cyrilzakka/clinical-trials huggingface dataset:
AZD9496 First Time in Patients Ascending Dose Study

This is a phase 1 open label multicentre study of AZD9496 administered orally in patients with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic dose(s) in patients with or without ESR1 mutations will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of AZD9496

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 in Women with Estrogen Receptor Positive HER-2 Negative Advanced Breast Cancer

Eligibility Criteria:
Inclusion Criteria: Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling and analyses. Aged at least 18 years. Any menopausal status. Pre- or peri-menopausal women must have commenced treatment with an LHRH agonist at least 4 weeks prior to starting study treatment and must be willing to continue to receive LHRH agonist therapy for the duration of the trial. Histological or cytological confirmation of adenocarcinoma of the breast. ER-positive according to local laboratory; HER-2 negative. Metastatic disease or locoregionally recurrent disease which is not amenable to treatment with curative intent. Disease progression after at least 6 months of endocrine therapy for ER+ breast cancer. Radiological or objective evidence of progression on or after the last systemic therapy prior to starting study treatment. Receipt of ≤2 lines of prior chemotherapy for advanced disease. Females of child-bearing potential must agree to use adequate contraceptive measures, must not be breast feeding and must have a negative pregnancy test prior to start of dosing. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.

Exclusion Criteria: Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of advanced breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia. Presence of life-threatening metastatic visceral disease, uncontrolled central nervous system metastatic disease or symptomatic pulmonary lymphangitic spread. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection. Unexplained symptomatic endometrial disorders. Uncontrolled symptomatic thyroid dysfunction. Inadequate bone marrow reserve or organ function
The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Elderly

Neurocognitive disorders and hypertension occur commonly with aging. While, by definition, older adults are at high cardiovascular risk, there is no guideline exist currently on blood pressure management of elderly hypertension. However, studies have shown that in aging adults, high blood pressure helps prevent against cognitive decline, and low blood pressure on antihypertensive drugs could accelerate it. This study aims at investigating if pharmacological treatment of hypertension in the very elderly is influenced by presence and severity of neurocognitive disorders. Our research hypothesis is that the drug management of hypertension in patients 80 years of age or older more is all the less aggressive as the neurocognitive disorders are advanced.


Eligibility Criteria:
Inclusion Criteria:

* to be 80 years of age
* with history of hypertension and/or on hypertensive drug(s)

Exclusion Criteria:

* legal protection measure.
Relationship Between Endothelial Progenitor Cells and Revascularization Effect of Moyamoya Disease

Moyamoya disease is a chronic cerebrovascular disease，The typical pathological manifestations are the stenosis or occlusion of the distal internal carotid artery and/or middle cerebral artery, and the proximal anterior cerebral artery. Meanwhile, the abnormal vascular net, which is the smokey vessel, occurs at the bottom of the brain. Currently the pathogenesis of this disease is unknown. Limited studies have reported the expression of endothelial progenitor cells (EPCs) in moyamoya disease, but the results were inconsistent. Some investigators believe that the number of EPCs in peripheral blood of patients with moyamoya disease is increased, while others believe that the number of EPCs in peripheral blood of moyamoya patients is reduced. Therefore, the investigators need to find a more accurate detection method to confirm the growth of EPC in patients with moyamoya disease. At the same time, whether there is endothelial injury in patients with smoke disease, and the expression of endothelial cells (CEC) in patients with smoke disease, there is no research on this aspect at home and abroad.

Objective: Detect the expression of endothelial progenitor cells and endothelial cells from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics.

Design: A single center study, and planned to enroll 120 patients. The present study was to detect the quantities of EPC from peripheral blood in Moyamoya disease by flow cytometry, and to identify the relationship of endothelial progeIlitor cells and effect of the revascularization on Moyamoya disease. The present study also use cerebral ischemia animal model foe intervention experiment, to explore whether EPC can promote vascular remodeling effect of ischemic cerebrovascular disease, and to provide new thought for the treatment of chronic cerebrovascular disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Whole-brain vessels angiography or magnetic resonance arteriography (MRA) has the following manifestations: stenosis or occlusion of terminal internal carotid artery or the anterior cerebral artery and/or initiating middle cerebral artery; In the arterial phase, the abnormal smokey vascular net near the occlusive or stenosis lesion can be seen.
2. For patients with stable stroke, there was no acute or subacute cerebral infarction or cerebral hemorrhage, and at least 3 months before the last cerebral infarction or cerebral hemorrhage events.

Exclusion Criteria:

1. Exclude atherosclerosis, autoimmune diseases, meningitis, intracranial tumors, multiple neurofibromatosis, Down syndrome, craniocerebral trauma, radiation injury, and other underlying diseases that may cause smoke.
2. Acute or subacute cerebral infarction or cerebral hemorrhage were excluded.
COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

The Radiologically Isolated Syndrome (RIS) is defined as incidental Magnetic Resonance Imaging (MRI) abnormalities fulfil the criteria for dissemination in space, suggestive of multiple sclerosis. Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects.


Eligibility Criteria:
Inclusion Criteria:

* patients belong to the RISC cohort;
* totally vaccinated ou partially vaccinated patient
* vaccination status known

Exclusion Criteria:

* presented a first clinical event before the COVID19 vaccination
Learning Retention in Radiograph Interpretation

Learning retention after the deliberate practice of radiograph interpretation may be challenging for image types which are common enough to be clinically relevant but not so common that proficiency can be sustained through clinical practice. This is especially relevant for radiographs such as paediatric elbow films (EXR) that carry high risks for the patient if pathology is missed. Building on prior research in this area, this study will develop an innovative computer learning application for paediatric EXR interpretation. After an initial learning period, this study will quantitatively determine the rate of skill decay and the optimal timing for refresher-education.

Objectives Learning retention after the deliberate practice of radiograph interpretation may be challenging for image types which are common enough to be clinically relevant but not so common that proficiency can be sustained through clinical practice. This is especially relevant for radiographs such as paediatric elbow films (EXR) that carry high risks for the patient if pathology is missed. Building on our prior research in this area, this study will develop an innovative computer learning application for paediatric EXR interpretation. After an initial learning period, this study will quantitatively determine the rate of skill decay and the optimal timing for refresher-education.

Design A prospective cohort design with purposive sampling will be used to develop the EXR education intervention. A four arm randomized control trial will be used to test for the outcomes of skill decay and optimal timing of refresher education.

Setting The education intervention will be developed at two tertiary care children's hospitals. Study participants will include physicians from two large paediatric education networks in the United States (Paediatric Outcomes in Simulation Education) and Canada (Paediatric Emergency Research Canada).

Statistical analysis For the primary analysis, a four-group multi-level model with time-points nested within participants will be used. Secondary analyses will include a time series approach within each block of 20 test EXR to check for sequential effects, and between each block to determine whether we can efficiently model skill decay curves that can separate the underlying learning attrition curve from the effects of "boluses" of education.

Conclusion This study anticipates that learners will increase their learning of elbow radiographs by participating in the deliberate practice of radiographs, with skill decay over time that will be mitigated by refresher education. The results will allow evidence based recommendations regarding refresher education for learning from item banks of radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric and emergency medicine residents enrolled in an accredited residency in Canada and the United States

Exclusion Criteria:

* None
A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body

The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) of 18.0 to 31.0 kg/m2 (inclusive) at screening
* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive) at screening
* Healthy on the basis of physical examination, electrocardiogram and laboratory tests
* Maximum (at peak) platelet aggregation ≥ 40%
* Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen/epinephrine and collagen/ADP below the upper limit of normal range at screening

Exclusion Criteria:

* Known hypersensitivity to AC-076 or drugs of the same class, or any of their excipients
* Family or personal history of prolonged bleeding or bleeding disorders, intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers
* Platelet count \< 120 × 109 L-1 at screening
* Known platelet disorders
* Orthostatic hypotension at screening (i.e., decrease from supine to standing BP of \> 20 mmHg in SBP or \> 10 mmHg in DBP after being in standing position for 3 min)
* Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs or any medication with blood thinning activity within 3 weeks prior to study drug administration; or with any other prescribed medications (including vaccines) or over the counter medications within 2 weeks prior to study drug administration
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus

The aim of the study was the evaluation of cardiovascular and renal benefits of moringa oleifera and stevia rebaudiana Bertoni in patients with type 2 diabetes mellitus before and after 8 weeks of add-on therapy.

The investigators performed a non-randomized single-arm clinical trial with a before and after design, carried out from November 2016 and May 2017.

Intervention consisted of the administration of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days. Before and after intervention, the following were done by the participants: bioelectrical impedance analysis (BIA), blood pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests, kidney function tests, urinary excretion of albumin tests and full blood counts. These were followed by morphological workup including Electrocardiograms (ECGs), transthoracic heart ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done before and after intervention.

Clinical evaluation with fasting blood sugar control, blood pressure controls and urinary excretion albumin tests were done for safety purposes.

Eligibility Criteria:
Inclusion Criteria:

* Known T2DM patients aged above 21years
* No change in anti-diabetic medication during the last three months HbA1c between 42 to 64mmol/mol (6-8%)
* Clearance of creatinine calculated according to the Modification of Diet in Renal Disease equation\> 60ml/min/1.73 m2

Exclusion Criteria:

* Patient already on moringa or stevia supplementation or other herbal medication drugs that could interact with moringa or whose effects may be amplified, as far back as 1 month before study.
* Cardiac, renal disease and liver pathologies Sensitivity, intolerance or allergy to moringa or stevia Discontinued intervention
* Withdrawal of consent
Study Evaluating Refacto For Pharmacovigilance

The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Proven diagnosis of Hemophilia A

Exclusion Criteria:

* Contraindications according to Summary of Product Characteristics
Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes

It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.


Eligibility Criteria:
INCLUSION CRITERIA:

* Males and females 40 to 75 years of age (inclusive at the time of screening)
* Type 2 diabetes mellitus as defined by the WHO criteria, diagnosed for at least 1 year
* Subjects receiving 1.5 to 3g of metformin alone at a constant dose for at least 8 weeks prior to visit 1
* Patients with 6.5% \< HbA1c \> 8% at visit 1 and visit 2
* 25 \< BMI \< 35

EXCLUSION CRITERIA:

* Patient with type 1 diabetes
* Treatment with other hypoglycaemic agents than metformin in the last 3 months
* FPG \>200 mg/dL at visit 2
* Hypersensitivity to the studied treatments (rosiglitazone, metformin chlorhydrate, gliclazide)
* Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
* Respiratory insufficiency
* Subjects who have required the use of insulin for glycaemic control in the past 6 months prior to visit 1 (except during pregnancy or acute episodes such as hospitalization, trauma or infection) or subjects with a history of metabolic acidosis including diabetic ketoacidosis
* Anemia defined by haemoglobin concentration \<11.0 g/dL for males and \<10.0 g/dL for females
* Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135.0 µmol/L in males and ≥110.0 µmol/L in females and/or creatinine clearance \<40 mL/min
* Presence of clinically significant hepatic disease, with ALT, AST, total bilirubin, alkaline phosphatase \>2.5 times the upper limit of the normal reference range
* Subjects with chronic diseases requiring periodic ot intermittent treatment with oral or IV corticosteroids
* Subjects receiving danazol, miconazole or phenylbutazone
* Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
* Women who are lactating, pregnant or planning to become pregnant
* Any clinically significant abnormality identified at screening which, in the investigator's judgement, makes the subject unsuitable for inclusion in the study
* Use of any other investigational agent within 30 days or 5 half-lives (whichever is longer) prior to visit 1
* Subjects who receive or anticipate receiving radiocontrast dye during the study
Ultrasound-Guided Adductor Canal Block for Total Knee Arthroplasty Surgery

The ultrasound-guided selective blockade of the saphenous nerve in the adductor canal provides effective analgesia and reduces postoperative pain in patients undergoing arthroscopic medial meniscectomy. Selective blockade of the saphenous nerve in the adductor canal provides effective analgesia without quadriceps muscle weakness. It has been shown that the adductor canal block (ACB) block increases the spread of local anesthetics in a distal and proximal way. Therefore, the proximal spread of local anesthetics may cause possible quadriceps weakness. The distal spread of local anesthetics may increase analgesic effect via sciatic nerve. The different volumes for ACB is a topic of discussion. The aim of this study is to compare the different volumes of US-guided ACB performing for postoperative analgesia management after total knee arthroplasty surgery.

Knee arthroplasty is one of the most common orthopedic procedures. Patients may complain severe pain due to the surgical trauma and the prosthesis. Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation and respiratory depression. Peripheral nerve blocks such as femoral block, adductor canal block (ACB) may be performed to reduce opioid consumption and opioid-related side effects.

Selective blockade of the saphenous nerve in the adductor canal for knee surgery provides effective analgesia without quadriceps muscle weakness. This is an important advantage of ACB since it there is no motor blockade in the postoperative period. Blocking of the motor branches leads to delaying of the mobilization and it increases the patient's falling risk. ACB, targets the saphenous nerve and the vastus medialis branch which are the two largest sensorial nerves of the femoral nerve that innervates the knee. ACB blocks the articular branches of the obturator nerve at the same time. Since the ACB is performed at the distal site of thigh it does not target majority of the efferent branches of the quadriceps muscle, therefore the strength of this muscle may not be affected. ACB is usually performed with a volume of 10-30 ml and studies may be needed including different volumes to understand its effectiveness.

The aim of this study is to compare the different volumes (20 ml, 30 ml, and 40 ml) of US-guided ACB for postoperative analgesia management after total knee arthroplasty. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), motor blockage, the first mobilization time, and adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for total knee arthroplasty under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis,
* receiving anticoagulant treatment,
* known local anesthetics and opioid allergy,
* infection of the skin at the site of the needle puncture,
* pregnancy or lactation,
* patients who do not accept the procedure
Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

1. Purpose of the study

   -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction
2. Subjects of the study

   -Patients who have biliary obstruction owing to malignant tumors
3. Methods of the study

   * Prospective randomized controlled study
   * Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
   * Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
   * After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.

1. Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin \>= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
2. Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT \> 1.5 INR, PLT \< 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction

Eligibility Criteria:
Inclusion Criteria:

* distal biliary obstruction due to malignant tumor
* unresectable tumor
* Jaundice

Exclusion Criteria:

* Children
* Hilar obstruction
* Active infection
* Bleeding tendency