cyrilzakka/clinical-trials huggingface dataset:
Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT): Phase Two

The study is the second phase of Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT).

During the first phase of the ANGEL-ACT (NCT03370939, a prospective multi-center registry study), problems and difficulties in the emergency work flow of acute ischemic stroke care in China have been identified, such as inadequate pre-hospital notification, delay of in-hospital diagnosis and treatment, difficulty in treatment consent, lack of professional training of endovascular treatment,etc., especially in the delay of in-hospital diagnosis and treatment.

ANGEL-ACT II is a cluster randomized, parallel controlled study. The aim of this study was to evaluate the effectiveness of multi-modal medical quality improvement measures on the delay of hospital-level emergency work flow of acute ischemic stroke management as well as its impact on patient prognosis. The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis.

This is a prospective, multi-centre, cluster randomized, open label, parallel controlled study that enrolled patients with acute ischemic stroke who underwent endovascular treatment in about 34 hospitals in China. The ratio Interventional arm control arm is 1:1, which means 17 hospitals and 332 participants in each arm.

Eligibility Criteria:
Investigational Sites Inclusion Criteria:

* Participated in the ANGEL-ACT registry study
* Secondary or tertiary hospitals
* Available of emergency department and neurology ward for stroke patients
* Must have 24 hours × 7 days emergency department for stroke
* Capable of rt-PA thrombolysis and endovascular treatment

Investigational Sites Exclusion Criteria

* Endovascular treatment volume \< 20 per year
* Unwillingness to participate ANGEL-ACT II and follow the protocol
* Currently participating other stroke treatment improving program/project or similar clinical studies

Participant Inclusion Criteria

* Age ≥ 18 years old
* Admitted from emergency or outpatient department;
* Acue ischemic stroke with large artery occlusion
* Within 24 hours after the onset, and eligible for endovascular treatment.
* The patient or legal representative give written informed consent

Participant Exclusion Criteria:

* Unsuitable for this study investigators' discretion
* Progressive stroke or in-hospital stroke
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease

The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy subjects (Part 1) and multiple ascending IV dose administrations in subjects with prodromal or mild Alzheimer's disease (AD) (Part 2).


Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria:

* Body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive (BMI = weight/height\^2) and body weight greater than 40 kilogram (kg) but less than 110 kg at screening
* Women must not be of childbearing potential

Specific Inclusion Criteria Part 2:

Each potential subject enrolled in Part 2 must satisfy all of the following specific criteria in addition to the general criteria to be enrolled in the study:

* Clinical Dementia Rating Scale (CDR) global rating score of 0.5 or 1.0 at screening
* Must have a reliable informant (example, relative, partner, friend)
* Must have cerebrospinal fluid (CSF) finding consistent with Alzheimer's disease (AD) pathology

Exclusion Criteria:

General Exclusion Criteria

Any potential subject who meets any of the following criteria will be excluded from participating in the study:

* History of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including but not limited to neurodegenerative disease (excluding AD for Part 2) \[example, Parkinson's disease\], seizure disorders, transient ischemic attacks, etc.), hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the subject
* Relevant history of or current neurological disease (other than prodromal AD or mild AD for Part 2), which in the opinion of the investigator may make interpretation of possible new neurological signs or symptoms difficult
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening (per screening evaluations)
* History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-Hepatitis C virus \[HCV\]) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening (per screening evaluations)

Specific Exclusion Criteria Part 1 - Mini-Mental State Examination (MMSE) score less than or equal to (\<=) 27 at screening

Specific Exclusion Criteria Part 2

- Evidence of brain disease, other than AD, that could explain the cognitive deficit (including, but not limited to, vascular encephalopathy or strokes, as imaged by cerebral Magnetic resonance imaging (MRI)
SRDK0921_ Analytical Performance Study

Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)

It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection.

The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD).

The SRDK0921 system (kit and software) is intended:

* to calculate a score of subclinical rejection in kidney transplant patients
* as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
* Subjects transplanted from living or deceased donors.
* Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
* Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
* Subjects under standard immunosuppressive treatments.

Exclusion Criteria:

* Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
* Subjects that have stopped immunosuppressive treatments.
Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma

The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed.

In the same way, mortality, global survival and free-progression survival after O-ESHAP treatment and TAPH will also analyzed.

In addition to the above:

* To asses the complete response rate after O-ESHAP.
* To asses the toxicity of O-ESHAP regimen
* To asses the stem cells mobilization capacity of O-ESHAP regimen
* To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and progression free survival (PFS)
* To investigate the correlation between the overall response and CD20 expression by tumoral cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed relapsed, partial response or refractory classical HL after first line chemotherapy. They will be included irrespective of CD20 expression on HRS cells. CD20 expression will be analyzed on all available biopsies and this data will be recorded for further evaluation.
* Age 18 to 65 years. Patient \>65 and \<70 years old with ECOG \< 2 and absence of comorbidities will be included in the study if considered adequate by the investigator.
* Leucocytes \> 3,0 x 109/L and platelets \> 100 x 109/L.
* ECOG \< 2.
* No major organ dysfunction.
* Written informed consent.
* HIV negative.
* No active hepatitis B or C infection.
* Availability of histological report of biopsy at diagnosis or at relapse and availability of biopsy to be revised by reference pathologists.
* Absence of other neoplasia, except basocellular tumor or carcinoma of the uterine cervix in situ.
* Contraception measures in fertile females.

Exclusion Criteria:

* Subjects who have current active hepatic or biliary disease
* presence of pathology that would contraindicate the administration of chemotherapy
* HIV positive
* Hepatitis B or C infection
* history of other malignancies in addition to those specified in the inclusion criteria
* informed consent not signed
* Pregnant and / or breast-feeding or reproductive capacity adults who do not use an effective method of birth control during study treatment and at least six months later. An effective method is that used at least one barrier mechanism.
Chinese Severe Brain Injury Trial

Building a Large Chinese Cohort(Chinese Severe brain injury Trial）


Eligibility Criteria:
Inclusion Criteria:

* a clear cause of brain injury
* disorders of consciousness, GCS≤12
* within six months of onset

Exclusion Criteria:

* not applicable
Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients

Although the COVID-19 pandemic was announced almost 2 years ago, societies are still facing the effects not only of individuals but also of entire populations. Clinical symptoms in patients depending on the variant of the virus range from fever, sore throat, cough, fatigue, or gastrointestinal or neurological symptoms. Symptoms of respiratory failure also occur, as well as heart and kidney damage. Therefore, it is important to implement appropriate pulmonary rehabilitation programs to counteract the effects of the disease. The current project aims to evaluate the effectiveness of a comprehensive pulmonary rehabilitation program for patients hospitalized for SARS-CoV2 infection.

Initial studies indicated that approximately 60 days after the first COVID-19 symptom onset, only 13% of patients previously hospitalized for COVID-19 were reported to be essentially free of any COVID-19-related symptoms, while 32% had one or two symptoms and 55% had three or more symptoms. Furthermore, the COVID-19 pandemic gives rise to new psychosocial and emotional stressors for recovering patients, including social isolation, physical distancing, loss of employment and uncertainties about the future. In the confrontation of such an uncertain prognosis, it seems justified to introduce preventive actions against the development of pandemic-related adverse effects. To date, only few publications assessed the effectiveness of early post-hospital rehabilitation of patients with COVID-19. This project is aimed to propose an innovative comprehensive intervention based on a stationary pulmonary rehabilitation (PR) programme for COVID-19 survivors. Moreover, this project assumes the use of virtual reality (VR) in rehabilitation processes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals hospitalized for COVID-19.

Exclusion Criteria:

* Failure to consent to participate in research,
* pneumonia,
* evidence of ischemic heart disease/acute changes on ECG,
* uncontrolled hypertension,
* insulin dependent diabetes mellitus,
* inability to exercise independently or musculoskeletal/neurological conditions that would prevent completion of the course,
* lung cancer,
* cognitive disorders, or Mini-Mental State Examination \< 24.
Objective Measure of Recovery After Outpatient Surgery

This is a study using wearable monitoring devices, patient activity and sleep patterns to monitor pre and post operative following outpatient inguinal hernia surgery to determine when these parameters return to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for outpatient inguinal hernia repair without significant medical comorbidities
* Patients who consent to participating and willing to wear device for designated time period per protocol

Exclusion Criteria:

* History of chronic opioid use
* Inability to speak English
* Inability to give informed consent
Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora

The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any intraocular surgical procedure.

Studies have demonstrated that the external bacterial flora of the patients in most cases is the actual source of infection. The objective of antisepsis is to eliminate or significantly reduce the number of microorganisms in the surgical field at the time of surgery. The eyelids and the conjunctiva are considered to be quite common sources of bacteria that can lead to endophthalmitis. Thus, it is believed that by reducing the number and growth of bacteria on the ocular surface and adnexa before surgery, the risk of postoperative infection would be lower. Povidone-iodine 5% eye drops has been used in preoperative cataract surgery to prevent endophthalmitis and is the standard prophylactic action in preventing postoperative endophthalmitis being widely compared with other antibiotic eye drops and their associations. The standard procedure of prophylaxis of postoperative endophthalmitis corresponds to applying a single drop of povidone-iodine 2min before any intraocular surgical procedure. However, few studies have assessed the effectiveness of povidone-iodine 5% eye drops using different dosing regimens to achieve the best bactericidal effect. The aim of this study is to investigate different dosages with respect to the use of povidone-iodine drops to optimize the effectiveness of the agent, ensuring the best exogenous endophthalmitis prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* No systemic or ocular infection;
* Absence of auto-imune disease or immunosuppressive therapy;
* No use of systemic or topic antibiotics in the last 30 days;
* No previous ocular surgery or trauma in the study eye in the last 30 days;
* No history of allergy to povidone iodine;
* Signed informed consent.

Exclusion Criteria:

* Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis;
* Diabetes Mellitus;
* Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza;
* Inability to understand and sign the informed consent.
Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma

The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.

This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 through 65 years of age.
* Smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day.
* Mild to moderate, stable, allergic asthma as defined by American Thoracic Society (ATS) criteria 1
* History of episodic wheeze and shortness of breath
* Subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.

Exclusion Criteria:

* History or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the Investigator
* History of serious adverse reaction or hypersensitivity to corticosteroids
* Abnormal chest X-ray that is judged clinically significant
* Pregnant or lactating or have positive plasma pregnancy test
* Use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks.
* Use of any other asthma-related medications within 1 month of Screening
Enhancing Systems of Care to Improve Hypertension Guideline Implementation

This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.

The trial will randomize 12 clinics within the Henry Ford Health System to two arms. The first arm will be comparison clinics that continue to use existing team-based strategies for hypertension management. The second arm will be intervention clinics. These clinics will have enhancements to existing team-based hypertension management. The first enhancement is clinical decision support based in the electronic health record. The second enhancement is improved protocols to implement telehealth prescribing that is nurse-led.

The trial will enroll participants through an urban emergency department. Participants will be assigned to one of these 12 clinics and continue study activities for 1 year. Clinicians at the clinics will manage blood pressure. Study specific visits will occur at 3, 6, 9, and 12 months. Primary outcome assessment is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) African Americans
* Lacks established primary care for BP management
* History of HTN
* SBP ≥ 140 mmHg

Exclusion Criteria:

* Pregnancy
* Need for hospitalization from ED
* Serious comorbid conditions
* Alcohol or drug dependence
* Suspected resistant HTN
* Anticipated poor-adherence to study designated primary care clinic
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study

The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.

The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up.

The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.

The revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction.

Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.

Eligibility Criteria:
Inclusion Criteria:

* patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
* patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient.
* male and non-pregnant female patients aged 18-75
* patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

* patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
* patient is a female of child-bearing age and not taking and not taking contraceptive pills
* patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
* patient has a known or suspected metal sensitivity
* patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
* patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
* patient is severely overweight with a BMI\>40.
A Study to Promote Physical Activity Motivation in Cardiovascular Disease Patients

This study investigates the feasibility of an app based intervention, which uses questionnaires and personalized motivational messages to achieve change in physical activity and sedentary behaviour of cardiovascular patients. The questionnaires and messages are based on behaviour change theories, such as the transtheoretical model. The intervention will take place over eight weeks. One week before and during the last week, physical activity will be measured via accelerometers. A comprehensive questionnaire will be given before and at the end of the intervention and Feasibility measures will be evaluated at the end as well, including an optional qualitative interview with the participants.

Cardiovascular diseases are the leading cause of death and disability worldwide. They are mainly caused by lifestyle risk factors, such as physical inactivity, which is also the fourth leading risk factor for mortality. Regular physical activity is crucial for the prevention and treatment of cardiovascular diseases. Nevertheless, success in achieving long-term adherence to physical activity recommendations after an acute cardiac event or even after exercise-based cardiac rehabilitation is rather low. Furthermore, even though most research has focused on physical activity, engaging in reduced amounts of sedentary behavior is also crucial, as it represents an important cardiovascular risk even after adjusting for physical activity. Health behavior change theories, such as the transtheoretical model, and empirical evidence highlight the importance of motivation and motivational factors in the behavior maintenance or change process. Thus, the main goal of the present study is to assess preliminary effectiveness of an intervention mostly based on the transtheoretical model to promote cardiovascular patients' motivation to be physically active and to engage in reduced amounts of sedentary behavior. Most intervention components will be delivered digitally to the participants' smartphones via a study specific app. Furthermore, weekly questionnaires allow the investigators' to individualize the intervention components and investigate associations not only between-subjects, but also within-subjects over time, which is essential and has been neglected in the literature. The primary objective is to assess study feasibility.

Eligibility Criteria:
Inclusion criteria:

* Cardiovascular disease patients
* Participating in cardiovascular rehabilitation OR having received the recommendation from a cardiologist to participate in cardiovascular rehabilitation and having refused
* Signing the informed consent form
* Owning a smartphone with internet access

Exclusion criteria:

* Age under 18 years
* Having a contraindication for physical activity
* Existing or suspected non-fulfilment of the participation requirements
* Inability to follow the procedures of the study (e.g., by not speaking German, being unable to read or write, or severe cognitive impairment)
* Being in palliative care
* Being pregnant
* Having an assisted living situation
* Stroke patients