cyrilzakka/clinical-trials huggingface dataset:
All Eyes on PCS - Analysis of the Retinal Microvasculature in Patients With Post-COVID-19 Syndrome

The goal of this observational, prospective study is to in depth analyze the retinal microvasculature in patients with Post-COVID-19 Syndrome (PCS). The main questions it aims to answer is:

Do patients with PCS show a prolonged endothelial dysfunction when compared with fully COVID-19 recovered participants? Does symptom severity in PCS patients correlate with the extend of endothelial dysfunction? Do these changes correlate with improvement in symptoms in the prospective observation?

The investigators will recruit patients with PCS, fully COVID-19 recovered participants and COVID-19 infection naïve participants. After comprehensive clarification and given written informed consent, measurements will take place in the Klinikum rechts der Isar. To evaluate the retinal microvasculature dynamic retinal vessel analysis (DVA) and optical coherence tomography (OCT) are used. Patient reported outcomes (PROM) of PCS typical symptoms will be collected using standardized questionnaires. To ensure data quality the investigators will use standard operating procedures (SOP) for both technical measurements and data collection. For DVA measurements all examiners will be trained by a single experienced supervisor and must reach high image accuracy and quality in at least 10 volunteers. Examiners are only involved in data acquisition.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Post-COVID syndrome (positive PCR or positive rapid antibody test ≥3 months) with a currently existing, PCS-typical complaint complex, ongoing for at least 2 months and cannot be explained by an alternative diagnosis.
* Control group: recovered from COVID-19 infection (positive PCR or positive rapid antibody test ≥ 3 months) without residual symptoms.
* Healthy cohort: no history of COVID-19 infection

Exclusion Criteria:

* Missing or incomplete consent form
* Age \< 18 years
* Pregnancy
* Malignancy
* Diseases associated with a significant change in life expectancy
* Autoimmune diseases of the rheumatological type
* Cataract
* Epilepsy
* Glaucoma
PET/MRI in PAH Patients

Aim of the study is to compare novel parameters of right ventricle (RV) function from right heart catheterization (RHC) and magnetic resonance imaging (MRI) with PET-derived RV FDG uptake.

Objectives In pilot study investigators aimed to compare novel parameters of right ventricle (RV) function from right heart catheterization (RHC) and magnetic resonance imaging (MRI) with PET-derived RV FDG uptake.

Background Right ventricular (RV) function is a major determinant of survival in patients with pulmonary arterial hypertension (PAH). Hemodynamic parameters like end-systolic elastance (Ees), arterial elastance (Ea), pulmonary arterial compliance (PAC) and Ees/Ea ratio have been shown to reflect RV function and prognosis in PAH. Increased RV 18F-fluoro-2-deoxyglucose (FDG) uptake in positron emission tomography (PET) was recently associated with progressive RV dysfunction in these patients.

Methods Twenty-five stable PAH patients (49.92±15.94 years) and twelve healthy subjects (control group, 44.75±13.51 years) had simultaneous PET and MRI scans performed. FDG was used as a tracer and its uptake was presented as a standardized uptake value (SUV) for both left (LV) and right ventricle.

Eligibility Criteria:
Inclusion Criteria:

- PAH

Exclusion Criteria:

The exclusion criteria were the following: patients in IV WHO class, Eisenmenger physiology, PAH associated with prevalent systemic-to-pulmonary shunts due to moderate to large defects (according to European guidelines) \[16\], group II, III, IV, V of pulmonary hypertension, diabetes mellitus and contraindications to cardiac MRI.
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Lugol's solution staining was regarded as a gold standard to detect early superficial lesion during esophageal cancer screening using endoscopy. However, the sensitivity and specificity were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was previously shown to improve the visibility of gastrointestinal tract. It's unknown if the pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A randomized double-blind clinical trial was designed to investigate whether or not pronase might improve detection rate of early esophageal lesion, especially high grade dysplasia and early cancer by improving the esophageal visibility.


Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years to 75 years old
* Patients less than 60 years old, but with one or multiple high risk factors for esophageal cancer including smoking and drinking addiction,family history of esophageal cancer, personal history of esophageal or head and neck malignancies, previous endoscopy documenting iodine void superficial lesion.

Exclusion Criteria:

* Allergy to iodine or any other medicine which used in this trial.
* Previous endoscopy revealing advanced esophageal cancer or other non-superficial lesions.
* Conditions interfering visibility of endoscope including gastrointestinal obstruction and upper gastrointestinal bleeding.
* Anatomic variation by surgery.
* Pregnancy
* Other conditions which investigator consider the patient at high risk for complications.
Underprescribing in Geriatric Patients: a Prevalence Study and Analysis of Factors Contributing to Potential Prescription Omissions (Under-PRES)

This observational study will determine the prevalence of underprescription in a cohort of elderly patients, recruited at the time of an outpatient geriatric visit, or hospitalized, upon admission to a geriatric ward.

Polypharmacy in older patients is associated with both inappropriate drug prescribing and underprescription or omission of appropriate medications. Potential prescriptive omission (PPO), defined as the underprescription of potentially beneficial drugs, is increasing across all care settings and is associated with adverse clinical outcomes. However, in some cases, PPO may represent a legitimate medical decision.

The aim of this study is to investigate the phenomenon of underprescription by differentiating between justified and inappropriate potential prescriptive omissions (PPOs) in elderly patients in both hospital and outpatient settings, using the Screening Tool to Alert to Right Treatment (START) criteria, version 3.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric ward admission or outpatient geriatric appointment
* Capacity to provide informed consent by the patient or legal guardian

Exclusion Criteria:

* Limited life expectancy as measured by the Clinical Frailty Scale (CFS) \>8
Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers

The purpose of this study is to id

transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .


Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
3. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
4. TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;
5. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；

7. Has repeated measurable intrahepatic lesions according to RECIST v1.1;

Exclusion Criteria:

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
3. Missing follow-up data;
Characteristics of Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection (COVID-19)

A multicenter observational, prospective cohort study that consisted of a large-scale data source of hospital ICU admissions and patient-level clinical data in Spain.

The main objective is to develop a national database belonging to SEMICYUC (Spanish Society of Critical Care) to describe epidemiological and clinical characteristics and risk factors related to ICU mortality in critically ill patients admitted to ICU due to severe COVID-19 in Spain.

Design: A multicenter observational, prospective cohort study

Setting: Intensive Care Units

Subjects: Adult Critical patients admitted to ICU with severe community-acquired pneumonia due to confirmed SARS CoV-2 infection (COVID-19).

Data Collection and Validation Data was obtained from a voluntary registry created by Spanish Society of Intensive Care Medicine-SEMICYUC. All consecutive cases admitted to the ICU were collected.

There were no patients excluded from the analysis that was enrolled to participating ICU and met criteria.

Data were collected using a paper CRF (case Report Form). CRF collect and record all protocol-required information, which is transcribed from patient source documents, such as hospital records and laboratory reports during the patient's participation in the study. Before being sent to the National Study Coordinator (AR) this data was de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. We implemented a double data entry model for potential errors in real-time. Data was entered twice by two different Data Entry personnel based on the same set of data collected in the paper CRFs. All data were reviewed, and values that appeared incongruent or out of range were manually validated by confirming the accuracy of the data with the Study Coordinator (AR). The database was validated and cleaned before the statistical analysis and the study database was locked to prevent any further changes, and to ensure data consistency and integrity for the statistical reporting and analysis.

Sample size calculation:

No statistical sample size calculation was performed a priori, and sample size was equal to the number of patients admitted to the participant's ICUs with confirmed COVID-19 during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Severe community-acquired pneumonia due SARS CoV-2 infection and acute respiratory failure with microbiological confirmation (RT-PCR) according international guidelines
2. Age \>= 16 years without upper limit

Exclusion Criteria:

1. Age \< 16 years
2. Patients with SARS-CoV-2 infection without acute respiratory failure
Training of Eye Movements in Glaucoma

The aim of the trial is to investigate the possibilities of improving visual impairments with eye training exercises (eye-yoga) in a total of 40 patients with glaucoma who have not previously been treated within a similar training program. 20 patients will be instructed how to do eye yoga to be performed dails for 4 weeks (max 30 min/day). As a control group of 20 patients will be instructed to read for 30 min/day for 4 weeks.

The following outcome measures will be investigated: High Resolution Perimetry, Humphrey Perimetry, Visual Acuity Test, Contrast Sensitivity Test, Microsaccades measurements, Intraocular Pressure Measurement, Electroencephalogram (EEG), Blood Pressure and Pulse Measurement and Dynamic Vessel Analysis (DVA - the blood supply in the eye (especially vascular dysregulation) .

Furthermore, factors that could influence response variability and the effectiveness of treatment will be analysed: (i) the role of mental stress (or stress resilience) and (ii) the influence of personality traits and quality of life.

The study is intended to further validate this home training program (eye yoga) for the treatment of visual impairment in glaucoma.

The aim of eye yoga is to improve microsaccade impairments in patient with primary open angle glaucoma. We will study how this affects visual performance and the physiology of the eye and brain

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of glaucoma
* residual vision
* the duration of the disease must be at least 6 months old
* the visual field defect must be stable

Exclusion Criteria:

* autoimmune diseases in the acute stage
* neurological and mental diseases
* diabetic retinopathy
* addictions
* hypertension (maximum 160/100 mmHg)
* retinitis pigmentosa-
* pathological nystagmus
* non-distant tumors or recurrent tumors
* photosensitivity
* pregnancy
Biomarkers in the Diagnosis of Acute Compartment Syndrome

This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.

Patients with a tibial fracture are included. P-myoglobin and P-creatine phosphokinase are analysed at 6-hourly intervals pre- and if applicable, postoperatively after surgical fixation or fasciotomy. Also, blood samples will be collected in 6 hourly intervals if acute compartment syndrome is suspected. An expert panel of senior orthopaedic surgeons will retrospectively assess study data and classify patients who had undergone fasciotomy into those with and without acute compartment syndrome.

Blood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.

Eligibility Criteria:
Tibial fracture group

Inclusion Criteria:

- Traumatic tibial fracture

Exclusion Criteria:

* Malignancy
* Acute myocardial infarction
* Kidney failure (GFR ≤35 ml/min)
* Muscle disease
* Paraplegia/tetraplegia

Non-fracture group

Inclusion Criteria:

- Suspected acute compartment syndrome

Exclusion Criteria:

* Malignancy
* Acute myocardial infarction
* Kidney failure (GFR ≤35 ml/min)
* Muscle disease
* Paraplegia/tetraplegia
* Associated fracture
* Acute vascular event
Different Doses of ZED1227 vs. Placebo in NAFLD

This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Has provided signed informed consent
* Is a male or female ≥ 18 and \< 75 years of age
* Has diagnosed NAFLD
* Has diagnosed significant fibrosis (stages 2 or 3)

Exclusion Criteria:

* Has a history of significant alcohol consumption (an average of \> 20 g/d in females and \> 30 g/d in males)
* Has a history or presence of any other significant concomitant liver diseases
* Has diagnosed type 1 diabetes mellitus (T1DM)
* Has presence of cirrhosis
Evaluation of the Safety and Efficacy of the DeScribe™ Patch

This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session.

This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session. One half of the tattoo will be randomly assigned laser treatment utilizing the Device (the "Device half"); the other half will receive laser treatment without the Device and serve as the control (the "Control half"). Based on statistical analysis sample size calculations, 30 subjects will be enrolled. The tattoo must be no larger than approximately 2 ½" x 6" or 3" x 5" in size, such that ½ of the tattoo can be covered with a single patch. Each subject will receive a single Treatment Session consisting of 5 minutes. Investigators will administer the standard laser treatment to both the Device and Control sites using well-established tattoo-removal treatment parameters for the laser used. Subjects will return for follow up approximately one month post-treatment. The presence of side effects and adverse events will be assessed and recorded for both Device and Control sites immediately after treatment and at the 1-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects presenting with tattoos approximately 2 ½" x 6" or 3" x 5" or smaller in size.
* Fitzpatrick skin type I - III
* Women of childbearing potential using an accepted form of contraception at least 3 months prior to enrollment and during the study period (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence)
* Subjects who provide written informed consent
* Subjects who agree to all treatment guidelines and follow-up visits

Exclusion Criteria:

* Subjects younger than 18 years of age
* Subjects with traumatic tattoos
* As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in the study
* Subjects who are pregnant or breastfeeding
* Subjects who are tan
* As per the investigator's discretion, subjects with a history of keloid scarring or abnormal wound healing
* Subjects who have used oral retinoids (isotretinoin or acitretin) within 12 months of study entry
* Subjects currently participating or planning to participate in any other clinical trial specifically designed to treat tattoos during the course of this study and for the duration of their participation in the study
* Subjects who refuse to sign this informed consent form and/or refuse to comply with all study requirements.
Chemotherapy in Treating Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic Ewing's sarcoma or primitive neuroectodermal tumor.

OBJECTIVES:

* Determine the activity of cisplatin and etoposide in terms of response of patients with metastatic Ewing's sarcoma or primitive neuroectodermal tumor.
* Assess the bone marrow and kidney toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 3 hours on days 1, 8, 15, 29, 36, and 43 and oral etoposide daily on days 1-15 and 29-43 in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed Ewing's family tumor as characterized by the following:

  * Positive MIC2 on immunohistochemistry OR
  * Evidence of a chromosomal translocation involving the EWS gene by conventional cytogenetics

    * t(11; 22) translocation or variant OR
    * Demonstration of EWS/FLI1 or EWS/ERG gene fusion by PCR or FISH
* Metastases outside the lung or pleura
* At least 1 measurable lesion outside of previously irradiated area
* No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 15 to 65

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm3
* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin less than 3 mg/dL
* Albumin greater than 2.5 g/dL

Renal:

* Creatinine less than 1.2 mg/dL
* Creatinine clearance greater than 70 mL/min

Cardiovascular:

* No history of uncontrolled cardiovascular disease

Other:

* No other severe medical illness, including psychosis
* No other prior primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* Not specified
Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows

To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 80 years of age;
2. Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI \<31ml or with a NIHSS ≥20 and 31ml\<Volume of infarction\<51ml(DWI);
3. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;
4. Endovascular Therapy in 6-24 hours of stroke onset;
5. The availability of informed consent.

Exclusion Criteria:

1. First ever stroke or mRS≤1 after previous disease;
2. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia
4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
5. Severe cardiac or pulmonary disease;
6. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
7. Pregnancy, plan to get pregnant or during lactation;
8. Patients with contraindication or allergic to any ingredient of drugs in our study;
9. Unsuitable for this clinical studies assessed by researcher
Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.

The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.

Moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.

Eligibility Criteria:
Inclusion Criteria:

* Dutch or English speaking adults
* 18 years or older ASA I-III physical class
* Scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria:

* History of allergy to a local anesthetic
* Baseline neurological deficit
* Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
* Recent history (\< 3 months) of drug or alcohol abuse
* Concomitant opioid therapy
* Preexisting coagulation disorder
* Infection at the injection site
* Pregnancy
Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn

The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.

We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are \>35 gestational week.

Eligibility Criteria:
Inclusion Criteria:

* \>35 gestational week
* wetlung

Exclusion Criteria:

* major congenital anomalies