cyrilzakka/clinical-trials huggingface dataset:
Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection

A prospective, longitudinal, observational cohort study looking at patients following COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury.

To date, correctly, all of the Government's efforts have been dedicated to providing sufficient hospital space, and the appropriate equipment, for treating the most serious cases of COVID-19. Equally, enormous resource is being dedicated to developing technologies that determine who has the disease, and who has developed antibodies to it.

However, patients recovering from serious disease will also pose a huge, ongoing challenge. Not only are people with co-morbidities including underlying fatty liver disease, metabolic syndrome and diabetes at higher risk for complications with COVID-19; but patients discharged from hospital after severe COVID-19 are reported to have liver and kidney injuries, and impacts on pancreas and spleen. However, the extent of organ health/damage has not been mapped.

This is a prospective, longitudinal, observational cohort study looking at patients recovering from COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury. This proposed study aims to measure the prevalence of organ volume changes and damage in lungs, heart, kidney, liver, pancreas, spleen as assessed by MRI among those having recovered, or recovering, from the SARS-CoV-2 infection - participants will have a final MRI scan at 12 months. Assessing the severity and sequelae of COVID-19 in patients is crucial to enable global planning for health-care needs. The study includes up to 3 visits for MRI scans and blood tests over a 12 month period. All participants will receive standard-of-care by their healthcare provider/s.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age and older willing and able to give informed consent to participate in the study
* Recent confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged 7 or more days from hospital).

Exclusion Criteria:

* Symptoms of active respiratory viral infection:

  * high temperature (over 37.8C/100.04F)
  * cough (consistent for over an hour; 3 or more episodes in 24 hours)
* The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to pregnancy, a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
* Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.
The Effect of a ChatGPT-Supported Online Group-Guided Self-Help Program on Uncontrolled and Emotional Eating Behaviors and Body Image in Overweight and Obese Woman Nurses

Nurses with overweight and female gender characteristics often experience disruptions in their eating behaviors due to stressful working conditions. These disruptions can lead to physical and psychosocial problems (Nicholls et al., 2017). Studies have shown that guided self-help programs, based on cognitive behavioral therapy interventions, are effective in addressing uncontrolled and emotional eating behaviors (Carrard et al., 2011; Cachelin et al., 2015). However, the use of supportive tools to assist the facilitator in group-based interventions of these evidence-based self-help programs and their impact on individual recovery processes remain unexplored. Additionally, no studies have been found investigating the application of these AI-supported guided self-help programs among female nurses, who are frequently exposed to stress and at high risk of obesity.

Given the demanding workloads of nurses, cost-effective and easily accessible online programs have been found to promote recovery (Jenkins et al., 2021). Therefore, it is essential to test this AI-supported program in an online group format with overweight and obese woman nurses.

The aim of this study is to evaluate the effect of a ChatGPT-supported online group-guided self-help program on uncontrolled and emotional eating behaviors and body image in overweight and obese woman nurses through a randomized controlled trial. Participants will be recruited via an announcement shared on social media platforms (Instagram). Nurses who respond to the announcement will be asked to complete a survey through Google Forms. Those randomly assigned to the intervention group will participate in online group sessions conducted via Google Meets. Pre- and post-test data will be collected using Google Forms.


Eligibility Criteria:
Inclusion Criteria:

* Hold at least a bachelor's degree in nursing from a nursing school.
* Work as a nurse in an institution.
* Be a woman.
* Have a BMI (Body Mass Index) greater than 24.99.
* Not have a hearing impairment that would prevent them from understanding and completing verbal instructions.
* Have access to a smartphone or computer with a camera.
* Agree to participate in the study.
* Score 50 or higher on the emotional eating and external eating subscales of the Dutch Eating Behavior Questionnaire (DEBQ).

Exclusion Criteria:

* Refusal to participate in the study.
* Diagnosis of chronic diseases such as diabetes, hyperlipidemia, hypertension, or hyperthyroidism.
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352).

(Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor \[TNF\] inhibitor).

* Must agree to use a reliable method of birth control.

Exclusion Criteria:

* Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
* Have a known hypersensitivity to ixekizumab or any component of this investigational product.
* Had investigational product permanently discontinued during a previous ixekizumab study.
* Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study.
* Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol.
* Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Open label safety and efficacy follow-up.

This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.
* Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.
* Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.

Exclusion Criteria:

* Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.
* Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).

MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY

* Calcitonin
* Bisphosphonates
* Fluoride at pharmacologic dose
* Strontium at pharmacologic dose
* Estrogenic steroids (except oral contraceptives)
* Selective Estrogen Receptor Modulator (raloxifene)
* Parathyroid hormone
* Any androgens, including prescription or nutritional supplement DHEA, other than study drug
* Additional Calcium supplements other than those prescribed as part of this study
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response.

1. To assess the impact of HSCT on the immune response to HIV by measuring HIV specific antigens in peripheral blood (via immune assays such as ELISA and Western blot) longitudinally.
2. To measure the decay of persisting HIV by sequencing and quantitating HIV RNA in plasma, and HIV DNA and RNA in peripheral blood cells including CD4+ T cells and CD4+ T cell subsets, as well as in tissue cells derived from fine needle lymph node aspirates, and/or bone marrow aspirates, and/or rectal tissue.
3. To determine the presence of the CCR5 delta 32 allele in the patient prior to and following HSCT which will provide information regarding the presence of this gene in the donor cells.
4. To correlate these findings to the clinical outcome of the individuals enrolled in this study based on their clinical standard of care assessments following HSCT.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
* Over 18 years of age
* Provision of written, informed consent

Exclusion Criteria:

* In the opinion of the investigator that the patient is not able to provide informed consent
* Hb \< 9 (g/dL)
* CD4+ T cell count \<100 (cells/µl)
* Serious coagulation abnormalities, platelet count \< 50.
* Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists)
* History of allergy to local anaesthetics
* Pregnancy
Safety and Pharmacokinetics of ELB353 in Healthy Men

The purpose of this trial is to study the safety and tolerability of repeated oral doses of ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances mediating inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Concomitant medication
* Concomitant disease
Multi-disciplinary Care for Brain Metastases

This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases.

This is a cohort study of patient with newly diagnosed brain metastases assigned to standard of care (SOC) or intensive multi-disciplinary care (IMDC). Care for all patients with brain metastases involves complex medical decision making and requires input for multiple stakeholders, including medical oncology, neurosurgery, radiation oncology, and neuro-oncology. Palliative care should be an essential component of the care team for all patients with brain metastases by the very nature of this advanced malignancy. At the University of Vermont, our current process for diagnosis and management of patients with brain metastases relies heavily on the physician and team who make the initial diagnosis to consult others as they see appropriate. This process may look different for different patients. We rationalize that a systematic approach with intensive multidisciplinary care (IMDC) will benefit patients with brain metastases by providing consistent access to multi-disciplinary discussion.

Eligibility Criteria:
Inclusion Criteria:

* Patients of all genders must be at least 18 years of age.
* Patients must have histologically confirmed, newly diagnosed brain metastases from known or suspected solid tumor primary neoplasms.
* Patients must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
* Patients must be able to complete questionnaires in English.
* Patients must have the ability to provide informed consent.

Exclusion Criteria:

* Patients who are \< 18 years of age are not eligible.
* Patients who are Pregnant are not eligible.
Arrhythmias Detection in a Real World Population

The study is a prospective multicenter registry. Consecutive patients with indications of implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be enrolled.

The primary objective of the study is to determine the predictors of appropriate anti-tachycardia therapy (with shock) in a non-selected population of patients implanted with an ICD.

Secondary objectives of the study are:

* the incidence of anti-tachycardia therapies;
* the predictors of inappropriate therapy and onset of arrhythmia burden;
* the adherence to the current guidelines in the Italian clinical practice;
* the predictors of heart failure (HF) onset and response to cardiac resynchronization therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with a Subcutaneous (S)- Ventricular Chamber (VR)- Dual Chamber (DR) - or Cardiac Resynchronization Therapy (CRT) Defibrillator (this study will utilize all the market released CRT-D or VR/DR-ICD systems and leads)
* Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
* Patient must be able to attend all required follow-up visits at the study center for at least 12 months

Exclusion Criteria:

* Patient is participating in another clinical study that may have an impact on the study endpoints
* Women who are pregnant or plan to become pregnant
Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France

The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France.

Down syndrome is the most common chromosomal abnormality, affecting 600 to 800 births per year. It results in a clinical picture that combines developmental delay, mental deficiency, facial dysmorphism and visceral malformations.

Optimal medical care of Down syndrome patients requires a good knowledge of the different systems affected by the disease, particularly respiratory damage.

Numerous articles have been published describing upper respiratory problems in children with Down syndrome. On the other hand, lower respiratory problems causing significant morbidity and mortality remain underestimated and poorly understood in this population.

The objective of this study is to describe lower respiratory problems in patients with T21, in order to improve their management.

This study will also make it possible to describe more precisely the impact that these attacks have on Down syndrome patients.

This study also describe the associated extra-respiratory disorders to improve overall care Finally, the respiratory care of these patients will be described, with the aim of standardizing practices.

Eligibility Criteria:
Inclusion Criteria:

* Child from 0 to 17 years old
* Carrier of Down syndrome confirmed by karyotype
* Having had follow-up in a pediatric pulmonology consultation for an infectious or non-infectious lower respiratory tract
* Not exclusively presenting upper respiratory otorhinolaryngological damage

Exclusion Criteria:

* Patient under guardianship or curators
* Adult or holders of parental authority informed of the study and having objected to it
Nutritional Biomarkers of Sarcopenia

This study proposes to characterize skeletal muscle amino acid kinetics to an EAA challenge, i.e., an oral amino acid tolerance test (OATT), in order to determine the state of muscle health. Analogous to the oral glucose tolerance test (OGTT) used to characterize alterations in glucose metabolism, the proposed OATT represents a potential low-cost solution to classifying patients' skeletal muscle health. The extrapolation of this work is the development of a simple analytical tool that would provide clinicians the ability to discern alterations in muscle amino acid kinetics prior to a loss of function.

Sarcopenia increases the risk of a number of deleterious health conditions and represents a major financial cost to our healthcare system. Among older adults who are hospitalized, those with sarcopenia on admission are 5-fold more likely to incur higher hospital costs than those without. The operational definition of sarcopenia is defined as meeting the criteria for all of the following: low muscle strength, low muscle quantity or quality, and low physical performance. The diagnosis of sarcopenia requires techniques that are both expensive and operator-dependent. Simple measurements, such as BMI, do not necessarily identify sarcopenia. Importantly, current techniques can only identify sarcopenia after a physical/functional impairment has occurred. Skeletal muscle amino acid kinetics predict muscle health and functionality. Altered amino acid kinetics lead to decrements in muscle mass, quality, and performance. Muscle response to circulating essential amino acids (EAA) determines muscle amino acid kinetics. Thus, this study proposes to characterize skeletal muscle amino acid kinetics to an EAA challenge, i.e., an oral amino acid tolerance test (OATT), in order to determine the state of muscle health. Analogous to the oral glucose tolerance test (OGTT) used to characterize alterations in glucose metabolism, the proposed OATT represents a potential low-cost solution to classifying patients' skeletal muscle health. The extrapolation of this work is the development of a simple analytical tool that would provide clinicians the ability to discern alterations in muscle amino acid kinetics prior to a loss of function.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 30 and 70-89 yrs

Exclusion Criteria:

* History of diabetes that requires insulin for control of blood glucose
* History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment
* History of gastrointestinal bypass/reduction surgery (Lapband, gastric sleeve, etc.)
* Pregnant females
* Unwilling to wear the breath-collection mask
* Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 2
* Concomitant use of oral or injectable corticosteroids
* Concomitant use of testosterone, IGF-1, or similar anabolic agent
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia


Eligibility Criteria:
Inclusion Criteria:

* Subjects presenting diagnosis of FD as defined by the Rome II
* Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom

Exclusion Criteria:

-
Stachybotrys Induced Hemorrhage in the Developing Lung

The majority of the workscope of this project is focussed on an infant animal model of toxigenic mold induced pulmonary hemorrhage. Clinically related studies are directed only to the description of human infants diagnosed with idiopathic pulmonary hemorrhage regarding their clinical parameters, and collecting samples of secretion, blood, and urine for analysis for fungal spores and mycotoxins. These latter analyses are being developed using the infant rat model.

Over the past seven years in the Cleveland, Ohio area there have been 47 cases of unexplained pulmonary hemorrhage in young infants. Sixteen of the infants have died. A CDC case-control study found an association with water-damaged homes and the toxigenic fungus, Stachybotrys chartarum, which requires water soaked cellulose to grow. The spores of this fungus are not infectious in the lung but do contain very potent mycotoxins which appear to be particularly toxic to the rapidly developing lungs of young infants. Secondary stresses, e.g. environmental tobacco smoke, appear to be important triggers of overt hemorrhage. Concern that there may be a larger number of undetected young infants with this disorder led to the examination of all infant coroner cases, which revealed six sudden infant death syndrome cases with major amounts of pulmonary hemosiderin-laden macrophages, indicating extensive hemosiderosis existing prior to death. All of these infants had lived in the eight zip code area where all but fifteen of the patients have lived. This disorder may extend beyond Cleveland since toxigenic fungi are widespread. We are aware of a total of 138 infants with idiopathic pulmonary hemorrhage across the country over the past four years.

The purpose of this proposal is to establish an infant animal model for this stachybotryomycotoxicosis which can be used to understand the developmental pathophysiology by which the fungal spores induce hemorrhage and to address practical problems faced in the clinical care of these infants and in public health prevention. The model uses tracheal instillation of toxic Stachybotrys spores in neonatal to weanling rats to initiate the pathological process, followed by stresses to trigger acute hemorrhage. Capillary fragility to transmural pressures will be assessed by morphometric analysis of electron micrographs. Markers of Stachybotrys exposure which can be applied to clinical cases are being developed and tested in the rats.

Eligibility Criteria:
Inclusion: infant (\<12 mo old) with unexplained pulmonary hemorrhage, discharged home from newborn nursery Exclusion: hemorrhage occurred in hospital prior to going home prior to discharge from newborn nursery
Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico)

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Presentation in the Emergency Department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.

Exclusion Criteria:

* Voluntary removal of the patient;
* Sending home with instructions to return for further services