cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent

This is a pilot study of patients with clinical symptoms of Ménière's disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures.

The goal is to reproduce imaging findings described by non-United States (US) institutions, improve on image quality with decreased scan time and evaluate the dynamics of the contrast movement into the inner ear structures.

Participants will be scheduled for study sessions on 2 consecutive days to include consent, baseline audiometric evaluation, intra-tympanic contrast administration, serial MR imaging, and follow-up audiometry evaluation in the injected ear.

Participants over 59 years old or who have medical conditions will have a blood test to check kidney function to ensure they can safely receive the contrast.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms and clinical exam consistent with Ménière's disease
* Ability to undergo MR exam
* Interest in participating in this study
* Ability to provide informed consent

Exclusion Criteria:

* Children (under age 18),
* Contraindication to MR imaging (see attached UCSD MR Screening Form)
* Claustrophobia precluding MR exam without sedation
* Contraindication to receiving intravenous gadolinium-based contrast agent (see attached UCSD Contrast Policy)
* Patients who are pregnant or breast feeding (intravenous contrast agents are Category C)
* Contraindication to osmotic challenge (congestive heart failure, renal failure, hepatic failure)
Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates

The purpose of this study is to compare Measurements of Arterial Blood Pressure by L\&T NIBP Module With Invasive Arterial Blood Pressure in Neonates.


Eligibility Criteria:
Inclusion Criteria:

* Neonates admitted to NICU in whom arterial catheterization (radial or umbilical) was clinically indicated for a purpose other than for the comparative study.

Exclusion Criteria:

* All neonates in whom arterial catheterization was not clinically indicated.
* If minimum of 5-paired measurements is not obtained either due to technical or clinical reason.
Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

This study will determine whether the psychological benefits of expressive writing extend to diabetic patients, how long the benefits will last, and whether additional expressive writing "booster" sessions will lead to greater and more sustained improvement in diabetes symptoms and well-being.

Diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower extremity amputation in the United States. Conditions such as stress and depression have been shown to worsen diabetic symptoms. Data indicate that expressive writing (an activity during which individuals deal with stressful experiences by writing about them on paper) has beneficial effects on psychological and physiological outcomes. This study will determine whether diabetes patients can benefit from expressive writing. This study will also determine the duration of the benefits and the effectiveness of booster sessions in improving their diabetic symptoms.

Participants will be randomly assigned to engage in expressive writing or neutral writing for 18 months. Participants in the expressive writing group will write about traumatic or stressful events; participants in the neutral writing group will write about neutral topics that do not affect them emotionally. Some participants in the expressive writing group will receive an additional 4 months of booster sessions of expressive writing. All participants will undergo interviews, blood collection, physical exams and complete clinical scales on their disease status, quality of life, and psychological well-being; these assessments will occur at study entry, every 4 months during the study, and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus made after age 24

Exclusion Criteria:

* Diabetes-related emergency room visit within 3 months prior to study entry
* Use of psychiatric medication within 3 months prior to study entry
* Visual or manual limitations that preclude reading and writing
* Use of insulin within the first year of diabetes diagnosis
* Pregnancy or plan to become pregnant
The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

Voiding dysfunction including overactive bladder, underactive bladder, and neuropathic bladder. Voiding dysfunction has a great impact on life quality, especially in the elderly society. The current medication for overactive bladder has limited efficacy and the patient easily to dropout the medication because of its side-effects. The underactive bladder is a new entity of voiding dysfunction, its optimal is still unknown. Sacral neuromodulation(SNM) and posterior tibial nerve stimulation(PTNS) have been applied for both overactive bladder and underactive bladder treatment and the results is promising, but the equipment of SNM or PTNS is not available in most places. Prolotherapy using glucose local injection causing inflammatory reaction to stimulate cytokine and growth factors release. Investigators combined the concepts of posterior tibial nerve stimulation and prolotherapy to treat voiding dysfunction. Investigators anticipate it maybe a new promising treatment for voiding dysfunction.

Inclusion criteria:1. Adults over 20 years-old. 2. The patient who meets the diagnostic criteria of overactive bladder or underactive bladder. 3. The patient who capable to complete 3-days voiding diary and the questionnaire. Exclusion criteria: 1. The patient has severe stress urinary incontinence, severe pelvic organ prolapse, acute urinary tract infection, urolithiasis, or urinary tract malignancy. 2. The patient who has active skin disease on legs or not suitable for leg local injection. 3. Pregnant women. Method: 40 overactive bladder patients and 40 underactive bladder patients. The patients will receive 5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks, then the patients will be followed up once-a-month for 3 months. OverActive Bladder Symptom Score(OABSS), Core Lower Urinary Tract Symptom score(CLSS) questionnaire, 3-days voiding diary, and urine nerve growth factor are used for assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 20 years-old.
2. The patient who meets the diagnostic criteria of overactive bladder or underactive bladder.
3. The patient who capable to complete 3-days voiding diary and the questionnaire.

Exclusion Criteria:

1. Severe stress urinary incontinence or severe pelvic organ prolapse.
2. Acute urinary tract infection.
3. Active hematuria, urolithiasis, or neoplasm of urinary tract.
4. Acute skin lesion over the ankle injection site or the patient who could not tolerate ankle injection.
5. Pregnant women.
Giant Cell Arteritis and PET Scan (GAPS) Study

Giant cell arteritis (GCA) is a medium to large vessel vasculitis with a predilection for the superficial cranial and intrathoracic arteries. Diagnosing the condition and predicting which patients will develop large vessel complications remains a challenge. There are limitations with temporal artery biopsy, magnetic resonance angiography and ultrasound of temporal arteries and American College of Rheumatology classification criteria.

Positron emission tomography (PET) has been shown to be a useful modality in detecting inflammation in large intra-thoracic vessels but previously has not been able to accurately detect FDG uptake in the superficial cranial arteries due to poor spatial resolution. Newer scanners can perform finer cuts of the head and can detect uptake in these arteries.

This study has three main components:

1. Cross sectional study assessing the accuracy of PET uptake in the superficial cranial and intrathoracic arteries of suspected GCA patients for the diagnosis of GCA
2. Cohort study assessing the prognostic implication of FDG aortic uptake on aortic diameter at 24 months
3. Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without FDG PET uptake at 0, 6 and 24 months


Eligibility Criteria:
Inclusion Criteria:

* Rheumatologist, neurologist or ophthalmologist suspect diagnosis of GCA
* Age \> 50
* Meet at least 2 of 1990 American College of Rheumatology classification criteria for GCA

  1. Age \>= 50
  2. ESR \>= 50
  3. New onset localised headache
  4. Temporal artery abnormality (tenderness or decreased pulsation)
  5. Positive biopsy (will not be available at time of enrolment)

Exclusion Criteria:

* Corticosteroid therapy for \> 72 hours before first PET scan
* Prolonged corticosteroid therapy (\> 1 week) for another indication in past 6 months
* History of vasculitis or connective tissue disease
* Active malignancy
Efficacy of Acupuncture for Discogenic Sciatica

This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.

Background: Sciatica is primarily caused by herniated discs with nerve-root compression. Acupuncture may effectively relieve the pain of discogenic sciatica, but the evidence is limited.

Methods/Design: Sixty patients with discogenic sciatica will be recruited and randomized to receive acupuncture or sham-acupuncture at a 1:1 ratio. Patients in both groups will receive treatment 3 times per week for 4 weeks. The following acupoints will be used: Dachang shu (BL 25), Shenshu (BL 23), Weizhong (BL 40), and Chengshan (BL 57).

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral leg pain diagnosed as discogenic sciatica;
2. Sciatica patients with an average leg pain VAS of 40 mm or higher in the last 24 hours;
3. Aged 18 to 75 years;
4. Leg pains that correlate with CT or MRI findings of lumbar disc herniation;
5. Patients who agree to follow the trial protocol.

Exclusion Criteria:

1. Severe cases with central or giant or ruptured lumbar disc herniation, cauda equina syndrome, foot drop, or surgery requirements;
2. Progressive neurological symptoms after 3 months of strict conservative treatment (e.g., nerve root adhesion, crossed straight-leg testing, or obvious muscle atrophy);
3. Severe cardiovascular, liver, kidney, hematopoietic system diseases, autoimmune diseases, or poor nutritional status;
4. Subjects with cognitive impairment;
5. Pregnancy;
6. Subjects who received acupuncture for sciatica within the past month.
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis

This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.

To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged ≥19 and \<75 years
* Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP)

Exclusion Criteria:

* Patients ineligible for gastroscopy
* Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP.
* Patients who have to continue taking drugs that may induce gastritis
* Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study
Ambulatory Lumbar Disk Surgery

Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in surgery for lumbar disc herniation.

Patients included: All patients in the neurosurgery department of the University Hospital of Reims or in the neurosurgery department of CHG Chalons en Champagne for surgical management of lumbar disc herniation and agreeing to participate in the research. The types of anesthesia (general anesthesia or spinal anesthesia) will be randomized.

Investigation Plan: Participation in the research will be available to any eligible patient during the anesthesia consultation prior hospitalization for surgery. If the patient agrees to participate in research, randomization of the anesthetic technique will be realized. The anesthetist and the patient will be informed of the outcome of this randomization. Hospitalization of patients will not be changed. They will be hospitalized in inpatient, as usual, with an entry the day before surgery and an outlet the next day (without complications). The surgery itself will not be changed. The patient's postoperative monitoring will not be changed. Data will be collected for each patient: demographic data, medical data, data about the intervention and anesthesia, postoperative data management.

Eligibility Criteria:
Inclusion Criteria:

* single lumbar disk herniation elective for surgery

Exclusion Criteria:

* Patients with haemostatic disorder
* Patients with lumbar spine surgery history
* Patients with sciatica called "hyperalgesia" resistant to treatment including systemic corticosteroids and 3 WHO bearing analgesics (oral morphine)
* Patients with true paralyzing sciatica with motor disorders compatible with the path of the root compressed by the herniation
* Patients with sphincter disorders
* Patients with herniated disc multistage
* Pregnant women
* Patients with comorbid against-showing the elongated position, including cardiorespiratory comorbidities
* Minors patients
* Patients protected by law.
Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1 or Type 2 diabetes mellitus according to American Diabetes Association (ADA) or World Health Organization (WHO) guidelines with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
* Patients with visual impairment due to focal or diffuse Diabetic Macular Edema in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
* The study eye must fulfill the following criteria at Visit 1:

  * Best-Corrected Visual Acuity (BCVA) score between 78 and 39 letters, inclusively, using Early Treatment of Diabetic Retinopathy (ETDRS) chart-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160).
  * Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.
  * Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.

Exclusion Criteria:

* Ocular concomitant conditions/ diseases:

  * Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment.
  * Active intraocular inflammation in either eye.
  * Any active infection in either eye.
  * History of uveitis in either eye.
  * Uncontrolled glaucoma in either eye.
* Ocular treatments:

  * Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study.
  * Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry.
* Systemic conditions or treatments:

  * History of stroke
  * Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine level \> 2.0 mg/dL.
  * Untreated diabetes mellitus
  * Blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg
* Compliance/ Administrative:

  * Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

Age-related hearing loss (ARHL), like neurodegenerative diseases, appears insidiously with age. As major public health issues, they are nonetheless under-diagnosed because the presence of one can hinder the objectification of the other.

The CogAudio project aims to detect early and in an ambulatory mode in a memory centre a speech perception disorder in noise thanks to the VRB test in patients weakened by cognitive disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patient with mild to moderate cognitive impairment, with an MMSE score ≥15/30
* Patient mastering the French language
* Patient who has given written consent to participate in the trial
* Socially insured patient
* Patient willing to comply with all study procedures and duration
* Patient accompanied by a study partner

Exclusion Criteria:

* Medical history of diagnosed deafness, fitted or not
* History of progressive otological pathology or presence of tympanic obstruction (\>1/3 of the surface of the eardrum)
* History of unstabilized psychiatric pathology
* Major visual impairment (Age-Related Macular Degeneration AMD...)
* Established diagnosis of major language disorders (Primary Progressive Aphasia APP...)
* Major under legal protection measure
Screening for Depression and Anxiety in Patients With Heart Disease

Depression is a risk factor for morbidity and mortality in patients with heart disease, and has a negative impact on quality of life, work capacity and treatment adherence. Screening for depression among heart patients are therefore recommended by the Norwegian Health Authorities. Also, symptoms of anxiety may negatively affect rehabilitation due to e.g. fear of physical activity and excessive worry. Patients currently receiving treatment for heart disease at Diakonhjemmet Hospital will be screened for symptoms of depression and anxiety. If such symptoms are detected, patients will be offered a counselling session with a clinical psychologist. Further, routines for collaborative communication between clinical psychologist, cardiologist and the patient's general physician will be emphasized.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years under treatment for myocardial infarction, heart failure, tachyarrhythmia and/or valvular heart disease at the Department of Internal Medicine, Diakonhjemmet Hospital.

Exclusion Criteria:

* Unable to provide informed consent.
* Unable to read and/or understand Norwegian.
* Unable to complete a survey.
Pain Types and Pain Severity in Chronic Low Back Pain

The aim of this study is to characterize the distribution of pain phenotypes in people with chronic low back pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life.

Participants will be examined to determine the type of pain and questions will be asked to identify the effects.


Eligibility Criteria:
Inclusion Criteria:

* having chronic low back pain
* be over 18 years old

Exclusion Criteria:

* Those under the age of 18
* Those with major psychiatric illness,
* Those with communication problems
Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

This is an observational retrospective cohort study of all patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary referral centre between 2009 and 2015. Patients were excluded if they were non-elective cases or had complex aortic aneurysms (juxta-renal, thoraco-abdominal or thoracic). Differences between both groups of repair were assessed, as well as short- and long-term complications including medical complications, duration of hospital stay, major cardiovascular events, mortality and vascular reintervention.


Eligibility Criteria:
Inclusion Criteria:

* This is an observational retrospective cohort study of all patients consecutively submitted to elective AAA surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015.

Exclusion Criteria:

* The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.
The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials

Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain will alter the binding properties of (\[11C\]diprenorphine), a molecule that can be used during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI) imaging will be used in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults, 21 to 50 years of age
* No contraindications to fMRI and PET scanning
* Within 15% of ideal body mass index (BMI)

Exclusion Criteria:

* Current significant medical, neurological, or psychiatric illness as assessed by the Physician Investigators
* Women who are pregnant or breast feeding, have gone through menopause, and/or have irregular menstrual cycles
* Claustrophobia
* History of head trauma
* Instability of responses to experimental pain (See Study Procedure Section Part II)
* History of asthma
* Use of psychotropic drugs or hormone treatments (including hormonal birth control) within one year of date of consent
* History of smoking
* Routine exercise in excess of one hour per day and/or three times per week
* Non-fluent English speaker
3D Echocardiography Managing Infantile Pompe's Disease

Pompe's disease, also known as glycogen storage disease type II, is a genetic disorder due to deficiency of acid glucosidase (GAA), which results in lysosomal glycogen storage in various tissues.

Very low levels of GAA usually present in infancy, lead to a progressive cardiac and skeletal muscle disorder and death before age 1 year.

Most infants develop massive hypertrophic cardiomyopathy which progresses to dilated cardiomyopathy and cardiorespiratory arrest.

3D echocardiography can be a simple, non-invasive method of following cardiac disease progression in infantile Pompe's disease.

We report the utilization of real-time 3D echocardiography and new in-line software to calculate cardiac mass, volume and function in two cases of infantile Pompe's Disease. Furthermore, the multi-dimension cine loop showed the severity of cavity obliteration during the cardiac cycle.

We present 2 cases seen at our institution between January - February, 2005 in infants ages 1 and 5 months, both with cardiac signs as initial presentation. The younger infant had cardiomegaly since birth and was hospitalized briefly for respiratory distress at 1 month. The older infant, diagnosed at 4 months with hypertrophic cardiomyopathy, was hospitalized after cardiac arrest one month later. Both children had various tests done during the course of diagnosis and treatment, including GAA enzyme assay, cardiac catheterization, endomyocardial biopsy, developmental assessment, genetic evaluation, EKG, CXR and echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Infant seen at Children's Healthcare of Atlanta, Egleston January - February, 2005 Infantile Pompe's Disease

Exclusion Criteria:

* Those who do not meet inclusion criteria