cyrilzakka/clinical-trials huggingface dataset:
Observational Study in HCV Chronic Infection

HCV infection is the most frequent cause of liver chronic disease, cirrhosis and hepatocellular carcinoma in western countries.

To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and 4, and is associated with important adverse side effects, that lead to treatment interruption in approximately 30% of cases.

The recent association of first generation HCV- specific direct-acting antiviral agents (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates, also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV. While several new DAAs are in development, the ultimate goal is represented by IFN-free regimens, that will provide a great advantage in terms of patients adherence to therapy and quality of life.

In this context, prospective observational studies are needed to evaluate the real and long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety, costs and impact on patients quality of life.

Italy is the European country with the greatest number of HCV infected people (average, 3% of population), with higher prevalence in the center and in the south of the country, especially in older individuals, and the highest mortality caused by hepatocellular carcinoma. Genotype 1 is the most frequent one (in more than 50% of infected people). DAAs were approved at the end of 2012. For these reasons, Italy represents an interesting context for collecting data on long-term efficacy, safety and tolerability of new anti-HCV treatments.

The PITER cohort study, developed in the frame of Italian Platform for the study of the therapy of viral hepatitis a prospective observational study, is based on a large cohort of HCV infected patients from more than 100 clinical centers distributed on the whole national area.

The main aims of the PITER longitudinal cohort study are: 1) to produce of an ongoing and continuously updated picture of the changing epidemiology of HCV infection in the country; 2) to evaluate in a real-life setting the expected impact of DAAs on the natural course of infection and on long-term morbidity and mortality.

Collected data will include clinical, laboratory and anatomopathological information and will be recorded in electronic CRF, at the enrollment and follow-up visits.

Special attention will be devoted to specific patient categories (with HIV, HBV, HDV and HEV coinfections, comorbidities, disease patients who presents signs of liver disease progression). Subjects starting an antiviral regimen will be followed according to specific guidelines.

A sub-study on quality of life/adherence to treatment/treatment satisfaction will be also conducted on all treated patients of the cohort.

Eligibility Criteria:
Inclusion Criteria:

- All HCV infected patients who will consecutively come to the participating clinical centers in a given time span (enrollment periods)

Exclusion Criteria:

* Younger than 18 years
* Patients treated at the moment of the enrollment
Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction

Postoperative cognitive dysfunction is defined as a cognitive decline arising after surgery. In the present study, the authors evaluate the level of D-Amino Acid Oxidase, D-serine and Serine in blood as an indicator of postoperative cognitive dysfunction after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cardiac surgery

Exclusion Criteria:

* MMSE \<24
* History of psychological or neurological diseases
* Illiteracy
Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).

The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate.

The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.

The CELEST double blind RCT demonstrated that 25mmHg elastic compression stockings (ECS) were non inferior to 35mmHg ECS to prevent post thrombotic syndrome (PTS) 2 years after a first proximal deep vein thrombosis (DVT). Likely because of lack of statistical power the investigators were not able to demonstrate that 25mmHg ECS were superior in the overall RCT population and that 35mmHg ECS were superior in patients optimally adherent to ECS. Furthermore, few data are available on the very long term (\>5 years).

The CELEST Long term is a prospective study, assessing the very long term risk of PTS in patients enrolled in the CELEST RCT. All patients enrolled in CELEST RCT and willing to participate are eligible and will benefit from a 7-year follow-up visit conducted over the phone.

Primary objective is to assess the proportion of patients with moderate-severe PTS defined as a patient reported Villalta score (PRVS) ≥10 or a venous leg ulcer ipsilateral to index DVT. Secondary objectives include predictors of moderate to severe PTS, impact of initial ECS strength on the development of moderate-severe PTS, impact of anticoagulant treatment (type and duration) on the development of moderate to severe PTS, proportion of PTS (defined as PRVS≥5 or ipsilateral leg ulcer) and impact of PTS on patient's QOL. Study should last 1 year and up to 288 patients may participate.

The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial CE strengths on the risk of PTS.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled and followed in the CELEST RCT\*

Exclusion Criteria:

* Patients who withdrew consent or died during the 2-year follow-up of the CELEST RCT.
* Patients who decline or are unable to participate (including severe memory loss issues) to the long-term follow-up

  * CELEST RCT main inclusion/exclusion criteria were: adult (\>18 years at time of enrolment) patients first unilateral acute symptomatic proximal lower limb DVT
A Community-Based Educational Intervention to Improve Colorectal Cancer Screening

This study investigates the facilitators and barriers to colorectal cancer screening in underserved populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area. Learning what encourages people and what keeps people from getting colorectal cancer screening may help researchers develop an educational tool for colorectal cancer screening that addresses colorectal cancer knowledge, beliefs, and cultural factors in underserved populations.

PRIMARY OBJECTIVE:

I. Develop a culturally tailored colorectal cancer education intervention for underserved and under-represented populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area.

OUTLINE:

KEY CONTACT INTERVIEWS: Participants participate an interviews over 60 minutes focusing on identifying facilitators and barriers to colorectal cancer screening, essential cultural factors to include in the educational intervention, and insights into the best use of the National Cancer Institute (NCI)'s Screen to Save materials.

FOCUS GROUPS: Participants attend focus groups over 60-90 minutes to examine and define further facilitators and barriers to colorectal cancer, cancer knowledge and beliefs, essential cultural factors to include in the educational intervention, insights into the best use of the NCI's Screen to Save materials, and identification of factors to consider for dissemination and sustainability.

After completion of study, participants are followed up for up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* • Focus Groups may be facilitated in Chinese (Mandarin), English, or Spanish depending on participant preference

Exclusion Criteria:

* • Individuals who do not meet the inclusion criteria

  * Individuals who have been diagnosed with colorectal cancer
Automated Brain Morphometry for Dementia Diagnosis

Early dementia diagnosis improves patient and carer experience, links them to appropriate care and support and enables timely symptomatic treatment. The guidelines of the UK National Institute for Health and Care Excellence recommend brain Magnetic resonance imaging (MRI) to assist with the diagnosis in suspected dementia. Recently, computerised analysis of MRI scans, also known as automated brain morphometry, has shown potential to detect the brain changes characteristic of early dementia, and may therefore be a useful addition to the standard reporting performed by a neuroradiologist. The present pilot study will assess whether adding brain morphometric analysis to the usual diagnostic pathway improve diagnosis in clinical practice as an addition to the existing diagnostic pathway in a memory clinic setting. The main purpose of the study is to compare measures of the clinicians diagnostic confidence in patients with and without brain morphometry.


Eligibility Criteria:
Inclusion Criteria:

* Subjects referred to a South London and Maudsley (SLaM) memory clinic for suspected dementia.
* Cognitive scores (standardised MMSE of 15 or more inclusive) and impairment in activities of daily living consistent with a diagnosis of mild to moderate dementia or mild cognitive impairment.
* Working knowledge of English.
* Must consent to the imaging and follow-up aspects of the study. If the patient lacks capacity to consent to the study, they will not be invited to participate.
* If the patient has a partner or carer able to provide an independent evaluation of functioning and able and willing to be involved in a follow-up interview about their experience of the diagnostic process, the carer should also consent to participate in the study.

Exclusion Criteria:

* Contraindications for MRI
* Patients 50 or younger (cognitive impairment in this younger population is only exceptionally due to a neurodegenerative condition). There are no upper age limits.
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18-45 years at screening.
* Patients undergoing elective laparoscopic surgery involving at least one adnexa.

Exclusion Criteria:

* Pregnant (including ectopic pregnancy) or breastfeeding patient.
* Patients with a documented diagnosis of cancer.
* Patients with a lymphatic, hematologic or coagulation disorder.
* Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™.
* Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
* Patients who have participated in another clinical study within 30 days of enrolment.
* Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
Aerosol Inhalation Treatment for Dyspnea - Patients

The purpose of this protocol is to develop and test aerosol furosemide, as a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

This is the second study in a series of studies investigating the treatment effect of aerosolized furosemide on hospitalized patients and outpatients with intractable dyspnea. The study will focus on patients who experience intractable dyspnea at rest or with minimal activity, e.g., dressing, bathing, cooking, or walking stairs or short distances.

There are two parts to this study: Study 2a is a pilot study on 5-10 patients. These trials are not blinded or placebo controlled; the investigators will use them to discover practical problems, and take the information back to the laboratory to develop solutions. We enrolled 7 subjects for Study 2a.

Study 2b will a randomized, placebo - controlled, double- blind study on 25 - 40 patients. The two planned treatments will be aerosolized furosemide and aerosolized saline, and will be given to each patient on two separate days. We failed to reach our enrollment goal, and ultimately enrolled 17 subjects for participation in Study 2b.

Eligibility Criteria:
Inclusion Criteria:

* Intractable dyspnea at rest or with minimal activity

Exclusion Criteria:

* Chronic congestive heart failure
* Liver or kidney disease
* Systemic lupus erythematosis (SLE)
* Receiving potassium supplementation or other indication of hypokalemia
* Major psychiatric disorders
* Furosemide hypersensitivity
* Not mentally competent and/or alert (unable to grant informed consent)
* Under 18 years old
* Not fluent in English
* Inadequate birth control
Treatment of Nighttime Pruritus in Atopic Dermatitis

This study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.

This will be a 6 week study to determine the efficacy of melatonin vs. first generation antihistamine vs. placebo in improving nighttime pruritus in children with atopic dermatitis.

Secondary aims will include:

1. Determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
2. Compare differences between treatment groups in disease improvement
3. Compare differences between treatment groups in quality of life

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed eczema covering more than 5% of body surface area
* Ages 2-12 years old

Exclusion Criteria:

* Sleep disorder, including underlying insomnia
* Neuropsychiatric disorder
* Condition that requires use of antihistamines
* On systemic eczema therapy or monoclonal antibody for allergic diseases
* Unable to discontinue other antihistamine use
* Autoimmune disease as melatonin is contraindicated
A Study Investigating Lu AG06474 in Healthy Young Participants

The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.

The study has 2 parts: Part A and Part B.

Part A consists of up to 7 sequential cohorts (Cohorts A1 to A7), with 8 participants per cohort randomized to receive multiple doses of either Lu AG06474 or placebo: 6 will receive Lu AG06474 oral solution and 2 will receive placebo.

Part B consists of 1 cohort (Cohort B1), with 12 participants: all participants will receive 2 single doses of Lu AG06474 (one as an oral solution and one in capsule form), taken 3 days apart.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m\^2) at the Screening Visit and at the Baseline Visit.
* The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is ≥45 bpm.
* The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

* The participant has previously been dosed with Lu AG06474.
* The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
* The participant has taken any investigational medicinal product ≥30 days or \<5 half-lives of that product, whichever is longer, prior to the first dose of IMP.
Study on the Evolution of Genes Mutation Related With Gastrointestinal Stromal Tumors

Mutations of tumor-related genes are dynamic. Gastrointestinal stromal tumor cells often are obviously more invasive in case of recurrence. The great majority of relapses may be associated with secondary mutation in the GIST related genes. Full gene sequences of c-KIT、PDGFRA and DOG1, which is extracted from the specimen cells of repeated surgical resection or biopsy tissue in GIST patients with postoperative recurrence, are analyzed with the screening-sequencing approach, in order to investigate the characteristics and variations associated with the different gene mutations of c-KIT、PDGFRA and DOG1 in GIST patients and be likely to find out the evolutionary pattern, try to learn the facts about the effect of tyrosine kinase inhibitors on the GIST related genes, make a survey of any association of c-KIT、PDGFRA and DOG1 gene mutations and provide the basis for seeking molecular marker of GIST for monitoring course of disease, and offer a theoretical basis and new therapeutic strategies for application of clinical treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients with Gist at the Department of Gastrointestinal and Glands Surgery of the First Affiliated Hospital of Guangxi Medical University in China.

Exclusion Criteria:

* patients with hepatitis and tuberculosis
A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage Disease Type 1a (GSD1a)

The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a.

The study includes a single ascending dose (SAD) stage and a multiple ascending dose (MAD) stage. Participants enrolled in the MAD stage have the option to continue treatment in an open-label extension (OLE) period that will assess long-term safety and clinical activity of mRNA-3745.

Eligibility Criteria:
Inclusion Criteria:

* Documented GSD1a with confirmation of biallelic gene encoding glucose-6-phosphatase-α (G6PC) mutations by genetic testing.
* Absence of hospitalization for hypoglycemia in the 4 weeks prior to Screening

Exclusion Criteria:

* Solid organ transplant
* Received gene therapy for GSD1a
* Presence of liver adenoma \>5 centimeters (cm) in size
* Diagnosis of type 1 or type 2 diabetes mellitus
* Presence of liver adenoma with growth of \>2 cm or \>5 newly diagnosed liver adenomas, in the previous 2 years

Note: Additional inclusion/exclusion criteria may apply, per protocol.
Batch Fermentation and Microbiome Analysis

The correlation between diet and microbiota as well as the effect of microbiota on human health is well established. Studies have shown that people following specific diets have different microbiome profile compared to those following traditional or ordinary diets. In order to screen several food ingredients for their effects on human microbiota composition and metabolic activities, in vitro studies are proposed. Nutrients are added in-vitro in fecal sample, eliminating the need for participants to consume any nutritional product. The batch fermentation in vitro system simulates human colonic microbiota from fecal samples, enabling the complex mixture of microorganisms. This system could serve as a simple model to simulate the diversity as well as the metabolism of human colonic microbiota. We will evaluate the effect on nutrient/s on the age specific microbiome via an in vitro fermentation approach for the 0 to 60 year-old period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant aged from 0 to 60 (based on medical history, physical examination and review of childhood growth chart)
* Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR) of toddlers and teenagers
* Written informed consent has been obtained for participants aged from 14 years old and above
* Child's parent(s)/legal representative or participant is willing and able to fulfill the requirements of the study protocol.
* Ability to collect their or their infant/child's fecal sample.

Exclusion Criteria:

* The parent(s)/legally acceptable representative (LAR) is not able to provide evidence of parental authority or legal representation.
* Participant following a particular regimen of any type such as vegan, vegetarian, ketogenic, paleo diet,
* Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily,
* Antibacterial/antifungal therapy during the 3 months prior to study enrolment,
* Medications or supplements that are known to alter gut function or microbiota (i.e. acid antisecretory drugs, pre-/probiotics supplements, laxatives) during the 4 weeks prior to study enrolment,
* Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy),
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer,
* Artificially sweetened beverage intake higher than 1000 ml/ per day,
* Current or history of gastrointestinal diseases like (Celiac Disease, Crohn's Disease, Ulcerative colitis, Irritable Bowel Syndrome, infantile colic, recurrent abdominal pain, functional constipation, ulcers, infections (based on anamnesis),
* Participants participating in another interventional study,
* Participants/parents having a hierarchical or family link with the research team members.
Pediatric Virtual Visits as a Strategy for Access to Care During the COVID-19 Pandemic in a Pediatric Hospital

In this study we will describe the factors associated with missed virtual visit appointments in an academic children´s hospital during the covid-19 pandemic and we will develop a predictive model that serves as the basis for improving the Telehealth Program.

Pediatric visits are a fundamental axis of health policies because actions to promote and protect health have a maximum effect on children. Due to the COVID-19 pandemic a marked decrease in pediatric visits was observed in scheduled and on-call visits. This fact can be explained by the restriction on people's circulation necessary to contain COVID-19 dissemination. In this context, the population that attends the Hospital General de Niños Pedro de Elizalde was especially affected, since 91% of the patients attending the institution live in another district.

In order to overcome this barrier in access to care, we decided to implement a Telehealth Program that uses virtual visits as a tool for access to care. Little is known about the effects that these programs can have on patients with exclusive public health coverage. Although virtual visits could be a solution for access to care in an oversaturated system, there is the possibility that virtual visits could not be carried out and that a significant proportion will be lost, increasing inequity and difficulties in access to health.

Due to the relevance of the topic and the little information available, we propose in this study to estimate the proportion of virtual visits appointments lost. On the other hand, considering the possibility of avoiding the loss of virtual visits appointments, we propose to describe the factors associated with missed appointments and develop a predictive model that serves as the basis for improving the Telehealth Program.

Eligibility Criteria:
Inclusion Criteria:

* All scheduled virtual visits

Exclusion Criteria:

* On-call virtual visits