cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)

The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.

This was a Phase 2, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 02 Nasal Spray in adult participants with dry eye disease. Approximately 160 subjects, at least 22 years of age, with a subject-reported history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo at Visit 1 and Visit 2.

Eligibility Criteria:
Inclusion Criteria:

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

Exclusion Criteria:

* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1
* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or study drug components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Impact of Steroids on Inflammatory Response in Covid-19

we designed this study to observe the efficacy and safety of dexamethasone versus methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response and to compare the outcome when these steroids will be given in covid-19 diseased patients in our ICU.

A written informed consent will be taken from the patients or their relatives. The study will involve adults (age 18-no limit years) who will be diagnosed covid-19 with destructive inflammatory immune response needing ICU admission to be run on steroid therapy.

Patients will be assigned randomly to two groups (30 subjects each). The study drug will be delivered in opaque bags labeled "study drug" and in (Group D) intravenous dexamethasone 8 mg/day given for 7 days, in (Group M) intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18-no limit years) who will be diagnosed covid-19
* With destructive inflammatory immune response needing ICU admission to be run on steroid therapy.

Exclusion Criteria:

* Severe immunosuppression like HIV (Human immunodeficiency Virus)
* Long term use of immunosuppressant for any other chronic illness
* Pregnant or lactating females
* Patients who are on chronic use of corticosteroids like asthma, rheumatoid arthritis.
Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil (AVISA)

This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.

This is an observational longitudinal study to assess incidence of SARS-CoV-2 infection in Brazil. The study sample is stratified in nine age groups according decades of life, equally distributed in both sexes, with an expected incidence of 10%, at least, during the study period of 24 months. For the first age groups, (0-9, 10-19 and 20-29 years), sample was calculated with the minimum expected incidence of COVID-19 among infected, regardless severity, is 10%. For the latest age groups (30-39, 40-49, 50-59, 60-69, 70-79 and 80+), the sample was calculated with the expected minimum incidence of hospitalization due to COVID-19 according to estimates per age group reported by Verity R et al. https://doi.org/10.1016/S1473-3099(20)30243-7 After the consent procedure, all participants will have a short interview, a IgG/IgM SARS-CoV-2 rapid test and a blood withdrawal to obtain serum for neutralizing antibodies. These procedures will be repeated every four weeks until the end of the study. Individuals with symptoms compatible will be followed-up to confirm COVID-19 diagnosis as well as to assess severity, need for hospitalization and assisted ventilation, sequels, and eventual reinfection. Levels of neutralizing antibodies and other immune markers will be prospectively assessed in all infected participants, either asymptomatic and symptomatic.

Eligibility Criteria:
Inclusion Criteria:

* Any sex or age
* Providing informed consent
* Agreement with all study visits, procedure and contacts

Exclusion Criteria:

* Previous suspected or confirmed COVID-19
* Febrile illness in the latest 72 hours
* Olfactory or gustatory dysfunction in the last three months
* Healthcare worker in a service with routine attention to COVID-19 patients
* Any conditions that can might hurdle participant's compliance to the study in tha opinion of the study team
INFLUENCE of ORIGINAL NATIVE TRICUSPID VALVE LESION (STENOSIS or STENO-INSUFFICIENCY or INSUFFICIENCY) on POST-IMPLANT STRUCTURAL BIOPROSTHETIC DEGENERATION AFTER TRICUSPID VALVE REPLACEMENT.

The structural deterioration process of the implanted bioprosthesis in tricuspid position for tricuspid valve pathology is gradual and irreversible and includes many changes, such as pannus growth, leaflet fibrosis and calcification, delamination of the connective tissue, ruptures and perforations of leaflets. 8 In the great majority of cases SVD consists of leaflet calcium deposits and can be clinically associated with young age, hypercholesterolemia, hypertension, diabetes mellitus, renal failure. The long term durability of these bioprosthesis is still missing.

It is not clear if the same biochemical, hemodynamic and immunological mechanisms leading to native valve calcification can cause bioprosthetic SVD. We hypothesize that the mechanisms protecting the native valve from calcification in the insufficiency disease may subsequently protect also the bioprosthetic valve from calcific SVD. In such a case, considering also the reduced incidence in insufficiency patients of prosthesis-patient mismatch, supposedly associated with increased risk of SVD, indication for bioprosthetic valve use could be expanded in patients with insufficiency. Because of the rising demand of bioprosthetic valve implantation, even a few years increase in the expected durability of the BHV, although limited to a defined population of patients, will have a very relevant clinical impact.

We aim to perform a retrospective, multi-center, observational study. All patients undergoing elective tricuspid valve replacement from 2000 to 2020 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Eligibility Criteria:
Inclusion Criteria:

- Age ≥ 18 years; 6

- Patients who underwent isolated tricuspid valve replacement for stenosis, regurgitation or steno-regurgitation

- Signed informed consent, inclusive of release of medical information where required by local governance.

Exclusion Criteria:

* Tricuspid valve replacement associated with other surgical procedures (CABG or other)

Previous cardiac surgery of any kind;

- Surgery for acute endocarditis

- Participation in another clinical trial that could interfere with the endpoints of this study.

- Pregnant or breastfeeding at time of screening.
A Study to Test Different Doses of BI 456906 in Patients With Obesity

Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years and \< 70 years of age at screening
* Body Mass Index (BMI) ≥ 27 kg/m2 and \<40 kg/m2 at screening
* A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening
* HbA1c \<6.5%
* Further inclusion criteria apply

Exclusion Criteria:

* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Supine blood pressure (BP) ≥160/100 mmHg at screening
* Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Further exclusion criteria apply
Risk Factors For Asthma in Laboratory Animal Allergy

To identify risk factors which predispose individuals to develop asthma and other manifestations of allergic disease on exposure to laboratory animals in the workplace.

BACKGROUND:

In 1982, asthma and allergy to laboratory animals among persons who worked with the animals gained increased recognition as an occupational health problem affecting researchers, veterinarians, technicians, animal handlers, and others. At that time, more than 90,000 workers across the United States were at risk due to their exposure to lab animals in the more than 1,100 facilities registered by the United States Department of Agriculture. Several surveys of exposed workers indicated a prevalence rate of allergic symptoms due to laboratory animal allergy ranging from 19-30 percent in animal workers. Asthma was also a frequent disease among animal workers; these surveys indicated that as many as 13-14 percent of exposed workers had asthma.

The problem of laboratory animal allergy and asthma involved a vast industry that included medical and veterinary colleges, research institutes and universities, pharmaceutical manufacturers, commercial laboratory animal producers, and hospitals.

DESIGN NARRATIVE:

Recruitment for this longitudinal study began in November 1983 and ended in July 1987. The initial visit consisted of an extensive interview to identify and to exclude those individuals with laboratory animal allergy, asthma, and other manifestations of allergy and to obtain an occupational history. Venipuncture was used to obtain serum for IgE and IgG antibody assays. Pulmonary function tests, including a methacholine challenge, were administered. Psychosocial questionnaires were administered. Subjects were evaluated at six month intervals with skin tests, venipuncture, and methacholine challenge. The degree of exposure to animal allergens was quantitated by aeroallergen sampling of workplace and personal breathing zone air and by work diaries.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
PharmacofMRI of Anxiolytic Medications (Pregabalin)

The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. In this case, the medication pregabalin will be used. The investigators hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.

Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, pregabalin. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Male, or female (not pregnant or intending to become pregnant during the study)
* Between the ages of 18-30.
* In good general health.
* No specific contraindications to the drug being administered

Exclusion Criteria:

* Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety disorder
* Subjects who meet criteria for substance abuse or dependence within the last 6 months
* Subjects with an positive urine screen for illicit drugs having clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the baseline visit
* Patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) within the last year
* Subjects who are left-handed.
* Subjects suffering suffers from claustrophobia, or phobia for injections or blood
* Magnetic Resonance Imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an I.U.D. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit).
Intra-operative Assessment of the PRAETORIAN Score During S-ICD Implantation

The PRAETORIAN score predicts defibrillation test success in subcutaneous ICD implantation but can only be calculated after the procedure. This pilot study aims to evaluate the feasibility of determining the PRAETORIAN score intraoperatively. Lead-to-sternum distance and generator position measurments during the implantation procedure will be evaluated. Ten consecutive patients scheduled for S-ICD implantation will be enrolled. The study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest X-ray on day one.

The PRAETORIAN score is an established tool to predict defibrillation test success in subcutaneous ICD implantation but can only be calculated post-procedure using chest X-ray. This pilot study aims to evaluate the feasibility of determining the PRAETORIAN score intra-operatively. This pilot study will assess whether lead-to-sternum distance and generator position can be accurately measured during the implantation procedure by manual measurements with non-fluoroscopic means. This would potentially allow risk stratification before intra-operative defibrillation testing. Ten consecutive patients scheduled for S-ICD implantation will be enrolled. The study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest X-ray on day one. If successful, this approach could improve implantation safety by identifying high-risk patients before defibrillation testing.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients presenting for S-ICD implantation at our institution

Exclusion Criteria:

* patients unable to consent.
* pregnancy
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis

Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis

Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand

Eligibility Criteria:
Inclusion Criteria:

* symptomatic Bronchiectasis
* history at least 2 exacerbation last year

Exclusion Criteria:

* comorbidity with chronic obstructive pulmonary disease
Surgical Decompression for Diabetic Neuropathy in the Foot

The purpose of the study is to determine whether or not surgical decompression of the common peroneal, tibial, and deep peroneal nerves in the legs of persons with diabetic peripheral neuropathy is effective treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Presence of Type 1 or 2 diabetes mellitus (fasting plasma glucose \> 7 mmol/L or casual plasma glucose \> 11.1 mmol/L and symptoms of diabetes or a 2hr plasma glucose in a 75g oral glucose tolerance test \> 11.1 mmol/L)
* Symptoms of paresthesias (including burning pain) or numbness present symmetrically in both feet, determined to be on a peripheral nerve basis
* Total Neuropathy score of ≥ 2 based on symptoms, signs, and nerve conduction study abnormality
* Average pain on Likert scale (range 0 - 10) ≥5
* Good diabetic control with Hgb A1C \< 8
* Presence of Tinel's sign at the Tarsal Tunnel
* Possession of valid Ontario Hospital Insurance Plan (OHIP) coverage

Exclusion Criteria:

* Other types of diabetes mellitus (gestational, drug-induced, etc.)
* Other cause of neuropathy than diabetes such as vasculitis, amyloidosis, toxic neuropathy, HIV, renal failure, alcohol abuse, etc. Pure entrapment neuropathy without evidence of DSP
* Symptomatic lumbosacral spine disease
* Symptomatic lower extremity vascular disease
* Previous foot ulceration or amputation. Other contraindications to surgery such as significant ankle edema, venous stasis, morbid obesity, or previous surgery/injury which would be incompatible with appropriate wound healing
* History of Peripheral Arterial Disease
* HbA1c \> 8.0 - Adults lacking capacity to consent, pregnant women, prisoners, non-English speakers who require an interpreter, and those unwilling or unable to participate in the full study follow-up
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Completed the previous protocol and wish to continue to receive pregabalin.
* Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

* Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to \< 18 years of age who are at risk of complications of influenza disease due to underlying diseases.


Eligibility Criteria:
Inclusion Criteria:

* Individuals 3 to \<18 years of age with underlying medical conditions that indicate an increased risk of complications from influenza infection.
* Further eligibility criteria may be discussed by contacting the site(s)

Exclusion Criteria:

* Individuals with any fatal prognosis of an underlying medical condition (\<12 month life expectancy).
* Individuals hospitalized at the time of enrolment.
* Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components.
* Further eligibility criteria may be discussed by contacting the site(s)
Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD

This study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (UDFF) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). Using a prospective, cross-sectional design, the study will compare UDFF results with established diagnostic methods, including liver biopsy, MRI proton density fat fraction (PDFF), and controlled attenuation parameters (CAP) measurements. The ultimate goal is to determine if UDFF can serve as a non-invasive alternative to liver biopsy for diagnosing and staging hepatic steatosis, potentially reducing the need for invasive procedures in MASLD management.

This prospective observational study, conducted at a single tertiary institution, will investigate the efficacy of ultrasound-derived fat fraction (UDFF) and point shear wave elastography (p-SWE) as non-invasive methods for quantifying liver fat content and fibrosis in patients scheduled for liver biopsy or surgery. The study will enroll 150 participants, suspected of MASLD and who are candidates for liver biopsy or resection.

The study will utilize Siemens ultrasound equipment to measure the UDFF using attenuation coefficient (AC) and backscatter coefficient (BSC) values for liver fat quantification. Additionally, TE parameters, such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM), will be recorded for comparison. The primary outcomes will assess UDFF's diagnostic accuracy against liver biopsy and MRI-PDFF. Secondary outcomes will include assessment of intra- and inter-observer variability, and correlations with patients' clinical data, such as BMI, liver fibrosis stages and liver function tests.

Expected benefits include validating UDFF as a reliable, non-invasive alternative for liver fat assessment, potentially reducing the need for invasive biopsies in managing liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 and younger than 80 years
* Patients suspected of MASLD
* Patients who are planned to undergo either liver biopsy or surgery
* Patients willing to provide written informed consent.

Exclusion Criteria:

* Patients with a large tumor in Rt. hemiliver causing difficulty in performing UDFF measurement
* Patients with previous liver surgery or transplantation
* Patients with insufficient pathologic specimen for analysis of steatosis and fibrosis grade.
* Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.