cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians

The Health Decision Sciences Center (HDSC) staff has deployed different approaches to training clinicians to engage patients in shared decision making for common medical tests and treatments. The purpose of the study is to compare the effectiveness of shared decision making (SDM) skills training courses using standardized patient interactions (SPI) and written evaluations.

There is limited evidence on approaches to training clinicians to engage patients in shared decision making for common medical tests and treatments. The purpose of the study is to compare the effectiveness of different approaches to shared decision making (SDM) skills training. Participants will be randomly assigned to either receive two decision aids or a webinar to review. Participants will also be randomly assigned to receive feedback on standardized patient interaction rating their shared decision making skills and highlighting opportunities for improvement or not. Clinician participants will be assigned to one of four intervention groups using a 2x2 factorial design:

Group 1: Decision aid viewing with feedback Group 2: Decision aid viewing and no feedback Group 3: webinar with feedback Group 4: webinar and no feedback

The pilot study will provide evidence on the comparative effectiveness and feasibility on training formats to determine if:

* Clinicians improved in SDM communication skills
* Clinicians have an increased confidence to use SDM with their patients
* The training is acceptable to clinicians

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 and older
* English speaking
* Physician
* Nurse Practitioner
* Physician Assistant
* Registered Nurse

Exclusion Criteria:

* Not clinically active (research faculty only)
* Medical Trainees
* Medical Students
* Medical Assistants
* Social Workers
Effect of Dental Treatment on Children's Growth

Severe dental decay affects children physically, emotionally, socially and thereby impacts on their quality of life. Evidence from developed countries showed that children with severe dental decay weighed less than their peers and following dental treatment children's growth and quality of life improved. This suggests that treatment of severe dental decay may enhance growth and wellbeing. A study was carried out in Saudi to test that hypothesis.


Eligibility Criteria:
Inclusion Criteria:

Having dental caries with at least 2 teeth with pulpal involvement.

Exclusion Criteria:

1. Children with illness known to adversely affect growth.
2. Children who required urgent dental treatment.
3. Children on regular nutritional supplements.
4. Anaemic children with Hb levels lower than 11.0 g/dl
Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With Chronic Kidney Diseases Not on Dialysis

The purpose of this study is to evaluate the safety,efficacy， pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic kidney disease (CKD) Who are not on dialysis


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥18 and≤70.
2. Chronic renal diseases stage 3 or 4 (estimated Glomerular Filtration Rate (eGFR) between 15 and 60 ml/min per 1.73 m2 using the CKD-EPI equation) and no expected need for dialysis during the study.
3. Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose.
4. Two hemoglobin values of ≥ 6.0 and \< 10.0 g/dL at Screening
5. Patients with a transferrin saturation ≥ 20% or a ferritin ≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
6. Signed informed consent.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Red blood cell transfusion within 3 months prior to study drug administration.
3. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products .
4. Hemolytic syndromes or coagulation disorder.
5. Hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, hemoglobinopathy, pure red cell aplasia).
6. Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.).
7. C reactive Protein (CRP)level greater than 30 mg/L within the 4 weeks prior to study drug administration.
8. Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH\>500pg/ml).
9. Poorly controlled hypertension within 2 weeks prior to study drug administration, per investigator's clinical judgment (e.g. systolic ≥ 160mm Hg, diastolic ≥ 100 mm Hg)
10. Chronic congestive heart failure (New York Heart Association Class IV).
11. Significant symptom within 6 months prior to study drug administration (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, or ALT\> 3 x upper limit of normal (ULN), AST\> 3 x upper limit of normal (ULN), etc.).
12. A positive test for HIV antibody.
13. Tumor malignancy.
14. Expected survival less than 12 months.
15. Major surgery (may Massive bleeding) during the study.
16. Expected conception within 4 Weeks after the end of the Study Treatment.
17. The subject has participated in other clinical trial within the 6 weeks prior to study drug administration.
18. Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
Smart Walk: A Physical Activity Program for African American Women

The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered PA program to improve and maintain high physical levels and reduce cardiometabolic disease risk among obese AA women.

A three-phase study will be used to refine and implement an established theory-based culturally relevant physical activity promotion intervention for obese African American women. Phase 1 (Aim 1a) will include formative research where 25 African American women provide feedback (via 9 focus groups) to further refine the physical activity intervention by specifying the deep structure cultural relevance of the theoretical mediators of self-regulation, self-efficacy, social support, behavioral capability, and outcome expectations.5 Phase 2 will focus on technical development of the refined culturally tailored intervention and 1-month demonstration trial of the Smartphone-delivered physical activity promotion program. Phase 3 (Aims 1b and 1c) will test the intervention and delivery strategy in a two-arm randomized trial where 60 sedentary, obese African American women will receive either the 8-month culturally relevant smartphone-delivered physical activity intervention or a 8-month wellness contact control condition

Eligibility Criteria:
Inclusion Criteria:

* Self-reported African American
* Insufficiently Active ( 60 mins or less of PA per wk measured by Exercise Vital Sign Questionnaire)
* BMI\>30
* English speaking and reading
* Own non-Kindle Smartphone iOS 7 or above, or Android 2.3 or above

Exclusion Criteria:

* Concurrent participation in another physical activity, nutrition, or weight loss program
* Endorsement of an item on the Physical Activity Readiness Questionnaire (PAR-Q) unless physical note is provided
* Pregnant or plans to become pregnant in next 12 months
* Plans to relocate out of Phoenix area in next 12 months
Metabolic Insights: the Impact of F-18 FDG PET/CT in Adult Lymphoma

1. To assess staging accuracy of F-18 FDG PET/CT in lymphoma
2. Determine the role of F-18 FDG PET/CT in monitoring treatment response and detecting relapse or residual disease in lymphoma
3. To evaluate FDG uptake correlation with histopathological subtypes and immunophenotypes as a prognostic factor.

The incidence of lymphoma in Egypt has been increasing in recent years, with a noticeable rise in both Hodgkin's and non-Hodgkin's lymphoma cases. This increase is due to better healthcare, awareness, and diagnostic advancements. Risk factors include infections, lifestyle, genetics, and immune system issues.

Lymphoma is now the fourth most prevalent cancer among Egyptian adults, accounting for approximately 8.4% of all new cancer cases annually. As the burden of lymphoma grows, it becomes essential to develop effective strategies for its diagnosis and management.

Flurodeoxyglucose F-18 (F-18 FDG) is a radiolabeled glucose analog that accumulates in metabolically active cells, such as lymphoma cells, making F-18 FDG positron emission tomography / computed tomography scan (PET/CT) highly sensitive for detecting malignant lesions. It plays a key role in staging lymphoma by assessing the extent of disease spread.

Additionally, F-18 FDG PET/CT is essential for assessing treatment response, detecting relapses early, and evaluating the prognosis of patients, offering prognostic value by evaluating residual disease and predicting recurrence. Its ability to monitor disease progression and detect recurrent lymphoma provides critical insights that guide therapeutic decisions and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age: Patient must be older than 18 years.
* Confirmed Diagnosis of Lymphoma: Patient must have a confirmed diagnosis of lymphoma based on histopathology and immunophenotyping.

Exclusion Criteria:

* Patients with Known concomitant malignancy.
* Pregnancy: Pregnant women due to the potential risks associated with radiation exposure from the PET/CT scan.
* Severe Renal or Hepatic Impairment: Patients with significant renal or hepatic dysfunction that could affect FDG metabolism or excretion.
* Uncontrolled Diabetes: Patients with uncontrolled diabetes (blood glucose \>200 mg/dL), as it can affect FDG uptake and PET/CT results.
Amphia Premature Infant Pain Study

Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.

The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.


Eligibility Criteria:
Inclusion Criteria:

* born at a gestational age between 32+0 and 36+6 weeks,
* being nourished with breast milk
* the necessity for a clinical blood sample.

Exclusion Criteria:

* perinatal asphyxia,
* birth trauma,
* condition of cardio-respiratory instability,
* condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
* drug abuse of the mother
* and application of sedative medication to mother or child.
Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.

The main questions it aims to answer are:

* Is the intervention feasible and acceptable among participants?
* Does the intervention enhance participants' cost-related health literacy?
* Does the intervention reduce participants' financial toxicity?

Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.

Participants will receive comprehensive information support, including:

* Strategies on patient-physician costs discussion
* Skills for inquiring and tracking treatment-related costs
* Basic knowledge about health insurance
* Guidance on accessing and applying for financial assistance
* Suggestions for returning to normal life and work
* Strategies for holding a financial-related family meeting


Eligibility Criteria:
Inclusion Criteria:

* (1) Newly diagnosed with breast cancer and undergoing surgery during this admission;
* (2) Female, age 18 years or older;
* (3) Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
* (4) Eastern Cooperative Oncology Group Performance Status 0-2;
* (5) Provided informed consent to participate in this study.

Exclusion Criteria:

* (1) Diagnosed with ductal carcinoma in situ (DCIS)
* (2) Presence of any serious psychiatric disorders;
* (3) Cognitive impairments;
* (4) Difficulty in reading, writing, or communicating in Chinese.
To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets and one HGP1206 125 mg tablet in healthy male volunteers.

An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and safety of Traclear 62.5 mg Tablets and HGP1206 125mg Tablet in Healthy Male Volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of Primary pulmonary hypertension to investigational product ingredients
* Hypotension or hypertension
Long-Term Efficacy and Safety of CT-P10 in Patients With RA

This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1


Eligibility Criteria:
Inclusion Criteria:

* Patient has disease improvement (moderate or good response) according to Disease Activity Score using 28 joint counts (DAS28) during the last course of treatment in Study CT-P10 1.1.
* Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study Period, including the Core Study Period and/or Extension Study Period.

Exclusion Criteria:

* Patient has been withdrawn from Study CT-P10 1.1 for any reason.
* Patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (SAEs) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.
Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers

Comparing the structural effects of TNFi and tocilizumab on the periarticular bone by performing a comprehensive analysis of the periarticular bone changes in RA patients treated with either TNFi or tocilizumab in a longitudinal Setting, using high-resolution peripheral quantitative computed tomography (HR-pQCT), a very sensitive method for visualizing and quantifying bone microstructure in RA patients. Quantitatively assessing the changes of erosions volume, osteophytes size and the area of cortical fenestration in a group of TNFi-treated and a group of tocilizumab- treated RA patients.

Inhibition of tumor necrosis factor alpha (TNF-α) and of interleukin- 6 receptor (IL-6R) emerged as highly effective cytokine blocking strategies in the treatment of rheumatoid arthritis (RA) in the last years. Both, inhibition of TNF-α (TNFi) and of the interleukin-6 receptor by tocilizumab ameliorate the signs and symptoms, reverse the elevated acute phase response and inhibit the progression of bone erosion in RA patients (1). Despite striking similarities with respect to their efficacy and safety in the treatment of RA, TNFi and tocilizumab are two entirely distinct approaches for targeting chronic inflammatory diseases in humans. This concept is highlighted by the differential response to TNFi and tocilizumab in other chronic inflammatory diseases such as psoriasis, psoriatic arthritis and spondyloarthritis, with clinical efficacy of the former but not the latter treatment modality (2). On the other hand, tocilizumab has a direct effect on the acute phase response and iron metabolism, which is not found with TNFi. Therefore, subtle differences may exist between TNFi and tocilizumab, which are relevant for the long-term treatment of RA patients.

Eligibility Criteria:
Inclusion Criteria:

* Females and males with RA erosions in the wrist and/or MCP joints
* Must be aged ≥ 18 years at time of consent
* Stable treatment with conventional DMARDs of at least 3 months

Exclusion Criteria:

* Patients exposed to abatacept or rituximab in the last 12 months
* Patients receiving glucocorticoids over 5 mg prednisolone per day
* Patients who are younger than 18 years
* Pregnant or lactating females
* Patients having received an HR-pQCT examination during the last 6 months before screening
Tongue Depressor-related Tongue Swelling

This study aimed to detect tongue swelling induced by the pressure exerted by tongue depressor; swelling detection was made through tongue surface area measurement using ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries.

The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue swelling through USG examination and to educate clinicians about the association between subacute tongue swelling and tongue depressor in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 years or younger
* Undergo adenoidectomy surgery
* Patients informed consent obtained from the parents

Inclusion Criteria for control group:

* Patients aged 16 years or younger
* Patients who did not need adenoidectomy surgery and any head and neck procedures
* Patients who underwent endotracheal intubation under general anesthesia except adenoidectomy and head and neck surgery.

Exclusion Criteria:

* Patients aged older than 16 years
* Patients with a history of syndromal craniofacial abnormalities
* Patients with systemic disorders and other otolaryngologic problems
COMPLEX Post Market Surveillance Electronic Registry

To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.

This Post Market Surveillance Registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial aneurysms treated with the Trufill DCS Orbit detachable platinum coils.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with angiographically documented aneurysms,
2. Either ruptured or unruptured,
3. Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization

Exclusion Criteria:

1) Patient / Treatment outside of the approved labeling, indications for use.
Mediators of Atherosclerosis in South Asians Living in America

South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at three United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.


Eligibility Criteria:
Inclusion Criteria:

* South Asian ancestry defined by having at least 3 grandparents born in one of the following countries: India, Pakistan, Bangladesh, Nepal, or Sri Lanka
* age between 40 and 84 years.

Exclusion Criteria:

* Physician diagnosed heart attack, stroke or transient ischemic attack (TIA), heart failure, or angina (or use of nitroglycerin)
* Current atrial fibrillation
* Past history of cardiovascular procedures (coronary artery bypass graft (CABG) Surgery, angioplasty, valve replacement, pacemaker or defibrillator implantation, or any surgery on the heart or arteries)
* Active treatment for cancer
* Life expectancy less than 5 years due to serious medical illness
* Impaired cognitive ability as judged by the reviewer
* Plans to move out of the study region in next 5 years
* Weight greater than 300 pounds
* Living in a nursing home or on a waiting list
* Unable to speak/read/write English, Hindi, Urdu, or Bangla
Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life

Participants will perform blood glucose monitoring (BGM) over the course of 14 days and, in parallel, wear continuous glucose monitoring (CGM) systems. Because current CGM systems typically achieve a lower level of analytical accuracy than BGM systems, participants will perform at least 5 blood glucose (BG) measurements per day. In addition, CGM systems are used to obtain minimally-invasive high-frequency glucose measurements to fill the gaps between BG measurements.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Written informed consent
* Subject is legally competent and has the capacity to understand character, meaning and consequences of the study
* Subject is willing to refrain from intake of salicylic acid and ascorbic acid and medication and/or compounds containing these substances

Exclusion Criteria:

* Anamnestically known diabetes mellitus
* Severe acute or chronic disease with potential risk of being adversely affected by the study procedures (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Pregnancy or lactation period
* Known severe skin reactions to adhesives
* Blood donation within the previous two months (according to the subject's statement)
* Language or other barriers potentially compromising an adequate compliance with study procedures
Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014

Retrospective review of the medical files of 115 patients with neuroendocrine tumours who were treated with Lutetium-177 DOTA-TATE under Health Canada's Special Access Programme (SAP) at the Cross Cancer Institute between January 2010 and April 30, 2014. Efficacy, safety, and other relevant data will be collected to support a separate clinical trial application.


Eligibility Criteria:
Subjects with neuroendocrine tumours who received Lu-177 DOTA-TATE treatment under SAP at the Cross Cancer Institute between January 2010 and April 30, 2014.