cyrilzakka/clinical-trials huggingface dataset:
Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.

A fever and a non-blanching rash is a relatively common reason for a child to attend an emergency department. A fever and a non-blanching rash can be an early sign of a life-threatening infection known as meningococcal disease. The aim of the PIC study is to determine how best to diagnose early meningococcal disease in children.

In particular the investigators are interested in researching how quick bedside tests can be used to do this.

A fever an a non-blanching rash is a relatively common presentation the the emergency department. A minority of children with a fever and a non-blanching rash with have a life-threatening infection. Currently it is very difficult to determine those children that require urgent treatment from those that have a simple viral illness.

The aim of the PIC study is to research how to better diagnose those serious infections earlier.

Data from the study will be used to test the effectiveness of current practice and to identify areas where current practice could be improved.

Eligibility Criteria:
Inclusion Criteria:

* Fever (recorded or reported) 38 degrees Centigrade or higher and a non-blanching rash (at the time of presentation)
* Features of meningococcal sepsis/meningitis

Exclusion Criteria:

* Known haematological conditions such as haematological malignancy, idiopathic thrombocytopenic purpura and coagulopathy
Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation

The aim of the present study will be to discover possible (i) improvements achievable in unilateral vestibular hypofunction patients using a self-assessed head-mounted device (HMD)-based gaming procedure when combined with a classical vestibular rehabilitation protocol (HMD group) as compared with a group undergoing only vestibular rehabilitation and (ii) HMD procedure-related side effects. Main outcomes will be: otoneurological testing (vestibulo-ocular reflex gain study by means of vHIT and posturography measures with particular attention on power spectra) and self-report and performance measures (DHI, DGI and ABC). Side effects of HMD implementation will be studied by means of Simulator Sickness Questionnaires.

Moreover, second part of the study would collect patients' data one year after the end of the vestibular rehabilitation or its implementation with HMD.

Due to the recent outbreak of virtual reality in the field of rehabilitation, the use of head-mounted devices has been proposed in addition to conventional vestibular rehabilitation therapy in unilateral vestibular hypofunction patients. This approach has been proved to be useful in maximizing vestibular rehabilitation outcomes, with minimum simulator-related side effects. Virtual reality-based devices have been tested in vestibular rehabilitation by many clinicians, due to the possibility of achieving habituation, substitution and adaptation, the effectiveness in people presenting visual vertigo, and the positive effects on anxiety.

Thus, due to the undeniable relevance of testing outcomes of vestibular rehabilitation, and the promising results of head-mounted device-based home exercises in ameliorating its effects, the aim of this study will be to compare - in terms of short- (one week) and long-term (one year) effects - the subjective and objective indicators of vestibular function in a population of patients with unilateral vestibular hypofunction after completing conventional vestibular rehabilitation therapy with a randomized group who underwent a mixed-methods protocol including vestibular rehabilitation and head-mounted device treatment over the same period of time.

Eligibility Criteria:
Inclusion Criteria:

- right-handed patients affected by right chronic Unilateral Vestibular Hypofunction, the diagnosis of which will be achieved with at least 25% reduced vestibular response at bithermal water caloric irrigations on one side when calculated by means of Jongkees' formula after at least 3 months from the onset of symptoms.

Exclusion Criteria:

* negative anamnesis for malignancy,
* negative anamnesis for head trauma,
* negative anamnesis for neuropsychiatric disorders
* negative anamnesis for metabolic diseases
* negative anamnesis for cardiovascular diseases
* negative anamnesis for endocrine diseases
* treatment with drugs possibly impacting on auditory and visuo-vestibular functions
* negative anamnesis for infectious diseases
* negative anamnesis for otoneurological diseases
Application of a Systematic Developmental Assessment to a Novel Population: Infants With Rare Genetic Disorders

The main objective of this study is to apply a well-established model of developmental surveillance (which evolved to characterize the outcomes of very low birth weight infants) to infants with genetic disorders. A novel clinical model for infants with rare genetic disorders has been created as a joint initiative between the Division of Newborn Medicine's NICU Growth and Developmental Support Programs (NICU GraDS) program and the Division of Genetics at Boston Children's Hospital (BCH). This study plans to enroll patients with genetic syndromes seen in this clinic into a prospective, longitudinal study in order to characterize their developmental profiles and needs.

The main objective of this study is to apply a well-established model of developmental surveillance (which evolved to characterize the outcomes of very low birth weight infants) to infants with genetic disorders. A novel clinical model for infants with rare genetic disorders has been created as a joint initiative between the Division of Newborn Medicine's NICU Growth and Developmental Support Programs (NICU GraDS) program and the Division of Genetics at Boston Children's Hospital (BCH). This study plans to enroll patients with genetic syndromes seen in this clinic into a prospective, longitudinal study in order to characterize their developmental profiles and needs. Related factors such as quality of life and parental stress will also be assessed which will complement the evaluation of the role of a "developmental home" for these high risk infants. It is also hypothesized that gaps in care - mismatches between services received and services indicated based upon the developmental evaluation - will be identified. The results of this study will be used to inform future research efforts utilizing targeted approaches to improve developmental outcomes.

For infants with rare genetic disorders, the aims are as follows:

Aim 1: Characterize physical and psychosocial development using standardized longitudinal assessments.

Aim 2: Identify developmental service needs, prescription, and utilization.

Aim 3: Assess parental stress and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are infants under 4 years of age with genetic disorders undergoing developmental surveillance in the NICU GraDS program.

Exclusion Criteria:

* Children 4 years of age or older will be excluded.
Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent
* Clinically normal physical findings and laboratory values

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within three weeks before the first dose
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)

The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia. SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable forms allows it to be given in almost any setting, does not require any staff time to administer and makes it practical to rapidly screen large numbers of individuals in the community or in their home.This trial is being conducted to study the validity of SAGE in a digital format (eSAGE) for cognitive screening.

The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.

Addendum:

The eSAGE was previously validated in an earlier stage of this trial. It was initially designed for tablet use and the exact same test has recently been formatted for smartphone use.

This addendum is being conducted to study the validity of the smartphone eSAGE compared to the tablet eSAGE for cognitive screening.

Participants will be recruited based on their eSAGE scores and evaluated with neuropsychological testing and medical history to determine their status as normal, mild cognitive impairment, or dementia.

The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.

Addendum:

Subjects will be scheduled for a one time visit where they will be administered both the tablet eSAGE and the smartphone eSAGE. eSAGE tablet scores will be compared to eSAGE smartphone scores to determine if the two formats are equivalent to each other.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 49 years old of either gender
* Vision and hearing sufficient for compliance with tests

Exclusion Criteria:

* Diagnosis by a physician of moderate or severe dementia
* Intellectual disability
Comparison of Bowel Cleansing Regimens for Colonoscopy

Colonoscopy is a frequently used method in colon cancer screening today. Routine bowel cleansing is performed for colonoscopy. When the guidelines are examined, there are various recommendations regarding colonoscopy preparation regimens and durations. In this study, participants using the same colon cleansing drug before colonoscopy will be compared in terms of colon cleansing of the patient group who had a clear diet in the last 24 hours before the procedure and the patient group who had a low fiber diet.

Studies have reported that inadequate bowel preparation reduces the detection of polyps that may have the potential to become cancerous. Unfortunately, however, many participants are unable to comply with bowel cleansing regimens due to strict dietary changes and large amounts of unpleasant laxative solutions that affect their quality of life before the procedure. In addition, participants with insufficient bowel cleansing should repeat similar preparation steps before the next examination. The European Society for Gastrointestinal Endoscopy (ESGE) recommends a polyethylene glycol (PEG) regimen for colonoscopy preparation and low-fiber food intake 24 hours prior to the procedure. In our country, PEG is not used routinely and frequently in terms of cost and lack of SGK payments. 'Sennoside A+B calcium', which is used for colonoscopy preparation in our country, shows its effect by increasing intestinal motility and causes the accumulation of water and electrolytes in the colon lumen. It has security and ease of application. In addition, the fact that it is paid by the Social Security Institution and the price is affordable makes it advantageous in the preparation of colonoscopy. Although there is not enough data for colonoscopy preparation in our country, each clinic determines the duration of the regimen in various ways. The aim of this study is to compare the patient group who used low fiber food for 24 hours before colonoscopy and who had a clear diet for 24 hours before colonoscopy in terms of adequate cleaning during endoscopy in participants who underwent bowel cleansing with 'Sennoside A+B calcium'.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and older
* Patients undergoing colonoscopy for colorectal cancer screening, or patients with nonspecific gastrointestinal symptoms

Exclusion Criteria:

* Patients with a serious medical condition such as severe heart
* Kidney or metabolic disease
* Psychiatric disease not complying with the recommended regimen
* Patients with a history of colon resection for any reason
* Patients with suspected intestinal obstruction or ileus
* Patients undergoing emergency colonoscopy
* Patients who did not accept the informed consent form.
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies

Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. Subjects with histopathologically and/or flow cytometry-confirmed diseases according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
3. Relapsed disease
4. For subjects with R/R MCL: Patients must have measurable disease
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 1 and a life expectancy of ≥ 6 months.
6. Adequate hematologic function
7. Patients with basically normal coagulation function
8. Patients with adequate hepatic, renal, pulmonary and cardiac functions
9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.

Exclusion Criteria:

1. Known central nervous system involvement by lymphoma/leukemia.
2. Known or suspected history of Richter's transformation.
3. Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior chimeric cell therapy (unless ≥ 3 months since cell infusion).
4. A history of allogeneic stem cell transplantation.
5. An interval of less than 5 half-lives from the last dose of a strong CYP3A or CYP2C8 inhibitor or inducer (chemical agent, herbal medicine and dietary supplement) to the first dose of the investigational product, or a plan to use concurrently medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with strong CYP3A or CYP2C8 inhibitory or inductive effect during study participation
6. Presence of active infection that currently requires intravenous systemic antiinfective therapy.
7. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
8. History of significant cardiovascular disease
9. Patients with previous or concomitant central nervous system disorders
10. Known alcohol or drug dependence
11. Female patients who are pregnant or lactating.
12. Unable to swallow tablets or presence of disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial

This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder. This is prospective randomized controlled trial and multi-center study. 100 frozen shoulder who diagnosed with limited range of motion in 2 more plane of flexion, abduction, external rotation of affected shoulder. Shoulder range of motion (ROM), Shoulder Pain and Disability Index (SPADI), pain evaluation with Numeral Rating Scale (NRS), quality of life evaluation with Short Form (SF)-36 Health Survey and EQ-5D-5L, activity daily living (ADL) evaluation with Canadian Occupational Performance Measure (COPM) will be evaluated on enrollment, 4-week, 8-week, 12-weeks, 18-weeks, and 24 weeks after enrollment.

The frozen shoulder is a disease in which severe pain and limited range of motion of the shoulder occur as an inflammatory change occurs in the articular capsular surrounding the shoulder joint. As a result, it has caused limitation in daily life movement.

Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.

The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder.

Eligibility Criteria:
Inclusion Criteria:

* Limited passive range of motion of the affected shoulder in 2 more plane (flexion \< 150˚, abduction \<150˚, external rotation \< 60˚)

Exclusion Criteria:

* Bilateral frozen shoulder
* Secondary frozen shoulder caused by trauma (shoulder fracture, dislocation), or/and inflammatory disease(rheumatoid arthritis)
* Those unable to perform exercise due to general deconditioning
* Those with communication difficulty
Gluteal Activation With or Without Traction Straight Leg Raise Technique

This study was a Randomized clinical trial conducted to determine the Effects of gluteal activation with or without traction straight leg raise technique among patients of sacroiliac joint syndrome so that in future this study will be helpful for other clinician to determine that how much gluteal activation is important in low back pain or sacroiliac joint syndrome, and how it affects our sling system.

Non Probability Convenient sampling was done . Patients following eligibility criteria from Sports and Spine Professionals ,Lahore were considered. Sample size was calculated with Epi tool calculator. 38 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given gluteal activation exercises with traction straight leg raise technique for hamstring and Group B was gluteal activation exercises without traction straight leg raise technique for hamstring. Duration of research was almost 6 months. Patient will undergo 10 treatments in five weeks. Each session will take 30 minutes. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via sphygmomanometer and numeric pain rating scale for assessing muscle strength of gluteus maximum and pain levels respectively. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with LBP below the level of L5,
2. With pain over the posterior aspect of SI joint around posterior superior iliac spine and buttock with or without above knee leg pain.
3. Females only

Exclusion Criteria:

1. Had radicular pain with neurological (sensory or motor) deficits,
2. Had a history of spinal surgery, spinal, pelvic, or lower extremity fracture; hospitalization for trauma or motor vehicle accident;
3. Hip or knee dysfunctions;
4. Pregnancy;
5. Any systemic disease such as arthritis, tuberculosis, liver, or kidney failure
6. Subjects with leg length discrepancies, because of its potential effect on hamstring muscle length were also excluded. -
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals

This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years

Exclusion Criteria:

* Known allergies or skin sensitivities to electrode hydrogel and/or acrylic-based adhesives
* Non-intact skin such as skin breakdown where the device is to be placed (upper back)
* Implantable pulse generators such as pacemakers and defibrillators
* Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin

Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial clinical and experimental evidence suggest that both diabetes and insulin resistance cause a combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular disease. It has been implicated as an independent risk factor for cardiovascular disease and premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as well as for patients with essential hypertension. A complete biochemical understanding of the mechanisms by which hyperglycemia causes vascular functional and structural changes associated with the diabetic milieu still eludes us. In recent years, the numerous biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of diabetic vascular disease have been distilled into several unifying hypotheses. The role of chronic hyperglycemia in the development of diabetic microvascular complications and in neuropathy has been clearly established. However, the biochemical or cellular links between elevated blood glucose levels, and the vascular lesions remain incompletely understood. A number of trials have demonstrated that statins therapy as well as angiotensin converting enzyme inhibitors is associated with improvements in endothelial function in diabetes. Although antioxidants provide short-term improvement of endothelial function in humans, all studies of the effectiveness of preventive antioxidant therapy have been disappointing. Actually, control of hyperglycemia thus remains the best way to improve endothelial function and to prevent atherosclerosis and other cardiovascular complications of diabetes.


Eligibility Criteria:
Inclusion Criteria:

* diabetic patient;
* therapy with aspirin and insulin;
* patient well responders

Exclusion Criteria:

* not diabetic patient;
* patients in dual antiplatelet therapy;
* patient with severe renal failure;
* patient poor responders