cyrilzakka/clinical-trials huggingface dataset:
Neuroendocrine Dysfunction in Critically Ill Pediatric Patients

Research studies in adults have shown that certain hormones may be decreased or may not work normally which contributes to how sick a person becomes. The purpose of this project is to study hormones in children. The investigators will look to see if a decrease of certain hormone levels affects how sick a child may become. This study is intended to develop a connection between hormone levels and severity of illness. It is hoped that the information gathered will help develop further studies that may more clearly explain the role of hormones in critically ill children and possibly the introduction of hormone replacement in critical illness.

Neuroendocrine dysfunction is an abnormality in the production or release of certain hormones. Studies completed in adult patients have shown abnormal hormone levels in critical illness can contribute to how long patients stay in the intensive care unit, how severe their illness is and whether or not they survive. In children hormones are produced differently and have different functions. Depending on the particular illness in question hormonal dysfunction may have grave clinical consequences.

Thus far, there have been few studies that have examined neuroendocrine dysfunction in children. The aim of our study is to identify the common hormone responses in children, and to identify any connection between hormone levels and outcomes (likelihood of child staying in the intensive care unit for multiple days, etc.).

To explore these aims we will draw blood from all critically ill patients admitted to the pediatric intensive care unit (PICU) and check various hormone levels. Only those patients who require blood samples as part of their admission will have blood tests for certain hormone levels. No change will be made from established standard of care for a patient's particular critical illness.

The study is designed to examine hormone responses to critical illness and identify a connection between hormone levels and severity of illness. Based on these lab values we intend to lay a foundation for further studies that may more clearly explain the role of hormones in critically ill children, and possibly the introduction of hormone replacement in critical illness.

Eligibility Criteria:
Inclusion Criteria:

* All patients, birth - 18 years of age
* Admitted to the pediatric intensive care unit requiring blood to be drawn as part of medical management consistent with "standard of care".

Exclusion Criteria:

* Elective post-operative surgical patients.
* Pre-existing/known neuroendocrine disorder including, but not limited to, disorders of the hypothalamus, pituitary, adrenal, or thyroid gland.
* Patients being treated with or having a recent history of taking anti-psychotic medications (e.g. ingestion).
* Patients whose laboratory specimens have already been drawn prior to admission (emergency room or another facility) and who do not require further blood draws for medical management within a 12 hour window.
Changes in the Permeability of the Blood Brain Barrier and Intestinal Barrier in Humans During Conditions of Stress and Immune Activation: in Vivo Studies

The relevance of BBB and IB permeability changes as a major precipitating cause for cognitive and digestive dysfunction in the military stress setting.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male troops (aged 18-50 yrs) scheduled to be engaged in a protracted multi-day stressful field exercises.

Exclusion Criteria:

* Significantly systemic disease, including cardiovascular, psychiatric, neurological (including polyneuropathies) and endocrine disease including diabetes mellitus.
* No written informed consent obtained from subject.
Improving Gout Care After an ED Visit

The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South.

The prevalence of gout has been steadily increasing and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeast U.S. - particularly in African Americans. Many patients with acute gout receive care at the emergency department (ED), particularly underserved urban populations in the Deep South. Appropriate outpatient follow-up for an acute flare after an ED visit is variable. Indeed, in a preliminary analysis of a retrospective cohort study of patients with acute gout treated at our urban medical center ED, only 46% of patients followed up with an outpatient clinician in our healthcare system within 6 months of their ED visit. Even fewer (36%) had an outpatient visit specifically addressing gout care within 6 months post-ED visit. This population of patients that seek acute gout care in the ED represent an important group that may benefit from interventions focused on improving gout quality of care, such as promoting outpatient follow-up.

While having a mechanism to identity acute gout patients in the ED is fundamental for enhancing care for patients with acute gout, recruiting people with acute gout who receive care in the ED outside regular business hours is challenging. One potential solution involves approaching patients after their ED visits remotely using patient navigators. The 36-72 hour period after their ED visit represents a critical time during which patients may be more receptive to efforts focused on improving healthy behaviors including scheduling outpatient follow-up (i.e., a "teachable moment). Patient navigators are trained, lay individuals of similar cultural background, and region, who provide personal guidance to patients and engage "hard-to-reach" groups, reduce access barriers, and encourage healthy behaviors such as engaging in outpatient chronic disease management.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Able to communicate and understand English or Spanish
* Confirmed acute gout flare by EMR review at ED visit

Exclusion Criteria:

* Enrollment in an ongoing RCT (NCT04075903) testing a behavioral intervention employing "storytelling".
Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation

This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

* Abel to provide written informed consent is obtained in the English language
* Age 18 to 95 years old
* Movement Disorder Society Clinical Diagnostic Criteria for probable idiopathic Parkinson disease
* Report disabling depressive or neuropsychiatric symptoms prior to study entry
* Capacity to understand the nature of the study;

Exclusion Criteria:

* Known structural brain disease such as a neoplasm, abscess etc.
* Pre-existing skull / scalp defects that would impede standardized electrode placement
* Current electronic or metal implants
* Diagnosis of Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
* Concurrent treatment with medication which may affect tDCS (benzodiazepines, anticonvulsants, dextromethorphan and pseudoephedrine)
* Endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
* History of substance abuse or dependence in the 2 months prior to screening;
* Considered to be at significant risk of committing homicide;
* Unstable medical condition;
* Score less than 22 on the Montreal Cognitive Assessment (MoCA)
* Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
* There has been a change in their depression or psychotherapy treatment regimen in the 2 weeks preceding screening;
Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis

The project is proposed based on multimodal ultrasonic imaging omics building used for accurate prediction of the breast cancer and axillary lymph node metastasis load artificial intelligence forecasting model, this method can dig the hidden features of ultrasonic image is not visible to the naked eye, make up the subjectivity in the process of clinical doctors in diagnosis and treatment, provide accurate, objective basis for clinical decision making.


Eligibility Criteria:
Inclusion Criteria:

* patients who have not received breast puncture biopsy or neoadjuvant chemotherapy, etc. prior to ultrasonography;
* patients who are not allergic to the ultrasound contrast agent (SonoVue) and have signed an informed consent form for ultrasonography
* patients with breast tumors who have undergone surgical treatment at our hospital and have complete case histories.

Exclusion Criteria:

* patients with incomplete case data;
* cases with large breast masses that do not completely show the region of interest (ROI);
* patients who have undergone breast aspiration biopsy or other treatments such as neoadjuvant chemotherapy or endocrine therapy before ultrasound examination.
Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)

The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (Treat and Observe). The second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients over the age of 50.
* Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization (CNV) to AMD with classic, minimal classic, or occult lesions.
* Patients with CNV area ≥ %50 of the total lesion.
* Total lesion area ≤ 12 disc areas for minimal classic/occult lesions and ≤ 9 disc areas for the classic lesions.
* Best-corrected visual acuity (BCVA) score between 73 and 34 letters in the study eye.

Exclusion Criteria:

* BCVA \< 34 letters.
* Patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, corticosteroids, or protein kinase C inhibitors, etc) or inclusion in another trial (for any eye).
* Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy application to the eye before the study.

Other protocol-defined inclusion/exclusion criteria may apply.
Skills of Home Helpers for a Better Quality of Life for Adults With Huntington's Disease Living at Home

Huntington's disease often brings together 3 types of symptoms at one time or another of the disease during its evolution: motor, cognitive and psychiatric. Management requires comprehensive and multidisciplinary health, social or medico-social support. Its development generates additional difficulties for professionals who very often qualify this disease as "very complex" because it leads to a deep and severe impairment of physical and intellectual capacities. The sick person gradually loses their autonomy and becomes dependent for the acts of daily life, hence the choice of this disease for our study. Our study is focused on the quality of life at home of patients followed by the Angers Reference Center, "expert" on neurogenetic pathologies.

Studies focusing on patients' quality of life at home have so far never been undertaken for a rare neurodegenerative disease like Huntington's disease.


Eligibility Criteria:
Selection Criteria:

Patient group :

* Genetic diagnosis of Huntington's disease
* Symptomatic patient
* Patient living at home
* Person able to carry out the interviews provided for in the study

Caregiver group :

* Person, defined within the meaning of the CNSA (National Solidarity Fund for Autonomy) as a natural caregiver, not concerned himself by the risk of developing the disease
* person able to carry out the interviews provided for in the study

Home Helper group :

- Professionals working at home with Huntington's disease patients employed by home help service providers.
Study of Coagulation Activation Markers and Pre Eclampsia

The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.

100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section).

Blood and urine samples will be collected at PE diagnosis, delivery and post partum.

Two axes will be considered:

1. Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram) and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers).
2. The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter CYP8A1).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* diagnosis of pre eclampsia

Exclusion Criteria:

* multiple pregnancy
* less than 18 year old
Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥75 years old;
* Planned elective PCI for patients with acute coronary syndrome;
* Life expectancy ≥ 1 year;
* Provide written informed consent.

Exclusion Criteria:

* Contraindications to angiography or PCI;
* Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
* Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
* Severe renal insufficiency (eGFR \< 30 mL/min/ 1.73 m2);
* Elevated AST, ALT level higher than three times of the normal upper limit;
* Advanced heart failure (NYHA classification grading of cardiac function ≥Ⅲ) Complicated with immune system diseases#
* Abnormal hematopoietic system: platelet count \< 100 × 109 / L or \>700 × 109 / L, white blood cell count \< 3×109/L etc;
* Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
* Known intolerance, or contraindication to any antithrombotic medication
* Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
* Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
* Patient's inability to fully cooperate with the study protocol
The Exceptional Patient in Cancer Care

The objectives of this study is to conduct a multicenter, dual country (United States and Israel), study examining the experience of patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.

The primary aim of the study is to develop a detailed description of patients' experience of an exceptional disease course. The secondary aim is to define the content domain for assessment and measurement of exceptional disease course in patients with cancer and identify lessons learned from these exceptional patients that can be a base for future studies to benefit others.

The investigators of this study are exploring the experience of people with cancer who are considered by their physicians as having an exceptional course of disease - people who have defied the odds and remain well despite the severity of the original diagnosis.

Participation in this study is completely voluntary. Lessons learned from recorded experience(s) may be helpful to other patients and can be a basis for future studies that may benefit other patients.

To participate in this important study is simple and not time consuming. You will have only one face-to-face or telephone interview with a research assistant. During the interview you will simply be asked to describe your perspective, thoughts, and behaviors that you think are related to your disease course and lessons that you think others may gain benefit from. The interview will last about one hour and will be conducted at a time that is convenient for you.

If you agree to participate a research assistant will schedule a time for a recorded interview by phone or if possible at a location convenient to you. The interviews will be taped and transcribed. All recorded interviews will be retained for a minimum of 6 years.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Ability to speak and read English with patients residing in the US, ability to speak and read Hebrew with patients residing in Israel.
3. Diagnosis of cancer confirmed by pathology.
4. Exceptional disease course as identified by patients' physician, in terms of survival and unusual disease course that is appropriately medically documented.
5. Consent to participate in this study.

Exclusion Criteria:

1. Inability to understand the intent of the study.
2. Medical condition that would preclude participation in an interview session lasting 30-45 minutes.
3. Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
Allogeneic Hematopoietic Stem Cell Transplantation Cohort Study

Clinical observational studies using epidemiologic theories and methods. Through the collection of various clinically relevant data, specific outcomes are evaluated in hematologic transplant patients, providing high quality real-world data for clinical practice, informing public health decision-making, and reducing the burden of disease

This is a retrospective, prospective, two-way cohort study in which clinical diagnostic and treatment data will be collected on patients enrolled in the study and followed up to characterize the natural course of the patient population as systematically as possible. All treatment decisions and clinical assessments will be made by the treating physician based on conventional treatment criteria and are not required by the study design or protocol.

The purpose of this study is to examine the natural course of the disease and current treatments. An in-depth analysis of treatment regimens and treatment duration, as well as the sequence of regimen use, will be conducted to describe treatment modalities and healthcare expenditures for this disease state. No clinical device or laboratory/assessment interventions will be conducted except for disease management requirements based on routine practice requirements or treatment monitoring based on locally approved product characterization requirements. Patients will be required to complete a separate questionnaire containing basic epidemiologic information (demographics, disease history, environmental exposure history).

During the duration of this study, some patients may be enrolled in interventional clinical trials. This is allowed and expected to occur in this study. Patients will not be required to withdraw from the cohort study and will continue to be followed up as normal, unless the investigator/patient feels it is more appropriate to withdraw from the study. All requirements of the clinical trial in question are documented according to the trial protocol.

Eligibility Criteria:
Inclusion Criteria:

1. At least one visit to a stem cell transplant center beginning January 1, 2021
2. Proposed to undergo or have undergone hematopoietic stem cell transplantation

Exclusion Criteria:

1. Long-term follow-up information for patients not available for any reason (e.g., unavailable or with serious concomitant disease) according to investigator opinion
2. Due to alcohol and drug addiction thus affecting their ability to follow the requirements of the study
3. Presence of conditions that could jeopardize patient safety or affect their adherence to the protocol, according to the investigator's opinion