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Congenital Abnormalities clinical trials

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NCT ID: NCT04076449 Recruiting - Epilepsy Clinical Trials

Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy

CRESS
Start date: September 3, 2019
Phase:
Study type: Observational

Cerebral cavernous malformation (CCM)-related epilepsy (CRE) impairs the quality of life in patients with CCM. Patients could not always achieve seizure freedom after surgical resection of the lesion, suggesting an inadequate treatment and evaluation of the epileptogenic zone or network. Iron deposition in cerebral cavernous malformations has been postulated to play an important role in triggering CRE. Quantitative susceptibility mapping (QSM), as an optimal in vivo imaging technique to quantify iron deposition, is employed to analyze the iron quantity in CCM patients with epilepsy and further combined with brain structural and connectome analysis, to describe the difference between CCMs with and without epilepsy. In vivo biomarkers predicting CRE risk in CCM natural history and CRE control outcome after CCM surgical resection will be further identified to improve management strategy.

NCT ID: NCT04073667 Recruiting - Clinical trials for Arnold Chiari Malformation

Investigation of the Effects of Exercise Program in Patients With Chiari Type 1 Malformation

Start date: November 20, 2019
Phase: N/A
Study type: Interventional

This study will be conducted in Hacettepe University Faculty of Medicine Neurosurgery Department and Hacettepe University Faculty of Physical Therapy and Rehabilitation. The study was designed as a randomized controlled trial. At the beginning of the study, demographic data and characteristics of the cases will be recorded. Patients will be evaluated in three different periods throughout the study. The first assessments will be performed on the first day after the patient's condition is appropriate after the surgical procedure for Type 1 CM. Following this evaluation, all patients will be divided into two groups using. a simple randomization method. The first group will be exercised for 6 weeks while the second group will not be intervened during this period and will be followed as a control group. Immediately after the exercise program administered to the first group after 6 weeks, both groups will undergo second assessments. After these assessment measures, the same exercise program in the first group will be applied to the second group only this time for 6 weeks. In the meantime, the first group will stop their exercise programs. After the 6-week exercise program of the second group has ended, both groups will be given the third assessment, the final assessment. At the beginning of the study, demographic data, characteristics and disease information will be recorded. The evaluations to be made are summarized below: - Visual Analogue Scale, pain threshold and pain tolerance tests, Neck Disability Index, for the determination of pain level in the neck region and throughout the body - Cervical range of motion (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3) device for the evaluation of the cervical region. - Berg Balance Scale for evaluation of performance-based balance, - Timed Rise Walk Test, Sharpened Romberg test and "8" shaped walk test (F8WT) for evaluation of fall risk, static and dynamic balance, - The International Ataxia Assessment Scale (ICARS) for coordination, - Grip Ability Test (GAT) for the assessment of fine motor skill in the upper extremity, - Posture evaluation, - Eating Assessment Tool (EAT-10) for evaluation of swallowing function - For daily living activities, Barthel Daily Living Activities Index, - For the quality of life, the Short Form 36 questionnaire will be used.

NCT ID: NCT04058561 Recruiting - Clinical trials for Early-Onset Scoliosis Deformity of Spine

Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals

MCGR
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.

NCT ID: NCT04043013 Completed - Clinical trials for Dental Arch Relationship Anomaly

Influence of Four Orthodontic Bracket Prescriptions in Arch Width and Torque

Start date: May 1, 2015
Phase: N/A
Study type: Interventional

The study compares torque and arch width changes between four different orthodontic bracket prescriptions and determine whether changes in dental torque are correlated to changes in arch width at the end of orthodontic treatment. From an initial sample of 250 patients who sought treatment at the Department of Orthodontics (University of Valencia, Spain), a subsample of 76 patients (31 men and 45 women) were selected to meet inclusion criteria. The sample was randomly allocated into four groups according to four different orthodontic bracket prescriptions: Prescription A (n=22): Mini-Taurus® (Rocky Mountain©); Prescription B (n=17): Smart Clip® SL3 High Torque (3M Unitek©); Prescription C (n=18): Tip-Edge Plus® (TP Orthodontics©); Prescription D (n=19): Victory® (3M Unitek©). Initial (T0) and final (T1) plaster and digital study models were available for all patients. Measurements were taken from frontal and occlusal images of the models by a single experienced operator.

NCT ID: NCT04041804 Recruiting - Maxillary Anomaly Clinical Trials

Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

Start date: February 2021
Phase: N/A
Study type: Interventional

OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.

NCT ID: NCT04039308 Not yet recruiting - Deformity, Foot Clinical Trials

Assessment of Surgical Correction of Deformity in Diabetic Charcot Arthropathy of the Foot and Ankle

Start date: October 1, 2019
Phase:
Study type: Observational

The surgical techniques described in the literature for surgical management of diabetic charcot arthropathy of the foot and ankle include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening. Patients are followed up at 1 year postoperative by an x-ray of the foot and ankle anteroposterior , lateral and oblique views to assess rate of union ,the correction of deformity by measuring the foot angles . The functional outcome is assessed by the AOFAS scoring system and the diabetic foot ulcer scaoeuulcer scale(18).

NCT ID: NCT04035928 Recruiting - Clinical trials for Maxillofacial Abnormalities

Digital Design for Maxillofacial Prosthetics

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

This study will use a 3D scanner to print a 3D model or mold for each patient's prosthesis. The goal of this study to provide patients with a new, faster method of imaging and creating prostheses that preserves the quality of the current method while reducing time spent by both the patient and providers. Patients that are eligible will have a non-invasive 3D scanner (Artec Space Spider) to image the indicated areas of their head and face to help create their new prosthesis. Patients will come in for visits as needed to fit and adjust their prosthetic. Additionally, patients will be asked to complete questionnaires and have follow-up visits at certain time -points pre and post prosthetic completion.

NCT ID: NCT04017065 Terminated - Deformity of Bone Clinical Trials

Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction System

Start date: October 1, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this international, prospective, multicenter case series (patient registry) is to gather the first evidence on the use of the MAXFRAME™ system in normal clinical settings during deformity correction of both, the upper and lower limb, and gain information on indications, the handling of the device from the patients' and surgeons' perspective, as well as number of re-planning needed. It is planned to prospectively follow up to 100 patients treated with the MAXFRAME™ system. Information on patients entered into the registry will be collected from before the surgery until the removal of the device.

NCT ID: NCT04000438 Completed - Clinical trials for Labor Onset and Length Abnormalities

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix

Start date: June 21, 2019
Phase: Phase 2
Study type: Interventional

The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are conclusive in favor of tafoxiparin, the study will continue by adding two additional tafoxiparin dose groups in Section B.

NCT ID: NCT03995823 Recruiting - Clinical trials for Cerebral Arteriovenous Malformation

Evaluation of Nidus Occlusion After Gamma Knife Radiosurgery of Cerebral Arteriovenous Malformations Using Magnetic Resonance Imaging

Start date: July 1, 2019
Phase:
Study type: Observational

Cerebral arteriovenous malformations (AVMs) are abnormal vessels, connecting cerebral arteries and veins. They form a bundle which is called nidus. Rupture of an AVM leads to intracranial hemorrhage often causing neurological impairment or even death. As treatment can be associated with high rates of morbidity and mortality, AVMs still remain a considerable challenge for neurosurgeons. For smaller AVMs, a well-established treatment option is non-invasive Gamma Knife radiosurgery (GKRS). GKRS uses radiation to obliterate the AVM nidus hence, eliminating the risk of hemorrhage. However, after Gamma Knife radiosurgery, occlusion of the AVM nidus takes about two years. To evaluate treatment success after GKRS, invasive digital subtraction angiography (DSA) is still the gold standard. For this procedure, patients have to undergo puncture of the femoral artery for application of a contrast media to receive adequate imaging of the cerebral arteries. In recent literature it has been discussed whether sufficient evaluation of treatment is possible with non-invasive magnetic resonance imaging (MRI). At present, it is unclear whether this method could replace the current invasive gold standard for treatment evaluation. To investigate on this issue, a few studies have compared the two methods however, only retrospective data exist. Thus, the investigators are conducting this prospective study including 50 patients with cerebral AVMs treated with GRKS to evaluate the sensitivity for nidus obliteration of MRI using DSA as a reference.