cyrilzakka/clinical-trials huggingface dataset:
CE-US in Renal Transplantation

Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes. Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover, it may but not contribute to clinical diagnosis in about 10% of cases because of the impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or readily applicable non-invasive procedures might therefore allow increasing the performance of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a surrounding phospholipid monolayer and last for several minutes in the systemic circulation before spontaneous degradation with absorption of the gaseous component by the lungs and the phospholipid shell by the liver. With the use of gasfilled microbubbles that act as scatterers within the blood stream and the development of low-MI ultrasound techniques that allow the visualization of the bubbles without destroying them, it is possible to improve the depiction of vessels and have access to structural and functional information on the microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to evaluate kidney disfunction.

Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be associated with different patterns of renal graft involvement during acute renal function deterioration and b. whether, conversely, different patterns of parenchymal perfusion detected by CE-US may help predicting different patterns of renal involvement will be investigated in 20 deceased or living donor kidney graft recipients.


Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years
* Kidney transplantation with a functioning graft (dialysis independence)
* Clinical indication to histologic evaluation of the kidney graft
* Written Informed consent (according to the Declaration of Helsinki guidelines)

Exclusion criteria:

* Specific contraindications to histologic evaluation of the kidney graft (bleeding time \> 15 min, intra-abdominal implantation of the graft)
* Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
* Recent Acute Coronary Syndrome (ACS) or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronar artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.
* Right-to-left shunts, severe pulmonary hypertension (PAP \>90 mmHg
New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients. The investigators will use this project to better characterize AE and PNS patients to identify new diagnostic and prognostic biomarkers and develop new diagnostic tools.


Eligibility Criteria:
* Inclusion Criteria \* :

  * patient with neurological disorder
  * patient without antibody
* Exclusion Criteria \* :

  * patient with characterized antibody
  * patient without neurological disorder
Nursing Students& Breastfeeding Education& Simulation

The study aimed to determine the effect of different simulation methods on nursing students' self-confidence, satisfaction, and clinical breastfeeding management knowledge and skills in managing and supporting breastfeeding in the early postpartum period.

This study aimed to investigate the effectiveness of simulation-based training methods in improving the breastfeeding management knowledge and skills of third-year nursing students. The study utilized a quasi-experimental design with pre-test and post-test control groups. The results of the intervention groups that received high-fidelity, hybrid, and telesimulation training were compared with a control group that received traditional training. A clinical follow-up phase was conducted after the interventions to evaluate their impact. The study used various data collection tools to measure different factors, including knowledge and skills, confidence in learning, satisfaction, training satisfaction, and self-assessment of simulations.

Eligibility Criteria:
Inclusion Criteria:

The voluntarily agree to participate in the study Not having experience with simulation Being a 3rd year nursing undergraduate student not working as a nurse

Exclusion Criteria:

During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-80 years of age;
* rheumatoid arthritis after inadequate response to \>=1 DMARD treatment;
* active disease;
* DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Exclusion Criteria:

* autoimmune disease other than rheumatoid arthritis;
* bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
* concurrent treatment with any DMARD or antiTNF-alfa;
* intra-articular or parenteral corticosteroids within 4 weeks prior to screening.
Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke

Acute ischemic stroke is a leading cause of disability and mortality. Intravenous thrombolysis is a major therapy for acute ischemic stroke, however, nearly half of patients failed to benefit from it. It is necessary to find new interventions combined to intravenous thrombolysis, which promote the efficacy of intravenous thrombolysis. The investigators' previous studies suggested levofloxacin to be a newly identified neuro-protective agent, which could reduce infarct volume and improve neurologic function in animal models. To evaluate the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years.
2. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)
3. mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15，la (NIHSS) level of consciousness \< 1

Exclusion Criteria:

1. Endovascular treatment
2. Patients using glucocorticoids, antiarrhythmic drugs (class I and class III antiarrhythmic drugs: quinidine, procaine amine, lidocaine, phenytoin sodium, verapamil, etc.), and quinolones within 14 days;
3. Patients with other diseases that may aggravate adverse drug reactions, such as ventricular arrhythmias, prolonged QT interval (male: QTc\>430ms, female: QTc\>450ms), severe cardiac insufficiency (NYHA functional grade ≥ III), myasthenia gravis, peripheral neuropathy, seizures, tendon-related diseases, severe immune system-related diseases, hematological diseases, active hepatitis or cirrhosis, serious respiratory diseases;
4. Abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamic pyruvic transaminase exceeds 3 times the upper limit of normal; Direct bilirubin or indirect bilirubin more than 3 times the normal upper limit; Blood creatinine exceeds 1.1 times the upper limit of normal; Creatinine clearance rate≤50ml/min; Urea nitrogen≥ 20mg/dL;
5. Concurrent infection;
6. Fasting blood glucose lower than 3.9 mmol/L;
7. Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization;
8. Patients allergy to fluoroquinolones or other antibiotics;
9. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons;
10. Not willing to be followed up or poor treatment compliance;
11. Patients who are participating in other clinical studies, or have participated in other clinical studies within 3 months before enrollment, or have participated in this study;
12. Other conditions not suitable for enrollment.
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)

Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences.


Eligibility Criteria:
Inclusion Criteria:

* Women victim of intimate partner violence
* Still in relationship with abuser
* Willing to attend 16-weeks sessions

Exclusion Criteria:

* In need of clinical supervision or treatment
* Severe mental disorders
* Cognitive disorders
* Refused to give written consent
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the standard treatment Neoral® for a treatment period of 6 months in stable renal allograft transplant recipients with respect to drug levels, dosage, and acute graft rejection and other adverse events.

The introduction of cyclosporine (CsA) into clinical practice resulted in improvements in acute renal allograft rejection rate and graft survival in renal transplant patients. Gengraf a microemulsion formulation of CsA though granted an AB-rated equivalent to Neoral, because of concerns over the use of generic drugs in transplantation, we undertook this study to evaluate the clinical efficacy and safety of Gengraf.

We conducted a multicenter, randomized, open labeled study to establish the equivalence between Gengraf and Neoral in stable renal transplant recipients for a treatment period of 6 months. 6 months post transplant patients with stable graft function and receiving a stable dose of neoral were recruited into the study. Eligible patients were randomly assigned to remain on Neoral or convert to an equal milligram-for-milligram dose of Gengraf. The primary end-point was serum creatinine at 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from patient or parents/guardian.
2. Patients who are more than 6 months post transplant
3. Stable graft function i.e. serum creatinine less than 300 umol/l
4. Patients currently on a stable dose of capsule Neoral within last one month

Exclusion Criteria:

1. Multiple organ transplantation
2. Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, Intra Uterine Device or diaphragms in conjunction with spermicidal foam and condom on the male partner.
3. Participation in any drug trial in which the patient received an investigational drug within 30 days preceding the screening phase of this study.
4. Those persons directly involved in the conduct of the study.
5. Active infection at the time of screening for enrollment into trial.
6. Acute graft rejection within the past 3 months
7. Mentally unstable or history of mental diseases
8. History of drug or alcohol abuse within the past 2 years.
9. History of non-compliance to medical regimen and patients who are unwilling or unable to comply with the protocol.
10. Decompensated liver disease
11. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
Physiological Changes From Hand Movement Training

11 participants with upper-limb impairment will be recruited from community sources. They will be invited to participate in a 15-day trial involving the IRegained device. The study will involve 2 assessment visits to Baycrest, before and after the treatment, and 15 treatment visits. The data from the pilot study will be analyzed both quantitatively and qualitatively, as outcomes and explicit feedback from participants will be used to further optimize the device for future studies.

This pilot study will investigate the potential changes in the brain area controlling hand movement following 15 days of exercises to improve hand function in participants with upper limb impairments resulting from stroke. A device developed by Dr. Vineet Johnson (IRegained Inc.) will be used to administer standardized exercises to improve hand function. To assess brain changes, transcranial magnetic stimulation pulses will be delivered to the motor cortex. The motor evoked potential (MEP), a muscle response evoked from the TMS, will be measured using electrodes on the hand. This study will test the feasibility of conducting motor therapy using this device while assessing potential changes in motor cortex function. Findings from this study will contribute to developing treatment trials aimed at improving impaired limb function in stroke patients and quality of life in these individuals

Eligibility Criteria:
Inclusion Criteria:

-Sustained a single stroke \>6months prior to start of study

Exclusion Criteria:

* Severe spasticity or contractures (2 or less in the CMSA)
* any other musculoskeletal or neuromuscular disorders that compromise sensation
* Prospective participants who are incapable of providing consent to participate in the research study will also be excluded (determined by an MMSE score of 24 or less).
* Botox Injections less than 2 months prior to starting the study
Periprocedural Myocardial Infarction: the Role of Human Neutrophil Peptide-1 to 3

The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Troponin negative patients
* Stable angina
* Unstable angina
* Positive screening tests

Exclusion Criteria:

* Troponin positive
* Technical failure of procedure
* Hemodynamic unstability
Intelligent Sports Injury Prevention and Training System

Sports injuries are a very important issue for baseball players. Previous studies have found that the incidence of sports injuries faced by baseball players is continuously increasing. Sports injury rates in professional baseball, high school baseball, and college baseball players were as high as 3.6, 4.6, and 5.8 per 1,000 players, respectively. The main cause of many pitching injuries is attributed to a large number of repetitive pitches. To avoid sports injuries, it is necessary to know how to assess the risk of injury caused by repetitive pitching. Throwing is a fairly complex action that requires the coordination of the entire body. It is critical to investigate the biomechanical changes of players in order to effectively analyze such complex movements.


Eligibility Criteria:
Inclusion Criteria:

* Healthy baseball pitchers
* Age between 18\~55 years old

Exclusion Criteria:

* Surgery history in pitching arm
* Musculoskeletal disease
* Neuromuscular disease
Cardiovascular Health And Risk Modification in Family Health Teams

Cardiovascular diseases remain the main cause of mortality in Canada. While effective interventions are available for reducing the risk of cardiovascular disease,there continue to be gaps between the potential reduction in risk that could be achieved by effectively managing these risk factors and levels of risk factor control currently in clinical practice. This study will evaluate the ability of a different model of risk factor care using other health providers assisting family doctors, along with information aids for patients and health professionals,to achieve better levels of cardiovascular risk factor control in adults.


Eligibility Criteria:
Inclusion Criteria:

* adults 50 to 80 years of age
* having attending a family medicine clinic for more than one year

Exclusion Criteria:

* not able to participate for one year
* not able to read English
* requires house calls
* nursing home resident
* cognitive impairment
* current chest pain or symptoms of active coronary heart disease
Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress

This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.


Eligibility Criteria:
Inclusion Criteria:

* Provides informed consent
* Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
* 3. Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 ≤300. The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas
* Requires oxygen supplementation at screening
* Is willing to follow contraception requirements

Exclusion Criteria:

* Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
* A previous MSC infusion unrelated to this trial
* Have any of the following medical conditions:

  * Cardio-pulmonary resuscitation within 14 days of randomization
  * Uncontrolled or untreated symptomatic arrhythmias. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening may enroll
  * Myocardial infarction within the last 6 weeks
  * Congestive heart failure (NYHA Grade 3 or 4)
  * Pulmonary hypertension (WHO Class III/IV)
  * Currently receiving extracorporeal life support or membrane oxygenation (ECLS/ECMO)
  * Alanine aminotransferase (ALT) ≥ 5x upper limit of normal (ULN)
  * Relevant renal impairment (eGFR \< 50 mL/min)
  * Any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study
* Pregnant or breast feeding or planning for either during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
* History of a splenectomy, lung transplant or lung lobectomy;
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable).
* Expected survival or time to withdrawal of life-sustaining treatments expected to be \< 7 days.
* Do Not Intubate order;
* Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus

the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to Chinese female and male patients with type 2 diabetes will be investigated.


Eligibility Criteria:
Inclusion criteria:

1. Chinese male and female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidinediones with at least one agent taken at 50% of its maximum dose or less, unchanged for at least 12 weeks before randomization
2. Glycosylated haemoglobin A1(HbA1c)\<=8.5% and \>=7.0% at screening,age\>=21 and age\<=70 years (male and female patients),BMI\>=19 and \<=40 kg/m2
3. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Exclusion criteria:

1. Patient who did not discontinue the antidiabetic treatment with insulin or glitazones, DPP-IV at least before 12 weeks before randomization
2. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast at screening visit
3. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:

4 Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) 5 Renal insufficiency (calculated creatinine clearance \< 80 ml/min/1.73m²) 6 Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \> 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA 7 Neurological disorders (such as epilepsy) or psychiatric disorders 8 Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections) 9 Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 10. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 11. A marked baseline prolongation of QT/QTc interval (e.g., ECG demonstration of a QTc interval \>450 ms ) at screening visit