cyrilzakka/clinical-trials huggingface dataset:
Optical Coherence Tomography in Retinal Vein Occlusion

This study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. The study will use OCT scans to assess changes in the retina and how these changes relate to vision improvement over time.

Objectives Evaluate how OCT data can predict visual outcomes by analyzing retinal changes and macular edema characteristics.

Assess the correlation between baseline OCT biomarkers and visual acuity improvements over time.

Study Design Type: Cross-sectional study.

Setting: Conducted at several eye care centers in Egypt.

Participants Inclusion Criteria: Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected eye.

Exclusion Criteria: Other retinal diseases, recent intraocular surgery, or significant media opacities.

Procedures Informed Consent and History Taking.

Ophthalmologic Examination: Includes BCVA, IOP, slit-lamp biomicroscopy, and fundus examination.

OCT Imaging: Using NIDEK RS-330 Retina scan duo 2 (SD-OCT) to assess macular changes.

OCT Image Evaluation: Classification of macular edema types and assessment of biomarkers like subretinal fluid and cystoid changes.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older.

Patients diagnosed with branch or central retinal vein occlusion.

Patients with macular edema confirmed by OCT due to vein occlusion.

Patients with no prior history of RVO in the affected eye.

Exclusion Criteria:

* Presence of other retinal diseases that could affect OCT interpretation (e.g., diabetic retinopathy, age-related macular degeneration).

History of intraocular surgery within the last three months.

Presence of significant media opacities (e.g., dense cataract, vitreous hemorrhage) that interfere with OCT imaging.
Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging

The primary goal of this intervention is to determine the efficacy of acute mitochondrial-specific antioxidants to improve vascular endothelial function in middle-aged and older (≥45 y) adults who do no perform regular aerobic exercise. In a double-blind, randomized, placebo-controlled crossover design participants with receive both MitoQ and placebo arm of the study. Primary endpoints will include vascular endothelial function assessed by brachial artery flow-mediated dilation and cardiac function assessed via pulse wave analysis. Secondary endpoints will include measures of aortic stiffness assessed by carotid-femoral pulse wave velocity and carotid artery stiffness (e.g. β-stiffness) and elasticity (carotid compliance, distensibility, and Youngs elastic modulus) from ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* Resting brachial blood pressure \<160 mmHg (systolic)/\<100 mmHg (diastolic)
* Body mass index ≤ 35 kg/m2
* Nonsmoker
* Women must be postmenopausal defined as cessation of menses ≥ 1 year.

Exclusion Criteria:

* cardiovascular/metabolic medications
* known clinical disease
* absolute contraindications to exercise testing
Interleukin-1 Receptor Antagonist and Insulin Sensitivity

Obesity is characterized by continuous low-grade inflammation. This is an important link between obesity and insulin resistance.

Results from the investigators' own group of in vitro and in vivo research on mice show that Interleukin-1 is involved in the process of developing insulin resistance. Earlier it has been shown that interleukin-1 receptor antagonist in human subjects improves glycemic control. The investigators' hypothesis is that this is due to improved insulin sensitivity.

The prevalence of obesity is increasing fast. Obesity is one of the most common acquired risk factors for insulin resistance. As a consequence the prevalence of type 2 diabetes mellitus is rising fast as well.

Interleukin 6 and Tumor Necrosis Factor alfa are well known pro-inflammatory cytokines that have been linked to insulin resistance. Results from our own group show that interleukin-1 is also involved in the process of developing insulin resistance.

Earlier research projects studied the effect of Interleukin-1 receptor antagonist (Anakinra) on glycemic control in subjects with type 2 diabetes mellitus. It was shown that glycemic control was improved. The authors conclude that this is the result of improved function of pancreatic beta cells.

These results are in contrast to our results of in vitro en in vivo research on mice, which show improved insulin sensitivity by Interleukin-1 receptor antagonist.

A possible explanation for not finding an effect on insulin sensitivity by earlier research projects may be that it is difficult to reliable quantify insulin sensitivity in this group of patients with concurrent changes in glycemic control, extensive co-morbidity and medication use, who might be at the rather extreme end of insulin resistance. Furthermore a relatively low dose of Anakinra was used.

Altogether we hypothesize that the effect of Interleukin-1 is not only mediated through better pancreatic beta-cell function, but that Interleukin-1 blocking by recombinant Interleukin-1 receptor antagonist will also diminish insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* adult subjects with a BMI \> 30 kg/m2
* 3 or more characteristics of the metabolic syndrome

Exclusion Criteria:

* inability to give informed consent
* age \< 18 years
* known diabetes mellitus
* fasting plasma glucose \> 7,0 mmol/l or HbA1c \> 6,2%
* presence of any medical condition that might interfere with the current study protocol
* immunodeficiency of immunosuppressive treatment
* anti-inflammatory drugs (100 mg of aspirin/day is allowed)
* signs of current infection
* history of recurrent infections
* pregnancy or breast feeding
* liver disease
* renal disease
* neutropenia
Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\], LASTE \[LArge Stroke Therapy Evaluation\], RESCUE-Japan LIMIT \[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\], SELECT 2 \[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\], and TENSION \[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (volume greater than 100 mL, ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

Clinical inclusion criteria:

1. Acute ischemic stroke within 24 hours from onset to enrollment;
2. The patient or patient's representative signs a written informed consent form;

   Imaging inclusion criteria:
3. If the occlusion site is located in the anterior circulation, internal carotid artery, or the middle cerebral artery M1 or M2, or the anterior cerebral artery A1, the baseline ASPECTS is 0 to 2 based on NCCT, or cerebral infarction core volume ≥85ml based on CT perfusion.
4. If the occlusion site is located in the vertebrobasilar artery, then the baseline pc-ASPECTS is 0 to 5.

Exclusion Criteria:

1. CT or MR evidence of hemorrhage;
2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
3. Currently pregnancy;
4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
5. Any terminal illness with life expectancy less than 6 months.
Minority AIDS Initiative Retention and Re-Engagement Project

The purpose of this study is to determine whether an enhanced peer intervention is effective in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.

This is a multi-site longitudinal study of an enhanced peer intervention to re-engage and retain high-risk people of color living with HIV into HIV primary care and other needed medical or social services. Three demonstration sites are implementing programs in which peers are employed as part of the health care team. Peers are trained to conduct educational sessions, provide emotional support, help prepare for and accompany patients to appointments, and debrief after visits.

Study participants will be current or newly enrolled patients of three clinics: CARE Resources, in Miami FL, the PATH Program at Brooklyn Hospital in Brooklyn, NY, and PR CONCRA located in San Juan Puerto Rico who (1) have been out of care for 4 months or more or (2) present a need for substance abuse, mental health, or housing services.

Data will be collected at baseline and follow up (at six and twelve months) through client questionnaires, selected medical chart data (visit dates, laboratory tests and values) and intervention encounter forms on approximately 375 HIV positive adults. The data collected for this study will allow us to assess changes in: (a) retention in HIV primary care, (b) viral load suppression, (c) health-related quality of life, (d) self-efficacy, and (e) HIV knowledge that may be associated with an enhanced peer intervention.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive; AND
* Age 18 years or older; AND
* Identifies as belonging to one or more of the following racial/ethnic groups: American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, native Hawaiian or other Pacific Islander; AND
* New patient to clinic (including newly-diagnosed) whose initial assessment or intake form indicates a need for substance abuse treatment, mental health or housing services, or a past history of substance abuse or mental health services; OR
* The individual has been out of medical care at your clinic for 4 months or more.
Neurothrombectomy France

The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It therefore remains a significant therapeutic challenge, especially for patients with against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty years of mechanical devices have been developed to remove, as quickly as possible, the cause of intracranial arterial occlusion and allow restoration of blood flow before brain damage is irreversible.

NTF The protocol is part of the evaluation process of our clinical practices recommended by the National Health Authority (HAS), in the specific context of mechanical thrombectomy performed in French centers of interventional neuroradiology working with neurovascular units (A V).


Eligibility Criteria:
Inclusion Criteria:

* Signature of the information notice by the patient or his legal representative
* Age\> 18 years
* Clinical and imaging consistent with ischemic stroke whose symptoms start back within 8h
* Thrombosis (TICI 0 or 1) of the carotid T, M1, M1-M2 bifurcation of the basilar artery occlusion in TANDEM ACI / M1.

Exclusion Criteria:

* Pregnant or lactating women
* Rapid improvement of NIHSS (gain of more than 4 points) between two pre-treatment assessments.
* ASPECT score \<7 on the scanner or \<5 on the diffusion-weighted imaging (DWI)
* Intracranial hemorrhage on imaging
* Inability of clinical evaluations at 3 months
* extensive lesions of the brain stem (the presence of a complete section of the brainstem hyperintense b1000)
* 0 Refusal to participate in the study
Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells.

PURPOSE: This phase II trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.

OBJECTIVES:

Primary

* Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in preventing relapse at 4 weeks post-treatment in patients with malignant ascites.

Secondary

* Determine any improvement in the quality of life of patients treated with this procedure.

OUTLINE: This is a nonrandomized study.

Patients undergo laparoscopic surgery to remove ascitic fluid and any intraabdominal adhesions and to place 2 inflow and 2 outflow catheters. Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.

Quality of life is assessed at study entry and at 4 weeks.

After completion of study treatment, patients are followed periodically for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or CT scan
* Not eligible for cytoreductive surgery based on any of the following criteria:

  * Metastases outside peritoneal cavity
  * Poor performance status
  * Unresectable peritoneal disease
* Must have undergone at least 1 prior paracentesis procedure
* No ascites caused by any of the following conditions:

  * Cardiac failure
  * Nephrotic syndrome
  * Pancreatic ascites
  * Chylous ascites
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 70,000/mm\^3
* Bilirubin ≤ 2.0 mg/dL
* Creatinine ≤ 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test

Exclusion Criteria:

* Prior peritoneal chemotherapy
* Dense intraabdominal adhesions limiting laparoscopy
Hemopatch Performance Evaluation: A Prospective Observational Registry

To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of any age
* Patients who had undergone open or minimal invasive surgical (MIS) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its IFU in the following organ systems:

  1. Hepato-biliary (liver, pancreas, gallbladder)
  2. General surgery (in thyroid and other regions)
  3. Cardiovascular (heart and vessels)
  4. thoracic (lung and mediastinum)
  5. Urological (kidney, prostate, and bladder
  6. Neurological (dura mater, brain and spinal cord)
* Provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery

Exclusion Criteria:

* Patients with known hypersensitivity to bovine proteins or brilliant blue
* Patients who had intraoperative pulsatile or severe bleeding at the target application site (TAS)
* Patients who had an active infection at the TAS
Reversed TESS Shoulder Artroplasty

Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. The radiologic phenomenom and clinical impact of scapular notching (SN) and arm length difference has been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Operated with a reversed TESS total shoulder arthroplasty at Sundsvall hospital.

Exclusion Criteria:

* Do not give informed consent
* Do not attend follow-up
Benidipine in Hypertensive And/or Chronic Coronary Syndrome Patients

Evaluation of the clinical outcomes of Benidipine initiated by physician's preference in patients with hypertension and/or angina pectoris (chronic coronary syndrome) presenting to cardiology outpatient clinics in Turkey.

* Benidipine is a dihydropyridine calcium channel blocker used in the treatment of hypertension and angina pectoris. There are currently no large-scale observational studies in these patient groups in Turkey.
* There is no record of benidipine in clinicaltrials.gov, which is an important database especially for the registration of drug and interventional studies.
* Therefore, it will be extremely important to include this study in clinicaltrials.gov and to evaluate the clinical efficacy of Bendipine in patients with hypertensive and/or angina pectoris in 7 geographical regions of Turkey.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension and/or angina pectoris on the background of chronic coronary syndrome who have been receiving Benidipine treatment for at least 1 month and will continue to receive Benidipine treatment
* Male or female outpatients, 18-80 years of age
* Patients with mild to moderate essential hypertension who have been receiving or will continue Benidipine treatment for at least 1 month
* Outpatients with clinically stable angina pectoris and patients who have been receiving or will continue Benidipine treatment for at least 1 month
* Those who signed the written informed consent form

Exclusion Criteria:

* Patients with secondary hypertension
* Emergency hypertensive patients
* Having to take other medications during the study that may affect blood pressure
* Allergic to DHP calcium antagonists
* Evidence of decompensated congestive heart failure, unstable angina or severe arrhythmia
* Severe renal or hepatic dysfunction
* Pregnant or lactating women
* Participation in other clinical trials within 3 months prior to this study
* Patients who did not sign the consent form of the study
7-Keto DHEA for the Treatment of PTSD

The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).

The main purpose of the study is to investigate the possible effect of 7-Keto Dehydroepiandrosterone (7-Keto DHEA) on decreasing Post Traumatic Stress Disorder Symptoms (PTSD) in a Veteran population. The study proposes, based on a 2006 report, that the use of the drug will show significant reduction in overall PTSD symptoms, a decrease in physiological stress response and higher patient-reported quality of life compared to placebo. This is a Phase 2, randomized, double-blind, crossover design with a placebo control. The sponsor for this study is Humanetics Corporation

Eligibility Criteria:
Inclusion Criteria:

* Veteran status and enrolled for care in the Veteran Health Administration
* Ages 18-64
* Primary diagnosis of PTSD as assess by the clinician administered PTSD scale and independent clinical mental health evaluation

Exclusion Criteria:

* psychosis
* Dementia
* Active alcohol and/or substance abuse or dependence
* Active suicidal or homicidal ideation
* Medical concerns that would exclude use of 7-Keto DHEA
Closed-loop Control Mean Arterial Pressure In Intensive Care Patients

The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients

In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) \< 72mmHg) during a two hours study protocol in critically ill patients.

The target MAP will be set at 80 mmHg, and the definition of hypotension is a MAP \< 90% of MAP target ( 80 mmHg - 10% = 72 mmHg)

The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.

The investigators will test the system in a short series of 10-12 critically ill patients in the ICU setting during a two hours study protocol.

Participants will receive standard patient care

Fluids will be given as a baseline crystalloid administration set at 1-2 ml/kg/h

Eligibility Criteria:
Inclusion Criteria:

* All patients in the intensive care unit (awake or under sedation)
* Requiring norepinephrine to maintain a MAP of 80 mmHg
* Equiped with an arterial line

Exclusion Criteria:

* Subjects under 18 years of age
* Subject with Atrial Fibrillation
* Subjects who are pregnant
Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.

This study includes three aims:

Aim 1. Evaluate the effectiveness of two different mental health interventions, CBT versus MBT, to improve patient-centered mental health outcomes, quality of life, well-being, and functional impairment among autistic adults with co-occurring anxiety and/or depressive disorders.

Aim 2. Explore patient characteristics (e.g., expressive language ability, intellectual ability, alexithymia, sensory sensitivity) that may moderate the relationship between CBT or MBT and patient outcomes.

Aim 3. Compare implementation outcomes of acceptability and feasibility of CBT relative to MBT as reported by patients and clinicians using mixed methods.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Co-occurring depression and/or anxiety as determined by a total score ≥10 on the PHQ-ADS
* Living in North Carolina or Virginia
* Ability to participate in therapy sessions over telehealth
* English-speaking
* Provide proof of a professional diagnosis of autism OR meet or exceed clinical cut-off on the Social Responsiveness Scale (SRS-2) autism screening instrument

Exclusion Criteria:

* Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
* Imminent risk of suicide