cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.


Eligibility Criteria:
Inclusion Criteria:

1. Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course.
2. 2.EDSS 0.0 - 6.5 inclusive
3. 18 to 55 years of age
4. 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions
5. Able and willing to sign and date an informed consent form

Exclusion Criteria:

1. Patients ever treated with Glatiramer Acetate or Mitoxantrone.
2. Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits.
3. Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
4. Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
5. Patients treated with intravenous or oral steroids within 28 days prior to initial MRI.
6. Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
7. Male patients and their partners must use contraceptive methods deemed reliable by the investigator
8. LVEF \< 50%
9. Patients using catheters or Foley catheters
10. Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: ALS, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), B12/folate deficiency, lyme disease, HTLV 1-myelopathy
11. Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate
12. Abnormal screening blood tests exceeding any of the limits defined below:

    Alanine transaminase (ALT) - twice the upper limit of normal Aspartate transaminase (AST) - twice the upper limit of normal Total white blood cell count \< 2.3 x 103/uL Baseline neutrophil counts of \< 1.5 x103/uL Platelet count \< 80 x 103/uL Creatinine \>1.5 mg/dL Prothrombin time greater than 150% upper limit of normal
13. Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by deficits in social communication, delay in language and repetitive behaviors. Results from genetic studies reveal one pathway associated with susceptibility to ASDs, which includes synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with ASD and search for circadian rhythms genes polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

* Patients with autistic spectrum disorders
* At least 6 years old
* Membership of a social security scheme
* Informed consent signed by the patient or both holders of parental authority if the subject is a minor, or by a guardian if the subject is under guardianship

Exclusion Criteria:

* Recent sleep symptoms
* Incapacity to keep rested for 24 hours
Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC

The purpose of this study is to compare the cost effectiveness, quality of life and outcomes of the endovascular stent graft repair with the open surgical repair of abdominal aortic aneurysms.

Abdominal Aortic Aneurysms have been traditionally repaired using the standard open surgical technique. The use of Endovascular stent grafts(EVAR) to treat aortic aneurysms has been ongoing for approximately 8-10 years. Use of EVAR to treat aortic aneurysms in high risk has been reported to be beneficial. However, the costs of this therapy are quite significant and therefore in order to best understand the cost effectiveness of this type of aneurysm treatment, an extensive prospective comparative evaluation is required. This study will compare outcomes and cost-effectiveness for patients receiving EVAR, with high surgical risk, and OSR, with low surgical risk, and OSR, where there is high surgical risk and not suitable for EVAR based on anatomical complexity. Demographic, medical, health care resource utilization, cost, and quality of life information is collected from participating patients over a period of a year following repair.

Eligibility Criteria:
Inclusion Criteria:

* infrarenal abdominal aortic aneurysm,
* \> 5.5 cm diameter
* scheduled for elective surgical repair

Exclusion Criteria:

* previous repair of AAA
TEE Image Quality Improvement With Our Devised Probe Cover

With using suction tube attached TEE probe cover, we will assess its pinpoint suction capacity on image quality and surgical decision making.

Background: Transesophageal echocardiography (TEE) has become a standard intraoperative diagnosis technique for clinical management of patients during cardiac and non-cardiac surgery. Accurate intraoperative diagnosis by TEE improves as image quality improves. Although we recently reported enhanced image quality using a TEE probe with an attached orogastric tube, its clinical significance is still unknown. Also, we are concerned about potential clinical complications including damage to the upper gastrointestinal tract due to its rough surface. Therefore, we devised a new TEE probe cover equipped with a suction catheter and ultrasound gel containing pad that functions as a cushion for preventing surrounding tissue trauma. Our long-term goal is to improve TEE image quality, which will help surgical decision-making with precise assessment. The study population will be elective cardiac cases and liver transplant cases at Henry Ford Hospital. The objective of this grant is to assess the image quality change with our newly designed TEE probe, and its clinical utility on patient care in different types of procedures.

Aim 1. To assess TEE image quality before and after pin-point suctioning with our newly designed TEE probe. We hypothesize that decreasing stomach air between the TEE probe transducer and tissue wall by pin-point suction with our newly designed TEE probe will reduce ultrasound reflection and lead to better image quality.

Aim 2. To evaluate the clinical utility of our newly designed TEE probe cover. We hypothesize our newly designed TEE probe cover will facilitate decision-making for both anesthesiologists and surgeons and it will not increase the occurrence of TEE probe related trauma.

Eligibility Criteria:
Inclusion Criteria: Cardiac procedures and liver transplants which had intraoperative TEE -

Exclusion Criteria: general contraindication with TEE, apparent complications which are related to TEE.

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A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.


Eligibility Criteria:
Inclusion Criteria

Prior Medication:

Allowed:

* Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Evidence of noncandidal systemic fungal infections.
* Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
* Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
* Leukemia requiring chemotherapy.
* Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.

Concurrent Medication:

Excluded:

* Warfarin.
* Immunostimulants.
* Interferon.
* Oral or topical antifungal agents.

Concurrent Treatment:

Excluded:

* Lymphocyte replacement.

Patients with the following are excluded:

* History of allergy to imidazoles.
* Abnormalities which may preclude esophagoscopy or endoscopy before or during the study.
* Inability to tolerate fluconazole or ketoconazole.
* Inability or unwillingness to give written informed consent.
* Life expectancy \< 2 months.

Prior Medication:

Excluded:

* Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole.
* Warfarin.

Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia.

Illicit or illegal drug use.
A Comparison of Seroquel vs. Risperidone in Schizophrenia

The purpose of this study is to show equal efficacy of both quetiapine and risperidone in subjects treated with study medication for up to 8 weeks.


Eligibility Criteria:
Inclusion Criteria

* Male / Female, 18-65 years old
* Schizophrenia (as per DSM IV)

Exclusion Criteria

* Concurrent use of psychotropic medication
* Does not fulfill moderately ill on CGI
Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients

The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.

Primary percutaneous coronary intervention (PCI) is currently the treatment of choice for patients with acute ST elevation myocardial infarction (STEMI). Nevertheless, despite restoration of normal epicardial flow, myocardial perfusion remains impaired in approximately half of patients and is associated with a poor prognosis. A variety of invasive and non-invasive techniques have been proposed to evaluate microvascular perfusion and several invasive hemodynamic measures have been closely associated with microvascular damage.In order to improve microvascular perfusion after primary PCI, a variety of treatment strategies have been developed, such as adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPIs). Although current ACC/AHA guidelines recommend that small molecule GPIs should be administered as a bolus followed by 18 hours of continuous infusion, changes in clinical practice may obviate the need for a maintenance infusion in current practice.

We hypothesized that when tirofiban is administered via intracoronary route, a bolus-only strategy may even be superior to intravenous bolus plus infusion strategy in maintaining myocardial perfusion. In order to evaluate microvascular function, we used a guidewire tipped with pressure and temperature sensors and measured the coronary hemodynamic parameters, as the index of microvascular resistance and coronary flow reserve, measures which have been closely associated with microvascular damage. In order to increase the predictive value of these indices, we performed these measurements four to five days after MI, because it has been shown that the extent of microvascular dysfunction changes, particularly within first 48 hours after reperfusion and stabilizes between 2 days and 1 week after perfusion

Eligibility Criteria:
Inclusion Criteria:

* Typical ongoing ischemic chest pain for longer than 30 minutes
* ST segment elevation of 0,1 mV or greater in at least two contiguous leads or a new left bundle branch block on the initial ECG.

Exclusion Criteria:

* Cardiogenic shock and / or clinical instability
* previous STEMI
* Malignant life threatening diseases
* Presence of an additional lesion causing more than 50% narrowing distal to the culprit lesion
* Contraindications to aspirin, clopidogrel, or heparin
* inability to give informed consent.
Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer

RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance.

PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.

OBJECTIVES:

* Identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (RIGs).
* Provide retrospective data on the predictive value of RIGs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance.

OUTLINE: This is a multicenter study. Patients are stratified according to response during tamoxifen citrate (TAM) therapy (resistant group \[i.e., those who develop recurrent breast cancer while being treated with TAM\] vs conditionally sensitive group \[i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with TAM\]).

Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy, and then every 6 months for 3 years or until relapse, whichever comes first. Samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional blood sample is obtained from patients at the time of relapse, if available.

Patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer

  * Initial pathologic stage I-IIIB disease
  * No stage IV disease
* Meets the following criteria for breast cancer therapy:

  * Received prior primary local therapy for breast cancer
  * Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks
* Hormone receptor status:

  * Estrogen-receptor positive tumor
* Female
* Pre- or post-menopausal
* Must be able to donate 20 mL of blood

Exclusion Criteria:

* Severe anemia, defined as hemoglobin \< 11 g/dL
* Psychiatric history that would preclude obtaining informed consent
Central Nervous Processing of Visual Food Stimuli in Severely Obese Subjects

Recent evidence has pointed to distinct alterations of brain functions in obese subjects some of which may even be causative for their obesity. The objective of this study was to examine food and non food related alterations in brain functions after excessive weight loss due to Roux-en Y gastric bypass surgery (RYGB), one of the most successful therapeutic approaches for long lasting weight loss. The investigators hypothesized that obese as compared with lean women show an altered activation pattern in the brain areas involved in the homeostatic regulation of eating behavior, i.e. the hypothalamus, in reward-related brain areas, such as the orbital frontal cortex (OFC) and the striatum as well as in prefrontal inhibitory control areas. Furthermore, the investigators hypothesized that women who had undergone a RYGB operation show a brain activity pattern that more closely mimics that of lean than severely obese women. In a supplementary test the investigators will assess gastrointestinal and metabolic response to a standardized meal in order to elucidate putative correlation of these responses with the results of fMRI scannings.


Eligibility Criteria:
Inclusion Criteria:

* women with BMI \> 35kg/m2
* women, who had undergone gastric bypass surgery at least one year ago
* lean women

Exclusion Criteria:

* known psychiatric or neurological diseases
* current medication with drug acting on the central nervous system
* drugs that are known to affect eating behavior
* contraindication for the fMRI scanning, e.g. metal implants or metal containing tattoos
Ultrasound Scanning of Vascular Access Sites

Inadvertent puncture of an unintended object in a vascular access procedure is common and can lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while targeting the internal jugular vein (IJV), for example, is reported to have an incidence of 2% - 8% and usually results in localized hematoma formation. The hematoma may enlarge rapidly if the patient is coagulopathic, or if a large puncture wound is produced by the introduction of the sheath itself into the CCA. Airway obstruction, pseudoaneurysm, arterio-venous fistula formation and retrograde aortic dissection have all been reported as a consequence of CCA puncture. In the presence of occlusive (atheromatous) carotid disease, inadvertent puncture may carry the risk of precipitating a cerebrovascular accident.

In this study, we aim to collect color Doppler and B-mode ultrasound videos from the most common ultrasound-guided vascular access sites - internal jugular vein, subclavian vein, femoral vein, basilic vein, and brachial vein. The videos will also include structures in close proximity to the intended veins. Using such database, we will run various vessel tracking and identification algorithms to evaluate their performance. Our ultimate goal is to develop an algorithm that will aid the ultrasound operator in identifying structures and differentiating between arteries and veins.

Inadvertent puncture of an unintended object in a vascular access procedure is common and can lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while targeting the internal jugular vein (IJV), for example, is reported to have an incidence of 2% - 8% and usually results in localized hematoma formation. The hematoma may enlarge rapidly if the patient is coagulopathic, or if a large puncture wound is produced by the introduction of the sheath itself into the CCA. Airway obstruction, pseudoaneurysm, arterio-venous fistula formation and retrograde aortic dissection have all been reported as a consequence of CCA puncture. In the presence of occlusive (atheromatous) carotid disease, inadvertent puncture may carry the risk of precipitating a cerebrovascular accident.

In this study, we aim to collect color Doppler and B-mode ultrasound videos from the most common ultrasound-guided vascular access sites - internal jugular vein, subclavian vein, femoral vein, basilic vein, and brachial vein. The videos will also include structures in close proximity to the intended veins. Using such database, we will run various vessel tracking and identification algorithms to evaluate their performance. Our ultimate goal is to develop an algorithm that will aid the ultrasound operator in identifying structures and differentiating between arteries and veins.

Eligibility Criteria:
Inclusion Criteria:

* The subjects will be any person age 18 and older who can legally consent to being scanned by ultrasound

Exclusion Criteria:

* No exclusion criteria shall be based on race, ethnicity, gender, pregnancy status, or HIV status
Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity

The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.

The study period per patient is 7 to 14 weeks: a screening period (1 to 8 weeks) will precede a 4-week double-blind treatment period and a 2-week follow-up period.

During the screening period, patients will be asked to start or continue adequate diet and exercise and to stop their lipid-lowering medication (for not treatment-naïve patients). For patient taking any lipid-regulating medication, a minimum of 8-week wash-out from lipid-regulating therapies (fibrates, statins, ...) is required.

Eligibility Criteria:
Inclusion Criteria:

* Male or post-menopausal female.
* Waist circumference ≥102cm for male, ≥ 88cm for female.
* Atherogenic dislipidaemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise).
* 150≤ fasting TG ≤ 600 mg/dL (1.69 ≤ fasting TG ≤ 6.78 mmol/L) at V2.
* Fasting HDL-C ≤ 40 mg/dL (≤ 1.03 mmol/L) for male, HDL-C ≤ 45 mg/dL (≤ 1.16 mmol/L) for female at V2.

Exclusion Criteria:

* Body Mass Index (BMI) ≥ 40 kg/m².
* Blood Pressure \> 160 / 95 mmHg.
* Type I or type II Diabetes Mellitus.
Comparison of the LMA Protector and the I-gel

Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.


Eligibility Criteria:
Inclusion Criteria:

* Requirement for mechanical ventilation under general anesthesia

Exclusion Criteria:

* Surgical position other than supine position
* Tumors or anatomical abnormalities in the upper airway
* Known or predicted difficult airway
* Body mass index \> 30 kg/m2
* Required postoperative mechanical ventilation
* Head and neck surgery
* Aspiration tendency
Child and Infant Learning Project

To learn more about the cognitive and motor development of infants and young children born with a craniofacial defect called craniosynostosis.

In the first phase of this multi-site, 10-year longitudinal study, infants with one of four types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral coronal, and left unilateral coronal. A case-matched "control" group of healthy, normal infants was also followed. This study, which is now in its second phase, is following this same cohort of children at the age of 7 years.

Eligibility Criteria:
Enrollment criteria at Phase 1:

* Confirmed diagnosis of single-suture, nonsyndromic craniosynostosis (sagittal, metopic, unilateral coronal, or lambdoid)
* Corrective (cranioplastic) surgery not yet performed
* Child born at 34 weeks gestation or later
* Absence of neurological conditions/significant health problems
* 33 months or younger at time of enrollment (male or female).

Enrollment criteria at Phase 2:

All participants enrolled in phase 1 are invited to participate in phase 2.