cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Validations Microsatellite Instability (MSI) Testing v Mismatch Repair (MMR) in Gastric Adenocarcinoma

To compare the Idylla microsatellite instability test versus mismatch repair immunohistochemistry (IHC) in gastric adenocarcinoma.

Gastric adenocarcinoma is a common form of cancer which is associated with a poor prognosis. Up to 22% of gastric adenocarcinomas arise via the microsatellite instability (MSI) / mismatch repair (MMR) pathway. These cases can be detected either by mismatch repair immunohistochemistry (IHC) or microsatellite instability testing. Detection of mismatch repair deficiency or microsatellite instability is important because patients with this type of gastric adenocarcinoma are shown to benefit from a different therapeutic approach. High concordance between mismatch repair immunohistochemistry and microsatellite instability testing has already been demonstrated. The implementation of either method is largely based on local availability. The Idylla MSI test presents a novel method of establishing MSI status in comparison to pre-existing MSI testing platforms. The Idylla MSI tests uses a fully automated, ultra-rapid system that can work on formalin-fixed, paraffin embedded tissue with no need for preceding DNA extraction. Implementation of the Idylla MSI test could reduce reporting turnaround times and requires less technical expertise to perform in comparison to other platforms.

The investigators department does not currently have the facilities to perform MSI testing on any platform, so the advantages of introducing the Idylla MSI test would also include the generic advantages of MSI testing. These advantages include: the ability to quickly check cases shown to have possible MMR loss on IHC (i.e. equivocal cases) with MSI testing; and providing an alternative to MMR IHC for screening of Lynch syndrome, reducing the burden on reporting pathologists and reduce the inter-observer variability associated with IHC interpretation.

The Idylla MSI test already demonstrates high concordance with other MSI testing platforms but has yet to be compared to the department's accepted standard of MMR IHC. This project aims to compare the Idylla MSI test to in-house MMR IHC to establish whether the two methods are concordant in reporting MMR / MSI status in gastric adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Adequate tissue including adequate tumour burden
* Diagnosis of adenocarcinoma in this biopsy

Exclusion Criteria:

* No patient consent
* Inadequate tissue or block not present in archive
* No adenocarcinoma in biopsy
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets

The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.

Exclusion Criteria:

* A hyperparathyroidism
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.

Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers

Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age 18-45 years
* Singleton pregnancy with no known fetal anomalies
* Gestational age between 10weeks 0 days and 22 weeks 6 days by menstrual dating confirmed by ultrasound, or ultrasound alone
* Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or insulin)
* Clinical diagnosis of diabetes diagnosed between 10 weeks and \< 20 weeks 6 days gestation
* Willing to start insulin therapy and discontinue oral hypoglycemic pills other than study pills
* Able to swallow pills

Exclusion Criteria:

* Clinical diagnosis of pre-existing renal disease, defined as creatinine \> 1.5 mg/dL
* Clinical history of lactic acidosis
* Known allergy to metformin
* Participation in another study that could affect primary outcome
* Delivery planned at non-MOMPOD study locations
* Unwillingness to use insulin treatment or follow prenatal care doctor's instructions for insulin and blood glucose monitoring
Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy

The optimal number of biopsy and the detection rate of neoplastic lesions are not established. The aim of this study is to assess the current practice pattern and effect of training in upper endoscopic biopsy.

The endoscopic examination is indicated in the diagnosis of variety of gastrointestinal diseases and screening for the neoplastic lesions. Especially, in Korea where the stomach cancer prevalent area, high-quality endoscopic examination is required not to overlook pathologic lesions. Endoscopic biopsy is the gold standard for the confirmation of endoscopic diagnosis. It is usually decided based on the abnormal morphology of the lesions or color change of the mucosa. Diagnostic accuracy is known to be improved by training or using optical techniques or chromoendoscopy. With the development of endoscopic imaging technologies such as narrow band imaging (NBI), confocal imaging or magnifying techniques, the diagnostic accuracy can be enhanced. However, inspection with conventional white light endoscopy is still the most prevalent and basic form of screening or surveillance endoscopy. Thus, detecting lesions by meticulous inspection and accurate approach by targeted biopsy are important for the diagnosis of pathologic lesions. However, the optimal number of biopsy and the detection rate of neoplastic lesions are not established. This study aimed at evaluating the current practice pattern and effect of training in conventional upper endoscopic biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic EGD including screening endoscopy for health check-up or endoscopic examinations for the symptomatic patients to make a diagnosis.

Exclusion Criteria:

* Specimens from therapeutic procedures, such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration

Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues

Because human bodies make testosterone naturally, it can be difficult to determine whether the testosterone in your body is natural or if it came from administering testosterone. Currently, testosterone abuse by athletes is detected by anti-doping laboratories in urine samples and use can also be inferred by testing blood samples. As a pharmaceutical preparation, testosterone is available to administer to your body in different ways. However, due to lack of controlled data on the various preparations of testosterone administrations related to the anti-doping field, this study id designed to look at five different testosterone preparations delivered three different ways and how they compare to each other in terms of anti-doping detection and how long they will be in circulation in your body.

Eligibility Criteria:
Inclusion Criteria:

* HEALTHY MALE ADULTS, AGED 18-60 YEARS

Exclusion Criteria:

* Individuals currently enrolled in a registered testing pool for anti-doping purposes
* Unwilling to provide urine or blood samples
* Individuals who are not actively exercising
* Individuals who show a high risk of heart attack or cardiovascular disease as defined by a physician
* Individuals that have an elevated baseline hematocrit as determined by the PI
* Individuals who are diabetic or are currently taking diabetic medications.
* Individuals that have donated blood (approximately 500 mL) in the past 8 weeks
* Individuals with severe acne
* Individuals with a history of cancer, cardiac, renal or hepatic disease
Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients

A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.

The patients staying in ICU for more than 24 hours were enrolled in the study. Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation were excluded from the study. At admission, patient's age, sex, weight and height were recorded. Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.

Eligibility Criteria:
Inclusion Criteria:

* The patients staying in ICU for more than 24 hours were enrolled in the study.

Exclusion Criteria:

* The Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure;
* Patients received massive blood transfusion;
* Patients with radiation therapy and patients with previous organ transplantation were excluded from the study.
Post Marketing Surveillance Study of Dysport

The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.


Eligibility Criteria:
Inclusion Criteria:

* adult or child over the age of 2 years
* scheduled to receive Dysport as per their normal treatment practice, and in conformance with their country's Summary of Product Characteristics

Exclusion Criteria:

* history of hypersensitivity to Dysport or drugs with a similar chemical structure
* treatment with any other investigational drug within the last 30 days before survey entry
Y-TZP and In-mouth Low Thermal Degradation: A Prospective Clinical Study

The objective of this work is to study in-mouth aging and LTD of monolithic zirconia restorations. Microstructural changes characteristic of LTD processes, wear, and clinical behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D laser surface analysis will be used, directly on the restorations, which will be removed at regular intervals.The working hypothesis is that LTD process is very slow at the scale at the lifespan of dental prostheses.


Eligibility Criteria:
Inclusion Criteria:

* Full zirconia crowns in the posterior region (molar/premolar)
* On teeth or implants
* Single unit restorations cemented on natural teeth and implants (including screw-retained restorations if possible, but no internal connections)
* Multi-unit restorations on implants
* If nightguard: to be performed on the antagonist

Exclusion Criteria:

* Patients with removable prosthesis as an antagonist
Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.

142 patients with at least one peripheral pulmonary nodule will be enrolled. They will underwent randomization in 2 arms: patients in the first arm will undergo transbronchial needle aspiration with a conventional bronchoscope patients in the second arm will undergo transbronchial needle aspiration with a ultra-thin bronchoscope. Every bronchoscopy will be performed by the same operator and will contemplate 3 passes for each nodule, followed by Rapid On-Site Evaluation (ROSE) assessed by a dedicated cytologist. If the cytological on-site evaluation is negative in patients in the first arm, they will be shifted to the second arm. Histological and molecular diagnosis will be assessed by a dedicated pathologist. Data will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18years;
* presence of at least one peripheral pulmonary lesion ≤ 3 cm on CT scan;
* ability to give an informed consent.

Exclusion Criteria:

* coagulopathy or bleeding diathesis that cannot be corrected;
* severe refractory hypoxemia;
* unstable hemodynamic status;
* inability to give an informed consent.
The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women

The aim of the project is to investigate the acute effect of exercise on blood glucose after glucose consumption. Thereby we wish to achieve knowledge that can improve prevention and treatment of gestational overweight and gestational diabetes mellitus (GDM). This will prevent serious complications during pregnancy and birth, but also long term complications like type 2 diabetes mellitus (T2DM) for both the mother and the offspring.

15 pregnant participants will perform two Oral Glucose Tolerance Tests (OGTT). One is followed by physical activity and the other is followed by inactivity and will serve as control. Blood glucose will be monitored continuously during the study.

Cases: 15 pregnant women recruited at the routine ultrasound scan at gestational week 19 at the Department of Obstetrics and Gynecology, Aarhus University Hospital. Subjects will receive both written and oral information before entering the trial. Subjects with a prepregnancy BMI \> 27 and no other risk factors of diabetes will be included in the study. The women will be examined during gestational week 27-30 where the routine Oral Glucose Tolerance Test (OGTT) will take place. The routine OGTT will serve as control.

Intervention: The subjects will perform two OGTT separated by a minimum of two days. One - the regular OGTT will serve as control and the second OGTT will be the intervention. The two days in between will function as a "wash out period" to avoid potential carry over effect. During the OGTT subjects will consume a liquid containing 75g of glucose. The control OGTT will be followed by inactivity. The intervention OGTT will be immediately followed by 20 minutes of exercise on a bicycle ergometer with a fixed intensity.

Study variables: Blood glucose will be monitored continuously using the IPro2 Continous Glucose Monitor (CGM) from Medtronic. A sensor is inserted into interstitial fluid and continuously generates an electrical current proportional to the glucose concentration. A recorder stores the average sensor current every 5 minutes.

In both control and intervention, blood tests will be taken at time 0, 1 and 2 hours after the OGTT. Blood samples will be analyzed for blood glucose, HbA1c, C-peptide and insulin.

Data on demography, family history of diabetes, prepregnancy BMI, gestational weight gain and complications during pregnancy are collected from medical records of the patients and their offspring.

Eligibility Criteria:
Inclusion Criteria:

* Prepregnancy BMI \> 27

Exclusion Criteria:

* Physical disability that affect movement
Peer Intervention Latino Immigrant MSM

This study evaluates a peer intervention with HIV/STI self-testing kits to increase HIV/STI testing and PrEP uptake among Latino immigrant men who have sex with men. Half of participants will receive the "Listos" intervention (peer counseling, PrEP information, and HIV/STI testing kits) and half will receive the active control intervention (peer only group with no HIV/STI testing kits).

HIV testing is crucial for early detection of HIV infection; yet, Latino immigrants are at high risk for late HIV diagnosis. Increased screening for HIV and STIs is particularly important for Latino immigrant men who have sex with men (MSM), a group disproportionately at risk for HIV that also encounters barriers to health access due to factors associated with immigrant status. Latino MSM recently experienced a significant increase (25%) in new HIV diagnoses (2008-2015), while diagnoses among MSM overall remained stable. Based on these trends, 1 in 4 Latino MSM will be diagnosed with HIV in their lifetimes, highlighting their urgent need for HIV prevention. Notably, pre-exposure prophylaxis (PrEP) can reduce risk of HIV among high-risk groups; yet, only 3% of Latinos who could benefit from PrEP have received it. As undiagnosed HIV contributes to 40% of new HIV infections, and STIs increase HIV risk, targeted interventions that address Latino immigrant MSM's barriers to HIV/STI testing and PrEP uptake are critical for curbing the HIV epidemic.

Studies have shown that peers can influence HIV-related behaviors by enhancing information, motivation, and behavior skills (IMB Model). Peers share characteristics with the target population, which facilitates role modeling and can empower individuals to engage in behaviors. While peer interventions have demonstrated success in shaping behaviors among Latino MSM, their utility for addressing immigrant-specific barriers to HIV/STI testing and PrEP use is less understood.

While the IMB Model and empowerment theory highlight relevant psychological determinants of behavior, competent attention to structural factors (i.e. access) is key for HIV prevention. The availability of HIV/STI self-testing kits presents opportunities to overcome structural barriers to testing. HIV/STI self-testing kits are convenient testing methods as they allow for at-home testing, reducing the need for health care visits. The research combines these approaches (peers and HIV/STI self-testing kits) to address individual and structural barriers to HIV prevention among Latino immigrant MSM.

Eligibility Criteria:
Inclusion Criteria:

* male sex (at birth)
* adult aged 18 and older
* immigrant (not born in continental U.S.)
* Latino (identifies as either Latinx or Hispanic
* reports sex with men in past 12 months
* reports not knowing their HIV status or being HIV negative

Exclusion Criteria:

* Does not identify as Latino/Hispanic
* Born in the continental U.S.
* Female sex (at birth)
* Does not report sex with men in the last 12 months
* Reports being HIV positive
* Younger than 18 years old
Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the diabetes prevention program (DPP) for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 after collection of objective eligibility measures. A prospective, randomized, nested by church, design was used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up.

Reducing obesity positively impacts diabetes and cardiovascular risk; however, evidence-based lifestyle programs, such as the diabetes prevention program (DPP), show reduced effectiveness in African American (AA) women. In addition to an attenuated response to lifestyle programs, AA women also demonstrate high rates of obesity, diabetes, and cardiovascular disease. To address these disparities, enhancements to evidence-based lifestyle programs for AA women need to be developed and evaluated with culturally relevant and rigorous study designs. This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the DPP for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data (N=64 AA adults) integrating five components: a brief pastor led sermon, memory verse, in class or take-home faith activity, promises to remember, and scripture and prayer integrated into participant curriculum and facilitator materials. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 (Mean age =48.8 ±11.2; Mean BMI =36.7 ±8.4; 52% technical or high school) after collection of objective eligibility measures. A prospective, randomized, nested by church, design was used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up. This study provides essential data to guide enhancements to evidence-based lifestyle programs for AA women who are at high risk for chronic disease.

Eligibility Criteria:
Inclusion Criteria:

* Identify as African-American
* Female
* 18 years of age or older
* Parishioner at enrolled church
* Overweight or obese
* Willingness to participate in a 10-month study.

Exclusion Criteria:

* Currently attending a weight loss program
* Diagnosed with diabetes
* Medical condition that interfered with physical activity or dietary changes
* Plans to move in the next 10 months.