cyrilzakka/clinical-trials huggingface dataset:
Steroids for Early Treatment of Radiation Retinopathy

Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.

The purpose of the project is threefold:

1. To study the natural history of radiation retinopathy using advanced imaging techniques. A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia and leakage. Potential role of OCT angiography in radiation retinopathy will be evaluated by comparison to other eye (control) and FA.
2. Currently there is no consensus on effective management strategy for radiation retinopathy. Patients in the interventional will be prospectively followed to study efficacy of steroids for early treatment of radiation retinopathy while comparing the multimodal therapeutic approach in a randomized trial.
3. Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Primary uveal melanoma
* Primary treatment with plaque brachytherapy
* Baseline visual acuity 20/200 or better
* Posterior tumor margin \>1.50 mm from the center of the macula
* Posterior tumor margin \> 1.50 mm from the closest disc margin
* Calculated total dose to center of the macula \>40 Gy

Exclusion Criteria:

* Iris melanoma
* Opaque media
* less than 21 years of age
* Inability to give consent
* Positive pregnancy test
Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)

To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are prescribed Azithromycin (Zithromac) IV for Legionnaires' disease.

Exclusion Criteria:

* Patients who have been prescribed Zithromac or Zithromac SR.
The Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients

Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in coronary artery disease (CAD) patients from those without CAD, which might account for the benefits of Atorvastatin in CAD patients.

1. Hypothesis: The VSELs might be mobilized in the situation of cardiac ischemia in CAD patients. In addition, the benefits derived from Atorvastatin administration in CAD patients may be related to VSELs via sCD40L-SDF1/CXCR4 signal pathway.
2. The number and function of peripheral blood VSELs in CAD patients compared with the controls.

   1. Included patients: including 200 CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.
   2. The IRB approve and all subjects sign the informed consent.
   3. All subjects will receive the detection and analysis of the peripheral blood VSELs, including VSEL number, immigration capability after sCD40L administration.
   4. All subjects will receive the follow-up for 1 year, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
   5. the association between VSELs and MACE in CAD patients will be statistically analyzed.
3. Atorvastatin administration improves the prognosis of CAD patients through exerting impacts on VSELs

   1. Included patients: including 200 CAD patients receiving coronary angiography as positive subjects, 100 as control who are negative for coronary angiography.
   2. The IRB approve and all subjects sign the informed consent.
   3. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
   4. All subject will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
   5. the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period.
   6. the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.

Exclusion Criteria:

* Infectious diseases, immunologically mediated disease, serious liver diseases, serious kidney diseases, malignant tumor, thrombocytopenia, pregnancy, occluded peripheral arterial diseases, bleeding or blood transfusion in the latest 2 months
Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach

The scientific aim of this study is to investigate the efficacy and safety of incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson"s disease. Our hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases the tremor amplitude and frequency leading to improvement of the patient"s function.

This is an investigator initiated, randomized, double blind, placebo controlled, cross over study which is supported by Merz pharmaceuticals. Patients with Parkinson"s disease (at Yale Neurology and Movement disorders clinics) will be approached by the members of the research team (PI and sub-investigators) to see if they meet inclusion and exclusion criteria and wish to participate in the study.

If eligible and consented to participate in the study, there will be a series of questionaires, examinations and treatment sessions.

Eligibility Criteria:
Inclusion Criteria.

1. Age more than 18 years
2. Both sexes
3. all races/ethnic groups.
4. Meeting the clinical diagnosis of Parkinson's disease with presence of moderate to severe Parkinson tremor that is refractory to standard medical treatments and which limits the patient"s functionality and/or poses significant discomfort.
5. Subjects who are able to read, speak, and understand English.

Exclusion Criteria.

1. Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders) or significant swallowing or breathing difficulties.
2. Pregnancy or planned pregnancy (determined by urine pregnancy test).
3. Active breast feeding.
4. Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
5. Any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication.
6. Subjects who are younger than 18 years of age. Neuromuscular-junction disorders.
7. Evidence of acute pathology in neuro-imaging.
8. Axis I diagnosis determined by a neurologist or psychiatrist.
9. Use of Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.
10. Those who received botulinum toxin injections in the past 4 months.
Memantine Treatment Study of Pathological Gambling

The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive 10 weeks of open-label treatment with memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with PG. We hypothesize that memantine will reduce the severity of gambling symptoms and improve patients' overall functioning. This study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Pathological Gambling using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
* Gambling behavior within 2 weeks prior to enrollment;
* For women, negative results on a urine pregnancy test and stable use of a medically accepted form of contraception.

Exclusion Criteria:

* Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
* Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen;
* History of seizures;
* Myocardial infarction within 6 months;
* Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
* A need for medication other than memantine with possible psychotropic effects or unfavorable interactions;
* Clinically significant suicidality;
* Current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence;
* Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID;
* Current or recent (past 3 months) DSM-IV substance abuse or dependence;
* Positive urine drug screen at screening;
* Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
* Previous treatment with memantine;
* Treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Apathy in Parkinson's Disease

The purpose of this research study is to attempt to treat apathy in Parkinson's disease (PD) using high-frequency repetitive transcranial magnetic stimulation (rTMS) of the brain and to investigate the patterns of brain activation that may be involved in apathy. It is hypothesized that high-frequency rTMS of the left mid-dorsolateral frontal cortex will improve apathy in PD.

Apathy is a syndrome characterized by a primary lack of motivation and it manifests in three domains: behavioral (lack of effort and productivity, dependence on others for structuring daily activities), cognitive (loss of interest in new experiences, lack of concern for one's problems) and affective (flattened affect and lack of response to positive or negative events). Apathy has been consistently attributed to functional disturbance of neural systems involving mesial frontal and the anterior cingulate cortex (ACC), an area with reciprocal connections with limbic, frontal cortices and the basal ganglia.

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive tool used to manipulate activity in specific brain neural circuits through the skull and, in turn, induce short-term (milliseconds) and long-term (minutes to hours) changes in behavior. The duration of effect depends on the stimulation mode. Several studies have now demonstrated that rTMS may facilitate or modulate behavior beyond the actual stimulation. rTMS of the mid-dorsolateral frontal cortex (MDLFC) has been used to treat depression presumably because of its modulatory effect on the fronto-cingulate system (MDLFC and the ACC circuitry). Studies have shown that rTMS of the left MDLFC modulates the blood flow response in the ACC. We therefore hypothesize that high-frequency rTMS of the left MDLFC will also improve apathy in PD.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment);
2. age 30 or over; and
3. on stable medications for at least 30 days.

Exclusion Criteria:

1. features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
2. history of deep brain stimulation or ablation surgery, significant headaches, epilepsy or seizure disorder, mass brain lesions, or major head trauma leading to loss of consciousness of any length;
3. family (1st degree relatives) history of epilepsy;
4. evidence for dementia;
5. presence of contraindications for functional magnetic resonance imaging (fMRI);
6. history of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year;
7. need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
8. unstable medical condition such as diabetes, cardiac disease, hypertension;
9. pregnancy; and
10. colorblindness.
Powered Handle Primary Sleeve Gastrectomy Study

The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.


Eligibility Criteria:
Inclusion Criteria:

1. Be within the range of 18-65 years of age
2. Patients undergoing primary sleeve gastrectomy procedures
3. Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.

Exclusion Criteria:

1. Prior bariatric surgery procedure
2. Sleeve gastrectomy procedure that is planned to be performed via open approach
3. Patients receiving anticoagulant medication(s)
4. Severe heart disease or lung problems
5. Known sensitivity to implant materials
6. Evidence of active (systemic or localized) infection at time of surgery
7. Women who are pregnant or planning to get pregnant in the next 12 months
8. Recent history of known alcohol and/or narcotic abuse
9. Investigational drug or device use within 30 days
10. Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study
OFDI-Quantified Intracoronary Thrombus, Antiplatelet Pretreatment Effect and Myocardial Reperfusion

The management of ST-elevation myocardial infarction in the acute phase requires an optimal antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of first medical contact. However, even with the new P2Y12 inhibitors, effective platelet inhibition which is required to inhibit the progression of intracoronary thrombus, is present only in half of the patients at 2 hours.

Optical coherence tomography (OCT) is the reference method for visualizing and quantifying intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was associated with altered myocardial reperfusion indices, which were themselves associated with the prognosis of the patient. However, the determinants of this post-stenting residual mass -mostly thrombotic- remain unknown.

Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced platelet reactivity is reported in patients with acute coronary syndrome and represents a high-risk situation for recurrent coronary events in this setting.

The study aims to:

1. to evaluate the relationship between the post-stenting residual intracoronary mass evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify Now
2. to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices
3. identify patients with high thrombotic risk who may require more intensive antithrombotic therapy
4. identify simple biological markers associated with the residual mass measured by OCT


Eligibility Criteria:
Inclusion Criteria:

* primary PCI with successful stenting for ST-elevation myocardial infarction
* pretreated with ticagrelor, aspirin and enoxaparin
* OCT and verifyNow performed in the acute phase

Exclusion Criteria:

* stent thrombosis
* known coagulation disorder
* clinical instability
* pregnancy
Anesthetic Management in Patients Undergoing Epicardial Ablation

The study is a retrospective study and is descriptive in nature. In this study, the investigators aimed to emphasize the importance of anesthesia management by cardiac risk assessment of patients undergoing epicardial ablation under general anesthesia and analysis of complications that developed during the procedure.

The study is retrospective observational and data were collected by examining the files of all epicardial ablation patients received in the angiography unit starting from 30.10.2020 until 30.10.2022 after ethics committee approval is obtained. Baseline characteristic features of the patients Sex, Age, (years, BMI (kg/m2) Hypertension, Coronary artery disease, COPD (Chronic obstructive pulmonary disease), CKD (Chronic kidney disease) Electrical storm, and ventricular tachycardia etiology, Ischemic cardiomyopathy, Dilated cardiomyopathy, the presence of ARVC (Arrhythmogenic Right Ventricular Cardiomyopathy), Hypertrophic cardiomyopathy will be recorded. NHYA classification will be examined in two groups as NHYA I or II and NHYA III or IV, also estimated glomerular filtration rate, left ventricular ejection fraction, PAAINESD (acute hemodynamic decompensation risk assessment score), iVT score (Risk of VT recurrence) Score information will be recorded. Ventricular tachycardia focus locations, dopamine, dobutamine, norepinephrine infusion requirement during the procedure, arrest development during the procedure, fluoroscopy time and ablation times will be recorded. In the follow-up of the patients after the procedure Causes of death, decompensated heart failure, transient ischemic attack, development of acute renal failure, and recurrence of ventricular tachycardia will be recorded. PAAINESD score (acute hemodynamic decompensation risk assessment score) will be recorded. The PAAINESD Score, developed to estimate the risk of periprocedural hemodynamic decompensation, has values ranging from 0 to 35 points (or 0 to 31 \[PAINESD\] when the modifiable intraprocedural variable "general anesthesia" is excluded). duration of the procedure, the need for inotropes during the procedure, whether the patient needed mechanical ventilation after the procedure, and the success rates after the procedure will be recorded.

PAINESD Pulmonary disease (chronic obstructive pulmonary disease) 5 Age \>60 years 3 Anaesthesia (general) 4 Ischaemic cardiomyopathy 6 NYHA class III or IV 6 Ejection fraction \<25 % 3 Storm (VT). 5 Diabetes 3 Data will be analyzed in three separate categories, the characteristics of the patients before the procedure, during the procedure and after the procedure. Descriptive tables and percentages of parameters will be created by statistical analysis.

Eligibility Criteria:
Inclusion Criteria: • age \> 18 years old who underwent elective VT ablation between 2020 - 2022,

* primary anesthetic type listed as general anesthesia

Exclusion Criteria: • age \< 18 years,

* missing follow-up data,
* patients who have previously undergone epicardial ablation
Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia

The present study aims to evaluate the modification of functional capacity induced by an adapted physical activity program in subjects with haemophilia.

The exercise program used aims to improve joint mobility, muscle strength, static and dynamic balance, motor coordination.

The program is structured in 1 hour sessions of 2 days/week and lasts 6 months.

The primary endpoint is the change in functional capacity calculated as the difference between the baseline assessment and the 3 and 6 month assessment of the 6 Minutes Walking Test measured with the G-Walk (BTS Bioengineering S.p.A).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemophilia A or B;
* Signature of informed consent;
* Availability of a medical certificate for non-competitive activities

Exclusion Criteria:

* Active bleeding
* Severe joint deformities that prevent exercise
* Insufficiency of communicative and/or sensory functions so severe that it is impossible to understand or carry out the trainer's instructions (dementia, aphasia, blindness, deafness)
* Heart failure (NYHA class \> 2)
* Unstable angina
* Lung disease requiring oxygen therapy
* Symptomatic peripheral arterial disease
* Myocardial infarction or hospitalization within the previous 6 months
* Symptomatic orthostatic hypotension
* Hypertension in poor pharmacological control (diastolic\> 95 mmHg, systolic\> 160 mmHg)
* Significant neurological conditions that impair motor or cognitive function
First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome

The management of thoracic outlet syndrome can be either surgical or nonsurgical. Fewer than 20% of patients experience benefits from nonsurgical treatments. Regarding the surgical approach, there's considerable debate about whether to resect the first rib or if a scalenectomy alone suffices. Recently, many experts have concurred on the resection of the first rib. Based on our observations, avulsion of the first rib results in improved outcomes and reduced post-operative pain compared to simple resection. Thus, this study aims to compare the outcomes of first rib resection versus its avulsion in patients with thoracic outlet syndrome.


Eligibility Criteria:
Inclusion Criteria: any patient diagnosed as a case of neurogenic thoracic outlet syndrome -

Exclusion Criteria: patients with other types of thoracic outlet syndrome (vascular TOS)

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The Banana Exercise Type 1 Diabetes Study

Former and current KADET athletes participate in two controlled training sessions: one with a banana 20 minutes pre-exercise and one without. Tandem Data recorded includes sensor glucose, training details, insulin dosing, and meal intake. Continuous glucose monitoring (CGM) data is assessed. Endpoints include differences in glucose levels, hypoglycemia events (SG \<3.9 mmol/L), and Time in Range during training

Participants:

Former and current KADET athletes invited via a Facebook group. Previous participants in study projects who have expressed interest in being contacted for future studies.

Protocol:

Participants provide written consent for data collection and use.

Each participant completes two training sessions under controlled conditions, including:

Same training time Standardized pre-training meal timing and insulin corrections Similar intensity and environmental factors If pre-training hypoglycemia occurs, training is rescheduled or corrected with glucose tablets, which are documented.

Study Conditions:

Session 1: Participant eats a banana 20 minutes before training. Session 2: No pre-training food intake.

Tandem Control IQ users (insulin pump) take a microbolus (0.05 IE) before banana intake.

Recorded Data by participant:

Training start and end times Sensor glucose (SG) at start and end of training Training type and intensity (Borg scale, heart rate monitoring) Last insulin dose (meal and correction) Last meal details (content and timing) Banana documentation (photo, weight with peel, ripeness level)

CGM data are also assessed.

Endpoints:

Differences in GCG glucose level Time to hypoglycemia and number of hypoglycemia events (SG \<3.9 mmol/L) on banana vs. non-banana days.

Percentage of Time in Range during training. Additional data is reported as available.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* cardiovascular comorbidity
* neuropathy