cyrilzakka/clinical-trials huggingface dataset:
Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

There has been an increase in the prevalance of type 2 diabetes in developed countries in recent years. The major contributing factors have been genetic predisposition, environmental factors, and unhealthy eating habits and stress. Adverse effects on cardiovascular and renal systems after prolonged hyperglycemia bring serious burden to patients, to their families and to the society.

Oxidative stress has been defined as the imbalance between the production of reactive oxygen molecules and antioxidant protective molecules. It has been claimed that oxidative stress that the organism is exposed to and disturbance in anti-oxidant mechanisms have been important in the initiation of diabetes and its complications. Malondialdehyde is the final product of lipid peroxidation and it is an aldehyde as well. It has been accepted that malondialdehyde has been a biomarker in measuring oxidative stress.

Type 2 diabetic people who are between 40 -65 years of age will be the subjects of our study. The levels of fasting glucose, HbA1c, LDL, triglyceride, AST and ALT and also malondialdehyte, hydrogen peroxide and oxidative stress will be determined in patients blood after making them consume a 1500 calory standard diet for 2 weeks, The patients will be randomly divided into two grouos at the end of the two weeks. Group 1 will take placebo in addition to the diet, Group 2 will receive polyphenol containing capsules with pomegranate extract (500 mg), green tea extract (300 mg) and a little bit of (60 mg) vitamin C for three months. At the end of three months the measurement of biochemical parameters will be repeated.

Patients with cardiac, renal, liver disease and smokers will be excluded from the study.

Patients in both groups will have a diet rich in vegetables, three servings of fruit, maximum three slices of bread with a total calory of 1500.

In addition to these, both groups will have a weekly aerobic exercise regimen of 150 minutes conducted after breakfast.

The biochemical results of the two groups will be compared at the end of the experiment and they will be statistically evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients between 40-65 years of age will be eligible for the study

Exclusion Criteria:

* Patients with cardiac, renal, liver disease and smokers will be excluded from the study.
Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients

Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is, in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia endothelium-dependent brachial artery dilation.

Coronary microcirculation, non invasively assessed with trans-thoracic echo-doppler (coronary blood flow before and after cold pressure testing), and biochemical markers of endothelial dysfunction will also be measured. Correlations between peripheral and coronary endothelial functions will be checked. The measurements will be performed and validated in two other groups

* 30 patients with overweight but free of diabetes, matched with the patients with diabetes for age, gender and body mass index
* 30 control subjects.Reproducibility of the methods will be assessed in 10 patients of the three groups of subjects.

Eligibility Criteria:
Inclusion criteria :

FOR TYPE 2 DIABETIC PATIENTS Asymptomatic:

* with normal resting ECG
* coronary primary prevention
* other cardiovascular risk factors justifying screening for silent myocardial ischemia and coronary stenoses in case of silent myocardial ischemia.

FOR PATIENTS WITH OVERWEIGHT:

* Asymptomatic with normal resting ECG
* coronary primary prevention
* Body mass index 25-40 kg/m²
* Without diabetes.

CONTROLS Asymptomatic:

* coronary primary prevention
* Body mass index 18-25 kg/m²
* Without diabetes
* Without cardiovascular risk factors including dyslipidemia, hypertension, smoking habits, No treatment

Exclusion criteria :

* pregnancy
* renal failure
* acrosyndrome
Clinical Application of an Automated Liquid Biopsy Platform for Early Detection of Colorectal Cancer

Colorectal cancer (CRC) is among the most preventable cancers when precancerous lesions are detected at an early stage. Current screening methods for CRC require bowel prep or stool-based testing that are inconvenient, resulting in low compliance. Stool based tests have limited sensitivity for the detection of precancerous lesions.

The CMx platform has been showed to be able to the detection of Circulating Tumor Cells (CTCs) in high sensitivity and specificity. In published studies, circulating Tumor Cells (CTCs) are captured and quantified in advanced-stages of colorectal cancer. In order to detect early and pre-cancer circulating tumor cells, we have developed an Automated Liquid Biopsy Platform that improves the detection of CTCs in early cancer stages. Therefore, this study goals are: 1) to establish a standard detection process utilizing the Automated Liquid Biopsy Platform. 2) Parallel comparison of laboratory manual operation and Automated Liquid Biopsy Platform. 3) Verify the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting.

1. Selection of patients:

   A. The disease group includes 300 patients diagnosed with stages 0-4 colorectal cancer not previously treated.

   B. The control group includes 450 control subjects who will undergo a colonoscopy procedure.
2. Study stages

   Stage I: The laboratory manually analyzes circulating tumor cells to establish a standard detection process for Automated Liquid Biopsy System

   Stage II: Comparison analysis between manual and Automated Liquid Biopsy Platform, establishing the procedural and analytical models for the Automated Liquid Biopsy Platform

   Stage III: Verification of the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting.
3. Methods

I. CTC isolation Peripheral blood drawn from subjects will be processed using the CMx platform or the automated liquid biopsy system for detection and capture.

II. Characterization of isolated CTC using Immunofluorescence Staining

III. CRC-related gene expression The serum and circulating tumor cells isolated from the blood will be used to extract RNA, and then be analyzed with the expression of different genes by real-time quantitative polymerase chain reaction (real-time PCR).

Eligibility Criteria:
Inclusion Criteria:

* 1. The disease group is diagnosed with colorectal cancer 0-4 and has not been treated.
* 2. The control group will receive Colonoscopy
* 3. Above 20 years old

Exclusion Criteria:

* 1. Refuse to sign the informed consent form
* 2. Received surgery within one month
* 3. Previous cancer history
* 4. Autoimmune diseases
* 5. Chronic inflammatory diseases
* 6. Acute inflammatory or infectious diseases in three months
* 7. Myelodysplastic syndromes and myeloproliferative disorder
* 8. Other diseases decided by PI
A Social Media Game to Increase Physical Activity Among Older Adult Women

This study will test the effects of a social media game on the physical activity of older adult women. The game will consist of playful weekly challenges that require sharing photographs on a private social media group and also wearing an activity monitor to track steps. Participants will be randomized to this game group or to receive the activity monitor only.

Older adult women are at risk for negative health impacts of physical inactivity, but current strategies to increase their activity have had disappointing long-term results. The intervention tested in this study seeks to test an innovative intervention that targets older womens' perceptions of enjoyment and their personal identity and values. The investigators will test the efficacy of a 12-month social media-based physical activity intervention for sedentary older adult women. Participants will be randomized to receive a standard Fitbit-only intervention or to an enhanced Fitbit + weekly social challenges intervention. The investigators hypothesize that participants in the enhanced intervention will demonstrate greater increases in autonomous regulation and objectively-measured steps as compared to those in the standard intervention. The investigators will also measure outcomes after a 6 month maintenance period (18 months after beginning the intervention). Additional outcomes will include engagement with the social network and self-reported playful experiences.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age between 65 and 85
3. Able to read and understand English
4. Willingness to be randomized to any condition
5. Daily availability of an iOS or Android mobile device that is capable of taking and sending photos
6. Willingness to use a private Facebook group
7. Sufficient internet access to post photos to Facebook at least once per week
8. Having an existing Facebook account or willingness to create one

Exclusion Criteria:

1. Unable to find transportation to the study location
2. Unable to walk for exercise (self-report)
3. Walk \<475 meters in 6 minute walk test during baseline assessment
4. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
5. Participant answered "yes" to any question on the PAR-Q+ and does not provide a doctor's note giving permission to begin a physical activity program
6. Self-reported weekly PA ≥ 150 minutes
7. BMI under 18 or over 40
8. Participant reports psychological issues that would interfere with study completion. Examples will be provided to illustrate potential psychological issues, such as dementia or schizophrenia.
9. Participant plans to move away from the Galveston-Houston area or to be out of town for more than 2 weeks at a time during the study period
10. Clinical judgment concerning safety
11. Currently participating in an organized commercial or research physical activity program
12. Uses a wearable activity monitor other than a simple pedometer and is unwilling to stop during the trial
13. Another member of the household is a participant or staff member on this trial
Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality.

Covid-19 patients admitted to the intensive care unit of Selcuk University Hospital were included in the study. Clinical frailty score was given during admission to the intensive care unit. Demographic data, laboratory data, radiological imaging and vital signs of the patients were recorded. Treatment and patient positions were recorded during the intensive care follow-up of the patients. Mortality status of the patients 6 months after admission to the ICU was recorded.

It is planned to include non-pregnant and non-traumatic patients over the age of 18, diagnosed with COVID-19, who are treated in the Intensive Care Unit of Selcuk University Hospital. The frailty status will be evaluated by using the clinical frailty scale at the admission of the patients to the intensive care unit. Evaluation from the patient himself, if the consciousness of the patients is clear; If not, it will be done near the patient. Patients will be divided into two groups using the clinical frailty scale (CFS) as frail if the score is ≥5 and non-fragile if the score is \<5. Demographic information and vaccination status (how many dose and type) will be questioned, SOFA score, APACHE II score will be recorded. Routine examinations made from the patient file; thorax computed tomography (CT) imaging, laboratory values, respiratory support information, drug treatments applied, patient positions will be recorded. Thoracic CT scans severity scores for each of the five lung lobes: 0 for no involvement (0%), 1 for minimal involvement (1%-25%), 2 for mild involvement (26-50%), 3 for moderate involvement (51%) -75) and 4 advanced involvement (76-100%). The total severity score will be the sum of the scores of the five lobes. If the score is ≤10, it will be considered as mild involvement, and if the score is \>10, it will be considered as severe involvement. Laboratory values; platelet and lymphocyte count, albumin, sodium, ferritin, D-dimer, crp, procalcitonin, interleukin-6 and glomerular filtration rate values, neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, CRP/Albumin ratio, arterial blood gas will be recorded. Whether or not he received respiratory support; type (invasive/non-invasive positive pressure respiratory support or high-flow nasal oxygen therapy), duration will be recorded. The use and duration of vasoactive drugs administered, renal replacement therapy and its durations will be recorded. Patient positions will be recorded as supine, lateral decubitus, and prone. The length of stay in the intensive care unit and mortality of the patients will be recorded. Comparisons will be made between frail and non-fragile groups on all these evaluated parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients who over the age of 18
* Patients who diagnosed with Covid-19

Exclusion Criteria:

* Trauma patient
* Pregnant
Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss Population

The purpose of this study is to collect blood samples to investigate the prognostic performance of the STHLM3 test in a population of Swiss and German men suspected of harbouring prostate cancer based on a combination of elevated PSA levels (e.g. \>2.5 ng/ml) and/or pathological digital rectal examination and/or MRI-findings.


Eligibility Criteria:
Inclusion Criteria:

* Planned prostate biopsy due to suspicion of prostate cancer (usually due to a combination of elevated PSA levels \[e.g. \>2.5 ng/ml\] and/or pathological digital rectal examination and/or MRI-findings)
* Written informed consent by the participant

Exclusion Criteria:

* Severe anemia (Hb \<60g/l)
* Previously already established diagnosis of prostate cancer.
Foot Reflexology and Pain and Ankle Brachial Index

This randomized controlled study aimed to determine the effect of foot reflexology on pain and ankle brachial index level in patients with peripheral artery disease

Patients with PAH may experience pain in the legs, cramps, pain or aching symptoms (claudication) in the hip, thigh or leg calf, along with compulsive movements such as walking. Reflexology is reported to have effects such as protecting the tissue integrity of the feet, increasing skin turgor, reducing neuropathic pain and increasing peripheral blood flow. For this reason, this study aimed to determine the effect of foot reflexology on pain and ankle brachial index level in patients with peripheral artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age with PAH;
* no fractures or open wounds in both lower extremities;
* absence of unilateral or bilateral amputation of the lower extremities

Exclusion Criteria:

* having an acute infection with fever;
* requiring an acute surgical condition
* undergoing femoral-popliteal bypass surgery
* Having a verbal communication problem such as Alzheimer's or dementia
Biomarkers of Synaptic Damage in Multiple Sclerosis

A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited As control groups.

Blood and cerebrospinal fluid samples will be subjected to the procedures required for the isolation of the different components immediately after the withdrawal. Subsequently, the levels of microRNAs, cytokines, chemokines, cell growth factors, neuronal damage markers (tau, phosphorylated and truncated tau, neurofilaments) and mitochondrial (lactate) and free d-amino acids (Objective 1) will be determined. Furthermore, synaptic alterations will be evaluated in the ex vivo chimeric model of MS, using the patch-clamp technique (Objective 2). Genotyping studies will be conducted in order to identify single nucleotide polymorphisms (SNPs) in coding and / or regulating regions of genes (microRNAs or proteins) involved in alterations of the synaptic transmission of MS and its murine experimental model (i.e. SLC1A3, NGFB, PDGFA, etc.), which correlate with specific clinical parameters (i.e. EDSS, BREMS, disease progression index, MS type, disease activity, etc.) and with the levels of potential biomarkers identified

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients (age between 18 and 65 years)
2. Diagnosis of MS in accordance with McDonald's (2010 rev) criteria,
3. EDSS between 0 and 5.5 (included),
4. Patients able to provide informed consent to participation in the study

Exclusion Criteria:

1. Inability to provide informed written consent
2. Altered basal blood count
3. Pregnancy or lactation
4. Contraindications for the execution of magnetic resonance imaging with gadolinium
5. Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.

multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.


Eligibility Criteria:
Inclusion Criteria:

* The patient's age is over 18 at the time of surgery.
* The patient suffers from Crohn's disease confirmed by instrumental and histological methods.
* The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year)
* The patient received, understood and signed informed consent for active participation in the study.
* The patient is able to understand the conditions of the study and to participate throughout the duration.

Exclusion Criteria:

* Patients with more than 1 internal and 3 external openings.
* Patients with ileus / colo ostomy.
* Patients with anus / rectum-vaginal fistulas.
* Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.
* Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
* Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc).
* Patients with clinical conditions that may compromise the success of the surgery or the follow-up.
* Pregnant or breastfeeding women.
Drug-drug Interaction Study of Midazolam and AT-527 (R07496998)

Drug-drug interaction study of midazolam and AT-527 (R07496998)


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities
Pathogenesis and Genetics of Environmental Asthma Ozone Study

The goals of the research are designed to accomplish genetic association studies of candidate genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent exercise in order to search for associations between defined genotypes/haplotypes and 3 specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure; b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20 FEV1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected in the Clearance Halftime of technetium 24 hours after ozone exposure. These studies have been carried forward to take place in 4 phases:

i) healthy individuals have been exposed to O3 using our standard exposure protocol; and we will increase the numbers of individuals available for study.

ii) perform genetic association studies for the endpoints of spirometry (FEV1, FVC, FEV1/FVC), PC20 FEV1 for methacholine, and epithelial integrity (Clearance Halftime) for 3 candidate O3 response genes taken from literature searches and/or previously characterized to demonstrate associations. These physiologic endpoints have been examined in terms of both a continuum of response, and discrete "responder" and "non-responder" endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with normal lung function values, and of normal body habitus (i.e., \< BMI of 30);
* Do not have a history of lung disease, and not taking any medications for lung disease or other clinical disorders, and no prior or current smoking history.

Exclusion Criteria:

* Non-willingness to sign a consent form for participation.