cyrilzakka/clinical-trials huggingface dataset:
Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease

Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)


Eligibility Criteria:
Inclusion criteria :

* Patient aged 18 and older treated in Fondation Rothschild (tertiary ophthalmology facility, Paris, France) from January 2006 through April 2015
* Presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia.
* The presence of at least one pretherapeutic MRI confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. The mandatory minimal MRI protocol include the following sequences: T1- and T2-weighted MRI image, in the transverse and coronal plane, and a fat-suppressed T1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate.
* Completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for IgG4.

Exclusion criteria :

* Clinical and biological signs of thyroid-associated orbitopathy
* Histologically proven lymphoma
* Pretherapeutic MRI that is insufficient for an adequate interpretation
* Absence of IgG4 testing in the pathology examination
The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers

This study examines the relationship between self-compassion and wellbeing in new mothers and whether an online self-help course for new mothers can help to improve their wellbeing and self-compassion.

This study is a randomised controlled trial (RCT) comparing an online self-help course ('Kindness for Mums') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 6) and at follow-up (week 12). Baseline data will also be used to examine the relationship between self-compassion and wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* New mothers (can be biological, adoptive or full-time foster mother)
* Able to complete baseline measures when infant aged 0-12 months
* Fluent in English
* Live in the United Kingdom
* Able to access the internet

Exclusion Criteria:

* Experiencing suicidal ideation at the time of enrolment
Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke

First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.

This is a prospective, single-arm, single-centre clinical safety and efficacy research.

The purpose of the study is to evaluate safety and efficacy the device designed by iVascular for thromboaspiration (iNstroke) in patients who have suffered a stroke and who undergo thromboaspiration due to an acute occlusion of neuro vessels.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion and receiving neurointerventional treatment with the iNstroke aspiration catheter.
2. Informed consent signed by the patient or their representative.
3. Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6 and occlusion of a large vessel (TICA, M1, and tandem with TICA or M1 occlusion, vertebral or basilar).
4. In those patients with more than 8 hours of symptom onset or with stroke on awakening or unknown onset stroke, treatment should be individualised and there should be a penumbra area in CT perfusion.
5. Baseline NIHSS obtained before procedure of ≥6 points.

Exclusion Criteria:

1. Patients under 18 years of age.
2. Patients with an ASPECTS score \<6.
3. Baseline NIHSS obtained before procedure of ≤ 6 points.
4. Severe comorbidity and/or shortened life expectancy
5. ERm \>2.
6. Severe allergy to contrast media.
7. Pregnant women.
8. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
9. Medical history of plateletopenia (Platelets \<100,000)
Frequency of Glucose Monitoring in Labor

The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.


Eligibility Criteria:
Inclusion Criteria:

* All female patients of reproductive age who have the diagnosis GDM
* Patient with singleton gestation presenting in labor or for induction

Exclusion Criteria:

* Patients below the age of 18
* Multiple gestation pregnancy
* Patients undergoing scheduled c-section
Catheter in the Prevention of Urinary Tract Infections and Crystallization Study(CPUTICS)

This is a single-center randomized controlled trial in comparison of Parylene-Coated versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization.

This study was a single-center randomized controlled trial, enrolling patients with indwelling urinary catheterization time greater than 2 weeks, and comparing the incidence of urinary tract infections in the two groups with different indwelling urinary catheter times by retaining mid-stream urine specimens for bacterial cultures on the 3rd, 7th, 10th, and 14th days after urinary catheter placement. And after removal of the urinary catheter,1-cm sections were taken from the head end and center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope. The incidence of urinary tract infections and crystal deposition on the inner wall of the catheter were compared between the patients in the matte catheter group (Parylene-coated) and the patients in the glossy catheter group (plain silicone) during the period of catheterization, so as to evaluate the effectiveness of the two types of catheters in the clinical application.

Eligibility Criteria:
Inclusion Criteria:

1. age greater than 18 years;
2. indwelling urinary catheter for ≥14 days;
3. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria:

1. patients with confirmed urinary tract infection before indwelling urinary catheter;
2. those with renal dysfunction;
3. those who are allergic to silicone or silicone material;
4. those with low immunity susceptible to infection;
5. those who have participated in other clinical trials within 3 months;
6. others who are judged by the investigator to be unsuitable for clinical trials;
Total Hip Arthroplasty Outcomes With Regional and Multimodal Analgesia

The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain and administration of multimodal oral analgesia have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.

Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome: Time to first ambulation, assitstance needed with ambulation, opiate and regional related side effects, time to discharge orders.

Eligibility Criteria:
Inclusion Criteria:

1. Primary total hip arthroplasty, (identified by current procedural terminology (CPT) code 27130) and
2. Either a) Epidural or b) Lumbar plexus peripheral nerve block with the administration of multimodal medication after July 2012.

   -

   Exclusion Criteria:Exclusion criteria include THA Revision, ICU admission postoperatively, and dementia, not allowing pain score communication.

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Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment

The principal objective of the study is the evaluation of the role of Human Papilloma Virus (HPV) in plantar warts (prevalence, genotype), resistant or not, treated or not, cured or not. This epidemiological study is an ancillary study of the prospective, randomized controlled, clinical study VRAIE (sponsor: APHP) comparing 5 usual strategies in the management of plantar warts.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged 18 years or more.
* Clinical evaluation
* Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm, whether previously treated or not
* In treated patients, all potentially active treatment on warts since at least one month should be stopped.
* Effective contraception for women of childbearing age
* Immunocompetent patients
* Patient with one or more warts on soles and board feet.

  * MYRMECIE : rounded warts, deep, covered with a stratum corneum more or less thick; after stripping, appear black points, very specific; often painful to pressure. They are lonely, single or not. They could regroup galley thick. The stripping can them to individualize.
  * Mosaic : plate small warts, superficial, often sitting on the heel or Forefoot. Little painful, they are often ignored by the patients when they appear
* Patient affiliated to the French social security.viral

Exclusion Criteria:

* Patient suspected to be immunocompromised
* Patient aged under 18 years
* Patient refusing to sign the consent
* Pregnant or lactating women
* Plantar calluses
* Known hypersensitivity to imiquimod (Aldara®) or any excipients of the cream (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, purified water)
* Known hypersensitivity to 5 fluoro-uracil (Efudix®) or any excipients of gel (stearyl alcohol, Vaseline, polysorbate 60, propyleneglycol, purified water - conservatives: METHYL PARAHYDROXYBENZOATE, PROPYL PARAHYDROXYBENZOATE)
* Contra-indication to Pomade M.O Cochon® (Known allergy to any components)
* Known hypersensitivity to Blenderm®
* Extra plantar concomitant warts (to exclude risk of endogenous recontamination by an extra plantar site)
* Plantar hyperhidrosis making impossible adhesion of plaster.
Effect of Hyperbaric Oxygen Therapy on Microcirculation

Previous studies shoes that hyperoxia alters microcirculation.The investigators hypothesize that hyperbaric may restore microcirculation integrity. This hypothesis is supported by a recent study in rabbits, but no data exists for humans.

The study will expose fifteen healthy volunteers to a succession of different fraction of inspired oxygen and barometric pressure and assess microcirculatory and macrocirculatory changes via sidestream dark field videomicroscopy, near-infrared spectroscopy, Laser Doppler, transthoracic echocardiography and bio-impedancemetry at every step.

Microcirculation alterations and hyperoxia are known to alter ICU-patients' prognostic.

Studies have shown that hyperoxia alters healthy volunteers' microcirculation, whereas hyperbaric oxygen therapy is commonly used to facilitate cicatrization. There seems to be a paradox. A recent study in rabbits has given some evidences that hyperbaria may restore microcirculation integrity, but to date, there is no such evidences in human.

To study hyperoxia and hyperbaric induced changes in micro and macrocirculation, fifteen healthy volunteers will be exposed to successive variations of inspired oxygen fraction and barometric pressure according to a predefine sequence so that only one parameter will change from a condition to the next one :

1. FiO2 0.21 - 1 ATA
2. FiO2 1 - 1 ATA
3. FiO2 1 - 2.5 ATA
4. FiO2 0.21 - 2.5 ATA
5. FiO2 0.21 - 1 ATA

At each time, and after a 30 minutes period of exposure, measures will be made using SDF-microscopy, Laser Doppler and NIRS to assess microcirculation.

As previously described, macrocirculation can modify microcirculation due to a mechanism called hemodynamic coherence.

Hence, the investigators planned to assess macrocirculation changes at every step of the protocol using bioimpedancemetry and transthoracic echocardiography.

Each volunteer will be his own control, using the first measurements (condition 1. FiO2 0.21 - 1 ATA) as reference.

Eligibility Criteria:
Inclusion Criteria:

* To provide a medical certificate of fitness to dive (\< 1 year)
* Consent given for study participation
* French health insurance affiliated

Exclusion Criteria:

* Temporary or definitive contra-indication to dive
* Pregnancy or \< 18 years of age
* Precedent dive \< 24 hours
* Under a legal protection measure
* Medical history of a disease known to alter microcirculation
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Isoniazid for TB prophylaxis ONLY.

Patients must have:

* HIV infection.
* MAC infection.
* Life expectancy of at least 16 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Perceived unreliability or unavailability for frequent monitoring.

Concurrent Medication:

Excluded:

* Antimycobacterial drugs other than the study drugs.
* Carbamazepine.
* Terfenadine.
* Theophylline.

Patients with the following prior condition are excluded:

History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.

Prior Medication:

Excluded within 7 days prior to study entry:

* Rifabutin.
* Rifampin.
* Ethionamide.
* Cycloserine.
* Clofazimine.
* Ethambutol.
* Amikacin.
* Ciprofloxacin.
* Ofloxacin.
* Sparfloxacin.
* Azithromycin.
* Clarithromycin.
* Pyrazinamide.

Excluded within 14 days prior to study entry:

* Carbamazepine.
* Terfenadine.
* Theophylline.
Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life

The aims of the research are:

* To predict factors affecting hand dysfunction in patient with rheumatoid arthritis
* To study the effect of hand dysfunction on quality of life in patient with rheumatoid arthritis

Rheumatoid Arthritis (RA) is the most common chronic autoimmune systemic inflammatory arthritis, associated with considerable impairments of Quality of life .

Hand is the principle means by which an individual interacts with people and objects in the external environment .Many factors affect hand function in addition to arthritis ,. Many RA patients suffer from an increased loss of muscle mass with a significant impact on these patients' quality of life , and also Distal sensory, mixed sensorimotor, mononeuritis multiplex and entrapment neuropathy are the most commonly reported types of neuropathy in RA .So assessment of factors causing hand dysfunction can provide us a quick and early insight on the debilitating effects of RA on functioning and disability.Thus Early intervention can then be initiated which will help limit joint damage and thereby improve functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients who fulfilled the American College of Rheumatology (ACR) (2010) criteria for RA, attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals.

Exclusion Criteria:

* Patients with other rheumatic diseases.
* Patients less than 18 years old.
* Patients with co-morbidities influencing disease activity and hand function (e.g., end- stage liver or renal disease, serious infections, or severe cardiac, respiratory, gastrointestinal disease) .
* Patient with any recent history of hand trauma, or surgery.
* Patient with neurological involvement as , peripheral neuropathy and radiculopathy
Optimized C-arm Cone Beam CT for the Endovascular Treatment (EVT) of Acute Stroke

When it comes to acute stroke, everyone deserves the best care. Today, more patients can benefit from endovascular treatment (EVT) in a comprehensive stroke center. With the significant advances in C-arm Cone Beam CT (CBCT) imagings directly in the neuro angio-suite (NAS), the investigators are now able to identify, plan and treat stroke patients in the NAS, without the need for a separate CT scan. This provides valuable, time-saving support for critical patients in acute need of EVT. The main objective is to assess the diagnostic confidence of this optimized C-arm Cone Beam CT, named in french ASO, in the NAS for the detection of brain abnormalities and hemorrhagic complications for critical patients with acute stroke. The secondary objectives are to study the variability of the diagnostic accuracy concerning the staging of the stroke, the analysis of the brain vessel, the relevance of artefact reduction post treatment and the amount of dose for this ASO.

Design: ASO-AVC is a french academic pilot study by exploring the diagnostic confidence of optimized C-arm Cone Beam CT (ASO) realized directly in the neuro angio-suite (NAS).

To compare the effectiveness and safety of ASO diagnostic, the variability of the diagnostic accuracy concerning the staging of the stroke, the analysis of the brain vessel, the relevance of artefact reduction post treatment and the amount of delivered dose, the investigator proposed to assess clinical usefulness of ASO in the diagnostic process of stroke.

Intervention: No modification of patient care will be required by this protocol.

All patients participating in the study will undergo standard diagnostic, procedural and control imagings, which consist of : diagnostic imaging studies (MRI or CT scan), usual C-arm Cone Beam CT in the NAS during EVT to insure no procedural complication and control imaging studies (MRI or CT scan) at 24 hours ; decisions concerning further diagnostics will be made by the physician in charge.

Apart from theses standard imagings, patients will undergo the ASO. The ASO imagings will be anonymized and recorded in a centralized database called PACS (Picture Archiving and Communication System), in order to a centralized radiological reading by the Imaging Core Lab. They will be reviewed by radiologist readers to rate diagnostic image quality through a questionnaire, and in a second time the data will be included in a comparative evaluation with the diagnostic and control imagings.

Eligibility Criteria:
Inclusion Criteria:

aged ≥ 18 years diagnosed with an acute stroke and needed for a EVT affiliation to compulsory French social security scheme (beneficiary or right-holder) Consent from the patient if their level of consciousness is sufficient or from their relatives. If none is possible at the inclusion, consent will be obtained as soon as possible

Exclusion Criteria:

Being under tutelage or legal guardianship ; Ongoing pregnancy, breastfeeding
Vascular Health and Exercise Performance of Overweight Children

The purpose of this study is to assess exercise performance in 20 healthy children 10-19 years of age with a body mass index greater than 85th percentile and to evaluate the effect of dietary and exercise intervention over 12 weeks.

Our hypothesis is that the vascular health in these children will improve at the end of intervention. The results of this study will help us in our long-term objective of improving vascular health of children with congenital/acquired heart disease, a group particularly at risk for premature atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

* 10-19 years old
* Overweight (BMI \> 85 percentile)
* Interested in a 12 week ¬home exercise \& nutrition program
* Have computer \& internet access
* Can come to Lucile Packard Children's Hospital at Stanford for a 3-hour test at the start \& end of the study (so only twice!)
* Are able to come to testing after fasting overnight
* Do not smoke
* Do not take any medications

Exclusion Criteria:

* non-overweight adolescents
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles \[LA\] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Inpatients (hospitalization during the entire study period is mandatory)
* Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D)

Main Exclusion Criteria:

* Known Zollinger-Ellison syndrome or other gastric hypersecretory condition
* Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
* On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm
* Acute peptic ulcer and/or ulcer complications
* Pyloric stenosis
* Known inflammatory bowel diseases