cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics

The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.

Performance of the system will be primarily evaluated by comparing the blood glucose measurements from the reference device, a blood glucose meter, to the CGM System values collected during the study. Specifically, performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of glucose meter reference value for glucose levels \>80 mg/dL and ±20 mg/dL of glucose meter reference values \<80 mg/dL. These G4-meter matched pairs will be analyzed across the 7 days of wear.

Safety data of the CGM System will also be collected and safety will be characterized by the incidence of anticipated device-related adverse events (ADEs) of subjects who participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2 to 17 years;
* Diagnosis of diabetes mellitus;
* Treatment of diabetes with insulin and/or oral diabetes medication Note: Insulin-using subjects only - willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
* Willing to refrain from the use of medications containing acetaminophen during the sensor insertion period and for one day prior to sensor insertion;
* Able to perform up to 7 fingersticks per day during home use (approximately 2 calibration fingersticks or as often as prompted by the device and approximately 5 for diabetes management and/or detection of hyper and hypoglycemia); and
* Subject or guardian is able to speak, read, and write English.

Exclusion Criteria:

* Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
* Known allergy to medical-grade adhesives;
* For subjects of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours prior to device insertion;
* Hematocrit value outside the range of the blood glucose monitoring system used in the study;
* Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
* Planned MRI scan, CT scan, or diathermy during the week of the study; or
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C, or HIV).
Acupuncture Safety/Efficacy in Knee Osteoarthritis

The goal of this research is to determine the efficacy and safety of Traditional Chinese Acupuncture (TCA) in patients with osteoarthritis of the knee. A three arm randomized controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group with a total sample of 525 is proposed. Primary hypothesis to be tested is that patients randomized to true TCA will have significantly more improvement in pain and function as measured by the Womac Pain \& Function Scales and patient global assessments than patients randomized to the sham acupuncture and education/attention control groups.

Secondary aims of the study are to 1) determine if improvement with TCA differs between patients below age 65 vs. those aged 65 and above, 2) to determine if improvement with TCA differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and 3) to determine if improvement with TCA differs by stage of radiographic severity of knee OA at baseline (KL grade 2, 3 or 4)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteoarthritis of the knee (fulfilling ACR criteria) for at least 6 months duration
* At least moderate pain in the knee for most days in the last month
* Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
* Documented radiographic changes of osteoarthritis (Kellgren-Lawrence grade\>2) at the time of rheumatological screening
* Signed informed consent
Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.

This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a "non-significant risk device" by the FDA, and there are no known risks associated with its use.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
* May be medicated or unmedicated

Exclusion Criteria:

* Contraindication for MRI due to metal in eyes/head
* Claustrophobia.
* Inability to lie flat.
* History of brain injury.
* Pregnant
* Current drug use/abuse/dependence
* History of polysubstance use
Multi Modal Stimulations in Pre-term Neonates

A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. There will be four blocks, with the matrix design of 4X14 here 14 being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects will be allotted to the group based on the randomly chosen chit by their parents. Once the block will be allotted, next row block was opened. Thus, equal number of NLBW will be assigned to each group over time.

Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B will be receiving regular lifesaving hospital care. Group A will receive the interventions for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.


Eligibility Criteria:
Inclusion Criteria:

1. Infants born between 28 and 36 week of gestation
2. Birth weight ranging from 1000-2500 g.
3. Medically stable preterm infants

Exclusion Criteria:

1. Medically unstable preterm infants.
2. Infants with congenital anomalies, congenital infections and central nervous system injury
Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites

Skin grafting is a standard treatment for deep wounds, but care of the donor site after transplantation is very important. The means of accelerating wound healing can increase overall patient satisfaction. In recent years, cytokine therapy has been an important strategy to promote tissue repair.Mesenchymal stem cells (MSC) have been considered the star cells that promote tissue repair. It works mainly through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1, and hepatocyte growth factor (HGF), have been found and reported in various MSC conditioned media (MSC-CM), And play a role in promoting tissue repair and regeneration. In here, we aim to explore the MSC-CM-derived pleiotropic factor in treating donor sites and further evaluate its safety and effectiveness


Eligibility Criteria:
Inclusion Criteria:

Mainly mild to moderate burns, III ° burn area is less than 20% (trauma factor is thermal burn); Thick-thickness skin (thickness 0.2-0.3mm), donor area and medium-thickness skin (thick 0.3-0.5mm) for the skin area study separately; Psychologically stable and able to complete the test process-

Exclusion Criteria:

History of clotting disorders, uncontrolled diabetes; Drug abuse, excessive drinking, malignant or autoimmune diseases, chemotherapy and immunosuppressive therapy; Significant local infection or combined systemic infection; Patients with severe heart, lung, liver, kidney, blood system and mental and nervous system diseases; Women during pregnancy and lactation-
Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment

The purpose of this study is to compare the endodontic outcomes of Bio-MA and ProRoot MTA in pulpotomy, orthograde MTA apical barrier, root perforation repair, endodontic microsurgery.

The patients were recruited at the Endodontic clinic, Faculty of Dentistry, Mahidol University, Thailand. Each treatment was provided following the standard protocol. The calcium silicate based material (Bio-MA or ProRoot MTA) was randomly selected and used in the treatment. The patients were periodically recalled at 6 to 12 months. The outcome of the three treatments based on the clinical and radiographic criteria was assessed by the calibrated examiners and interpreted as ''healed/healing" or ''disease.''

Eligibility Criteria:
Inclusion Criteria:

* Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery

Exclusion Criteria:

* Teeth with un-restorable condition
* Teeth with crack or fracture
* Teeth with external or internal root resorption
* Teeth with chronic periodontitis with marginal bone loss more than 5 mm
School Lunch Salad Bars and Fruit and Vegetable Consumption

The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .


Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in any grade between grades one and twelve
* Student ID number matches that on a list of randomly selected student ID numbers from the population of student enrolled in school
* Students who elect to receive a hot entree at lunch
* Students who assent to participate

Exclusion Criteria:

* Students in detention
* Students in special education
* Students in Kindergarten
* Students not in school for any reason (e.g. illness, vacation)
Impact of the Respiratory Isolation on the Quality of Life in Patients Hospitalized for Tuberculosis or COVID-19

The respiratory isolation could have a harmful impact on the well-being of patients, especially in a psychological point of view such as anxiety and depression disorders or through the relationship with medical team and/or relatives but also in terms of informations.

The evaluation of the impact of respiratory isolation in patients hospitalized for tuberculosis or COVID-19 could allow to identify the different kinds of problems encountered by these patients (physical, psychological, sociological, informations, ...) in order to adapt the environment for efficient care and to improve patient's well-being.

The purpose of this research is to evaluate the psychological impact of the respiratory isolation on the quality of life in patients hospitalized for tuberculosis or COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who are more than 18 years old hospitalized in respiratory isolation for tuberculosis or COVID-19.
2. Patient able to understand questions and to communicate verbally with investigators.
3. Patient who has given his consent.

Exclusion Criteria:

1. Patient deprived of their rights
2. Patient under tutorship or guardianship or under the protection of a conservator
3. Tuberculosis without respiratory isolation
An Intervention to Improve Motor Skills in Young Children

The goal of "PLAY" is to adapt and test a developmentally appropriate intervention delivered on a mobile app to parents, with the goal of teaching fundamental motor skill (FMS) proficiency to their preschool-aged children (ages 3 to 5 y). Seventy-two children (3 to 5 y of age) were randomized. Of these children, 36 parents were randomized to use the FMS app and 36 were randomized to use a version of the app that promotes unstructured PA as a comparator group. Parents in the FMS condition accessed instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to their child over a 12-week period. Parents in the comparator arm used a version of the app that provides instructional lessons to promote the equivalent amount of unstructured PA for their child. Parents were asked to guide the intervention, as parental support, modeling, and co-participation predict children's engagement in PA.

Preschoolers spend 4 hours/day in front of a screen, while fewer than one-quarter engage in the recommended two hours of daily physical activity (PA). The decline in PA, increase in screen-based behaviors, and onset of obesity during preschool years have been linked to lifetime risk of obesity and related comorbidities. However, emerging evidence indicates that "screen time" can actually be leveraged as a tool to increase children's PA and promote healthy weight. Specifically, PA interventions delivered over digital devices can provide real-time encouragement for children to be physically active. Prior interventions delivered over mobile devices were effective in increasing PA levels, including our own P-Mobile study that provided behavioral strategies to parents of children aged 6 to 10 years.

When considering how to support and motivate parents whose children are preschool-aged, teaching and modeling fundamental motor skills (FMS) are critical to enable children's PA. FMS like running, jumping, or throwing a ball, are basic, goal-directed movement patterns developed in early childhood that provide a foundation for children to be physically active and competent movers. These skills enable a child to function independently in their surrounding environment, engage with peers, and contribute to their ability to be physically active. Evidence has shown that children must establish a minimal level of FMS proficiency to continue participating in PA opportunities as they age. FMS and PA behaviors have a dynamic and reciprocal relationship. Children with higher levels of FMS are more physically active both during childhood and into adolescence. Therefore, a PA intervention for preschoolers should focus on developing FMS competence.

Eligibility Criteria:
Inclusion Criteria:

* 3-5 years of age
* Physically capable of exercise
* Has no parent-reported mobility limitations that impairs performance of fundamental motor skills

Exclusion Criteria:

• Gross Motor Quotient at "gifted or very advanced" based on the Test of Gross Motor Development (TGMD-3)
Level of Physical Activity and Fear Learning

The proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high AS and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.

This is an experimental study (not a treatment study) aiming to examine the effects of acute exercise vs. sitting on fear extinction learning in a 2-day paradigm. 50 eligible (after screening) men and women ages 18-60 with high anxiety sensitivity (AS) and an anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder) will participate in a consecutive 2-day paradigm. Participants will be randomized to 1 of 2 conditions immediately following the emotional learning paradigm: 1) moderate intensity exercise (n=25) or 2) sitting(n=25), for 20 minutes. Day 2 will include testing of emotional learning. Primary outcomes are physiological arousal (skin conductance, heart rate) during Day 2 procedures. Mechanistic factors, including expected negative consequences of exercise, affect during exercise, threat/shock expectancy, and changes pre-post exercise in stress related neuroendocrine markers (cortisol and alpha-amylase) and their effects on extinction recall will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 18-60
* A primary diagnosis of a DSM-5 anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder)
* Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
* Able and willing to provide informed consent

Exclusion Criteria:

* Lifetime Bipolar Disorder or psychosis
* Past 3 months substance use disorder or eating disorder
* Current PTSD (past PTSD \> 6 months prior to screening is allowed)
* High risk for exercise according to the Physical Activity Readiness Questionnaire and American College of Sports Medicine guidelines with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
* Women who are currently pregnant
* Acute suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS)
* Benzodiazepine use
* Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
* Stable psychiatric medications for at least 4 weeks prior to experimental procedures
Compare Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial

In this randomized control trial the investigators aim to compare the bleeding complication between cold snaring and hot snaring polypectomy with a large sample size.

The investigators will enroll subjects who receive screening or surveillance colonoscopy with small colorectal polyp, 4 to10 mm in size, from multiple centers in Taiwan. Subjects who are less than 40 years old and has contraindication will be excluded from this study. All the candidates for enrollment will sign the inform consent at the outpatient clinic. Once the candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy will be randomized into either cold snaring or hot snaring polypectomy group. In the group with cold snaring, polypectomy will be done without electrocautery. In the hot snaring group, the polypectomy will be performed with electrocautery. The bowel preparation and colonoscopy insertion are the same in both groups as conventional colonoscopy method. The colonoscopy will be performed by experienced endoscopies who performed more than 100 polypectomies per year.

Eligibility Criteria:
Inclusion Criteria:

* Candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy

Exclusion Criteria:

* Subjects who are less than 40 years old and has contraindication will be excluded from this study
Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy

This study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.

Chemotherapy induced neuropathy (CIN) is a common and disabling toxicity of cytotoxic chemotherapy. Depending on the drug, it is often irreversible even after the offending agent is removed. The consequence of terminating effective anti-tumor therapy or dose reduction can be catastrophic to the effect of a patient's cancer treatment. Given the morbidity of taxane induced neuropathy, the lack of effective preventative treatment for taxane induce neuropathy and the safety of acupuncture, it is reasonable to test the efficacy of this non pharmacological intervention in woman with Stage I-III breast cancer receiving adjuvant or neo-adjuvant weekly paclitaxel for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age\>21 years
* History of stage I-III breast cancer
* Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks
* Signed informed consent

Exclusion Criteria:

* Previous treatment with acupuncture in the last 12 months
* Diabetic Neuropathy or other neurological conditions
* Inflammatory, metabolic or neuropathic arthropathies
* Current narcotic use
* Severe concomitant illnesses
* Severe coagulopathy or bleeding disorder
* Dermatological disease within the acupuncture area
* Have a pacemaker
Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients

This is a study of the registration of tobacco, coffee and substance abuse among acutely admitted psychiatric patients.

We will include all patients acutely admitted to Østmarka Psychiatric Hospital to register this population's use of coffee, tobacco and substances. We will determine whether this differs from other populations, between diagnoses, age, etc.

We will also compare results of substance in immunologic rapid urine tests taken by the nurse at the hospital with substance in urine tested in laboratory with LC/MS (liquid chromatography/mass spectrometry).

Eligibility Criteria:
Inclusion Criteria:

* All patients acutely admitted to Østmarka Psychiatric Hospital

Exclusion Criteria:

* Dementia
* Serious brain damage
Glucocorticoid Receptor Antagonism in Subclinical Cushings

The purpose of this study is to assess the effects of reducing the activity of endogenous glucocorticoid in patients with low-grade cortisol excess


Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for inclusion if: they are males and over 18, lack clinical features classically associated with Cushing's syndrome; have evidence of excess circulating cortisol

Exclusion Criteria:

* Evidence of local or systemic malignancy; overt Cushing's syndrome; severe uncontrolled diabetes mellitus or hypertension; pregnancy; clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure); severe liver disease (liver enzymes ≥ 3 x the institutional upper limit of normal range); significantly impaired renal function (eGFR \<30/min); uncontrolled severe active infection; treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents, within four weeks of admission; In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause; requirement for inhaled or systemic glucocorticoids for existing disease; impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent.