cyrilzakka/clinical-trials huggingface dataset:
Composite Variability Index Versus Bispectral Index (BIS)

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).

Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I and II patients requiring general anesthesia for elective surgical procedures

Exclusion Criteria:

* patient refusal
* weight less than 70% or more than 130% of ideal body weight,
* neurological disorder
* recent use of psycho-active medication, including alcohol.
Bladder Tumor Biopsy Study to Improve Preoperative Determination of Stage and Grade

To assess whether the addition of a bladder tumor biopsy improves the level of agreement between the pretreatment endoscopic impression and the final postoperative pathology determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.

Non-invasive bladder cancer is challenging to treat because it is a condition characterized by frequent recurrences that lead to numerous invasive procedures for detection and treatment. The mainstay of therapy for non-muscle invasive bladder cancer, which has remained unchanged for decades, relies on surgical resection (TUR) associated with utilization of intravesical immunotherapy and chemotherapy. Despite our best efforts, these tumors continue to have suboptimal rates of recurrence and require long-term follow-up with costly and invasive procedures. The rationale for this study is to show that the preoperative biopsy, taken at the time of the office cystoscopic evaluation, improves pre-TUR staging and grading correlation with the final pathology of the resection. Indirectly, this will suggest that the routine use of pre-TUR biopsy provides more accurate information for intraoperative decision-making that can ultimately lead to better management of these patients with non-muscle-invasive bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male or females, age 21 or older;
* Clinical evidence of urothelial carcinoma of the bladder;
* Clinically (endoscopic, by physical examination, and/or axial-imaging) deemed non-muscle-invasive tumor of the bladder (cTis-Ta-T1), of any grade, single or multiple, at initial occurrence or recurrent with \>12 months interval free of disease;
* Surgically eligible for the TUR;
* Patient or authorized proxy needs to have signed the informed consent form.

Exclusion Criteria:

* History of any muscle-invasive or non-organ confined bladder tumors (T2 or higher);
* Patients with sessile appearing bladder tumors, which may be T2 or higher stage;
* Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract;
* Concurrent use of anticoagulation medication or chronic use of NSAIDs, including aspirin (other than cardio protective doses of 80mg daily) that has not been appropriately interrupted before the office cystoscopic evaluation;
* Patient deemed medically or psychologically unfit for the surgical procedure;
* Subject has received any investigational medication within 30 days prior to the registration or is scheduled to receive an investigational drug during the course of the study;

Women Exclusion

* Pregnant or lactating women.
A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus

The purpose of this study is to evaluate the natural history of coronary atherosclerosis development and progression over time by CCTA and to identify risk factors attributable to the development of coronary atherosclerosis in a Korean DM population.

Patients with diabetes mellitus, who underwent initial CCTA (coronary computed tomographic angiography) at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012, will be evaluated for inclusion in the study. All DREAM-CCTA study patients will undergo follow-up CCTA based on order from their primary physician. CCTA and demographic data, medical history, cardiovascular risk factors, and laboratory data was collected in case report forms at the time of the initial CCTA and at the time of follow-up CCTA.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Asymptomatic patients with type 2 DM who had undergone initial CCTA evaluation at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012
* Willing and able to provide informed written consent

Exclusion Criteria:

* Blood test results that the Creatinine level exceeds 1.5 mg/dL
* A person with a history of anaphylaxis or allergic shock associated with a contrast medium
* Pregnant women
* Unable to undergo follow-up CCTA
* Uninterpretable CCTA
In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus

In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine

High-dose cyclophosphamide and sirolimus have been successfully used for the prevention of Graft-versus-host Disease (GVHD) and have shown to enhance the Tregs subpopulation. The addition of low dose IL-2 and a demethylating agent such as azacitidine will also be studied in an attempt to promote and stabilize the FoxP3 expression of Tregs.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a documented clinical diagnosis of grade II-IV acute graft-versus- host disease defined as graft versus host disease (GVHD) occurring within the first 100 days of transplantation
* Patients must be steroid-refractory defines as progression after 3 days of corticosteroid therapy or no response after 5 days of corticosteroid therapy.
* Progression is defined as up-grading
* No response is defined as no down-grading
* Progression after 3 days requires patients to have received at least 2 mg/mg/day for a total of 6 mg/kg of methylprednisolone or its equivalent.
* No response after 5 days requires patient to have received at least 2 mg/kg/d for a total of 10 mg/kg of methylprednisolone or its equivalent.
* Patients with exacerbation of GVHD during steroid taper will require re-treatment with 2mg/kg/d of corticosteroids and will need to meet the criteria
* Age 18-70
* Patients must have received an allogeneic hematopoietic stem cell transplant within 100 days of study enrollment.
* Serum creatinine \< 2 mg/dL

Exclusion Criteria:

* Patients cannot have active central nervous system (CNS) disease.
* Patients must not have received cyclophosphamide for GVHD prophylaxis
* Patients must not have pneumonia requiring oxygen supplementation
* Unable or unwilling to sign informed consent.
Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia

The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.


Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory chronic lymphocytic leukemia.
2. Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
3. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
4. No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
5. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
6. Expected remaining life span \> or = three months.
7. ECOG performance status 0 - 2.
8. 18 years or of legal age.
9. Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
10. Negative serum pregnancy test, if fertile female.
11. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

1. Evidence of CNS involvement.
2. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
3. Previous therapy with Campath.
4. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
5. Concurrent immunotherapy.
6. Concurrent use of steroids.
7. Use of an investigational medication or device within 1 month of initiating study therapy.
8. Patients who have had allogeneic bone marrow transplantation.
9. Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
10. AST or ALT \> 2.5 times the upper limit of normal.
11. Any condition or any medication which may interfere with the conduct of the study.
Ventilator Settings on Patients With Acute Brain Injury

The present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema.

The primary goal is to carry out baseline measurements to enable conclusions concerning the safety of lung protective ventilator settings before extending the study to patients with more severe brain and/or lung injury in the future.

The primary objective is to investigate if lung protective ventilator settings (higher Positive end-expiratory pressure and lower tidal volume) as compared with conventional settings.

1. increase intracranial pressure
2. diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index, ie pressure reactivity index will turn positive, which means that it will change the state from intact to impaired autoregulation.

The secondary objective is an exploratory analysis of the relationship between ventilator settings and other well defined respiratory, cerebral, and cardiovascular variables, including transpulmonary pressure.

Eligibility Criteria:
Inclusion Criteria:

* • Any tracheally intubated or tracheotomized adult patient with ABI with GCS\< 9 on controlled ventilation requiring continuous ICP measurement.
* Proxy informed consent from relatives.

Exclusion Criteria:

* • ICP \> 22 mmHg before treatment of high ICP
* Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (PaO2/FiO2) ratio \< 40 kPa and Xray pathology
* History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.
* Body mass index (BMI) \> 35.
* Known right or biventricular cardiac failure with cardiac index \< 2,5 L/min/m2 or ejection fracture \< 40 %.
* Refractory hypovolemia as diagnosed with pulse pressure variation \> 12 % with tidal volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg rise test with \> 10 % increase in stroke volume measured by VTI echocardiography or PICCO.
* Medulla lesion that affect the autonomic nervous system.
* Patients who has undergone decompressive craniectomy.
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib plus Vinorelbine versus Lapatinib plus Capecitabine in patients with previously treated HER2-positive metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
* Patients were previously treated with trastuzumab in the advanced setting and a taxane in any setting.
* Patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from Jun 2015 to Jan 2021.
* Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

Exclusion Criteria:

* Incomplete medical history
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.

After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Male or non-pregnant female; aged from 18 to 80 years old.
* Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria:

* Any contraindication against the use of ticagrelor.
* On treatment with a P2Y12 receptor antagonist in past 30 days.
* Known allergies to aspirin or ticagrelor.
* On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
* Known blood dyscrasia or bleeding diathesis.
* ST-segment elevation acute myocardial infarction.
* Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
* Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.
Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy

This study is a comparison of multifocal electroretinogram assessment between the laser treatment group and the photodynamic therapy group in chronic central serous chorioretinopathy.

1. Laser Group: extrafoveal focal leakage on FAG
2. PDT Group: no definite focal leak on FAG subfoveal or juxtafoveal focal leakage on FAG, or serous retinal pigmentary epithelial detachment involving foveal center

Inclusion criteria

1. Chronic serous chorioretinopathy (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and OCT
2. Ability to maintain steady fixation for mfERG
3. Presence of abnormal dilated choroidal vasculature in ICGA
4. Symptom duration over 3 months

Exclusion criteria

1. previous PDT or laser treatment history
2. evidence of Choriinal neovascularization in FAG
3. other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies

follow-up Visit

1)baseline 2)1month 3)3months 4)6 months

each visit: multifocal electroretinogram, visual acuity, optical coference timography should be measured.

Eligibility Criteria:
Inclusion Criteria:

1. CSC (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and OCT
2. Ability to maintain steady fixation for mfERG
3. Presence of abnormal dilated choroidal vasculature in ICGA
4. Symptom duration over 3 months

Exclusion Criteria:

1. Previous PDT or laser treatment history
2. Evidence of CNV in FAG
3. Other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies
Cerebral Oxygenation and Awareness During VT Ablation

It is aimed to examine the effect of the decrease in blood pressure that occurs during the ventricular tachycardia ablation process on cerebral oxygenation and awareness.

Patient's age, cardiac measurements (ejection fraction-EF), basal vital values, procedure time (especially activation and pacing mapping), and localization of the arrhythmia, may affect the NIRS and BIS response to blood pressure drop. In addition to the effects of patients' demographic information, cardiac capacity and procedure time on NIRS and BIS values (downtrend and duration), correlations of these values with other monitoring parameters (ETCO2 and SpO2) intended to be displayed.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Patients who will undergo VT ablation
* Patients who want to participate in the study

Exclusion Criteria:

* Patients whose baseline values could not be obtained before induction
* Patients with severe neurological or psychiatric illness
* Patients who do not want to participate in the study
To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy

The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.

The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group.

The investigators compare these two group for outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. The age at the time of consent acquisition is 20 years old or over.
2. OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
3. lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
4. Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
5. Document consent has been obtained from the subject person to this research.

Exclusion Criteria:

1. Patients who have received treatment with PCSK 9 inhibitor in the past
2. Patients whose treatment was interrupted before follow-up catheterization during the observation period
3. Patients underwent LDL apheresis.
4. In the case that the researchers judges it as inappropriate as the object of this research.
A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Participants With Transfusion-Dependent β-Thalassemia

This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 18 participants less than or equal to (\<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), who have a β0/β0, β0/IVS-I-110, or IVS-I-110/IVS-I-110 genotype. The study will evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product.


Eligibility Criteria:
Inclusion Criteria:

• Participants less than or equal to (\<=) 50 years of age at the time of consent or assent (as applicable), and able to provide written consent (adults, or legal guardians, as applicable) or assent (adolescents or children). Provided that the data monitoring committee (DMC) has approved enrolling participants younger than 5 years of age, participants younger than 5 years of age may be enrolled if they weigh a minimum of 6 kilograms (kg) and are reasonably anticipated to be able to provide at least the minimum number of cells required to initiate the manufacturing process.

* Diagnosis of TDT with a history of at least 100 milliliter per kilogram per year (mL/kg/year) of pRBCs in the 2 years preceding enrollment (all participants), or be managed under standard thalassemia guidelines with \>= 8 transfusions of pRBCs per year in the 2 years preceding enrollment (participants \>=12 years).
* Clinically stable and eligible to undergo HSCT.
* Treated and followed for at least the past 2 years in a specialized center that maintained detailed medical records, including transfusion history.

Exclusion Criteria:

* Presence of a mutation characterized as other then β0 (e.g., β+, βE, βC) on at least one β-globin gene (HBB) allele.
* Positive for presence of human immunodeficiency virus type 1 or 2 (HIV-1 and HIV-2), hepatitis B virus (HBV), or hepatitis C (HCV).
* A white blood cell (WBC) count less than (\<) 3×10\^9/liter (L), and/or platelet count \<100×10\^9/L not related to hypersplenism.
* Uncorrected bleeding disorder.
* Any prior or current malignancy.
* Prior HSCT.
* Advanced liver disease.
* A cardiac T2\* \<10 ms by MRI.
* Any other evidence of severe iron overload that, in the investigator's opinion, warrants exclusion.
* Participation in another clinical study with an investigational drug within 30 days of Screening.
* Any other condition that would render the participant ineligible for HSCT, as determined by the attending transplant physician or investigator.
* Prior receipt of gene therapy.
* Pregnancy or breastfeeding in a postpartum female or absence of adequate contraception for fertile participant.
* A known and available human leukocyte antigen (HLA) matched family donor.
* Any contraindications to the use of granulocyte colony stimulating factor (G-CSF) and plerixafor during the mobilization of hematopoietic stem cells and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients.