cyrilzakka/clinical-trials huggingface dataset:
Optical Correction and Visual Functions of Adults With Amblyopia

Amblyopia is a developmental anomaly resulting from abnormal visual experiences in early life. Amblyopia causes reduced visual acuity in the absence of a pathology. Adult sensory systems are believed to be structurally invariant beyond early, critical periods of development. However, recent evidence suggest that visual functions in adults with amblyopia can be improved with optical correction alone. This study aims to investigate whether improvements in best corrected visual acuity and other visual functions can result following appropriate optical correction in adults with amblyopia. Functional measures relating to vision, binocular vision, and eye movements will be used to assess the efficacy of refractive correction for improving vision. This study will help us better understand the improvements in visual functions following optical correction, as well as the mechanisms underlying neuroplasticity in adults with amblyopia.


Eligibility Criteria:
Inclusion Criteria:

* 18-39 (inclusive) years of age
* Anisometropic amblyopia (difference of ≥0.50D spherical equivalent or ≥1.50D astigmatism between eyes) or mixed mechanism amblyopia (strabismus and anisometropia)
* Best corrected visual acuity (BCVA) in the amblyopic eye of 0.3 logMAR to 1.0 logMAR (inclusive)
* BCVA in the non-amblyopic eye of 0.1 logMAR or better, and an interocular VA difference of 2 logMAR lines or more
* Difference of 1.00D or more between current refractive correction and study prescription
* Good general health

Exclusion Criteria:

* Other pathological ocular anomalies known to cause reduced visual acuity
* Presbyopia (based on amplitude of accommodation)
* Inability to tolerate prescribed refractive correction in spectacles (e.g., due to aniseikonia)
* Contraindication to cycloplegic eye drops
* Currently under amblyopia treatment/therapy
* Inability to comprehend test instructions and/or provide consent
* Eccentric fixation
* \>-6.00DS of myopia in either eye with spectacles
* Bilateral amblyopia
* Presence of amblyopia that is not due to strabismus and/or anisometropia
* Presence of (current or previous) psychiatric, visual, or neurological disorders
Esmolol in Sepsis Management:Evaluating Immunomodulatory Effects and Impact on Patient Outcomes

Evaluate the effectiveness of esmolol, a selective β1-adrenergic receptor blocker, in modulating immune responses and improving patient outcomes in sepsis.

The research aimed to investigate the immunomodulatory effects of Esmolol in sepsis treatment. A comprehensive study was conducted, incorporating both direct experimental assays and data extraction from Electronic Health Records (EHR) to evaluate physiological and immunological responses in septic patients. Specifically, Norepinephrine (NE) levels were measured, and CD4+/CD8+ T cells were quantified to assess changes influenced by Esmolol administration. Additionally, cytokine profiles, Procalcitonin (PCT) levels, complete blood counts (CBC), and routine biochemical functions were monitored through data retrieved from EHR systems, providing a broad perspective on patient health and response to treatment. This multifaceted approach aimed to determine how Esmolol affects key immune parameters and overall patient outcomes, addressing both the direct and systemic impacts of this treatment on septic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 90 years.
2. Diagnosed with sepsis or septic shock according to the diagnostic criteria in Suivival Sepsis of 2021.
3. Received adequate fluid resuscitation and necessary exogenous Norepinephrine (NE).
4. No contraindications to Esmolol and appropriate heart rate levels determined by clinical assessment.
5. Provided written informed consent.

Exclusion Criteria:

1. Deceased within three days following ICU admission.
2. Pregnant or lactating individuals.
3. Underwent surgical procedures within the last two weeks.
4. Severe cardiac failure exceeding NYHA Class III.
5. Usage of long-term oral β-blockers or any form of extracorporeal circulation within the last two weeks.
6. Presenting with sinus bradycardia or atrioventricular block.
7. Received high doses of corticosteroids in the past three months.
8. Underwent significant hormone therapy, persistent blood loss of more than 500 ml within any 24-hour period, or were treated with Esmolol for less than three days.
Multimodal Prognostic System for Heart Failure: A Multi-Center Study

This study is a multicenter retrospective research aimed at developing a heart failure prognosis warning system based on multimodal clinical data to improve the diagnosis and treatment of heart failure.

This study aims to address the following main questions:

1. What are the clinical characteristics and current treatment status of heart failure patients?
2. What factors influence the onset of heart failure and the prognosis of patients?
3. How can real-world big data be utilized to construct an accurate heart failure prognosis assessment model?
4. How can this prognosis assessment model help improve the therapeutic effects and quality of life for heart failure patients?


Eligibility Criteria:
Inclusion Criteria:

Age Requirement: We plan to include adult patients aged 18 and above to ensure the study covers a broad spectrum of the adult heart failure patient population.

Diagnostic Criteria: Patients should have a discharge diagnosis of heart failure according to the guidelines for heart failure diagnosis and treatment.

Time Frame: The discharge time of patients should be between January 2011 and December 2024 to collect and analyze data from the past several years.

Data Integrity: There is a preference for including medical records with high data integrity, but the specific criteria may be adjusted according to the actual situation of the dataset.

Exclusion Criteria:

Data Missing: Patients with more than 30% missing data in their medical records may be considered for exclusion to ensure the accuracy and reliability of the analysis.

Diagnostic Inconsistency: Patients with unclear diagnoses or potential for confusion with other diseases may be excluded to ensure the specificity of the study.

Non-standard Treatment: Patients who have not received treatment according to the established treatment protocol may be excluded to reduce the impact of treatment variability on the study results.
Imaging Modalities in Detection of Coronary Artery Disease in End-stage Renal Disease Patients

This study investigates hypothesizes that the combination of dobutamine stress echocardiography with dobutamine stress echocardiography with real time perfusion myocardial contrast echocardiography and coronary computed tomography is a better modality for detecting coronary artery disease in end-stage renal disease patients than coronary angiography, and in predicting patient outcomes. Demonstrating this would lead to increased use of DSE with RTCE and coronary CT at kidney transplant centers throughout the nation, leading to improved anatomical and functional detection of CAD without the need for further invasive procedures.

Primary: To examine the ability of dobutamine stress dobutamine stress echocardiography with real time perfusion (DSE with RTCE) and coronary computed tomographic angiography (cCTA) to detect anatomically significant coronary artery disease (CAD) as defined by quantitative coronary angiography in end-stage renal disease (ESRD) patients Secondary: To identify which of these tests is most predictive of patient outcomes.

This will be a pilot study enrolling 75 participants. This is based off obtaining 80% power and a 90% rectangular confidence region for sensitivity and specificity using one-sided confidence limits, this corresponds to two 95% univariate confidence intervals (one for sensitivity and one for specificity). With 73 patients screened in total there will be 80% power to form a 90% rectangular confidence region around 90% sensitivity and 90% specificity, excluding sensitivities less than 69% and specificities less than 73%. We believe the sensitivities and specificities of both DSE with RTCE and cCTA will be within these confidence regions.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus
2. Patients undergoing kidney transplant evaluation.
3. Currently on hemodialysis
4. Adults 19-65 years of age
5. Written informed consent from a participant who is deemed medically competent by principal investigator, secondary investigators, or participating personnel as written in II.26 (b)
6. Male or female

Exclusion Criteria:

1. Previous history of percutaneous coronary intervention
2. Coronary artery bypass surgery
3. Prior myocardial infarction or AMI (troponin greater than 1.0) within 48 hours of the test
4. Atrial or ventricular arrhythmias that cannot be controlled to heart rates \<65 beats per minute
5. Known allergy to iodinated contrast
6. Decompensated Congestive Heart failure
7. Acute respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia
8. Pregnant (based on history/information obtained from the patient)
9. Possibility that potential subject may be pregnant (based on history/information obtained from the patient)
SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS: RANDOMIZED TRIAL

We present a research project in the form of a controlled clinical trial with the aim of analyzing and demonstrating whether the surgical treatment of upper limb spasticity is an effective and efficient measure to improve dependence and quality of life perceived by patients with sequelae of stroke and therefore, should be included in the therapeutic protocols, in which it is not usually contemplated, as a complement or alternative to traditional treatment with botulinum toxin, rehabilitation and occupational therapy.

Cerebrovascular accident (CVA) or "stroke" is the leading cause of permanent disability in adulthood and many patients require lifelong medical treatment and assistance from other people for the development of their daily activities. The repercussion in the family, professional, labor and social fields is enormous, producing a very important economic expense. The usual treatment of spastic upper limb secondary to stroke is rehabilitation, occupational therapy and periodic injection of botulinum toxin, and surgical correction is not usually considered. A two-arm Randomized Clinical Trial \[surgical treatment (n=22) vs. botulinum toxin (n=22)\] is proposed with the aim of investigating the efficacy and efficiency of surgery for upper limb spasticity with respect to treatment with botulinum toxin in patients with established spastic sequelae after stroke.

We will evaluate the effect on functionality and "hygienic" changes; the impact on quality of life, sleep quality, anxiety and depression; as well as on brain activity by Functional Magnetic Resonance Imaging, at baseline and at 6 and 12 months follow-up. The health and care costs of the established groups of patients will also be evaluated. This research is framed in the context of chronic diseases, aging and patients with functional and mobility difficulties. The results of this work are expected to have a great impact due to the high prevalence of the disease, the severe disability it causes, and the number of patients who would benefit, in addition to the savings in healthcare resources. The incorporation of surgery into stroke care would change the current treatment paradigm, favoring the formation of multidisciplinary teams for the treatment of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age, with spasticity in the upper limb due to stroke, with a minimum evolution time of 12 months, who, after being informed orally and in writing of the objectives of the study, sign the informed consent form (themselves or their legal representatives).

Exclusion Criteria:

* Absence of consent, refusal of possible surgical treatment, stroke evolution time of less than 12 months, anaesthetic risk (ASA) class IV or higher, presence of involuntary movements, inability to respond adequately to surveys, deformities that cannot be addressed by surgical treatment or inability to follow up for at least one year.
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* 30-70 years of age
* History of mixed hyperlipidemia
* Prescribed a Step 1 diet at least 30 days prior to screening
* Women were not pregnant, breast-feeding, or plan to become pregnant during the study
* Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
* Serum LDL-C \>/= 115 mg/dL; Serum TG \>/= 150 \& \< 750 mg/dL

Exclusion Criteria:

* BMI \>40
* HbA1C \> 10%
* Type 1 diabetes
* Intolerance to fibrates
* History of intolerance to colesevelam HCl
* History of swallowing disorders or intestinal motility disorders
* Any other disorder that might interfere with the conduct of the study
* History of drug or alcohol abuse
* Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)
RAFT - Pace &Ablate

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.

A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with permanent AF/persistent AF (in AF)
2. Patients with NYHA Class II -IVa HF symptoms
3. Guideline driven medical therapy for HF for at least 3- months with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year

Exclusion Criteria:

1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
3. Acute coronary syndrome \<4 weeks or coronary revascularization \<3months
4. Unable or unwilling to provide informed consent
5. Uncorrected primary valvular disease or prosthetic tricuspid valve
6. Restrictive, hypertrophic, or irreversible form of cardiomyopathy
7. Severe pulmonary diseases requiring oxygenation
8. Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension
9. Patients enrolled in competitive clinical trials that will affect the objectives of this study
10. Existing CRT/BiVP
11. Patients who are pregnant or intend to become pregnant
12. Guideline indication for CRT
Neuro-COVID-19: Neurological Complications of COVID-19

The prevalence and typical patterns of neurological complications in hospitalized COVID-19 patients admitted to the intensive care units of the University Hospital Zurich will be investigated. The impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes will be analyzed.

This study is a prospective observational cohort study to document prevalence and severity of neurological symptoms among patients requiring critical care admission for confirmed novel coronavirus disease (COVID-19). COVID-19 is classified as severe acute respiratory syndrome 2 (SARS-CoV-2) and shares significant structural and biological similarities with SARS-CoV, which has neuroinvasive properties and brainstem involvement. Early reports of COVID-19 progression indicate presence of severe neurological complications, including seizures, coma, encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage, and cerebral venous sinus thromboses. In addition, recent data from Zika-virus and H1N1 influenza pandemics reveal a high incidence of neurological complications, including Guillain Barré syndrome and neonatal microcephaly for Zika-virus and narcolepsy with H1N1 infections. Early reports from China suggest neurological symptoms may occur in approximately 36% of SARS-CoV-2 positive patients, with increased prevalence among more severe cases, and fall into three categories: central nervous system symptoms or diseases, peripheral nervous system symptoms, and skeletal muscular symptoms. However, the exact prevalence of these conditions and impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continues to rapidly rise on an international level, it is imperative to capture prospective data to accurately document prevalence, severity and clinical characterization of neurological components of COVID-19, the influence of treatment regimens of neurological complications, and role of these confounders on patient and organizational outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \> 18 years old) treated at ICUs
* Admitted with confirmed COVID-19 infection
* Patient exhibiting acute neurological manifestations
* General consent of the Institute of Intensive Care Medicine available from patient or legal representative

Exclusion Criteria:

* Pre-existing severe neurologic dysfunction
Decitabine and Anti-PD-1 in R/R DLBCL

Patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial.

To evaluate the effectiveness and safety of patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial. Enrollment was planned to be completed within 2 years, and all trials were followed up for 12 months after the last enrolled patient completed treatment. All cases will be followed up and the long-term curative effect will be observed and recorded.

Eligibility Criteria:
Inclusion Criteria:

* 14-80 years old, male or female;
* Pathologically confirmed relapsed/refractory diffuse large B cell lymphoma with extranodal (central nervous system) involvement;
* Expected survival of more than 3 months;
* AST and ALT ≤ 3.0 ULN; TBIL and CCr ≤ 1.0 ULN;
* Inactive infection and severe mental illness
* ECOG score 0\~2
* According to the New York Heart Association (NYHA) cardiac function grading standards, the heart function grading should be grade I or Grade II; Cardiac ejection fraction \>50% or not lower than the lower limit of the range of laboratory test values at the study center; No pathological abnormality was found in ECG; There was no clinically significant pericardial effusion or pleural effusion
* The serum pregnancy test of female subjects must be negative
* Signed informed consent

Exclusion Criteria:

* Subjects with any autoimmune disease requiring long-term use of corticosteroids or immunosuppressive drugs or with a history of other tumors;
* Severe uncontrolled medical disease or active infection (including HIV+);
* Active gastrointestinal bleeding or 1 month history of gastrointestinal bleeding;
* Received allogeneic hematopoietic stem cell transplantation within 6 months or are participating in other clinical studies;
* Pregnant or nursing women;
* Subjects who must be forcibly detained for the treatment of mental or physical diseases (e.g. infectious diseases);
* The researcher thinks it is not suitable for this clinical study (such as poor compliance, drug abuse, etc.)
* The situation that the researcher judged was not suitable for inclusion
Institutional Registry of Rare Diseases

The goal of this observational study is to create a single macro registry system with data collection on common clinical features, grouping the different rare diseases (RD).

Moreover, the specific goals are to generate an alert system for possible cases of RD with data from the electronic medical record, to describe the occurrence of RD in the evaluated population, to characterize the population, to describe patterns of diagnosis and treatment of RD present at the time, and to explore patient-reported outcomes.

Rare Diseases (RD) pose a health challenge due to their complexity and low prevalence, generating a burden in terms of morbidity and mortality and costs.

The fragmentation of data on these diseases makes it difficult to understand them comprehensively. Therefore, the creation of a macro institutional registry that brings together information on RD would facilitate research in this field.

The registries are organized systems of systematic data collection of a large number of patients quickly and efficiently on a particular disease at a given time.

The main difficulty of the registries is the guarantee of the quality of their data.

The main objectives of the registry are:

Understand risk factors and prognosis. Evaluate the diagnostic and therapeutic comparison with current standards. Advance knowledge of the disease to optimize the assessment, treatment and monitoring of patients.

Analyze the effectiveness of new therapies. Studying differences between populations. Quickly estimate the morbidity, mortality and resource utilization associated with a disease entity.

Examine the course of a disease Formulate novel hypotheses for further prospective studies.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and/or molecular diagnosis of any of the following rare diseases: Amyloidosis, Sarcoidosis, Phacomatosis, Pheochromocytoma, Paraganglioma, Von Hippel-Lindau Disease, Immunoglobulin G4-Related Disease, Demyelinating Diseases, Inborn Errors of Metabolism, Eosinophilic Gastrointestinal Disorders, Hypertrophic Cardiomyopathy, Gaucher Disease, Congenital Adrenal Hyperplasia, Hereditary Angioedema, Pulmonary Hypertension, Wilson Disease, Vascular Anomalies, Mastocytosis, Multiple Endocrine Neoplasia, Inflammatory Bowel Diseases, Prader-Willi Syndrome, Hirschsprung Disease, or Cushing Syndrome.
* Must be followed at Hospital Italiano de Buenos Aires.

Exclusion Criteria:

- Refusal to participate in the study or in the informed consent process.