cyrilzakka/clinical-trials huggingface dataset:
Method and Sample Comparison Study Minicare BNP - COMP-BNP-CE03-AN2016

Sample Comparison The objective of this study is to compare the Philips Minicare BNP test with the Centaur BNP test. BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed. Matrix Comparison To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.Prior to the study start, a proficiency study will be performed on the Minicare BNP, Architect and I-STAT BNP assay to be sure that devices are performing according to expectations. Approximately 100 EDTA patient whole blood samples covering the entire measuring range of Minicare BNP from LOQ until end of measuring range (expected to be approximately 5000 ng/L) (Ref 7) will be tested (according to CLSI EP09A3 (Ref 5)) at a central laboratory using the Minicare BNP, Alere BNP, I-STAT BNP system. The outcome of the site routine assay (Centaur BNP systems) will be used to evaluate if the blood samples cover the entire distribution range of the assay. If necessary, up to 20% of the samples may be spiked so that the entire range of the assay is covered. The central laboratory will identify the blood tubes with a BNP request. Approximately 1000 μl EDTA whole blood will be available (left over material) for testing on the non-routine devices (i.e., Minicare BNP, Alere BNP, and I-STAT BNP). Testing for the Alere BNP, I-STAT BNP, and Centaur BNP systems will be performed according to the respective IFU's (Ref 1, 2, 3, 4). For the Minicare BNP system, test will be performed according to a DRAFT IFU or a similar document describing the sample treatment and handling for the Minicare BNP system. Alere BNP, I-STAT BNP and Minicare BNP samples should be tested within 6 hours after collection and Centaur BNP samples within 8h of collection. Although different stability claims for BNP, it is highly recommended to perform all measurements on all systems within 2 hours. For Alere BNP, I-STAT BNP, Centaur BNP analysis will be performed using a single blood sample for each patient. Alere BNP and I-STAT will use EDTA whole blood samples as sample type Centaur BNP will be tested on EDTA plasma samples. For the Minicare BNP, both EDTA whole blood and EDTA plasma will be tested for each patient. For the Minicare BNP system the whole blood samples will be tested using a pipette and the same sample will be tested using the SmearSafe Blood Dispenser (transfer device) to investigate a reliable use of such transfer device.

Only the routine Centaur BNP outcomes will be used as part of support for patient diagnosis.


Eligibility Criteria:
Left over blood samples from eligible patients with BNP requests, available at the test site CENTRAL LABORATORY will be selected for this study.
Genetics of Insulin and Incretins in Cystic Fibrosis

Cystic fibrosis related diabetes (CFRD) is associated with worse CF-relevant outcomes.

The mechanisms underlying CFRD development are not fully understood, but recent evidence suggests Type 2 Diabetes Mellitus (T2DM) mechanisms may be involved and may involve incretins (gut secreted hormones that augment insulin secretion in response to a nutrient load).

This study will examine the prevalence of Genome wide association study (GWAS)-implicated T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in CF and will use this information to compare incretin and insulin secretion in non-diabetic children and adults with high risk and low risk alleles.

CFRD is associated with worse nutritional status, greater pulmonary function decline, and increased mortality, highlighting its relevance in CF and arises primarily from compromised insulin secretion--traditionally considered a by-product of pancreatic exocrine tissue damage and fibrosis. Recent developments in the field of diabetes are propelling a re-examination of this basic explanation. Genome-wide association studies have associated genetic variants in TCF7L2, a transcription factor implicated in enteroendocrine function, with increased susceptibility to T2DM and CFRD.

The Objectives of this study are to perform targeted sequencing of TCF7L2 and other GWAS-associated T2DM genes in the pediatric and adult CF populations and then to compare insulin secretory capacity, β-cell sensitivity to glucose, and incretin secretion in non-diabetic CF subjects with high and low-risk alleles.

Phase 1 will include 450-500 subjects (Children age\>= 2 years, adolescents, and adults) for TCF7L2 genotype and ten other GWAS-implicated T2DM genes. The distribution of TCF7L2 and other GWAS-implicated T2 DM genes across the spectrum of glucose abnormalities will be described. Phase 1 requires a single blood or saliva sample and review of medical records.

Eligibility Criteria:
Inclusion Criteria

1. Subjects age \>2y
2. Diagnosis of Cystic Fibrosis
3. For subjects\< 18 years, parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria 1. Established diagnosis of non-CFRD (cystic fibrosis related diabetes) (e.g T1DM)

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Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery

Cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in France. A new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the French healthcare insurance.

An estimated 700,000 cataract procedures are performed every year in France, with this amount of surgeries predicted to climb as the population there, as well as around the world, ages. Currently, phacoemulsification alone is the conventional cataract surgery. The femtosecond laser-assisted cataract surgery has to be compared with the standard process to provide information on how it could benefit the patient population treated every year for cataract surgery. This economic study has received a grant from the French Ministry of Health to evaluate the economic impact of femtosecond laser-assisted process for the French healthcare system. For this goal, this prospective, randomized, parallel, multicenter and simple blind study will determine the incremental cost/effectiveness ratio for femtosecond laser-assisted process versus phacoemulsification surgery. Visual acuity results and intraoperative or postoperative complication rate will be compared between both groups. The learning curve of the femtosecond laser assisted cataract surgery will be also evaluated for each surgeon involved in the study.

Ethic and regulatory autority authorisations were obtained at 19/Dec/2012 and 15/Feb/2013, respectively. Date of first inclusion: 9/Oct/2013. Date of first NCT release: 13/Nov/2013. 30 patients were included between this period. French regulatory process dos not require NCT registration before first inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Cataract with impaired visual acuity (\> or equal +0.3 LogMAR) or with cataract-related visual symptoms (Halos, Monocular diplopia, glare)
* French healthcare insurance beneficiary

Exclusion Criteria:

* Pupil size lower than 6mm
* Iris constriction
* Iris synechiae
* Preoperative zonular instability or crystalline lens subluxation
* Obstructive Corneal scars
* Obstructive pterygion
* Axial length \<20.5 mm
* Corneal astigmatism \>1.5 diopters
* Fuchs corneal dystrophy
* History of Central retinal vein or artery occlusion
* History of uveitis
* History of optic nerve head neuropathy except glaucoma
* Progressive glaucoma
* Nystagmus
* Uncontrolled diabetes mellitus
* General history of dementia or psychotic disorders
* Pregnancy, breast feeding
* General medications: Alpha-blockers, Carbonic anhydrase inhibitors
Diagnosis of Bacterial Vaginosis Comparing Modified Hay/Ison With Molecular Diagnosis

Among 300 women that are scheduled a therapeutic abortion screening diagnopsis of BV are done using Gram stained vaginal smear and with a molecular test using PCR for 5 different bacteria.

The molecular test will test for Atophobium vaginae, Leopitrichia spp, Megasphaera Mobiluncus and BVAB2

Eligibility Criteria:
Inclusion Criteria:

women scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis

Exclusion Criteria:

* women not pregnat
Diagnostic Value of UTB and TB for PPL

The purpose of the study is to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy.

The study aims to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) with the guidance of virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy. The study is designed as a prospective, multicenter, randomized controlled clinical trial. The participating centers are The First Affiliated Hospital of Guangzhou Medical University, Cancer Hospital Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, and Henan Provincial People's Hospital. Patients are divided into three groups: UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group. Each subject will be randomized to each group. The study is expected to enroll a total of 577 patients with 193, 192 and 192 in UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old.
* Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) that need to be confirmed by pathology. The length diameter of the lesion is no less than 8 mm and no more than 5 cm.
* Patients without contraindications of bronchoscopy.
* Patients have good medical adherence and signed informed consent.

Exclusion Criteria:

* Peripheral pulmonary lesion is pure ground-glass opacity.
* Absence of bronchus leading to or adjacent to the lesion on thin-slice chest CT.
* Visible lumen lesions in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus).
* Diffuse pulmonary lesions.
* The investigators believe that patient has other conditions that are not suitable for the study.
Evaluating the Burst Pressure of Simulated Bowel Anastomosis Constructed Using the Reverse Half-Hitch Alternating Post Knots

Square knots are the gold standard for hand-tied surgical knots; however, they are difficult to reproduce in deep body cavities and can inadvertently result in slipped knots. The investigators have shown in previous work that the reversing half-hitch alternating post (RHAP) surgical knot is a non-inferior alternative to the square surgical knot based on its tensile strength and performance in limited working spaces. Prior to introducing RHAP knot in routine surgical practice, it is important to objectively demonstrate similar physical characteristics of anastomosis created using RHAP and standard square knots. This study aims to compare the burst pressure of cadaveric porcine small bowel anastomosis constructed using RHAP and standard square knots on a flat surface and in a simulated deep body cavity.

The investigators are conducting a prospective randomized controlled study of novice medical students allocated to proficiency-based training in RHAP and square surgical knots. Knot tying proficiency will be assessed using a knot-tying checklist. Number of repetitions and time required to achieve proficiency will be tracked for each group. Once proficiency has been achieved by participants in RHAP and square knots group, each participant will perform two-hand sewn small bowel anastomosis using cadaveric porcine small bowel. One anastomosis will be performed on a flat surface and the other will be formed in a simulated deep body cavity. Burst pressure of the anastomoses will be tested using a column of water, and results will be compared between groups. Simple descriptive statistics will be performed for both groups. Between group comparisons of knot-tying proficiency and burst pressure will be performed using t-test. Learning curves within each group will be analyzed using paired 1-way ANOVA. SPSS Statistics (v. 21, IBM, New York, USA) will be used for all statistical analysis, with significance set to p\<0.05.

The investigators hypothesize that burst pressure of cadaveric porcine small bowel anastomosis will be equivalent for anastomosis constructed using RHAP and standard square knots.

The results of this study will provide further validity evidence in support of RHAP as suitable alternative to the square surgical knots.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate first or second year medical/non-medical student

Exclusion Criteria:

* Third year or greater undergraduate medical student
Evaluation Of Linezolid Pk Profile In Burns Patients

Evaluation of linezolid pk profile in burns patients


Eligibility Criteria:
Inclusion Criteria:

* Subject with a Body Mass Index (BMI) \< 30 kg/m\&#178;. For patient with major thermal injuries, the weight will be collected before the burn ;
* Patients with major thermal injuries \>40% body area including 3rd degree burns with full thickness burns ;
* Patients hospitalized for at least 10 days since their thermal injury occurred ;

Exclusion Criteria:

* Contra-indications to use linezolid as mentioned in the SmPC (Summarized Product Characteristics) : hypersensitivity to linezolid use or to any of its components, non-controlled hypertension, phaeochromocytoma, carcinoid syndrome, hyperthyroidism, bipolar disorders, schizoaffective disorders, acute confused state of mind, pregnancy, and breastfeeding ;
* Drugs metabolised by monoamine oxydase (MAO) should be evaluated for potential drug-to-drug interaction;
* Subject treated by: selective serotonin reuptake inhibitors (Prozac\&#174;, Effexor\&#174;, Ixel\&#174; \&#133;), tricyclic antidepressant (Anafranil\&#174;, Sinequan\&#174;, Surmontil\&#174;, Tofranil\&#174;), 5HT1 receptor agonists (triptan) direct or indirect sympathomimetic (including adrenergic bronchodilator, pseudoephedrine and phenylpropylamine), vasopressor (adrenaline and noradrenaline), dopaminergic drugs (dopamine, dobutamine), phenetidine or buspirone should be evaluated for potential drug-to-drug interaction;
The Validity and Reliability of Self Measurement of Upper Limb Volume

Lymphedema is a common, chronic, side effect resulting from the treatment of breast cancer.Insufficiency in the lymphatic system causes edema in the upper limb. The accepted conservative treatment is based on the anatomy and physiology of the lymphatic system. The aim of the treatment is to reduce the volume of the upper limb by, initial, intensive treatment and then to keep the arm volume at this reduced level.The measurement of limb volume involves measuring the circumference of the arm at defined points and then with the use of a formula the volume of the arm can be calculated. After intensive therapy is complete the responsibility for measuring limb volume moves to the patient. This study will examine the reliability and validity of self measurement of limb volume. The investigators will compare the results of self measurement using the accepted plastic tapemeasure against a paper tape measure adapted for self measurement.Both methods will be compared to the "gold standard volume displacement. In the study there will be two meetings with the subjects where the patient and physiotherapist will use the three methods.


Eligibility Criteria:
Inclusion Criteria:

* Women with arm edema after breast cancer who are being conservatively treated by a physiotherapist.

Exclusion Criteria:

* Active malignant disease
Enhancing Lung Cancer Screening Through Human-Centered Intervention

The purpose of this study is to further understand the factors involved in increasing lung cancer screening.

The study aims to identify patient, primary care team and health system factors that facilitate participation in lung cancer screening. Additionally, conduct a two-arm randomized comparative effectiveness intervention study to increase lung cancer screening compared with a usual care control arm and further evaluate the differential impact of the intervention conditions compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

Interviews:

* UC Davis Health Systems (UCDHS) primary care providers and clinic staff who provide services to patients ages 50-80.
* Patients who are eligible for lung cancer screening.

Screening Intervention:

- Patients ages 50-80 who have a history of smoking per review of their electronic medical record and who receive care at the following UCDH ambulatory care clinics: Ellison Ambulatory Care Clinic; Elk Grove; Midtown.

Exclusion Criteria:

Interviews:

* Non-consenting patients and patients who do not speak English or Spanish
* Patients aged 49 and younger
* Non UCDHS primary care providers and clinic staff

Screening Intervention:

* UCDHS patients who have already received Lung Cancer Screening
* Patients with existing Cancer diagnosis
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients

The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with placebo in the treatment of patients with schizophrenia.

This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses of RBP-7000 compared with placebo over an 8-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 to 55 years, inclusive
* Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria
* Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and Rule (SAFER) interview
* Subjects who are otherwise healthy on the basis of their physical examination

Exclusion Criteria:

* Subjects who have an improvement in their total Positive and Negative Syndrome Scale (PANSS) score of 20% or greater between the initial screening visit and the first day of treatment.
* Subjects taking daily oral risperidone at a dose ≥ 6 mg/day
* Subjects who have received a depot antipsychotic within 120 days of screen
* Subjects with treatment resistant schizophrenia, as judged by the investigator, who have been treated with antipsychotics for adequate durations and with adequate dosages.
Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis

This study evaluates a diagnostic serological test for Non-Tuberculous Mycobacteria (NTM) infection in cystic fibrosis patients by measuring T cell response. It aims to highlight a dynamic response associated to the pathogen's presence. This multicenter case-control study involves two populations, providing a better understanding of the circulating T-IFNγ-MNT response in these patients.

Background: Evidence shows that Non-tuberculous Mycobacterial (NTM) infections have increased and are 1,000 to 8,000 times more frequent in patients with cystic fibrosis compared to the general population. The diagnosis is based on clinical, radiological, and microbiological criteria. Unfortunately, the first two criteria lack specificity, and microbiological detection of NTM is limited due to frequent sputum contamination by other pathogens in cystic fibrosis patients. Given these factors and the high incidence of NTM infections in this population, alternative diagnostic methods are necessary.

Aim: This study aims to validate an innovative diagnostic test based on the IGRA (Interferon-Gamma Release Assay) method, which measures T lymphocyte response to Interferon gamma (IFNγ). The test will be conducted on a subset of patients selected from the CIMeNT cohort (ID-RCB: 2017-A00025-48). This cohort consists of cystic fibrosis patients whose NTM infection prevalence has been previously assessed.

Method: This research is a multicenter case-control study. It includes two groups: a case group of patients with positive serological and/or microbiological responses indicating NTM infection, and a control group of patients without such responses. The test measures the host's immune response by evaluating circulating T cell activity. Specifically, it measures IFNγ release when T cells are in contact with NTM antigens. This method provides more informative diagnostics of NTM infection dynamics compared to serology or microbiology, which have known technical limitations.

The study involves a single visit, which is part of the routine care for cystic fibrosis patients. During this visit, a routine blood draw will be performed and an additional 7 ml tube will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years
* Patient previously included in the CIMeNT study
* Patient with a confirmed diagnosis of cystic fibrosis regardless of CFTR genotype
* Patient affiliated to the social security system
* Patient registered in the French Cystic Fibrosis Registry
* Adult patient capable of spontaneous expectoration or after induction

Exclusion Criteria:

* Lung transplant patients
* Person placed under judicial protection
* Pregnant and breastfeeding women
Cost of Parkinson's Disease in Hong Kong

The goal of this study is to estimate the cost of disease and falls among people with Parkinson's disease in Hong Kong . There will be no intervention delivered to the participants.

The healthcare cost of 12 months will be recorded using self-report and and the Hospital Authority Clinical Management System.

Objective: Estimate the cost of disease and falls among people with Parkinson's disease in Hong Kong.

Design: Prospective cost-of-illness analysis with one baseline assessment and two follow-up assessments after 6 and 12 months.

Participants: Community-dwelling participants with Parkinson's disease. Intervention: N/A. Outcome measures: Self-reported questionnaires and the Hospital Authority Clinical Management System will be used to inform the healthcare utilisation. We will also assess the number of falls, severity of Parkinson's disease, level of disability, balance, risk of falls, and quality of life. Predictors of cost include fall frequency, balance status, disease severity, level of disability, quality of life and disease duration.

Analysis: Cost-of-illness analysis will estimate the direct and indirect cost, using a prevalence-based approach, by converting physical units to monetary value based on unsubsidised charges for healthcare in Hong Kong published by the Hospital Authority for the year 2022. A multiple regression analysis will determine predictors influencing the overall cost. A two-way ANOVA will assess differences in healthcare costs among frequent, infrequent and non-fallers. Sensitivity analysis will include (1) tornado plots for studying the degree of impact of the cost variables on mean cost, (2) analysis after removing cost outliers and (3) varying the expenses on selected cost items by 25%.

Eligibility Criteria:
Inclusion Criteria:

Community-dwelling participants with a confirmed diagnosis of Parkinson's disease Reside in Hong Kong

Exclusion Criteria:

Patients who are bedridden or solely wheelchair users, Have atypical Parkinson's syndrome and Have other associated major illnesses, such as stroke.