Col. Los Filtros, San Luis Potosã, Mexico
Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns
Study design: This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1. The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications. Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time. Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.
Phase
N/ASpan
105 weeksSponsor
University of JordanAmman
Recruiting
Healthy Volunteers
Retrospective Case-Control Study for Developing an Artificial Intelligence (AI) Tool for Lesion Detection Using Magnetic Resonance Imaging (MRI) and Clinical Variables for Early Diagnosis of Axial Spondyloarthritis (axSpA)
BACKGROUND The spondyloarthritis (SpA) are a group of chronic inflammatory diseases of autoimmune nature that share common clinical and genetic features, including an association with HLA-B27 antigen. They are among the most common rheumatic diseases with a prevalence of 0.01-2,5%. All of these conditions make the patients to move on a chronic disabling disease. Patients with SpA can be classified based on their clinical presentation into either predominantly axial SpA (axSpA) or predominantly peripheral SpA. Axial SpA is characterized by primary involvement of the sacroiliac joints (SIJs) and/or the spine, leaading to substantial pain and disability. Until recently, the diagnosis of axSpA relied on detecting of structural changes evocative of sacroiliitis in the SIJs using plain radiography. The introduction of Magnetic resonance imaging (MRI) for evaluating the SIJs has significantly advanced the recognition of axSpA. MRI can detect early inflammatory processes even in patients who do not yet have structural lesions. Besides, MRI has shown superiority over radiography in detecting structural changes in the SIJs. However, the definition of a "positive MRI" in SpA remains controversial, as both sensitivity and specificity have their limitations. Early diagnosis of SpA has become increasingly important, as treatments are now available, and MRI is emerging as the preferred choice for early diagnosis. A number of randomized controlled trials of anti-tumour necrosis factor agents in ankylosing spondylitis have demonstrated regression of inflammatory lesions in the spine by MRI. Moreover, the role of MRI in the early diagnosis of SpA has become better established, and imaging features of active sacroiliitis by MRI have been defined for axSpA diagnosis. RATIONALE OF THE STUDY Despite the current advances in medical imaging and ongoing efforts to improve the classification criteria for axSpA, a high proportion of axSpA patients remain under-diagnosed, leading to delays in diagnosis that can result in a poor prognosis. The volume of unstructured data coming from medical imaging contributes to diagnostic delays. The integration of AI and machine learning technologies in medicine for processing large datasets has led to faster and more accurate analysis, identification of real-world evidence gaps, and the agile generation of evidence to address healthcare providers' and healthcare systems' needs. This study aims to develop an AI diagnostic tool that combines quantitative MRI data with clinical information to aid in the early diagnosis of axSpA. OBJECTIVES Primary objective: To create an AI tool that allows the early diagnosis of axSpA and lesion detection based on MRI. Secondary objective: Clinical validation of the AI module. Exploratory objective: - Automated characterization of lesions (oedema, erosion, fat metaplasia and ankylosing) based on texture quantification and radiomics and deep features analysis. - Determination of normative values for texture imaging biomarker on the SIJs. SAMPLE DESCRIPTION The dataset will consist of 900 MRIs, collected retrospectively. MRI exams will be sourced from patients with active axSpA and from those with inactive or no axSpA (control group). The control-to-case ratio will be set at 40/60, allowing the algorithm to learn from both subsets without favoring one group over the other. Since AI can more easily characterize normality than pathology, the proportion of non-axSpA and normal MRIs can be lower (approximately 40%) compared to the 60% allocated to axSpA MRIs. Among the active axSpA group, the distribution of MRIs across classification categories (oedema, ankylosing, erosion, and fat metaplasia) should be as balanced as possible, ideally with 25% assigned to each category. Each MRI does not necessarily come from a different patient, as they may represent different time points for the same individual. ANALYSIS PLAN 1. Image Quality Control. All the images received from sites will be checked by imaging technicians to guarantee the homogeneity of the data 2. Centralized Image Interpretation. A centralized radiological review of the MRI images will be conducted by senior MSK expert radiologists. Each case will be evaluated by two radiologists. If there is a disagreement between the two, a third radiologist will review the case. The radiologists will classify the MRIs into the study's various classes and cohorts based on the ASAS criteria for defining active sacroiliitis on MRI for the classification of axial spondyloarthritis. All radiologists involved in the project will receive training to detect lesions according to the ASAS criteria, and this training will be documented and stored in the study's repository. 3. Annotation process. The imaging technicians will delineate the lesions detected by the MSK expert radiologists to generate a 3D volume. This will be then reviewed by the MSK expert radiologist. 4. Imaging Biomarkers Extraction. To obtain further information of the lesions labeled, a texture analysis will be performed to quantify several features related to the heterogeneity of the tissue that can be considered as an indicator of the pathological process. The radiomic panel will be based on the following features: - Structural or shape features: Descriptive of the geometric properties of the image. Examples of these features are volume, maximum orthogonal diameter, maximum surface area, compactness, fractal dimension or sphericity of a lesion. - Statistical characteristics are those that are inferred by statistical relationships. They can be in turn: - First-order or distributional: They provide information on the frequency of individual voxel values without taking into consideration their spatial relationships. This distribution is presented in the form of histograms, which report the mean, median, maximum and minimum in the intensities of the voxels, but also on the asymmetry, kurtosis, uniformity or entropy of the distribution. - Second order or texture: They reflect the relationships between neighboring voxels, allowing to obtain a spatial arrangement of their intensities, thus giving an idea about the architecture and heterogeneity of the studied tissue. These relationships are obtained by means of statistical analyses, such as cooccurrence matrices, which measure the probability that two neighboring voxels have the same signal intensity. - Higher order: These are combinations of features obtained by complex statistical analysis, such as fractal analysis, on images to which filters or mathematical transformations have been applied to maximize or minimize patterns, remove noise, or highlight certain details. - Deep features: These are properties obtained by analyzing images with convolutional neural networks (CNN) or other deep learning algorithms. These algorithms are trained to be able, in an image, to automatically determine and select those features or sets of classifying features, without the need of human intervention. 5. AI Module Development. Using the MRIs collected together with the imaging biomarkers and other clinical information available, the data scientists will create an AI-based model that will provide a probability score of axSpA for each subject. To create the AI module, the database will be divided in three non-balanced sub datasets (training, validation and test). The bigger dataset of images will be used for training the module. After the training phase, the validation database will be used to check if the classification is well done or the model should be trained again. Training: Set of cases used to fit the model during the training process. These will be the cases the model will use to tune its weights, i.e. the cases that the model will use to "learn". Validation: Set of cases used to evaluate the model during the training process, therefore, are not used to tune the model weights. This dataset is used for three main purposes: - Hyperparameters tuning. - Overfitting detection: During the training process, after each training iteration (epoch), the model is evaluated over both the training and validation datasets. - Selection of the "best" model during the training process, this means that the weights from the training iteration in which the best validation metrics are obtained are stored. Test: A separate set, not used for training or validation, will be used for the final model evaluation. In this study, MRI exams will be obtained from various scanners and institutions. Therefore, the acquisition protocols and reconstruction techniques may vary between scanners. To address this, preprocessing techniques will be applied to standardise the images across different scanners.
Phase
N/ASpan
124 weeksSponsor
Ángel Alberich BayarriAmman
Recruiting
Healthy Volunteers
Effect of Animated Education on Anxiety and Vascular Complications
After ethical approvals are obtained, to facilitate the process of data collection, the researcher will contact the director of nursing and the head nurse of the pediatric cardiac clinic to inform them about the purpose, protocol, and duration of data collection. All days of the week, excluding holidays and weekends, between the hours of seven AM and four PM, recruitment, intervention, and data collecting will take place. To identify the clinical data regarding the health status of the children who will participate, the researcher will review children's medical records and contact their cardiologists. The researcher will introduce herself to the study participants, a simple explanation of the study's aims without mentioning anxiety level specifically, and the method of data collection will be clarified to gain their approval to participate in the study. Data collection for this study will be carried out for three months. Every child with parents will be interviewed individually by the researcher to collect the necessary data, and the interview will be conducted within 20 minutes. The interview will be classified into four phases (assessment phase, planning phase, implementation phase, and evaluation phase). Assessment phase In QACHD, the schedule for the CC procedure is informed at 2 pm on the day before CC, when it is confirmed, which children will undergo CC the next day, the following steps will be followed; The researcher will approach the children and parents in the children's rooms and provide them with a description of the study phases. Children who expressed interest in participating in the study and are eligible to participate, researchers will ask their parents to sign the consent form, and the children's assent will also be obtained. The researcher will collect the baseline sociodemographic questionnaire from both study groups (Tool 1). Then randomize study groups for control and intervention as mentioned before. Implementation phase Usual care will be presented to both study groups by the health team members in the pediatric unit. The researcher will present an animated education program individually to the children in the intervention group 24 hours before undergoing CC. To reduce interruptions during a teaching session and data collecting, a sign stating "Study in progress please do not disrupt" will be posted on the front door of the children's room. The AEP will be loaded on a laptop. The program will be presented in 12 minutes. The animated education program will familiarize children and their parents with the events occurring before, during, and after the post-CC procedure. Children's acquisition of the knowledge and skills taught in the AEP will be evaluated by using the ten-minute discussion that will be offered after they receive intervention from the researcher. Children in the intervention group will be encouraged to ask questions related to the material presented in the AEP. All answers to participants' questions will be provided based on the material available in the literature so that the same questions will be answered in the same way. Evaluation phase: After giving standardized instructions to respond to the SASC presented to children, children will be asked to read and answer the Arabic version of the SASC. Children will be informed to ask the researcher's assistance (data collector) to read the tool for them if they find difficulties in reading. Children's anxiety level will be assessed 2 hours before undergoing CC; based on previous literature findings CC-related anxiety is highest on the day of the procedure just before the CC procedure. Vascular complications will be assessed 2 hours post sheath removal by trained staff nurses in the pediatric ward; if vascular complications are present will be confirmed by an expert nurse who works in the CC lab. Flat time will be assessed and will be recorded after admission to the recovery area until physician discharge orders are obtained.
Phase
N/ASpan
57 weeksSponsor
University of JordanAmman
Recruiting
Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia
The study will assess the PK, safety and tolerability of QUAR when administered as a single IM injection, in patients with schizophrenia. The study will be conducted with 3 different dose strengths and up to two formulations. After eligibility confirmation, an oral treatment period follow by a washout period will be performed before QUAR IM administration. The different cohorts will be administered with one of the following dosages of Risperidone QUAR: Cohort 1/2: Formulation 1 or 2. Dose level 1 (Gluteal); Cohort 1a/2a: Formulation 1 or 2. Dose level 2 (Gluteal); Cohort 1b/2b: Formulation 1 or 2. Dose level 3 (Gluteal); Cohort 1c/2c: Formulation 1 or 2. Dose level 3 (Deltoid); The progression to the next cohorts will take place after a clinical safety assessment. Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points. After assessment of Cohort 1 (formulation 1, Dose Level 1, -gluteus-) progression to the next cohort with same formulation and escalating dose will take place (Cohort 1a -gluteus-). After assessment of Cohort 1a, progression and randomization (gluteus/deltoid) to the next cohorts with same formulation and escalating dose will take place (Cohort 1b -gluteus- and Cohort 1c -deltoid-). In this scenario, none of the Cohorts 2 will be conducted. If the assessment for Cohort 1 is not adequate, none of the subsequent Cohorts 1 (a/b/c) will be conducted and progression to the next cohort (Cohort 2) with different formulation and same level of dose as Cohort 1 will take place (Cohort 2: Formulation 2, Dose Level 1 -gluteus-). After assessment of Cohort 2, progression to the next cohort with same formulation and escalating dose will take place (Cohort 2a -gluteus-). After assessment of Cohort 2a, progression and randomization (gluteus/deltoid) to the next cohorts with same formulation and escalating dose will take place (Cohort 2b -gluteus- and Cohort 2c -deltoid-).
Phase
1Span
140 weeksSponsor
Rovi Pharmaceuticals LaboratoriesAmman
Recruiting
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.
Phase
1Span
147 weeksSponsor
University of JordanAmman
Recruiting
Teeth Decrowding With and Without Fixed Appliances
In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.
Phase
N/ASpan
48 weeksSponsor
Samer MheissenAmman
Recruiting
Healthy Volunteers
First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641
This is a first-in-human, multi center, randomized, double-blinded, single and multiple ascending doses (SAD and MAD) Phase I study in healthy adult volunteers (HV). The SAD cohorts will consist of six cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 48 HV). Additional cohorts may be added. The MAD cohorts will consist of 3 cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 24 HV). The subjects in MAD cohorts will be dosed once daily for 7 consecutive days. Additional cohorts may be added. Each entire cohort of 8 HV subjects will be enrolled at the same site.
Phase
1Span
53 weeksSponsor
LAPIX Therapeutics Inc.Amman
Recruiting
Healthy Volunteers
Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of ADL-018 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of the study is up to 42 weeks. At baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of ADL-018 300 mg, XOLAIR 300 mg, ADL-018 150 mg or XOLAIR 150 mg (main treatment period). At Week 12, prior to receiving their fourth dose of study medication, patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of XOLAIR (at the same dose level as prior to randomization, or switch to 3 doses of ADL-018 (transition period) at the same dose level as prior to randomization. All patients in the ADL-018 groups will continue to receive ADL-018 at the same dose levels.
Phase
3Span
88 weeksSponsor
Kashiv BioSciences, LLCAmman
Recruiting
Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms.
In this prospective cohort study, participants referred for a sleep study by in-lab polysomnography at the Jordan University Hospital and those who preferred their study conducted at a private clinic or with an at-home sleep study kit will be screened and physically examined for any facial discoloration which will be accordingly graded as low, moderate, or high based on severity of difference from normal skin colour and texture and pictured with patients' consent and privacy maintained. In addition to a general history, participants will be asked in detail about their smoking habits, vasovagal symptoms, sleeping habits, and any specific obstructive sleep apnea symptoms. After the sleep study is performed, positive and negative results will be collected and correlated with presence of facial discolouration. Severity of OSA will be graded by apnea-hypopnea index (AHI) and recorded as mild (5 - 15 events/hour), moderate (15 - 30 events/hour), or severe (> 30 events/hour). Participants with positive results will then be followed up with at 3 weeks and 6 months to determine what treatment they were given, assessed for improvement on treatment, and be questioned regarding smoking and vasovagal symptoms again. Improvement is defined as better sleep quality and reduction of initial symptoms. Participants with negative results will also be followed up with and asked about their smoking habits and vasovagal symptoms. Correlation will then be made between the group that improved on treatment and the group that did not (whether due to ineffective treatment or not receiving treatment at all) to see if improvement reduces smoking tendency with alleviated vasovagal symptoms, and compared with participants with negative sleep study results for any change in smoking habits as well. A purposive sampling technique will be utilized to determine the study population. The target population is patients above the age of 18 referred for sleep study at the Jordan University Hospital and Jordan Hospital. Patients who agree to participate in this study and sign the consent form. Researchers will interview patients in person at their initial sleep study visit to physically examine and observe participants' faces for discoloration and take pictures for future reference with consent. Follow up at 3 weeks and 6 months will be done either in the clinic or over the phone and Email. The data will be analysed using frequencies, means, standard deviations, and chi-square tests using SPSS for windows. The chi-square test will be used to assess the significance of the correlation between obstructive sleep apnea and facial discolouration, which will be considered significant at below p<0.05. Prevalence of vasovagal symptoms as well as smoking habits in patients referred for polysomnography will be recorded and evaluated for significance, and then compared with patients' follow up at 3 weeks and 6 months to assess changes on improvement using the chi-square test as well. Informed consent will be obtained from participants with anonymity confidentiality assured. The study will be explained to patients, after which they must sign a consent form. Each will be assigned a number and the collected data will be used for analysis without reference to patients' identities. Participation does not add risk to the patients since their treatment plan will not be altered, only followed up with.
Phase
N/ASpan
103 weeksSponsor
Jordan Collaborating Cardiology GroupAmman
Recruiting
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
The prevalence of chronic heart failure among the industrialized countries is 1-3%, and can exceed 30% in the elderly population. As the population ages, there is an increase in the number of co-morbidities among heart failure patients. These comorbidities are associated with an increase in major adverse cardiac events (MACE), cost, and complexity of care. Iron deficiency is one of the most common comorbidities occurring in patients with heart failure. Its prevalence can be as high as 59%, even if patients are non-anemic[4]. Iron deficiency in heart failure can lead to an impaired exercise capacity, a decreased quality of life and an increased risk of hospitalizations and mortality regardless of anemia. The relationship between the severity of iron deficiency and the prognosis is a linear one, with increased severity being associated with increased mortality. Intravenous iron treatment has been shown to improve the quality of life, with an increased exercise capacity and a reduced risk for hospitalizations. The prevalence of iron deficiency in HFrEF and HFmrEF patients in Middle Eastern population has not been studied. We suspect a higher prevalence compared to Western populations especially in women.
Phase
N/ASpan
78 weeksSponsor
Jordan Collaborating Cardiology GroupAmman
Recruiting