cyrilzakka/clinical-trials huggingface dataset:
Comparing Photodisinfection of Chitosan NP Enriched ICG Over ICG as Adjunct to OFD: RCT

The current study is a prospective randomised study-Comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage II/III grade B/C periodontitis.

A total of 24 patients fulfilling inclusion criteria will be randomly assigned into two treatment groups (Test and Control). Open flap debridement followed by photodynamic therapy using dyes is carried out.

Test group (n=12) - PDT with Chitosan nanoparticles enriched ICG Control group(n=12) - PDT with ICG Microbial levels of P.gingivalis is analysed with PCR analysis on baseline and 3 months after intervention.

Eligibility Criteria:
Inclusion criteria:

* Systemically healthy subjects
* Age group 30-55yrs.
* Diagnosed with Stages II/III grade B/C periodontitis.
* Presenting with persistent pocket depth ≥5mm after initial non-surgical therapy.
* Optimal plaque control
* Good compliance

Exclusion criteria:

* Subjects on antibiotic therapy within last six months of enrollment
* Previous history of periodontal surgery
* Allergy to drugs and materials used in this study
* Pregnant woman
* Subjects with deleterious habits like smoking, tobacco chewing.
Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Research objectives:

The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe), NT-Pro BNP and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.

Method and proposal steps:

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
2. All participant agreed to take part in this clinical study and provide informed consent.
3. 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital.
4. Serum samples will be collected for measuring the biomarkers.
5. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride
6. All patients will be followed up during 3 months' period.
7. At the end of 3 months, step 4 will be repeated.
8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
9. Measuring outcomes: the primary outcome is the change from baseline to post-treatment insulin sensitivity reflected by change of serum level of measured marker after 3 months.
10. Results, discussion, conclusion, and recommendations will be given.

Methodology:

1. Fasting blood glucose (FBG) 2 hrs. post prandial blood glucose(2hPPBG) will be measured by glucometer.
2. HbA1c %, Fasting plasma insulin (FPI), Interleukin-34 (IL-34), NT-Pro BNP and extracellular domain of insulin regulated aminopeptidase (IRAPe) will be assayed by Enzyme-Linked Immunosorbent Assay (ELISA).
3. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. 60 Patients with type 2 DM diagnosed clinically. The age ranged from 18 to 70 years. There are no limits to the duration of DM and gender.
2. HbA1c ≥ 7

Exclusion Criteria:

1. Other types of DM
2. Hypersensitivity to the drug
3. Abnormal liver function
4. Patients with renal impairment (eGFR ≤ 60 ml/min)
5. Previous history of bladder cancer
Identifying Toddlers and Their Parents Who Are Suffering From Posttraumatic Distress Following War and Terror

The project is aimed at identifying children who are suffering from posttraumatic distress and increasing capacity to provide treatment for them and for their caretakers. The project will be implemented in 3 cities in Israel, Haifa, Kiryat Shmona and Sderot, exposed to terrorism and the effects of war

A. Screening of young children and implementation of treatment The screening will consist of self-report questionnaires and a clinical interview with parents, conducted by trained professional about exposure to traumatic events and resulting post-traumatic specific symptoms among the toddlers and their parents. The screening procedure is bases on the accumulated clinical experience and empirical data gained in the ongoing similar project in Sderot. The level of cooperation by parents and teachers in the ongoing project has been exceptionally high, indicating a tremendous need for knowledge, skills and support. Based upon our previous experience, it is anticipated well-baby clinic nurses will also be extremely interested participation.

B. Workshops for parents, teachers, nurses The knowledge and skills of preschool teachers and nurses working in all our projects sights (well baby clinics, day care centers and kindergartens) as well as parents will be increased by providing training regarding the impact of war related trauma on preschool children. Workshops will better equip teachers, nurses and parents with knowledge about the emotional impact of trauma on young children and will increase the skills to help preschool children contain emotional distress as well as to help them in coping with the emotional consequences of trauma exposure.

C. Treatment Interventions All toddlers identified with posttraumatic distress will receive dyadic treatment focused on dealing with posttrauma. Dyadic treatment involving parents and children is aimed at increasing the attunement of parents to their toddlers and their needs in times of crises. Local practitioners in Sderot implementing this cutting-edge treatment received specialized training adjusted to the context of terror and trauma by a child trauma specialist from Mount Sinai Medical Center in New York.

D. Evaluation of treatment Evaluation of treatment efficacy (dyadic treatment) will be assessed by pre and post interviews that will be conducted by trained professionals with all parents participating in the dyadic treatments in each of the three cities

Eligibility Criteria:
Inclusion Criteria:

* Families with children between the age 1-6 years.
* Families living in Sderot, Kyriat Shmona and Haifa

Exclusion Criteria:

* Severe developmental problems
CompuFlo CathCheck

The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patients (age 18-99 years old) undergoing epidural placement for an operative procedure will be eligible for participation in this study.

Exclusion Criteria:

* All patients unable to receive or who refuse placement of epidural will be excluded
* patients who are unable to consent
* non-English speakers, pregnant individuals)
* Individuals with known or who have an allergic reaction to bupivacaine
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC

Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.

Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.

Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.

Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.

Study procedure:

1. Initial Visit (V0-Baseline): For the purposes of the study the following information will be collected: the demographics, medical and social history, the characteristics of the disease (stage, molecular characterization e.t.c) and the treatment regimen that is followed. As part of the visit, 20 mL of peripheral blood will be drawn prior to their treatment according to physician's suggestion as per common clinical practice. Blood samples will be then sent to ACTC laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Primary tumor tissue samples will be also collected
2. Follow-up visit (V1): Response to treatment by RECIST based on restaging CTs/MRIs will be documented during this visit, which will take place 3 months after treatment initiation. As part of the visit, 20 mL of peripheral blood will be drawn.

Blood samples will be then sent to laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Survival status and clinical response (CR, PR, SD, PD) will be also documented.

Eligibility Criteria:
Inclusion Criteria:

1. Female aged ≥ 18 years of age.
2. Histological confirmed ER+/HER2- metastatic Breast Cancer prior to beginning a treatment
3. Life expectancy permits participation to the study.
4. Available tumor tissue sample for molecular analysis.
5. Signed informed consent form.

Exclusion Criteria:

1. Female younger than 18 years old.
2. History of another malignancy within 3 years or current 2nd primary malignancy.
3. Patients that have not signed the informed consent.
The Effect of Aronia Melanocarpa Extract on Cognitive Function

There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance . Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance.

There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance. Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance. The product in this study is aronia melanocarpa which contains polyphenols. A limited number of clinical studies have already been carried out to see the effect of similar products on cognitive functioning. However, these studies have often been done in older study populations or over a longer period of time. In this study, in healthy adolescents (ages between the 18-35 and with a BMI between 18.5 and 30), the investigators want to test the short term (7 days) effect of aronia melanocarpa extract on cognitive functioning. The investigators will also test the effect of supplementation on the particpant's mood, vascular function, blood biomarkers, retinal vasculature, and subjective cognition.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults: ages between 18 and 35
* BM between 18.5-30 kg/m2

Exclusion Criteria:

* Current use of (antioxidant) dietary supplements and not willing to quit for the duration of the study duration
* Pre-existing or history of neurological illness
* High blood pressure (\>140 systolic and/or \>90 diastolic mmHg)
* Use of medication that might have influence on endpoints (e.g. antidepressant)
* Known pregnancy or lactation
* Food allergy to the study product
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study, to be decided by the principle investigator, in the 180 days prior to the study
* Abuse of products (\> 20 alcoholic consumptions per week and drug usage)
* Participation in a scientific intervention study which may interfere with this study in the 180 days prior to this study
Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

This randomized controlled trial is to clinically assess and compare impression quality of polyvinylsiloxane impression material using one step (experimental) and two step (control) impression techniques and its effect on marginal fit of prosthesis and proximal contact of prosthesis.

Study participants will be randomly allocated to either of the two groups (experimental or control) through software-generated random numbers.

Indicated tooth will be prepared to receive a fixed prosthesis under local anesthesia as per standard guidelines.

Polyvinylsiloxane (PVS) impressions will be recorded in stock tray after moisture control, according to the assigned group.

In experimental group, light body and putty PVS will be mixed simultaneously and placed in stock tray to record impressions in single stage.

In control group, a putty PVS impression will be recorded first in stock tray and allowed to set. After setting of putty PVS, light-bodied PVS material will be applied to recorded impression surface and reseated in mouth to record final impression in second stage.

All impressions will be disinfected according to the recommended guidelines. All impressions will then be assessed by a senior clinician using 3.5 x magnification loupe and graded according to the selected criteria.

Impressions will then be poured in dental stone and prosthesis will be manufactured in dental lab.

Participants will be recalled for prosthesis trial and fit assessment of prosthesis margins using a dental explorer instrument and visual evaluation. Proximal contact of prosthesis will be graded according the criteria and assessed using dental floss.

Satisfactory prostheses will be cemented after final adjustments.

Eligibility Criteria:
Inclusion Criteria:

* Indication of fixed-fixed partial denture or crown
* Good oral hygiene
* Sound abutment tooth (vital/non-vital)

Exclusion Criteria:

* Failure to provide written consent to participation in study
* Long span bridges (Greater than 3 units)
* Patients with bleeding disorders
* Cases indicated for resin-bonded prosthesis
Examining the Impact of Tampon Use on the Vaginal Microbiota

The vaginal microbiota is the community of bacteria in the vagina. The composition of the vaginal microbiota (which bacteria are present and how many of each are present) is known to affect vaginal health and contribute to the development of bacterial vaginosis (the largest cause of vaginal discharge and malodor, and the most common vaginal disorder). It is also known that the composition of the vaginal microbiota changes across a menstrual cycle with the largest changes happening during a woman's period. However, it is not know how tampon use affects vaginal microbiota composition. This study is being done to learn what effect tampon use has on vaginal microbiota composition during a woman's period and between periods.


Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycles lasting 21-35 days
* menses lasting for at least 4 days
* current tampon user
* good self-reported general health
* good self-reported vaginal health

Exclusion Criteria:

* currently pregnant
* planning to become pregnant in 4 months following enrollment
* difficulty using tampons
* current toxic shock syndrome
* history of toxic shock syndrome
* current sexually transmitted infection
* current urinary tract infection
* currently using antibiotics
* antibiotic use in 4 weeks prior to enrollment
* current antifungal use
* antifungal use in 4 weeks prior to enrollment
* autoimmune condition
Diagnostic and Prognostic Model of Pulmonary Fibrosis After COVID-19 Pneumonia and Mechanism Study

The infection of COVID-19 has caused serious threat to the life and health of all mankind and increased huge economic burden. According to the current statistics, the incidence of pulmonary fibrosis after COVID-19 infection is about 27.7% -87%, 81% of severe patients and 37% of moderate patients have residual lung lesions, and 53% of patients still have residual lung abnormalities one year after infection, resulting in restrictive pulmonary dysfunction and affecting the health and life of patients. Therefore, it is very important to study the diagnostic and prognostic markers of pulmonary fibrosis after infection of COVID-19. At present, relevant studies have been carried out on imagomics and serum proteomics of pulmonary fibrosis after COVID-19 infection, and serum biomarkers and imagomics marker models for diagnosing pulmonary fibrosis after COVID-19 pneumonia have been developed. However, there are few studies combining imageomics and serum proteomics, and the mechanism of pulmonary fibrosis after COVID-19 has not been fully clarified. In this study, it is planned to recruit patients with moderate, severe and critical COVID-19 pneumonia infection, collect venous blood from subjects, and perform chest HRCT follow-up. Blood samples were screened by proteomics and verified by expanded samples to screen diagnostic and prognostic markers of pulmonary fibrosis after COVID-19 infection. At the same time, based on deep learning technology, a model was developed to predict the occurrence and prognosis of pulmonary fibrosis after infection of COVID-19 combined with clinical characteristics, serum markers and AI imagomics, so as to provide ideas for further elucidating the mechanism of occurrence and development of pulmonary fibrosis after infection of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-90 years
2. novel coronavirus nucleic acid or antigen confirmed novel coronavirus infection
3. Meet the diagnostic criteria for moderate/severe/severe coronavirus infection in China (Trial Tenth Edition)
4. Chest CT showed that the extent of lung lesions was greater than 50%

Exclusion Criteria:

1. pregnant and lactating women
2. previous severe lung disease, such as known chronic lung disease: chronic obstructive pulmonary disease, asthma, interstitial lung disease, etc.
3. severe organ dysfunction: severe liver, kidney and heart dysfunction
4. severe epidemic defects (including tumors/severe rheumatism/organs, bone marrow transplantation/HIV, etc.)
5. inappropriate enrollment judged by the investigator
Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With TACE and HAIC in Unresectable Hepatocellular Carcinoma

Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.


Eligibility Criteria:
Inclusion Criteria:

* (a) a confirmed diagnosis of uHCC;
* (b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria;
* (c) Child-Pugh Grade A or B.

Exclusion Criteria:

* (a) previous exposure to other anti-cancer treatments;
* (b) diagnosis of any other primary malignancy;
* (c) significant esophageal varices or observable red wale marks;
* (d) a history of severe cardiac, pulmonary, or renal comorbidities;
* (e) incomplete follow-up records.
Metformin as an Upstream Therapy in Atrial Fibrillation

The purpose of this study is to see if the study drug metformin will help patients who are overweight and have atrial fibrillation. This study aims to see if metformin helps patients stay in normal sinus rhythm after a catheter ablation.

Metformin is investigational for use in patients with atrial fibrillation. Metformin is approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes Mellitus. Metformin is used with a proper diet and exercise program to control high blood sugar, and has been shown to help people lose weight. This study aims to look at the effects of metformin on weight loss and heart rhythm in patients with atrial fibrillation.

Enrollment: Consent, medical history, and dietary education. Randomization. treatment Metformin 500mg daily and increased as tolerated to 2000 mg daily over three weeks or control -no treatment. 6 weeks. Pre procedure safety labs, EKG, Atrial Fibrillation Severity Score survey, metformin held 48 hours prior to rhythm control procedure. Treatment resumed 48 hours post procedure or when renal function at baseline. Treatment plan for 6 months or discontinuation at any time they are found to meet the baseline exclusion criteria. Follow-up at 3 month and 6 month post procedure. Continuation of treatment at study completion determined by primary cardiologist or care provider.

Eligibility Criteria:
Inclusion Criteria:

* All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the study. All subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Individuals who are already taking metformin or other antidiabetic medications including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate \<22 mEq/L), have a history of significant alcohol use (\>2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X greater than the upper limit of normal), have a history of New York Heart Association (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.