cyrilzakka/clinical-trials huggingface dataset:
Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria

Chronic glomerular diseases are one of the main causes leading to end stage renal disease (ESRD). Hypertension and proteinuria are two modifiable factors promoting the progression of ESRD. Podocyte are terminally differentiated epithelial cells and play a central role in the progression of chronic kidney disease and in the development of glomerulosclerosis. The presence of podocyte in urines (podocyturia) has been documented by several teams with continuous and regular podocyturia during glomerular disease. This facts suggests that podocyturia could become a marker of podocyte loss and glomerular damage. In our university hospital, we developed a technique to evaluate the number of microparticles (cellular fragments) in different biologic samples. The podocytary origin of microparticles will be determinated thanks to specific antibodies. The aim of the present study is: i) to quantify podocyturia during glomerular nephropathies by dosing podocyte microparticles ii) to study the relationship between podocyturia and other biologic markers such as proteinuria iii) to evaluate the effect of angiotensine 2 blockage on podocyturia. This is an open-labelled randomized monocenter cross-over study. Twenty subjects with hypertension and glomerular nephropathy characterized by proteinuria and a normal or slightly altered renal function will be included. Patients will be treated successively by an angiotensin receptor blocker (ARB), losartan and by a thiazide, hydrochlorothiazide, (after a wash out period). We will study the impact of these two therapies on podocyturia. Results will be compared with others markers like proteinuria (and its selectivity). We may finally dispose of a non invasive urinary marker of podocyte lesions responsible for glomerulosclerosis and for ESRD progression. Moreover mechanism of nephroprotection of the ARB may be more comprehensive.


Eligibility Criteria:
* Hypertension (TAs \> 130, TAd \> 80mmHg or under antihypertensive treatment)
* Glomerular nephropathy, proteinuria \> 1 g/day, serum creatinin \< 200 µmol/L ;
* Informed consent given ;
* No contraindication for ARB and hydrochlorothiazide ;
* Efficient contraception for women
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates

The purpose of the study is to demonstrate that the device is safe and performs as intended under anticipated use conditions.

The performance of Neola will be evaluated in terms of ability to continuously measure and display the relative lung volume and absolute oxygen gas concentration on neonates. The results of this clinical investigation will provide further information for the design of a subsequent full-scale clinical investigation.

Eligibility Criteria:
Inclusion criteria:

* Preterm or term born neonates with gestational age between 28 and 40 weeks
* Post-natal age between 1 and 14 days
* Weight between 1000 g and 3000 g
* Signed informed consent prior to any study related procedures by the legal representatives of the patient
* Legal representatives are 18 years or older
* Legal representatives can absorb and understand the content of the informed consent form

Exclusion criteria:

* Known cardiopulmonary congenital anomalies
* Patients with trisomies or other chromosomal abnormality
* Patients not expected to survive
* Non-intact skin or other skin conditions (such as skin lesions) that do not allow the use of skin adhesives. (e.g., Bullous impetigo, Staphylococcal scalded skin syndrome, localized lesions of herpes simplex virus)
* Thorax curvature does not allow placement of the probe sets without air between the surface of the probes and the skin.
Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen

To compare the healing of intrabony periodontal defects treated with either open flap debridement and a volume-stable collagen matrix (VCMX) or a deproteinized bovine bone mineral with 10% collagen. The results will shed light on the clinical potential of VCMX in regenerative periodontal surgery and help to develop new treatment strategies.


Eligibility Criteria:
Inclusion Criteria

* Patients with localized or generalized periodontitis Stage III and Stage IV, Grade A-B-C
* Males and females
* Age at least 18 years and older
* Presence of interdental intra-bony defects (I, II and III walls) in either the maxilla or the mandible with a PD ≥ 6 mm
* Defects with an intra-bony component \&amp;gt; 3 mm for both groups
* Intra-bony defect located only at one aspect (mesial or distal)
* Presence of at least 2 mm of keratinized soft tissue. Exclusion Criteria
* Patients with systemic disease that could interfere with periodontal wound healing
* Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery
* Pregnant or lactating
* Smokers with \&amp;gt; 10 cig./day
* Patients with FMPS and FMBS \&amp;gt; 25 % after completion of non-surgical periodontal therapy
* Multi-rooted teeth with furcation involvement
* Third molars
* Teeth with circumferential defects
* Interdental craters
* Written Informed Consent
European Perioperative Brugada Survey

The aim of this survey is to assess the current perception and clinical practice of Resident and Board-certified Anaesthesiologists and Intensivists regarding perioperative care of patients burdened with the Brugada Syndrome. It is intended to investigate this primarily on national and secondarily on European level.


Eligibility Criteria:
Inclusion Criteria:

* All participants must have received an invitation to participate in the survey through the online platform of the European Society of Anaesthesiology and Intensive Care.

Exclusion Criteria:

* Uninvited participation in the survey is not possible.
Combining Default Choices and a Decision Aid to Improve Tobacco Cessation

The FIRST cluster randomized trial will evaluate the effect of 1) a training program encouraging general practitioners to offer smoking cessation treatment as a default choice to all current smokers consulting a general practitioner (GP), and 2) an interactive, electronic decision aid to guide smoking cessation treatment, on the proportion of current smokers seen in primary care who have quit smoking 6 months after a baseline visit to their GP, as compared to enhanced usual care.

Smoking cessation medications are underused in primary care, likely because general practitioners (GP) lack detailed knowledge about prescribing and the fact that smokers seen in primary care must "opt-in" to treatment. Currently GPs only offer treatment to patients who say they are ready to quit smoking and desire treatment, making the default choice no treatment. Those who are not ready to quit or are hesitant do not discuss quitting or learn about options to help them quit. Further, GPs often lack confidence to discuss smoking cessation medications or do not provide patients with a choice. A decision aid can both help to present quitting with a medication as the default choice and promote shared decision making by allowing patients to see the menu of options available.

The current study will combine the use of 'default choices' when approaching smokers and shared decision making with a decision aid for choosing between smoking cessation treatments. The investigators will train GPs to offer smoking cessation as the default choice while involving patients in key decisions using a decision aid. This innovative approach has not been tested in primary care and has the potential to increase the number of current smokers who make a quit attempt with a proven quit aid, thereby increasing the number of patients who quit smoking.

The investigators will implement the training as part of the Vivre sans tabac programme for GPs run by the Swiss Medical Association (FMH).

Eligibility Criteria:
Patient-level inclusion criteria:

* Consider the GP they are seeing in consultation to be their primary care doctor
* Use tobacco daily (cigarettes, cigars, smokeless tobacco)
* ≥18 years of age at the time of inclusion

Patient-level exclusion criteria:

* Consulting for an urgent complaint that precludes even a brief discussion of smoking cessation
* Inability to follow the procedures of the study, e.g. unable to read French-language consent materials, severe psychiatric disorders, dementia, etc.
* Previous enrolment in a smoking cessation trial \<1 year prior
* Current daily user of a pharmacologic smoking cessation aid

GP-level inclusion criteria:

* GP in private practice in French-speaking Switzerland (Vaud, Geneva, Jura, Neuchâtel, Fribourg or Valais) or metropolitan France
* Primarily French-speaking patients with \>80 individual patients seen in a typical month

GP-level exclusion criteria:

* Completed an intensive smoking cessation curriculum \<2 years prior (ie. at least half-day of training)
* Have plans to retire or relocate outside of Switzerland or France in \<12 months
Testing a New Imaging Agent to Identify Cancer

The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease

Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization \[ISH\]-negative, including FISH.

* Biopsy proven primary malignancy or metastatic disease
* At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
* Age 18 years or greater
* ECOG performance of 0-2

Exclusion Criteria:

* Creatinine \> 2 times normal limit (obtained with 8 weeks of enrollment)
* AST/ALT \> 2 times normal limit (obtained with 8 weeks of enrollment)
* Life expectancy \< 3 months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.

The main objectives of MAN-BIOPSY are therefore

* to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and
* to identify predictive markers for treatment response and type/severity of side effects for these disorders.


Eligibility Criteria:
Inclusion Criteria for patients:

* DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) by a structured clinical interview (SCID)
* aged 18 to 50 years
* drug-free within the last three months prior inclusion
* willingness and competence to sign the informed consent form

Inclusion Criteria for remitted subjects:

* a previous DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) but no symptoms at present, determined by SCID
* aged 18-50 years
* drug-free within the last three months prior inclusion
* willingness and competence to sign the informed consent form

Inclusion Criteria for healthy control subjects:

* Inclusion criteria for healthy control subjects are
* willingness and competence to sign the informed consent form
* aged 18-50 years
* drug-free

Exclusion Criteria:

* concomitant major internal or neurological illness
* concomitant psychiatric disorders (except depression and anxiety for patients, excluding PTSD, claustrophobia and bipolar disorder)
* ingestion of any antipsychotic, antidepressant, or anti-anxiety agent within the last three months prior to the screening visit
* current substance abuse
* failure to comply with the study protocol or to follow the instructions of the investigating team
The Effect of Probiotics on Gums Health and Bad Breath

the study is about using healthy bacteria to improve the overall gingival and overall health and prevent or decrease the bad odor of the mouth caused by bad bacteria

The goal of this study is to verify the effect of Probiotics on oral Health Status and eliminate the gingival disease and Halitosis by measuring the levels of salivary biomarkers (cytokine IL-1b and proteases Matrix metalloproteinase (MMP-8) in saliva) and level of volatile sulfur compounds (VSCs) and their effects on improving gingival diseases clinical parameters in person age of (17-25) years old. The participants are randomly divided into two parallel groups (A, B). Group A will take probiotics and group B will take placebo for 28 days. The levels of IL-1b, MMP-8 in saliva, and VSCs measurement will be recorded respectively in different intervals of zero time and repeated on 14 days and 28 days.

Statistical analysis will be done then comparative between two groups

Eligibility Criteria:
The Inclusion criteria

* Subjects (male and female) between the age range 17-25 years old.
* Subjects with mouth breathing habit.
* Subjects with orthodontic and prosthodontic appliance
* Race from Iraq.
* Subjects having a dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant).

The Exclusion criteria

* History of chronic disease.
* History of systemic disease.
* Patients with autoimmune diseases.
* Patients under antibiotic treatment.
* Pregnant, lactating females.
* History of undergoing nonsurgical and surgical periodontal therapy in the last 6 months.
BAROSTIM NEO Hypertension Pivotal Trial

The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

All subjects are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during visits are:

* Office Cuff Blood Pressure
* Physical Assessment
* Subject Medications
* Serious adverse events

Eligibility Criteria:
Inclusion Criteria:

* Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
* Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

* Treating physician decision that the subject should not continue with therapy.
Endometrial Gene Expression Profile in Controlled Ovarian Stimulation Cycles With Premature Luteinization

Previous studies have suggested that premature luteinization (PL)during controlled ovarian stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium receptivity. This study aims to describe the impact on endometrial gene expression of PL in GnRH antagonist and GnRH agonist cycles.


Eligibility Criteria:
Inclusion Criteria:

* Oocyte donors
* Age between 18-35 years old
* BMI 18-29
* NORMOGONADOTROPHICS
* PROGESTERONE ≥ 1.2 ng/ml on hCG day

Exclusion Criteria:

* PolyCystic Ovarian Syndrome (PCOS)
* Endometriosis
Influence of Beta Amyloid Imaging on Care of Patients Cognitive Complaints.

When older patients develop cognitive problems - like memory loss - there may be any of several underlying causes, sometimes occurring in combination. Clinicians have a better chance of providing appropriate treatment if they understand what the cause of the problem is. A diagnostic tool can help the patient by helping the clinician to make a more accurate diagnosis. This study investigates whether a new diagnostic tool - beta amyloid imaging - may potentially improve medical practice. The tool can potentially improve practice only if it can influence clinical judgment. This study investigates whether the provision of beta amyloid imaging information influences clinical judgment. The investigators will conduct a survey that presents clinicians with descriptions of hypothetical older patients with cognitive complaints. Some of the respondents also receive beta amyloid imaging information. The investigators will test the investigators hypothesis that the information will affect diagnostic judgment and management recommendations by comparing the responses of clinicians who receive the beta amyloid information to the responses of clinicians who do not.


Eligibility Criteria:
Inclusion Criteria:

* Practicing clinicians describing their training and practice as any of the following: neurologist, geriatrician, psychiatrist.
* Included respondents must also attest that they are a physician who is experienced in the assessment and diagnosis of dementia.
Home Usability Study of the SARS-CoV-2 (COVID-19) Test

The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.

This study is a prospective observational human factors usability study designed to evaluate the Instructions For Use (IFU) in the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid SARS-CoV-2 test result.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent

Exclusion Criteria:

* Prior medical or laboratory training
* Prior experience with COVID-19 specimen self-collection
* Prior SARS-CoV-2 testing
Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.

This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.

This is a Phase I, open-label study of PB1003 administered orally to patients with ALK-positive (ALK+) advanced NSCLC. The study includes a Dose-escalation Part (part A) and a Dose Expansion Part (part B). The aim of the part A is to estimate the MTD and to identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1003 single agent as well as to determine the PK/PD profile. Once response has been observed in certain dose level, then followed by the expansion part to further assess the clinical efficacy and safety of PLB1003 single agent. Aprox 40 patients will be enrolled in PART A, while 12-24 patients for expansion cohort .

PLB1003 is a potent selective ALK inhibitor. PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age≥18 years
* Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy.
* Must have evidence of ALK positivity from the results of molecular pre-screening evaluations
* At least one measurable lesion as per RECIST v1.1
* Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
* ECOG Performance Status of 0-2

Exclusion Criteria:

* Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
* Clinically significant, uncontrolled heart diseases. Unstable angina. History of documented congestive heart failure (New York Heart Association functional classification III-IV) .
* Active peptic ulcer disease or gastritis
* Major surgery within 4 weeks prior to starting PLB1003
* Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003..
* Pregnant or nursing women
* Involved in other clinical trials \< 30 days prior to Day 1
Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.

This study aims to determine the effectiveness of the different programmes of four Spanish hospitals about prevention of axillary lymphadenectomy sequels in breast cancer patients.

This study aims to describe the different programs for the prevention of sequels of axillary lymphadenectomy in patients with breast cancer in four Spanish hospitals, to determine the degree of compliance of these programs and to register the frecuency of lymphedema and limitation of mobility of the upper limb in breast cancer patients undergoing axillary lymphadenectomy between 2014 and 2016 in the four hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from axillary lymphadenectomy due to breast cancer treatment between 1 january 2014 until 31 december 2016.

Exclusion Criteria:

* Lymphedema prior to surgery in any of the upper limbs or any malformation or injury that prevents comparison of both upper limb volumes.
* Cognitive impairment or intellectual disability that would prevent understanding the instructions of the study, as well as the purpose of the same.
* Serious condition.
Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol

This double-center, prospective, interventional study aims to include 200 gastroscopic procedures and investigate the relationship between fasting time and feeling of subjects. The subjects will all receive examination between 10:30 to 11:30am. In the control group, the subjects are required to start the fast at 10:00pm the day before examination and can not drink water after 8:00am on the day of examination. In the test group, the subjects are required to have customized rice congee before 6:30am on the examination day and can not drink water after 8:00am. All subjects complete questionnaire which include discomfort and willingness to accept the same fasting regimen.


Eligibility Criteria:
Inclusion Criteria:

* No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum)

Exclusion Criteria:

* Subjects that cannot stand the gastroscopy procedure or cannot cooperate with endoscopists
* Emergency endoscopy and therapeutic endoscopy
* Subjects with history of esophageal or stomach surgery or endoscopic surgery
* Pregnant
* Subjects that refuse to cooperate with data collection or sign the informed consent