cyrilzakka/clinical-trials huggingface dataset:
Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests

This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience.

Importance. Enhancing the management of messages from patients and providing high-quality, consistent care are top priorities for The Permanente Medical Group (TPMG) and Kaiser Foundation Hospitals/Health Plan (KFH/P). A special extension of the Ryan Haight Act currently enables providers to prescribe controlled substances via telehealth interactions, but expires in December 2024. Information about the quality of care provided via telehealth prescribing of controlled substances by pharmacists and primary care physicians would be helpful to inform care delivery within Kaiser Permanente and beyond.

Objective. To compare pharmacist management of secure message requests for refills of attention deficit hyperactivity disorder (ADHD) medications with primary care physician management regarding quality of care, efficiency of service, and parent satisfaction.

Design, setting, and participants. This cluster randomized clinical trial will include parents of children in Kaiser Permanente Northern California who request ADHD medication refills via secure messages from April 29 to June 28, 2024. Of KPNC's 63 facilities eligible for inclusion, we will assign 32 to Pharmacist Care and 31 to PCP Care.

Intervention. In the intervention group, a regional team of pharmacists will manage ADHD medication refill requests made via secure message using a standard protocol. In the comparison group, primary care physicians (pediatricians and family medicine physicians) will manage these visits using a similar protocol.

Main Outcomes and Measures. The primary outcome is whether a patient who did not have a weight recorded in the 6 months before the refill request was referred for a primary care follow-up visit. Secondary outcomes are the days from the secure message request to the prescription order and medication fill, and parent satisfaction.

Potential Results. We will test the hypotheses that Pharmacist Care compared with PCP Care will have higher quality of care, faster time to prescriptions and fills, and higher patient satisfaction.

Potential Conclusions and Relevance. If pharmacist care for ADHD medication refill requests has better or similar outcomes compared with PCP care, this will provide evidence supporting continuation of this approach. This study's findings will be useful for KPNC and to inform discussions about renewing the special extension of the Ryan Haight Act that allows this approach.

Eligibility Criteria:
Inclusion Criteria:

* Parent or caregiver requested an ADHD medication refill via a secure message

Exclusion Criteria:

* The ADHD medication refill request was not straightforward and had to be handled by the primary care provider (and thus not eligible for random assignment to Pharmacist Care or PCP Care)
Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.

This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged ≥18 years
* Participants with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention or CTA within 4 weeks around gadobutrol-enhanced CMRI
* Willingness to undergo stress/rest CMRI and to follow directions and complete all study procedures
* Women of childbearing potential (e.g. age \< 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test

Exclusion Criteria:

* Suspected clinical instability or unpredictability of the clinical course during the study period
* Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers)
* History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents according to the investigator's assessment / judgment
* Estimated glomerular filtration rate (eGFR) value \<30 mL/min/1.73 m\^2 derived from a serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any participant on hemodialysis or peritoneal dialysis is excluded from enrollment.
* Acute renal insufficiency
* Coronary artery bypass grafting (CABG)
* Acute myocardial infarction (\< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure
* Irregular heart rhythm
* Condition that precludes the safe administration of pharmacological stressor according to the respective approved label such as sinus node disease, 2nd or 3rd degree atrioventricular block, obstructive lung disease
The Personal Patient Profile Decision Support for Patients With Bladder Cancer

There is a pressing need to develop a personalized, value-based decisional tool for bladder cancer patients undergoing radical cystectomy (bladder removal) and urinary diversion to help them with communication with the physicians, shared decision making, and preparation for disease-management and follow-up care. The proposed intervention, the Personal Patient Profile - Bladder Cancer (P3-BC), will be the first intervention to address these issues. Results of this pilot randomized feasibility study will provide evidence of the feasibility and acceptability of the P3-BC and will guide further refinement of the tool for a larger experimental trial, with potential dissemination of the program via the Internet and hand-held computing devices.


Eligibility Criteria:
Inclusion Criteria:

* Patients: cystectomy for MIBC and NMIBC;
* at least 18 years;
* able to communicate in English; and
* competent to give consent.

Exclusion Criteria:

- Existence of other cancers or ongoing cancer treatment.
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)

Both mindfulness meditation and expectancy effects are known to reduce pain intensity, pain unpleasantness and pain catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.

As many as 1 in 4 Australians experience chronic pain. Further, it is yet unknown the effects of the Coronavirus (COVID-19) pandemic on Australians with or at risk of chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will investigate how mindfulness meditation and common expectancy effects interact and will further characterise the mechanisms underlying these effects. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Recurrent pain (two or more days in the last month)
* Chronic pain (pain most days in the last three months)
* Able to read and understand English

Exclusion Criteria:

* Not experiencing recurrent or chronic pain
* Incomplete or invalid data (response time \< 32 minutes, failing attention checks)
* Completing the 20-minute training module in \< 18 minutes or \> 90 minutes
Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution

The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Eligibility Criteria:
Inclusion Criteria:

* Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
* Patient must be able to read.
* Vision correctable to 20/30 or better with contact lenses.

Exclusion Criteria:

* Sensitivity to multi-purpose solutions.
* Using any topical ocular OTC or prescribed topical ocular medications.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* With a medical condition or using medications that cause ocular side effects.
* Participation in any investigational study within the past 30 days.
Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Ambulatory surgery is increasingly used in anesthesia. In case of general anesthesia, it is recommended to use anesthesia molecules with a short half-life and low doses of opiates to ensure a rapid awakening and to prevent nausea and vomiting by systematic administration of anti-emetics during the operation.

Opiates (including sufentanil) have recently been called into question because of the nausea and vomiting and the delay in waking up induced by these molecules. To combat these side effects, the authors have proposed either to reduce the doses or to substitute them with dexmedetomidine, a sedative antihypertensive drug. Recent studies have demonstrated that opiates used in general anesthesia can be replaced by dexmedetomidine. However, literature data are controversial concerning the hemodynamic impact. No study has compared the hemodynamic profile of opioid-free anesthesia with dexmedetomidine versus conventional anesthesia with opioids.

The ambulatory context lends itself to the use of dexmedetomidine because it is aimed at a population without strong cardiac pathology, concerns non-major interventions, with the need to optimize pain and side effects.

The study authors therefore wish to compare the effects of induction of general anesthesia with low-dose Dexmedetomidine versus sufentanil, on post-induction hemodynamic stability in scheduled outpatient surgeries. The investigators hypothesize that hemodynamic stability at induction of general anesthesia with low-dose dexmedetomidine is not inferior to that obtained with sufentanil in scheduled ambulatory surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patient with scheduled surgery under general anesthesia for one of the following: oral, orthopedic, urological, digestive and gynecological surgeries.
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study
* The subject is unable to give consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient with a known allergy to dexmedetomidine or other drugs.
* Patient with a contraindication to general anesthesia or outpatient management.
* Patient treated with beta-blocker, ACE inhibitor or ARB2
* Patient with an ASA4 score.
* Patient with HR \< 50 bpm.
* Patient with the following cardiovascular comorbidities: coronary insufficiency, obstructive cardiomyopathy, severe hypertension, ventricular rhythm or conduction disorder.
* Patient with hepatic (prothrombin rate \< 70%, liver enzyme/Bilirubin X 3) and/or renal (clearance \< 50 ml.min) insufficiency.
* Pregnant, parturient or nursing patient
TOnicity of Perioperative Maintenance SoluTions

Prospective randomized double blind phase IV trial studying the efficacy and safety of the tonicity of two different perioperative maintenance solutions: an isotonic solution containing NaCl 0.9 in glucose 5% with an added 40 mmol/L of potassium or a commercially available premixed solution (Glucion 5%) containing a.o. 54 mmol/L of sodium and 26 mmol/L of potassium. Both solutions are administered at 27 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine and serum and clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adult (at least 18 y.o.)
* Undergoing elective lung resection (wedge resection, segmental resection, (bi)lobectomy, but not pneumonectomy) via thoracotomy or video- or robot assisted (VATS, RATS)
* Normal renal function (eGFR \>60 ml/min/1.73m² (CKD-EPI))

Exclusion Criteria:

* Under chronic treatment with diuretics or desmopressin
* Heart failure (NYHA III-IV)
* Liver Failure
* Brittle diabetes mellitus
* Neurological contra-indication for hypotonic fluids
* SIADH or hyponatremia \<130 or \> 150 mmol/L at preoperative assessment
* Hyperkalemia \> 5 mmol/L at preoperative assessment
* Under treatment with artificial nutrition (enteral or parenteral)
* Pregnancy

Additional pre-defined exclusion after initial inclusion

* Massive perioperative transfusion or intraoperative resuscitation of +2.5L of crystalloids/colloids
* Absence of admission to ICU
A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer

The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer.

Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family interactions.

* Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of adjustment, coping skills, and pretend play compared to previous sample norms.
* Hypothesis 1b: The child's adjustment will be mediated by factors related to their involvement in the sibling's medical care, such as parent's level of communication regarding their sibling's illness, frequent isolation from the family and other social support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c: Parents of children diagnosed with cancer will report higher levels of parenting stress compared to previous sample norms.

Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and adjustment.

* Hypothesis 2a: Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
* Hypothesis 2b: Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
* Hypothesis 2c: Parents of children in the play intervention group will report decreased parenting stress following the intervention.

Once parents consent to participate and their child provides assent, they and their child will complete the baseline questionnaires and measures. Immediately following completion of the baseline measures, the child will be randomly assigned to either the play intervention or active control group.Children will also be asked to rate their mood at the beginning of each play session. The outcome parent and child questionnaires will be administered again at a session approximately one week after the third play session, for a total of four play sessions each spaced approximately one week apart. Children will also be asked to rate their satisfaction with the treatment at the outcome session (e.g., "How much did you like being a part of this study?").

Eligibility Criteria:
Inclusion Criteria:

* Families who have had children diagnosed with any type of cancer in the past year.
* At least one sibling between the ages of 4 and 10 years old
* Patients will be targeted 1-2 months after diagnosis, but could be included in the study up to 12 months following diagnosis.

Exclusion Criteria:

-
Evaluating Fracture Risk Assessment Tools (FRAX) From Different Regions in Central South Chinese Postmenopausal Women

We evaluated fracture risk assessment tools (FRAXs) from different regions in Chinese postmenopausal women.

This cross-sectional study recruited 264 postmenopausal women aged ≥50 years in September 2017. Basic information, general condition, history of illness, family history, and clinical risk factors were evaluated via a questionnaire. All subjects underwent a bone mineral density examination of the femur and lumbar spine and thoracolumbar spinal X-ray. The 10-year major osteoporotic fracture (MOF) and hip fracture (HF) risks were calculated using FRAXs from mainland China, Hong Kong, Taiwan, and Asia-America. All data were analyzed using SPSS 17.0. Sensitivity, specificity, and likelihood ratio were used to compare the effectiveness of each FRAX.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.

Exclusion Criteria:

* The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs.
Frequency of Functional Gastrointestinal Disorders in Children

cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain

school aged children from age of 5 to age of 15 who are complaining of recurrent abdominal pain will be included in the study , detailed history , examination and investigations will be done

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of recurrent abdominal pain
* the child can express and locate site of the pain

Exclusion Criteria:

* children less than 5 and adolescents more than 14
* mentally retarded children
A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy

The investigaotors want to establish a real-time and computerized score reporting system based on the significant predictors of the measured sonographic parameters and demographic data.

One hundred eight patients with neck lymphadenopathy, receiving ultrasonography and ultrasound-guided fine-needle aspiration (US-FNA), were used to construct a predictive model. This model was validated by another independent patient cohort.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previously untreated neck masses underwent neck US

Exclusion Criteria:

* The neck mass was not lymph node
* No US-FNA cytology result
Ascorbic Acid Treatment in Congenital Glucocorticoids and Mineralocorticoids Deficiency Due to NNT Mutation

Nicotinamide nucleotide transhydrogenase (NNT) mutations cause glucocorticoid and mineralocorticoid deficiencies through decreased detoxification of reactive oxygen species (ROS) in adrenocortical cells.

Ascorbic acid is well known by its high antioxidant activity due to the neutralization of free radicals and other reactive oxygen species.

Preliminary results of NNT_p.G200S homozygous fibroblasts' treatment with 10 micro molar L-ascorbic acid shows significant improvement in mitochondrial morphology and in ROS content.

The aim of this study is to figure out if ascorbic acid treatment improves the phenotype of NNT patients by reducing ROS in their adrenocortical cells and preventing their apoptosis.

Most cases of familial glucocorticoid and mineralocorticoid deficiency are caused by mutations interrupting steroidogenesis such as 21- hydroxylase deficiency. Recently, nicotinamide nucleotide transhydrogenase (NNT) mutations were found to cause isolated glucocorticoid deficiency or combined mineralocorticoid and glucocorticoid deficiency through decreased detoxification of reactive oxygen species (ROS) in adrenocortical cells.

NNT mutation in mice causes also glucose intolerance. Ascorbic acid is an essential water-soluble vitamin with excellent reducing properties, well known by its high antioxidant activity due to the neutralization of free radicals and other reactive oxygen species. This vitamin acts as the first line of defense during oxidative stress in the human body.

Ascorbic acid treatment for variant disease (e.g. - cancer, type 2 diabetes, anxiety, depression, asthma and cardiovascular diseases) have been meticulously studies with no major adverse effects.

In a previous study, the investigators demonstrated a higher ROS levels, a lower ATP content and a change in mitochondrial morphology in NNT_p.G200S homozygous fibroblasts compared with control fibroblasts.

Preliminary results of NNT_p.G200S homozygous fibroblasts' treatment with 10 micro molar L-ascorbic acid shows significant improvement in mitochondrial morphology and in ROS content.

The aim of this study is to figure out if ascorbic acid treatment improves the phenotype of NNT patients by reducing ROS in their adrenocortical cells and preventing their apoptosis.

During the study NNT_p.G200S homozygous patients (no.-3) will be hospitalised for ACTH and OGTT tests and start ascorbic acid treatment at a doses of 75-80% of the upper limit of allowance according to IOM. ACTH and OGTT will be repeated 6 months later to assess improvement in glucocorticoids production and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* NNT mutation homozygous patients with glucocorticoids deficiency
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Recent evidence suggests that hyperinsulinemia (i.e., elevated insulin levels) is the primary causative factor in obesity. Insulin promotes fat storage and prevents fat breakdown, suggesting that weight loss would be optimized if insulin levels are managed and kept low. Understanding how different foods impact insulin levels could therefore aid in personalized weight loss (or weight maintenance) advice. It has been shown that salivary insulin can track plasma insulin following different meals and can delineate between lean and obese people. Thus, it was suggested that salivary insulin could be a potential surrogate for plasma insulin. The purpose of this study is to measure fasting saliva insulin, and salivary insulin responses to a standardized meal tolerance test in individuals with different body mass index (BMI).


Eligibility Criteria:
Inclusion Criteria:

* non-smoker
* have a body mass index greater than 18.5 kg/m2
* have not been diagnosed with type 2 diabetes or other medical conditions affecting glucose or insulin levels

Exclusion Criteria:

* You have been. diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) or any other diagnosed chronic condition that may impact your glucose or insulin levels or the outcomes of this study.
* You take any medication which may affect your glucose and insulin level
* Unable to travel to make your testing appointments.
* Unable to consume the meal tolerance test drink/shake and/or provide finger stick glucose or saliva samples for the study.