cyrilzakka/clinical-trials huggingface dataset:
Interferon α 2b Pharmacovigilance Study

Multicenter prospective follow-up of a not controlled chronic hepatitis C genotypes 2/3 patients cohort with treatment indication with interferon α 2b and ribavirin for 24 weeks, and the verification of sustained virological response at week 48.

The eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health:

http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf


Eligibility Criteria:
Inclusion Criteria:

* Genotype 2/3 Chronic Hepatitis C confirmed by biomolecular technology (RNAVHC);
* Treatment naive;
* Signing the Informed Consent Form;
* Eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health: http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf

Exclusion Criteria:

* Serious adverse events;
* Intolerance to treatment;
* Lost to follow up.
Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled, Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week, Open-label Period and a post-treatment 28 week observational safety follow-up period designed to evaluate the short-term efficacy and the short- and long term safety of brazikumab in participants with moderate to severe, active Crohn's disease (CD) who have failed or are intolerant to anti-TNFα therapy as determined by the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for \> 3 months prior to screening
* Men or women age 18 - 80 years at the time of screening
* Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) and endoscopic demonstration of inflammation
* Stable dose of medications for Crohn's disease therapy
* Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent
* Effective contraception from screening, and for 36 weeks after the last dose of investigational product
* No known history of active tuberculosis (TB) \& negative assessment for TB/latent TB

Exclusion Criteria:

* Severe underlying immunosuppression
* Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
* Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization
* Recent treatment with approved or investigational biologic therapy for Crohn's disease
* Recent or planned live attenuated vaccine
* History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the cervix with apparent cure ≥ 12 months before screening
* Pregnancy/breast feeding
* Drug abuse
Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes

The present study wants to compare the Dexcom G6® continuous glucose monitoring (CGM) system (experimental group) with the FreeStyle Libre flash glucose monitoring (FGM) system (control group).

The ALERTT1 trial will have three phases: a baseline, study, and extension phase.

During the baseline phase, eligible patients will be screened for in- and exclusion criteria, wear a blinded Dexcom G6® for 28 days, together with their FreeStyle Libre FGM system, and receive a uniform education moment.

In the study phase, patients will be randomized into two groups (1:1): the experimental group will use an unblinded Dexcom G6® CGM for 6 months, the control group will keep using the FreeStyle Libre FGM system for 6 months. Before the 6 month time point is reached, patients in the control group will wear a blinded Dexcom G6® CGM for 28 days, together with their FreeStyle Libre FGM.

In the extension phase, patients in the initial control group will start using unblinded Dexcom G6® for 30 months. The initial experimental group will keep using the unblinded Dexcom G6® for the next 30 months.


Eligibility Criteria:
Inclusion Criteria:

* signed ICF
* diagnosis of type 1 diabetes ≥6 months
* using FreeStyle Libre FGM system ≥6 months
* intensified insulin therapy/insulin pump therapy
* HbA1c ≤10%
* willing to wear the glucose monitoring device \>80% of the time
* willing to download glucose monitoring data at regular intervals

Exclusion Criteria:

* non-type 1 diabetes participants or diagnosis \<6 months
* participant with T1D not on insulin, or on non-intensified insulin therapy
* pregnancy or planning pregnancy within next 6 months
* severe cognitive dysfunction or other disease which makes sensor use difficult
* current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
* abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo)
* presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR \<30 mL/min \[stage ≥4\])
* beta-cell transplantation and c-peptide positive and/or under immunosuppressive therapy
Development of Pain Related Avoidance of Movement Questionnaire

In recent studies, it has been shown that people may have avoidance of movement due to pain. However, there is no scale that evaluates avoidance of movement due to pain in musculoskeletal problems. The aim of this study is to develop a scale to measure how much pain-related movement and activity is avoided in individuals with musculoskeletal pain, and to examine the results of its clinical application.

Approaches and methods to be applied in the research;

* Demographic information (age, gender, weight, height, pain location, pain duration and diagnose) form will be recorded.
* Creation of questionnaire items
* Reviewing of items/questions
* Patients who accept to fill out the questionnaire and who has complain of musculoskeletal pain will be asked to answer the questions.
* Editing the scale according to the answers
* Reliability and validity studies of the questionnaire
* Investigation of the results of applying the scale with clinical follow-up

To compare results of Pain-Related Avoidance of Movement Questionnaire following common used questionnaires are going to be used;

* Visual Analogue Scale (VAS)
* Tampa Kinesiophobia Scale
* Oswestry Low Back Pain and Disability Index-2.0

SPSS version 23 (SPSS Inc, Armonk, NY) program will be used in the analysis of the data.

Eligibility Criteria:
Inclusion Criteria;

* Having agreed to fill out the questionnaire
* Having pain caused by problems related to the musculoskeletal system
* Not having any disability in performing activities of daily living

Exclusion Criteria;

* Individuals who are not allowed to move due to pain
* If they have undergone surgery, individuals who have inconveniences in moving due to surgery
* Individuals who have cognitive problems in completing the questionnaire
Prospective Validation and Application of an Artificial Intelligence-based Model for Evaluating the Efficacy of Breast Cancer Patients After Neoadjuvant Therapy

Breast cancer has become the world's number one cancer. While its therapeutic efficacy is increasing, how to achieve non-invasive evaluation of the efficacy of neoadjuvant therapy (NAT) for breast cancer patients and thus avoid surgery has become a bottleneck problem that needs to be broken through in clinical diagnosis and treatment. Existing non-invasive evaluation strategies are limited to single-center, single-modality modeling, and have problems such as low performance and poor versatility. Therefore, in the early stage of this study, multi-modality breast cancer patient data from multiple centers across the country were collected and the establishment of an artificial intelligence (AI) efficacy prediction model was preliminarily completed. On this basis, this project intends to further improve the multi-center prospective validation study of the prediction model. The research results will help solve the scientific problem of non-invasive judgment of NAT efficacy in breast cancer patients and provide a new paradigm for the research of high-performance AI diagnosis and treatment auxiliary systems applicable to multiple centers.

(1) Prospectively collect breast MRI original images (DCE and ADC sequences) and corresponding clinical and surgical pathological data of multi-center breast cancer patients before and after neoadjuvant treatment, store and transport them via mobile hard disks, and input the processed data into the established efficacy determination model stored in a dedicated cloud server; (2) Use artificial intelligence to automatically delineate the ROI area and extract the imaging genomics and deep learning features therein, and combine the clinical pathological characteristics of the patients to further prospectively verify the effectiveness of the established pCR efficacy determination model.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were treated in the above research centers between January 1, 2024 and October 31, 2025;
* ≥18 years old, female, ECOG score ≤2;
* Pathological biopsy confirmed invasive breast cancer;
* AJCC (8th edition) stage I-III;
* MRI imaging data before and after neoadjuvant therapy;
* Planned mastectomy or breast-conserving surgery after neoadjuvant therapy, and postoperative pathological information obtained.

Exclusion Criteria:

* Bilateral breast cancer, multiple lesions, or occult breast cancer;
* Poor MRI data quality;
* Patients who had received other anti-tumor treatments before enrollment;
* Patients with other malignant tumors
Adaptive Recalibration of Prosthetic Leg Neural Control System

The purpose of this study is for transfemoral amputees to walk with an experimental robotic prosthesis. Electric signals will be measured from their muscles and used to help control an artificial leg. The investigators will record from sensors placed on a prosthesis and electric signals measured from muscles in the participants leg to see if the investigators can develop better computer programs to help predict subject actions and prostheses function.

The investigators propose to use a powered knee-ankle prosthesis that is not yet commercially available. The hierarchical control framework the investigators are developing will be equally applicable to any prosthetic leg that needs to be transitioned between ambulation modes, including microprocessor-controlled passive devices.

The overall objective is to develop and evaluate an adaptive framework for controlling lower limb prostheses that compensates for changes in EMG signals. When a participant walks on a lower limb prosthesis, the output of the high-level controller (or ambulation mode predictor) directly influences patterns generated by the participant. After the participant has completed the subsequent stride, a gait pattern estimator (GPE), will provide a label of what the participant actually did. This may differ from the ambulation mode predictor output if there was a misclassification. The label will then be used to update the ambulation mode predictor algorithm such that future steps are predicted with higher accuracies. Finally, the resulting system will be transferred to an embedded system and tested in real-time with transfemoral amputees and compared to a non-adaptive system.

Eligibility Criteria:
Amputee Subjects

Inclusion Criteria:

* Lower Limb Amputees
* K2/K3/K4 ambulators

Exclusion Criteria:

* Over 250lbs body weight
* Inactive, physically unfit
* cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments
* Pregnant women
* co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

Able-bodied Subjects:

Inclusion Criteria:

* no injury on either lower extremity

Exclusion Criteria:

* inactive, physically unfit
* over 250 lbs body weight
* cognitive deficits or visual impairment that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments
* Pregnant women (status determined by self-reporting)
* co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)
Usability of the Software MacuFix for the Categorization of Metamorphopsia

The usability of a novel test to categorize a distorted visual impression (metamorphopsia) is examined with the questionnaire "SUS"

Introduction Diseases of the retinal centre (macula) can lead to a distorted visual impression (metamorphopsia). The usability of a novel on-screen test to categorize metamorphopsia is to be examined with the questionnaire "SUS" to determine how user-friendly the software is perceived.

Purpose To examine the usability of the software for persons perceiving metamorphopsia employing the questionnaire SUS.

Aim of the work Improvement of the software in terms of user-friendliness.

Methods For this observational pilot study, 30 persons are to be recruited from the patient pool of a private practice.

Primary endpoint: Score of the SUS questionnaire.

Each participating person performs the test once with each eye wearing appropriate near correction. The test shows on a screen 4 square fields with a grid pattern of horizontal and vertical lines. All 4 fields have lines that are partially distorted. The task of the test person is to select the field with more distinctively distorted lines when viewed with one eye.This selection must be made at least 10 times per eye: an algorithm determines the smallest correctly named distortion difference. Afterwards each person answers the System Usability Scale (SUS) questionnaire, SUS contains five positive and five negative statements on the usability of the system being evaluated. For each statement, the study participant gives his or her approval or rejection in the form of a scale ranging from 1= "strong approval" to 5= "strong rejection" of the statement. The results of the SUS questionnaire are used to calculate a numerical value (SUS score).

Eligibility Criteria:
Inclusion Criteria:

1. Distorted visual impression in at least one eye, detected with Amsler grid:
2. Best-corrected visual acuity (BCVA): at least 20/200; age over 18 years; presence of a declaration of consent to participate in the study

Exclusion Criteria:

No distorted visual impression in both eyes; best corrected visual acuity under 0.1; age under 18 years
Respiratory Distress Syndrome and Elective Cesarean Section at Term

Cesarean section is a life-saving surgical operation for women and their newborns. In Egypt, caesarean sections are over-utilized. The rate increased from 27.6 % in 2008 to 51.8 % in 2014, reaching 72.2 % in 2021. Cesarean section has been associated with an increased risk of adverse respiratory outcomes in newborns. Studies have shown a higher risk of neonatal respiratory distress syndrome in babies born by elective cesarean section, especially at 37 and 38 weeks' gestation. Neonatal respiratory distress syndrome is one of the leading causes of neonatal morbidity and mortality. Many non-invasive tools have been used to predict the risk of neonatal respiratory distress syndrome. Most of these studies assessed the predictors of neonatal respiratory distress syndrome in low birth or preterm fetuses, and none of them talked about neonatal respiratory distress syndrome with term fetuses. Doppler velocimetry provides a simple and non-invasive method to assess the fetal pulmonary circulation. Pulmonary Doppler velocimetry is used to determine lung maturity in complicated pregnancies. The magnitude of neonatal respiratory distress syndrome among term neonates depends on the availability of medical services and the number of trained medical personnel. So, there is a need to assess the rate and predictors of eonatal respiratory distress syndrome among low-risk term fetuses delivered by Cesarean section to give attention and appropriate intervention for these predictors to decrease the morbidity and mortality associated with eonatal respiratory distress syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Maternal age of 20-39 years.
2. Women with singleton pregnancy ≥ 37 weeks
3. Pregnant women who received corticosteroid to enhance lung maturity and will be subjected to elective cesarian section (before onset of labour) within 1 week after administration of corticosteroid

Exclusion Criteria:

1. Women with oligohydramnios or polyhydramnios.
2. Women with underlying disease requiring corticosteroids.
3. Pregnant women with any medical disorders such as hypertension, diabetes, renal diseases, antiphospholipid syndrome, intrauterine growth restriction, preterm premature rupture of membrane, placenta previa, antepartum haemorrhage, on anticoagulant thereby.
4. Women with confirmed fetal malformation.
5. Women who will refuse to participate.
Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea

The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been diagnosed with moderate-to-severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants ≥19 years of age
* Diagnosis of moderate-to-severe plaque psoriasis
* Candidate for phototherapy or systemic therapy
* Will begin deucravacitinib according to approved product label

Exclusion Criteria:

* Participants prescribed deucravacitinib for therapeutic indications not approved in Korea
* Participants for whom deucravacitinib is contraindicated as clarified in Korean prescribing information by ministry of food and drug safety (MFDS)
Visual Perception Exploration Using Eye-tracking Technology in High-fidelity Medical Simulation

The aim of this observational study is to compare the visual interests between residents in high-fidelity simulation practice

Eighteen first year residents were asked to take part in a nine-minute scenario based on an ACLS bradycardia algorithm in which a high-fidelity mannequin required external pacing. The scenario was considered a success if the material was correctly set by the participant to obtain electrical and mechanical pacing in nine minutes. All participants were wearing Tobii Glasses® which is a mobile eye-tracking system that automatically aggregates gaze data. Infrared markers were placed in the simulation room to create Area of Interest (AOI), from which results were obtained. Three AOI were created: the vital signs monitor, the defibrillator/pacing unit and the head of the patient. Eye-tracking data were analyzed using the Tobii Studio® program.

Eligibility Criteria:
Inclusion Criteria:

* First-year residents from various specialties in their first three weeks of training

Exclusion Criteria:

* Underwent a previous residency
* Attending physicians in another country
Palliative Care Costs for Outpatient Setting Management in Catalunya

Cost-of-illness studies in palliative care (PC) are a growing area of interest in health economics activity. They are, in part, stakeholders' basis for deciding the allocation of the scarce public and private economic resources. There is no standard methodology to capture the formal and informal costs and expenses that health services and patients and their caregivers make during the PC attention period due to non-standard health services, and data capture approaches.

Methods / Analysis Prospective study on the burden of disease of PC on the outpatient/domiciliary attention. Proposed in three phases: Phase I: Systematic Review of Literature to identify de types of costs and proposed methodologies to identify and determine de economic burden of PC. With collected data, create a questionnaire to register the costs of services covered by the healthcare system and those covered by patients/caregivers (PROSPERO CRD42021250086). Phase II: Questionnaire piloting. Phase III: Transversal study of costs, collecting data from public healthcare billing and patient/caregivers payments to cover PC on selected patients. Final methodologic proposal to study billing/costs of outpatient/domiciliary PC.

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of breast, lung, and colorectal neoplasm or Chronic Heart Failure (CHF) or Chronic Obstructive Pulmonary Disease (COPD).
* Patient and caregivers must be able to maintain a 1-hour telephonic interview.
* Patient and caregivers must allow one (1) more telephone call to revise data.

Exclusion Criteria:

* Cases with an open legal process.
* Family/caregivers of patients that can't communicate in fluent Spanish or Catalan.
Respiratory Outcome of Children From the FEPED Cohort

Early lung function deficits represent a significant risk factor for the evolution toward chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke exposure are already known to predispose children to develop a non-reversible obstructive ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less certain. In humans, low vitamin D concentrations during pregnancy are associated to an increased risk of asthma in children. In murine models, low vitamin D concentrations during pregnancy are associated to structural abnormalities of the airways in mouse pups. Investigators hypothesized that vitamin D play a role in early airways development, from the first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will study the association of airway resistance in children aged 5 to 6 years old with the concentration of vitamin D during the first trimester of pregnancy in their mothers.

Children aged 5 to 6 years old will be included from the FEPED cohort. The FEPED cohort is a cohort of French pregnant women designed to study the association between vitamin D status during pregnancy and the risk of pre-eclampsia. Vitamin D concentration at first and third trimester of pregnancy as well as in cord blood is available for 1400 women. Investigators will include 200 children born from these women. Children will undergo lung function tests and prick-tests and parents will answer the ISAAC questionnaire that is a standardised questionnaire designed to evaluate asthma and rhinitis symptoms. The main outcome of this study will be specific airway resistance. The investigators will look for an association between specific airway resistance and vitamin D concentration measured during the first trimester of pregnancy in their mothers.

Eligibility Criteria:
Inclusion Criteria:

* term-born child (gestational age ≥ 37 weeks of post-menstrual age) whose mother was included in the FEPED cohort
* measure of vitamin D concentration available at the first and third trimester of pregnancy and in cord blood
* cord blood sample available for DNA extraction
* child's age between 5 and 6 years old at the time of participation
* written informed consent obtained from the legal guardian of the child
* health insurance

Exclusion Criteria:

* parent's' refusal
* underlying disease that does not allow the performance of lung function tests