cyrilzakka/clinical-trials huggingface dataset:
Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With CFA Disease

To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for coronary and endovascular interventions. An institutional procedural database, based on electronic medical record information will be abstracted to collect this information.

The overall objective of the study will be to examine the safety and efficacy of the VASCADE closure device compared to manual compression (standard of care) to achieve hemostasis after endovascular procedures requiring access within a severely diseased CFA.

This study will be a retrospective single center review of 200 patients undergoing endovascular procedures utilizing vascular access within a severely diseased CFA between 2018 and 2020 at Yale New Haven Hospital. A random selection of patients undergoing hemostasis with manual compression (n = 100) and VASCADE vascular closure system (n = 100) will be conducted. The two groups will then be statistically compared with respect to 48-hour and 30-day safety and efficacy outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. 5, 6 or 7 Fr access within the CFA
2. ACT \< 300 seconds
3. Age 18 - 90 years old
4. Severe common femoral arterial disease Percent stenosis \> 50, which will be core-lab adjudicated

Exclusion Criteria:

1. Ipsilateral CFA access within 30 days preceding or subsequent to the index case
2. Prior ipsilateral closure device use, other than VASCADE
3. High bleeding risk ACT \> 300 or \> 250 with IIb/IIIa inhibitor Plt \< 50K INR \> 1.7 on the day of procedure Inherent coagulopathy NOAC, warfarin, or lovenox administered within 24 hours of the procedure
4. Suspected intraluminal thrombus, dissection, pseudoaneurysm, hematoma, or AV Fistula
The Relationship Between Cognitive Status and Exercise Capacity, Fatigue Perception in Coronary Artery Patients

The study aimed to examine the relationship between cognitive status, exercise capacity, and fatigue perception in coronary artery disease patients.

Exercise training for patients with coronary artery disease is an essential element of multicomponent cardiac rehabilitation. For the successful implementation of exercise-based cardiac rehabilitation programs, adequate cognitive function (e.g. executive function, selective attention, memory) is an important prerequisite. In patients with atherosclerotic coronary artery disease, the presence of coronary microvascular dysfunction as determined by low coronary flow reserve is associated with abnormal cerebral flow hemodynamics and mild but significant impairment in cognitive function. In the literature, there is no study examining the relationship between cognitive level and fatigue perception.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being diagnosed with coronary artery disease
* To cooperate with the tests to be performed
* Signing a consent form

Exclusion Criteria:

* Presence of neurological disease that may affect cognitive status
* Presence of clinically unstable cardiac disease
* Left ventricular ejection fraction \<30%
* Being diagnosed with end-stage renal failure
* Diagnosed with active myocarditis or pericarditis
* Being diagnosed with rhythm disorder
* Having amputation, peripheral arterial disease, musculoskeletal and/or neurological diseases that will prevent participation in functional capacity tests
* Not volunteering to participate in the study
Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedures

The occurrence of postoperative cognitive dysfunction (POCD) might be related to intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated with head rotation, elevation, flexion or extention that may affect blood brain inflow and outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in extreme head position with the development of cerebral ischemia or functional changes of brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt correction could modify the occurence of POCD after these procedures.

Standardized anesthesia and perioperative care will be provided to all patiens with positioning for neurosurgical or spinal procedures, where the head is elevated, extended. flected or rotated. In group A before the start of general anesthesia, the baseline level of cerebral tissue oxygenation (rScO2) will be measured using the near-infrared spectroscopy NIRS (Invivo Medtronic) . Continuous measurement of rScO2 will be used for detection of cerebral tissue desaturation. Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimalisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration. In group B neither measurement of rScO2 nor interventions are provided. Cognitive dysfunction will be assessed by Adenbrooke test before operation and on the fifth postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale 15, American Society of Anaesthesiologists (ASA) Physical Status Classification System Grade I-III, patient positioning with elevation, rotation, flexion or extention of head

Exclusion Criteria:

* Inability to past the Addenbrooke test, postoperative ventilation, awake phase during surgery, lung disease with retention of carbon dioxide, neurological disease before surgery (aphasia, paresis, blindness, deafness)
Prevention of Surgical Wound Infection

To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery

It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.

Eligibility Criteria:
Inclusion Criteria:

* patient scheduled to cardiac surgery.
* signed informed consent form

Exclusion Criteria:

* hypersensibility to dressings
Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT

Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).

Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon alpha-2b (Peg Intron®; Schering-Plough) 1\~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments.

Eligible patients were age 14 to 60 years with molecular, hematological or radiography relapsed hematological malignancies post allogeneic hematopoietic stem cell transplantation.

Molecular relapse was defined as reappearance or 1 log increase of molecular markers or decreasing donor chimerism by more than 5%; Hematological relapse was defined as reappearance of blast in bone marrow smear by more than 5%; radiography relapse was defined as enlargement of lymph nodes by more than 25% or infiltration of tumor cells in other sites.

Patients were excluded if they need immunosuppressant treatment for ongoing grade II～IV acute GVHD or moderate to severe chronic GVHD.

Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1\~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments. Patients were followed up every week. Physical exams and blood tests including complete blood count (CBC), chemical were performed every week. Disease status evaluation was performed every month.

Number of subjects: 50 Single center, one group, prospective.

Eligibility Criteria:
Inclusion Criteria:

1. Age 14-60 years, male or female
2. Allo-HSCT recipients with malignant hematological diseases
3. Disease relapse after allo-HSCT, including hematological relapse, molecular relapse
4. Able to provide written informed consent and to comply with all study procedures

Exclusion Criteria:

1. Pregnant or nursing woman
2. Cardiac ejection factor \< normal lower limit
3. Active acute or chronic GVHD with immunosuppressant treatment
4. Known hypersensitivity or allergy to interferon
5. Patient might develop serious complications according to investigator's experiences
6. Patient is undergoing other experimental medication
Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

The primary aim of this study is

- to explore the usefulness of abdominal compression on intubation.

Other aims include

1. to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure
2. to get the knowledge of the formation of colon loops and its frequency
3. to clarify the impact of intubation with loops on adenoma detection rate


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment

Exclusion Criteria:

* Pregnant female patients
* Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
* Patients who had previous abdominal surgery
* Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
* Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
* Patients who have inadequate bowel preparation
* Patients who reject to participate in this study
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
* No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
* Tissue or Programmed death-ligand 1 (PD-L1) results available

Cohort 1A Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score 2 or
* Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol

Cohort C Inclusion Criteria:

* High Tumor Mutation Burden

Exclusion Criteria:

* Untreated brain metastases
* An active malignancy that requires concurrent intervention
* Active, known or suspected autoimmune disease
* Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

Other protocol-defined inclusion/exclusion criteria apply
The Association of Resistance Exercise With the Inflammasome Activation in Obesity Subjects

The intervention study consist in 3 months of follow up to evaluate the effect of resistance exercise on NLRP3 and interleukin-18 (IL-18) gene expression, and IL-18 and IL-1b cytokines levels in obese subjects, due to, the current evidence has been suggested that aerobic physical exercise could reduce the low-grade chronic inflammation through the downregulation of the NLRP3 inflammasome in obesity subjects, however, there are not enough evidence with resistance protocol. The investigator randomized into two intervention groups: a) group with resistance exercise training plus hypocaloric diet, and b) group with hypocaloric diet. The blood sample was taken fasting at baseline and final intervention (3rd month). The serum was separated for biochemical analyzes and the quantification of cytokines levels. The RNA was obtained from leukocytes to expression assay.

Obesity is a metabolic condition with a high worldwide prevalence. It is characterized by low-grade chronic inflammation and high cytokines level as consequence of the excessive accumulation of adipose tissue. The NLRP3 protein is part of the NLRP3 inflammasome, a multiprotein complex related to inflammation and the risk of developing metabolic disorders. In this sense, the evidence has been suggested that physical exercise could reduce the inflammation through the downregulation of the NLRP3 inflammasome. The aim of this study is evaluate the effect of resistance exercise on NLRP3 and IL-18 gene expression and and IL-18 and IL-1b cytokines levels in obese subjects. This is an experimental study with 3 months of follow up. Participants were randomized into two intervention groups: a) group with resistance exercise plus hypocaloric diet, and b) group with hypocaloric diet. The exercise program was design by certified personal trained, and consisted in 3 phases: conditioning, development and maintenance. Dietary information was collect by validated retrospective questionnaires (24-hour record and 3-days dietary diary) and analyzed in Nutritionist Pro software. Body composition was evaluated by bioimpedance. The biochemical analyzes were performed on serum sample using spectrophotometry equipment. RNA was obtained from leukocytes from peripheral blood, cDNA synthesis was performed with a ThermoFisher kit, and the expression assay was performed by real-time polymerase chain reaction (PCR) using Taqman probes with the 2-ΔΔcq relative quantification method. Cytokines quantification were perform using a commercial ELISA kit. Statistical analysis will be using the Statistical Package for Social Sciences (SPSS v.25) software and a value of p\<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Both sex
* Older than 25 years old
* Women with waist circumference ≥ 80cm and men with ≥ 90cm
* Subjects with BMI between 30 and 40 kg/m2

Exclusion Criteria:

* Subjects with diagnosis of metabolic alterations
* Subjects with chronic pharmacological treatment
* Subjects with anti-inflammatories drugs prescription
Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer

If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.


Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patient \> 18 years.
* Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with ≤ 10% ER expression by immunohistochemistry (IHC) analysis.
* Patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (ER, protein/gene expression analysis).
* Patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. Planned procedure may include lumpectomy or mastectomy as clinically indicated.
* Patients must have an ECOG Performance Status of 0 - 1.
* Patients must have the ability to understand and willingness to sign an English or a Spanish language written informed consent document.

Exclusion Criteria:

* Male breast cancer patient.
* Patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. Patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
* Patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
* Patients should not have known or strongly suspected BRCA mutation by history (genetic testing not required).
* Patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. Patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.
PENG-block Versus FIB-block in Emergency Room

The trial aims to verify a possible greater analgesic efficacy of PENG (Pericapsular Nerve Group) block compared to iliac fascia block (FIB block) in elderly patients (age \> 65 years) suffering from traumatic fracture of proximal femur in emergency room.

Prospective randomized double-blind single-center preliminary study aimed to demonstrate a possible greater analgesic efficacy of the PENG block compared to the iliac fascia block (FIB block) in elderly patients (age \> 65 years) suffering from traumatic fracture of the proximal femur in emergency room.

The study will cover patients aged \> 65 years suffering from a proximal traumatic fracture of the femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Roma 1).

Eligibility Criteria:
Inclusion Criteria:

* all patients \> 65 years suffering from a proximal traumatic fracture of a femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Rome 1), for whom surgical treatment of osteosynthesis is recommended within 48 hours in accordance with the guidelines of Regional Health System (Regione Lazio).

Exclusion Criteria:

* Failure to acquire written and valid informed consent
* ASA \> 3
* Obesity (BMI\> 35 kg / m2)
* Contraindications to performing regional anesthesia (severe coagulopathies and / or thrombocytopenia, septic state and / or infections at the block site, allergy to local anesthetics)
* Patients on therapy with antiplatelet agents, anticoagulants or who regularly use opioids, NSAIDs, acetaminophen for chronic painful conditions;
* History of alcohol or drug abuse;
* Severe kidney or liver failure;
* Cognitive alterations, dementia, psychiatric pathologies
Antiproteinuric Effect of Valsartan and Lisinopril

Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up.

Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients.

Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies.

Design: Multicentric, randomized, double blind, parallel group, active controlled.

Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20


Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients aged 18-70 years,
2. Chronic nephropathy, as defined by a serum creatinine concentration of \> 3 mg/dL or calculated glomerular filtration rate of \> 30 mL/min/1.73 m2.
3. Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).
4. Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: \<125/75 mmHg).
5. Written informed consent to participate in the study prior to any study procedures.

Exclusion Criteria

* Immediate need for renal replacement therapy.
* Treatment resistant oedema.
* Need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs.
* Proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/L.
* Renovascular hypertension
* Malignant hypertension
* MI, cerebrovascular accident within last year, severe peripheral vascular disease, CHF, chronic hepatic disease.
* Angiotensin converting enzyme inhibitors and angiotensin II receptors blockers within one month prior to randomization.
* A serum creatinine concentration \>265 ümol/L

Other protocol-defined exclusion criteria may apply.
Concentration of Ertapenem in Colorectal Tissue

The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.

The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.
* Patients with benignant disorders (e.g. colonic diverticulosis) will be preferred.

Exclusion Criteria:

* Pregnancy or lactation in women
* Emergency surgery, history of serious allergy or intolerance to β-lactam antibiotics and other carbapenems
* Systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry
* Ongoing intraabdominal infections
* Terminal illness
* Chronic immunosuppressive therapy
* Severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST \> 6 x upper limit of normal (ULN) and bilirubin \> 3 x ULN, severe renal insufficiency with a creatinine clearance ≤30 mL/min., neutrophil count \< 1000 cells/mm3, platelets \< 75000 cells/mm3 and coagulation studies (INR) \> 1.5 x ULN, ongoing therapy with valproin acid.
Daridorexant to Prevent Delirium After Heart Surgery

The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.

Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Having surgical aortic valve replacement or coronary artery bypass graft surgery at Strong Memorial Hospital
* Can provide informed consent
* Able to speak, read, and write English
* Family member or close friend available for collateral

Exclusion Criteria:

* Prior heart surgery
* Infectious endocarditis
* Emergency surgery
* Delirium at baseline
* Auditory/visual impairment preventing study procedures
* Active alcohol or substance misuse
* Psychotic disorder
* Dementia-level deficits
* Use of a sleep aid before surgery
* Use of a strong 3A4 inhibitor
* Intolerance to daridorexant
* Severe kidney or liver impairment
* Narcolepsy
* Any condition that, in the opinion of the PI, compromises patient safety or data quality if enrolled in the study