cyrilzakka/clinical-trials huggingface dataset:
Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care

The objective of this project is to increase the proportion of patients with AF that receive adequate stroke prevention therapy. Over half of patients with AF who suffer strokes are permanently disabled. Yet there remains a large portion of patients who do not receive appropriate stroke prevention therapy. The investigators hypothesize that a toolkit of quality improvement strategies in primary care could increase the proportion of patients with atrial fibrillation appropriately treated with stroke prevention therapy. The investigators' goal is to ensure the toolkit of interventions can be easily incorporated into day-to-day practice in primary care and can be readily and broadly disseminated if successful.

The prevalence of atrial fibrillation (AF) is growing as the population ages and 15% of all strokes are already attributed to AF. Unfortunately, half of patients with AF do not receive prescriptions for anticoagulation to prevent stroke due to a variety of system, provider, and patient-level barriers. The investigators will conduct a pragmatic, cluster-randomized controlled trial to test a 'toolkit' of quality improvement interventions in primary care. In keeping with the recommendations of the chronic care model to simultaneously facilitate proactive care by providers and activate patients, the toolkit includes provider- focused strategies (education, audit and feedback, electronic medical record-based tools including decision support and reminders) plus patient-directed strategies (educational letters and reminders). Thirty three primary care clinics will be randomized to the intervention or usual care. The trial will last 12 months and will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-concordant care for stroke prevention. Analysis will be blind to allocation.

Eligibility Criteria:
Inclusion Criteria:

* Physicians are participants in the Electronic Medical Record Administrative-data Linked Database (EMRALD).
* Patients are rostered to participating physicians, with a diagnosis in the chart of atrial fibrillation

Exclusion Criteria:

* Physicians who do not consent to data sharing
* Patients who change physicians during the course of the study
The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors

The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes

Exclusion Criteria:

* Women with breast, ovary or other cancers in recent 5-year
* Severe renal or liver dysfunction
* Women with androgen excess
* Smokers
* Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea Before and After Treatment With CPAP.

We wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years
* Obstructive sleep apnea
* Hypertension or normal blood pressure

Exclusion Criteria:

* Drug or alcohol abuse
* Pregnancy
* History or clinical signs of disease in the heart, lungs, brain,liver, kidneys or endocrine organs
* Diabetes
Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation

Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Ability to provide informed consent
3. Patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps
4. Non-pedunculated polyps ≥ 20 mm size

Exclusion Criteria:

1. Pedunculated polyps
2. Inflammatory bowel disease
3. Inability to provide informed consent
4. Lesions \< 20 mm in size (largest dimension)
5. Lesion involves the lips of the ileocecal valve, is located at the appendiceal orifice and/or is fully circumferential.
6. Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients

The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.
2. DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:

   2.1. Break up time. 2.2. Lissamine green staining. 2.3. OSDI and Patient Symptomatology Questionnaire.
3. The patients, whose are going to be submitted for refractive surgery.

Exclusion Criteria:

1. Any patient with punctual occlusion or punctual plugs.
2. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,
3. Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.
4. Patients with Epiphora.
5. Patients must not have participated in any investigational therapeutic drug or device trial within the 30 days prior to their start date for this trial.
6. Any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.
The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers

This study aimed to accomplish the following objectives:

1. Develop a family-centered preoperative preparation program.
2. Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.


Eligibility Criteria:
Inclusion Criteria:

* aged 3-12 years, received general anesthesia, and admitted for elective outpatient ear, nose and throat, orthopedic, ophthalmology or general surgery.

Exclusion Criteria:

* Children with severe development delay or chronic illness were excluded. Caregivers were excluded if they could not accompany their child to the hospital on the day of the surgery.
Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients

Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.

The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up.

The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.

Predictors of the clinical outcomes will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patient successfully\* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU
* Signed and dated informed consent
* The subject will be available for postoperative follow-up beyond one year

Exclusion Criteria:

* Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study)
* Already included in another clinical study that could confound the results of this study
* Not available to attend routine follow-up visits
* Not able to understand the aim of the study and its procedures
* Minor age (according to local regulation)
* Drug / alcohol addiction or abuse
* Known pregnancy
* Under guardianship
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.

This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds.

This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).

Eligibility Criteria:
Inclusion Criteria:

Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at Visit 1.

* COPD Diagnosis: Subjects with an established clinical history of COPD
* Screening clinical laboratory tests must be acceptable to the Investigator.
* Screening ECG must be acceptable to the Investigator
* Individual Compliance: Subjects must be willing to remain at the study center as required per protocol to complete all visit assessments
* Patients should be on scheduled maintenance treatment with one or more inhaled bronchodilator therapies.

Exclusion Criteria:

* As judged by the investigator, any evidence of significant diseases other than COPD, i.e., disease or condition which, in the investigator's opinion makes it undesirable for the subject to participate in the trial.
* Spirometry Performance:

  1. Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS acceptability criteria.
  2. Repeatability: Subjects who cannot perform technically acceptable spirometry in accordance with ATS repeatability criteria
* Cancer: Subjects who have cancer that has not been in complete remission for at least five years.
* Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse alcohol or drugs
* Subjects who in the opinion of the investigator are unable to abstain from prohibited medications including LABA/LAMAs/ICS
Optical Tomographic Scanner for Skin Lesions

Optical coherence tomography is technology widely used in medicine. In this study, the investigators will use an optical tomographic scanner to scan skin tissue image.

The investigators will use optical tomographic scanner to scan skin specimen and obtain tissue images. Part of skin specimen obtained from skin biopsy or surgery will be scanned.

Eligibility Criteria:
Patient who receive skin biopsy or surgery due to skin cancers, benign skin diseases, or inflammatory skin diseases.
Prognosis Study of Renal Transplantation in Children

Kidney transplantation is the worldwide recognized best renal replacement treatment for children with end-stage renal disease. Successful kidney transplantation can not only alleviate uremia symptoms, improve survival and quality of life, but also achieve optimal growth and cognitive development in children. Clarifying the cause of end-stage renal disease before transplantation is of vital importance to the comprehensive assessment and follow-up of the extra renal organs, reducing the risk of recurrence of the primary disease, the choice of the timing and the mode of transplantation, the scheme of immunosuppressive agents, as well as providing accurate genetic counseling for families. Timely molecular diagnosis and correct data analysis play a positive role in promoting the etiological diagnosis of uremic children before renal transplantation. We hypothesized that identifying the molecular diagnosis can improve prognosis of kidney transplantation. 300 cases of end-stage renal disease children were included and whole exome sequencing are performed to identify the molecular diagnosis. The cohort was divided into 2 groups according to whether the molecular diagnosis was clear. Clinical information before and after renal transplantation of each group are collected, and the decision tree analysis model and logistic regression model are used to study the effect of clear molecular diagnosis on the 3 year survival rate of renal transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Donors and recipients who accepted kidney transplantation at centers included in this study

Exclusion Criteria:

* Older than 18 years old.
* There are severe systemic diseases and/or local and/or spiritual system diseases.
* There are systemic acute or chronic infections, infectious diseases.
* The donated organ dysfunction, or other causes that are damage to donors and recipients.
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.


Eligibility Criteria:
INCLUSION CRITERIA - ALL SUBJECTS :

* Males or females ≥ 50 years of age
* Body weight ≥ 45 and ≤ 110 kg
* Willing to adhere to calcium and vitamin D supplementation requirements
* Females must be of non-reproductive potential

INCLUSION CRITERIA - SUBJECTS WITH RENAL IMPAIRMENT (GROUPS 1 AND 2):

* Group 1 - Stage 4 RI (estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73 m²)
* Group 2 - End stage renal disease requiring hemodialysis

INCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3):

• Renal function defined as an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73 m²

EXCLUSION CRITERIA - ALL SUBJECTS:

* History of metabolic or bone disease (except for metabolic bone disease in renal impairment (RI) subjects)
* History of osteoporosis, vertebral fracture, or fragility fracture of the wrist, humerus, hip, or pelvis after age 50
* Recent bone fracture
* Vitamin D insufficiency
* Hypocalcemia or hypercalcemia
* Hypomagnesemia
* Hypophosphatemia
* Untreated hyper- or hypothyroidism
* Females with a positive pregnancy test
* Males with pregnant partners
* Females who are lactating/breastfeeding or plan to breastfeed on study and for 3 months after receiving the dose of study drug
* History of spinal stenosis
* History of facial nerve paralysis
* Positive for human immunodeficiency virus (HIV) antibodies
* Positive for hepatitis B surface antigen or detectable hepatitis C
* Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical, or breast ductal carcinoma in situ) within 5 years before screening
* History of solid organ or bone marrow transplants EXCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3)
* Current hyper- or hypoparathyroidism
Novel Treatment For Pusher Syndrome Using Physical Therapy

The purpose of this study is to see if a specific physical therapy intervention speeds recovery from stroke-related "pusher syndrome."


Eligibility Criteria:
Inclusion Criteria:

* Recent (within 2 months) unilateral stroke
* Burke Lateropulsion Scale ≥ 2
* Age 21 to 89 years
* Ability to provide informed consent
* English-speaking

Exclusion Criteria:

* Prior stroke within the past 6 months
* Cerebellar stroke
* Stroke-related brain imaging (MRI or CT) unavailable
* Global or receptive aphasia
* Prior documented neurologic disorder (e.g., multiple sclerosis, Parkinson's)
Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System

The purpose of this study is to evaluate the safety and tolerability of a single iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery System in healthy adult human volunteers.

This is a single center, randomized, single-masked, comparative group, safety and tolerability study of single dose levels of citrate buffer delivered through transcleral iontophoresis administered via the EyeGate® II Drug Delivery System. The current study will also determine the safety and tolerability of the dose ranges of transcleral iontophoresis from 2 mA through 7 mA and will determine the safety and tolerability of the application of the Eyegate II system on the eye for time ranges of up to 10.5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Normal ophthalmic examination in both eyes

Exclusion Criteria:

* Presence of subjective ocular symptoms
* Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge
* Ocular trauma
Vaginal DHEA for Women After Breast Cancer

There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.


Eligibility Criteria:
Inclusion Criteria:

* women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed.

Exclusion Criteria:

* women using products to alleviate vaginal dryness.
* women taking medication for urinary incontinence
* women not sexually active, for other reasons.
Effect of Higher Volume and Lower Dose on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural

It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.

This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy nulliparous women
2. American Society of Anaesthesiology Score of II
3. During active labor
4. At weeks 37-42.
5. Singlet vertex presentation
6. Cervical dilation \<5 cm at the request of labor analgesia
7. VAS score \>40

Exclusion Criteria:

1. Age \<20 or \>45,
2. Morbid obesity
3. Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia)
4. History of drug abuse
5. Contrindication for neuraxial blocks
6. Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries)
7. Diagnosed fetal abnormalities
8. Cases where dura gets punctured unintendedly with the epiduralneedle
9. Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture
10. Cases where a cesarean section is performed at any stage of labor
11. Cases where labor is completed in 1 hour from the start of analgesia procedure.
EEG Parameters Between Remimazolam- and Propofol-based Anesthesia

This is an observational study comparing perioperative quantitative EEG parameters between the conventional propofol/remifentanil and remimazolam/remifentanil. We aim to compare and analyze the differences in EEG patterns during the postoperative recovery in a group that underwent remimazolam and remifentanil-based total intravenous anesthesia(TIVA), in comparison to propofol and remifentanil-based TIVA


Eligibility Criteria:
Inclusion Criteria:

Patients aged 19 to 65 years who meet the American Society of Anesthesiologists (ASA) physical status classification 1-3 and undergo laparoscopic cholecystectomy at Severance Hospital.

Exclusion Criteria:

Pregnant women, individuals with arrhythmias, emergency surgeries, obesity (BMI \> 30), day-surgery, foreigners, and illiterate individuals.
Inhaled Corticosteroids on Airway Smooth Muscle in Asthma

The main objective is to evaluate how treatment with inhaled corticosteroids (ICS) affects the characteristics of airway smooth muscle (ASM) cells from asthmatic subjects. Our hypothesis is that airway smooth muscle cell dysfunction plays an important role in the pathogenesis of asthma, and that treatment with inhaled corticosteroids reverses the abnormalities in airway smooth muscle cell function.

Aims and Objectives

Most of the work published to date on the effect of steroids on ASM has been carried out in animal models or in in vitro experiments. We would like to evaluate in vivo whether abnormalities in ASM function respond to ICS. Because ASM cells can be obtained from bronchial biopsies obtained via bronchoscopy, we will examine endobronchial biopsies from corticosteroid-naïve, mild asthmatic subjects. In particular, we will examine whether ICS have any effect ASM mass, proliferation and expression of different contractile proteins (α-actin and myosin) and chemokines, and will assess in vitro the response of ASM cells to stimulation by TGF-β and IL-1β. We will also examine the effect of dexamethasone on chemokine release and induced proliferation in vitro before and after treatment with ICS.

We will examine the effect of inhaled corticosteroids in 12 subjects with mild asthma. The subjects will be studied during a baseline period and again after receiving treatment with inhaled corticosteroid therapy with Budesonide Turbohaler (400 ug bd) for 4 weeks. The results of these two periods will be compared.

There will be 5 study visits. In the first two visits, the subjects will undergo spirometry with reversibility testing, a methacholine challenge test, skin prick tests and IgE levels, measurement of exhaled nitric oxide, and subjects will complete an Asthma Control Questionnaire and an Asthma Quality of Life Questionnaire. The third visit will be the day admission for the bronchoscopy. They will be given asthma control diary cards to complete during the 4-week treatment with ICS and receive their ICS turbohaler. At visit 4, they will have repeat spirometry and methacholine challenge to assess if there has been a change secondary to treatment with ICS. The final visit will be for the second bronchoscopy, when the dairy card and ICS inhaler will be collected, and the subjects will complete the Asthma Control and Quality of Life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of asthma
* Age 18-60
* Intermittent asthma symptoms \< once/week
* FEV1\>80% of predicted
* Not on inhaled corticosteroid therapy

Exclusion Criteria:

* Previous long-term use of inhaled corticosteroids (within 1 year of entry into study)
* Past history of hypersensitivity to budesonide
* Current smokers, or less than 3 years since quitting smoking
* Less than 4 weeks from an exacerbation
* On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin
* Concomitant anti-IgE therapy
* Pregnancy
* Previous bronchoscopy within three months of this study