cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Vanguard DD RP

This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population

This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo primary total knee replacement:

  * with painful and disabled knee joint resulting from any of the following diagnoses:
  * Osteoarthritis,
  * Traumatic arthritis,
  * Rheumatoid arthritis with one or more compartments involved.
  * Correction of varus, valgus, or posttraumatic deformity.
  * Correction or revision of unsuccessful osteotomy or arthrodesis.
* Need to obtain pain relief and improve function.
* Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
* A good nutritional state of the patient.
* Full skeletal maturity of the patient, patients who are at least 18 years of age.
* Patients of either sex.
* Consent form read, understood, and signed by patient.

Exclusion Criteria:

* Absolute contraindications include the following diagnoses:

  * Infection
  * Osteomyelitis
  * Previous partial or total prosthetic knee replacement on the operative side
  * Skeletal immaturity of the patient
  * Sepsis
  * Patients who are less than 18 years of age
* Relative contraindications include:

  * uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  * osteoporosis,
  * metabolic disorders which may impair bone formation,
  * osteomalacia,
  * distant foci of infections which may spread to the implant site,
  * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
  * vascular insufficiency, muscular atrophy, neuromuscular disease,
  * incomplete or deficient soft tissue surrounding the knee
SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment

Cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia assistant. Currently this is performed WITHOUT monitoring and the force applied is determined by the individual's "educated hand" that is derived from his/her experience from past training and practice. Studies have shown that the actual force applied by nurse and anaesthesia assistant is inconsistent and deviates from the optimal force. Under application of cricoid force results in ineffective cricoid pressure and the risk of pulmonary aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia, long Intensive Care Unit stay and even death. Over exertion of cricoid force results in distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on manikin with and without direct feedback. Nurses were instructed to apply a range of force of 30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was used. Unblinded nurses performed significantly better with feedback using the load sensor then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid force is developed to give feedback and guide the operator to exert and maintain the TARGET cricoid pressure during rapid sequence induction (RSI).

In this study we aim to verify the sensor system with a manikin and compare the forces applied by nurses with the sensor system and without.

A total of 22 nurses or anesthetists will be recruited Inclusion criteria include healthy subjects Exclusion criteria include (1) pregnant subjects (2) history of back pain or injury

Cricoid pressure applied on manikin will be measured

1. By electronic medical grade weighing scale
2. By sensor system electronically

Eligibility Criteria:
Inclusion Criteria:

- Healthy status

Exclusion Criteria:

* Pregnant state
* History of problems/ surgery to neck or spine.
IRIS-Coroflex NEO Cohort

The objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 19 years old
2. Patients receiving Coroflex ISAR NEO stents.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Patients with a mixture of other DESs
2. Terminal illness with life expectancy \<1 year.
3. Patients with cardiogenic shock
PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)

The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus Community focused intervention will improve weight loss maintenance compared to Standard follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (\> 18 yr. old) after receiving a standard individual-focused behavioral intervention. The primary hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused plus community-focused intervention vs. a standard follow-up after receiving a standard individual-focused behavioral intervention will have significantly higher rates of weight loss maintenance.

The long term mission of the PILI 'Ohana Program is to integrate community wisdom and expertise with scientific methods to conduct research on health disparities with a specific emphasis on obesity in NHs and PPs. Recognizing that recent advances in medicine such as the reduction of cardiovascular disease mortality and the prevention of type 2 diabetes mellitus, have not translated into benefits for all sectors of the U.S. population, especially ethnic and racial minority populations, the PILI 'Ohana Program aims to address this gap through community-academic partnerships focused on interventions to promote change in obesity-related disparities in NH and PP communities. One of the scientific goals of the PILI 'Ohana Program focused on designing and implementing research activities aimed at completing a pilot intervention study to provide the basis for a more definitive, hypothesis-driven 5-year research study in the future.

Eligibility Criteria:
Inclusion Criteria:

* Native Hawaiian, Filipino or other Pacific Islander ethnic background;
* Age 18 years or older;
* Overweight or Obese defined as BMI \> 25 kg/m2 (NH or Pacific Islanders) or \> 23 kg/m2 (Filipino ethnic background);
* Willing and able to follow a behavioral weight loss intervention program that could potentially include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to induce weight loss of \~1-2 lbs per week;
* Able to identify at least 2-3 family, friends or co-workers that would be willing to support the participant during the course of the study.

Exclusion Criteria:

* Survival less than 6 months;
* Planning to move out of the community during the intervention study period (16 months);
* Pregnancy;
* Any dietary or exercise restrictions that would prevent an individual from fully participating in the intervention protocol (i.e. end stage renal disease on a renal diet, etc.);
* Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e. severe arthritis, hemi-paresis, major psychiatric illness, eating disorders, etc.).
Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery

This study is planned to investigate the relationship between duration of extracorporeal circulation and the extent of (acquired) platelet dysfunctions in patients undergoing cardiac surgery.

Patients undergoing complex cardiac surgery are planned to be included. At several intra- and postoperative measuring point, blood is drawn for multiple electrode aggregometry to investigate ex-vivo platelet aggregation as a surrogate for platelet function.

Transfusion rate of allogenic blood products as well as postoperative blood loss is planned to be recorded.

Eligibility Criteria:
Inclusion Criteria:

* duration of extracorporeal circulation \> 120 min

Exclusion Criteria:

* pregnancy
A Case Control Study of Resveratrol Effects in Coronary Artery Disease Patients With Metabolic Syndrome

The aim of this study is to explore the role of Canonical β-catenin/Wnt and forkhead box O (FOXO) pathways by means of investigating their target genes in coronary artery disease (CAD) pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD patients.

Metabolic syndrome is a constellation of cardiovascular and metabolic risk factors including obesity, insulin resistance, hypertension and dyslipidemia. Coronary artery disease (CAD) is considerably linked with these risk factors. Oxidative stress has a major role in development of atherosclerosis that is believed as the most common pathologic process underlying CAD. The up-regulated gene-expression of free radical scavenging enzymes such as manganese superoxide dismutase (MnSOD) by members of the forkhead box O (FOXO) transcription factors is considered to be one of the paramount cell defensive mechanisms against oxidative damage. It is now well recognized that β-catenin binds to FOXOs during oxidative stress and acts as the pivotal mediator in canonical Wnt signaling, so that it translocates to the nucleus and interacts with the family of transcription factors T-cell factor/lymphoid enhancer factor (TCF/LEF), to regulate the expression of Wnt target genes. Recent evidence suggested that the canonical Wnt signaling plays a profound role in regulation of lipid metabolism and glucose homeostasis. Peroxisome proliferator-activated receptor delta (PPAR-δ) is one of the Wnt target genes which is believed to be operative in cardiometabolic protection. Interestingly, it has been demonstrated that impaired Wnt signaling pathway is contributed to inflammation, foam cell formation, and endothelial dysfunction which are recognized as atherosclerosis pathogenic factors. Resveratrol (RES) (3, 4´, 5 trihydroxystilbene), a natural polyphenol with antioxidant effects can be found in red grapes and its processed drinks (e.g. red wine), peanuts, pomegranates and mulberries.Increasing body of evidence suggest a protective role for RES against CAD, however the underlying mechanisms still remain to be elucidated. We perform this study on 10 metabolic syndrome patients with three-vessel CAD and 10 sex-aged matched (men with 40-55 years old) healthy subjects as controls. The effects of RES on β-Catenin, manganese superoxide dismutase (MnSOD), and peroxisome proliferator-activated receptor delta (PPAR-δ) expression are evaluated in peripheral blood mononuclear cells (PBMCs) of participants.

Eligibility Criteria:
Inclusion Criteria:

-Three vessel coronary artery disease with metabolic syndrome based on WHO criteria

Exclusion Criteria:

* Malignancy,
* Myocardial infarction,
* Unstable angina,
* Previous coronary intervention,
* Inflammatory diseases,
* Diabetes,
* Hypertension,
* Endocrine disorders,
* Other known chronic diseases,
* Antioxidant therapy or vitamin supplements in the previous 12 months,
* Smokers .
Promoting CT Engagement for Pancreatic Cancer With App

To develop a culturally tailored informational mobile application and test whether it will increase participation among Black pancreatic cancer subjects in clinical trial discussions with their care team.

This project aims to identify and address barriers to enrollment of Black subjects in pancreatic cancer clinical trials using a culturally informed mobile health application to promote participation.

The clinical trial education and communication needs of Black people with pancreatic cancer will be determined. A new mHealth application for clinical trial education and communication tailored to subject needs will be developed. It was hypothesized that a culturally tailored informational mobile application will increase the participation of Black subjects in clinical trial discussions with their care team among the target population.

This study focuses on Black pancreatic cancer subjects, who experience higher mortality rates and lower clinical trial participation than White subjects. Research shows that the disparity between clinical trial participation is in part due to inequitable recruitment practices. This study will use mobile application technology (mHealth app) as an educational, communication, audit, and feedback tool to promote patient-initiated clinical trial discussions among Black people with pancreatic cancer and their cancer care team.


Eligibility Criteria:
Inclusion Criteria

Participants must meet the following inclusion criteria in order to participate in communication \& education interview component of the study:

1. Informed consent obtained to participate in the study
2. 18 years or older
3. English speaking
4. Able and willing to participate in a 1-hour interview
5. History of pancreatic cancer diagnosis
6. Identify as Black

Exclusion Criteria:

All participants meeting any of the following exclusion criteria will be excluded from the study:

1. Inability to read and speak English
2. Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.
Laparoscopic Ileal Interposition and Weight Regain

The investigators will study the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones

This prospective, controlled, randomized intervention study will investigate the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, health-related quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones. The participants will also be assessed for alcohol abuse, depressive symptoms, level of physical activity, eating disorder symptoms, and dumping syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to initial laparoscopic after initial Roux-en-Y gastric bypass for at least 3 years
* Loss of excess weight between 60 to 80%
* Rate of weight regain ≥60%
* Body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2, with at least 2 comorbidities associated with obesity
* Present a previous evaluation by the multidisciplinary team with a favorable opinion of the revision surgery.

Exclusion Criteria:

* Active chemical dependency on alcohol and/or illicit drugs
* Severe psychotic or depressive disorder or history of suicide attempts in the last 12 months
* Eating behavior disorder (uncontrolled)
* Secondary causes of obesity
* Pregnancy
* Severe organ failure
* Active neoplastic
* Infectious or inflammatory disease
* Severe coagulopathy
* High anesthetic-surgical risk
* Intellectual inability
* Lack of preoperative follow-up
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.


Eligibility Criteria:
Inclusion Criteria:

* Subject is of Chinese descent
* Subject is in good health
* Subject is a non-smoker

Exclusion Criteria:

* Subject has a history of stroke or chronic seizures
* Subject has a history of cancer
* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction

To learn if there is a connection between low vitamin D level and hardening of the arteries.

Osteoporosis and vascular disease are two of the most common disorders affecting postmenopausal women. A potential association, beyond aging, has long been speculated. Our previous study revealed evidence of loss of vascular compliance in postmenopausal women with lower bone density, suggesting women with lower bone density had "stiffer" blood vessels. This proposal further investigates that association and a potential role of vitamin D deficiency as a possible common link between both bone loss and "hardening of the arteries".

Eligibility Criteria:
Inclusion Criteria:

* Females ages 50-70 with ability to give informed consent
* One year past last menstrual period
* 20 women with Vitamin D levels \< 15 mg/ml
* 20 women with Vitamin D levels \> 30 mg/ml

Exclusion Criteria:

* women receiving hormone replacement therapy
* women receiving medication known to effect vascular compliance, including anti-hypertension medications
* subjects receiving therapy for osteoporosis
* hyperthyroidism
* untreated hypothyroidism
* history of metabolic bone disease
* current or previous use of medications known to accelerate bone loss
* chronic liver disease
* chronic renal disease
* diabetes mellitus
* obesity, BMI \> 24
Development of a Non-Invasive DNA Methylation-Based Assay System for the Risk Assessment of Urothelial Carcinoma

Bladder cancer ranks the ninth in worldwide cancer incidence. Approximate 90% of bladder cancer is the malignancy of urothelium tissues, the urothelial cancer (UC). The mortality of bladder cancer is mainly due to recurrence and metastasis. Unfortunately, the currently available cytology or cystoscopy examination is of limited value because of low sensitivity of early disease. New biomarkers as well as detection technology are thus required to improve early diagnosis. By the aid of quantitative methylation-specific PCR (QMSP), which allows detecting tumor-derived DNA from tissues and body fluids, DNA methylation-based assay is thus developing for early detection and prognosis.

The goal of this proposed project is to develop a panel of DNA-methylation based biomarkers for UC diagnosis, prognosis, and prediction of responses to therapy (especially the recurrence, invasion, survival, and responses to therapeutic agents). Although numerous studies have investigated the aberrant promoter hypermethylation in bladder cancers or UC, inconsistent results are observed. DNA hypermethylation determination may rely on not only the conditions of QMSP, but also the biopsy specimens of different race, environmental expose factors, and regional variation. We thus need to profile the DNA methylation pattern of UC patients in Taiwan to establish a panel of potential prediction biomarkers for local patients.

In the recent years, technologies of genomics, expression analysis and proteomics have been brought to guide the study of risk assessment and early detection of cancers. This proposed study aims to develop a non-invasive DNA methylation-based assay system elucidating a panel of aberrantly hypermethylated genes from urothelial tumors and urine sediments, to improve the risk assessment of urothelial carcinoma; such as early diagnosis, prognosis, and prediction of response to therapeutic regimes. This proposal will establish several techniques to study the methylation status on gene promoter regions. Three tasks will be achieved in this study: (1) Profiling the aberrant DNA methylation in urothelial carcinoma and determining potential prediction biomarkers. (2) Establishing a non-invasive assay by detecting DNA hypermethylation status in exfoliated cells collected from void urine; (3) Mapping the DNA hypermethylation changes from normal to malignant urothelial tumors and studying the underlying mechanism. Through the collaboration of a genetic toxicologist (Te-Chang Lee, PhD, IBMS), a urologist (Yeong-Shiau Pu, MD/PhD, NTUH) and epidemiologists (Hung-Yi Chiou, PhD, Taipei Medical University), we will explore the risk biomarkers for urothelial carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* those with histopathological-confirmed urothelial carcinoma will be included.

Exclusion Criteria:

* those were younger than 40 years old or with previous history of any other cancers will be excluded.
Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to Reduce Renal Insult

comparing the effect of low dose norepinephrine infusion versus fresh frozen plasma in patients undergoing HIPEC to reduce renal insult

To compare the efficacy of maintaining intraoperative hemodynamic stability through infusing low dose norepinephrine versus fresh frozen plasma in patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy in cancer patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* World Health Performance Status ≤2
* scheduled for CRS/HIPEC operations

Exclusion Criteria:

* patient's refusal
* allergy to any of the used drugs
* impaired renal or liver functions
An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring

The purpose of this clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.

The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.

Eligibility Criteria:
Inclusion Criteria:

* BMI is 30 or less
* 18 years of age or older

Exclusion Criteria:

* Pregnant
* Open wounds (sores, cuts, ulcers, etc.)
* Individuals with or being treated for any cancerous growth
DM1 Heart Registry - DM1 Respiratory Registry

Myotonic dystrophy type 1 (DM1) is the most frequent neuromuscular disease in adults. DM1 patients have an impaired prognosis (mean age of death \<60 years) due to cardiac and respiratory complications.

Our primary objective was to identify cardiac and respiratory prognostic factors in DM1.

1. Patients with genetically proven DM1 who were admitted in Pitié Salpêtrière Hospital from 2000 and 2010 will be identified. These patients systematically underwent neurological, cardiac and respiratory investigations.
2. Baseline medical and genetic information will be entered in a dedicated database, including cardiac and respiratory investigations.
3. The occurence of severe cardiac and respiratory adverse events will also be collected.
4. Statistical analysis will be performed to look for correlations between baseline patient characteristics and cardiac or respiratory adverse events during follow up.

Eligibility Criteria:
Inclusion Criteria:

* DM1 mutation (\>50 CTG repeats)
* Age \> 18 years

Exclusion Criteria:

* Patient refusal