cyrilzakka/clinical-trials huggingface dataset:
Haemodialysis Outcomes & Patient Empowerment Study 03

This is a prospective, single-arm observational study that aims to assess the validity and reproducibility of an algorithm for assessing fluid status in a cohort of dialysis patients.

The study will externally validate an existing algorithm for dry weight prediction in real-time in a cohort of dialysis patients.

Volume Overload is a contributing factor to the high rates of cardiovascular and all-cause mortality demonstrated in haemodialysis patients. At present, no method exists that can consistently refine volume status and provide patients with feedback to allow adjustments to their fluid intake. Current standards used to assess volume are either poorly predictive of fluid status, cumbersome to use, or lack an adequate patient interface.

An automated, accurate and periodic assessment of dry weight would be clinically useful, low-cost, and rapidly scalable. Machine learning methods have been widely studied in nephrology. Large amounts of precise haemodialysis data, collected and stored electronically at regular intervals, have the potential to be leveraged in the prediction of patients' extracellular volume or ideal fluid status.

A number of proof-of-concept machine-learning models for the prediction of dry weight in haemodialysis data have been created using retrospective data. This study will evaluate the usability of the machine learning models in managing fluid volume in haemodialysis patients while also assessing their validity and reproducibility against validated measurements; in this instance the Body Composition Monitor (BCM) by Fresenius.

As the machine learning model for assessing fluid status was trained and tested on retrospective data, there is sufficient justification for testing the model's performance, acceptability and usability in a controlled, observational prospective study.

This will be an 8-week trial with a 2-week run-in period conducted in a single centre in Beaumont, Dublin, Ireland. Bioimpedance measurements using the Fresenius BCM will be performed every 2 weeks. Haemodialysis data will be processed continuously throughout the trial. The algorithm will use haemodialysis data to predict the BCM output. The algorithm prediction will be compared to the BCM prediction to assess its usability.

Eligibility Criteria:
Inclusion Criteria:

* Receiving maintenance haemodialysis in an ambulatory care setting
* Aged at least 18 years
* Demonstrates understanding of the study requirements.
* Willing to give written informed consent.

Exclusion Criteria:

* Conditions precluding accurate use of bioimpedance (e.g. limb amputations,severe malnourishment, pregnancy, cardiac resynchronisation devices, pacemakers).
* Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.
Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma

Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stage II, III or IV (resected) melanoma
* Treated by surgery and adjuvant immunotherapy between January 1st of 2019 and January 1st of 2029
* Gave informed consent to allow the use of biological samples for research purpose
* Has read the information sheet regarding this study
* With tumor samples available at the biobank center

Exclusion Criteria:

* Patients under 18 years old
* Patients placed under the judicial protection
* Opposed to this study
MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation

Cerebral infarction by proximal occlusion of the anterior circulation is common with major personal and societal consequences.

MRI is the gold standard for exploring stroke, especially ischemic, and a number of biomarkers on initial MRI (before reperfusion) are predictive of neurological prognosis. However, their spatiotemporal evolution in the suites of reperfusion is unclear.

Close monitoring by MRI would make it possible to precisely know the tissue, vascular and microvascular evolution of the infarct area and the penumbra after reperfusion, and thus to characterize MRI biomarkers associated with efficient tissue reperfusion.

The aim of the MR-Reperfusion study is to characterize new MRI biomarkers of efficient tissue reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* To be over 18 year-old
* Perfusion MRI assessment on admission;
* Admission for an acute infarction of the anterior circulation with proximal occlusion (tandem, distal internal carotid, or M1 segment of the middle cerebral artery);
* Initial mTICI = 0-1 on the initial angiography before treatment;
* Patient in complete autonomy (mRS ≤ 2) before the onset of symptoms;
* Mechanical thrombectomy (in combination or not with intravenous thrombolysis), within the first 6 hours of the onset of symptoms, or within 24 hours in case of clinical-radiological or radiological mismatch;
* Success of reperfusion estimated by an mTICI = 3 at the end of the procedure;
* Availability of MRI within 3 hours of angiographic reperfusion;
* To be able to understand the instructions given;
* Written consent given by the patient or a trusted person;
* To be enrolled in a social security plan;

Exclusion Criteria:

* Posterieur circulation obstruction;
* 3 months follow-up impossible with the completion of the MRI;
* Subject under a measure of legal protection
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.


Eligibility Criteria:
Main Inclusion Criteria:

* General good health, other than perennial allergic rhinitis
* History and diagnosis of perennial allergic rhinitis by skin prick
* Normal body weight as defined by the study protocol

Main Exclusion Criteria:

* Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period
* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the excipients in the formulations
* Use of any prohibited concomitant medications as defined by the study protocol
* Previous participation in an intranasal ciclesonide study
* Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit
Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) Amyloidosis

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated amyloidosis (ATTR).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of TTR amyloidosis
* Adequate blood counts, liver and renal function
* Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control
* Males agree to use appropriate contraception
* Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria:

* Known human immunodeficiency virus (HIV) positive status
* Receiving antibiotics for bacterial infection within 7 days of screening
* Known or suspected systemic viral, parasitic or fungal infection
* Receiving an investigational agent within 30 days prior to study drug administration
* Poor cardiac function
* Considered unfit for the study by the Principal Investigator
* Known sensitivity to oligonucleotides
* Employee or family member of the sponsor or the clinical study site personnel.
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.


Eligibility Criteria:
Only participants who completed the pilot or pivotal phases of the trial may proceed to take part in this open-label extension phase of the trial.

Key eligibility criteria for the blinded phase were as follows:

Key Inclusion Criteria:

* Participant is diagnosed with IS and has failed to respond adequately following treatment with 1 or more approved IS therapies.

Key Exclusion Criteria:

* Participant is currently taking or has taken clobazam or any mammalian target of rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.
* Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), of 460 msec or greater on ECG.
* Participant's caregiver is currently giving or has given recreational or medicinal cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the screening visit.
* Participant's caregiver is unwilling to abstain from giving the participant (including the participant's mother abstaining themselves, if breastfeeding)recreational or medicinal cannabis, or synthetic cannabinoid-based medications (other than the study drug) during the trial.
* Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug, such as sesame oil.
* Participant has significantly impaired hepatic function at the screening visit.
* Participant has received an investigational medicinal product as part of a clinical trial within a minimum of 5 half-lives prior to the screening visit.
Use of Death Cafes to Prevent Burnout in ICU Healthcare Employees

Burnout affects a significant number of healthcare employees and leads to worsened mental health, increased job turnover, and patient safety events. Those caring for critically ill patients may be especially susceptible due to high patient mortality, long hours, and regular encounters with traumatic and ethical issues. Preliminary studies suggest that debriefing opportunities may reduce burnout through reflection on distressing patient events, enhancement of social support, and interprofessional collaboration. Death Cafés are a specific form of debriefing that focus on discussing death, dying, loss, and illness.

The purpose of this study is to evaluate whether biweekly Death Cafe group debriefing sessions can prevent burnout in ICU physicians and staff.


Eligibility Criteria:
Inclusion Criteria:

* Physicians, nurses, pharmacists, or therapists working in the Intensive Care Unit and have worked for the full-time equivalent of at least 1 week in the preceding 4 weeks

Exclusion Criteria:

* Not physicians, nurses, pharmacists, or therapists
* Have worked less than the full-time equivalent of at least 1 week in the preceding 4 weeks
BLU-5937: First-in-Human, Single and Multiple Doses Escalation, Safety, Tolerability, Pharmacokinetics and Food Effect

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. The influence of food on the pharmacokinetics of BLU-5037 will also be investigated.

BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and/or female (non-childbearing potential or, for women of childbearing potential, using 2 forms of acceptable birth control or agreed to abide by true abstinence),
* Age: 18 to 55 years (inclusive).
* Body mass index (BMI) : ≥18.5 and ≤30 kg/m².
* Non or ex smoker.

Exclusion Criteria:

* Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) outside from normal and deemed by the investigator to be clinically significant.
* Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy.
* Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration.
* Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration.
* Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.
The Predictive Ability of 4MGS in IPF

This study investigates whether usual walking speed, measured by the 4 metre gait speed test (4MGS), and change in usual walking speed over 6 months predicts death and hospital admissions in patients with Idiopathic Pulmonary Fibrosis.

This observational study is investigating a simple test of usual walking speed, measured using the 4 metre gait speed (4MGS) test in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is a lack of reliable measurements that can assess the effectiveness of treatment. Death and hospital admissions are currently considered meaningful endpoints in research trials due to the lack of fully validated surrogate endpoints in IPF. Using surrogate endpoints could reduce the sample size, cost and duration of clinical trials in IPF perhaps permitting more rapid drug development. Slow walking speed has been shown to be consistently associated with survival and a risk factor for disability, institutionalisation and hospitalisation in older adults and people with another lung disease called Chronic Obstructive Pulmonary Disease (COPD). We are interested to see whether usual walking speed and change in usual walking speed over 6 months predicts death and hospital admissions in IPF patients. This will help inform us of the potential use of 4MGS as a surrogate endpoint. To do this, participants who consent to taking part in the study will be timed walking at their usual walking speed over a distance of 4 metres (13.12 feet) at one time point and then six months later. Incidence of mortality and non-elective hospital admissions will be assessed at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* IPF diagnosis according to NICE guidelines

Exclusion Criteria:

* Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)
* Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease)
* Any condition that precludes providing informed consent e.g. cognitive impairment or poor English
Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities

The purpose of this study is to evaluate the safety and efficacy of the Minnow Medical GRST Peripheral Catheter System in the treatment of new lesions in the superficial femoral artery or the popliteal artery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥18 years of age
* Patient is Rutherford category 2-4
* De novo lesion in the SFA or popliteal artery with a diameter stenosis ≥50%
* Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of \<99%
* Target lesion stenosis has a length of ≤100 mm based on visual assessment
* Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment
* Angiographic evidence of distal runoff defined as minimum one (1) patent tibial artery with a straight flow to the foot
* Patient is willing and able to provide written informed consent prior to any study specific procedure
* Patient is willing and able to comply with specified follow-up evaluations at the specified times

Exclusion Criteria:

* Any prior intervention in the intended target lesion including 10 mm proximal or distal from the intended treatment area
* Evidence of thrombus in the target vessel
* Prior ipsilateral or contralateral lower limb arterial bypass
* Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure
* Target lesion is severely calcified
* Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated).
* Any planned surgery within 30 days of the study procedure.
* Renal failure (serum creatinine \> 2.0 mg/dL)
* Female with childbearing potential without a negative pregnancy test
* Patient has had an organ transplant
* Patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study
* In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial

The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
* albumin-to-creatinine ratio \>= 300 mg/g creatinine in first morning urinalysis
* serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men

Exclusion Criteria:

* type 1 diabetes
* non-diabetic nephropathy
* history of myocardial infarction
* history of cardiac bypass grafting within 3 months
* history of percutaneous coronary intervention (PCI) within 6 months
* history of carotid artery or peripheral artery revascularization within 6 months
* stroke or transient ischemic attack (TIA) within 1 year
* unstable angina pectoris
* heart failure of NYHA functional classes III or IV
* rapid progression of kidney disease within 3 months
* severe orthostatic hypotension
* serum potassium level =\<3.5 mEq(mmol)/L or =\>5.5 mEq(mmol)L
* history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
* poor glycemic control: HbA1c level =\>11%
* history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months
A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye

The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Have a participant-reported history of dry eye for at least 6 months prior to Visit 1
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
* Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1
* Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort \& 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2
* Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at Visits 1 and 2
* Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2
* Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
* Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1
* Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution
* Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
* Be a woman who is pregnant, nursing or planning a pregnancy
Salivary Catecholamines in Aphthous Stomatitis (Canker Sores)

The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing.

The purpose of this study is to determine if salivary catecholamines are elevated in patients with the disease aphthous stomatitis. The results of this study will be combined with those performed in collaboration with a co-Investigator to understand the effects of catecholamines on mucosal wound healing and oral epithelial cell migration.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older, both genders
* History of recurrent aphthous ulcers with 4 or more episodes per year

Exclusion Criteria:

* History of salivary gland disease including Sjogren's disease, parotitis, and sialolithiasis
* History of benign or malignant salivary gland tumor
* History of celiac disease, ulcerative colitis or Crohn's disease
* Patients on medications that affect salivary flow such as anti-depressants and anti-cholinergic medications