cyrilzakka/clinical-trials huggingface dataset:
A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea

The purpose of this study is to evaluate safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected in the precautions for use, ADRs already known, non-serious ADRs and other safety related information among participants who have received alogliptin for type 2 diabetes mellitus.

This is a long-term prospective, observational post-marketing surveillance study of alogliptin in participants with T2DM. The study assessed the safety and effectiveness of alogliptin for its approved indication within a real-world setting in South Korea.

The study will enroll approximately 3000 participants. The data is collected prospectively at the study sites and recorded in electronic case report forms (e-CRFs). All the participants are assigned to a single observational cohort:

• Nesina® Tablet

The multi-center study is conducted in South Korea. Data is collected at 13 and 26 weeks after enrollment during standard of care office visits. The overall study was conducted during re-examination period of approximately 5 years and 4 months.

Eligibility Criteria:
Inclusion Criteria:

1. Had one of the following treatments with alogliptin for the first time as an adjunct to diet and exercise to improve glycemic control:

* Monotherapy with alogliptin
* Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with metformin or sulfonylurea or thiazolidinedione single therapy
* Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with thiazolidinedione and metformin combination therapy
* Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with insulin (single therapy or combination with metformin) therapy
* Combination therapy with metformin in patients who have no prior history of antidiabetic medication and may not achieve adequate glycemic control with monotherapy alogliptin

Exclusion Criteria:

1. Had alogliptin treatment outside of the locally approved label in Korea
2. Had a contraindication for the use of alogliptin (as described in the Korean product label)
Microelectrode Recordings From the Vagus Nerve in Awake Humans

This Anchillary project uses a refined technique of ultrasound-guided microneurography of the human cervical vagus nerve, an approach developed by Professor Vaughan Macefield and used safely to-date in 44 prior study participants.

The overall goal of this project is to build upon prior data obtained using this approach by undertaking a detailed neurophysiological investigation of the human vagus nerve and to identify the nerve fibers activated during vagal nerve stimulation (VNS) in participants with implanted VNS devices in response to different stimulation parameters. In addition to providing data in unprecedented detail into the physiology of the human vagus nerve, this project will investigate different stimulus intensities, durations and frequencies that differentially excite myelinated and unmyelinated nerve fibers. These results will inform the CSP and guide future development of novel neural interfaces for VNS for various clinical applications.


Eligibility Criteria:
Inclusion Criteria:

* The participant is greater than or equal to (≥)18 years and is less than or equal to (≤) 40 years of age
* English speaking
* Medicare covered or equivalent health insurance from a partner country

Exclusion Criteria:

* Pregnant
* Smokes and is unwilling to abstain from smoking on the day of the experiment.
* Inability or unwillingness to provide written informed consent.
* Individuals with difficulty standing unassisted for 5 minutes during the tilt-table testing
* Individuals found to have a significant carotid artery plaque or intima-media thickness \> 1 mm as assessed by ultrasonography during the ultrasound-screening steps of the study visit
* Vagus nerve not visible on ultrasound
* VNS electrodes are not in a suitable location to allow for microelectrode insertion
* Any other clinical reasons deemed by the investigators
A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients

The proposed study will be conducted to investigate the mechanism of patients' responses to prone positioning with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS utilizing lung ultrasound.

This is a prospective observational study of adult patients with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS who are intubated, in the prone position and receiving mechanical ventilation in the intensive care units at Rush University Medical Center. In this study design, we will prospectively enroll subjects, who fulfill eligibility criteria, to investigate the mechanism of their responses to the first three prone positioning sessions, utilizing lung ultrasound (LUS). Inclusion criteria include: adult subjects 18 years and older with a diagnosis of ARDS, endotracheally intubated and receiving assisted mechanical ventilation, meet criteria for prone positioning (ratio of arterial oxygen tension to the fraction of inspired oxygen (PaO2/FiO2) of ≤ 150 mm Hg with ventilator parameters of positive end-expiratory pressure (PEEP) ≥ 10 cm H2O and FiO2 of .60, and order for prone positioning. Patients will be excluded from the study if they meet the following criteria: pregnant, tracheostomy, receiving extracorporeal membrane oxygenation (ECMO), palliative care, received prone positioning more than once during intubation in an outside hospital, or receive invasive ventilation in an outside hospital for more than 72 hours. Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects 18 years and older, diagnosis of ARDS
2. endotracheally intubated and receiving assisted mechanical ventilation
3. meet criteria for prone positioning: PaO2/FIO2 (P/F ratio) of ≤ 150 mm Hg with ventilator parameters of PEEP ≥ 10 cm H2O and FiO2 of .60
4. receive an order for prone positioning.

Exclusion Criteria:

1. Pregnant
2. Tracheostomy
3. Receiving ECMO
4. Palliative care
5. Receive prone positioning more than once during intubation in an outside hospital
6. Receive invasive ventilation in an outside hospital for more than 72 hours
Screening Platform for Clinical Trials in Advanced Colorectal Cancer

The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials.

Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients.

A major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients.

The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.


Eligibility Criteria:
Inclusion Criteria:

* Colo-rectal cancer (advanced or metastatic)
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Absence of patient's consent
The Vitamin B Status in Type 2 Diabetes (VITA) Study

The objective of this study was to evaluate vitamin B deficiency (particularly vitamin B6 deficiency) in diabetic patients in Germany in relation to the presence or absence of proteinuria, and global vascular risk.

This observational study recruited either control subjects or patients with type 2 diabetes for over 5 years and collected information on cardiovascular risk factors. Fasting blood samples and urine were collected and biomarkers of B-vitamins were measured and were related to renal function or to global cardiovascular risk. Global cardiovascular risk was calculated from established models that include Routine clinical and laboratory markers such as plasma lipids, smoking, hypertension, and BMI.

we measured the following markers: Glucose (fasting plasma glucose); HbA1C; serum creatinine; Glomerular filtration rate (GFR), urinary Albumin, C-reactive Protein, Soluble vascular cell adhesion molecule 1 (sVCAM-1), cystatin C, vitamin B1, vitamin B12, holotranscobalamin, methylmalonic acid, homocysteine, and different vitamin B6 forms.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent before any study-related activities
2. Ambulatory subject \>18 years of age

   For patients with type 2 Diabetes:
3. Duration of diabetes ≥ 5 years
4. Glycated haemoglobin (HbA1C) \<10%
5. Body mass index (BMI) 19-40 kg/m2

   For healthy controls:
6. No diabetes (normal fasting glucose levels measured by stick)

Exclusion Criteria:

1. End stage renal disease (creatinine clearance \<10 mL/min)
2. Severe excess alcohol consumption (\>50 units/week)
3. Severe co-morbidities
4. Renal and/or pancreatic transplant
5. Vitamin B1, B6 and/or B12 substitution (incl. multivitamin preparations)
6. Participation in an interventional study within 30 previous days;
7. Patient is female and pregnant or lactating
8. Patient is female in a childbearing age without adequate contraceptive precaution
Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults.

The purpose of this study was to evaluate the effects of a video-supported group-based Otago exercise programme intervention on balance, mobility, physical performance and aerobic endurance in community-dwelling older adults 65+ years old.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years and older.
* Living in the community (Valencia, Spain).
* Able to ambulate independently without a walking aid.
* Have no severe medical contraindication for physical activity.
* Able to communicate.
* Have self-reported visual and auditory capacities to follow commands.
* Provide signed informed consent.

Exclusion Criteria:

* Unable to ambulate independently.
* Mini-mental state examination score of \<24.
* Barthel Index score of \<80.
* Severe visual and auditory disabilities.
* Unstable cardiovascular disease.
* Neurological disorder that could compromise them from exercising.
* Upper or lower extremity fracture in the past year.
Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS

The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Patients with symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
* Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
* Left ventricular ejection fraction \> 30%;
* Patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement;
* Target de-novo lesion;
* Target lesion located in a target vessel with a diameter ranging from 2.5 to 3.75 mm;
* Target lesion diameter stenosis \> 50% and \< 100% by visual estimate, with a TIMI flow of \>=1;
* Discrete lesion with a length ranging from 13 to 25 mm;
* The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (Cre8 or Vision/Multilink 8), according to the randomization arm;
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Female with childbearing potential or lactating;
* Patient presenting with acute myocardial infarction with ST elevation;
* Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
* Cerebrovascular accident within the past 6 months;
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
* Thrombocytopenia (platelet count less than 100,000/mm³);
* Known bleeding or hypercoagulable disorder;
* Currently under immunosuppressant therapy;
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
* Patient underwent target vessel revascularization with a DES;
* Heavily calcified vessel and/or lesion which cannot be successfully predilated or imaged by OCT
* Target lesion is located or supplied by an arterial or venous bypass graft;
* Lesion located very distally, difficult to be imaged by OCT;
* Lesion located in angulated (\>70°), sharp take-off vessel;
* Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
* Target lesion located in the left main stem;
* Ostial lesion location;
* Target lesion has TIMI 0 flow;
* Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.
Incidence and Predictors of Delirium After Cardiac Surgery

The objective of the present research is to evaluate the incidence and independent predictors of delirium observed among patients after cardiac surgery. Moreover, to asses the sensitivity and specificity of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (DSM-IV) and International Statistical Classification of Diseases and Health Related Problems - Tenth Revision criteria (ICD-10), and the cut-off values of the Memorial Delirium Assessment Scale (MDAS) and Delirium Index (DI) in diagnosing postoperative delirium.

Since 1954, the issue of delirium as a complication following cardiac surgery has been extensively investigated. Despite this, postoperative delirium is still a serious event that results in higher morbidity and mortality rates, and prolongs hospitalisation.

Moreover, there is a considerable discrepancy between studies on the incidence and risk factors of delirium among cardiac surgery patients.The first potential reason for this observation is retrospective design of some studies, secondly, the modest number of participants in numerous prospective studies which does not provide strong statistical power to select patients with delirium and detect risk factors of this complication. Unfortunately, reports with a more considerable number of patients often have methodological limitations. Additionally, in previous studies authors usually analyzed pre- and intraoperative variables ignoring potential postoperative risk factors of delirium. Finally, some variables which seem to have a crucial role in aetiology of delirium after cardiac surgery, particularly perioperative hypoxia, anaemia, and preoperative psychiatric disorders like depression and cognitive impairment, have not been properly investigated to date.

Therefore, we made an effort to design a prospective study on the incidence and predictors of delirium after different types of cardiac surgery, conducted by experienced investigators, and with the use of valid diagnostic tools.To our knowledge this is the first research pointing out the association between preoperative psychiatric comorbidity, anaemia and postoperative hypoxia, and delirium after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and older
* Patients who signed an informed consent
* Patients scheduled for cardiac surgery with extracorporeal circulation (coronary-artery bypass grafting (CABG), cardiac valve replacement (CVR), combined CABG + CVR, excision of cardiac myxoma)

Exclusion Criteria:

* Patients who refuse to participate before or after operation
* Patients who undergo urgent surgery
* Patients in poor general condition
* Patients with preoperative dementia, delirium or illiterate
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.

Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles.

The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. ≥ 18 years old at the time of informed consent
3. Ability to provide written informed consent and HIPAA authorization
4. Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
5. Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion

Notes:

* Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy
* Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center

Exclusion Criteria:

1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
2. Not a candidate for curative radiation therapy per radiation oncologist's discretion
3. Prior radiation therapy to the pelvis
4. Women who are pregnant or nursing
A Study to Learn About the Study Medicine (Called Tofacitinib) in People With Psoriatic Arthritis

The purpose of this study is to learn about the safety and effects of the study medicine for the potential treatment of Psoriatic Arthritis (PsA). Psoriatic Arthritis is a joint swelling disease that can also affect the skin, nails and eyes. The study medicine is called Tofacitinib. This study is seeking participants who:

* Started taking tofacitinib alone or with other approved medicines (eg. methotrexate, leflunomide, sulfasalazine, apremilast) for PsA disease. We will only look at participants' who started tofacitinib after December 14, 2017.
* Have a 6-month follow-up visit (with a 3-month window) This is an observational study. Participants receiving Tofacitinib will be included to assess how well tofacitinib works. We will look at participants' demographic information and therapy history. We will also monitor participants' disease progression before and 6 months after treatment. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.

Tofacitinib is an oral Janus kinase (JAK) inhibitor approved in 2017 by the US Food and Drug Administration (FDA) for the treatment of adult patients with active PsA who have had an inadequate response or intolerance to methotrexate or other disease modifying antirheumatic drugs (DMARDs). As of December 3, 2021, Tofacitinib is approved for use in patients who have had an inadequate response or intolerance to one or more TNF blockers.

This is an observational retrospective cohort study that will be conducted using patients enrolled in the CorEvitas PsA/SpA Registry, initiating tofacitinib on or after December 14th, 2017. Patients receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and when stratified by key variables of interest. More specifically, the overall aim will be to describe baseline demographic, therapy history, and disease activity characteristics and assess change in disease activity measures six months after initiation of tofacitinib.

There are two primary objectives for this study:

1. To describe the effectiveness of all tofacitinib initiators at 6 months in PsA patients
2. To describe the effectiveness of all tofacitinib initiators at 6 months stratified by monotherapy and combination therapy of PsA

Eligibility Criteria:
Inclusion Criteria:

* PsA patients in CorEvitas initiating tofacitinib monotherapy or in combination with oral small molecules (eg methotrexate, leflunomide, sulfasalazine, apremilast) after 14 December 2017 (market approval of tofacitinib in the US) with no prior use of tofacitinib. Only the patient's first initiation after December 14, 2017 will be included in the analysis
* Have a 6 month follow-up visit (with ±3 month window)

Exclusion Criteria:

* Patients taking tofacitinib in combination with any other bDMARD
Study In Patients With Dyslipidaemia

Study in patients with dyslipidaemia.


Eligibility Criteria:
Inclusion Criteria:

* Waist circumference =102cm (men) or =88cm (women) at visit 1.
* Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1.
* Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1.
* Subjects whose plasma LDL C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1.

Exclusion Criteria:

* History of diabetes
* History of cardiovascular disease
* Diagnosis of genetic lipid disorders
* History of muscle pain
* History of cancer