cyrilzakka/clinical-trials huggingface dataset:
ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study)

The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.

The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.

This study is planned as a follow-up. Participants who meet the eligibility criteria will be recruited from sites staffed by the trained photographers. After assessing eligibility and securing written informed consent, fundus photographs will be captured using a nonmydriatic ocular fundus camera. Images will be taken according to a specific RAssbyAI Check Eye's imaging protocol provided to camera operator, and then analyzed by the RAssbyAI Check Eye's. The photography protocol consists of two images of the ocular fundus (one optic disc centered, one fovea centered).

Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of Diabetes mellitus as defined by:

   A. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA) B. Hemoglobin A1c (HbA1c)\>= 6.5% based on repeated assessments C. Fasting Plasma Glucose (FPG) \>= 126 mg/dL (7.0 mmol/L) based on repeated assessments D. Oral Glucose Tolerance test with 2 hr plasma glucose \>= 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.

   E. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose \>=200mg/dL (11.1 mmol/L).
2. Understanding of the Study and willingness and ability to sign informed consent
3. Patient age 18 or above
4. Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes

   -

Exclusion Criteria:

1. Patients under 18 years of age;
2. Failure to give informed consent;
3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.
4. A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
PET Assessment of Acute Lung Transplant Rejection

The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.

Positron emission tomography with fluorodeoxyglucose (FDG-PET) is a potential way we can measure lung inflammation. FDG-PET imaging is a clinically accepted and FDA-approved method that is commonly used in the diagnosis and management of cancer. PET is a machine that detects radiation and generates pictures using a donut shaped scanner similar in appearance to an x-ray "CAT" computerized axial tomography or computed tomography (CT) scan. FDG stands for \[18F\] (flourine 18) fluorodeoxyglucose, a radiolabeled sugar that is used to identify areas of inflammation with the PET scanner. A CT scan takes a picture of what the lungs and airways look like.

T cells are the primary cause of acute rejection of lung transplants. Because T cells must divide in order to be activated and cause rejection, imaging them while they are dividing is another way that we can determine whether acute rejection is occurring. A new PET tracer called \[18F\]ISO-1 (18F-labeled σ2-receptor ligand for PET, N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-18F-fluoroethoxy)-5-methylbenzamide (18F-3c), binds to dividing cells. Therefore, \[18F\]ISO-1 may help us measure acute rejection more accurately. \[18F\]ISO-1 is an investigational drug.

Eligibility Criteria:
Inclusion Criteria:

* Double-lung transplant recipient
* Scheduled for bronchoscopy with transbronchial biopsy
* Capable of lying still and supine with arms raised above the head within the PET/CT scanner for \~1.25 hours
* Capable of following instructions for breathing protocol during CT portion of PET/CT
* Able and willing to give informed consent
* BMI \< 35
* Already scheduled to undergo bronchoscopy with bronchoalveolar lavage (BAL) for clinical reasons
* Willing to donate a portion of BAL and biopsy specimen for laboratory testing

Exclusion Criteria:

* Glucose level \> 150 mg/dl at time of \[18F\]FDG PET scan (however, up to 160 mg/dl, with repeat testing showing level is stable or decreasing, is acceptable)
* Pregnancy (confirmed by qualitative urine human chorionic gonadotropin (hCG) pregnancy test)
* Lactation
* Presence of implanted electronic medical device
* Enrollment in another research study of an investigational drug
* Inability to lie flat with arms raised above the head for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT
Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs

The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.

The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.

The other basic aim of the study is to determine whether there is a difference (\>6mmHg) between the two drugs regarding the reduction of the mean 24hour blood pressure and the effect of them on the hemodynamic parameters.

The hemodynamic parameters that will be measured by applanation tonometry are augmentation index, central blood pressure and pulse wave velocity.

The hemodynamic parameters that will be measured by impedance cardiography are cardiac index, thoracic fluid content index, systemic vascular resistance index and others.

The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.

The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Drug naive patients with 1st or 2nd grade Arterial Hypertension according to the ESH/ESC guidelines 2013
* The patient has signed the concent form

Exclusion Criteria:

* Secondary Hypertension
* 3rd grade of Arterial Hypertension
* Chronic renal failure
* Diabetes Mellitus
* Sleep apnea syndrome
* Chronic or acute inflammatory diseases
* Stroke, myocardial infarction, angina pectoris in the past 6 months
* Heart failure
* Liver disease
* Neoplasms
* Pregnancy
* Valvular Heart disease
* Heigt \< 120cm or \> 230cm, Weight \<30kg or \>155kg
* Heart Arrhytmias
* Artificial cardiac pacemaker
* Hemodymanic unstable patients
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157

This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines.
2. Subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.
3. Subject is \> 18 and \< 85 years of age.
4. Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.

Key Exclusion Criteria:

1. A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
2. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
3. Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
4. Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.
5. Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula.
6. Subject has type 1 diabetes mellitus.
7. Subject has history of Myocardial Infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques.
8. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain

The aim of the project is to determine the feasibility of delivering a Singing for Chronic Pain (SCP) programme to patients with chronic pain attending a pain clinic.

The investigator will also be looking to provide a preliminary estimate of the benefit of SCP on self-efficacy, self -management skills, mindfulness and well-being as measured by standardized outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.

Exclusion Criteria:

* Having a mental health and/or physical health diagnosis that might prevent active engagement/participation in group sessions; Severe hearing impairment; Severe/profound cognitive impairment that may limit active engagement/participation in group sessions.
The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy

The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ruptured brain aneurysm deemed suitable for neuroendovascular repair
* Normal baseline brain MRI
* Female subjects of childbearing potential have a negative pregnancy test.
* Signed informed consent prior to entering study

Exclusion Criteria:

* Dissecting or mycotic brain aneurysm.
* Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment
* Renal insufficiency with creatinine ≥ 265 umol/L
* Severe, sustained hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg)
* Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
* Pre-morbid modified Rankin scale score of greater than 1
* Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations Patients who are unable to have an MRI scan for any reason.
* Currently participating or previously participated in any investigational drug or device study within 6 months.
Effectiveness Study of the International Child Development Program

The objective of this study is to evaluate the effect of the International Child Development Program (ICDP). Research questions to be answered:

1. Does the ICDP affect children's psychosocial functioning compared to treatment as usual?
2. Does the ICDP change parent-child interaction?


Eligibility Criteria:
Inclusion Criteria:

* SDQ \>/= 9, subjective treatment need

Exclusion Criteria:

* Already in treatment
Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia

Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.

Metatarsalgia is a common condition that affecting about 10% of the general population. Central metatarsalgia involves pathology of the 2nd to 4th metatarsal and their respective metatarsophalangeal joints. This randomized control trial is designed to compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity, foot and ankle functional abilities as well as the occurrence of plantar callosities.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Complain of foot pain on the 2nd to 4th MTPJs during walking in shoes, rating the pain intensity as ≥ 50mm on the Visual Analogue Scale (VAS);
* Able to be ambulant

Exclusion Criteria:

* Peripheral vascular disease (PVD)
* Neurological dysfunctions or neuromuscular disorders
* Active infection, i.e., cellulitis, osteomyelitis, shingles
* Cognitive impairment
* History of lower limb surgery and currently undergoing rehabilitation
* Active ulceration on foot and ankle
* Current utilization of prescribed insoles
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged \>= 50 years.


Eligibility Criteria:
Inclusion Criteria:

* Japanese descent male and female adults who do not have the potential to bear children \>= 50 years of age.
* Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible.
* Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine.
* Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine.
* Documented S pneumoniae infection within the past 5 years before study vaccination.
Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms

This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing respiratory abnormalities in Rett Syndrome in an initial double blind 24 week period followed by an open label treatment phase of up to 168 weeks (the latter for patients with no safety and tolerability issues).

This is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of multiple doses of sarizotan in patients with Rett syndrome with respiratory abnormalities. The study participants will be randomized to either sarizotan between 2 and 10 mg bid or placebo bid, based on age and weight criteria.

All patients who have completed the final evaluations at Week 24 (Day 168) and have no safety or tolerability issues that would preclude continuing on the study medication and have been compliant with the trial requirements will have the option of continuing open-label treatment with Sarizotan for up to 168 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 10 kg
* Age ≥ 4 years
* Diagnosis of Rett syndrome based on consensus clinical criteria and patients with MECP2 duplications will not be eligible.
* Has at least 10 episodes of breathing dysrhythmia, defined by episodes ≥10 seconds of breath holding (apnea), per hour during cardiorespiratory monitoring
* Ability to take study medication provided either as capsules or combined with food/drink.
* Patient is cooperative, willing to complete all aspects of the study, and capable of doing so with assistance of a caregiver.

Exclusion Criteria:

* Meets any of the diagnostic exclusion criteria for Rett syndrome, Typical (Neul et al, 2010);
* Patient is participating in a clinical trial with another investigational drug
* Hypersensitivity to sarizotan or other 5-HT1a agonists;
* Current clinically significant (as determined by Investigator) cardiovascular, respiratory (e.g. severe asthma), gastrointestinal, renal, hepatic, hematologic or other medical disorders, in addition to those directly related to the patient's Rett syndrome;
* QTcF interval on the ECG is greater than 450 msec.
* Surgery planned during the study (except for insertion of gastrostomy tube);
* Severe diabetes mellitus or fatty acid oxidation disorder.
* Ophthalmologic history including any of the following conditions: albino patients, family history of hereditary retinal disease, retinitis pigmentosa, any active retinopathy or severe diabetic retinopathy.
* Females who are pregnant, breastfeeding, or of childbearing potential and not using a hormonal contraceptive.
Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.

Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.

Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with degenerative knee arthritis with only one compartment affected

Exclusion Criteria:

* Inflammatory Arthritis
* Tricompartmental arthritis
* Patients with fixed varus deformity greater than -10 degrees
* Patients with fixed valgus deformity greater than -5 degrees
* Patients with knee range of motion less than 90 degrees
* Patients with more than 10 degrees of flexion contracture"
Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery

Patients with heart failure NYHA \>= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)


Eligibility Criteria:
Inclusion Criteria:

patients with heart failure NYHA \>= II (HFrEF and HFpEF) or LVEF \<= 40% non-cardiac surgery planned later than 24 hours age \> 18 years written informed consent

Exclusion Criteria:

patients on intensive care life-expectancy \< 3 months
Study of Efficacy of Bowel Preparation Before Colonoscopy

The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Are men or nonpregnant women who are scheduled for an elective colonoscopy and who are at least 18 years of age,
* Are, in the opinion of the Investigator, able to communicate with study personnel and comply with the requirements of the study,
* Are able and willing to follow the study-specified testing including the diet and hydration regimen, and
* Have been informed of the nature and risks of the study and have given written informed consent at Screening and before any study-related tests are done.

Exclusion Criteria:

* Have any known contraindications to the study procedures or treatment,
* Have clinically significant active cardiovascular disease, including a history of myocardial infarction, within the past 6 months and/or heart failure
* Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus,
* Have any history of prior colon surgery,
* History of active inflammatory bowel disease,
* Have clinical evidence of dehydration,
* Are pregnant or breast-feeding,
* Are unwilling to abstain from alcohol consumption from the day before colonoscopy until discharged from the study,
* Are unwilling to use any prohibited medications, including laxatives, 4 days before receiving the first study dose,
* Have received any investigational agent within 30 days before dosing,
* Have any known or suspected allergies, sensitivity or an unwillingness to consume components of the study medication,
* Known or suspected phenylketonuria (PKU) or sensitivity to products containing phenylalanine, or is on a phenylalanine-reduced diet,
* A history of hemolysis or taking concomitant medications known to precipitate hemolytic reactions,
* Have any other condition which in the Investigator's opinion would make the subject unsuitable for inclusion into the study.
Comparison of Medial Rectus Resection and Plication in Exotropic Patients

Purpose: To determine the surgical outcomes of the plication technique in comparison with the resection method on exotropic patients.

Methods: In this randomized clinical trial, a total of 52 exotropic patients (female, 51.9%) who are candidate for medial rectus strengthening will be randomly classified into plication (n=24) and resection (n=28) groups. The comprehensive visual and ocular examinations will be performed on all study subjects and they will be followed- up for three months postoperatively. Plication technique is the same as resection up to muscle suturing, in the next step, the sutures are passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures.


Eligibility Criteria:
Inclusion Criteria:

Patients with a residual exotropia and history of uni- or bilateral lateral rectus recession or recession and resection (R \&R) and those exotropic patients who were going to have already recession and resection (R \& R) operation due to unilateral constant exotropia will be considered as eligible cases to be included.

Exclusion Criteria:

Subjects with a history of prematurity, intellectual disability, lack of central fixation (nystagmus, eccentric fixation, retinopathy of prematurity) subjects with systemic or other ocular diseases, neurological disorders, uncooperative patients and participants with less than three-month postoperative follow-up will be excluded from this study.