cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Antiplatelet Efficacy of Aspirin Combined With Clopidogrel and Aspirin Combined With Half-dose Ticagrelor in Patients With Unruptured Intracranial Aneurysms With Normal CYP2C19 Metabolizer Phenotype

The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. The main questions it aims to answer are:

If aspirin combined with half-dose ticagrelor is comparable to or better than aspirin combined with clopidogrel? What medical problems do participants have when taking aspirin combined with half-dose ticagrelor? Researchers will compare aspirin combined with half-dose ticagrelor to aspirin combined with clopidogrel to see if aspirin combined with half-dose ticagrelor works to treat patients with unruptured intracranial aneurysms received endovascular treatment.

Participants will:

Take aspirin combined with half-dose ticagrelor or aspirin combined with clopidogrel every day for 6 months Visit the clinic 1 month and 6 months for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unruptured intracranial aneurysms who are scheduled for stent-assisted embolization;
2. mRS score less than or equal to 2 on admission;
3. Normal CYP2C19 metabolizer genotype;
4. Age 20 or above, 70 or below, regardless of gender;
5. The subject or the entrusted family member voluntarily signed the informed consent for this trial

Exclusion Criteria:

1. Use of drugs that affect coagulation function or significant abnormalities in platelet/coagulation function before admission;
2. Previous history of cardiovascular and cerebrovascular disease;
3. Complications of major organ dysfunction, chronic inflammatory diseases or malignant tumors at admission;
4. Known allergy or contraindication to heparin, aspirin, clopidogrel, or ticagrelor;
5. Patients with any severe or active pathological bleeding;
6. Pregnant and lactating female;
7. Those deemed unsuitable to participate in this trial by the responsible physician
A New Method for Deltoid Ruptures: Gap Sign

"Deltoid Gap Sign" which would be a new method of examination for deltoid ligament injuries will be investigated. It will be analyzed if it is correlated with the external rotation stress test. The study is designed as a blinded, comparative and prospective trial.

Ankle fracture patients who applied to our clinic agreed to be included in the study and underwent surgical intervention will participate in the study. The pediatric age group will not be included in the study, since deltoid ligament tears are not common in ankle fractures in pediatric age. However, since this fracture can also be seen in pregnant women, if there is a pregnant patient who will require surgical treatment, they can be included in the study.

"Deltoid Gap Sign" which is the main subject of this study, will be performed in patients firstly at patients' ward i) without pre-operative anesthesia, secondly at operating theatre ii) under anesthesia before the operation. The examination will be carried out by two different physicians and the opinion of both physicians will be noted. Physicians will be blinded and will not know others' decisions.

External rotation stress test (ERST) in dorsiflexion, which is another examination method accepted in the literature in the evaluation of the deltoid ligament, will also be performed by two physicians and the opinions of the physicians will be noted. ERST will be analyzed under fluoroscopy control.

After the examination, open surgery will be performed around the medial malleolus. It will be noted whether the deltoid ligament was injured (ruptured/ not ruptured), which fibers of the deltoid ligament (superficial/deep/superficial + deep fibers) were ruptured.

Statistical ratios such as positive predictive value, negative predictive value, sensitivity, specificity, and likelihood ratio will be calculated based on the results obtained.

Deltoid gap sign will be checked whether it is correlated with ERST and the results will be compared with the ERST.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had operated on because of ankle trauma
* Patients who had been performed an open surgery at the medial malleolus region
* Patients with Maisonneuve fractures

Exclusion Criteria:

* Medial malleolus fractures
* Talus fractures
* Patients in pediatric age
Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes

This study is a pilot behavioral intervention trial, designed to initially examine cognitive behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression and poorly controlled type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes that is poorly controlled (HbA1C greater than or equal to 8.0%) despite treatment with insulin.
* Diagnosis of major depression and/or dysthymia, or current subclinical symptoms of depression in spite of being treated with antidepressants.
* Age 18-80.
* If on an antidepressant, stable for two months. Oral hypoglycemic medications stable for 2 months, and insulin prescription stable for 2 months (if prescribed).

Exclusion Criteria:

* Active or untreated major mental illness that would interfere with participation (e.g., untreated psychosis), untreated/unstable bipolar disorder, eating disorder, mental retardation, dementia, or active suicidality.
* Unable or unwilling to provide informed consent.
* History of or current CBT for depression.
* Currently on dialysis.
Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.

Total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis.

Recently, the direct anterior approach (DAA) has gained popularity by maintaining abduction force and reducing dislocation rates.

Soft tissue stability in the anterior is increased by adding capsule repair with the preservation of the posterior structures in the DAA.

The degradation of the biological structure of the capsule due to degenerative changes in the end stage coxarthrosis questions the effectiveness of the capsule repair. therefore, the effect of capsule repair on stability is still controversial.


Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral or bilateral primary total hip arthroplasty
* Direct anterior surgical approach
* 18 years of age or older
* Avascular necrosis of the hip

Exclusion Criteria:

* Rheumatoid arthritis of the hip
* Revision hip arthroplasty
* Younger than 18 years of age
* Crowe type 3 and 4 coxarthrosis
Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD

The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg).

This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.

Eligibility Criteria:
Inclusion Criteria:

* Subfoveal CNV secondary to AMD.
* Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).
* ETDRS best-corrected visual acuity of:

  * 20/40 (73 letters) or worse
* Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.

Exclusion Criteria:

* Prior treatment with VEGF Trap, bevacizumab or ranibizumab.
* Any investigational agent within 12 weeks of Visit 2 (Day 1).
* Presence of other causes of CNV.
* Active ocular infection.
Study Comparing Liquid and Tablet Buprenorphine Formulations - 5

The purpose of this study is to compare liquid and tablet buprenorphine formulations.

Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.

Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%

This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.

This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years and older currently undergoing femtosecond or manual cataract surgery with or without astigmatic keratotomy.
2. Patients willing to take an electronic survey about their tolerability of either study medication.

Exclusion Criteria

1. Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.
2. Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:

   1. Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure.
   2. Clinically significant ocular trauma.
   3. Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
   4. Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
   5. Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
3. Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
4. Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
5. Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
6. Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
7. Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
8. Participation in this trial in the same patient's fellow eye.
9. Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Distress and Quality of Life During the Diagnostic Phase of a Suspected Serious Lung Disease

The purpose of this study is to gain insight in the distress experience and quality of life of patients suspected of having a serious lung disease during the diagnostic phase and the period between diagnosis and start of treatment

A life-threatening disease often leads to distress, an emotional experience that can interfere with coping. Studies in lung cancer patients show high prevalence of distress during the course of the disease. However until now, very few research was done during the diagnostic workup. This prospective study will describe and explore distress, quality of life and illness perception in lung cancer patients during the diagnostic period until first follow-up visit 4 weeks after start of therapy. Patient reported questionnaires will be used.

Eligibility Criteria:
Inclusion Criteria:

* ambulatory patient
* imaging suggestive of lung cancer
* written informed consent
* able to complete questionnaires

Exclusion Criteria:

* solitary pulmonary nodule
* previous diagnosis of cancer
Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

The goal of this observational study is to compare pulmonary health parameter measurements from the VQm PHM™ to existing clinical measurements. The main questions it aims to answer are:

* Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM™ when compared to available reference measurements.
* Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow, functional residual capacity and physiological dead space found on the VQm PHM™ when compared to available reference measurements.

This is a multi-site, international, prospective, non-blinded, non-randomized, observational study. This study aims to compare measurements from the VQm PHM™ to existing clinical measurements, assess safety of the device and determine effects that standard clinical events have on the VQm PHM™ measurements. This study does not include changes to clinical care based on measurements from the VQm PHM™. Each patient will serve as their own control.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years old or above, at the time of the inclusion
* Patient currently admitted in the ICU, who are indicated for cardiac output monitoring using a pulmonary artery catheter and who require pressure or volume controlled mechanical ventilation using an ETT
* Provision of signed and dated informed consent form (ICF) by the patient or a trusted person

Exclusion Criteria:

* Male or female under the age of 18 years old, at the time of screening
* Patient under guardianship
* Patient who requires tidal volumes of less than 250cc
* Pregnancy
* Patient whose care requires the use of an anesthetic conserving device
* Patient whose care requires a closed-loop ventilator
* Patient who is unable to tolerate a transient increase in inhaled CO2
* Patient who is unable to tolerate a transient inhalation of N2O or is contraindicated to N2O use
Chronic Inflammatory Rheumatism: Management of Comorbidities in Ambulatory Medicine

Identification of factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes

In the rheumatology department of the CHU Grenoble Alpes, Professor Baillet and other rheumatologists have set up a holistic assessment of inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) and associated co-morbidities in a day hospital. Based on this assessment, a hospital report is drawn up summarising the patient's treatment options, which is then sent to the patient's referring physician. They analysed the first 100 patients in the cohort and showed that 98% of patients were not up to date with their care. Their longitudinal analysis shows that patients update two thirds of the recommendations made within 12 to 18 months. Therefore, the investigators would like to assess the applicability of this screening in these patients, through a questionnaire sent to the 400 patients of the cohort and to their treating physicians.

Eligibility Criteria:
Inclusion Criteria:

* Patient cohort :
* men and women over 18 years of age
* Informed volunteers who have consented to participate in the study
* have rheumatoid arthritis, spondyloarthritis or psoriatic arthritis
* have been hospitalised in a day hospital in the rheumatology department of the Grenoble-Alpes University = SCORIC cohort of the department
* Cohort of referring physicians :
* volunteers who received informed information and consented to participate in the study
* be the referring physician of a patient of the SCORIC cohort of the rheumatology department of the South Hospital of the CHU Grenoble-Alpes

Exclusion Criteria:

* Patient cohort :
* psychiatric pathologies or history of behavioural disorders
* persons referred to in articles L1121-5 to L1121-8 of the Public Health Code
* persons under guardianship or curatorship
* not affiliated to the social security system
* minors
* Refusal to participate by the patient and/or unreturned questionnaire
* Cohort of referring physicians:
* the physician is no longer the patient's referring physician
* refusal of the doctor to participate and/or questionnaire not returned
Improving Congenital Heart Disease Care

The theory-informed digital health intervention, called as "Empower My Congenital Health (EmpowerMyCH)" aims to activate and engage ACHD patients in building confidence toward navigating the adult healthcare system. This tool is built after incorporating the theories of behavior change, gathering inputs from target patients in all stages of its design and implementation. The key features of the tool include a digital medical passport, updated congenital information, community support, and patient stories and advice. The investigators aim to test the acceptability, feasibility, efficacy, and effectiveness of the intervention.

The goal of this clinical trial study is to learn whether a digital multi-component intervention would increase the knowledge, self-efficacy, self-advocacy, and patient engagement skills of adults with congenital heart disease (CHD) to confidently navigate the health care system and have timely recommended specialist visits.

The multicomponent intervention contains features such as a digital medical passport, updated health-related specific information, opportunities to engage with CHD community, peer-support, doctor visit reminders, etc. The intervention components are designed with inputs from the patients and the CHD community and have the potential to be adapted on an ongoing basis depending on the needs of the patients.

The main question it aims to answer is:

Does the digital multi-component CHD patient engagement intervention enhance the patient engagement skills and lead to timely specialist visit?

Participants will be recruited from the clinics, through word of mouth, social media, and others. Participants can use the website link or a QR code to sign an electronic consent form to be eligible to participate. Once consented, the participants will receive surveys to collect baseline and health status information as well as intervention components at regular intervals. The study will be available for participants to join on the web or mobile, depending on their preferences.

Eligibility Criteria:
Inclusion Criteria:

* have congenital heart disease
* 18 years or older
* can sign the informed consent

Exclusion Criteria:

* developmentally delayed
* unable to consent
A Drug Interaction Study of LY3154207 in Healthy Participants

The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m²)
* Have clinical laboratory test results within acceptable range for the population

Exclusion Criteria:

* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
* Intend to use over-the-counter or prescription medication (with exception of hormonal contraceptives and acetaminophen), including herbal preparations containing St. John's wort, kava, garlic, ginger, ginkgo biloba, or guarana, within 14 days prior to Check-in and during the study
* Use of any drugs or substances that are known inducers and/or inhibitors of cytochrome P450 (CYP) 3A within 14 days prior to the administration of study drug and during the study
* Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of \< 80 milliliters per minute (mL/minute), calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
The Value of TOI in Evaluating Renal Function Damage in Hypertensive Emergency Patients

TOI was used to measure heart rate, respiration, blood pressure, heart rate variability and psychological stress. At the same time, the patient's urine protein, creatinine, urea nitrogen and other indicators were detected. According to different renal function, they were divided into observation group and control group, and 100 general inpatients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared.

TOI technique was used to measure the heart rate, respiration, blood pressure, heart rate variability, psychological pressure, etc. At the same time, the urine protein, creatinine, urea nitrogen and other results of these patients were measured. According to the different renal function, they were divided into observation group and control group, and 100 ordinary hospitalized patients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared. The data management platform provides intelligent management of patients' out-of-hospital follow-up, and the dynamic physiological indicators and psychological assessment data of patients are mastered through the hospital port, so as to provide telemedicine guidance for patients, so as to improve the prognosis of hypertensive emergency patients.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure (SBP)\>180mmHg
* Diastolic blood pressure (DBP)\>120mmHg

Exclusion Criteria:

* Severe head and facial skin injury
* Cerebral hemorrhage or severe shock after admission
* Patients who insist on refusing to participate in this clinical tria
* Patients who could not participate in the study for other reasons.
Evaluation of a Gamified Electronic Medication Administration Record (eMAR) System

This research project will evaluate a gamified electronic medication administration record (eMAR) system simulator as a mechanism to improve students' learning of medication administration in simulated clinical education. The gamified eMAR simulator will be evaluated using a pragmatic randomized controlled trial design in order to determine the effectiveness of the game as a technology-enabled, online learning intervention.

The main objective of this study is to examine whether the use of a gamified medication administration simulator improves nursing students' medication administration safety within simulated practice; increases student self-efficacy and knowledge of the medication administration process; and, improves motivational and cognitive processing attributes related to student learning in a technology-enabled environment. It is hoped that by completing this trial, the effectiveness of using an eMAR simulator as an educational tool to better prepare nursing students to administer medications using eMAR technology for practice will be ascertained.

Eligibility Criteria:
Inclusion Criteria:

* (1) second year nursing students; and, (2) partaking in clinical simulated education in either in Fall 2017 or Winter 2018 semesters.

Exclusion Criteria:

* (1) A student who is not enrolled the BScN program at the respective site of data collection, in Fall 2017 or Winter 2018.