cyrilzakka/clinical-trials huggingface dataset:
Influence of Gait and Running on Foot Posture

Objective: To evaluate in a sample of healthy non-athlete subjects, if the foot tends to a pronated position during a period of running compared to walking, evaluated during and after one hour after performing said activity.

Design: Quasi-experimental study, experimental and control group. Setting: Subjects who attend the Podiatry Clinical Area of the University of Seville.

Participants: N=72 healthy non-athlete volunteer adults who regularly run.

Interventions: The volunteers will participate in the research on three occasions, the day of data collection, one day when they will carry out a one-hour walking period and on another occasion where they will carry out an hour of running. Changes in foot posture \[FPI\] or foot pronation position (navicular drop \[ND\]) were identified in various periods of time at the time of the initial assessment and examination (p1), after 30 minutes of walking or running ( p2), 45 minutes of walking or running (p3) and 60 minutes of walking or running (p4) of the activity elapsed.

Main outcome measures: Foot position will be measured using the Foot Posture Index (FPI) and navicular height using the navicular drop test (ND) at p1, p2, p3 and p4.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria are: healthy adults, of both sexes, who come to the center on the indicated date and who are professional athletes but who do practice some regular physical activity, understood as running for one hour three times a week as minimum.

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Exclusion Criteria:

a congenital or traumatic foot deformity, wearing plantar supports, pregnancy or being in current rehabilitation treatment or serious illness.

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Time Efficiency and Obturation Quality of Rotary Versus Manual in Primary Teeth

The aim of this study is to evaluate the quality of obturation and the time efficiency of rotary versus manual instrumentation in roots of deciduous molars clinically where the:

* Primary objective Is to evaluate the time efficiency
* Secondary objective Is to evaluate the quality of obturation Clinical and radiographical follow up will be performed for 18 months to investigate the clinical and the radiographic success for the Conventional and Rotary groups.

The study will be conducted in two parts as follows:

In-vitro part as a training part to practice, test the speed of the rotary system, followed by application clinically.

Obturation will be done using two different filling techniques:

* Incremental filling Technique
* Disposable syringe Technique.

Then the instrumentation time and the quality of obturation will be recorded.

The study will be conducted by recruiting patients from the Outpatient clinic of The Pediatric Dentistry and Dental Public Health department, Faculty of Dentistry, Ain Shams University:

Eligibility Criteria:
Inclusion Criteria:

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Children included in the study should conform to the following criteria:

1. Patients between ages 4-7 years old with at least one mandibular vital or non-vital primary molar indicated for pulpectomy will be selected.
2. Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.
3. No physiological root resorption.
4. The teeth should have enough coronal structure for full coverage Stainless-Steel crowns.

Exclusion Criteria:

* 1. Children who are extremely uncooperative and difficult to manage 2. Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN) 3. Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.
Comparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain

The effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. Therefore, the investigators plan to make a comparison of the effect of a weight bearing protocol and a non-weight bearing protocol on osteoporotic women with chronic low back pain.

40 women with osteoporosis and low back pain will be divided into two groups. Each group will be given a specific exercise protocol, twice a week for four weeks, 45 minutes each time. The participants will be tested before starting the program, immediately after finishing it and again two months later. The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS (Visual Analogue Scale) and lumbar range of motion measurement by a digital Inclinometer.

Statistical analysis will be made in order to compare the dependent variables between groups.

40 women with osteoporosis and low back pain will be recruited by referral of doctors to the physical therapy clinic in Bat-Yam, Israel. Each woman will be tested by one investigator after meeting the criteria of eligibility and after obtaining formed consent . The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS and lumbar range of motion measurement by a digital Inclinometer. By order of appearance, each participant will be assigned to one of two groups - weight bearing group or non-weight bearing group. After recruiting at least 3 participants in each group, a different investigator will begin a specific exercise protocol for each of the groups for four weeks - twice a week, 45 minutes each time, a total of 8 sessions. After each participant finishes all 8 sessions, she will be tested for the second time by the first investigator, the same tests as the first time. A third identical test will be preformed two months after finishing the program.

After all the participants finish the program statistical analysis will be made in order to compare the dependent variables between groups.

Eligibility Criteria:
Inclusion Criteria:

* women with osteoporosis (T score lower than -2.5)
* women whom had suffered from non specific low back pain for the last 3 months or more.

Exclusion Criteria:

* history of operations in the spine
* history of cancer or neurologic disease
* history of fractures
* previous trauma to the spine
* persons whom for any reason cannot sit on a chair or lie on a mattress for 45 minutes
Effectiveness of Music Therapy on Sleep Disorders

The purpose of this study is to determine whether listening to music before falling asleep can improve sleep quality in patients with sleep disorders.

Sleep is a key factor in a person's health, and we actually spend one third of our lives sleeping. The latest figures show a prevalence of insomnia in 20-30% of French adults. Sleep disorders are a growing public health concern.

Treatment for insomnia is often some form of drugs; however, the side effects of these treatments (sedatives, hypnotics or anti-anxiety medications) are significant. Non drug-treatments like music therapy are growing in popularity. The objective of this study is to demonstrate the effectiveness of musical interventions on sleep disorders in general population.

It is a prospective, multicentered, double-blind, randomized comparative intervention study, comparing 3 parallel patient groups. Patients included in this study will be selected by their physicians according to the severity of their disorders. Enrollment period will last for 2 months and the study will last 3 months. The primary outcome (score on Pittsburgh Sleep Quality Index, PSQI) is a discrete quantitative variable. The statistical tests used will concern the comparison of the average deltas of each group by using analysis of variance (ANOVA). The selected alpha risk, or Type 1 error, is 5%.

The results expected in this study are a significant decrease in Pittsburgh scale scores in the music intervention group. The decrease in Pittsburgh scale scores should be compared to the results from this study: Qun Wang and Al; The Effects of Music Intervention on Sleep Quality in Community-Dwelling Elderly, The Journal of Alternative and Complementary Medicine, 2016. In this 3-month study, the average change compared to the baseline is 6.44 in the musical intervention group and 3.28 in the control group. The pooled standard deviation is estimated to be 3.53.

Musical intervention is non-invasive, so it's a low-risk therapeutic tool for general practice that may be useful in the management of sleep disorders. Its effectiveness, if demonstrated, could lead to new recommendations for the treatment of sleep disorders, and reduce the use of medication such as sedatives and hypnotics.

Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years old
* speaking French,
* with sleep complaints at least 3 times a week for more than 3 months,
* or with a sleep medications at least 3 times a week for more than 3 months,
* and an ISI score (Insomnia Severity Index) greater than 14

Exclusion Criteria:

* Age \< 18 years old.
* Patients with severe cognitive disorders or comprehension disorders deemed incompatible with the study protocol by the physician.
* Patients with severe hearing loss, not using hearing aids.
* Patients who do not own a music distribution device (smartphone, tablet, laptop, hifi system...).
* Patients without internet access.
Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy

The purpose of this study is to determine the effects of Central Nervous System Stimulants, represented by Methylphenidate and Modafinil, compared to placebo control on motor performance in children with Cerebral Palsy. This study will be a triple-masked study per the American Academy of Neurology guidelines for clinical trials.

Cerebral Palsy (CP) is a neurological disorder that commonly cause disability and limit physical function in children, and this disability persists into adulthood. There are several treatment options for motor impairments associated with CP, including oral medications (diazepam or related benzodiazepines, baclofen, dantrolene, and tizanidine hydrochloride), intraspinal infusion (baclofen), paralyzing agents (Botulinum toxin), and surgical interventions (dorsal rhizotomy). However, these interventions have drawbacks that could impact their benefits, such as drowsiness with oral medications and permanent change in muscle tone with the rhizotomy surgery. Other rehabilitation interventions showed significant improvements in motor function such as constraint-induced movement therapy (CIMT) and strength training. A few researchers attempted using central nervous system stimulants (i.e., Modafinil \[Provigil\]) off-label for improving motor control and reducing spasticity in children with CP. Another medication that has been used for motor impairments is Methylphenidate (MPH), also a central nervous system stimulant. However, this medication was used for improving muscle tone and motor performance in children with Attention-deficit/Hyperactivity Disorder (ADHD), but not in children with CP. MPH is useful for children with combined CP and ADHD and showed beneficial results for ADHD symptoms and behavioral outcomes with minimal side effects. Therefore, the purpose of this pilot randomized controlled trial (RCT) is to examine the effects of Central Nervous System (CNS) stimulants (Modafinil and MPH) vs. placebo in addition to physical therapy intervention on gross motor function and spasticity in children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with spastic diplegic or quadriplegic CP by a physician.
* Children aged between 7-12 years old.
* Children with CP classified as level I \& II based on the gross motor function classification system (GMFCS).
* Children with CP that are receiving physical therapy for ≥ 3 months.

Exclusion Criteria:

* Children that had a seizure attack in the past 6 months
* Children that have been diagnosed with attention deficit/ hyperactivity disorder (ADHD)
* Children that had any surgery within the last 6 months
* Children that has lower-extremity contractures determined by the passive range of motion (hips, knees, and ankles)
* Children that use medications that interfere with spasticity (e.g., Baclofen)
Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation

One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI) recipients was reported to be the placement of the electrode array in the scala tympani. It seems that the correct placement of the electrode initially into the scala tympani and subsequent avoidance of dislocation into the scala vestibuli as the insertion progresses, is a key factor in achieving good speech perception outcomes. Another important aspect related to the performance is the achievement of consistent electrical coverage with the electrode. Data reported for electrodes of different manufacturers give depths ranging from 240 - 600 degrees showing the considerable variation across subjects. The HiFocus mid scala electrode was developed to cover one and a quarter turn and with the pre-curved design to be less susceptible to variations in individual cochlea dimensions and insertion techniques. A further mechanical feature of the pre-curved design is the avoidance of forces against the cochlear lateral wall and associated lower susceptibility of the electrode for moving out of the cochlea following insertion. Recently, a cone beam CT (CBCT) technique is being explored in the field of ENT with the potential to overcome some of the issues associated with the conventional CT techniques such as scattering, radiation and low isometric resolution. Images with comparable details to those of e.g. micro CTs are possible with much lower radiation dose. Modern imaging software i.e. 3D Slicer (www.slicer.org) may be used for 3D reconstruction, post processing and Brainsfit for registration. Registration is the alignment of two scans in the same coordinate system. This enables the identification of differences between two images recorded at time x and y. Once accurately superimposed any difference between the two images may be identified with an accuracy of 0.2 mm. Using these methods, one can assess the stability and the position of the electrode in the cochlea.

Objective: The primary objectives of this study are to evaluate the feasibility of using cone beam CT technique in combination with (high resolution) MRI to identify electrode movements following cochlear implant surgery and identify the inter-scalar position of the HFms electrode. The secondary objective is to quantify the average insertion depth and variations of the HFms electrode


Eligibility Criteria:
Inclusion Criteria:

* Adults 18y or older meeting the conventional Dutch CI criteria
* The patient will receives the HiFocus Mid Scala electrode
* No cochlear or neural abnormalities that could compromise the placement of the electrode as assessed by the CI surgeon

Exclusion Criteria:

* Physical or non-physical contraindications for MRI or CT imaging
* No additional disabilities that may prevent active participation and testing as per protocol
Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain

Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

This is a multicenter, open-label, single-arm study designed to characterize the PK and to evaluate the safety of ALO-02 in children and adolescents 7 to 17 years of age who require opioid analgesia for moderate-to-severe pain. The study consists of 4 study periods (screening, titration, maintenance, follow-up) occurring over a period of up to 9 weeks. The study will enroll approximately 140 children and adolescents with at least 100 subjects once stabilized during the titration period to complete a minimum of 2 of the 4 weeks study duration in the maintenance period to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last dose.

Eligibility Criteria:
Inclusion Criteria:

* Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
* Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to \> 6 mg per day of oxycodone, for a period of 3 consecutive days immediately prior to first day of dosing.

Exclusion Criteria:

* Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
* Hypersensitivity to morphine, naltrexone.
* A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
* Undergone surgery within 3 days prior to the first day of dosing.
Effects of Hamstring Stretching Using Pressure Biofeedback Unit in Patients With Low Back Pain.

To determine the effects of Hamstring stretching using a pressure Biofeedback unit on muscle length, pain, and functional status in patients with low back pain.

Several studies have been conducted regarding hamstring stretching with the pelvis anteriorly tilted for treating low back pain but there is very little evidence regarding the use of a pressure biofeedback unit for maintaining anterior pelvic tilt so this study aims to find out whether the hamstring stretching while maintaining anterior pelvic tilt using pressure biofeedback is more effective than hamstring stretching without using pressure biofeedback in patients with low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific low back pain
* Chronic pain \> 3 months
* Participants having (ODI) score minimum 20% to 40%
* Participants with hamstrings shorter than 70 degrees bilaterally
* Participants who scored 3 or more than 3 on the Numeric Pain Rating Scale (NPRS)

Exclusion Criteria:

* History of fracture and surgery
* Patients with osteoarthritis and spondylolisthesis
* Patients with systemic disease except for diabetes mellitus and hypertension
* Patients with disc herniation and leg length discrepancy
* Pregnant females
* Participants with severe back pain or excessive lumber lordosis
Psychotherapy of Anxiety Disorders With Noninvasive Brain Stimulation - Using Virtual Reality

The aim of the study is to transfer the rTMS stimulation protocol by Raij et al. (2018) into a therapeutic setting to improve exposure therapy in acrophobic patients. The quasi-randomized, placebo-controlled and double-blinded study will include 88 patients with height phobia (according to DSM 5). All participants will perform two exposure sessions in virtual reality (VR). Before exposure therapy, one group will receive verum rTMS of the left frontal cortex, which is indirectly functionally linked to the ventromedial prefrontal cortex (Raij et al., 2018). The control group will receive sham stimulation. A structural MRI and a TMS navigation system will be used for precise localization of the left FC. Anxiety symptoms will be measured using subjective ratings (e.g. Acrophobia Questionnaire) and the behavioural approach task (BAT) in VR and in real life before and after the treatment, and at 6 months follow-up. Furthermore, blood samples will be collected before rTMS and after exposure treatment to assess epigenetic and gene expression based changes.

The following hypotheses are derived:

1. Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly stronger reduction of phobic symptoms immediately after exposure therapy, compared to the sham stimulation group.
2. Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly greater increase in approach behavior and significantly less distress during the BAT immediately after exposure therapy, compared to the sham stimulation group.
3. The postulated differences in hypotheses 1 and 2 are still detectable at follow-up after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Acrophobia (according to DSM-5)
* Right handed
* German native speaker
* Written informed consent

Exclusion Criteria:

* Neurological and/or severe physical illnesses
* Comorbid Axis I disorder (other than phobias)
* Pretreated phobia of heights
* Use of tricyclic antidepressants, antipsychotics, or other substances that increase cerebral seizure susceptibility
* Craniocerebral injuries, head surgery
* Epileptic seizures, or family history of epilepsy
* Metal parts in the head area
* Cardiac pacemakers
* Infusion pumps
* Heart diseases
* Increased intracranial pressure
* Pregnancy
* Cochlear implants
* Tattoos (done before the year 2000)
* Piercings (if not completely removable)
* Permanent make-up
* Nicotine or pain patches
* other MRI contraindications
Application of a Training Program for Executive Functions in a Sample of Egyptian Children With Learning Disorder

In recent years, significant progress has been made on ways to improve Executive Functions (EF) skills for school readiness involving direct EF training and classroom educational programs. Due to the absence of a well-structured Arabic program for EF training in children, the rationale of this study is to implement a comprehensive, evidence-based intervention program to help Egyptian children with learning disorders to overcome their EF impairment. It uses the multimodality approach to help meet the needs of students with a variety of learning styles. The aim of this study is to adapt the combined form of the "Executive Functions Training-Elementary", and the "Promoting Executive Function In The Classroom" programs and its application in order to test its effectiveness in the rehabilitation of Egyptian learning disordered children.

The study was conducted on 40 children with dyslexia and Executive dysfunction attending unit of phoniatrics, Otorhinolaryngology department, Alexandria University. The results were compared before and after intervention.

The "Executive Functions Training-Elementary" program is an evidence-based practice that targets Executive function skills in the early elementary years by training students how to plan, execute, complete, and monitor tasks. It develops cognitive abilities and behavior control with classroom-related activities for varying ability levels.

The "Promoting Executive Function In The Classroom" program helps to incorporate Executive function processes (such as planning, organization, prioritizing, and self-checking) into the classroom curriculum. Chapters provide effective strategies for learning by improving how to learn.

Data were collected and entered to the computer using (Statistical Package for Social Science) program for statistical analysis (version 21).

Data were entered as numerical or categorical, as appropriate. Kolmogorov-Smirnov test of normality revealed no significance in the distribution of the variables, so the parametric statistics was adopted.

Data were described using minimum, maximum, mean, standard deviation and 95% Confidence Interval of the mean.

Categorical variables were described using frequency and percentage. Comparisons were carried out between two studied dependent normally distributed variables using paired t-test.

Comparisons were carried out between more than two independent normally distributed subgroups using one-way Analysis Of Variance (ANOVA) test. When F ratio of ANOVA was significant Levene test of homogeneity of variances was done, and if significant Brown-Forsythe Robust test was adopted. Post-hoc multiple comparisons was done using Games-Howell.

Eligibility Criteria:
Inclusion Criteria:

* children complaining of specific learning disorder and executive function deficits

Exclusion Criteria:

* brain damage, mentally retarded or history of fits or subclinical fits
* hearing or visual impairment
* psychic problems