cyrilzakka/clinical-trials huggingface dataset:
Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study

This is the clinical trial designed to assess the cardiac diastolic function of long term treatment with teneligliptin compared to that without teneligliptin in patients with type 2 diabetes mellitus by two arms; one includes patients showing E/e' by echocardiography less than 8, the other includes patients showing E/e' by echocardiography more than 8.


Eligibility Criteria:
Inclusion Criteria:

* Asians aged from 20 to 85 years old at baseline
* Patients with type 2 diabetes mellitus and including either A) or B) criteria.

A) Patients necessary to start the treatment using anti-diabetic agent(s) or to change the anti-diabetic agent(s).

B) Patients possible to change the anti-diabetic agent(s).

* Patients with left ventricular ejection fraction more than 40%
* Patients with written informed consent

Exclusion Criteria:

* Patients with type 1 diabetes mellitus
* Patients with slowly progressive type 1 diabetes mellitus positive for pancreatic islets related autoimmune antibody as GAD antibody or IA-2 antibody or ICA antibody
* Patients with diabetes mellitus caused by evident genetic factors
* Patients with diabetes mellitus caused by secondary factors as endocrine disease or liver disease
* Patients with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome
* Patients with any severe infectious diseases or planed any surgical treatments or suffered any severe traumas
* Patients with severe liver dysfunction
* Patients with hypophyseoprivic or adrenal insufficiency
* Patients under malnutrition or starved state or irregular caloric intake or calorie insufficiency or hyposthenia
* Patients judged to be unsuitable for the study as they are planning to exercise intensively
* Patients judged to be unsuitable for the study as they may drink excessively or abuse drugs
* Patients showing QT prolongation in the electrocardiogram
* Patients with any past histories of heart failure showing NYHA classification grade more than 3 at baseline
* Patients with any past histories of acute coronary syndrome or coronary intervention or cardiac surgery developed within 6 months
* Patients with any surgical past histories of mitral valve replacement or mitral valve repair or severe calcification of mitral valve
* Patients already treated with Teneligliptin
* Women with breast-feeding
* Pregnant women or patients who have possibilities of pregnancy
* Patients expected to live less than 3 years
* Patients with any past histories of drug hypersensitivity against Teneligliptin
* Patients already involved in any other interventional clinical trials or planned to be involved
* Patients judged to be inappropriate for the study by the doctors in charge
Study Evaluating the Efficacy and Safety of Etanercept

To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.


Eligibility Criteria:
Inclusion Criteria:

* A negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide).
* Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation because of lack of clinical efficacy).
* Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid arthritis.

Exclusion Criteria:

* Uncooperative patients with a history of poor compliance.
* Known hypersensitivity to etanercept or any of its components.
* Known significant concurrent medical disease
Effect of Melatonin Patches on Sleep in Urological Surgery

Patients undergoing urological surgery may experience a decrease in sleep quality due to many factors such as hospitalization, different environment, pain, stress and anesthesia. After surgery, melatonin secretion decreases and circadian rhythm becomes irregular in patients. This problem can lead to sleep disorders in patients. Melatonin is an important hormone that regulates both sleep and circadian rhythms. The aim of this study is to observe the effect of a melatonin skin patch designed to produce melatonin in a way that ensures a stable increase in melatonin levels in the blood, on patients undergoing urological surgery.

The purpose of this study was to observe the effect of a melatonin skin patch designed to produce melatonin, which would provide a stable increase in blood melatonin levels, on patients undergoing urological surgery. The patients were applied a melatonin patch before surgery. The other group received routine nursing care.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone planned urological surgery,

  * Those who receive melatonin patch therapy,
  * Those who are between the ages of 18-70,
  * Those whose hemodynamic conditions are stable will be included.

Exclusion Criteria:

* •Patients who used different sleeping pills/hypnotics during the study period,

  * Patients with delirium/psychiatric illness,
  * Patients with hearing and speech problems will not be included.
Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries

Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. The Genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.


Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years old
* lesion in native coronary artery
* de-novo stenosis
* indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic FFR)
* range of reference diameter 2.5 to 4.0mm

Exclusion Criteria:

* lesion in saphenous vein graft
* chronic total occlusion
* bifurcation lesion requiring stenting of main and side branch
* left main stenosis
* restenosis
* in-Stent restenosis
* contraindication for dual antiplatelet therapy for the following 6 months
* coronary aneurysm in target vessel
Performance of Pulmonary Embolism Risk Scores Out Come in CTPA Confirmed Patients

1. Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients.
2. Compare PERFORM score with the currently validated PESI in risk stratification of patients

Pulmonary embolism (PE) is a common and potentially lethal condition in the emergency department requiring early and accurate management.

The short-term mortality rate of PE varies widely and ranges from less than 2% in many patients with non massive PE to more than 95% in patients who experience cardiorespiratory arrest.

Although several prognostic models of acute PE are currently used, all of them have practical limitations.

Of all clinical scores integrating PE severity and comorbidity, the Pulmonary Embolism Severity Index (PESI) and its simplified version,(sPESI) have been most extensively validated to date.

However, current prognostic scores for pulmonary embolism (PE) are partly based on patients without PE confirmation via computed tomographic pulmonary angiography (CTPA), involving subjective parameters and complicated scoring methods \[8\].

Therefore, an objective, accurate, and simple prognostic model in CTPA-confirmed patients to predict the risk of 30-day mortality. help clinicians assess patients' risks and improve therapeutic decision-making that is called PERFORM score (pulmonary embolism risk score for mortality)

Eligibility Criteria:
Inclusion Criteria:

- Patients above 18 years old with PE confirmed by CTPA are considered for inclusion in the study.

Exclusion Criteria:

* • Patients who have contraindications for CTPA eg. Renal impairment

  * Patients diagnosed and treated as PE without doing CTPA.
  * Patients who refuse to participate in the study
Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

Single Ascending Dose Study


Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed Consent
* Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* Inability to understand or cooperate with given information
* Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis
Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care

Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly immobilized persons, increasing the burden of care to professionals in the health system, as well as pharmaceutical spending. There are studies of the effectiveness of various products in the prevention of the UPP, most made in hospitals and using fundamentally composed based on oily hyperbecome oxygenated acids (AGHO).

There do not exist studies realized specifically with cream of olive oil.

AIMS:

Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost - efficiency of this new intervention opposite to AGHO's application.

To value the degree of satisfaction of the patient and his keeper with regard to the use of cream of olive oil.

METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil to the group of intervention and AGHO's administration to the group control. Follow-up for one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and clinical data, presence of technical supports, information of the caragiver and questionnaire of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio. Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the increase cost efficiency (ICER). Logistic regression model multivariant.


Eligibility Criteria:
Inclusion criteria:

* Patients with nursing diagnosis "risk of impaired skin integrity. "To determine this risk assessment tool we will use as the Braden scale. We will include only patients immobilized with increased risk of pressure ulcers (score less than or equal to 16).
* Patients with malnutrition or suspected malnutrition. To determine this state as an instrument we will use Mini Nutritional Assessment Scale "MNA" (score 10 points or less)
* Over 18 years.

Exclusion criteria:

* Patients refusal to participate in the study.
* Moved (patient no habitual residence in the health center where they make the study).
* Patients with plans to be out of the study area during the monitoring year.
* Hospitalized during the uptake phase of the sample
* Patient-terminal.
* Patient with the presence of pressure ulcers.
Evaluating a Social and Communication Intervention for Preschoolers

The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with ASD in real world, large scale settings. ASD preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.

In Phase 4, KKI staff trained Delaware preschool teachers to serve as model coaches and educators through the Delaware Autism Program. Families whose children were enrolled in participating classrooms were consented through DAP using the school's consent to be videotaped. Any families who did not consent for their child to be videotaped for this training received the nonparticipant consent form currently utilized in this study and staff videotaping took every effort to keep those children out of frame when taping. This cohort involved KKI study team members training 1-2 coaches, who then trained five Delaware school teachers. The IES model was implemented in the teacher's classrooms (n= 5-10 students participating in each classroom; 20-40 children total).

In the current phase of the study, Phase 5 and 6, KKI study team members will continue the evaluation of the IES model, by testing the efficacy of the intervention model in a larger sample (Phase 5) and then analyzing the corresponding data (Phase 6). The larger efficacy study (phase 5) will be conducted on teachers and students recruited from public school districts in Maryland, Delaware, and Pennsylvania using the same IES model and recruitment methods in the previous phases.

Eligibility Criteria:
Inclusion Criteria:

For Teachers:

- Work in an ASD preschool classroom within a cooperating Baltimore County Public School.

For Children:

* Meet Autism Diagnostic Observation Schedule-Generic (ADOS; Lord et al., 2002) and expert clinical judgment criteria for ASD
* Have an IQ or Developmental Quotient of at least 40 based on the Early Learning Composite from the Mullen Scales of Early Learning (Mullen, 1995)
* Be enrolled in a participating Baltimore County Public School ASD preschool classroom
* Be between the ages of 3 and 6 and enrolled in a participating ASD preschool classroom.

Exclusion Criteria:

Children and educators may be taken out of the study if they:

* Are unable to comply with the study protocol
* Change schools due to relocation

Children may also be taken out of this study if they:

* Sustain a head injury or other serious physical injury during the study
* Are not being brought in for testing as designated in the protocol
Clinical Utility Study for Exo-PDAC

This is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 250 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPV®s describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV® administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV® administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.

If physicians are randomized to an intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV® administration. They are asked to review these materials before moving to the next CPV® administration round. The time to review educational materials is estimated to be approximately 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Board-certified for at least two years
* Averaging at least 20 hours per week of clinical and patient care duties over the last six months
* Routinely evaluate patients at risk for pancreatic cancer in their practice
* Practicing in the U.S.
* English speaking
* Access to the internet
* Informed, signed, and voluntarily consented to be in the study

Exclusion Criteria:

* Non-English speaking
* Unable to access the internet
* Not practicing in the U.S.
* Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
* Previous exposure to the test
* Do not voluntarily consent to be in the study
An RCT to Compare Early Continence Recovery After RARP With or Without Sustainable Functional Urethral Reconstruction

The study is a prospective randomized controlled trail to compare early urinary continence recovery after robotic-assisted radical prostatectomy with or without sustainable functional urethral reconstruction (SFUR).

Early urinary incontinence has always been a tricky problem for both patients and urologists, even though over 90% patients can recover 1 year after surgery. Many urologists are trying to modify the surgical technique to resolve this problem. Sustainable functional urethral reconstruction (SFUR) is a novel technique which may improve early urinary continence recovery for both local and locally advanced prostate cancer, and even for those with high volume prostate by providing adequate urethral length with bladder neck tubularization and making sustainable periurethral support with peritoneal flap. The purpose of this study is to verify the impact of this new technique on early recovery of urinary continence, as well as on urinary function and oncological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥40, but ≤75 years old；
* Histological confirmed prostate cancer；
* Localized or locally advanced prostate cancer；
* Presence of urinary continence prior to the procedure;
* Informed consent signed;

Exclusion Criteria:

* Metastatic prostate cancer confirmed by ECT, PSMA or whole-body MRI;
* Presence of any prostatic surgery(such as transurethral resection, laser therapy, microwave therapy, radiofrequency ablation and so on) prior to the procedure;
* Radiation therapy of the prostate or pelvis prior to the procedure;
* Uncontrolled intercurrent illness that would limit compliance with study requirements;
* Any condition that contraindicates a radical prostatectomy;
Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagonlike peptide-1 (GLP-1) mimetics or analogs, which rely on the gastrointestinal hormones that are part of the incretin system for the treatment of T2DM, provide a therapeutic alternative to common oral antihyperglycemic agents (eg, sulfonylureas, thiazolidinediones). Although GLP-1 analogs and DPP-4 inhibitor medications are effective, there are differences between these products, including method of administration (injectable versus oral). Previous studies have shown that patients prefer additional oral agents over injectable agents because of fear of injections and the desire to avoid them. Patient preference is both clinically and financially important, as it can have long-term implications in terms of patients' motivation and insight into their disease state and its treatment, which might have a direct impact on the patient's compliance and treatment adherence. The aim of the current study is to evaluate the proportion of T2DM patients preferring oral anti-diabetic treatment with vildagliptin + metformin versus an injectable anti-diabetic treatment with liraglutide after 4 weeks of treatment with each medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Metformin monotherapy \> 12 weeks
* Hemoglobin A1c (HbA1c) \> 6.5 % and \< 9.0 %
* Body mass Index (BMI) 19-35 (kg/m²)

Exclusion Criteria:

* acute diseases at randomization
* kidney diseases with creatinin \> 120 µmol/l, glomerular filtration rate (GFR) \<50 ml/min
* contraindication for Gliptins or glucagon-like-peptide-analogues according to the respective Summary of Product Characteristics (SmPC)
* previous use of dipeptidyl peptidase-4-inhibitors and GLP-1-mimetics

Other protocol-defined inclusion/exclusion criteria may apply.
Oseltamivir Pharmacokinetics in Morbid Obesity

This trial asks the question: do people of much greater than average body weight need more of a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given to people who have influenza, and currently is also being used to fight the new H1N1 influenza. Some people of larger than average body weight require larger amounts of drugs to see the same effects as others of an average body weight. No studies have ever been conducted looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis states that those of an above average body weight will have different amounts of drug in their blood than those of people of normal body weight if they are given the normal amount prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half of the people will be of normal body weight and the others will be of a much higher than normal body weight. Using blood samples the investigators will determine if the amounts of oseltamivir are significantly lower in the blood of patients in the above normal body weight group.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 55 years
* Written informed consent
* Subjects without medical history, physical finding or laboratory finding, which, in the opinion of the investigator, could pose a safety concern or interfere with the protocol.

Exclusion Criteria:

* Allergy to oseltamivir
* Blood donation within 3 months before oseltamivir administration
* Medications that may interfere with the disposition of oseltamivir (e.g. probenecid)
* Anemia
* Estimated Creatinine clearance \< 60 ml/min (As calculated by the modified Cockcroft Gault equation below) Creatinine Clearance= (140-Age) x 1.2 x Adjusted Body weight (x 0.85 if female) Serum Creatinine (umol/L)

Adjusted body weight = Ideal body weight + \[0.4 (Actual Bodyweight-Ideal Body Weight)\]

* Gastrectomy
* Enterectomy (or any other surgical procedure that would interfere with absorption)
* Clinically significant haematological (RBC count, WBC count, WBC differential count, platelets count and haemoglobin level) or biochemical (ALT, AST, creatinine and urea) abnormalities as per the judgement of the investigator
* Clinically significant cardiac conduction abnormality noted on baseline electrocardiogram.
* Influenza like illness (fever and/or cough plus one of the following sore throat, fatigue, myalgia, headache) within 7 days of enrolment
* Pregnancy
* Inability to consume study meals provided due to special dietary requirements such as food allergies.