cyrilzakka/clinical-trials huggingface dataset:
NobelProceraTM Bridge Shaded Zirconia

Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 5 years


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
* The subject is healthy and compliant with good oral hygiene
* The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
* The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
* Obtained informed consent from the subject prior to the study.
* No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
* Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
* The subject should be available for the 5-year term of the investigation.

Exclusion Criteria:

* The subject is not able to give her/his informed consent to participate.
* Alcohol or drug abuse as noted in patient records or in patient history.
* Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
* An existing condition where acceptable retention of the restoration is impossible to attain
* Mobility greater than grade 1 of the tooth to be restored.
* Pathologic pocket formation of 4 mm or greater around the tooth to be restored
* Severe bruxism or other destructive habits
* Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or attachment loss greater than half of the root length).
* Health conditions, which do not permit the restorative procedure
Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

The overall purpose of this research is to determine whether new macromolecular measures optimized for whole brain (gray matter and white matter) magnetic resonance imaging (MRI), predict neuro-cognitive impairment in multiple sclerosis (MS) patients.

MRI is a vital component of a MS work-up, providing noninvasive evidence of MS lesions, detecting active inflammatory lesions, and measuring brain atrophy to assess neurodegeneration. Recent years of MRI research have generated strong evidence of gray matter (GM) involvement in MS, resulting in the reclassification of MS as a whole-brain disease. Similar to white matter (WM), a primary target of MS pathology in GM is myelin, the protective sheath insulating the penetrating axons within GM and extending brain connectivity all the way to the neuronal bodies.

This aim of this research is to examine if the associations between imaging measures of GM disease and cognitive performance can establish GM-based imaging correlates predicting the disease course and accurately assessing treatment results.

This observational research will enroll adults diagnosed with MS both with and without cognitive impairment. Subjects will be asked to complete a single research visit that includes the administration of a MRI scan and a neuro-cognitive testing session.

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite MS
* Adult age 18 to 60

Exclusion Criteria:

* Contraindication to MRI
* Changes in MS therapy in the last 6 months
* Less than 6 weeks after relapse or corticosteroid use
* Currently taking medication that may affect cognition (e.g. donepezil, rivastigmine, adderall)
* History of significant alcohol or drug abuse
* Current or recent significant migraines
* Confounding neurological or cognitive disorders or deficits (stroke, Parkinson's disease, Alzheimer's disease, epilepsy)
* Sensory or physical impairments that might interfere significantly with cognitive testing
* History of developmental or learning disability or attention-deficit/hyperactivity disorder.\\

Exclusion Criteria for Healthy Controls:

* history of alcohol/drug abuse
* history of migraines
* developmental or learning disability/attention-deficit/hyperactivity disorder
* currently pregnant/breastfeeding
An Exploratory Study Investigating Adhesive Reaction to Output

The objective is to investigate the impact that faecal output has on adhesives.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than 3 months
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter (≤) 35mm

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal area
5. Convex user
6. Participate in other interventional clinical investigations
Positive Effects of Daily Consumption of Bread Enriched With Hydroxytyrosol on the Results of a 12-week Dietary Intervention on Subjects With Type 2 Diabetes Mellitus and Overweight/ Obesity

Hydroxytyrosol is a phenolic compound drawn from the olive tree and its leaves as a by-product obtained from the manufacturing of olive oil and has antioxidant and antidiabetic effects. The use of HT extract in food products is a good strategy to improve their nutritional quality. However, this extract has a strong odour and flavour, so it is important to be encapsulated for the odour and flavour to be covered up. The purpose of the study is to investigate the effects of regular consumption of bread enriched with HT on biochemical parameters (blood glucose and cholesterol levels).

Subjects with type 2 diabetes mellitus and overweight/ obesity will participate in the present study. They will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of bread enriched with hydroxytyrosol. The effects of the dietary intervention on biochemical parameters (blood glucose and cholesterol levels) and body weight reduction will be examined.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* bmi : 25-40 kg/ m-2
* normal exercise and dietary habits
* weight stable for at least 3 months before enrollment

Exclusion Criteria:

* HbA1C \> 8.5%
* pregnancy
* chronic medical illness
* regular intense exercise
* alcohol consumption (\> 2 drinks/day)
Diaphragm Thickness by Ultrasonography in Neurological Disorders

participants will be allocated into three groups, acute neuropathy (Guillain Barre Syndrome) group, neuromuscular junction disorder(myasthenia gravis ) group, and control group(people with neurological disorders not affecting the respiratory system.Ultrasonography is done on the diaphragm. The index test (ultrasound imaging of the diaphragm) is used. A high-resolution portable ultrasound machine is used, with a 7- to 13-MHz linear array transducer. Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration. objectives: primary outcome: to compare diaphragm thickness between the three examined groups. Secondary outcome: correlation between clinical scores and reference US values of diaphragm

after IRB (institutional research board ) approval, of the faculty of medicine, Mansoura University, Egypt, written informed consent from all participants will be taken. participants will be allocated into three groups, acute neuropathy (Guillain Barre Syndrome) group, neuromuscular junction disorder(myasthenia gravis ) group, and control group(people with neurological disorders not affecting the respiratory system. inclusion group: age more than 18, both sexes. exclusion criteria: cardiopulmonary disease, chest trauma, diaphragmatic injury, body mass index more than 30. Any participant who shows respiratory dysfunction on doing arterial blood gases and pulmonary function tests will not be enrolled in the study. methods: Ultrasonography is done on the diaphragm. The index test (ultrasound imaging of the diaphragm) is used. A high-resolution portable ultrasound machine is used, with a 7- to 13-MHz linear array transducer. Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration. objectives: primary outcome: to compare diaphragm thickness between the three examined groups. Secondary outcome: correlation between clinical scores and reference US values of diaphragm

Eligibility Criteria:
Inclusion Criteria:

* all adult patients admitted to the neurology department

Exclusion Criteria:

* cardiopulmonary diseases
* chest trauma
* diaphragmatic diseases
* Body Mass Index (BMI) \> 30
Physical Activity and Motor Memory in Pedal Dexterity

The main purpose of this study was to investigate if a six months period of physical exercise, could improve motor memory consolidation in elderly people on pedal dexterity

34 subjects of both genders, with a mean age of 71 years old participated in the study. Subjects were divided in two groups: a control group and an experimental one. Before the intervention of physical exercise program, subjects performed a Tapping Pedal Test to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.

Eligibility Criteria:
Inclusion Criteria:

* individuals not engaged in physical activity;
* persons aged from 65 years.

Exclusion Criteria:

* sensory abnormalities;
* mental abnormalities;
* motor abnormalities;
* other atypical health problems.
The Nasal Airway in Chronic Obstructive Pulmonary Disease

The study is based on the theory of a "unified airway" that considers the nose and paranasal sinuses together with lower airways as one integrated unit. The upper and lower respiratory tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes in one portion of the airway, can provoke similar changes throughout the airway. This is well documented in asthmatic patients but documented poorly in patients suffering from chronic obstructive lung disease (COPD).

COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal involvement has been found to directly affect the lower airway, sinonasal disease is under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger project where the goal is to gain knowledge supporting the theory of a "unified airway" in patients with COPD.

Here sinonasal, pulmonary and generic health related quality of life will be studied in a group of patients with COPD versus a control group. The severity of nasal airway obstruction will be linked to the the severity of pulmonary airway obstruction. Assessment of pathological changes in the nose with nasal endoscopy, as well as performing a nasal cytological brushing for the identification of nasal inflammatory responses in the nose, will be conducted in both the control and study group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD: all stages
* Healthy individuals for the control group

Exclusion Criteria both groups:

* asthma
* systemic disease such as Cystic Fibrosis, Kartagener syndrome, sarcoidosis
* upper airway infection during the last 2 weeks
* COPD exacerbation during the last 6 weeks
* previous surgery in the nose and paranasal sinuses
* ongoing treatment for malignant disease
* severe depression, Alzheimers disease and Parkinson's disease
* pregnancy or nursing
Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms

The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Women and men \>18 years of age
* A score of \> 4 on the OAB-q short form for urgency (question 1)
* Average urinary frequency \> 10 times in one 24 hour day based on a 3-day voiding diary
* Self-reported bladder symptoms present \> 3 months
* Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)
* Off all antimuscarinics for at least 2 weeks prior to enrollment
* Capable of giving informed consent
* Ambulatory and able to use a toilet independently, without difficulty
* Capable and willing to follow all study-related procedures

Exclusion Criteria:

* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
* Neurogenic bladder
* Botox use in bladder or pelvic floor muscles in the past year
* Pacemakers or implantable defibrillators
* Primary complaint of stress urinary incontinence
* Current urinary tract infection (UTI)
* Current vaginal infection
* Current use of InterStim
* Current use of Bion
* Current use of TENS in the pelvic region, back or legs
* Previously been treated with PTNS
* Use of investigational drug/device therapy within the past 4 weeks
* Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
* Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy)
* Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function
Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache.

The purpose of this study is to evaluate the clinical results in cervical spine range of motion, endurance deep cervical muscles, headache impact and physical activity enjoyment by a training protocol with the new device for cervical treatment (CDAT) versus conventional training protocol (CT) in subjects with cervicogenic headache.

The cervical spine is the most mobile region of the spine and must be strong enough to support the weight of the skull. Strength deficits of the deep cervical muscles are related to different clinical conditions, such as cervicogenic headache. Cervicogenic headache is a secondary headache defined as a unilateral headache associated with neck pain, related to a decreased cervical range of motion and strength deficits of the deep cervical muscles.

Training protocols can help to improve pain, function, posture and cross-sectional area. However, there are no training protocols in subjects with cervicogenic headache including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.

Eligibility Criteria:
Inclusion Criteria:

* Deep flexor strength deficit in craniocervical flexion test.
* Deep extensor strength deficit in neck extensor muscle endurance.
* A positive result in the flexion-rotation test
* ≥ 50 score in Headache Impact Test (HIT-6).
* Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)

Exclusion Criteria:

* Have received head/cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
* Have received cervical manual therapy treatment during the last six month
* A history of head/cervical trauma or surgery during the last year.
* The use of pacemakers (the magnets in the CROM device could alter their signal
* Inability to perform the flexion-rotation test.
Validation Study of the SAGIT® Instrument in Acromegaly

Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required.

SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing endocrinologists to manage acromegalic patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth factor 1(IGF-1) concentration -I; Tumour size- T.

The instrument has been pre evaluated during a qualitative pilot study. The purpose of the validation study is to define and validate the scoring of the SAGIT® instrument.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years-old or above at study inclusion
* Treatment-naïve and non treatment-naïve patients with a diagnosis of acromegaly
* Data required to complete the SAGIT® tool are available in the patient medical records and do not require additional assessments or tests
* Data required to complete the SAGIT® tool are recorded within the 3 months preceding the inclusion visit (6 months for MRI)

Exclusion Criteria:

* Acute uncontrolled disease requiring intensive care
Endoscopist and Endoscope Motions During Digestive Endoscopy

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient who are scheduled for a gastroscopy procedure under sedation
* Patient able to understand the study and provide written informed consent
* Patient affiliated to the French social security system.

Exclusion Criteria:

* Patient with an altered upper GI anatomy due to previous surgery
* Patient with a known anomaly of the upper GI anatomy
* Patient carrying an implantable medical device (pacemaker...)
* Patient with a condition preventing its participation to study procedures, according to investigator's judgment
* Pregnancy or breastfeeding
* Patient in custody
* Patient under guardianship
Toronto BNB Pilot Study

As treatments improve and patients live longer with cancer, even after it has spread to the brain, efforts to improve quality of life are growing. Neurocognitive function (thinking ability and memory) is an area of particular concern for patients with brain metastases (cancer that can spread to the brain). Although there are established tests to measure neurocognitive function, these require a face-to-face assessment and can take a long time to complete. As a result, efforts to use these tests to measure changes in neurocognitive function in patients following treatment for brain metastases have resulted in a large proportion of patients who do not return for follow-up. This has limited the ability to evaluate the impact of current treatments on neurocognitive function. This study aims to evaluate a shorter, telephone-based neurocognitive assessment tool, which would make it easier for patients to complete these tests in follow-up. If this new tool is found to reliably measure neurocognitive function, it could be used for future studies evaluating new interventions that prevent or treat neurocognitive deterioration following treatment of brain metastases. This is the first prospective study to evaluate the feasibility and reliability of a novel telephone-based brief neurocognitive assessment battery (Toronto BNB) compared with the same battery delivered face-to-face in this population. The investigators hypothesize that telephone administration of this brief neurocognitive battery will reliably evaluate neurocognitive function and improve patient ability to complete follow-up assessments.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years old) with newly diagnosed brain metastases planned for whole brain radiotherapy
* Performance status ECOG 0-2
* English-speaking (due to small sample-size in this pilot study, only English testing will be completed)

Exclusion Criteria:

* Prior whole brain radiotherapy
* Presence of any condition which can prevent completion of neurocognitive assessment, including:
* Hearing impairment which is sufficient to prevent the patient from comprehending English instructions in a quiet environment
* Major psychiatric diagnosis or neurological condition associated with cognitive impairment which, in the judgement of the investigator, would make the patient inappropriate for study participation (e.g., schizophrenia, multiple sclerosis, Parkinson's disease, prior ischemic stroke, dementia, traumatic brain injury with loss of consciousness for greater than 30 minutes, expressive/receptive aphasia, developmental delay)
* Patients with planned systemic therapy or additional radiotherapy within the interval between clinic and telephone Toronto BNB testing
* Minimal English skills such that subjects would be unable to follow simple English instructions (either verbal or written) or be unable to read questionnaires of a grade 8 standard with the help of a research assistant.