cyrilzakka/clinical-trials huggingface dataset:
Time to Treatment and Disease-free Survival of Patients With High-risk Head-neck Cutaneous Squamous Cell Carcinoma

The purpose of this study is to investigate the association between time to treatment (defined as date of pathological diagnosis to date of start treatment) and disease free survival in patients with high risk cutaneous squamous cell carcinoma in the head-neck region.

Skin cancer is the most common type of cancer in the Netherlands. Cutaneous squamous cell carcinoma (cSCC) accounts for 20% of all cutaneous malignancies. The incidence of cSCC has been rising over the years in the Netherlands, from 8,966 new cSCCs cases registered in 2012 to 14,873 cases in 2022. cSCCs mostly involve patients aged 75 years and older. Since exposure to UV radiation is the main risk factor for the development, cSCCs particularly occur on sun exposed areas of the skin such as in the head-neck region and the extremities. Other risk factors include a Fitzpatrick skin type I or II, use of immunosuppression, exposure to arsenic, and infection with human papilloma virus.

Risk of metastasis and recurrence in general cSCCs are 2.6-5% and 1.9-3.7%, respectively. However, these risk ratios may increase to 37% in high-risk cSCCs. High risk cSCCs are defined as cSCCs with risk factors for development of metastatic disease or recurrence, e.g. poor histological differentiation, perineural/lymphovascular infiltration, diameter ≥20 mm.

Due to the increasing incidence, advanced age, risk of metastasis and recurrence, and the high risk-location in the head-neck region related to functional and cosmetic importance, high-risk cSCCs in the head-neck region (high-risk HNcSCCs) require complex and multidisciplinary care. Therefore, care pathways have been developed. An important part of these care pathways are waiting times and, in particular, the time to treatment. For example, in mucosal head-neck tumors, prolonged waiting times have been described to be associated with reduced survival rates. This led to the hypothesis that prolonged waiting times result result in lower survival rates for patients with high-risk HNcSCCs. This study aimed to investigate the association between time to treatment defined as date of pathological diagnosis to date of start treatment) and disease free survival in patients with high risk HNcSCCs.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with high-risk HNcSCCs, defined as T2 to T4 HNcSCC
* Treated in the Maastricht University Medical Center+ (MUMC+) or Radboud University Medical Center (RadboudUMC)
* Treated between 2010 to 2018

Exclusion Criteria:

* Patients aged younger than 18 years
* Patients with a T1 HNcSCC
* Patients with recurrence or metastatic disease of a previously treated HNcSCC
Shared Health Information System for Febrile Neutropenia

The use of e-health in improving the quality of health services is a rapidly expanding research area, in particular its usefulness in patient management of the home-hospital care pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy and better identification of low-risk patients who can be treated at home could be made possible by these technologies.

The objective of this study is to evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims to compare the average length of hospital stay for febrile neutropenia among patients receiving NEUTROSIS and those receiving standard care

Materials and methods A shared information system (NEUTROSIS) has been developed to connect a smartphone web application for the patient to the existing shared medical record of the Paris Sud hospital group (AP-HP, France - 4D software).

The study consists of conducting a randomized controlled trial to compare a cohort of patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by the hospital's standard care over a treatment period of six months (n=100). During the 15 days following each chemotherapy cycle, the 2 groups of patients must take their temperature daily. Both groups are trained like any patient under chemotherapy to contact the team in case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team who will be alerted in case of fever and will contact the patient. The control group will indicate these same data in a paper diary and will have to contact the health team in case of fever as done in the usual care.

The two groups of patients will be followed 6 months through a questionnaire asked to the patient at each hospital visit for chemotherapy cycle. The questionnaire collects information on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study will take place in two hospital sites of the Paris University hospital (A Béclère and Kremlin-Bicètre).


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Patient receiving cytotoxic chemotherapy for solid tumor or hematological malignancy
* Patient having signed consent to participate in the study
* Patient able to understand the protocol of care
* Patient covered by health insurance
* Patient with the use of a smartphone or tablet with Internet connection

Exclusion Criteria:

* patient refusing to participate in the study
* patient participating in a drug trial
* patient receiving or shifting to a weekly chemotherapy protocol
Safety Evaluation of SS-POR11

The goal of the present study is to assess the safety of a topical probiotic (probiotic strain; SS-POR11) on acne prone-skin, and the impact of SS-POR11 on the distribution of porphyrins, in subjects with mild-to-moderate acne \[Investigator's Global Assessment (IGA) 1-3\].


Eligibility Criteria:
Inclusion Criteria:

* Participant's first language of French or English, given the written language of the ICF
* Participants willing to sign the ICF upon entering the study
* Participant must be willing and able (in the PI's opinion) to comply with all study requirements
* Participant must be aged 18-40 years
* Participant must have a screening and baseline IGA score of 1 (rare blemishes/clear skin) or 2-3 (mild to moderate facial acne vulgaris)
* Participant must agree to appear on all evaluation days and conform to all study-related instructions
* Participant must agree not to undergo any topical treatments in the areas under investigation during the study period

Exclusion Criteria:

* Participants under the age of 18 years or over the age of 40
* Refusal to sign the ICF
* Participants has any injuries or tumors in the areas under investigation
* Participant has a recent (i.e., 3 months) surgery or invasive treatment in the areas under investigation
* Use of oral antibiotics within 4 weeks prior to start of study
* Use of oral or topical "probiotic" products within one month prior to start of study
* Prior (3 months) or planned use of chemical peels, microdermabrasion, microneedling, or exfoliants during the course of the study
* Participant is using or has used within 3 months drugs such as corticosteroids, immunosuppressants, or others collagen-production inhibitors
* Participant is pregnant or lactating or wishes to get pregnant within the next 3 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential)
* Participant has active herpes simplex in the investigated areas or a history of herpes labialis with four or more outbreaks in the 12 months prior to baseline
* Participant has immunocompromising diseases; any known allergy or hypersensitivity to any of the ingredients of the investigational product
* Participants possessing any of the contraindications for use of SS-POR11
* Participant has tattoos, piercings, excessive scarring (e.g., hypertrophic or keloid scars) in the areas under investigation
* Current or prior (3 months) change in the use of retinoids; Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; and any other criteria that at the discretion of the Investigator, could interfere with study assessments or expose the subject to undue risk by study participation.
Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS

Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. During the acute phase of ACS, blood glucose was monitored using a continuous glucose monitoring system (CGM) for 14 days, and for patients who had been hospitalised for less than 14 days, they continued to wear the CGM for monitoring blood glucose until 14 days after discharge. During this period, stool and serum samples were analysed for multi-omics (16s rRNA sequencing and metabolomics). Subsequently, a follow-up period of at least 1 year was performed to observe the patients for the occurrence of adverse cardiovascular events (MACE) during the follow-up period and to assess the impact of glycaemic variability and gut flora and its metabolites on the prognosis of patients with T2DM combined with ACS.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).

Clinical diagnosis of Acute Coronary Syndrome (ACS).

Exclusion Criteria:

History of hemodialysis.

Recent antibiotic use within the past two weeks.

Active malignant tumors.

Pregnancy and breastfeeding.

Inability to wear sensors due to severe skin conditions.

Coagulation disorders, anemia, or abnormal hematocrit levels.

Requirement for MRI during the sensor-wearing period.

Inability to follow study instructions or deemed unsuitable for the trial by the treating clinician/nurse.

Inability to understand informed consent or communicate with researchers due to cognitive decline or mental illness.
Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection

The traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect on the treatment of autoimmune diseases such as rheumatoid arthritis. Now that immunosuppression therapy has recently become a new strategy for HIV infection, it's reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected patients. So we designed a randomized, double-blinded, placebo-controlled study to explore the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection.

Acquired immune deficiency syndrome(AIDS) is a severe fatal disease caused by HIV infection. Despite viral suppression achieved, antiretroviral therapy(ART) cannot ameliorate HIV-induced immune activation and the consequent non-AIDS complications including cardiovascular, renal, hepatic diseases. Recently, immunosuppression therapy has become the focus since it can suppress exorbitant immune activation and inflammation so as to reduce the risk of non-AIDS cardiovascular and central neural system complications. Triptolide Wilfordii is a traditional Chinese herbal remedy and has long been used in the treatment of autoimmune diseases such as rheumatoid arthritis. Moreover, a recent study has shown that Triptolide Wilfordii combined with ART is associated with increased CD4 T cell counts and reduced immune activation in immunological non-responders, who were defined as patients with CD4 cell counts\<350 cells/μl despite over 2 years of ART. Hence we expect Triptolide Wilfordii to bring up similar improvement in treatment naïve HIV infection. This randomized, double-blinded, placebo-controlled study is designed to investigate the safety and efficacy of Triptolide Wilfordii and hopefully provide evidence for a new treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* 18\~65 years old;
* Male or female;
* Good adherence and promise to follow-up;
* Inform Consent signed;
* Positive for HIV antibody test or serum HIV-RNA positive for 2 times or more;

Exclusion Criteria:

* Present opportunity infection defined according to national AIDS treatment guideline or active opportunistic infection(not stable within 14 days ) within 3 months before recruitment or AIDS-related carcinoma;
* Hemoglobin (HGB) \< 9 g/dl, white blood cell (WBC) \< 3000/ul, granulin (GRN) \< 1500 /ul, platelet (PLT) \< 75000 /ul, Cr \>1.5x upper limit of normal (ULN), ALT or AST or alkaline phosphatase (ALP) \>3x ULN, total bilirubin (TBIL) \>2x ULN;
* Pregnancy or breastfeeding;
* Woman with pregnancy plan;
* Severe organ dysfunction;
* Administration of immunosuppressor, immunomodulator(including thymocin) or systemic cytotoxic drugs within 6 months before recruitment.
MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen

The first results of Anti-Vascular Endothelial Growth Factor (VEGF) therapy were very promising and superior to established therapies. Three different substances (all of them applied intravitreally) are available, but comparative studies have not yet been conducted. In this pilot study, the safety (number of adverse events) and efficacy (distance acuity testing retinal thickness measurement) of Avastin and Macugen applied as monotherapy will be compared to a combined treatment of Avastin followed by Macugen used for retreatment.

At least equal results of the combined therapy are expected.

The role of Vascular Endothelial Growth Factor (VEGF) in the pathogenesis of neovascular diseases like choroidal neovascularization (CNV) and proliferative diabetic retinopathy has been demonstrated in a series of publications. Therefore intravitreally applied VEGF antagonists have been used in the treatment of CNV in age-related macular degeneration (AMD) and diabetic cases. Three anti-VEGFs are available: Macugen® (Pegaptanib), Avastin® (Bevacizumab) and Lucentis® (Ranibizmab). Pegaptanib sodium is an aptamer designed to bind the VEGF 165 isoform with high affinity. Bevacizumab is a humanized monoclonal antibody to VEGF designed for intravenous administration and approved for the treatment of colorectal cancer. Ranibizumab is an anti-body binding site fragment that is derived from the same anti-VEGF antibody as bevacizumab. The decrease of retinal thickness measured in the OCT provides information concerning the amount of intraretinal fluid accumulation and therefore for the activity of a neovascular lesion. It has been proven that the aqueous humor levels of VEGF of eyes with CNV are significantly higher than those of eyes without ocular or systemic diseases. The retinal thickness and the VEGF concentration in the aqueous humor should give a good correlation to the anti vasogenic effect of the intravitreal treatment. In this study bevacizumab and pegaptanib as monotherapy should be compared with a combined therapy of bevacizumab applied first with pegaptanib used for retreatment. The benefit of this combined therapy should be that an initial blockage of all VEGF isoforms is necessary whereas for retreatment the blockage of the most important isoform in the pathogenesis of CNV is sufficient and the normal function of the retinal pigment epithelium and the choriocapillaris is not affected.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Predominantly occult CNV
* Greatest diameter of the lesion \< 5400µm
* Distance acuity \> 0.1

Exclusion Criteria:

* Complicating general disorders inflicting with healing process
* Vision threatening diseases other than CNV
* Prior treatment for CNV
* Ophthalmic surgery within 4 weeks
* Not consented patients
Developing and Pilot Testing an Opioid Tapering Protocol

This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. In a pilot randomized controlled trial (RCT), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("TapPro") compared to usual care. As there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in OPR dose over six months. Separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. The central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.

In a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (TapPro) or to usual care. Over three months, participants in the TapPro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. In the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. Participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18
2. chronic prescription opioid use (\>3 monthly prescriptions from the clinic within prior 6 months)
3. morphine milligram equivalents (MME) ≥50
4. poorly controlled pain (PEG pain score ≥ 5/10)
5. providers considering opioid taper but no reductions in opioid dose over the past 6 months.

Exclusion Criteria:

1. Active cancer or other serious progressive illness, by medical review and by self-report
2. Moderate or severe opioid use disorder, as per DSM-V
3. Inability to give informed consent
4. Active suicidal ideation.
Comparison of Self Directed Learning and Small Group Teaching Methods on Pressure Injury Assessment

The purpose of this study is to determine the effect of pressure injury assessment training given by self-directed learning and small-group teaching methods on the knowledge and skill levels of nursing students: a three-group, pre-test - post-test, randomized controlled, parallel-group experimental study.

Pressure injury is a common health problem worldwide. The global prevalence of hospital-associated pressure injuries was 8.4%. Regular wound assessment is required to determine appropriate treatment methods, monitor wound healing, and identify complications early in the pressure injury treatment process in order to achieve clinical goals.

According to the literature, nurses and nursing students have a low level of knowledge about pressure injury and there is a knowledge gap between nurses' knowledge of pressure injury and pressure injury practices. As a result, it is necessary to teach skills so that they can put their knowledge into practice. Individuals born after 2000, referred to as Generation Z, make up the majority of students beginning undergraduate education today. The most significant difference between Generation Z and other generations is that they were born during a period when digital high technology was widely used. This generation, also known as the "Internet generation," is constantly surrounded by new technological opportunities, communication, and transportation facilities. Because of these characteristics, it is critical to use teaching methods that will appeal to them when educating students in this group.

In a classroom, there are fast and slow learners. The amount of time allotted to students naturally decreases as the number of students in the class grows. Furthermore, student differences prevent the entire class from learning at the same time. Some students do not learn right away, others later, and still others do not learn at all in such a classroom. Education should be personalized in order to eliminate all of these non-occurrences.With the widespread use of smart phones today, mobile learning has become commonplace. Students gain clinical practice skills and experience when mobile technology is used as a support tool in nursing education practices.

For this purpose, the trainings to be given with the mobile application in this study will be supported by the activities in which the students can practice individually in the skill laboratory.

Eligibility Criteria:
Inclusion Criteria:

* To be registered for the Nursing Vocational Application Course
* Volunteering to participate in the research
* Having a mobile device (smartphone, tablet PC etc.)

Exclusion Criteria:

* To have received training on the evaluation of pressure injuries other than the basic nursing education
Confocal Laser Endomicroscopy vs Conventional Histology for the Identification of Intestinal Metaplasia

Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with Conventional Histology for the Identification of Specialized Intestinal Metaplasia

The incidence of esophageal adenocarcinoma has risen over 800% over the past several decades and is associated with a high mortality rate. Barrett's esophagus (BE) has been identified as the number one risk factor for the development of esophageal adenocarcinoma. Gastroesophageal reflux disease (GERD) has been identified as the major risk factor for development of BE. Current guidelines for BE diagnosis and surveillance, according to the Seattle protocol, include four-quadrant random biopsies at 2-cm intervals (1-cm intervals if suspected high grade intraepithelial neoplasia). This random biopsy protocol can be time-consuming, expensive, and prone to sampling error, as very little of the esophageal surface area is actually sampled. Probe-based confocal laser endomicroscopy (pCLE) generates optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally invasive manner. Comparing pCLE with conventional histology for the identification of specialized intestinal metaplasia has the potential to result in a new standard of care for the diagnosis of BE. The aim of this study is to compare pCLE to traditional tissue biopsies for the diagnosis of BE.

A patient with GERD will be scheduled for upper endoscopy as part of routine evaluation. Routine endoscopy will be performed, including white light and narrow band imaging photo documentation. Probe-based confocal laser endomicroscopy will be performed at the gastroesophageal junction. Biopsies of columnar lined esophagus will then be taken in four quadrants starting at the squamocolumnar junction and proceeding in 1 cm segments to the gastroesophageal junction. Optical biopsy images will be reviewed immediately following endoscopy by endoscopist and later reviewed by blinded independent reviewer. Pathology specimens will be reviewed by a pathologist. The results of the optical biopsies obtained with probe-based confocal laser endomicroscopy will be compared with the pathology results.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18; Clinical diagnosis of GERD; Undergoing upper endoscopy for reflux evaluation

Exclusion Criteria:

* Age \<18, Contraindication to receiving fluorescein, Inability to provide informed consent, History of esophageal ablation