cyrilzakka/clinical-trials huggingface dataset:
3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training

This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.

With the aging of the population, the incidence of cardiovascular diseases has exceeded that of respiratory diseases and cancer, corresponding to the rapid increase in the number of coronary stent implantation. Therefore, the standardized training of interventional cardiologists is particularly important. Nowadays percutaneous coronary intervention (PCI) training mode is mainly for the trainees to operate on the patients under the experienced operator. Although this kind of training method can truly show the operation process, it has obvious limitations. For beginners, it takes repeated training and revision to achieve proficiency and accuracy.Learning only through real surgery may result in longer operative times, increased radiation exposure, and increased complications.This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.

Eligibility Criteria:
Inclusion Criteria:

* Previous experience in coronary intervention
* Understand the process of trail and be willing to participate

Exclusion Criteria:

* No previous experience with coronary intervention
* Unwilling to participate the trail
* Unable to complete the trail due to other problems
Effect of Using Myopia Prediction Algorithm on Myopia School-aged Children

In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm

The investigators propose to enroll myopia children aged 8-10 in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-10
* Has the record of eye refraction examined in the past year, SER\<-0.5D
* Current BCVA≥0.8, SER\<-0.5D, Astigmatism less than 1.50 D, anisometropia less than 1.50 D
* Written informed consents provided

Exclusion Criteria:

* Definitive diagnosis of other diseases except for refractive error
* Previous eye surgery
* Previous usage of orthokeratology lenses and atropine
* Unwilling to participate in this trial
Relationship and Central Mechanism Between Diabetes and Cognitive Impairment Based on Simultaneous EEG-fMRI Approach and Peripheral Neuropathology Biomarkers Assay

This is a cross-sectional and longitudinal study to investigate the relationship and central mechanism between type 2 diabetes and cognitive impairment based on the simultaneous EEG-fMRI approach and peripheral neuropathology biomarkers assay.

Little is known about the high risks of cognitive impairment and Alzheimer's Disease (AD) in people with type 2 diabetes. The goal of this study is to characterize brain imaging biomarkers of preclinical AD and related cognitive impairment in people with type 2 diabetes using the simultaneous EEG-fMRI approach and peripheral neuropathology biomarkers assay. We will recruit 400 patients with type 2 diabetes in the outpatient and inpatient departments. Each subject will undergo simultaneous EEG-fMRI scan, classical multimodal MRI scan, cognitive assessments and peripheral neuropathology biomarkers assay at the baseline. This study will qualify gray matter volume, cortical thickness, gray matter and white matter microstructure, cerebral blood flow, spectrum changes, as well as resting state and dynamic functional network connectivity from the imaging examination. Study duration was 3 years with a follow-up every 12 months. Cognitive assessments and imaging scan will be conducted in each follow-up visits. At the end of the study, all of the assessments will be performed again for all recruited subjects.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-75 years
* Right handedness
* Possessed over 6-year education
* Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

* Control participants would be excluded if they had a fasting blood glucose level \>7.0 mmol/L; glucose level\> 7.8 mmol/L after oral glucose tolerance test (OGTT); HbA1c\>5.7%
* Control participants would be excluded if they had a Montreal Cognitive Assessment (MoCA, Beijing edition) score of \< 26
* History of other dementia-related neurological or psychiatric disorders, including psychotic developmental disorders, mania, depression, and schizophrenia
* Central neural system diseases, including traumatic brain injury, intracranial hemorrhage, and acute cerebral infarction
* Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hypoglycemic coma
* Complicated with severe impairment of liver, kidney or heart function
* Metal implants, unable to complete the MR scanning
* Pregnant or lactating women
Kinetics of D-Dimers After Abdominal Surgery

The purpose of this study is to investigate the natural kinetics of D-dimers that occur after abdominal surgery.

Venous thromboembolism (VTE) is a potentially fatal disease with an estimated incidence of 0.1%. One third of the VTE occur as pulmonal embolism with a mortality up to 25% (White RH. Circulation 107:2003)

Serum d-dimer levels are used as sensitive marker for the diagnosis of VTE (Kelly J et al. Arch Intern Med, 162: 2002). Because of its sensitivity, the determination of serum D-dimer levels is an accepted method to exclude VTE in the outpatient setting meaning that VTE may be excluded in case of normal D-dimer levels (Kelly J. Lancet 359: 2002). The specificity of the D-dimer testing, however, is low. This is true especially in the postoperative phase. The interpretation of elevated D-dimer levels in surgical patients remains elusive.

The natural kinetics of D-dimers after surgery is not known. The question to what extent D-dimer levels rise after surgery and how long it may take D-dimer levels to return to normal after surgery is not yet determined. This information is needed to be able to use D-dimer testing for VTE diagnosis in surgical patients.

In this study, D-dimer levels are measured in surgical patients immediately before (day 0) and repeatedly after surgery. D-dimer level measurement will be stopped after D-dimer levels returned to normal.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective surgery

Exclusion Criteria:

* age \< 18 years
* patients not speaking german
* patients involved in another study
* pregnancy
* concommitant inflammatory disease
* patients with oral anticoagulation
* patients having received fresh frozen plasma
Correlation Between Spinopelvic Alignment and Uterine Dimensions in Primary Dysmenorrhea

This study was conducted to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.

Primary dysmenorrhea (PD) is a common condition characterized by severe menstrual cramps and lower abdominal pain before or during menstruation, without any underlying pelvic pathology. It is highly prevalent among adolescents and young women, with 16% to 93% of adolescents and 70% to 90% of young women experiencing PD. The severe menstrual discomfort associated with PD often leads to absenteeism from school or work, with approximately one-third to half of individuals missing at least one day per menstrual cycle, and 5% to 14% experiencing more frequent absences.

While the exact etiology of PD is not fully understood, researchers have proposed a potential relationship between PD and musculoskeletal factors. One hypothesis suggests that abnormal pelvic and lumbar spine alignment, coupled with abdominal muscle spasms, may affect the positioning of the uterus, increasing the susceptibility to dysmenorrhea. Additionally, lumbar spine misalignment could potentially impact uterine blood supply through vasoconstriction, contributing to menstrual pain.

Spinal misalignment has been proposed as a possible underlying cause of PD, with some studies suggesting that manual therapy techniques may alleviate PD symptoms. Furthermore, a lack of coordination between the pelvic floor muscles and surrounding soft tissues has also been implicated as a potential causative factor. However, research investigating the relationship between PD and musculoskeletal factors remains limited, and further exploration of the biomechanical factors influencing the pelvic region is needed. Therefore, this study aimed to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Virginal and non-smokers.
* They should have regular menstrual cycles, verified through a three-month calendar record, with cycle durations averaging between 28 to 35 days.
* The body mass index (BMI) varied between 18.5 to 25 kg/m2.
* Additionally, girls in the study group should have moderate to severe PD (WaLIDD score ≥ 5).

Exclusion Criteria:

* Pelvic or gynecological disorders.
* Musculoskeletal disorders as low back pain.
* Spinal deformities as kyphosis and scoliosis.
* History of lower limb injuries.
* Diabetes.
* Cardiopulmonary diseases.
* Any physical impairment.
* They didn't use analgesics, non-steroidal anti-inflammatory drugs or oral contraceptives.
Risk of Malignancy in Endemic Long Standing Nodular Goitres: a Prospective Cohort Study

To determine the incidence of thyroid cancer in patients with long standing goitres presenting for surgery.

This is a prospective cohort study The objective is to determine the incidence of cancer in patients with long standing goitres( more than 10 years ) who present for surgery in Khartoum Teaching Hopspital - Sudan.

Introduction: goitre is endemic in Sudan with prevalence ranging between 5-42% in different regions of the country. Patients are referred for surgery only if they develop pressure symptoms.

The incidence of thyroid carcinoma is high in endemic goitrous areas. Determining the risk of cancer in patient with long standing goitres may help in early early referral and early surgical intervention.

Methods: This is prospective cohort study including 160 patients with long standing goitrers of 10 years or more who presented from March 2017 to September 2017 to Khartoum Teaching Hospital-Sudan

Eligibility Criteria:
Inclusion Criteria:

* All patients with long standing goitres of 10 years or more

Exclusion Criteria:

* Non
Cognitive Behavior Therapy for Insomnia in Primary Care

The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach. The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL). Following an active treatment-control period, the control group were re-assigned to CBT. The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group. Primary outcome measure was a brief self-report screening form, Insomnia severity index.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilled research criteria for chronic insomnia

Exclusion Criteria:

* other untreated sleep disturbance
* pregnancy
* shift work
* concurrent medical or psychiatric condition that could be negatively affected by the treatment
* drug abuse
* severe depression
* dementia
Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique

The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.

This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy.

After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups:

* Control group: resynchronization via a transvenous left ventricular lead (TVN CRT);
* Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT).

All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads.

Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.

Eligibility Criteria:
Inclusion Criteria:

* Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
* Have a stable pharmacological therapy.

Exclusion Criteria:

* Have a contra-indication to general anesthesia;
* Have a scheduled cardiac surgery;
* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
* Have a life expectancy of less than 6 months;
* Are unable to provide informed consent;
* Are unable to comply with the follow-up schedule and tests;
* Are minor (age below 18 years);
* Are pregnant or are planning for pregnancy in the next 6 months.
The Efficacy of Steroid Therapy in Vestibular Neuritis

The purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test.

This study was a prospective, randomized controlled study. The enrolled vestibular neuritis patients were randomized to conservative treatment or steroid treatment when they are diagnosed with caloric test. After initial vestibular work-up including caloric, video head impulse tests, and a questinnaire (DHI), the patient was examined with the same tests again at 6 months later. The efficacy of steroid for the patients with vestibular neuritis would be determined by the comparison of the data of each group.

Eligibility Criteria:
Inclusion Criteria:

* Ages over 18 years
* Acute vertigo that occurred within 7 days
* The spontaneous nystagmus should be detected
* Caloric weakness over 20%

Exclusion Criteria:

* Suspicious or verified a central nervous system lesion
* If the patient has denied.
* Other otologic disease (acute/chronic otitis media, otosclerosis, etc)
* The patient with history of otologic surgery
* The patient with history of brain surgery
Aspirin Response in High Risk Patients With Coronary Artery Disease

Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon "aspirin low-responsiveness". Laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown.

The investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher risk of thrombosis.

The purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (CAD) having a reduced biochemical response to aspirin compared with CAD patients having a normal biochemical response to aspirin. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease verified by coronary angiogram
* Treatment with aspirin 75 mg/d for at least the previous 7 days
* Previous myocardial infarction more than one year ago (groups with previous myocardial infarction)
* Type 2 diabetes mellitus treated with oral antidiabetics and/or insulin (groups with type 2 diabetes mellitus)
* Renal insufficiency; glomerular filtration rate \<60 ml/min at the time of blood sampling (groups with renal insufficiency)

Exclusion Criteria:

* Treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function
* Ischemic vascular event within the previous 12 months
* Revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months
* Platelet count \<120 x 10\^9/L or \>450 x 10\^9/L
* For patients without diabetes: fast glucose \>7 mmol/L
* Unable to give informed consent
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)

This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.

This multi-center study is a first-in-human, single ascending dose, Phase 1/2 trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of various dose levels in people with CF who are ineligible or intolerant to CFTR modulator therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, age 18 to 65 years at Screening Visit, inclusive
2. Diagnosis of CF
3. ppFEV1 value between 50-100% (inclusive)
4. Resting oxygen saturation ≥94% on room air by pulse oximetry 5 . Clinically stable CF disease as assessed by the Investigator and not requiring any new class of interventional treatment within the last 3 months prior to Screening

Exclusion Criteria:

1. Any change in established pulmonary treatment (including antibiotics) within 28 days prior to Screening Visit. However, inhaled beta-agonists can be included within 2 weeks prior to Screening Visit.
2. Clinically significant episode of hemoptysis (\>50 mL or ¼ cup or 10 teaspoons per day) within 12 weeks prior to dosing with study drug on Day 1
3. Lung infection with Mycobacterium abscessus associated with a more rapid decline in pulmonary status
4. Currently receiving treatment for active lung infection with Burkholderia cenocepacia or Burkholderia dolosa
5. History of solid organ or hematological transplantation
6. History of clinically significant cirrhosis with or without portal hypertension
7. History of pulmonary hypertension
8. History of cardiotoxicity, a history of known coronary artery disease, and/or existing cardiomyopathy
9. Current active fungal infection (not just a positive culture), acute blood, lung, or bladder infection, clinically significant hepatic or renal dysfunction, and/or viral infection (including human immunodeficiency virus or hepatitis virus B or C) requiring the initiation of new therapy within 30 days prior to Screening
10. History of allergic bronchopulmonary aspergillosis (ABPA)
11. Uncontrolled diabetes mellitus, as evidenced by hemoglobin A1c \>9% at Screening
12. Clinically significant laboratory abnormalities at Screening
13. Subjects with any medical condition or abnormal laboratory result that, in the opinion of the Investigator, will interfere with the safe completion of the study
14. Subjects who received any investigational products within 30 days (or 5 therapeutic half-lives, whichever is longer) prior to Screening
15. Subjects who have previously received any gene therapy agent
16. Subjects with known sensitivity to SP-101, doxorubicin or its excipients
Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement

The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.


Eligibility Criteria:
Inclusion Criteria:

* Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families and their primary care providers
* Discharged from pediatric hospital medicine service at our hospital

Exclusion Criteria:

* Patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities
* Patients admitted for end of life care
* Patients admitted for suicidal or homicidal ideation
* Patients who previously enrolled in the study
* Patients in county custody
Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography

The aim of this study is to evaluate the effects of screening using the fluoroscopy-save function on reduction of radiation exposure and quality of angiogram during cardiac catheterization when compared to traditional cinematography-guided coronary angiography.

The study will be a prospective, randomized study of patients undergoing clinically-indicated coronary angiograpy in the New York University (NYU) Langone Medical Center cardiac catheterization laboratory. Patients will be randomized to one of two coronary angiography protocols: (1) Coronary anatomy visualized under fluoroscopy, documented using the fluoroscopy-save function, and further visualized using cinematography only when higher quality is necessary (fluoroscopy-save technique) versus (2) Coronary anatomy visualized and documented using cinematography alone (standard technique). The primary outcome will be a measure of radiation exposure to the patient, surface peak skin dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's back during the procedure. Other outcome measures will include radiation output recorded by the fluoroscopy machine, amount of contrast used, and quality of angiograms performed. To determine if the quality of the angiograms performed using the fluoroscopy-save technique is non-inferior to the standard technique, one extra picture will be taken at random using the mode that the study was not randomized to. For example, in the fluoroscopy-save group, a picture that was not visualized under cinematography during the study will be repeated and documented under cinematograpy. In the standard group, a picture will be repeated and documented using the fluoroscopy-save function. These 2 pictures from each study will then be collated and put together in no particular order with all identifiers removed. These single pictures will be read by 2 interventional cardiologists not involved in the study in a blinded fashion. The degree of coronary artery disease as determined by these 2 readers will be compared between the fluoroscopy-save picture and cinematography picture.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited from the cardiac catheterization laboratory at the NYU Langone Medical Center.
* Patients will be eligible if they are more than 18 years of age and are referred for coronary angiography.

Exclusion Criteria:

* Patients will be excluded if they have reduced renal function since they must receive as minimal of contrast amount as possible, and if their abdominal circumference is \> 45 inches since the quality of images under fluoroscopy alone is poorer in patients with increased abdominal girth.