cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke


Eligibility Criteria:
Inclusion Criteria:

* Subjects with acute ischemic stroke, aging ≥ 19
* Confirmed to have acute anterior circulation cerebral artery occlusion in intracranial internal carotid artery (IICA) or middle cerebral artery (MCA) M1 segment by CT or MR angiography.
* National Institutes of Health Stroke Scale(NIHSS) is 6\~30 before endovascular recanalization therapy (ERT)
* Subject who is reperfused with 2b or 3 stages of thrombolysis in cerebral infarction (TICI) (However, if angiography is conducted for thrombectomy after IV tPA treatment and the effect of tPA results in TICI 2b-3 reperfusion, the subject can participate)
* Subject who can administer IP within 6.5 hrs of symptom development
* Subject who can administer IP within 30 min of vascular reperfusion
* Subject who can evaluate MRI within 90 min of vascular reperfusion

Exclusion Criteria:

* Subject who is contraindicated for endovascular recanalization
* Subject who has hypersensitivity to contrast agent or component of investigational product
* Prohibited or unable to perform MRI test
* Medical history that is related to bleeding
* History of hemorrhagic stroke within 6 months of study participation
* Subjects with chronic liver disorder
* Kidney disorder (Serum creatinine \> 3 mg/dL)
* Life expectancy is less than 3 months due to concomitant disease other than stroke
* Pregnant or lactating women
* Those who have taken tirofiban (anticoagulant agent) during endovascular recanalization therapy
* Those who have taken other investigational drugs and/or medical instruments 12 weeks prior to screening
* Subject is unable to be followed up
* Subject is deemed unable to participate the study in the opinion of the investigator.
Phenylephrine Versus Norepinephrine in Ophthalmic Surgery

In ophthalmic surgery the specific anaesthesiological challenges necessitate the administration of a combination of relatively high doses of hypnotics and analgetics. In order to preserve adequate organ perfusion, there is often a need to administer pharmacological agents for haemodynamic support. Depending on the experience of the anaesthetist a continuous infusion of phenylephrine or norepinephrine is used. It is currently not known which of these agents has the most favorable haemodynamical profile.

Haemodynamic parameters (continuous blood pressure, cardiac index, stroke volume and systemic resistance), peripheral tissue oxygenation and cerebral tissue oxygenation will be monitored noninvasively using the Nexfin® , Inspectra®, and Foresight® and O2C® monitoring devices.


Eligibility Criteria:
Inclusion Criteria:

Patients requiring general anaesthesia for ophthalmic surgery.

* Age \> 18 years and older
* Diabetes or cardiovascular disease or age \>55 years

Exclusion Criteria:

* Patient refusal
* Patient \< 18 years
Primary Care Online Emotion-regulation Treatment

We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.

Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and are creating substantial economic costs to society. Existing treatments are not fully addressing these problems because they focus on a subset of mental health problems; they are limited in efficacy; and are not provided to most youth in need. Transdiagnostic digital treatments that address mechanisms underlying mental health problems, such as emotion regulation, have been called for to address these problems. As an initial pilot study we will include 60 participants aged 12-17 years and their parents in a randomized controlled feasibility trial comparing a 6-week Primary care Online Emotion-regulation Treatment (POET) to a 6-week active Supportive Treatment (ST). Both interventions will be delivered in blended format combining online therapist-supported treatment modules with a video-link session. The primary study aims are to examine the feasibility and acceptability of study protocol and treatment protocols. Preliminary utility of the experimental condition will be evaluated by youth-reported, parent-reported, and clinical-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Presenting with mental health problems

Exclusion Criteria:

* Acute suicidality and severe mental illness that require specialized care
A Trial of SHR6508 in Secondary Hyperparathyroidism

The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving stable hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Conform to the ASA Physical Status Classification
6. Stably use of concomitant medication of other therapies of SHPT
7. Meet the standard of iPTH level, cCa and HB

Exclusion Criteria:

1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Subjects with a history of parathyroidectomy or planned during the study
8. Subjects with a history of kidney transplant or planned during the study
9. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
10. Subjects with a treatment history of similar drugs
11. Allergic to a drug ingredient or component
12. Pregnant or nursing women
13. No birth control during the specified period of time
14. Subject with a history of alcohol abuse and drug abuse
15. Participated in clinical trials of other drugs (received experimental drugs)
16. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

The main purpose of this project is to identify the medium-term prognostic factors for patients with Severe Acquired Brain Injuries and evaluate their impact.

The secondary aim is to create a system of continuous assessment of the quality of care for each rehabilitation unit.

For each unit involved, it will be collected these data :

* Structural and organizational data of the Rehabilitation Units for Severe Acquired Brain Injuries;
* Detailed information on patients upon entering Rehabilitation Units for Severe Acquired Brain Injuries;
* Detailed information on patients, re-evaluated 4 months after the acute event

Statistical models will be implemented, in order to identify prognostic factors that could predict the probability to observe three events, which represent objectives of the rehabilitation process: decannulation, trunk control and total feeding by os. These events should be evaluated four months after the acute episode.

Eligibility Criteria:
Inclusion Criteria:

* patients with Serious Acquired Brain Injuries
* admission to rehabilitation units

Exclusion Criteria:

- patients admitted more than 14 weeks after the acute event
Autonomic Modulation After Spinal Anesthesia With Depth of Anesthesia and Vital Signs.

Spinal anaesthesia has the advantage that produced nerve block by the injection of local anaesthetic into cerebrospinal fluid (CSF). However, the greatest challenge in spinal anaesthesia is to control the spread of local anaesthetic through the CSF to provide a block which is adequate for the proposed surgery without unnecessary extensive spread, and increased risk of complications.

The activity of the autonomic nervous system is of fundamental importance in the regulation of vital bodily functions. Unbalance of autonomic nerve system results in considerably disordered vital function. Clinically, this is of great significance, because if an anesthetic agent produces cause the sympathetic system to block, the effects can be serious in individual cases, particularly on the cardiovascular system. If complications are to be avoided, it is essential to assess the degree of block correctly. Clinical monitoring has a variety of applications, a particularly useful one being measurement of the sympathetic system during regional anesthesia, for which quantification of the blocking effect is a clinical necessity and the degree of block needs to be ascertained without delay. The autonomic nervous system (ANS) plays an important role in the regulation of hemodynamics during anesthesia. Analysis of beat-to-beat fluctuations of heart rate and blood pressure is a promising new approach to the clinical diagnosis and management of alterations in cardiovascular regulation. Continuous Wavelet Transform (CWT), which could overcome the limitation of the steady-state assumption in the classical spectral analysis, is believed as a reliable and robust method to access cardiorespiratory dynamics of the ANS and the investigators will applied during spinal anesthesia to evaluate the detail changes.

Eligibility Criteria:
Inclusion Criteria:

1. patients scheduled for operation with spinal anesthesia

Exclusion Criteria:

1. recently treat with a sedative, beta-blocker, parasympatholytic, or opioid agent
2. emergency surgery
3. hypovolemia and hypothermia, arrhythmia, diabetes, or impairment of renal, hepatic, coagulation, cardiac, or respiratory function
Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab

It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.

Biological factors will be correlated to clinical outcome measures.

100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.

Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.

Bevacizumab will be administered according to investigators appreciation.

Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line.
* At least one extra-osseous, non-irradiated, measurable site (\>= 10 mm with spiral CT).
* No prior radiotherapy treatment unless treatment is over for at least 4 weeks.
* Adult patients.
* PS \<= 2.
* Life expectancy greater than 3 months.
* Mandatory affiliation with a healthy security insurance.
* Signed written informed consent.

Exclusion Criteria:

* Prior chemotherapy for the metastatic cancer.
* Prior bevacizumab treatment.
* Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease.
* Patient deprived of freedom.
* Pregnant or lactating women.
VITAMIN D METABOLITES AS BIOMARKERS FOR THE IDENTIFICATION OF KIDNEY INJURY IN CARDIAC SURGERY

We will be measuring vitamin D metabolites in blood samples drawn from patients undergoing cardiac surgery to determine the correlation with renal function as assessed by serum creatinine. We will include 20 patients in each of the following 3 groups based on serum creatinine measured within 28-days of surgery: 1) normal kidney function (eGFR \> 60 mL/min, n=20), 2) moderate impaired kidney function, eGFR between 30 and 60 mL/min (n=20) and 3) severe kidney dysfunction eGFR \< 30 mL/min (n=20).


Eligibility Criteria:
Inclusion Criteria

* ≥ 18 years
* Patients undergoing cardiac surgery
* Serum Creatinine measured with 28 days of surgery

Exclusion Criteria

* Exogeneous calcitriol (1,25(OH)2D3) intake
* History of parathyroidectomy
* Patients with liver or kidney cancer
* Patients with liver disease (e.g. liver failure, cirrhosis)
Non-invasive Pain Monitoring in Post-operative Patients

During the current pain monitoring system the patient is awake and he/she is asked to give a numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop later a method/algorithm for automatic evaluation of pain (objective measurement of pain). The measurement is done using standard ECG electrodes placed in the hand palm of the patient. The patient feels nothing during the observations, perhaps irritation of skin may occur as result of long time measurement. As a comparison to the investigators prototype, a commercial device is also used in (randomly selected) patients, i.e. the MedStorm device.

The study will try to answer the following questions:

* Are the measurements with the ANSPEC-PRO correlated with the NRS values?
* What is the (mathematical) relationship between the measured values and the NRS?
* Is there difference between the two devices in measuring pain levels? And what is this difference if pain alleviation medication is given to the patient?
* A number of 26 patients is envisaged for this study, equally distributed to be evaluated with the two devices.


Eligibility Criteria:
Inclusion Criteria:

* patients postoperative of a painfull operation
* between 18 and70 years old

Exclusion Criteria:

* day surgery patients
* chronic pain patients
* taken medication : anticonvulsants
Effect of PMSCs and Their Secretome for the Treatment of GvHD

In this clinical trial study, 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. The method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential.

This study is a safety, feasibility, and efficacy trial that was conducted on eligible GvHD patients with the diagnosis of expert doctors after obtaining permission from the respected ethics committee and registering the trial at the Iranian Trial Registration Center. During the phone call, while stating the title and objectives of the study, the entry and exclusion criteria were checked. If they are eligible, they were asked to attend the Ghazi Hospital if they wish to participate in the study. In the face-to-face meeting, the objectives of the research were fully explained and the study criteria were re-examined. The written informed consent was obtained and questionnaires fulfilled three times which include personal-social characteristics, medical characteristics, appetite questionnaire, 24-hour food record (Food record), and family members. At the beginning of the study, 50 cc of blood was used to collect serum and to culture and condition mesenchymal stem cells. 200 men with GvHD were randomly assigned using random block method using blocks of 4 and 6 and RAS (Random Allocation Software) and allocation ratio 1:1 to two groups receiving intravenous secretome with The first protocol (30 people) and receiving the mesenchymal stem cells secretome of the second protocol (30 people) were allocated and they received the skin spray for 1 year. Participants in the first protocol group at the beginning of the study, day 3, end of the week, the end of the second week, and the end of the month 5 times and in the second protocol group at the beginning of the study, skin spray were done. The secretome of both groups was the same.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute GvHD with fever and requiring hospitalization

Exclusion Criteria:

* Patients with sepsis
Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Management at Primary Health Care

Type 2 Diabetes Mellitus is a chronic disease with increasing incidence globally. It needs a comprehensive and continuous management approach that includes five pillars: education, nutritional management, physical activity, pharmacological treatment, and monitoring. To achieve good glycemic control, prevention of complications, and good quality of life as diabetes management goals, patients' capability to properly navigate diabetes management is a key. One evidence-based model to empower patients' self-management abilities is diabetes education and health coaching. Diabetes management at primary health care needs special concern since they play an important role in initial and continuing care for diabetes patients in the community. Therefore, the implementation of diabetes education and health coaching in primary health care is expected to improve the self-management abilities of people with diabetes

A randomized control trial, pre and post study involving 180 subjects randomized into 2 arms:

* Control : received education in group
* Intervention : received education group + personal health coaching Education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.

Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.

Laboratory examination, anthropometric measurement, echocardiography, electrocardiography, Heart Rate Variability measurement, diabetic eye screening, and questionnaire collected at baseline, 3 and 6 months after intervention

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* \>= 18 years old
* Willing to follow the research by signing an informed consent

Exclusion Criteria:

* Patients with cognitive disease (such as dementia)
* Patients with hearing or sight problem
* Unable to live independently on daily basis
Nutraceutical on Hyperuricemia

The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and \< 7 mg/dl after 3 months of therapy.

The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and \< 7 mg/dl after 3 months of therapy.

Patients will be randomized to Uricemin® or placebo for three months. We will evaluate body weight, fasting plasma glucose (FPG), lipid profile, uricemia (UA), high-sensitivity C-reactive protein (Hs-CRP) at baseline and after 3 months since the study start. Treatment tolerability will be assessed evaluating transaminases, and creatinine, and all adverse events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with uric acid levels between ≥ 6 and \< 7 mg/dl
* Patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents)

Exclusion Criteria:

* Patients with previous gout attack
* Patients with impaired hepatic function
* Patient with impaired renal function
* Patients with gastrointestinal disorders
* Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
* Patients with weight change of \> 3 Kg during the preceding 3 months
* Patients with history of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Patients taking (within the previous 3 months) hypouricemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, antidepressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
* Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.
Assessment of Myocardial Tissue Damage in Aortic Stenosis

Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (IB), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS interval have a role in risk stratification for AS patients and to apply those methods to identify which patients would benefit from surgical intervention.

The investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of the severity of myocardial damage. The investigators will measure the severity of myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe aortic stenosis determined by echocardiography
* Adults \> 65 years old

Exclusion Criteria:

* Ejection fraction \< 50%
* Valvular diseases of more than or equal to moderate degree other than aortic stenosis
* Prior myocardial infarction or coronary artery disease needs revascularization
* Atrial fibrillation (chronic)
* Pacemaker/defibrillator implanted
* Previous valve replacement performed
* Cardiomyopathy(HCM, infiltrative cardiomyopathy, constriction)
* Renal dysfunction (estimated GFR \< 30ml/min/1.73m² or end stage renal failure)
* Patients with contraindication for MRI
* Patients with poor echocardiographic images