cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is between 6.5% - 10.0%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients who are accepting treatments of arrhythmias
* Patients with serious diabetic complications
* Patients who are habitual excessive alcohol consumption.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
The Association of G9a Protein and Outcome of Patients With Endometrial Cancer

Tumor invasion and metastasis are the major causes of cancer-related death. Some studies have found that histone methyltransferases, such as EZH2, specifically affect metastasis in breast, gastric and prostate cancer. The functional roles of other members of the HMT family such as G9a in cancer remain obscure. Therefore, the investigators will investigate whether G9a have a role in recurrence/metastasis of endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* all cases with endometrial cancer underwent staging operation

Exclusion Criteria:

* nil
DiamondTemp Global Registry

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned procedure using commercially available DiamondTemp™ Ablation System
* Willing to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
* Subject with exclusion criteria required by local law
Myocardial Infarction Genes (MI-GENES) Study

This study is being done to better understand how genetic information might improve assessment of heart attack risk.

This study aims to randomize patients to 2 arms. The first arm will receive the conventional Framingham risk score for coronary heart disease while the intervention arm will receive the genetics-informed risk for coronary artery disease.

The investigators will assess baseline blood lipid levels and follow the 2 arms up to 6 months after randomization. Primary endpoint is change in LDL levels between the 2 arms. Secondary outcomes include blood pressure control, weight, smoking cessation, and other lifestyle modifications.

This trial will help us understand whether coronary artery disease risk derived from genetic information would have a significant impact on patients' perception of coronary artery disease risk and motivate healthy lifestyle modifications that reduce their long term risk.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 45-70 years
* Patients who have participated in the Mayo Clinic Biobank or a previous research study at Mayo Clinic
* Patients who live in Southeast Minnesota

Exclusion Criteria:

* Taking statin or other lipid lowering medications
* Patients with a history of myocardial infarction, coronary artery disease, or other atherosclerotic medical conditions
Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers

The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.


Eligibility Criteria:
Inclusion Criteria:

* Normal renal function

Exclusion Criteria:

* History of multiple clinically significant drug allergies
Realize the Current Situation of COPD Patients in China

This is a multi-centre, prospective, observational study to realize the current situation of COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites around China and followed up for one year. During this study, patients will undergo clinical assessments and receive medical care as determined by their treating physician.

This is a multi-centre, prospective, observational study. This study aims to observe the general situation in clinical practice, and the evolution and outcome of current usual care of COPD in China.This is an observational study. It will be carried out under routine clinical practice and the treatment will be determined by patients' treating physicians. Information about exposure to treatments as part of routine care will be collected (dose, frequency and duration).

A multi-stage, stratified and cluster sampling method will be used to select a nationally representative sample from the tertiary and secondary hospitals with respiratory department in six geographic regions around China as the study sites. Approximately 5000 patients with COPD will be enrolled from 50 selected study sites in order to recruit a nationally representative study population and followed up for one year.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients, more than 40 years old
* Clinically diagnosed as COPD (the patients are clinically diagnosed as COPD based on chronic cough, sputum, wheeze and a history of exposure to harmful factors, and confirmed by spirometry(FEV1/FVC\<0.7, post-bronchodilator according to GOLD 2016)
* Sign (or their legally-acceptable representatives must sign) and date the informed consent form indicating that they understand the purpose of and procedure required for the study and are willing to participate in the study.

Exclusion Criteria:

* Participated in any interventional clinical trial during the last 30 days
* With acute exacerbation within 4 weeks before enrolment
* Not suitable for study observation judged by investigators.
MPM Medical CoMatryx Surgical Bovine Collagen Study

The objective of this prospective enrollment study is to collect data confirming safety, performance and clinical benefits of the CoMatryx Surgical Collagen powder at a minimum 1-year follow-up and compare it to a historical control group who did not receive the product at the time of surgery.

The primary objective is to confirm safety and clinical benefits of the product. This will be assessed by recording the rate of wound healing and incidence and frequency of wound care related complications. Relationship of complications to the product should be specified.

The CoMatryx Surgical Collagen powder is a soft tissue repair product made of 100% Type I Bovine collagen. It is non-hydrolyzed and not cross-linked chemically. It is biocompatible, biodegradable and free of synthetics. The product does not have any specific storage requirements.

The CoMatryx Surgical Collagen powder provides a physiologically favorable environment to promote healing at the wound site. When administered, the powder conforms to the wound site and forms a gelatinous occlusive barrier. Along with providing 19 amino acids directly to the wound site it also occludes live nerve endings reducing pain. Treating the wound with the CoMatryx Surgical Collagen powder provides the non-hydrolyzed collagen wound surface promoting autolytic debridement. The powder is effective in all phases of wound healing and can be delivered with antibiotics in areas where there may be a cavity. This product has FDA 510(k) clearance for surgical wounds, full thickness wounds, traumatic wounds and skin tears.

Eligibility Criteria:
Inclusion Criteria:

* • Subjects must be 18 years of age or older

  * Subject must be willing and able to sign IRB approved informed consent
  * Subject must have a BMI of 35 or higher
  * Surgical approach of only ASI (anterior supine)
  * Primary total hip arthroplasty
  * Revision total hip arthroplasty

Exclusion Criteria:

* • Subjects more than 85 years of age

  * Subjects who will be or have undergone bilateral total hip replacements
  * Subject is known to be pregnant or nursing
  * Subject is an alcohol or drug abuser
  * Subject has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
Cognitive and Affective Processes Online

This study will provide data for evaluating the psychometric characteristics of the tests assessing cognitive flexibility, including their (1) internal consistency, (2) feasibility and tolerability, their (3) convergent and discriminant validity of cognitive and affective constructs such as those introduced to understand mental disorders, and (4) sensitivity (and correspondence) to individual differences. For these tests to be useful in studying clinical conditions, they must show adequate reliability, validity, and sensitivity in large samples of convenience.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* English-speaking
* Live in the U.S.
* Have access to an internet connected computer
* Users of the mTurk and Prolific survey website

Exclusion Criteria:

* NA
Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage

The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.

The physicians and nurses responsible for the individual patient's care will be given a questionaire. They are asked to estimate the functional and cognitive status as well as quality of life of their patient. The patient with intracerebral hemorrhage and subarachnoid hemorrhage is examined and assessed with respective established and validated prognostic scores and models at the same time points.

The actual prognosis is assessed by telephone interview and questionaires at 3 and 6 months, either from the patient or his/her caretaker.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage
* Treatment in Centers with neurocritical care expertise

Exclusion Criteria:

* Language other than German and English
* Restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives
* Admission \> 48 hours after symptom onset
* Hemorrhage due to trauma
Pulmonary Rehabilitation in Lymphangioleiomyomatosis

Lymphangioleiomyomatosis (LAM) is a rare disease in which reduced exercise capacity is frequently present. The mechanisms applied are airflow obstruction, abnormal diffusion capacity and dynamic hyperinflation (DH).

Pulmonary rehabilitation (PR) has proved benefit in improving exercise tolerance, dyspnea, and quality of life in chronic obstructive pulmonary disease. There are no studies evaluating the impact of PR in patients with LAM.

The hypothesis under study is that PR determine improvement in exercise capacity, dyspnea, quality of life, muscle force, functional limitation and DH in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lymphangioleiomyomatosis established by tissue biopsy and / or a combination of history and high-resolution computed tomography scanning
* Clinical stability, defined as no exacerbations or hospitalizations related to the underlying disease for a minimum of 6 weeks and no change in the treatment regimen in the last 3 months
* Low level of physical activity, defined as patients who walk less than 10 thousand daily steps and / or are not performing regular physical activity for at least 4 months before the start of rehabilitation
* Signature of the free, prior and informed consent for participation in the study

Exclusion Criteria:

* Lung transplant recipients
* Musculoskeletal disorders that would prevent the patient from performing exercise training
* Severe (NYHA IV) or uncontrolled heart disease
Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack

Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time.

Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack.

Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA).

If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Successful primary percutaneous coronary intervention (PCI) within the previous week with no major complications at the index procedure
* Bystander disease in a non-culprit vessel planned for clinically indicated staged angiography +/- PCI
* Able to provide written informed consent.

Exclusion Criteria:

* Cardiogenic shock requiring intubation, inotropes or a mechanical support device
* Creatinine clearance \<30ml/min
* Prior coronary artery bypass grafting
* Life expectancy less than 3 years
* Pregnancy.
* Target lesion in the left main coronary artery
* Severe calcification or tortuosity that would threaten safe placement of a pressure wire or OCT catheter
* Chronic total occlusion of a major epicardial vessel.
Bupropion and Cigarette-Related Cues in Smokers

Randomized, double-blind, before-after controlled trial to assess changes in regional brain activation in response to cigarette-related cues from before to after treatment with bupropion (vs placebo).


Eligibility Criteria:
Inclusion Criteria:

* Treatment-seeking cigarette smoker
* Meet DSM-IV criteria for nicotine dependence
* Negative result on urine test for drug use during screening

Exclusion Criteria:

* History of any Axis I psychiatric diagnosis other than nicotine dependence
* Medical conditions that might affect brain function
* Current use of medications that could alter brain function
* Pregnancy
* Current illicit drug use other than occasional use of marijuana
A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD

Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

CE Mark approved indication of use which includes

* At least 55 years of age
* Bilateral visual impairment due to geographic atrophy or disciform scars
* Evidence of cataract

Exclusion Criteria:

* Active CNV (or 'wet' AMD)
* Prior cataract or refractive surgery in the study eye
Influenza Reminder Text-Messaging

Through a large, population-level quality improvement effort within the Children's Hospital of Philadelphia Care Network, we will evaluate text message reminders on flu vaccination rates for both patients with and without a scheduled well child care visit during flu season.

This is a randomized control trial with two patient cohorts: patients with and without a scheduled well child care visit during the upcoming 2024 flu season. Patients with a scheduled well child visit will be randomized into one of three groups (control, intervention message #1, or intervention message #2). Patients within the intervention groups will receive a one-time text message reminder to get their flu shot for their child at their child's upcoming well visit. Intervention groups will be texted at the same time, the same month as their child's well visit. The text message language will differ between groups. Patients without a scheduled upcoming well child visit during the 2024 flu season will also be randomized into one of three groups (control, intervention message #1, or intervention message #2). Intervention groups will be texted at the same time, at the start of flu season. The text message language will differ between groups.

Flu vaccine uptake will be measured within each patient cohort.

Eligibility Criteria:
Inclusion Criteria:

* All patients between ages 6 months-18 years old who have an upcoming well visit during the Fall of 2024 (September through December 2024) or had a completed well visit from January 2023 through August 2024
* Patients have a mobile phone number within their medical record
* Patients have opted-in to text communications from CHOP
* English-speaking

Exclusion Criteria:

* Subjects who do not meet the above inclusion criteria will be excluded
Spironolactone in CKD Enabled by Chlorthalidone: PILOT

Highly prevalent among patients with chronic kidney disease (CKD) and poorly controlled blood pressure (BP), is a modifiable risk factor to abrogate both kidney failure progression and cardiovascular (CV) disease. Spironolactone (SPL), a mineralocorticoid receptor antagonist, is widely used to treat resistant hypertension, however one of the most common side effects is an increase of serum potassium (K). This side effect occurs frequently in those who suffer from CKD. Alternatively, chlorthalidone (CTD) is a thiazide-like diuretic used for treating hypertension and decreases serum K. In this pilot study, our goal is to assess whether the combination of SPL and CTD can improve BP control, while also reducing the risk of hyperkalemia over a period of 12 weeks. We hypothesize that among patients with CKD and poorly controlled hypertension, compared to SPL and placebo, treatment over 12 weeks with CTD will counter the hyperkalemia effect of SPL, and therefore the combination of SPL with CTD will result in a lower BP. This pilot study will be performed at Richard L. Roudebush VA in Indianapolis, Indiana.

This is a placebo-controlled, double-blind, randomized controlled trial of spironolactone (SPL) and chlorthalidone (CTD) in patients with CKD and poorly controlled hypertension

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years.
2. GFR estimated by CKD-EPI formula \< 45 ml/min/1.73 m2 but ≥ 15 mL/min/1.73 m2 using IDMS-calibrated creatinine.
3. Hypertension. Using AOBP monitoring, BP of ≥ 130/80 mmHg.
4. Treatment with antihypertensive drugs: This would require the use of at least one antihypertensive drug. One of the drugs should be either an ACE inhibitor or ARB or a beta-blocker at the time of randomization.
5. Serum K 3.5 to 5.2 mEq/L at the time of randomization. In patients with eGFR \< 45 ml/min/1.73 m2 and serum K \> 5.2 mEq/L

Exclusion Criteria:

1. Use of spironolactone, eplerenone, amiloride, triamterene, thiazides, or thiazide-like drugs or the use of K supplements or K binders in the previous 12 weeks.
2. Expected to receive renal replacement therapy within the next 6 months.
3. Myocardial infarction, heart failure hospitalization, or stroke ≤ 12 weeks prior to randomization.
4. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
5. Known hypersensitivity to thiazide or spironolactone.
6. Clinic AOBP \<110 mmHg systolic at their first visit
Study on Fear of Movement After Total Knee Arthroplasty

Total knee arthroplasty is one of the effective methods for the treatment of end-stage osteoarthritis. Postoperative rehabilitation exercise is an important method for the recovery of knee joint function. Exercise fear refers to an enlarged psychological phenomenon that patients are afraid of sports leading to injury, which is not conducive to the functional exercise of patients and hinders the recovery of knee joint function

Object: the purpose of this study is to investigate the occurrence of fear of movement after total knee arthroplasty and analyze its influencing factors, so as to provide theoretical basis for reducing the occurrence of fear of movement after total knee arthroplasty, promoting the rehabilitation exercise of patients and promoting the recovery of knee joint function.

In this study, 121 patients with total knee arthroplasty were investigated by questionnaire, including general demographic data, sports fear scale, anxiety and depression scale, self-efficacy scale and so on. Multivariate logistic regression was used to analyze the influencing factors of postoperative fear of exercise.

Eligibility Criteria:
Inclusion Criteria:

（1） meeting the criteria of knee arthritis established by American Society of rheumatology （ 2) Total knee arthroplasty was performed for the first time （ 3) Good Chinese reading and comprehension ability （ 4) The patient's condition was stable, and there were no serious diseases of the heart, lung, brain and other important organs （ 5) Informed of the study and signed informed consent.

Exclusion Criteria:

（1）deep venous thrombosis of lower extremity （ 2) Other diseases affecting walking function （ 3) Suffering from cognitive or mental disorders （ 4) Had a history of knee surgery