cyrilzakka/clinical-trials huggingface dataset:
Addiction Treatment Outcome Monitoring Study

This research evaluates a tool designed for measurement-based care in addiction treatment. Patients in addiction treatment will be invited to complete weekly measures indicating treatment progress and goals. For half the patients, their addiction treatment clinician will be able to view their weekly progress and goals via a secure dashboard. The research will test the feasibility and acceptability of the measurement-based care tool and will evaluate its impact on within-session discussion topics and clinical outcome measures.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Self-reports that they are a patient at Harborview Mental Health and Addiction Services (HMHAS) clinic.
3. Self-reports that they are receiving services at HMHAS clinic for an alcohol or drug-related concern.
4. Has a smartphone with a working phone number and a mobile plan that allows text messages and internet connection.
5. AUDIT-C score indicates past-year hazardous drinking (summed score is at least 3 or 4 for women or men, respectively), or self-reports any drug use for non-medical reasons in the past year.
6. Does not anticipate moving away from the Seattle area within 6 months.
7. Does not anticipate becoming incarcerated in next 6 months.
8. Able to speak and read English (based on self-report).
9. Must be receiving clinical services from an HMHAS clinician who is also participating in the study, which will be evidenced by having at least 3 appointments with a participating HMHAS clinician that were either completed within the past three months or are scheduled to occur within the next three months, verified by the electronic health record.

Exclusion Criteria:

* None
Comparing Everolimus and Sirolimus in Renal Transplant Recipients

This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).

Zortress is FDA approved, is used as standard of care at some other institutions, and may also be given as standard of care if it is believed to be the best immunosuppression regimen for a particular kidney transplant recipient. The rationale for testing Zortress vs. Rapamune is to determine which of these drugs is more effective in preventing chronic rejection of the transplanted kidney. Because these two drugs are related to each other there is no current literature addressing the replacement of Rapamune with Zortress in an immunosuppression regimen, therefore the goal of this study is to compare these two immunosuppression drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must give written informed consent before any assessment is performed.
2. Primary renal transplant recipients between ages 18 and 75 years of age.
3. Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation and practice an effective form of birth control for the duration of the study and 12 weeks after discontinuation of the study drug if applicable.

Exclusion Criteria:

1. Total cholesterol \> 300 mg/dl or triglycerides \> 400 mg/dl despite lipid lowering therapy
2. Pre-existing bone marrow suppression (White Blood Cell count of \< 3000, platelets \< 100,000)
3. Active infection (Hepatitis B Virus, HIV)
4. Malignancy (except for adequately treated squamous or basal cell skin carcinoma) unless patient has written clearance from an Oncologist or if patient has had no malignancy for at least 2 years prior to the transplant
5. Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte globulin
Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis

We conduct this study to investigate the efficacy of triple therapy (high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor) compared with dual-therapy regimens (high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor) and whether it reduces the risk of poor pulmonary prognosis in patients with moderate to high risk anti-MDA5+ DM.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
* Anti-MDA5 Antibody-positive

Exclusion Criteria:

* Complicated with other connective tissue diseases
* Complicated with cardiovascular and respiratory disease caused by other reasons
* Interstitial lung disease caused by environment and drugs
* Patients with key research missing data or without informed consent
Improving Antiretroviral Therapy Adherence Through Urban Gardening and Nutritional Counseling in the Dominican Republic

This pilot study proposes to develop, implement, and evaluate the feasibility, acceptability and preliminary effectiveness of a culturally appropriate, multi-component intervention combining peer nutrition counseling with sustainable urban gardening among people with HIV in the Dominican Republic. The overall hypothesis is that this combined intervention will improve adherence to antiretroviral therapy (ART) and virologic suppression among food insecure HIV+ individuals with suboptimal adherence.

The purpose of this pilot clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of a culturally appropriate, multi-component intervention that targets food insecurity and nutritional health with the ultimate goal of improving antiretroviral therapy adherence and virologic suppression for people with HIV in the Dominican Republic. Through an initial phase, we conducted formative research on dietary patterns and locally available foods and, together with our preliminary research on nutritional counseling and urban gardening, developed a multi-component nutrition intervention to address food insecurity among people with HIV that integrates culturally-appropriate, peer-led nutritional education with a sustainable urban garden component. During the clinical trial phase, we will enroll 120 HIV+ adults with food insecurity and suboptimal adherence in 2 HIV clinics (60 participants in the intervention clinic and 60 participants in the control clinic) and will evaluate the feasibility, acceptability and preliminary effectiveness of urban gardening plus peer nutritional counseling on improving virologic suppression and ART adherence in both the short (month 6) and longer terms (month 12). We will also explore preliminary intervention effects on potential mediators (food security, nutritional status, internalized HIV stigma, and social support). As one of the first studies to develop a sustainable food production approach with peer nutrition counseling among people with HIV, key products will include: 1) an easy-to-use peer nutritional counseling curriculum and urban gardens training materials; 2) pilot data on the feasibility, acceptability, and effects of our intervention on primary outcomes and potential mediators; and 3) if results are promising, an R01 application to conduct a fully-powered cluster randomized controlled trial that examines effects across a larger number of clinics in the Dominican Republic.

Eligibility Criteria:
Inclusion Criteria:

* HIV+ and on ART
* Has moderate or severe household food insecurity
* Has detectable viral load (\>50 copies) and/or suboptimal adherence to ART

Exclusion Criteria:

* Does not meet above criteria
MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma

This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R/R iNHL.

This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R/R iNHL.

All patients with untreated or R/R (not previously treated with Bendamustine) iNHL (Follicular Lymphoma (Grade 1-3a2), Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma) are candidates for this trial. Patients requiring treatment per treating physician's discretion are eligible for the trial.

Patients who recently started on and received two cycles of Bendamustine at 90 mg/m2 dose with Ritxumab 375 mg/m2 are also eligible for this trial. For these patients, C2D1 BR should be no more than 14 days prior to the time of study enrollment (i.e. enrollment no later than C2D14). Patients who have received two cycles of 90mg/m2 Bendamustine dose with Rituximab 375 mg/m2 can enter the study and initiate cycle 3 once pre-screening and screening procedures have been completed.

Eligibility Criteria:
Inclusion Criteria:

Patients must have pathologically confirmed:

* indolent Non-Hodgkin Lymphoma, consistent with one of the below diagnoses:
* Follicular Lymphoma (Grade 1-3a)
* Marginal Zone Lymphoma
* Lymphoplasmacytic Lymphoma

Patient may be treatment naïve or relapsed/refractory without having received prior Bendamustine or patients recently started on Bendamustine 90 mg/m2 with Rituximab 375 mg/m2 are eligible if C2D1 BR is no more than 14 days prior to enrollment and they otherwise meet eligibility criteria

* Age \> 18 years
* ECOG performance status 0-2

Patients must have normal organ and marrow function as defined below:

* Absolute Neutrophil Count \>1000mm3 and Hemoglobin \>8 g/dL (unless due to bone marrow involvement by lymphoma)
* Total bilirubin \> 1.5x upper limit of normal (patients with Gilbert's syndrome can have total bilirubin up to 3x upper normal limit)
* Aspartate aminotransferase/ alanine aminotransferase (serum glutamic-oxaloacetic transaminase/ serum glutamic-pyruvic transaminase) \< 5 times institutional normal limits
* Creatinine clearance \> 30 Ml/min

Exclusion Criteria:

* Radiation or systemic treatment for lymphoma within the past 28 days prior to cycle 1 day 1 of BR.
* Patients with pathologically confirmed transformed lymphoma, including diffuse large B cell lymphoma or other high grade lymphomas
* Patients on active treatment for second malignancy with the exception of endocrine therapy for non-metastatic breast cancer, hormone therapy for prostate cancer, or local treatment for non-melanoma skin cancer.
* Pregnant or breast-feeding. Refer to section 5.4 for further detail.
* Failure to identify a dominant clonal sequence with ClonoSEQ from pre-treatment specimen or inadequate tissue for testing
Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth


Eligibility Criteria:
Inclusion Criteria:

* Good general and oral health
* At least 20 natural gradable teeth
* Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or equal to 2.00 at the first baseline visit
Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain

This study is to see if applying red and violet low-level laser light can help to reduce foot pain associated with diabetic peripheral neuropathy,

The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy, when used at home by non-medical professionals.

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with diabetes-induced Peripheral Neuropathy by a qualified health Physician.
* Over the age of 18 years of age
* Able to read and write English.
* Constant feet pain on-going over at least the past 3 months.
* Subject is willing and able to refrain from consuming any OTC and/or prescription medications including muscle relaxants and/or herbal supplements and/or recreational and medical drugs including cannabis intended for the relief of pain and/or inflammation throughout the course of study participation, except for the study-specific pain relief medication of OTC Tylenol.
* Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
* Self-reported foot pain on the Numerical Rating Scale (NRS) is 50 or greater

Exclusion Criteria:

* Pregnant or think you might be pregnant.
* Open wounds (sores, cuts, ulcers, etc) around the feet
* Cancerous growths around the feet
Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback

This study is designed to explore the effect of feedback counseling using professional continuous glucose monitoring on glycemic control, self-efficacy, and self-management behaviors among middle aged and older adults with poor controlled type 2 diabetes mellitus. This study also explores the difference on timing of feedback after continuous glucose monitoring exam.

After scheduled routine professional continuous glucose monitoring (CGM) exam, participants in both the intervention and control group receive ordinary education and regimen adjustment as indicated based on CGM results. For participants in the intervention group, they will also receive CGM counseling immediately on the day of CGM sensor removal. For participants in the control group, they will receive CGM counseling on the day of routine 3 months outpatient visit.

Qualitative data are collected through in-depth interview: User expectation, acceptability and satisfaction of CGM are also explored during in-depth interview with a semi-structured questionnaire.

Quantitative data were collected through validated questionnaires, including evaluation of depression by a short form of the Center for Epidemiologic Studies Depression Scale Revised (CES-D-R), emotional stress by Problem Areas in Diabetes Scale (PAID), self efficacy by Stanford Self-Efficacy for Diabetes (SES), at pretest and 3 months after CGM counseling.

Anthropometric Measurements. Body height, body weight, body mass index, and blood pressure were recorded at pre-test and post-test interview.

Blood Tests. Routine biochemistry, fasting plasma glucose, hemoglobin A1c (HbA1c) are collected within 2 weeks of pretest and posttest day.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 years old or more at recent outpatient visits;
* Type 2 diabetic patients followed up at National Cheng Kung University Hospital;
* Patients planned to receive CGM suggested by primary care physician due to inadequate controlled blood glucose.

Exclusion Criteria:

* Patients with diagnosis of generalized inflammation, advanced malignancy, end-stage renal disease on regular dialysis, status post renal transplantation, end-stage liver, heart or pulmonary disease;
* Patients who are taking systemic glucocorticoids;
* Any acute or chronic inflammatory disease as determined by a leukocyte count over 10,000/mm3 or clinical signs of infection;
* Patients who could not complete the questionnaires or who could not follow order due to cognitive impairment or in bed-ridden status;
* Patients diagnosed as thalassemia, glucose-6-phosphate dehydrogenase deficiency, and any other hemoglobinopathies that may influence the accuracy of hemoglobulin A1c measurement were also excluded. Patients who received blood transfusion in recent 3 months were also excluded.
Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment

Many patients receiving radiation therapy for breast cancer experience fatigue although doctors do not fully understand why. The purpose of this study is to test if patients who experience fatigue during radiation treatment for breast cancer have changes in their capability to perform exercise on a treadmill.


Eligibility Criteria:
Inclusion Criteria:

* Female
* ECOG performance status 0 or 1
* Medical clearance from attending radiation oncologist or medical oncologist to undergo a symptom-limited CPET
* Currently undergoing intact breast radiotherapy for early stage breast cancer (including TisN0, T1N0, T2N0) or has completed intact breast RT in the last 3 months.
* Receiving or received a prescribed dose of 4240 cGy in 16 fractions to the whole breast without treatment directed at nodal basins. Patients may also be receiving or have received a boost to the lumpectomy bed at the discretion of the treating physician.
* Subjects may be treated in the supine or prone position at the discretion of the treating physician.
* Subjects may be treated with or without a deep inspiratory breath hold technique at the discretion of the treating physician.
* Identified by the treating radiation oncologist as having significant treatment-related fatigue or minimal treatment-related fatigue and not simply baseline fatigue. A score of "0" on the RTOG fatigue scale will be considered minimal fatigue, while a score of "2" or greater will be considered significant fatigue (moderate fatigue causing difficulty performing some ADLs).

Exclusion Criteria:

* Currently undergoing post-mastectomy radiation
* Has received chemotherapy previously or has a plan to receive chemotherapy during the timeframe of study assessment.
* Any of the following absolute contraindications to CPET, as per American Thoracic Society (ATS) recommendations

  * Acute myocardial infarction (within 3-5 days of any planned study procedures)
  * Unstable angina
  * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  * Recurrent syncope
  * Active endocarditis
  * Acute myocarditis or pericarditis
  * Symptomatic severe aortic stenosis
  * Uncontrolled heart failure
  * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
  * Thrombosis of lower extremities
  * Suspected dissecting aneurysm
  * Uncontrolled asthma
  * Pulmonary edema
  * Room air desaturation at rest ≤ 85%
  * Respiratory failure
  * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
  * Mental impairment leading to inability to cooperate
Influence of Risk Factors on ISR and Nonintervened Lesions

This study enrolled patients who used to received PCI therapy with nonintervened coronary lesions. Baseline characteristics and laboratory testing were collected to find out the risk factor difference between ISR and nonintervened coronary lesions.


Eligibility Criteria:
Inclusion Criteria:

* (1) PCI therapy with drug-coated stents was performed in the past, and nonintervened coronary lesion remained except in the target vessel.

  (2) CAG was performed again due to re-examination, recurrent angina symptoms, positive treadmill exercise test or coronary CTA showing moderate to severe vessel diameter stenosis.

  (3) Long-term regular oral administration of statins and lipid monitoring were conducted after PCI.

Exclusion Criteria:

* Patients with a history of CABG, renal replacement therapy, autoimmune disease, and malignancy
Age Stereotype Priming and Social Participation

Memory performance is shown to be affected by age stereotypes among older adults. The purpose of the study is to examine the effects of age stereotype primes on episodic memory using priming intervention. The moderating effects of social participation is also examined.

All participants are community-dwelling older adults residing in Hong Kong. They are invited to review their social participation profile and given a brief psycho-education about memory.

They are then randomly allocated to one of the two following conditions. Participants are primed either with age stereotypes or non-age stereotypes words by implicit priming intervention in the context of a reaction task prior to the episodic memory tasks. Other measures such as demographic variables and social participation rate are collected by questionnaire during the delayed recall interval.

Eligibility Criteria:
Inclusion Criteria:

Indication of largely normal cognitive functioning as screened on the Montreal Cognitive Assessment (MoCA) with Hong Kong norms -

Exclusion Criteria:

Sensory deficits and evidence of cognitive impairment as screened on the Montreal Cognitive Assessment (MoCA) with Hong Kong norms

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Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.

Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR).

POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.


Eligibility Criteria:
Inclusion Criteria: all adult (\> 18 years old) trauma patients treated in our Emergency Department with a TASH score \> 18

Exclusion Criteria:

* dead on arrival
* no blood product administered after randomization
Paediatric European Group A Streptococcal United Study.

Introduction Since 2022 there are reports of a rapid increase in invasive group A streptococcal infections (iGAS) in children in some but not all European countries. Detailed information on this increase is lacking. Furthermore, an increase in other invasive infections as well as the emergence of novel pathogens and disease entities is seen, such as MIS-C and severe hepatitis of unknown origin.

Aims To set up a European research network and describe the incidence, risk factors, clinical phenotypes, microbiology and resistance, treatment, and outcomes of iGAS in children across Europe. The network will subsequently be utilized for early alerting regarding the rise of other invasive and emerging infections in children. It will enable swift data collection pertaining to patient characteristics, presentation, progression, and treatment.

Methods International, retrospective cohort and observational surveillance study of children 0-18y attending the ED or admitted to the hospital with iGAS. Clinical and microbiological data, national vaccination schedules, and COVID non-pharmaceutical interventions (NPIs) will be collected and compared between countries. Subsequently, the network will be employed to raise alarms regarding the surge of other invasive infections or emerging infections in children. Anonymous data about these novel infections will be collected, similar to the data from iGAS (clinical characteristics and microbiological data). The study is a non-profit study.

Significance Our study will describe variation in the clinical phenotypes of iGAS, will aid in the understanding of its association with COVID NPIs and allow for comparison between countries. Furthermore, it will aid in early recognition of invasive and emergent infectious diseases in children and the reduction of outbreaks.


Eligibility Criteria:
* All children (1 month-18 years)
* attending the Emergency Department and/or admitted to the participating hospital - with iGAS infection or other invasive or emergent infectious disease.