* Patient participating in another research including an exclusion period still in progress
* Pregnant or breastfeeding patient

For non randomized patient

* Patient with a contraindication to general anesthesia: severe and/or decompensated cardiac/hepatic/renal insufficiency, ASA score 4
* Severe hemostasis disorders that cannot benefit from correction.
* History of transient and/or definitive stroke of the ischemic type
* Atheromatous overload
Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

The purpose of this expanded access protocol is to provide access to trilaciclib for chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for small cell lung cancer (SCLC).

Patients will receive trilaciclib intravenously as a 30-minute infusion prior to chemotherapy dosing and on each day that chemotherapy is administered.

Supplementary to providing access to trilaciclib, this expanded access program will also capture Real World Data to help inform subsequent trilaciclib development.

Requests for access to trilaciclib will be managed by Bionical Emas. G1 Therapeutics will review eligibility of, as well as complete a medical review of, each patient access request.


Eligibility Criteria:
Inclusion Criteria:

* Patients who require treatment with either intravenous etoposide + platinum (carboplatin or cisplatin) ± an anti-PDL1 or anti-PD1 checkpoint inhibitor OR intravenous topotecan
* Pathologically confirmed diagnosis of SCLC
* Extensive-stage or limited-stage SCLC; patients with limited-stage SCLC receiving chemotherapy with concurrent radiation are NOT eligible.
* Age ≥ 18 years
* ECOG 0 to 2
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L at time of initiation of therapy in this EAP
* Platelet count ≥ 100 x 10\^9/L at time of initiation of therapy in this EAP
* Glomerular filtration rate (GFR) of ≥ 20 mL/minute at time of initiation of therapy in this EAP
* Total bilirubin ≤ 1.5x ULN (upper limit normal) at time of initiation of therapy in this EAP
* AST or ALT ≤ 2.5x ULN (≤ 5x ULN in the presence of liver metastases) at time of initiation of therapy in this EAP
* QTcF interval ≤ 450 msec (males) or ≤ 470 msec (females) at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF ≤ 500 msec
* No personal or family history of long QT syndrome
* Female patient is not lactating or currently pregnant, or plans to become pregnant, while participating in this expanded access program
* Female patients of reproductive potential agree to use effective contraception while in the program and for at least 3 weeks after the last dose of trilaciclib
* Patient agrees not to participate in another expanded access program or clinical trial with an experimental treatment during participation in this EAP
* Active clinical trial with trilaciclib is not available (or if available, it is not appropriate) for the patient

Exclusion Criteria:

* Patients requiring treatment with oral etoposide or oral topotecan
* Patients outside of the United States
Comparison of Three Different No-contact Pachymetries

Study wants to compare central corneal thickness (CCT) obtained through 3 different no-contact instruments and to compare them with contact ultrasound pachymetry, actually the gold standard technique.

Corneal pachymetry is the measurement of corneal thickness, usually expressed in microns (μ).

Pachymetry is systematically used for the monitoring of corneal oedema, for the management and assessment of the progression risk of the ocular hypertension, for the diagnosis, the management and follow-up of keratoconus, as well as it is important in the pre and postoperative management of corneal surgical procedures. CCT is a factor well known to influence tonometry. Its assessment is fundamental in glaucoma practice to allow a correct intraocular pressure (IOP) evaluation.

The purpose of this study is to compare CCT measurements using four different instruments: Scheimpflug camera tomography, spectral-domain optical coherence tomography (SD-OCT), anterior chamber SD-OCT and ultrasound pachymetry.

Eligibility Criteria:
Inclusion Criteria:

* subjects that gave a valid consensus to be included in this experimentation,
* aged between 18 and 75 years,
* Best-Corrected Visual Acuity (BCVA) of 20/100 or better,
* refraction included between -6 and +6 dioptres,
* astigmatism included between -2 and +2 dioptres.

Exclusion Criteria:

* History of refractive surgery or any keratoplasty procedure,
* corneal opacities or diseases that make not suitable applanation tonometry or pachymetry.
* Use of contact lenses.
* History of corneal dystrophies or degenerative diseases, (like keratoconus and pellucid marginal degeneration).
* History of glaucoma or ocular hypertension.