cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association
* Participant consents to AH collection
* Collection of \> 90 microlitres (µL) AH (at each visit required per schedule of activities \[SoA\]) if deemed feasible and safe by the Investigator.
* Macular thickening secondary to DME involving the center of the fovea with CST \>= 325 µm at screening
* Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive) at screening
* Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
* Diagnosis of non-proliferative DR
* Treatment-naive and Pre-treated participants after washout

Exclusion Criteria:

* Any major illness or major surgical procedure ≤ 4 weeks before Day 1
* Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
* Active cancer ≤ 1 year prior to Day 1
* Cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to Day 1
* HbA1c ≥ 12% at screening
* Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
* History of vitreoretinal surgery/pars plana vitrectomy
* Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
* History of any glaucoma surgery including laser glaucoma procedures
* Uncontrolled glaucoma
* Any active intra- or periocular infection on Day 1
* Any active or history of Intraocular inflammation
* Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
* Any proliferative DR
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma

A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.

A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and execute written informed consent
2. Males or female subjects at least 22 years of age.
3. Subjects qualifying for cataract surgery
4. Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
5. Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg

Exclusion Criteria:

1. Women of child-bearing potential
2. Modified Shaffer angle grade \< 2
3. Patients with severe or advanced glaucoma
4. Intraocular surgery within the last 6 months or laser surgery within the last 3 months
5. BCVA worse than 20/80 in either eye
6. Patients with a previous peripheral iridotomy.
7. Ocular infection or inflammation within the last 6 months.
8. Any medication that would be contraindicated for a glaucoma surgical procedure.
A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities

The aim of this study was to find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

There is a growing interest in evaluating physical activity and energy expenditure (EE) to provide feedback to the user. The use of mass-market sensors such as accelerometers offers a promising solution for the general public due to the growing smartphone market over the last decade.

Thus, the proposed EE estimation function has been created using accelerometry data collected from 10 volunteers equipped with a smartphone and two research sensors (Armband and Actiheart) used to estimate EE during several controlled activities. The research sensors' data serves as reference during the creation and evaluation of the proposed function.

It has been evaluated with data of 6 other volunteers in free-living conditions. This new EE function using the smartphone technology is dedicated to light- and moderate-intensity activities, and we believe it can be a new way to help people controlling their daily physical activity level.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* age: 18-60 years
* BMI between 18.5 and 25 kg/m²
* subject considered as healthy after clinical examination and medical questionnaire
* women of childbearing age: negative beta-HCG
* subject with normal rest electrocardiogram (validated by a cardiologist)
* subject with normal blood pressure (\<140/90 mm Hg) with or without medical treatment
* subject with no foot pad problem
* subject giving his/her written informed consent
* subject willing to comply with study procedures
* affiliated to National Health Insurance

Exclusion Criteria:

* respiratory failure or cardiovascular problem
* known cardiac decompensation or myocardial infarction
* surgery made less than 6 months before the study beginning
* pregnant women and nursing mother
* current infectious pathology
* abnormal electrocardiogram
* not affiliated to national health insurance people
* under legal guardianship
* refusal to sign informed consent
* refusal to be registered on the national volunteers data file
* currently participating or who having got 4500€ in this year before to have participated in another clinical trial
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862

Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.

Clinical pharmacology

Eligibility Criteria:
Inclusion Criteria:

* Healthy male white subjects
* 18 to 46 years of age
* Body mass index (BMI): 18 - 29.9 kg/m²

Exclusion Criteria:

* Clinically relevant findings in medical history or in the physical examination
* Systolic blood pressure below 100 or above 140 mmHg
* Diastolic blood pressure below 50 or above 90 mmHg
* Heart rate below 45 or above 95 beats / min
A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM

The purpose of this study is to determine the potential of JMT103 to treat hypercalcemia of malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates.

This is a Phase I/II, Single arm, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With refractory Hypercalcemia of Malignancy.

Eligibility Criteria:
Inclusion Criteria:

1. Fully informed and signed informed consent.
2. Male or female, Adults (\>/=18 years).
3. Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) \> 12.5 mg/dL (3.1 mmol /L).
4. Last IV bisphosphonate treatment must be \>/= 7 days and \</= 30 days before the screening corrected serum calcium; or Last hydration therapy must be \>/= 24 hours before the screening corrected serum calcium（Incompatible bisphosphonate）.
5. Adequate organ function.

Exclusion Criteria:

1. Pregnancy.
2. Hyperparathyroidism, or other granulomatous disease.
3. Hepatitis b surface antigen positive.
4. Hepatitis c antibody positive, or HIV antibody positive.
5. Receiving dialysis for renal failure.
6. Known sensitivity to JMT103 composition.
7. Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of screening CSC.
8. Treatment with cinacalcet within 4 weeks prior to the date of screening CSC.
9. Currently participating another clinical study，or Four weeks or less since receiving an investigational product in another clinical study.
10. In the opinion of the investigator , being unsuitable for inclusion in the study，or subjects withdraw informed consent.
11. Treatment with monoclonal antibody to RANK ligand (RANKL) within 180 days prior to the date of the screening CSC.
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 29 to 33 weeks of gestation
* Birth weight \< 1800 g
* Postnatal age \< 96 hours

Exclusion Criteria:

* Small for gestational age (\<5th percentile)
* Major congenital/chromosomal anomalies
* Terminal illness needing withhold or limit support
Repeat Emergency Department Visits Among Patients With Asthma and COPD

The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.


Eligibility Criteria:
Inclusion Criteria:

* Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
* Patient age ≥ 18 years
* Resident of the City of Buffalo or Erie County
* Discharged to home
* Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
* Able to provide informed consent
* Able to comprehend English language

Exclusion Criteria:

* Received oral or inhaled corticosteroids in the week before ED presentation
* Presented to the ED primarily for prescription refills
* Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
* Admitted to ECMC or discharged to another facility
* Previously enrolled during a prior visit to the ED during the study period
* For female patients--pregnant or pregnancy status indeterminate
* Antibiotics are prescribed to treat current asthma/COPD exacerbation.
Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

This study aims to evaluate specialized proresolving mediators (SPM) concentrations for the first time in subjects infected with Pneumocystis jirovecii. SPM will be measured in blood and urine in patients with favourable or unfavourable outcome of Pneumocystis pneumonia and in patients colonized by Pneumocystis jirovecii. The hypothesis is that low levels of SPM in the blood could be predictive of a negative outcome of pneumocystosis.

Pneumocystis pneumonia is a severe fungal disease threatening immunosuppressed subjects such as patients suffering from AIDS, oncohematological diseases or solid organ transplanted patients. The disease is characterized by an important inflammation in the infected lungs which is mainly responsible for lungs lesions. Despite an adequate treatment introduction, mortality is still around 20% which can not be explained by a treatment resistance. Specialized proresolving mediators (SPM), including lipoxins, maresins, protectins and resolvins, are newly described molecules implicated in the active process of inflammation resolution. The investigators hypothesis in this study is that high levels of SPM could be predictive of a good resolution of the harmful inflammation, thus a good evolution of the disease, in adequate pneumocystosis therapy conditions. On the contrary, low levels of SPM could be predictive of an unfavourable outcome despite a treatment targeting Pneumocystis jirovecii

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with a social security cover.
* Free and informed oral consent given.
* Pneumocystis infection or colonization diagnosed on BAL (Broncho-alveolar liquid) or sputum at Toulouse University hospital Mycology laboratory.
* Adequate Pneumocystis therapy for infected patients (cotrimoxazole).

Exclusion Criteria:

* individuals placed under juridical protection,
* individuals placed under guardianship, or supervision.
* Pregnancy or breastfeeding.
Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy

Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)).

This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy.

This was a non-confirmatory, multicenter, patient- and investigator-blinded, randomized, and placebo-controlled, proof-of concept trial assessing nidufexor vs. placebo in patients receiving standard of care (optimal tolerated doses of ARB or ACEI) for diabetic nephropathy due to type 2 diabetes.

The study consisted of three distinct study periods:

Screening (Day -30 to Day-1): lasted up to a maximum of 30 days and comprised a screening / baseline assessment. This visit was used to confirm that the study inclusion and exclusion criteria were met and served as baseline assessment prior to randomization. Participant randomization occurred prior to day 1 as soon as participant eligibility was confirmed.

Treatment period (Day 1-168): Participants were randomized in a 1:1 ratio to receive nidufexor 50 mg or placebo once daily for 24 weeks. Nidufexor and placebo were given in addition to SoC (optimal tolerated doses of ARB or ACEI).

End of Study (EOS) and Safety follow-up (Day 169 to Day 197): Study assessments were performed until the EOS visit (Day 169). Post Study Safety Contact occurred approximately 28 days after discontinuing study treatment until day 197.

Eligibility Criteria:
Inclusion Criteria:

* Male/female patients, 18-75 years
* Written informed consent
* Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening
* Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker that is the standard of care as judged by the study doctor.

Exclusion Criteria:

* History of type 1 diabetes mellitus
* Severe renal impairment manifesting as serum creatinine eGFR \< 30 mL/min/1.73 m\^2 at screening
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment
* Uncontrolled diabetes mellitus at screening
* History or current diagnosis of ECG abnormalities prior to first study dose
* History of kidney disease other than diabetic nephropathy at screening
* Uncontrolled hypertension at screening
* Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2 inhibitors.
Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia

Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, especially in tropical and sub-tropical countries. A promising strategy aimed at blocking the circulation of arboviruses is to release Aedes aegypti mosquitoes carrying the endosymbiotic bacterium Wolbachia. In 2019, the Wolbachia strategy was implemented in Nouméa as part of the World Mosquito Program. This intervention will modify the epidemiological profile of arboviruses in New Caledonia.

Epidemiological surveillance of arboviruses requires molecular characterization of the virus contained in the serum obtained from the blood collected from patients. This molecular characterization by RNA isolation techniques, RT-qPCR monitoring and sequencing allows the construction of phylogenetic trees.

In the context of the implementation of the World Mosquito Program in Nouméa, the investigators plan to follow the molecular evolution of arboviruses, over the period preceding the releases of mosquitoes carrying Wolbachia (from 1995 to 2019) then over a period of 5 years. following the releases.

At the same time, the virus can be isolated by cell culture techniques and in vitro infections, allowing its study in vitro in cells or in vivo in mosquitoes. This study allows us to measure the impact of the Wolbachia strategy on the evolution of the virus's ability to replicate in cells in the presence of Wolbachia and to be transmitted by the mosquito.

Collection of blood samples from patients with arbovirus infection

This study is a non-interventional study with retrospective part.

This study will improve :

* the assessment of the molecular evolution of arboviruses in the period preceding the implementation of the Wolbachia strategy
* the knowledge of the impact of Wolbachia on the diversity and molecular evolution of arboviruses
* the understanding of arbovirus transmission and replication mechanisms in the presence of Wolbachia

Eligibility Criteria:
Inclusion Criteria:

* Appearance of clinical signs suggestive of an infection with an arbovirus in the 7 days preceding the blood sample,
* Diagnostic confirmation by RT-qPCR of mono-infection with dengue virus or another arbovirus.
* Patients or their representative (s) informed of the possible secondary use for research purposes of the samples initially taken for diagnostic purposes and their derivatives, and who have not since expressed their opposition to the secondary use of the samples diagnostics or their derivatives for research,

Exclusion Criteria:

* Documented opposition from a patient or his representative (s)
* Previously established viral load too low.
* Sample obtained from a sample taken more than 7 days after the appearance of clinical signs of infection.
Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve

Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.

Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI), who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin. This is an observational study; patients will be managed according to the standard clinical care of the local site. Where available, a CT scan will also be acquired for attenuation and/or scatter correction. Studies may be one day (rest/stress or stress/rest) or two day (rest and stress on separate days) All studies will be analyzed locally but the raw data will also be anonymized and forwarded to the core facility for reprocessing. Central processing will allow comparison between sites and the repeat processing will provide an estimate of inter-operator variability in the measurements. The core lab will also compare the relative perfusion from immediate and delayed imaging for image quality and diagnostic accuracy (visual and quantitative).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* BMI ≤ 40 kg/m2
* Able and willing to comply with the study procedures
* Written informed consent
* Intermediate to high probability of CAD
* Suspected or known CAD on a stable medication regime

Exclusion Criteria:

* History or risk of severe bradycardia (heart rate \< 50 beats per minute) not related to chronotropic drugs
* Known second- or third-degree AV block without pacemaker
* Dyspnea (NYHA III/IV), wheezing asthma or COPD
* Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or within 45 days after consent (early revascularization)
* Percutaneous coronary intervention (PCI) within 30 days prior to screening or within 45 days following consent (early revascularization)
* Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
* Known hypersensitivity to dipyridamole or adenosine
* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent