cyrilzakka/clinical-trials huggingface dataset:
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms

The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon

The hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:

* Immunological aspect: lack of humoral response or immune activation
* Virological aspect: Reduced HIV reservoir size
* Determine the HLA phenotype in the different groups of children included and the KIR genotypes.

There will be two phases of the study :

* A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.
* A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank

Eligibility Criteria:
Inclusion Criteria:

Case control study

* Children included and followed in the ANRS 12225 study - Pediacam III
* Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up.

Control (4 groups)

* HIV-infected children with positive serology and viral load (VL) \<400 copies /ml
* HIV-infected children with positive serology and VL ≥400 copies / ml
* HIV-uninfected children born to HIV-positive mothers
* HIV-uninfected children born to HIV-uninfected mothers Selection of cases and controls will be matched on gestational age (premature \<37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010).

Cross sectional study Inclusion criteria

* All children still followed in the ANRS - Pediacam III cohort
* Written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of HIV statusfor infected children for participation to the study.

Exclusion Criteria:

* Refusal by one of the parents or the guardian for the child's participation in the study
* No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children)
Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions

To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker c-Met is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging.

Edinburgh Molecular Imaging Ltd (EMI) has developed a fluorescent tracer specifically targeting c-Met by labeling a small peptide to a fluorescent fluorophore: 'EMI-137'. The investigators hypothesize that when EMI-137 is administered intravenously, it accumulates in c-Met expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling (early) cancer visualization using a newly developed fluorescent fiber-bundle. This hypothesis will be tested in the current pilot intervention study.

See brief summary.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, eligible for a diagnostic and/or therapeutic endoscopy;
* At least a suspicion of low grade dysplasia (LGD) based on a prior endoscopy;
* World Health Organization (WHO) performance score of 0-2;
* Written informed consent;
* Mentally competent person that is able and willing to comply with study procedures;
* For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:

  * A negative serum pregnancy test prior to receiving the tracer;
  * Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Exclusion Criteria:

* Pregnancy or breast feeding;
* Advanced stage EAC patient not suitable for endoscopic resection;
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
* Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment
* The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months.
* History of myocardial infarction (MI), Transient Ischemic Attack (TIA), CerebroVascular Accident (CVA), pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
* The subject had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to Investigational Medicinal Product (IMP) administration. Occasional use of analgesics, such as non-steroid anti-inflammatory drugs and/or paracetamol, was permitted at the discretion of the investigator. Use of hormonal contraceptives is permitted.
Multimorbidity Management Supported by a Digital Platform

This study aims to assess whether the use of the METHIS digital platform using a patient-centered approach contributes to an improvement in the quality of life, mental health and physical activity of patients with multimorbidity followed up in Primary Health Care. Practices will be randomly allocated between: providing access to consultations through the METHIS platform (intervention) or following patients by the traditional method (control). They will complete questionnaires on quality of life, mental health and report the number of steps taken, at the beginning and end of the study.

A superiority, cluster randomised trial will be conducted at Primary Health Care Practices (1:1 allocation ratio). All public practices in the Lisbon and Tagus Valley Region, Portugal, not involved in a previous pilot trial, will be eligible. The intervention combines a training programme and a customised Information System (METHIS). Both are designed to help clinicians to adopt a Goal-Oriented Care Model approach and to encourage patients and carers to play a more active role in autonomous healthcare.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling people
* aged 50 or older
* with complex multimorbidity (co-occurrence of three or more chronic conditions affecting three or more different body systems)
* with access to an Internet connection and a communication technology device

Exclusion Criteria:

* inability to: provide informed consent, to read or write, inability to access an email or electronic device, even when helped by an informal caregiver
Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy

This is a single-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.
2. Patients with incurable locally advanced or metastatic or recurrent NSCLC who have experienced treatment failure with first-line treatment using a PD-1/PD-L1 inhibitor combined with platinum-based doublet chemotherapy (except docetaxel) or treatment failure with sequential first-line treatment using a PD-1/PD-L1 inhibitor and platinum-based doublet chemotherapy (except docetaxel) may be eligible. Previous treatments include anti-VEGF monoclonal antibody. For patients with operable early stage or locally advanced NSCLC who have received adjuvant and/or neoadjuvant therapy, radical radiotherapy or radiochemotherapy, disease progression or recurrence within 6 months after the last anti-tumor therapy, adjuvant/neoadjuvant/radiochemotherapy is considered as first-line therapy.
3. Subjects must have at least one measurable lesion according to RECIST v1.1.

Exclusion Criteria:

1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) component.
2. Sensitivity mutation of EGFR or ALK fusion; known ROS1 fusion, BRAF V600E mutation, MET 14 exon skip mutation, RET fusion, etc. Gene mutation. The EGFR and ALK fusion status must be tested in patients with non-squamous cell carcinoma (the mutation status must be confirmed based on the tissue test if the blood test is negative); the genetic test is not mandatory for patients with squamous cell carcinoma.
3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis

A total of 80 patients with knee osteoarthritis (KOA) aged between fourty five and seventy years will be recruited by simple random sampling to participate in two group, randomized, double blind, controlled study. Recruited patients will be randomly divided in to two groups high intensity-laser therapy (HILT) group and ibuprofen gel phonophoresis (IGP) group. Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.The pain and quality of life will be assessed at the baseline and at the end of 8-week post-intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study

Exclusion Criteria:

* Unwillingness to participate in the study
* Recent history (within the last 3 months) of physical therapy to the same joint
* Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
* History of knee surgery/fracture
* Acute synovitis/arthritis including the infectious conditions
* Presence of malignancy
* Pregnancy
* Taking pain relief medications
Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy

The present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. Patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All participating surgeons have experience of the traditional approach with electrocautery. The operation time as well as the surgeons own evaluation of difficulty and performance are noted. Selected films are analyzed by independent surgeons with experience of the fundus first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to record the intra and postoperative complication rate.

The present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. Patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All participating surgeons have experience of the traditional approach with electrocautery, but limited experience from gallstone surgery with ultrasonic tissue coagulation dissection.

The operation time as well as the surgeons own evaluation of difficulty and performance are noted. Selected video recordings are analyzed by independent surgeons with experience of the fundus first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to record the intra and postoperative complication rate. The study is intended to serve as a pilot study for a subsequent randomised controlled trial, comparing surgery with electrocautery and ultrasonic tissue coagulation dissection.

Eligibility Criteria:
Inclusion Criteria:

* Preoperatively discovered choledocholithiasis

Exclusion Criteria:

* Symptoms and signs of acute or chronic cholecystitis
Effect of Game-Based Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Care

Purpose: The purpose is to determine effect of game-based virtual reality phone application on nursing students' knowledge and skills on intestinal stoma and peristomal skin care.

Material and methods:This study will be conducted as a single-blind randomized controlled experimental study between March-April 2023. The students in the experimental group will play the developed mobile game on stoma and peristomal skin care as much as they want for 5 days, while the students in the control group will perform skills on stoma and peristomal skin care on the model in the skill laboratory for only one day. After performing the inteventions, the skills and knowledge measurements of the students in both groups will be measured by the researcher through the forms prepared in accordance with the literature. After four weeks, the permanence levels of the students in both groups regarding stoma and peristomal skin care will be measured and the data collection process of the study will be terminated.


Eligibility Criteria:
Inclusion Criteria:

* To register for the Nursing Fundamentals Course for the first time,
* Participating in theoretical lessons and group work,
* Participating in knowledge and skill assessments on stoma and peristomal skin care,
* Having an Android phone,
* Having internet access,
* Volunteer to participate in the research.

Exclusion Criteria:

* Have any previous training in stoma and peristomal skin care
Way to Be Active I (Teams)

Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. We will assess outcomes each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility Criteria:
Inclusion Criteria:

* 1. We will use a minimum age of 18 to ensure all individuals are legally able to consent.
* 2. Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

* Conditions that would make participation infeasible: 1a. Inability to consent 1b. Illiteracy and/or inability to speak, read, and write English 1c. Participation in another research study 2. Conditions that would make participation unsafe: 2a. Current treatment for drug or alcohol use 2b. Consumption of at least 5 alcoholic drinks per day 2c. Myocardial infarction or stroke within the past 6 months 2d. Current addiction to prescription medicines or street drugs 2e. Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia) 2f. Pregnant or currently breastfeeding 2g. Metastatic cancer 2h. Unstable medical conditions that would likely prevent the participant from completing the study
Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

our aim is to evaluate the effectiveness of virtual brief mindfulness based interventions on psychological wellbeing, resiliency, and anxiety of frontline HCP to cope for (COVID19) stressors

Our specific objectives are: To measure frontline HCP's level of anxiety, resilience, and how mindfulness based interventions affect anxiety and psychological resilience of HCP.

Eligibility Criteria:
Inclusion Criteria:

* COVID19 frontline health care providers namely, physicians, nurses and respiratory therapist at 2 main hospitals in the eastern province of KSA

Exclusion Criteria:

1. History of psychotic disorder,
2. Substance abuse or dependence within the last 6 months
3. Current severe neurotic disorder, severe depression or severe anxiety.
4. Concurrent psychotherapy.
5. Significant personality disorder
Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Several studies have shown that pulmonary arterial hypertension (PAH) was common in AS patients referred for TAVI and that it was an independent predictor of mortality after TAVI.

Currently, there is no data in the literature regarding the evolution and prognosis value of PAH measured using right heart catheterization (reference method). PAH could either regress after TAVI or continue to progress despite the treatment of valvulopathy, resulting in a refractory right heart failure that can lead to death.

The hypothesis of this study is that patients with PAH before TAVI procedure and at the 3-month follow-up visit (PAH persistence) have an increased risk of cardiovascular mortality compared to patients with no PAH at 3 months or having a significant reduction of their PAH (PAH regression).

The aim of the study is to evaluate the prognostic impact of the evolution of PAH after TAVI in 424 patients using right heart catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Aortic stenosis
* Indication of TAVI

Exclusion Criteria:

* Contra-indication of right heart catheterization
* Pregnancy
* Persons deprived of their liberty
Fistula Laser Closure

The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function.

For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence.

Recently there is one of them , named FiLAC using a clip system not yet evaluated.

The purpose is to assess the success rate of his new surgery technique.


Eligibility Criteria:
Inclusion Criteria:

* Patient with anal fistula drained at least 3 months before inclusion.

Exclusion Criteria:

* Fistula not well drained
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)

This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145 through the evaluation of serum and urine. It will evaluate the radiographic density in regions of interest (ROI) and the overall diagnostic quality following administration of GE-145.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females between 18 and 60 years of age.
* For women who are either surgically sterile or are postmenopausal, enrollment in the study without a pregnancy test at screening will be allowed. For women of childbearing potential, the results of a serum and urine HCG pregnancy test (with the result known on the day of and before IMP administration) must be negative.
* Subjects are able and willing to comply with study procedures and sign an informed consent.

Exclusion Criteria:

* Known history of a reaction to any iodinated-based contrast agent or with multiple allergies (i.e. foods, pets, medications, etc).
* Subjects receiving any medication for which the use of an iodinated contrast agent is contraindicated (i.e.. metformin).
* Subjects with suspicion or diagnosis of hyperthyroidism.
* Women that are breastfeeding at the screening and/or enrolment period.
* Usage of any non-FDA-approved pharmaceutical or therapy within 30 days prior to screening or enrolment in another clinical study within 30 days prior to screening.
Automated Diagnostic Test for Diabetic Retinopathy in Brazilian Mass Screening

In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR). Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system. The automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders.

In the South and Central America Region, an estimated 9.4% of the adult population (20-79 years) has diabetes in 2015, and Brazil is the first country in number of people with diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR)(1).

The rising number of people with diabetes in the world has become a real challenge for the public health system to provide care for patients with DR and for people with diabetes at risk for this complication(2). A large proportion of patients with diabetes was inadequately controlled in Brazil, which may contribute to increased rates of diabetic complications (3).

The detection of any degree of DR may result in improved medical monitoring and optimization of risk factors, delaying the progression of the disease(4). In Brazil, the great demand in the public service causes delay in early diagnosis, worsening health status of patients with diabetic retinopathy and increasing the cost of their treatment.

Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system.

Several studies have shown that systematic screening for DR is an effective way of prevention (5). Furthermore, the automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders(6). There are no reports on automated DR detection in Brazilian population, especially in screening campaigns with large-scale diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years with type 1 or 2 diabetes mellitus

Exclusion Criteria:

* Previous cataract, trabeculectomy or vitrectomy
* Aphakia
* External ocular infections
* Glaucoma (IOP of \> 21 mmHg or regular use of more than 2 IOP lowering drugs)
* Pregnancy or breastfeeding.