cyrilzakka/clinical-trials huggingface dataset:
Clopidogrel Versus Cilostazol on Vessels

Diabetes is an increasing cause of atherosclerotic and cardiovascular illnesses in South Korea. The clinical application of ultrasound for measuring carotid intima-media thickness, which helps in early detection and surveillance of atherosclerosis, is advancing. Due to lifestyle changes and an aging population, Koreans, especially diabetics, are developing more vascular diseases and are at higher risk for peripheral vascular disorders. Diabetics with lower limb peripheral artery disease require effective therapy to avoid major complications and a reduced quality of life. Although licensed for symptom control, Clopidogrel and Cilostazol have not yet been established for primary prevention of cardiovascular risks. These medications will be evaluated for their potential as primary preventive agents against cardiovascular disease in type 2 diabetes patients. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and to evaluate their influence on hemorheological changes in individuals with Type 2 diabetes. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and evaluating their influence on alterations in blood flow among individuals with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adults with diabetes aged 19 and older
* Individuals with a carotid ultrasound cIMT (carotid intima-media thickness) of 1.0mm or more
* Those who have not changed their combination therapy medications (including oral hypoglycemics, antihypertensives, and lipid-lowering drugs) in the last three months
* Individuals with an HbA1c level of 10% or less
* Those who have voluntarily signed the written consent form and agreed to participate in the study

Exclusion Criteria:

* Individuals currently using antithrombotic or anticoagulant medications other than aspirin
* Individuals with bleeding or conditions that may increase the risk of bleeding, such as:

  * Hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary bleeding, hemoptysis, vitreous hemorrhage, etc
  * Active peptic ulcer, hemorrhagic stroke within the last 6 months, surgical operations within the last 3 months, proliferative diabetic retinopathy, uncontrolled hypertension
* Patients who have had cerebrovascular or cardiovascular complications within the past 6 months (including stroke, transient ischemic attacks, myocardial infarction, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention)
* Patients with severe renal or hepatic diseases
* Patients with congestive heart failure
* Individuals with a history of hypersensitivity to the drug or its components
* Pregnant women or women who may be pregnant
* Women who are breastfeeding or plan to breastfeed during the study
Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes

As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.

The primary objective of this randomized crossover study is to determine whether a very low carbohydrate diet improves glycemic changes (measured by continuous glucose monitors) when compared to a standard carbohydrate diet in youth with type 1 diabetes.

The secondary objectives of the study are to compare metabolic changes after 2 weeks on each diet using the 2-step hyperinsulinemic euglycemic-hypoglycemic clamp and stable isotope infusions. The euglycemic portion of the clamp will allow us to determine the hepatic glucose production and adipose tissue lipolysis. Secondary objectives also include measuring the neurohormonal response to hypoglycemia after 2 weeks on each diet.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least 1 year
* Hemoglobin A1c level \< 10% within the past 2 months
* Provision of signed and dated informed consent form by the adult (if person is at least 18 years old) or parent and assent form if the participant is \<18 years old.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* All sexes are eligible
* Diagnosis of type 1 diabetes for at least 1 year
* Insulin pump use for at least 2 months.
* Ability to perform daily blood ketone checks, wear a continuous glucose monitor, willing to wear an activity monitor, willing to adhere to the study diets and keep a diet journal.
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the dietary intervention.
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

* Current use of glucose-lowering agents other than insulin
* Unstable psychiatric disorders, including eating disorders
* Weight loss medications within the last 6 months
* Pregnancy or lactation, or planning pregnancy within the next 6 months
* BMI \< 19 kg/m2 for individuals 18 years of age or older
* BMI \< 5%ile for individuals under 18 years
* Weight less than 49 kg or 108 pounds
* Other medical conditions that may interfere with glucose metabolism and insulin sensitivity
Effect of Different Music Types on Implant Surgery Anxiety

A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed.

This delay in dentistry typically leads to much more serious dental problems, often leading to more expensive, more invasive and possibly emergency treatment. Therefore, reducing anxiety is important both in terms of patient, physician and cost.


Eligibility Criteria:
Inclusion Criteria:

* Will undergo elective implant surgery,
* between 40-70 years

Exclusion Criteria:

* Who does not agree to participate in the study,
* Under 40, over 70 years,
* Patients with ear disorders (ie, not suitable for musical intervention),
* arrhythmia
* patients with physical condition III or higher (American Society of Anesthesiologists)
Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia

This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.

Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery.

Exclusion Criteria:

1. Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
2. Pregnancy or lactation.
3. Patients with a history of allergy to aminophylline.
4. Patients with recurrent sinus surgery, hypertension.
A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors

INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically-documented solid tumors.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
3. Demonstrate adequate organ function.

Exclusion Criteria:

1. Prior history of or active malignant disease other than that being treated in this study.
2. Known brain metastases or cranial epidural disease.
3. A known hypersensitivity to the components of the study therapy or its' analogs.
Treatment Of Radiation Retinopathy Trial

The purpose of this study is to demonstrate a statistically significant improvement of visual acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in patients with radiation retinopathy.

Approximately 30-40% of patients develop a deterioration of visual acuity within 5 years after treatment of uveal melanoma using radiation therapy and TTT due to radiation retinopathy (Shields 2002, Bartlema 2003). By administration of either Lucentis® or Triamcinolone® we hope to treat complications of radiation therapy, by demonstrating a statistically significant improvement in visual acuity and a reduced amount of macular edema and vascular leakage. Additionally, we hope to obtain a better understanding of the pathophysiologic processes involved, by demonstrating a possible relation between high levels of angiogenic factors (VEGF) in the anterior chamber fluid, and radiation retinopathy. In conclusion, we hope to provide evidence for a new therapy in patients with retinopathy, due to radiation in uveal melanoma. There is no scientifically proven treatment available at this time.

Eligibility Criteria:
Inclusion Criteria:

* The eye was previously irradiated for treatment of a uveal melanoma;
* Decrease of visual acuity after irradiation therapy by more than 10 letters (ETDRS) and is now 20/40 or less;
* Vision decrease is considered to be due to central radiation retinopathy with significant macular edema or optic disc edema;
* Age 18 years or older;
* The patient is fully competent;
* Written informed consent to participate in the trial is given.
* Patient is not pregnant (or not fertile) and is willing to use contraceptives for the duration of the trial (one year)
* Patient is willing and able to return for follow-up.

Exclusion Criteria:

* Vision decrease is considered to be due to ischemic radiation retinopathy without macular edema or optic disc edema;
* Other, approved therapy indicated for treatment of condition;
* Presence of metastasis;
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
* Pre-existing retinopathy due to other disorders;
Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin

The objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition including fat and muscle mass with volume status.

The objectives of this study are to compare the effect of 50mg of ipragliflozin, a SGLT2 inhibitor, on glucose-lowering effect with 100mg of sitagliptin, a DPP4 inhibitor in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin.

We are also going to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers.

Changes of body composition including fat and muscle mass with volume status will be also examined.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with HbA1c 7.5% - 9.0% at screening visit
* Male or female between 20 and 75 years of age
* Patients taking sulfonylurea (glimepiride 1\~8mg or gliclazide 30\~120 mg or equivalent dose) and metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
* BMI ≥23 kg/m²
* Estimated GFR ≥ 60 ml/min/1.73m²
* Women of child bearing potential must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose and must have a negative urinary pregnancy test.

Exclusion Criteria:

* Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
* Patients with acute coronary syndrome within 3 months prior to screening visit
* Patients with acute coronary syndrome within 3 months prior to screening visit
* Pregnant or breastfeeding women or reproductive-age women who refuse contraception
* Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
* Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
* Other clinical trials within 30 days
* Alcohol abuse
* Contraindication to SGLT2 inhibitors or Dipeptidyl-peptidase 4 inhibitors
* Taking insulin, oral hypoglycemic agents other than metformin, sulfonylurea, and the study drugs.
Proteolytic Enzyme Induction Within the Human Myocardial Interstitium

A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor left ventricular (LV) function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF.

Patients with a reduced LVEF were prospectively randomized, in a blinded fashion, at the time of elective coronary revascularization and/or valve replacement requiring CPB, to infusion of the highly-selective and potent ET-ARA, sitaxsentan at 1 or 2 mg/kg (IV bolus) or vehicle (saline). Infusion of the ET-ARA/vehicle was performed immediately prior to separation from CPB and again at 12 hrs post-CPB. ET and hemodynamic measurements were performed at baseline, at separation from CPB (Time 0) and at 0.5, 6, 12, 24 hrs post-CPB.

Eligibility Criteria:
Inclusion Criteria:

* \>60 years of age
* Body mass index \<40 kg/m2
* Left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram
* Patients undergoing coronary artery bypass (CABG), aortic and/or mitral valve replacement or combined CABG and valve procedures requiring CPB.
* If diabetic, be under proper control, (fasting glucose \<350 mg/dL or recent hemoglobin A1c \[HgbA1c\] \<9%).
* If hypertensive, be on a stable medical regimen with no significant changes over the past 30 days.
* Female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years
* The patient is an appropriate study candidate as determined by the Investigator on the basis of medical history and physical examination

Exclusion Criteria:

* Emergent revascularization
* Previous stroke or thrombo-embolic event in the 3 months prior to study entry
* A previous myocardial infarction within the last 7 days
* Documented coagulopathy
* Hepatic dysfunction as defined by aspartate transaminase (AST) or alanine transaminase (ALT) \> 1.5 times the upper limit of normal
* Patient is pregnant or breastfeeding
Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) \< lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide informed consent
* Chronic HBV infection for at least 6 months
* Willing to follow protocol-specified contraception requirement

Key Exclusion Criteria:

* Have extensive fibrosis or cirrhosis in the liver
* Have or had liver cancer (hepatocellular carcinoma)
* Have an autoimmune disease
* Have chronic liver disease other than HBV
* Females who are breastfeeding, pregnant, or who wish to become pregnant during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Different Interfaces for Noninvasive Positive Pressure Ventilation (NPPV)

In this study the investigators aimed to study the ventilatory performance of different interfaces during NPPV delivering.

We will test the ventilatory performance in term of ventilatory pattern, muscle effort and gas exchange of different interfaces for NPPV.

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy subjects

Exclusion Criteria:

* Barotrauma
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France

The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 month history of GERD symptoms
* Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment
* Remaining GERD symptoms despite optimized PPI treatment
* Able to read and write in French, and able to comply with study requirements

Exclusion Criteria:

* Patients that have not experienced any GERD symptom improvement at all during PPI treatment
* Involvement in the planning or conduct of the study
* Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
* Prior surgery of the upper GI tract
Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy

Indications for colostomy are rectal or anal cancer, diverticular disease, radiation enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and functional disorders. It is frequently required in critically ill patients who may not be able to tolerate a laparotomy. Laparoscopic-assisted colostomy is an alternative method for colostomy without laparotomy, but require general anesthesia.

Additionally, percutaneous anterior colopexy under colonocopic control offers the possibility for improved and faster fixation of the anterior colonic wall to the anterior abdominal wall.

The objective of this study is to evaluate the feasibility of performing fecal diversion with the help of a colonoscope and colopexy, without the additional morbidity of abdominal exploration.

The colonoscope will be passed transanally into the left colon. It will be identified the endoscopic transilluminating point to the abdominal wall. Percutaneous anterior colopexy will be performed, using a gastropexy device that is included in the percutaneous endoscopic gastrostomy (PEG) kit . This technique involves the placement of a threaded nylon fastener into the colon through a needle.

The endoscope will be manipulated until the light approaches the premarked site. A small skin disc will then be removed at this location and a loop colostomy will be made. The colonoscope will also be used as a guide to identify the proximal and distal limbs of the loop colostomy.

Eligibility Criteria:
Inclusion Criteria:

* good health and without surgery

Exclusion Criteria:

-
Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting

The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard laboratory blood gas analysis (COHb) have reported contradictory results.

the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO poisoning, enabling rapid detection and management of patients with suspected CO poisoning in the prehospital emergency setting This study assesses the diagnostic value of pulse CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital management of patients with suspected carbon monoxide (CO) poisoning.

Transcutaneous SpCO will be obtained using the RAD-57 simultaneously with blood sampling for laboratory blood gas analysis, at the time of prehospital management by emergency medical services. The diagnostic performance of SpCO for the screening of CO poisoning will be determined using ROC curve analysis, and Blood COHb levels \>5% and 10% as the reference standard for CO poisonning for non-smokers and smokers respectively. Correlation between SpCO and COHb will be assessed using Bland and Altman's method.

Eligibility Criteria:
Inclusion criteria:

* Patient aged 18 years or older
* Patient managed by prehospital emergency medical services.
* Patient with a suspected CO exposure presenting or not with clinical signs of CO poisoning

Exclusion criteria:

* Patient for whom venous blood sampling cannot be obtained prehospitally
* Patient for whom SpCo measurement cannot be performed prehospitally (cardiac arrest, peripheral vasoconstriction)