cyrilzakka/clinical-trials huggingface dataset:
Airflow Perturbation Device (APD) for the Evaluation of Pulmonary and Sleep Disorders

In a prospective, observational study the investigators compared resistance values measured using the airway perturbation device (APD) to impulse oscillometry and spirometry. The investigators also created reference equations for normal APD resistance ranges using the data from clinically normal volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects \> 18 years
* Referred for PFTs and/or PSG at WRNMMC
* All races and ethnicities will be included
* Pregnant women will be included

Exclusion Criteria:

* \< 18 years of age
* If mental status is questionable, the patient will be excluded at the discretion of the consenting provider
* Unable/unwilling to follow the directions necessary for APD use
Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease (COPD) leads to a reduction in exercise capacity that affects the quality of life and increases mortality of these patients. So, exercise tests are considered as an essential component of the clinical evaluation of the patients with COPD. The objective of this study is to evaluate the reproducibility sensitivity and validity of the Six Minute Step Test (6MST) in patients with COPD and in health volunteers, and verify its relation with the "Body-Mass Index, Airways Obstruction, Dyspnea and Exercise Capacity" Index (BODE). This Observational, Transversal, Prospective study will be conducted in the "Special Unit of Respiratory Physiotherapy", of the "Federal University of São Carlos". To participate in this study, 120 subjects, both gender, will be invited and will be allocated in five groups: Group I (30 healthy young subjects of 17 to 27 years old), Group II (30 healthy elderly individuals of 60 to 75 years old), and patients COPD, 60 to 80 years old, with mild, moderate, severe and very severe obstruction determined by the forced expiratory volume in one second (FEV1) by forced vital capacity (FVC) relation "FEV1/FVC" \<70% and FEV1 in predict percentage \< 80% composing the Group III (20 COPD patients in GOLD stage I), Group IV (20 COPD patients in GOLD stage II) and Group V (20 patients COPD stages III and IV). All subjects will be submitted to body composition and anthropometric assessment, pulmonary function test, three 6-minutes walk test (6MWT) and three 6MST. Furthermore, the patients of the groups III, IV and V will answer the Modified Medical Research Council (mMRC) scale, and BODE index will be calculated to each of them.


Eligibility Criteria:
Inclusion Criteria:

* Young and elderly healthy subjects presented pulmonary function within the normal range, confirmed by spirometry
* Patients with clinical and spirometric diagnosis of COPD

Exclusion Criteria:

* Lung disease exacerbated
* Decompensated heart disease
* Rheumatic, neurological or orthopedic disease, preventing them from doing the tests by limiting the exercise
* Peripheral oxygen saturation \< 80% without physical effort
* Subjects who does not complete the first day of evaluation
Thromboelastography (TEG) and Clopidogrel Withdrawal Time in Elderly Patients With Hip Fracture

In the elderly patients with hip fracture, some often take antiplatelet drugs such as clopidogrel due to the ischemic cardiovascular or cerebrovascular diseases. In traditional practice, these patients often need to stop medication for 5-7 days before surgery. But on the other hand, delayed surgery will lead to a significant increase in fracture related complications. Therefore, the appropriate time for drug withdrawal is particularly important in this population.

Thromboelastography is a monitoring method that can accurately judge the anticoagulation status of patients. We hope to use thromboelastography to guide the time of drug withdrawal, shorten the time of drug withdrawal as much as possible, and reduce the incidence of fracture related complications without increasing the risk of massive hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture and operation
* taking clopidogrel for more than one week before injury, with or without taking aspirin at the same time

Exclusion Criteria:

* high energy injury (such as traffic accident, falling from height), bilateral hip fracture, multiple fractures or injuries, pathological fracture
* malignant tumor patients
* hormone users
* patients with recent active bleeding or bleeding ulcer
* primary or secondary coagulation dysfunction or depression caused by other reasons than taking antiplatelet drugs (for example, taking warfarin)
* patients with other acute or unstable diseases requiring delayed surgery (acute heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, severe pulmonary infection, deep vein thrombosis or pulmonary embolism, etc.)
RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial

Increased use of radial access for cardiac catheterization is being advocated because studies have showed lower arterial access related complication rates and higher patient satisfaction as compared to femoral access. However, little is known on patients with prior coronary artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed to test the hypothesis that bypass graft angiography and intervention via radial access provides lower vascular complication rates, similar contrast and equipment utilization and higher patient satisfaction when compared with transfemoral approach.

This is a phase III, single-center, prospective, randomized trial that will compare resource utilization, clinical outcomes and patient satisfaction between radial and femoral access for patients with prior coronary artery bypass graft (CABG)surgery undergoing coronary and graft angiography and intervention. During clinically-indicated coronary angiography of patients with prior CABG, the amount resources used, radiation exposure to patients and operators, occurence of complications and patients satisfaction will be compared between the two treatment arms to determine whether compared to femoral approach radial access will result in:

1. similar contrast utilization (primary endpoint)
2. similar procedure time (secondary endpoint)
3. similar fluoroscopy time (secondary endpoint)
4. similar radiation exposure of the patient - measured as DAP \[dose area product\] and AK \[air kerma\] (secondary endpoint)
5. similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
6. similar number and types of catheters and guidewires used (secondary endpoint)
7. reduction in vascular access complications (secondary endpoint)
8. reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
9. higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)

Eligibility Criteria:
Inclusion Criteria:

* Age \>18-years
* Prior coronary artery bypass graft surgery
* Referred for clinically-indicated coronary and graft angiography and/or intervention
* Able to provide informed consent

Exclusion Criteria:

* Known pathologic Allen's test
* Known difficulty that limits vascular access at the femoral or radial arteries
* Age \> 90
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors

The purpose of this study is to develop a comprehensive care program for their return to normal life and community among lung cancer survivors and evaluate the effectiveness of the program.

Lung cancer patients scheduled for curative surgery will be enrolled in this study. The comprehensive care program will be developed, and provided to the intervention group before and after surgery. Outcomes will be assessed 6 months and 1 year after surgery. To evaluate the effectiveness of the program, a control group will be enrolled first and used as a comparator.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with non-small cell lung cancer(NSCLC) and scheduled for curative resection.
* NSCLC with clinical stage Ⅰ-Ⅲ
* Patients who understood the study and gave written informed consent.

Exclusion Criteria:

* Recurred lung cancer
* Patients with extra-pulmonary synchronous double primary cancer.
* Patients with history of other cancer diagnosis or treatment in the last 3 years.

Drop Criteria:

* When surgery was canceled or pathologic stage IV was confirmed after surgery.
* When the tumor was not found to be non-small cell lung cancer, including benign tumor, after surgery
* Withdrawal informed consent.
Multimodal Brain Monitoring as an Early Warning and Prognostic Tool for Acute Brain Injury

The primary aim of this study is to evaluate the effectiveness of multimodal brain monitoring technologies as both an early warning system and a prognostic tool in patients suffering from acute brain injuries. This research seeks to determine how effectively these tools can predict clinical outcomes and prevent complications by providing early alerts to healthcare professionals.

Acute brain injury, including traumatic brain injury (TBI) and stroke, presents significant challenges in clinical management, primarily due to the complexity of the brain's response to injury and the critical timing required for effective intervention. Multimodal brain monitoring, which integrates various physiological data points like brain electrical activity, cerebral blood flow, and brain tissue oxygenation, offers a comprehensive view of a patient's cerebral status. This study builds on the premise that a better understanding and real-time monitoring of these variables can significantly improve patient outcomes by enabling timely and targeted interventions.

Eligibility Criteria:
Inclusion Criteria

1. Must be 18 years of age or older.
2. Diagnosed with Traumatic Brain Injury (TBI) or has suffered from acute brain injury due to intracranial hemorrhage or subarachnoid hemorrhage.
3. Defined as an admission Glasgow Coma Scale (GCS) Eye Response score of 1 (unable to open eyes) and a GCS Motor Response score of ≤5 (unable to obey commands).
4. Occurs within 48 hours of admission, where the patient does not open eyes and motor score drops to 5 or below.

Exclusion Criteria

1. Patients who were not admitted to the Intensive Care Unit (ICU) are excluded.
2. Patients with forms of acute brain injury other than those specified (TBI, intracranial hemorrhage, subarachnoid hemorrhage) are also excluded.
3. Patients with known severe liver or kidney dysfunction are excluded.
4. Patients whose vital signs are extremely unstable after admission, with a very poor prognosis and considered unable to survive, and whose family has decided to forgo further treatment.
5. Patients who had a Modified Rankin Scale greater than 2 before the onset of the current illness.
6. Patients with a history of congenital or acquired hemorrhagic diseases, coagulation factor deficiencies, or thrombocytopenic disorders.
7. Pregnant or lactating women, as well as those planning to become pregnant within the next 90 days.
8. Patients with severe psychiatric disorders or dementia who are unable to provide informed consent or complete follow-up requirements.
9. Patients who have participated in other interventional clinical trials within 30 days prior to randomization, or who are currently participating in other clinical research.
10. Any other reasons that the researcher deems unsuitable for participation in this trial.
Primary Cell Culture of Hepatic Tumorous Cells From Routine Fine-needle Aspiration

The purposes of this prospective study were to evaluate the successful rate of primary culture of hepatocellular carcinoma cells and cancer-associated fibroblasts from the residual specimens in routine fine-needle aspiration of hepatic tumor and the potential application of this method as an additional tool for personalized treatment of hepatocellular carcinoma patients.

Fine-needle aspiration (FNA) cytology or biopsy of hepatic tumor is frequently applied in the collection of specimens because it is considered safe, efficacious, accurate and cost effective. Our previous study from small number of patients showed that specimens obtained from FNA had potential to be applied for primary culture of cancer cells. This study was to modified our method for primary culture of both hepatocellular carcinoma cells and cancer-associated fibroblasts in patients with tumor measuring larger than or equal to 3cm. All patients received one session of aspiration for the diagnosis of hepatic tumor. The aspirated specimens were applied for both cytologic and pathologic examinations at first. After then, 10 mL 0.9% NaCl was aspirated by the same needle connected with the same syringe and injected into 15 mL sterilized centrifugation tube. If the tube contained visible specimens, these specimens were sent for primary culture.

Eligibility Criteria:
Inclusion Criteria:

* patients had residual aspirated specimens for primary culture.

Exclusion Criteria:

* patients did not have residual aspirated specimens for primary culture.
Revaluation of Wells' Clinical Prediction Score of Deep Vein Thrombosis (DVT) in Inpatients With Thromboprophylaxis Treatment

This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.


Eligibility Criteria:
Inclusion Criteria:

* Any patient addressed to an Vascular Medicine unit for a clinical suspicion of DVT, with risk stratification through the modified Wells score by the referent doctor.

Exclusion Criteria:

* Patient addressed to our Vascular Medicine unit for any other reason.
* Patient addressed to our Vascular Medicine unit for DVT detection to help in a pulmonary embolism suspicion.
* Age under 18 yo
* Patients unable to express their informed consent.
Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

Eligibility Criteria:
Inclusion Criteria:

* Macular edema secondary to central retinal vein occlusion
* BCVA worse than 20/40
* Central macular \>250 mc with OCT

Exclusion Criteria:

* Diabetic retinopathy or other retinopathy
* Media opacity that does not allow following
* steroid responder
* diagnosed glaucoma or IOP \> 21 mmHg
Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion

To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.

The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of moderate to severe lumbar spinal stenosis. The device is specifically designed to provide stabilization without fusion in cases of stenosis with or without facet joint hypertrophy, subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two levels in the region of L1 - L5.

The height of the neuroforamen is maintained and the facet joints will be relieved. By this a further destruction is prevented. Unlike conventional stabilization methods as for example spinal fusion, the function of the segment will be maintained and adjacent structures will be effectively protected.

Possible risks, which could occur after implantation of the coflex® Interlaminar Technology are breakage of the implant, displacement of the implant, pain which is caused by the implant, infections, bleedings and hematoma. The benefit of the study lies in the fact that first-time retrospective data is raised for potential improvement regarding therapy of lumbar back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to an improvement of the therapy.

In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for patients treated with the coflex® Interlaminar Technology during normal conditions of use. This data will provide evidence to support publications and marketing.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the criteria specified in the device labeling including radiographic confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal at one or two contiguous levels from L1-L5 that require surgical decompression.

Exclusion Criteria:

* There are no exclusion criteria's for this study.
Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)

This project is working on orthoptic rehabilitation for low vision people. The aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. It leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient.

Using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. It also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to adopt better strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from visual impairment, with a need for visual rehabilitation
* Visual acuity (≤1.3 logMAR)
* Good knowledge of French language
* Informed consent of research

Exclusion Criteria:

* Medical treatment that may interfere with the study
* Degenerative diseases or any other diseases that may interfere with the study.
* Mini-Mental State Examination Score without visual item ≤ 20/25
* Pregnancy and lactation.
European Study of Cardiovascular Risk

The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries.

The patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office.

Study variables will be measured:

* By an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication.
* By questions asked to the physician: physician perception of patients' CV risk factor, guidelines adherence and cost-containment.
* By measurement performed to the patient during the visit: weight, height, BMI, waist and hip circumference will be measured.
* CV risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent.
* Patients 50+ years old, with at least one additional CV risk factor (with no previous CV event or hospitalisation for a CV event) from Primary Care or hospital outpatient clinic.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent
* Previous CV disease event or hospitalisation for a CV event
* Current participation in a clinical trial
Elderly Appropriate Treatment in Primary Care (EAT)

The general practitioner (GP) is confronted, for a part of his clientele, with the management of patients suffering from multimorbidity, leading most often to a polypharmacy. It has five major consequences: increasing the number of inappropriate treatments, increasing the risk of potentially dangerous drug interactions, increasing the risk of contraindications associated with several concomitant pathologies, decreasing adherence to treatments by patients and the increased cost of care. Drug misuse in the elderly is particularly common, due to the age-related physiological changes and physiological alterations, with the consequent increase in the risk of adverse events, particularly hospitalizations. Several tools have been proposed to decrease morbimortality in elderly patients with polypharmacy. The studies concluded that the STOPP/START tool was the most structured, sensitive and had the most appropriate use format for clinical practice. However, there are currently no ambulatory studies demonstrating the impact of prescription revision with STOPP/START on the morbimortality of persons aged 75 years and over. This study aims to assess the effectiveness of an intervention targeting GPs to decrease morbimortality in elderly patients with polypharmacy. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in systematic medication review by GP with STOPP/START. In both groups, patient morbimortality will be measured at the end of the study.

STOPP/START criteria for potential inappropriate prescribing in older people recognise the dual nature of inappropriate prescribing by including a list of potentially inappropriate medications (STOPP criteria) and potential prescribing omissions (START criteria).

Eligibility Criteria:
Inclusion Criteria:

* Patient 75 years of age or older
* With polypharmacy (≥ 5 medications)
* Not institutionalized
* Patient affiliated with the French health care system
* Oral consent given to participate in the study
* Patient who can be followed up 12 months
* Patient visiting the GP for any reason

Exclusion Criteria:

* Patient protected by law (under guardianship or curatorship)
* Having an estimated life expectancy of less than 12 months
* Participating in a therapeutic trial during the study period
African American Knowledge Optimized for Mindfully Healthy Adolescents

The purpose of this study was to better understand how African American families identify and treat emotional and behavioral concerns associated with depression in their adolescent youth. The goals of the study included (a) identifying factors associated with participation in psychiatric research and treatment and (b) developing an intervention to increase participation in psychiatric research and treatment.

The aim of this study was to obtain an in-depth understanding of African Americans' perceptions of barriers to adolescent and family engagement in psychiatric treatment and research utilizing a mixed methods approach in two Phases. Phase I consisted of data collected via surveys, focus groups and individual interviews with African American adults and youth. The data generated in Phase I provided a foundation for the domains incorporated into manual development and therapist training procedures of the subsequent intervention phase of the project (Phase II).

After the research team developed the depression treatment engagement intervention, the intervention was pilot tested in a sample of depressed African American youth and families (Phase II)

Eligibility Criteria:
Inclusion Criteria:

* Persons who self-identify as Black or African American
* Adolescents aged 11 to 17 at the time of recruitment
* Adult parents
* Parent consent and adolescent assent
* Demonstrated cognitive ability to understand participation

Exclusion Criteria:

* Diminished capacity to participate