cyrilzakka/clinical-trials huggingface dataset:
WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE

WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE) is a multi-centre, prospective, observational, 4-week inception cohort study being carried out by the Acute Respiratory Failure section of ESICM. Weaning represents a challenge for intensivists and patients spend a considerable amount of time in being liberated from mechanical ventilation. While guidelines do exist on the classification of weaning, a recent study has shown that these may not be applicable to all patients. Moreover, different practices exist in regard to weaning procedures. WEAN SAFE will prospectively assess the burden of, management and spectrum of approaches to weaning from ventilation, in patients that require invasive mechanical ventilation for any reason, for a time period of at least 24 hours.

The purpose of this study is to describe, in a large population of ICU patients the burden of, management and spectrum of approaches to weaning from ventilation, in patients that require invasive mechanical ventilation for any reason, for a time period of at least 24 hours. It will answer the following questions:

* What are the current approaches taken to wean patients from invasive mechanical ventilation?
* What is the frequency of delayed weaning from invasive mechanical ventilation?
* What are the factors that are used to determine when patients are in the weaning phase?
* What are the barriers to effective weaning from invasive MV?
* What factors (patient, institutional, medical practice) contribute to failed attempts to wean from invasive mechanical ventilation?
* What is the impact of premorbid conditions on weaning from invasive MV?
* What is the utility of existing classifications for weaning from invasive MV?
* What is the impact of early versus delayed and/or failed weaning from invasive MV?

Patients will be screened for the study when undergoing mechanical ventilation and admitted in the ICU.

Day 1 will be defined as the first day when IMV commences Day 2 commences at 6-10am (fixed time point each day per ICU practice) after IMV commences. Patients undergoing invasive mechanical ventilation on the morning of day 1 will be screened for the study Patients still undergoing IMV on Day 2, will be enrolled in the study Patients not undergoing invasive mechanical ventilation or liberated from invasive mechanical ventilation on day 1 will be re-evaluated daily for the presence of inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

Screening: all patients admitted in the ICU and aged \>16 will be screened daily

- A patient will be included if he/she is undergoing Invasive mechanical ventilation on the second morning (between 6am and 10 am) after initiation of mechanical ventilation or after ICU admission (if ventilation was already in place).

Exclusion Criteria:

* Lack of informed consent (where required)
* Patients already present in the ICU at the beginning of the study, independently of the form of ventilatory support
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of T2DM
* On a stable dose of insulin as defined by the protocol
* On a stable does of metformin (if applicable) as defined by the protocol
* Age 18 to 80 years
* HbA1c of 7.5 to 11.0%
* Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion Criteria:

* Type 1 diabetes
* Short-acting or rapid-acting insulin
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined inclusion/exclusion criteria may apply
Effect of Polyphenol-rich Cocoa Products on Cognitive Function

This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.

Healthy cognitive ageing is an important aspect of the ageing process as it involves larger numbers of people compared to those who have already been diagnosed with conditions on the dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle factor modification interventions to help maintain cognitive well-being are warranted.

With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role in successful ageing by helping to delay the onset of age-related conditions (Hendrickx, McEwen \& van der Ouderaa, 2005; Brown, Riby \& Reay, 2009; Monti, Moulton \& Cohen, 2015). Studies have investigated the potential role of polyphenols as part of a neuroprotective lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al., 2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few.

Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu \& Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against cellular alteration by modulating the neuronal function against endogenous neurotoxins and inhibition of glial induced neuroinflammation (Vauzour, 2012).

Eligibility Criteria:
Inclusion Criteria:

* Males \& Females aged 50-60years of age with normal or corrected to normal vision
* BMI cut off points of ≥18.5 to ≤29.9 kg/m2
* Waist circumference smaller than 102cm for males \& smaller than 88cm for women
* Blood pressure of ≥ 90 over 60 and ≤ 120 over 80
* MoCA test score ≥ 26

Exclusion Criteria:

* Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya
* Smoker
* Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding
* Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension
* No previous history of stroke, brain trauma and other head-related injuries
* No diagnosis of depression and/or anxiety
* No previous cancer diagnosis
* Taking antibiotics
* Taking steroids and non-steroidal anti-inflammatory drugs (NSAIDS)
* Women on Hormone Replacement Therapy (HRT)
* Taking medication that can cause drowsiness or affect cognitive functioning
* Taking polyphenol supplements including (but not limited to) green tea extract, acai berry extract
* Taking soy/a supplements
* History of alcohol misuse
* Fear of needles and/or fainting when blood is taken
The CMCPCTH Research in Chinese Children

To obtain hemorrhage rate after coblation tonsillectomy, and to investigate risk factors of hemorrhage after coblation tonsillectomy in children.

This study is a prospective and multi-centre trail in China. It intends to enroll 25000 patients underwent coblation tonsillectomy in 22 clinical centers in China. Hemorrhage rate and risk factors of hemorrhage after coblation tonsillectomy will be investigated through questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. under 18 years old;
2. Clear indications for tonsill surgery;
3. No clear contraindications for tonsill surgery;
4. Parents of the children patients accept surgical treatment;
5. Parents of the children patients able to cooperate with the visit and follow-up.

Exclusion Criteria:

1. Children patients with a history of adenoid or tonsillectomy surgery;
2. Associated with refractory bleeding diseases;
3. Combined with cleft palate;
4. Down syndrome, Prader-Willi syndrome (PWS) or other chromosomal abnormalities;
5. Neuromuscular diseases (including cerebral palsy);
6. Other diseases that affect physical health, such as severe heart disease, kidney disease, lung disease, etc;
7. Contraindications to surgery and anesthesia;
8. Unable to obtain informed consent.
The China-Anhui Birth Cohort Study (C-ABCS)

The China-Anhui Birth Cohort Study (C-ABCS) was set up to examine the delayed, cumulative and interactive effects of maternal environmental exposures on birth outcomes and children's development. The C-ABCS recruited pregnant women from six major cities of Anhui province, China, between November 2008 and October 2010. A range of data (including demographic, obstetric, occupational, nutritional and psychosocial factors) were collected by both interviews and laboratory tests. In each trimester, women's blood samples were drawn, and pregnancy complications were abstracted from physician's medical records. By the end of 2011, birth outcomes/birth defects were observed/identified by clinicians within 12 months after the delivery of 11 421 singleton live births of six cities and those outcomes among the remaining 2033 live births are still being observed. In addition, 4668 children from Ma'anshan city will be further followed up during the pre-school period till they reach adolescence to obtain the data on familial environmental exposures as well as children's physical, psychological, behavioural and sexual development. The interview data and information on laboratory examinations are available on request from archives in the Anhui Provincial Key Laboratory of Population Health \& Aristogenics.


Eligibility Criteria:
Inclusion Criteria:

1. Having been lived in local city at least 6 months;
2. Establishing maternal card in the hospital for the first time;
3. Gestational week ≤ 16 weeks;
4. Willing to have antenatal checkups and childbirth in the hospital where they establish maternal cards.

Exclusion Criteria:

1. Women who have abnormities in speaking and can not complete the survey by themselves;
2. Women with mental disorders;
3. Women who plan to leave local places.
Microbial Etiology of Ventilator-associated Pneumonia in COVID-19 Infected Patients

National multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for VAP in patients infected or not by SARS-CoV-2 and their resistance to antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

Exclusion Criteria:

* All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.
NT-proBNP in Acute Dyspnea: Effects on Treatment, Hospitalisation and Costs

Diagnostic uncertainty in patients with complaints of shortness of breath presenting to the Emergency Department of a hospital may delay treatment and proper care. In patients with shortness of breath due to heart failure increased plasma levels of NT-pro-B-type natriuretic peptide (NT-proBNP) can be demonstrated. The use of NT-proBNP as a biomarker for heart failure in patients presenting to the emergency department with dyspnea might improve care and reduce length of hospital stay.

To investigate the effect of NT-proBNP testing on patient care and time to discharge the NT-proBNP test will be randomized. In patients in the study group, the NT-proBNP plasma level is determined at admission and the physician in charge will immediately receive the result of the test. In patients in the control group blood will be sampled but the physician will recieve no information on the NT-proBNP plasma level.

In our study we will investigate the effect of introduction of NT-proBNP as biomarker for heart failure on treatment, time to discharge and costs.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Acute dyspnea as their most prominent complaint

Exclusion Criteria:

* Acute dyspnea due to a trauma
* Acute dyspnea due to cardiogenic shock
* Renal failure requiring dialysis
A Phase 2A Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism

This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to identify an appropriate starting dose of DP001 to be used in subsequent studies in this population and for evaluation of pharmacokinetics of DP001 in ESRD patients.

Vitamin D hormone or analogs, when bound to the vitamin D receptor, suppress PTH synthesis by binding to a negative regulatory element in the promoter of the PTH gene, and have been used successfully in the clinic to reduce elevated PTH levels in dialysis patients and other CKD patients. DP001 is a highly potent vitamin D compound.

In two clinical trials testing DP001 in postmenopausal women, oral DP001 reduced PTH levels in a dose-dependent manner, with a dose of 220 ng lowering PTH by at least 30% in a majority of patients following one or six months of daily dosing.

This study is an open-label, dose-ranging study of DP001 in ESRD patients with secondary hyperparathyroidism. Cohorts of up to 6 patients will be enrolled and administered oral DP001 at 110 ng three times per week for four weeks. Laboratory data from each cohort will be assessed and used to determine a dose for the next cohort. Up to 5 dose-ranging cohorts will be studied, with the goal of identifying an appropriate dose for a randomized, placebo-controlled study of oral DP001 for 12 weeks. The data will also be used to select an appropriate dose for an additional cohort of 12 open-label patients in the current study in which the pharmacokinetics of DP001 following a single dose and after repeated doses will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months
* Plasma intact PTH value \>/= 300 pg/mL

Exclusion Criteria:

* Currently taking drugs affecting vitamin D metabolism
* History of symptomatic ventricular dysrhythmias, congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, or coronary artery bypass grafting
* Active malignancy
* Clinically significant liver disease
* Active infections
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones.

Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to demonstrate the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave™ technology. Up to 116 patients will be screened to participate. Depending on the institution, the procedure may be performed in an outpatient hospital surgical environment, or in a non-surgical environment such as a clinic or office procedure room. Subjects will have a target stone diagnosed to be \>4millimeter (mm) to 10 mm in size.

Safety will be measured by the adverse event occurrence, unplanned emergency department or clinic visits, and the need for further intervention. Effectiveness will be determined by the size of fragments identified at the 10 week follow-up imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects presenting with at least one stone apparent on radiographic imaging.
2. Target stone must be within the upper urinary tract.
3. Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
4. Target stone size is \> 4 mm and ≤ 10 mm.
5. Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
6. Target stone can be individually visualized from other stones.

Exclusion Criteria:

1. Subject has an acute untreated urinary tract infection or urosepsis.
2. Subject has an uncorrected bleeding disorder or coagulation abnormality.
3. Subject is confirmed to be or suspected to be pregnant.
4. Subject has a urinary tract obstruction distal to the stone.
5. Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
6. Subject has stones that are not echogenically visible with ultrasound.
7. Subject belongs to a vulnerable group (prisoner, etc.).
8. Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
9. Subject is under 18 years of age.
10. Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
11. Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
12. Subject has a solitary kidney.
13. Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
14. Subject is unable to read or comprehend the consent form.
Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease

This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands.

The reproducibility is measure on patients and not on recorded data.


Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 80 years old
* Patients recruited during the multidisciplinary consultation of Sjogren's Disease, filling the criteria of Sjogren's Disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands
* The patients will have to be capable of adhering to the protocol of study and of having understood it.
* The patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion

Exclusion Criteria:

* Not cooperative patient and having refused to sign the informed consent.
* Patient incapable to understand the protocol, under guardianship or under guardianship.
* Unaffiliated patients to the Social Security.
Metabolic Alkalosis in Heart Failure

Metabolic alkalosis (MA) is the most common acid-base disorder and when it's severe it can have effects on cellular function and contribute to an increase in mortality.

MA is a common complication of heart failure (HF) especially when patients are treated with diuretics, but few studies have analyzed the prevalence of acid-base disorders in patients with HF.

All these studies have shown that MA is more common in patients with HF in more advanced stages and that the use of diuretics increases the prevalence of MA.

The study hypothesis, based on clinical experience and the few data that exist in the scientific literature, is that MA is a frequent analytical disorder in patients admitted for decompensated HF and that its presence entails a worse short-term vital prognosis.

The ALCALOTIC study is an observational cohort and prospective study.

The main objectives of the study are the following:

1. To determine the prevalence of MA in patients admitted for decompensated HF
2. To analyze if there are differences in patients admitted for HF according to the presence of MA on admission
3. To determine if the presence of MA has an influence on the short-term prognosis in patients admitted for decompensated HF


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted for decompensated HF (main admission diagnosis), who meet the diagnostic criteria of the 2016 European HF Guidelines and who sign the informed consent to participate in the study
* Patients must give their written consent to participate in the study

Exclusion Criteria:

* Patients whose main reason for admission is not decompensated HF. Those patients who are admitted for another reason and who also have decompensated HF secondarily cannot be included
* Patients who do not strictly meet the diagnostic criteria for HF of the European HF Guidelines.
* Patients for whom analytical values are not available in relation to acid-base balance at the time of admission
* Patients with a pathological history that can clearly justify metabolic alkalosis, such as primary or secondary hyperaldosterism
* Patients who were taking sodium bicarbonate prior to admission
* Patients with factors present at admission that may justify the presence of metabolis alkalosis: vomiting, diarrea, etc.
* Patients who do not give their consent to participate in the study
A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug

The primary purpose of this study is to evaluate how a person with liver impairment processes and reacts to the study drug. Information about any side effects that may occur will also be collected.


Eligibility Criteria:
Inclusion Criteria - All subjects:

* Male and females ≥18 years old
* Women must be of non-childbearing potential
* Adequate hematologic and renal function
* BMI 18-35 kg/m2

Inclusion Criteria - Liver Impaired subjects:

* Subjects must have stable liver impairment diagnosed with standard classification - Child Pugh

Exclusion Criteria - All subjects:

* Inability to swallow or absorb oral medication
* Uncontrolled medical disorder or infection
* Use of CYP3A4 inhibitors/inducers or drugs with risk of Torsades de Pointes
* Uncontrolled or Significant cardiovascular disease
* Any significant bleeding disorder
* Female subjects of childbearing potential
* Male subjects unwilling to use an effective method of contraception throughout the conduct of the study and for 2 months thereafter
Regional Observation of the Metabolic Syndrome

The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a regional basis, defined according to National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPIII) guidelines criteria.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Laboratory analysis (lipidic profile and glycemia) performed in the last year

Exclusion Criteria:

* Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study
* Pregnancy or breast feeding
* Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs
Validity and Reliability the Turkish Version of the Oxford Participation and Activities Questionnaire in Older People

To evaluate the validity and reliability of Turkish version of the Oxford Participation and Activities Questionnaire (Ox-PAQ) for Turkish older population. Following the translation protocol of the Ox-PAQ, Short Form-12, Katz Index of Independence in Activities of Daily Living Scale, The Five Times Sit to Stand Test were administered to 230 older people. End of this study, occupational therapists, physiotherapists can use the it to assess activity and participation level of older people living in community


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Mini Mental State Examination score greater than 24,
* Able to mobilize independently.

Exclusion Criteria:

* Severe vision and hearing loss
* Having an orthopaedic, vestibular, neurological or mental problem
* Failure to cooperation
* Presence of an acute disease during recovery.