cyrilzakka/clinical-trials huggingface dataset:
Comparison of Optic Nerve Head and Retinal Nerve Fiber Layer Parameters Derived From Two Different Methods of Scan Alignment

This prospective, monocentric, non-invasive clinical study is designed to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in normal, healthy volunteers and glaucoma patients. The main goal of the study is to provide an analysis of the comparability of these parameters between two different software versions and their respective method of scan centration on the optic disc center. The study will include at least 40 eyes of 40 subjects; 20 normal, healthy subjects and 20 glaucoma patients. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, and visual field testing in one single visit. Total study duration (first patient first visit to last patient last visit) is anticipated to be approximately 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to undergo the test procedures, give consent, and to follow instructions
* Subjects that understand the nature of the trial
* Signed informed consent
* Age : 18 years or older
* For "normal subjects", "normal" means, there is no reason that would prevent imaging of the eye, therefore:
* Self-reported healthy eyes without prior intraocular surgery (except cataract surgery and laser in situ keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve (e.g. impacting central VA or RNFLT measurements as determined by the expertise of the investigator)
* Visual field GHT within normal limits
* For "glaucoma subjects": Early to advanced glaucoma according to existing medical charts and visual field GHT outside normal limits on at least two occasions during the testing.
* Refraction between +6 and -6 diopters spherical equivalent and astigmatism ≤ 2 diopters
* When both eyes are eligible, one randomly selected eye will be evaluated in the analysis

Exclusion Criteria:

* Vulnerable subjects (as defined in ISO 14155 GCP)with the exception of employees of the site, and , if applicable, students of the respective university. Staff that is directly involved in the study is excluded from participation.
* subjects unable to read or write
* Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
* Unusable disc stereo photos.
* Inability to undergo the tests.
* Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance).

Minimum requirements are:

* Retina completely included in image frame,
* Quality Score ≥ 20 in the stored ART mean images, and
* For ONH-R scan: Center position error ≤ 100 μm.
* Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test

Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).

Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years
2. Past medical history and allergy skin test or who have been diagnosed with allergic or non-allergic rhinitis, based on serum specific immunoglobulin E .
3. People who have experienced symptoms of rhinitis within 12 months from the time of study enrollment.
4. People who have rhinitis symptoms requiring medication at the time of study enrollment.
5. People who can read and write korea language.
6. People who signed a written consent form approved by the Institutional Review Board of their respective organizations to participate in this study freely hearing to explain fully the purpose for the contents of this study prior to participation in research.

Exclusion Criteria:

1. People diagnosed with Rhinitis medicamentosa.
2. People determined that bacterial or viral respiratory infection at the time of study enrollment.
3. People who have evidence of nasal infection
4. People associated anatomical abnormality that causes severe nasal congestion as deviation of nasal septum.
5. People determined that acute or chronic sinusitis according to the researchers determined.
6. In case that pregnancy test is positive, or ambiguous conclusions among female patients.
7. people deemed unsuitable for clinical trial participation due to other reasons.
The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders

The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.

Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (France) is eligible for the study, whatever the dose and the number of planned infusions. The enrollment is definitive at the time the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Pharmacovigilance. Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco- immunological studies.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* rituximab is prescribed off-label for an auto-immune disorder
* rituximab prescription is validated by an institutional board
* Patients have given their informed consent to be included in the cohort

Exclusion Criteria:

* Follow-up for 6 months presumably doubtful
* Rituximab is prescribed for rheumatoïd arthritis
* Rituximab is prescribed for lymphoma
* Pregnant or breath feeding women
Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients

The purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post dural puncture headache in obstetric patients

Background and objectives: Post dural puncture headache(PDPH) is a common complication of lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space through the dural tear. The prevalence of PDPH is higher in pregnant women.Sphenopalatine ganglion block (SPGB) is a non-invasive intervention with minimal adverse effects, it is indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia, post herpetic neuralgia and pain due to head and neck cancer.SPGB can be performed by different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.Transnasal is the easiest, least invasive approach which can be done at bedside.

The objective of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients.The following will be recorded: pain score will be assessed using the numeric rating pain scale(NRS),heart rate and mean arterial pressure, onset and duration of analgesia, total dose of ketorolac, duration of hospital stay and patient satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Female patients ASA I or II post caesarean section
* Body weight between 60-100 kg
* Active PDPH within days after spinal anesthesia not relieved with standard treatment such as, intravenous fluids, bed rest and caffeine.

Exclusion Criteria:

* Patient refusal to participate in the study
* Body mass index \>35kg/m2
* Patients with :coagulopathy ,nasal septal deviation,polyp
* History of nasal bleeding
* Allergy to local anesthetic
The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment

Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.

The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.

The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.

Primary outcome The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.

Secondary outcomes Change in the brain functional network from the baseline to the postintervention assessment was also assessed as a secondary outcome ascertained by the analysis of resting state fMRI, which has been used to show correlated spontaneous activity within cortical and subcortical regions that are functionally related.

Further secondary outcomes were changes between the baseline and the post-intervention assessment on cognitive function measured by validated neuropsychological tests such as SNSB and CANTAB on participants' depressive and anxiety symptoms scored by Geriatric Depression Scale and Geriatric Anxiety Inventory respectively, on self reported memory problems measured by Korean Dementia Screenng Questionnaire, Multifactorial Memory Questionnaire and Prospective and Retrospective Memory Questionnaire, on functions of daily living acitivity measured by Bayer ADL, on quality of life measuared by WHOQOL-bref.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling volunteers aged 60 years or older
* without dementia
* MMSE=26 or above

Exclusion Criteria:

* if they had known dementia or significant cognitive impairment accompanied by dysfunction of daily living activities;
* had 6 years of education or under;
* were illiterate
* were unavailable during the testing and intervention periods of the study;
* had severe losses in vision or hearing; had major neurological or psychiatric illness history including any history of stroke, transient ischemic attack or traumatic brain injury;
* had a medication history which might affect on cognitive function such as acetylcholinesterase inhibitor or memantine
* had medical problems such as thyroid, liver and renal disease;
* had a significan structural abnormalities on their baseline brain MRI.
Effects of Gastric pH on the Pharmacokinetics of Dasatinib

The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers pre-treated with proton-pump inhibitors (PPIs).


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-59 years of age
* Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations
* BMI between 18.5-30 kg/m2
* Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen)
* Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
* Be able to provide written informed consent and comply with requirements of the study
* Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until the completion of the entire study
* Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
* Fast from food and beverages at least 8 hours prior to medication dosing
* Be able to read, speak, and understand English

Exclusion Criteria:

* Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease, or dyspepsia
* Subjects with a fasting gastric pH of \> 4 (i.e. hypochlorhydria)
* Subjects with a history of dysphagia, achalasia, or difficulty swallowing capsules, tablets, or pills
* Subjects on prescription or chronic over-the-counter (OTC) medications (including hormonal contraceptives)
* Subjects with known allergies to rabeprazole or any other proton pump inhibitors (PPI's) or betaine hydrochloride
* Subjects who smoke tobacco
* Subjects with ongoing alcohol or illegal drug use
* Subjects who are pregnant, lactating, or attempting to conceive
* Subjects unable to maintain adequate birth control during the study
Assessment of QSant™ for Underlying Allograft Rejection

The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.

The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. Each participant will be tracked for 24 months. QSant testing will be performed according to the intended use guidelines specified in "LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38671)", along with all standard of care testing, such as serum creatinine/ estimated glomerular filtration rate (SCr/eGFR) as described in the study schedule. Participants will be compared to a site-specific retrospective cohort of KTRs without QSant testing having received a kidney transplant no more than 5 years prior to study initiation as well as the national cohort derived from UNOS (United Network for Organ Sharing) data.

Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney transplant.
2. Able to understand risks and requirements of participation and provide informed consent
3. Willing and able to comply with the study requirements

Exclusion Criteria:

1. Inability to provide a voided urine sample per collection protocol
2. Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.
Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes

A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants (1) are females, (2) have menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and women who are pregnant or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
* Resides in the United States
* Endorses less pain as a primary desire
* Selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid US shipping address and mobile phone number
* The calculated validated health survey (PRO) score during enrollment represents less than mild severity
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports current enrollment in a clinical trial
* Lack of reliable daily access to the internet
* Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
* Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAO
Positive Expiratory Pressure for the Treatment of Acute Asthma in Children

Asthma is a leading cause of emergency department (ED) visits for children. A novel way of treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory pressure works by creating pressure in the lungs to keep airways open and to clear mucus from the lungs. PEP is already used in the treatment of asthma at the investigators institution, but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This study plans to learn more about the use of PEP therapy in the treatment of asthma exacerbations in children in the emergency department. Specifically, the study aims to evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it reduces the need for additional therapies and admission to the hospital. This study will be a randomized control trial comparing children who receive standard therapy to those who receive standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to 18 years presenting to the ED with moderate to severe asthma exacerbations will be included in the study. Reduction in clinical asthma severity will be measured by change in the Pulmonary Asthma Score (the respiratory severity score used at the investigators institution). The need for additional therapies and hospitalization will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 2 and \< 18 years of age
* Established diagnosis of asthma, defined as at least two prior episodes of treatment with bronchodilators in their lifetime
* Initial ED presentation with a moderate to severe asthma exacerbation, as defined by a pulmonary asthma score (PAS) \>7
* PAS score \>7 and \<12 after completion of first line therapies (three doses albuterol/ipratropium bromide and oral corticosteroids)

Exclusion Criteria:

* Do not receive complete first line therapies
* Immediately receive a disposition (admission or discharge) as determined by the treating clinician after completion of first line therapies
* Receive prednisone or more than two doses of inhaled bronchodilators prior to main ED evaluation (e.g. during EMS transport or primary care visit)
* Co-morbid illnesses interfering with or contraindicated to usual asthma therapy (e.g. facial or airway abnormalities, pneumonia, chronic lung disease, congenital heart disease, cystic fibrosis, or pneumothorax)
* Critically ill at presentation
* Pregnant women (women known to be pregnant at the time of enrollment)
Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up

During coronary bypass surgery, veins are taken from the leg and applied to the heart and aorta to 'bypass' narrowings in the coronary arteries. However using an artery in the chest, the internal mammary artery, means that the bypass lasts longer than using veins. The investigators recently showed that using an artery from the arm as a bypass vessel, the radial artery, also had less furring up than veins 5 years after surgery. Now the investigators would like to ask patients to come back for an angiogram 10 years following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Included in the RSVP study
* Willing to attend for coronary angiography
* Willing to give written informed consent

Exclusion Criteria:

* Contraindication to coronary angiography
* participation in research project within previous 60 days
* unwilling to give written informed consent
Latissimus Dorsi Flap Reconstructions: Retrospective Study

Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site.

Currently, there are no universally accepted guidelines regarding when it is advisable to resort to a LD flap for the repair of a large defect and when it is considered contraindicated. Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients treated at IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola in past years, in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site with the baseline conditions of the patients, the site and the extension of the defect.

Eligibility Criteria:
Inclusion Criteria:

* Duration of surgery, expressed in minutes;
* Hospitalization time, expressed in days;
* Need for reoperation within 30 days of the first operation;
* Survival and recurrences, based on the last available follow-up

Exclusion Criteria:

* Incomplete or missing data