cyrilzakka/clinical-trials huggingface dataset:
The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

This study was designed to examine the effects of using virtual reality and kaleidoscope during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into three groups. Accordingly, the study sample consisted of a virtual reality group with 42 children, a kaleidoscope group with 42 children, and a control group with 42 children, totaling 126 children. Fear and pain were evaluated by both the researcher and the child before and after the procedure. Anxiety was assessed by the child after the procedure. The Wong Baker Faces Pain Rating Scale was used for pain, the Children's Fear Scale for fear, and the Child Anxiety Scale-State Version for anxiety.


Eligibility Criteria:
Inclusion Criteria:

* being 48 months
* being conscious (with the ability to communicate).

Exclusion Criteria:

* Having a physical and psychological condition that prevents them from wearing glasses to view VR;
* Having a visual problem
* Having mental or physical disabilities
* Taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
* Having chronic or life-threatening disease
* Refusing the VR or kaleidoscope intervention during vaccine injection.
Phase II Trial Evaluating Elimination of Radiation Therapy

The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue


Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx .
* Treated with surgical resection with one (or both) side(s) of the neck pathologically N0.
* Indication for radiation therapy at the primary site or neck consisting of any of the below characteristics:

  * Close margin (\<= 0.5 cm)
  * Positive margin
  * Perineural invasion
  * Lymphovascular space invasion
  * Metastatic disease in more than one lymph node
  * Metastatic disease in more than one lymph node group
  * Extracapsular extension in any lymph node
  * Constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion.
* Age \>= 18.
* Patients must sign study specific, Institutional Review Board (IRB)-approved consent form.

Exclusion Criteria:

* Previous head and neck cancer other than non melanoma skin cancer.
* Previous head and neck surgery.
* Female patients who are pregnant or nursing.
Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt.

Cross sectional study to investigate the relation between Smartphone addiction and temporomandibular disorders among youth population in Egypt. An online- based questionnaire study. A 296 participants who are Egyptians with age between18 and 35 years old without prior neck and upper extremity related diseases, orofacial trauma or surgeries, history of rheumatoid arthritis or congenital musculoskeletal problems. An online- based questionnaire will be sent through different social media platforms, it will include three screens, the first includes the consent form, the second includes the demographic data (year of birth, current educational status, gender and geographic information ), and the third page includes questionnaires

.


Eligibility Criteria:
Inclusion Criteria:

* both males and females adults
* Their ages between18 and 35 years old
* ability to use Smartphone

Exclusion Criteria:

* any neck and upper extremity related diseases
* orofacial trauma or surgeries
* history of Rheumatoid arthritis
* congenital musculoskeletal problems.
Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19

The purpose of this study is to assess whether convalescent plasma therapy is associated with reduced 30-day all-cause mortality in a population of Veteran inpatients with non-severe coronavirus disease 2019 (COVID-19).

The convalescent plasma (CP) of individuals who have recovered from COVID-19 may help reduce symptoms and mortality when given to ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical trials are needed to provide definitive evidence of the benefits and harms of CP in the treatment of COVID-19. While clinical trials are underway, observational research plays a critical role in providing preliminary scientific evidence to guide clinical practice.

This observational study aims to estimate the association between CP therapy and mortality after 30 days in a sample of SARS-CoV-2-positive patients with non-severe illness. Patients include those hospitalized at a facility within the Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA), the largest integrated healthcare system in the United States. Using VA electronic health record data, the study is designed to emulate a target trial of convalescent plasma transfusion and mortality. The primary exposure of interest is the use or non-use of COVID-19 convalescent plasma, and the primary outcome is 30-day all-cause mortality.

A nested trial design will be used, in which patients will be followed from each day in which eligibility criteria are met (while hospitalized and after date of first positive SARS-CoV-2 test) for 30 days. The association between CP therapy and mortality will be assessed using pooled logistic models to estimate 30-day cumulative incidence curves, risk differences, and hazard ratios. Inverse probability weighting derived from propensity scores will be employed to minimize confounding by indication and other biases.

Eligibility Criteria:
Inclusion Criteria:

* US Veterans aged 21-80 years old
* Hospitalized between May 1, 2020 and November 17, 2020 with a SARS-CoV-2 positive test, at a VA Medical Center where convalescent plasma had been administered to at least one patient and remained a current practice at that VA Medical Center
* SARS-CoV-2 positive test within 7 days before or after hospital admission
* Minimum oxygen saturation (measured within the past day) \>=90%
* Vitals (pulse, respiration, temperature, systolic blood pressure) and acute labs (hemoglobin, platelet, white blood cells) measured within the past 2 days
* Albumin, Alanine Aminotransferase (ALT), creatinine measured within the past 30 days
* Weight measurement recorded in the past 2 years

Exclusion Criteria:

* Prior intubation, ventilation, high flow oxygen, extracorporeal membrane oxygenation (ECMO), dialysis, or vasopressors during current hospitalization
* Record of prior treatment with CP
* Received long-term care in a domiciliary or nursing home in the past 90 days
* First CP recipient at a site
* Less than 30 days of follow-up
Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease

The Objective of this research was to study the effectiveness of sensory integration training on balance and confidence in patients with Parkinson's disease.

Null Hypothesis:

Sensory integration training and conventional balance training have no significant difference in improving balance and confidence of patients with Parkinson's disease.

Alternative Hypothesis:

Sensory integration training and conventional balance training have a significant difference in improving balance and confidence in patients with Parkinson's disease.

The study design will be randomized controlled clinical trial. Patients who fulfill the inclusion criteria will be identified by individual physiotherapist and will be enrolled for particular study. A sample size of 46 patients will be taken in this study by expecting a mean change 10.42 using 80% power of study and 95% level of significance and 20% dropout will also be included. So each group contains 23 participants.

The study will be single blinded. The outcome assessor will be unaware of the treatment given to both groups. Sample will be collected through simple random sampling technique, and randomization sequencing will be generated with help of lottery. After selection the sample patients will be divided into two groups, allocation concealment will be ensured by using sealed envelopes. Group A will be given conventional balance training along with routine physical therapy without sensory integration and Group B will be given sensory integration physical therapy along with routine physical therapy. Group A will be called control group and Group B will be called experimental group. Every patient has to pick up an envelope which will be placed in patient's file which later will be opened by the researcher who will provide patient treatment accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed by a neurologist with Parkinson's disease.
* Patients having BBS score between 21-40
* At least 6 months post neurological Sensory/Motor deficit patient.
* Age between 30 -65 years.
* Ability to maintain standing position without aids for at least 5 minutes.
* Normal vision
* No severe systemic disorders
* An ability to understand and perform the test

Exclusion Criteria:

* Patients with other existing neuromuscular disorders or medical conditions that substantially influences their gait and balance performance
* Neuropathy patients
* Vestibular disorders, paroxysmal vertigo.
* Presence of orthopedic conditions involving the lower limbs.
* Patients with psychiatric disorders.
* Pregnant patients.
Assessment of LBR-101 In Chronic Migraine

The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.

Two distinct doses of subcutaneous LBR-101 (fremanezumab) administered monthly will be compared to placebo for safety and efficacy. The mean change from baseline in the number of cumulative headache hours measured at the 28-day period ending with week 12.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 65 years of age.
* A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
* Chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013)
* Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and 120 kg inclusive.
* Demonstrated compliance with the electronic headache diary during the run-in period headache data on a minimum of 22/28 days (80% diary compliance)

Exclusion Criteria:

* Onset of chronic migraine after the age of 50 years.
* Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 6 months prior to study entry.
* Subject is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on more than 4 days per month for the treatment of migraine or for any other reason.
* Failed \> 2 medication categories or \> 3 preventive medications (within two medication categories) due to lack of efficacy for prophylactic treatment of episodic or chronic migraine after an adequate therapeutic trial
* Treatment with an investigational drug or device within 30 days of study entry or any prior exposure to a monoclonal antibody targeting the CGRP pathway.
A Study of the Safety and Efficacy of rhGAA in Patients With Infantile-onset Pompe Disease

Pompe disease (also known as glycogen storage disease type II, "GSD-II") is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. This study is being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for Pompe disease. Patients diagnosed with infantile-onset Pompe disease who are less than or equal to 6 months old will be studied.


Eligibility Criteria:
Inclusion criteria:

* The patient or the patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed;
* The patient must have clinical symptoms (documented in his or her medical record) of infantile-onset Pompe disease. In addition, the patient must have: a. an endogenous GAA activity less than 1% of the mean of the normal range as assessed in cultured skin fibroblasts; AND b. cardiomyopathy (LVMI greater than 65 g/m2) by echocardiography;
* The patient must be no older than 26 weeks and 0 days, when he/she receives the first dose of rhGAA;
* The patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol.

Exclusion criteria:

* Symptoms of respiratory insufficiency, including: a. Oxygen saturation less than 90% in room air as measured by pulse oximetry; OR b. venous PCO2 greater than 55 mmHg on room air OR arterial PCO2 greater than 40 mmHg on room air; c. any ventilator use at the time of enrollment;
* Major congenital abnormality;
* Clinically significant organic disease (with the exception of symptoms relating to Pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial or potentially decrease survival;
* Use of any investigational product within 30 days prior to study enrollment;
* Received enzyme replacement therapy with GAA from any source.
Arm and Finger Measurement for Blood Pressure Surveillance

Accurate blood pressure (BP) measurement is critical in peripartum care. The cuff and bladder sizes affects the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC). However, evidence have shown the discrepancies between these sizes, leading to inaccuracy of BP measurement. This study will measure arm and finger size of 300 parturients in third trimester to determine whether the MAC, finger measurement or body mass index (BMI) is the best clinical predictor for non-standard cuff sizes for BP measurement.

Accurate blood pressure (BP) measurement plays an important role in peripartum care as it is essential in detecting hypertensive disorders in pregnancy and medical decision making during the pregnancy. The cuff and bladder size have been highlighted as an important factor affecting the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC) assuming the arm is cylindrical in shape. However, evidence have shown a mismatch between these sizes, leading to BP overestimation or underestimation in obese patients. This is because the shape of the arm is a truncated cone instead of a cylinder, and the cuff will expand irregularly during inflation thus yielding inaccurate BP measurements. This is especially evident in Asian pregnant patients whereby no available guideline can recommend a suitable cuff for parturients with different MAC. Nexfin is a finger cuff device that can be a suitable alternative BP measurement device for such patients. In this study 300 parturients will be recruited in third trimester and undergoing nonemergent caesarean section in KKH. Patients' arm and finger sizes will be measured, and their user experience on current practices on BP measurement. The arm measurements will help to identify the proportion of women that may require non-standard cuff sizes for BP measurement. A conicity index will be determined whether the MAC, finger measurement or BMI is the best clinical predictor. The finger measurements will also help to determine the proportion of women that may require non-standard cuff sizes on the Nexfin device for BP measurement. The knowledge gathered in this pilot study will be used to design future studies in which the accuracy of Nexfin will be compared with standard BP measurement, which in turn will improve BP detection, subsequent patient monitoring and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists physical status 1 or 2 (ASA 1 or 2) parturients at 32 or more weeks of gestation
* Multiparous or nulliparous;
* Age 21-50 years old;
* Undergoing Caesarean section in our institution.

Exclusion Criteria:

* Emergent Caesarean section such that consent and measurements cannot be taken.
Acetaminophen Concentration in Cerebrospinal Fluid in Infants

Acetaminophen is the most commonly used drug in children. Inhibition of COX-3 in the brain has been suggested as the primary central mechanism by which acetaminophen decrease pain and possibly fever. However there is very limited data about acetaminophen concentrations in the brain and no such data is available for newborns. The objective of the current study is to describe concentrations of acetaminophen in the fluid around the brain of infants after administration of acetaminophen.

The mechanism by which acetaminophen causes analgesia and antipyretic effect is not entirely clear. Recently a new COX isoenzyme was identified and termed COX 3. In humans this isoenzyme is most abundant in cerebral cortex and heart. Inhibition of COX-3 could represent a primary central mechanism by which acetaminophen decrease pain and possibly fever (10). An effect on of acetaminophen on presynaptic 5-HT(2) receptors in the hypocampus has been demonstrated (11) suggesting again that the primary effect of acetaminophen is in the CNS.

Many studies (12-16) described the pharmacokinetics of oral and rectal acetaminophen in infants and neonates. Yet, the data on acetaminophen concentrations in the CSF is very limited. Two studies in adults (17;18) used intravenous propacetamol and described concentrations of acetaminophen in the plasma and CSF. Acetaminophen was detected as early as 15 minutes after the administration and reached peak concentrations in the CSF at the 4th hour. A small study (19) of nine children who had indwelling ventricular drains found that cerebrospinal fluid concentrations lagged behind those of plasma with an equilibration half time of 0.72 h. This study did not describe CSF concentrations in neonates and used a dose of 40mg/kg, which is higher than the recommended dose in children. To the best of our knowledge there is no data on acetaminophen CSF concentrations in neonates.

The objective of the current study is to describe concentrations of acetaminophen in the CSF of infants after single administration of acetaminophen. A better understanding of the pharmacokinetics of acetaminophen and its penetration into the CSF will enable us to better predict the effects of this commonly used drug.

Eligibility Criteria:
Inclusion Criteria:

* Age: 1week - 2 years
* Rectal temperature \> 38.0OC
* A sepsis work up is indicated
* Acetaminophen was given prior to lumbar puncture (LP)

Exclusion Criteria:

* Hypersensitivity to acetaminophen
* Known metabolic disorder
* Known liver or kidney disease
* Hydrocephalus
* Informed consent could not be obtained from a legal guardian
Evaluation of a Group-based Parenting Intervention for Early Childhood Development

This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. This study is enrolling primary caregivers with children 0 to 24 months of age to promote caregiver knowledge and skills about nurturing care for young children and support caregiver psychosocial wellbeing. Parenting groups will leverage existing community group networks and be facilitated by trained volunteers for 20 total sessions (groups will meet twice a month for 10 months). ChildFund Kenya and its community partners will implement the program in Busia and Homabay counties. The research study design will involve a cluster-randomized controlled trial and a qualitative implementation evaluation. This research is being led by Emory University with funding from the Conrad N. Hilton Foundation.

This research has two study components and aims. First, a cluster-randomized controlled trial will be used to quantitatively estimate the effectiveness of the parenting program on early child development and caregiver outcomes. For the research study sample, villages in Busia and Homabay counties were randomly selected and randomly assigned in each county to either the intervention or waitlist control group. Villages in the intervention group will receive the parenting program first, while villages in the control group will receive the program after the completion of the research study. In total, 64 villages have been selected into this study. Then in each village, 10 primary caregivers with children 0-24 months of age will be enrolled into the study for a total of 640 caregiver-child dyads. A caregiver survey and observational assessment of early child development skills will be administered to study participants at baseline and endline to evaluate changes in outcomes between groups over time. Second, and following the completion of the program, qualitative in-depth interviews will be conducted with participants and various stakeholders (e.g., program participants, parenting group facilitators, community health volunteers, ChildFund program staff) to understand their roles and experiences with the parenting program as well as the challenges and successes to inform future implementation. This qualitative implementation evaluation will seek to identify the barriers and facilitators to program impact, quality delivery, scale-up, and sustainability.

Eligibility Criteria:
Inclusion Criteria:

* primary caregiver of a child aged 0-24 months at the time of enrollment
* the household resides within the geographic boundary of the village that was sampled into the research study
* primary caregiver provides informed consent for themselves and their child to participate

Exclusion Criteria:

* none
Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma

Asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in asthma. Doctors have different ways to measure the inflammation in the airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by the lungs when asthmatic inflammation is present. The investigators have been using NO as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. In most asthmatics, even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in some people this does not seem to happen. The investigators now have portable NO machines that are designed for patients to use in the home. The investigators want to follow NO readings in patients with high levels to measure how they respond to different doses of steroid inhalers. The investigators hope this will help the investigators better understand asthma inflammation and treatments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
* FENO greater than 30ppb on treatment

Exclusion Criteria:

* Recent RTI or prednisolone
* Smoking within 1 year or 10 pack years
* ABPA, COPD, bronchiectasis