cyrilzakka/clinical-trials huggingface dataset:
Interest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear

Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays are divergent, forming a cone.

As a result, this technique is less irradiating that the scanner. The purpose of this exploratory study is to compare the performance of the scanner and the cone beam in the detection of anatomical structures of the ear.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Indication of a CT scan of the ear
* Written and signed informed consent by the patient to participate in the study

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Patient under a legal protection procedure
* Lack of affiliation to a social security system
3h of PNE on BDNF and Pain Levels

The promotion of neuroplasticity in conjunction with strategies for restructuring maladaptive cognitions that largely cause the activation of neural networks that contribute to the perpetuation of pain is therefore a fundamental neurophysiological principle for establishing a neurophysiological basis for pain.

perpetuation of pain, is therefore a fundamental neurophysiological principle for establishing physiotherapy therapeutic to establish therapeutic strategies from physiotherapy that contribute to improve the quality of life of patients with chronic pain. Based on the theory that neurotrophic factors such as BDNF play a fundamental role in the initiation and or maintenance of hyperexcitability of central neurons in pain, we consider that the levels of this neurotrophic factor, such as BDNF, may have an important role in the perpetuation of pain. That the levels of this neurotrophic factor may be modified by the application of a therapeutic education protocol, favoring therapeutic education protocol, favoring a reduction in pain intensity.


Eligibility Criteria:
Inclusion Criteria:

* males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months
* patients recruited by information pamphlets from the university clinic of the Rey Juan Carlos University, and CSEU La Salle
* ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent.

Exclusion Criteria:

-Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
Synovial Fluid Bank From Arthritic Patients

The objectives of this group project is to collect synovial fluid (SF) and paired sera and carry out preclinical studies to evaluate, alone or by combination testings, the potential of novel biomarkers for their prevalence and diagnostic/prognostic values in patients with arthritis, and to determine how therapeutic intervention regulate their levels.

Our group has developed interdisciplinary expertise in biomarkers related to distinct aspects of inflammation-induced joint damage, most notably those associated with degradation of components of the extracellular matrix, bone loss, or associated with post-translational changes on protease inhibitors.

The objectives of this group project is to collect SF and paired sera and carry out preclinical studies to evaluate, alone or by combination testings, the potential of novel biomarkers for their prevalence and diagnostic/prognostic values in patients with arthritis, and to determine how therapeutic intervention regulate their levels.

More specifically, we will study (1) biomarkers associated with osteoclastic bone resorption and synthesis/degradation of cartilage, (2) inhibitors of enzymes (calpastatin) that are preferentially targeted by rheumatoid patients, as well as (3) enzymes (e.g. Matrix Metalloproteinases (MMPs)) responsible for the cleavage of components of the articular cartilage.

Finally, we propose to characterize the repertoire of specific active proteases in the SF of arthritic patients concomitantly to the use biomarkers (neoepitopes of cleaved collagens) previously associated with cartilage destruction and synthesis to identify new targets for the development of protease inhibitors for the treatment of arthritis. Furthermore, our project will also provide the opportunity to test the potential of measuring the net proteolytic activity by Fluorescent-Activated Substrate Conversion as a method of monitoring disease activity and treatment efficiency in a clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Significant joint effusion

Exclusion Criteria:

* Hemorrhagic effusion
* Traumatic effusion
* Less than 3 ml total of collected fluid (used for routine analysis and culture)
* Inability or refusal to consent
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Japanese descent with all 2 biological parents of Japanese descent
* On hemodialysis (HD) or hemodiafiltration (HDF) with single-pool Kt/V (spKt/V) ≥1.2, using arteriovenous (AV) fistula or AV graft ≥3 months prior to Screening 1 at a healthcare center, and is on the same dialysis regimen ≥2 weeks prior to Screening 1
* Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* On peritoneal dialysis or other dialysis modalities except for HD and HDF
* History of deep vein thrombosis or pulmonary embolism
* History of vascular access thrombosis within 1 month prior to Screening 1
* Personal or family history of bleeding disorder
* History of GI bleeding, duodenal polyps or active gastroduodenal ulcer within 5 years prior to Screening 1, or history of severe hemorrhoidal bleed within 3 months prior to Screening 1
* History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis
* At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial
* History of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or a brand of Rho(D) immune globulin (RhoGAM) within 1 year prior to Screening 1
* History of receiving any biological therapy within 3 months prior to Screening 1, or vaccination within 1 month prior to the dose of study intervention
* Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs)
* Participated in another investigational study within 1 month prior to Screening 1
* Has blood coagulation test (activated partial thromboplastin time \[aPTT\] or prothrombin time \[PT\]) above 1.2X upper limit of normal (ULN) at Screening 1 from the central laboratory for safety
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.

This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
* Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
* Clinically normal cervical smear result within 12 preceding months or at screening.
* Clinically normal breast examination findings. For patients \>/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.

Exclusion Criteria:

* Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
* Known or suspected pregnancy.
* Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
* Current or recurrent pelvic inflammatory disease.
* Abnormal uterine bleeding of unknown origin.
* Acute cervicitis or vaginitis not responding to treatment.
* History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.
* Any active acute liver disease or liver tumor.
Comparison of Vitreous Levels of Acular LS 0.04%, Xibrom 0.09%, and Nevanac 0.1%

To compare the penetration of three different NSAIDs.


Eligibility Criteria:
Inclusion Criteria:

* Males or females scheduled to undergo Vitrectomy surgery
* Likely to complete all study visits and able to provide informed consent
* Visual potential of 20/25 or better

Exclusion Criteria:

* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies
Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns

The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy term newborns.

Lamellar bodies represent the storage form of lung surfactant. Surfactant is produced in alveolar type II cells and transported to the alveolar surface as lamellar bodies. Lamellar bodies are present in the amniotic fluid and also gastric aspirate.It has become a preferred test for determine fetal lung maturity, because of the rapid, inexpensive, easily accessible and easily applicable method.

Eligibility Criteria:
Inclusion Criteria:

* infants born at ≥ 37 weeks of gestation and birth weight ≥ 2500 g

Exclusion Criteria:

* intubated immediately after birth, infants with respiratory distress, infants with gestational pathology that can influence fetal lung maturity (cases with premature rupture of membranes, preeclampsia/eclampsia, gestational diabetes, oligohydramnios/polyhidramnios or antenatal steroid use), infants with major congenital or chromosomal abnormalities and lack of parental consent, therapeutic infusion was given in the amniotic cavity or if gastric aspirate contaminated by meconium, pus or blood.
Eye Health Intervention Study in Upper Manhattan

Our team of vision researchers have designed the Eye Health Intervention Study in Upper Manhattan (EYES-UM) to provide eye health screenings to individuals living in Upper Manhattan. The proposed innovative, 2:1 cluster-randomized clinical trial, will recruit adults age 40 and older in Upper Manhattan with known rates of inadequate eye care. A total of 10 settings in Upper Manhattan, comprised of primary care offices, senior centers, and organizations, confirms access to 17,000 individuals living at or below the NYC.gov poverty measure. This study will conduct ocular tests (visual acuity, intraocular pressure, fundus images) during screenings. To ensure that all participants receive the basic level of service, all participants who fail the eye health screening will be seen the same day by a study optometrist and eyeglasses will be provided at no charge. Educational workshops and an Advisory Board will support recruitment. Intervention Arm participants will receive ongoing support with scheduling eye exams and transportation by trained Study Coordinators. All participants will be followed prospectively for 2 years. The study is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework. An economic analysis will be conducted to evaluate the costs and benefits of the proposed multi-level Eye Health Screening Intervention. This will include calculating the cost per case of eye disease detected (such as glaucoma, cataracts, and retinal conditions) and assess the cost-effectiveness of the Intervention in comparison to Usual Care.

The investigators and an interdisciplinary team with experience in clinical research, ophthalmology, optometry, biostatistics/data analysis, implementation science, mixed-methods epidemiology, and health economics designed the study to promote eye and vision health in adults and their families. This is an innovative study with a 2:1 cluster-randomized clinical trial enrolling individuals living in Upper Manhattan with inadequate eye care.

A total of 10 settings, consisting of primary care offices, senior centers, and organizations, will be included to give access to 17,000 individuals at high-risk of eye disease. Clinical measures (visual acuity, intraocular pressure, fundus images, visual field test and contrast sensitivity), and quality-of-life will be assessed. All participants referred to ophthalmology in the Intervention Arm will receive assistance from a Study Coordinator with scheduling an initial in-office eye exam appointment and arranging transportation to these appointments over 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Individuals age 40 years or older.
* Living independently.

Exclusion Criteria:

* Self-reported terminal illness with life expectancy of less than 1 year.
* Inability to provide informed consent due to dementia or other reason.
Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years

The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.

The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.

Adult subjects (≥18 to \<65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
2. Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
3. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule \[bisacodyl/enemas\].

Exclusion Criteria:

1. Subjects in whom constipation is thought to be drug-induced
2. Subjects using any disallowed medication.
3. Subjects who previously used prucalopride.
4. Subjects suffering from secondary causes of chronic constipation.
Multimodal Imaging Outcome Measures for ALS (Image ALS)

The primary aim of this study is to determine whether longitudinal neuroimaging acquired across multiple research and clinical centers is a feasible biomarker to use as an outcome measure for clinical trials in amyotrophic lateral sclerosis (ALS)

ALS is a progressive neurodegenerative disorder that manifests with extensive clinical heterogeneity, including variable degrees of upper motor neuron (UMN) and lower motor neuron (LMN) impairment. While ALS is classically defined as a neuromuscular disorder, approximately 15% of individuals also develop cognitive and/or behavioral dysfunction of the frontotemporal variety, ranging in severity from ALS with cognitive or behavior impairment to a frank form of dementia consistent with FTD2

* Recent consensus criteria capture this heterogeneity by defining these conditions together as amyotrophic lateral sclerosis frontotemporal spectrum disorder (ALS-FTSD)3
* There are emerging and in-progress interventional clinical trials underway that aim to arrest ALS and/or FTD disease progression; however, there are limited objective and quantitative biomarkers to directly track disease progression during life. Multi-modal neuroimaging provides an ideal candidate biomarker for clinical trials because ALS-FTSD affects a distributed neuroanatomic network and we can reliably measure neurodegeneration of grey matter (GM) and arterial spin labeling based perfusion MRI (pMRI) measurements of cerebral blood flow (CBF). However, there are many unaddressed technical challenges associated with measuring disease progression using neuroimaging techniques in a multi-center setting. The overall aim of this protocol is to leverage a team science approach to develop disease-specific candidate neuroimaging outcome measures for ALS-FTSD clinical trials.

Eligibility Criteria:
Inclusion criteria for participants in PET sub-study (Penn Only):

1. Enrolled in the MRI study at Penn.
2. Willing to participate in a 30 minute \[18F\]-FDG and 1.5 hour \[11C\]-PBR28 PET scan within 15 days baseline and longitudinally at the 3-month and 6-month follow-up visits, if able.

Exclusion criteria for PET sub-study participants:

1. Females who are pregnant at the time of study visits will not be eligible for the PET sub-study; urine or serum pregnancy test will be performed in women of child-bearing potential at each of the baseline, 3-month, and 6-month study visit.
2. Homozygous genotype for the threonine-associated substitution allele (A) in the rs6971 polymorphism.
3. Blood glucose less than or equal to 250 mg/dl, or at the discretion of the authorized user
Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

The purpose of this study is to determine the risk of failing the visual field criteria to hold a driving license following retinal laser treatment delivered with a multi-spot photocoagulator.

Despite improvements in the management of diabetes, the incidence of severe diabetes -related eye disease remains high. Laser treatment (panretinal photocoagulation (PRP)) is the gold standard treatment for reducing the risk of visual loss. However, evidence suggests that PRP can be damaging on visual field function and thus jeopardize patients' eligibility to drive. In the UK, it is the patient's responsibility to inform the DVLA that they are receiving retinal laser.

With the use of a multi-spot Photocoagulator for application of PRP at Moorfields the investigators are in a unique position to assess the effects of laser applied with this new delivery system on visual fields in a detailed fashion. Thus providing more accurate advice on visual prognosis and visual field function and addressing the risk of losing the ability to drive.

All treatment-naive patients with severe diabetic retinopathy requiring bilateral retinal laser treatment will be identified. Following informed consent these patients will undergo baseline visual field testing which will be of a duration of approximately 30 minutes and complete a quality of life questionnaire. All patients will receive their laser treatment as part of standard clinical care via the multi-spot Photocoagulator which will require approximately four 20 minute sessions. At 6 months following the completion of treatment the patients will undergo repeat visual field testing as conducted at baseline and complete a quality of life questionnaire. The investigators hope to recruit 100 patients.

Analysis of visual fields will principally involve assessment of whether patients have met the UK driving standards on Estermann VF testing. A quantitative assessment of change in retinal sensitivity will be undertaken by comparing retinal sensitivity pre and post-PRP.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex aged 18 years or over.
* Diabetes mellitus (type 1 or type 2).
* Best corrected visual acuity (BCVA) \> or equal 6/60 in both eyes.
* Requiring full bilateral PRP.
* No previous laser treatment.
* Subject cooperation sufficient for adequate visual field testing.
* Ability to return for regular study visits.

Exclusion Criteria:

* Co-existent ocular/systemic condition that may affect visual field.
* Visual acuity less than 6/60 that may affect accuracy of visual field test.
* Presence of vitreous haemorrhage.
* Intraocular surgery/other intervention anticipated in either eye during the duration of treatment and VF assessment.
* Previous PRP.
* Age below 18.
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.

Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that greater neuroplastic effects occur when electrical stimulation of peripheral nerves is combined with voluntary drive. In this pilot study, we will investigate the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.

Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be recruited and undergo 12-sessions of iCycle training. Function will be assessed before and after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.

Eligibility Criteria:
Inclusion Criteria:

1. using a wheelchair for at least two hours per day

Exclusion Criteria:

1. cardiac pacemaker
2. pressure sores or unresolved skin problems
3. unhealed lower limb fractures
4. pregnancy
5. active heterotrophic ossification (lower limbs)
6. severe osteoporosis
7. complex regional pain syndrome
8. metal implants near electrode sites
9. lower limb malignancy
10. T6 and below spinal malignancy
11. uncontrolled autonomic dysreflexia
12. history of knee dislocation/subluxation
13. allergy to electrodes
14. cognitive difficulties
15. severe spasticity (Ashworth scale 4 or 5 in muscle groups that would prevent smooth pedalling) or
16. neurological degenerative diseases.