cyrilzakka/clinical-trials huggingface dataset:
Intracerebral Electrical Stimulation and the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy

Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct brain electrical stimulations is a standard clinical practice to assess seizure sensitivity and for functional mapping. However the efficiency of these stimulations can be questioned and could potentially be improved. Indeed, only two typical frequencies are commonly used in our epilepsy centre, 1Hz and 50Hz, without clear clinical or scientific justification for these specific frequencies.

This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies could improve the definition of the seizure onset zone and hence the presurgical planning. We will maintain the usual stimulation frequencies (standard clinical stimulations condition) and add new frequencies to the protocol (research stimulations condition). The choice of these new frequencies will be based either on the spontaneous frequency of the onset of the patients' typical seizures or on physiological frequencies depending on the brain structures stimulated (i.e., theta in the medial temporal lobe).

The protocol will be proposed to all patients undergoing a stereo-electro-encephalography (SEEG) in our epilepsy center and the efficiency of the two conditions (standard clinical stimulations condition vs research stimulations condition) will be compared. The efficiency will be assessed as any epileptic event, recorded in the intracerebral EEG or symptom induced by the stimulations. This project will last 36 months. 20 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old.

Exclusion Criteria:

* usual excluding criteria for a SEEG.
UC-MSC Transplantation for Left Ventricular Dysfunction After AMI

A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation

In this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord MSCs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of MSCs cell transplantation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade.
* Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form;
* Good compliance, willing to take drugs and follow up according to the requirements of the plan;
* Life expectancy exceeds one year.

Exclusion Criteria:

* Those who cannot tolerate cell therapy;
* Patients with severe hepatic and renal insufficiency (ALT\>1.5 times the upper limit of normal value, Cr \>1.5 times the upper limit of normal value);
* Patients with malignant tumors or extremely weak patients;
* Patients with severe infection;
* Patients who are expected to have the second coronary intervention or bypass grafting within 3 months;
* Patients with other serious systemic diseases and organ dysfunction;
* Patients with cardiogenic shock;
* Patients with hemorrhagic diseases;
* Researchers believe that anyone who is not suitable for inclusion
CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe

CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting

Traumatic brain injury (TBI) is among the leading causes of death and disability and the main cause of death among the under-45s. Most patients with moderate to severe TBI are admitted to intensive care units (ICUs).

The 'PROmoting patient SAFEty and quality improvement in critical care' ICU network was recently established in 6 European countries through European Union funding (PHEA 2007331), and has continued to collect high-quality data beyond the grant duration. In 2012, 242 ICUs had joined 'PROmoting patient SAFEty and quality improvement in critical care', recruiting a total of 85,965 patients. Of these ICUs, 180 admitted at least one TBI patient, totaling more than 3,300 cases. Hence, the network is expected to enroll 7-9,000 moderate-to-severe TBI patients in 4 years, in about 125 participating ICUs. The 'PROmoting patient SAFEty and quality improvement in critical care' consortium has already focused attention on TBI and has just started collecting additional information on this condition in order to develop a prognostic model to identify centers of excellence in TBI management. Aims of the CREACTIVE project are to consolidate the existing network in order to better describe the epidemiology of moderate-to-severe TBI in 7 countries (Cyprus, Greece, Hungary, Israel, Italy, Poland, Slovenia); establish centralized repositories of biological samples (blood and derived fluids, CSF) and clinical imaging data, to be exploit for prognostic purposes; build a prognostic model based on clinical and biological data to predict short- and long-term outcome; identify most effective clinical interventions for optimally treating TBI patients; recognize the determinants of optimal vs. suboptimal performance.

All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity, will be recruited. Centralized repositories of imaging data and biological samples for the analysis of phenotypic and genotypic biomarkers will be established for approx. 2,000 adult TBI patients.

Follow-up will be performed six months after the trauma event, and will be two-tiered. The first level will be administered over the phone and constituted of the extended version of the Glasgow Outcome Scale (GOSe) and a health-related quality of care questionnaire. The second level will encompass a patient's full examination that, for children, will include a dedicated sleep disturbances study. The second level follow-up will be performed in a selected subgroup of ICUs.

Eligibility Criteria:
Inclusion Criteria:

All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity,will be recruited.

Exclusion Criteria:

Absence of Informed consent
Prostatic Artery Embolization in Advanced Prostate Cancer

This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.

PAE has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction.

Advanced (defined as locally advanced, metastatic or both in this study) PCA is frequently associated with both of these conditions. The currently most frequently performed palliative surgical treatment is TURP. Though performed endoscopically, TURP is associated with significant side effects in this setting. PAE has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to TURP.

In addition, there is growing evidence that patients with advanced PCA might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). However, recent methods of cytoreductive treatment of PCA hold the risk of being highly invasive and are associated with severe side effects. PAE might represent a minimally invasive alternative in this setting.

Therefore, efficacy and safety of PAE in patients with advanced prostate cancer is assessed in this pilot-study.

Eligibility Criteria:
Inclusion Criteria

* Advanced PCA (i.e., locally advanced, metastatic, combination of both. This includes T3-4, any T in case of N1 and any T in case of M1a/b/c)
* PAE is indicated for the treatment of Lower urinary tract symptoms like bladder outlet obstruction or recurrent prostatic bleeding.
* IPSS at baseline ≥ 8
* Witten informed consent

Exclusion Criteria:

* Curative treatment of PCA intended
* Contraindications for MRI
* Renal impairment (GFR \< 30ml/min)
* Allergy to i.v. contrast medium
* Vascular conditions that seem to make successful PAE impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to PAE.
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure

The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 yrs - 80 yrs.
* patients with iliac and / or femoral artery atherosclerotic lesions
* Rutherford grade of 1-5;
* Target lesion stenosis≥70% (visual estimation) (proportion of Trans-Atlantic Inter-Society Consensus(TASC) B, C and D grade lesions not less than 60% )
* Patients being able to understand the purpose of the test, and being volunteered to participate in and sign the informed consent.

Exclusion Criteria:

* Patients not suitable for receiving interventional surgeries of lower limb arteries for treatment;
* Patients require intervention of lesions besides unilateral iliac and femoral artery lesions at the same time;
* Patients have been involved in clinical trials of other drugs or medical devices within the past three months;
* Patient is unable or unwilling to participate in this trial;
* Patients with serious heart and brain, liver and other vital organs failure;
* Patients with life expectancy less than 6 months;
* Pregnant women.
Rate of Pelvic Inflammatory Disease at St. Michael's Hospital

A retrospective review of women who came through the ER at SMH with a pelvic inflammatory disease (PID) or tubo-ovarian abscess (TOA) between 1995-2005. They were looking at people with this diagnosis to determine how they were treated, whether as inpatient or outpatient and whether they were treated with drugs and how were these given and also did they develop an abscess.


Eligibility Criteria:
Inclusion Criteria:

* women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000

Exclusion Criteria:

-
Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study

This study aims to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and a reference for clinical treatment of DPN moxibustion. Patients will be randomly assigned to 3 clinical centers, 30 in each center, and then equally divided into 3 groups, including a drug treatment group, a 15-minute moxibustion group, and a 30-minute moxibustion group. Patients in the drug treatment group were given mecobalamin tablets and epalrestat at the same time of daily treatment (hypertension and hyperlipidemia combined with basic drug treatment) for 4 weeks. The frequency of moxibustion was 15/30 minutes per acupoint twice a week for 4 weeks. The results were evaluated during the baseline period (the day before the grouping), the treatment period (the end of the 8th treatment), and the follow-up period (a month after the end of treatment). The results of this part are expected to confirm the therapeutic effect of moxibustion on diabetic peripheral neuropathy. The results of this part will be expected to confirm the optimal amount of moxibustion in the treatment of diabetic peripheral neuralgia and provide a reference for the standardization of clinical treatment of moxibustion.


Eligibility Criteria:
Inclusion Criteria:

1. History of diabetes mellitus;
2. Persistent pain and/or abnormal sensation in the extremities (at least in both lower limbs), decreased bilateral or unilateral ankle reflexes, decreased vibratory sensation (weaker in the medial ankle than in the medial tibial condyle), and decreased nerve conduction velocity on the affected side, and TCSS score \>5;
3. 18 years ≤ age ≤ 80 years;
4. Gender is not limited;
5. Those who have the ability of independent daily life and can cooperate to complete all the examinations;
6. Those who are conscious without serious mental diseases and cognitive disorders, and those who do not have serious cardiac, cerebral, hepatic, renal and other internal diseases;
7. Voluntary participation and signing of informed consent.

Exclusion Criteria:

1. Those with peripheral neuropathy, ulcers and gangrene of the limbs caused by various other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or those with a history of skin ulcers or lesions that do not heal easily;
2. Women who are in preparation for pregnancy, during pregnancy or breastfeeding;
3. Those with acute complications such as combined diabetic ketoacidosis, lactic acidosis, severe infections, etc.;
4. Those who suffer from serious liver or kidney damage or serious cardiovascular and cerebrovascular diseases (angina pectoris, myocardial infarction, multiple cerebral infarctions, cerebral haemorrhage, etc.);
5. Those who have scars or pigmentation on the skin of the testing site, which will affect the accuracy of the test;
6. Those who are participating in other acupuncture or drug clinical trials.
Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects

Polydextrose (PDX) (8-30g/day) has been reported to increase faecal bulk and consistency, leading to easier stool passage in healthy subjects. Studies on its effect on defaecation frequency and colonic transit time have provided mixed results. The primary objective was to investigate the effect of PDX consumption by mildly constipated subjects on faecal bulk, measured as total faecal wet weight of 4-day collections. Secondary outcomes (faecal dry weight, defaecation frequency, stool consistency, ease of stool passage, total colonic transit time and gastrointestinal symptoms) were also explored. 51 subjects participated in a 4-week, two-center, randomized, double-blind, placebo-controlled, parallel study testing a control (CON) and a PDX treatment (18 g/d included in biscuits and drink mixtures)


Eligibility Criteria:
Inclusion Criteria:

1. Mildly constipated healthy adults (who defecate 3- 5 days per week assessed by a 7-day bowel diary)
2. Provision of signed and dated informed consent prior to any study procedures
3. Body mass index (BMI) ≥ 19 and ≤ 29 kg/m2 at the screening visit
4. Total score on fibre intake questionnaire max 17 points for women and 20 points for men (where each point represents approximately 1 g fibre intake)
5. Use of adequate contraception in females of childbearing potential

Exclusion Criteria:

1. Regular use of laxatives
2. Use of medication which alters study subjects' gastrointestinal function (e.g. including but not exclusive neuroleptic medication, medication for Parkinson disease, opioids)
3. History of digestive disease (e.g. celiac disease, Crohn's disease, ulcerative colitis, gastrointestinal malignancy, fistula of intestine, ischemic colitis, bile acid malabsorption, repeated diverticulitis)
4. Type I and II diabetes
5. Previous major gastrointestinal surgery (e.g. intestinal resection, total gastrectomy, subtotal gastrectomy) or surgical treatment of obesity (within 6 months before the screening visit)
6. Present cancer (except basal cell skin cancer or squamous cell skin cancer, carcinoma in situ)
7. Untreated thyroid disease
8. History of stroke or myocardial infarction within six months prior the screening visit
9. Subjects who were actively dieting for weight loss, or had eating disorders (anorexia, bulimia)
10. Lack of compliance to the study procedures
11. Females who were pregnant or breast-feeding or planning pregnancy
12. Known or suspected abuse of alcohol (more than 14 units of alcohol per week, one unit = 4 cl spirit, 12 cl wine or 33 cl medium strong beer / cider),
13. Allergy/hypersensitivity/intolerance to study products
14. Vegetarians or regularly consuming fibre supplements/fibre supplemented foods
15. Any clinically significant disease/condition which in the Investigator's opinion could interfere with the results of the study
Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer

The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.

Biopsy and/or surgical samples from Her2-positive breast cancer patients treated with Trastuzumab alone or in combinations with other regimens of chemotherapy with known clinical outcomes will be collected and subjected to mRNA sequencing. Expression profiles will be analysed using original bioinformatic platform Oncobox. Based on comparison of molecular pathways activation strength and clinical response to Trastuzumab and chemotherapy, this study aims to identify molecular markers predicting efficacy of therapy with Trastuzumab and the possibility of further relapse.

Eligibility Criteria:
Inclusion Criteria:

* adult females
* histologically confirmed HER2-positive breast cancer
* available FFPE samples of breast cancer tissue
* patients treated with Trastuzumab alone or in combination(s) with other regimens of chemotherapy with known outcome according to RECIST 1.1
* stage II or more
* patients who have signed an informed consent

Exclusion Criteria:

* less than 70% of intact tumor cells in available FFPE samples
Clinical Characteristics and Pathophysiology of Post-Traumatic Headache

To better understand the clinical characteristics and complex pathophysiological events that constitute persistent post-traumatic headache (PPTH) and to identify possible calcitonin gene-related peptide (CGRP) hypersensitivity in PPTH patients.

The present project will embark upon identifying novel PTH-specific biomarkers by incorporating a plethora of scientific approaches. First, clinical biomarkers will be assessed by deep phenotyping of clinical characteristics and associated comorbidities using a semi-structured interview and multiple validated questionnaires. Second, biochemical biomarkers will be determined by plasma levels measurements of blood markers for headache hypersensitivity and neuronal/axonal damage. Third, imaging biomarkers will be established by magnetic resonance imaging (MRI) to assess structural and functional changes in the brain. Lastly, molecular biomarkers will be identified by examining whether intravenous infusion of calcitonin gene-related peptide (CGRP) provokes headache attacks mimicking the usual headache phenotype in subjects with PTH. This would determine whether PTH patients exhibit hypersensitivity to CGRP (molecular biomarker) and advance our understanding of the complex pathophysiological events that constitute the headache phenotypes in PTH sufferers.

Eligibility Criteria:
Inclusion Criteria for PPTH patients:

* 18-65 years of age
* Subject has PPTH in accordance with the diagnostic criteria of the International Headache Society (IHS)
* Concussion (mild traumatic brain injury) occured \> 12 months ago
* Subject, who are fertile women, must be on safe contraceptives

Exclusion Criteria for PPTH patients:

* Pre-trauma existing primary headache disorder (maximum 1 day/per month with tension-type headache) and medication-overuse headache
* \> 1 episode with a sustained concussion
* Whiplash
* Pregnant or lactating women
* Cardiovascular disease of any kind
* Hypertension on the experimental day
* Hypotension on the experimental day
* Pre-trauma existing psychiatric disorder of any kind - unless well-regulated
* Any anamnestic or clinical signs of any kind deemed relevant for the study by the physician examining the subject
* Any MRI contraindication and a wish of not being informed about unexpected MRI changes
Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions

The objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI(Body Mass Index) of 30 or less.

Exclusion Criteria:

* Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular, disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result not to be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
* All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
* Subjects who do no tolerate venipuncture will not be allowed to participate.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.