cyrilzakka/clinical-trials huggingface dataset:
Sensory Intervention for Children With Autism

Greater than 80% of children with autism spectrum disorder (ASD) experience sensory differences that make it difficult for them to fully participate in meaningful everyday activities. In this research study, we will use MRI and behavioral methods to assess how sensory interventions might change sensory brain structures, allowing us to better predict which sensory interventions might work best for whom.


Eligibility Criteria:
Inclusion Criteria: Male children 6 years, 0 months to 8 years, 6 months of age with a diagnosis of autism spectrum disorder (ASD) will qualify for inclusion. Our inclusion age ensures all study participants will complete intervention/control conditions and be retested before they turn 9 years of age. Additional inclusion criteria include:

1. The families of children will have access to transportation to attend intervention sessions 2 times per week for 16-weeks.
2. Children who qualify will be verbal, and will speak and understand English. The native language of caregivers can include Spanish.
3. Children who qualify will have sensorimotor delays as assessed by the study team using the standardized, norm-referenced assessments described in this research proposal (z-scores on 3 of 5 tests -1.0 or lower).

Exclusion Criteria: Children younger than 6 years of age or older than 8 years, 6 months of age will be excluded. Additional exclusion criteria include:

1. Female children
2. Auditory hyperresponsivity as assessed during screening procedures.
3. Medical co-morbidities such as extreme prematurity (less than 28 weeks), blindness, deafness, cerebral palsy, Down Syndrome, tuberous sclerosis, or head-injury with loss of consciousness.
4. History of individual occupational therapy services in a clinical setting that includes sensory equipment.
5. Non-removable metal in the head or body (e.g. dental fillings \& braces, metal pins, screws or plates).
6. Children unable to complete neurocognitive or sensorimotor testing.
7. Children unsuccessful in 3 mock scanning sessions during baseline testing.
Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish

* Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period.
* Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. Approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90% \[β=0.10\] with a 2-sided type-I error of α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire.
* Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride, respectively, than 38% SDF, their use would be more favourable than SDF in young children.


Eligibility Criteria:
Inclusion Criteria:

* Kindergarteners who have joined our outreach dental service will be invited to join this study. Preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study.

Exclusion Criteria:

* Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.
Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patients without CSI are common and may be associated with harm. Spinal precautions result in well-documented adverse physical and physiological sequelae. Of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. Most children who receive spinal precautions and/or are imaged for potential CSI, and particularly those imaged with computed tomography (CT), are exposed to potential harm with no demonstrable benefit. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment Tool that can be used in the prehospital and ED settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for CSI.


Eligibility Criteria:
Inclusion Criteria:

* Age 0-17 years
* Known or suspected exposure to blunt trauma

At least one of the following applies to the patient:

* Undergoing trauma team evaluation
* Transported from the scene to participating facility by EMS
* Undergoing cervical spine imaging at participating facility
* Transferred to participating facility with cervical spine imaging

Exclusion Criteria:

* Exposed to solely penetrating trauma (e.g. a gunshot or stab wound)
A Study of Brexpiprazole in Patients With Major Depressive Disorder

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period
* Male and female patients ≥ 20 to \< 65 years of age (at the time of informed consent)
* Patients who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
* Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode," and whose current episode has persisted for at least 8 weeks

Exclusion Criteria:

* Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
* Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final

IMP administration. For birth control, 2 of the following methods must be used:

vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.

* Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated
* Patients with a history of electroconvulsive therapy
* Patients with a diagnosis of any of the following diseases according to DSM-5

  1. Neurocognitive disorders
  2. Schizophrenia spectrum and other psychotic disorders
  3. Bipolar and related disorders
  4. Feeding and eating disorders
  5. Obsessive-compulsive disorder
  6. Panic disorder
  7. Posttraumatic stress disorder
Assessment of the Effectiveness of Progressive Relaxation Techniques in Individuals With Ulcerative Colitis

Ulcerative colitis is a chronic disease that follows a course of remission and flare-ups. Especially during flare-ups, the worsening of symptoms negatively affects all aspects of the individual's life and decreases their quality of life. Individuals sometimes have difficulty accessing healthcare facilities. In addition, every hospital admission causes an additional burden on healthcare institutions and the individual, both physically and financially. Therefore, it is of great importance to support and develop self-management behaviors for individuals to control their symptoms.

Progressive relaxation techniques are a relaxation method based on the principle of voluntary contraction and relaxation of muscle groups in our body. It has been reported that progressive relaxation techniques, which are applied in many chronic diseases and procedures, improve symptoms and disease parameters reported by individuals, especially pain, anxiety, and stress.

When the literature in the world and Turkey is examined, no study applying progressive relaxation techniques to ulcerative colitis patients has been encountered. It is known that especially stress and anxiety affect the number and severity of flare-ups in ulcerative colitis patients. It is thought that this study will contribute to the self-management behaviors of ulcerative colitis patients in the rare diseases group for the Turkish population and fill the gap in the literature.

The purpose of the research is to investigate the effect of progressive relaxation techniques on disease clinical activity, anxiety, sleep, and quality of life in individuals with ulcerative colitis.

We assigned 56 patients who met the inclusion criteria to the progressive relaxation group, the relaxing music group, and the control group using stratified randomization. The intervention (progressive relaxation) group was provided with a booklet and shown a video about progressive relaxation techniques.For the placebo (relaxing music) group, music from MusiCure, which consists of sounds of nature, was played. Reminder SMS messages were sent twice a week to the intervention and placebo groups. No intervention was administered to the control group.Forms were filled out again by individuals in the intervention, placebo, and control groups at the fourth and eighth week.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with UC at least six months ago
* Having been taking medication for at least three months
* Willingness to participate in the study
* Being 18 years of age or older
* Having been in remission for at least 3 months according to the partial Mayo score (Mayo score \<2)
* Being able to use a computer, internet, and mobile phone
* Residing in Izmir or surrounding cities
* Being cooperative and able to communicate

Exclusion Criteria:

* Patients with advanced comorbid conditions such as cancer, diabetes, and chronic obstructive pulmonary disease have been excluded from the study due to the potential for more pronounced effects on symptoms and disease activity.
Surface EMG Biofeedback for Children With Cerebral Palsy

Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent voluntary movement. Studies have suggested that using biofeedback to increase awareness of muscle activation can improve motor function in patients with motor deficits. The investigators hypothesize that the daily use of a surface electromyographic (SEMG) biofeedback device for one month will improve motor function in children and young adults with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the muscle(s) the subject has difficulty in controlling and provides vibratory feedback about muscle activation. Groups of children and young adults (ages 3-21), with dystonia, hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory feedback device on their affected muscle(s) for 5 hours a day for one month. The device will vibrate and emit a blue light when the muscle is activated. At the start of the experiment, subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one month, subjects will practice goals without device. After a month, subject will be assessed again and be given device to practice goals for a month. After one month, the subjects will be tested on the outcome measures again and return device.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy, or associated movement disorders such as dystonia, spasticity, and/or hypertonia
* Able to wear device for given amount of time

Exclusion Criteria:

* Unable to wear device for at least 5 hours day for a month.
Preoperative Pocket Echocardiography Trial

This study will compare findings using a handheld ultrasound device (GE VScan) with those using a diagnostic ultrasound machine in adult patients referred for transthoracic echo (TTE), prior to non-cardiac surgery at Hammersmith Hospital, London.

The handheld TTE (VTTE) will follow the standard Hammersmith Hospital diagnostic TTE (DTTE) protocol (with the exception of spectral Doppler) and will be reported on a simple 'tick box' form. A different echocardiographer will then perform and report the DTTE as per routine practice. The results from VTTE and DTTE will be directly compared. The echocardiographers performing the VTTE and DTTE are all fully accredited in diagnostic TTE and will be blinded to each others findings.

The study aims to recruit a total of 96 patients with an anticipated study completion date of November 2015.

Handheld echocardiography has become a practical reality with the development of small and highly portable devices. The GE VScan is one such device and a number of studies have examined its diagnostic capabilities in different clinical settings however, no study has examined its capability for screening non-cardiac surgical patients in the preoperative setting. If VTTE could be shown to safely screen patients preoperatively then there is potential to save time and money. DTTE is more costly than VTTE and there are often delays in performing DTTE prior to surgery.

Adult patients \> 17 years old who are referred for a preoperative TTE prior to non-cardiac surgery (elective or emergency procedures) are eligible for recruitment. Once an eligible patient is identified verbal and written consent to participate will be obtained.

VTTE will be performed by one of six accredited echocardiographers working in Hammersmith Hospital Echocardiography Department. Based on pilot data and previously published studies it is estimated the VTTE will take between 3 and 7 minutes. The VTTE is reported on a 'tick box' form with the findings separated into significant pathology (red zone) and insignificant pathology or normal findings (black zone).

DTTE will then be performed by a different echocardiographer and a written report prepared as per normal practice. The written DTTE report will be converted to a 'tick box' report enabling direct comparison of VTTE and DTTE.

The primary aim is to assess the ability of the VTTE to detect significant pathology identified on DTTE.

A proportion of DTTE and VTTE will be re-rated to obtain a measure of inter- and intra- observer variability.

Eligibility Criteria:
Inclusion Criteria:

• Adult surgical (non-cardiac) patients referred preoperatively for resting transthoracic echocardiogram

Exclusion Criteria:

• No consent or withdrawal of consent.
Technology and Health Communication in Improving Health Outcomes in Patients Scheduled for Mammography

This pilot clinical trial studies how well technology and health communication works in improving health outcomes in patients scheduled for mammography screening. The Mobile Mammography Screening Program provides a vital health service and it is important that all women scheduled for an appointment show-up to be screened. Technology and health communication may help decrease no-show rates among patients scheduled for mammography screening.

PRIMARY OBJECTIVES:

I. To decrease the mobile mammography unit no-show rate by sending text message appointment reminders to patients.

II. To assess the efficacy of the text message reminders at addressing the no-show rate by collecting satisfaction survey data from patients that received the texts and that came to their scheduled appointment.

OUTLINE:

Patients receive 1-2 text messages a few weeks before and 1 text message 24 hours before their mammography screening appointment. Patients also receive a phone call reminder as per standard practice.

Eligibility Criteria:
Inclusion Criteria:

* Appointment is at a participating location
* Has a cell phone that can send and receive text messages
* Agrees to receive the text messages
* Can read either English or Spanish
* Not yet sent text messages to 100 patients in community or corporate sites
* Scheduled at least 1 week prior to the appointment date
* PATIENTS FOR FOLLOW UP: come to their scheduled appointment
* PATIENTS FOR FOLLOW UP: received the text message reminders
* PATIENTS FOR FOLLOW UP: can read either English or Spanish
How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance

Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition


Eligibility Criteria:
Inclusion Criteria:

* vo2max \> 55 ml/kg/min
* females on contraceptive pill

Exclusion Criteria:

* recent skeletal muscle injury
* cardiovascular injury
* metabolic disease
Does Vibration Therapy Induce Higher Than Normal Bone Strains and Strain Rates Than Those Experienced During Habitual Daily Activities

The overall aim of this study is to test the hypothesis that vibration exercise can induce higher than normal bone strains and strain rates than are experienced during habitual locomotor activities.

The investigators plan to study healthy young volunteers to:

1. Determine the relationship between tibial bone strain and

   * the frequency and amplitude of vibration therapy
   * a range of habitual locomotor activities;
2. Determine the transmission of vibrations during vibration therapy, in terms of

   * amplitude attenuation and phase shift of positional coordinates and accelerations at anatomic landmarks along the lower leg and other skeletal sites
   * the relationship between these and different frequencies and amplitudes of vibration therapy;
3. Determine the muscle power in the lower limb associated with various habitual locomotor activities and its relationship to the measured tibial bone strain.

The investigators subsequently hope to use the data captured in this experiment to develop a QCT-based finite element (FE) model of the human lower limb (tibia, fibula and foot). The investigators will then validate this model in relation to the characteristics (amplitude and phase shift) of the measured tibial bone strain and transmission of vibrations to the different anatomical landmarks during vibration therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers, ages 18 to 50 years
* Generally healthy, as determined by review of medical history and physical exam
* Ambulatory
* Willing and physically able to undergo all study procedures
* BMD (measured by DXA) at the lumbar spine and hip within ± 2 SD of the young normal range
* BMI \< 30

Exclusion Criteria:

* Previous diagnosis of osteoporosis
* History of fracture of the spine, pelvis, leg or foot
* History of bone or joint disorders affecting the shoulders, spine, pelvis, legs or feet (e.g. arthritis, congenital hip dislocation, spinal spondylolisthesis)
* Ongoing conditions or diseases known to cause secondary osteoporosis
* Malabsorption syndromes (e.g. coeliac or Crohn's disease)
* Known disorders of calcium metabolism
* Known history of thyroid disease
* Osteomalacia
* Paget's disease
* Diabetes
* History of cancer within the previous 5 years
* Epilepsy
* Ongoing conditions or use of medications that may impair vision or balance
* Use of the following medications within the previous 2 years

  * Bisphosphonates
  * Fluoride (except use for oral hygiene)
  * Strontium
  * Teriparatide
  * Other bone agents (e.g. SERMs, isoflavones, HRT, calcitonin etc)
  * Steroids
* Alcohol abuse or illicit drug use
* Pregnancy or currently trying to conceive (women only)
* Inability to give informed consent
* Known hypersensitivity to the antibiotic penicillin or cephalosporins
* Known hypersensitivity to the local anaesthetic lignocaine.
Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova

This trial aims to increase the wellbeing of tuberculosis patients and their adherence to medication in Chisinau, The Republic of Moldova. The design is an individually randomised controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of treatment. The trial will have two arms; 200 patients will form the control group and receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually Observed Treatment (VOT).

VOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video messages rather than in-person. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. VOT allows patients to take their treatment in the comfort of their home and means they don't have to travel to their polyclinic every day.

There will be a central VOT observation centre where VOT observers will view and respond to video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health app. The VOT observers will also respond to the patients by sending feedback to the patients. The trial duration will depend on the recruitment rate of eligible patients but is expected to take 16 months.


Eligibility Criteria:
Inclusion Criteria:

1. Consent to being part of the trial
2. Live in Chisinau and no plans to move away from Chisinau during the four months
3. Aged 18 or over
4. At least four months of care remaining

Exclusion Criteria:

1. Having MDR-TB
2. Homeless
3. Is not homeless
4. Suffer from alcoholism or drug misuse
5. In prison
6. Has a treatment regimen with injections