cyrilzakka/clinical-trials huggingface dataset:
Neulasta in Type 1 Diabetes

The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. The secondary purpose of this research study is to determin if giving GCSF to patients with T1D changes the immune system or preserves insulin production.

As a participant in this study the following will happen:

Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being produced, Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood sugar control, and randomized to either receive the 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).

Eligibility Criteria:
Inclusion Criteria:

* Must be \> 12 years old and have a confirmed diagnosis of "recent onset T1D" as defined by:
* T1D for \< 6 months,
* Stimulated C-peptide ≥ 0.2 pmol/ml
* Presence of at least one diabetes-related autoantibody (e.g., GAD, IA-2, IAA, ICA)
* Normal screening values for CBC
* Willing to comply with intensive diabetes management
* No history of allergy to GCSF
* Females having reproductive potential must be willing to avoid pregnancy and have a negative pregnancy test

Exclusion Criteria:

* Known hypersensitivity to E.Coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
* Chronic use of steroids or other immunosuppressive agents
* Active infection
* Inability to maintain intensive diabetes management
* Pregnancy
* History of malignancy
* Currently participating in another type 1 diabetes treatment study.
* Use of non-insulin pharmaceuticals that affect glycemic control
Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children

Randomized controlled trial involving 40 pediatric primary care clinicians with high rates of diagnosing and treating middle ear infections. Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month trial: 1) personalized education and feedback about proper ear infection diagnosis; 2) use of a digital otoscope; 3) both education and feedback plus use of a digital otoscope; 4) control (no intervention).

Randomized controlled trial involving 40 pediatric primary care clinicians with rates of otitis media diagnosis and antibiotic prescribing in the top quartile of the entire clinician population of the Pediatric Physicians' Organization at Children's over the previous 12 months who consent to enroll in the trial after direct outreach from the study team. Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month intervention period: 1) personalized education and feedback about proper otitis media diagnosis following criteria from the American Academy of Pediatrics; 2) use of the Wispr digital otoscope; 3) both education and feedback plus use of the Wispr digital otoscope; 4) control (no intervention).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric primary care clinicians from the Pediatric Physicians' Organization at Children's with an Otitis Media Treatment Index for the previous 12 months in the top quartile of all Pediatric Physicians' Organization at Children's clinicians with at least 100 qualifying encounters in the year

Exclusion Criteria:

* Currently using any digital otoscope
* More than one other clinician from the same practice participating in the trial
Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia

Identify new or novel genes which may impact on cholesterol level, and establish the relationship between those gene mutations with atherosclerosis, as well as responses to lipid-lowering drugs.

To better understand the genetics basis for LDL-C elevation and develop an optimized lipid-lowering strategy, we propose to do the following studies:

1. To establish a China HoFH registry, and collect DNA and blood samples from all available family members of each proband (pedigrees);
2. To detect gene mutations known to cause FH and identify family suitable for future whole genome sequencing aimed to identify novel genes controlling cholesterol levels.

3.To establish the relationship between types of gene mutations and lipid and atherosclerosis profile, as well as responses to lipid-lowering agents.

Eligibility Criteria:
Inclusion criteria:

Patients of any age and sex who meet clinical or genetic criteria for hoFH as follows:

* Cutaneous xanthomata before the age of ten years
* LDLC \> 13 mmol/L before treatment or \> 7.76 mmol/L despite treatment
* Phenotypic features in keeping with HeFH in both parents

Exclusion criteria:

Inability of patient, or, if less than 18, a parent, to sign informed consent.
Evaluation of Yoga for the Treatment of Pediatric Headaches

This study will examine the feasibility and acceptability of yoga for adolescents seen by a medical practitioner for their headaches. The study will also examine whether yoga decreases anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 13-17 years
* patient seen in the headache clinic at Children's Hospital of Wisconsin

Exclusion Criteria:

* neck, spinal, or back injuries
Use of MRI and PET for Assessing Disease Activity in Takayasu's Arteritis

Assessing disease activity in people with Takayasu's arteritis is difficult, as most people with the disease do not exhibit visible, measurable symptoms. Combination positron emission tomography/computed axial tomography (PET/CT) is a particularly sensitive, accurate scanning method that may improve researchers' ability to evaluate people with the disease. This study will determine the effectiveness of PET/CT in assessing disease activity in people with Takayasu's arteritis.

Takayasu's arteritis is a rare inflammatory disease that affects the aorta and its branches. The disease is much more common in females than in males, and disease onset typically occurs between the ages of 15 and 30. People with this disease often experience general discomfort, fatigue, fever, night sweats, weight loss, and joint pain. In the late stages of the disease, weak arterial walls may lead to aneurysms. Many patients do not exhibit any visible symptoms until this point, however. Because many people with Takayasu's arteritis do not have overt disease symptoms, the assessment of disease activity is difficult. Laboratory tests can help, but are often unreliable. Novel approaches to assessing disease activity are urgently needed to enhance and facilitate research on Takayasu's arteritis. This study will determine the effectiveness of combination positron emission tomography/computed axial tomography (PET/CT) in assessing disease activity in people with Takayasu's arteritis.

Participants in this study will enroll while their disease is active. The first PET/CT scan will take place upon study entry, while there is active disease. Participants will have a second PET/CT scan 3 months later, and a third scan 3 months after that if there is still active disease present. Participants will have a maximum of 3 scans unless a scan needs to be repeated because of technical failures, though this does not often happen. If there is no active disease at the time of the second scan, a third scan will not be done. All PET/CT scans will be scheduled within 10 days of participants' routine MRI scans. This study will not require any follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Takayasu's arteritis, as defined by the VCRC Longitudinal Study #5503
* Currently enrolled in the VCRC Longitudinal Study #5503
* Active disease has occurred in conjunction with a disease relapse within 2 weeks before study entry (A detailed definition of "active disease" is available in the study protocol.)
* Willing and able to comply with the schedule for imaging studies and follow-up procedures

Exclusion Criteria:

* Pregnant or breastfeeding
* Unable to comply with study guidelines
* Unable to safely undergo MRI scanning
Misdiagnosis Between Interstitial Lung Disease and Cardiac Patients

Aim of the study To determine the frequency misdiagnosis of cardiac congestion as interstitial lung disease based on initial High Resolution CT interpretation alone.

To identify specific HRCT findings that are more commonly associated with misdiagnosis versus correct diagnosis of the underlying condition.

To establish diagnostic criteria or HRCT patterns that distinguish cardiac congestion from interstitial lung disease

Observational study of 150 patients found that cardiac congestion was misdiagnosed as interstitial lung disease in 24% of cases on initial HRCT imaging alone. Echocardiography and clinical correlation were needed to make the correct diagnosis .

Misdiagnosis can lead to inappropriate treatment with immunosuppressive drugs which could exacerbate right heart failure in patients who actually have cardiac congestion. Correct diagnosis is important for prognosis and management.

Subtle findings like upper lobe predominance of opacities, septal lines and a mosaic attenuation pattern on HRCT favor interstitial lung disease, while diffuse ground glass with central and perihilar distribution favors cardiac congestion .

Associated findings on HRCT like enlarged cardiac silhouette, pleural and pericardial effusions help suggest the diagnosis of cardiac congestion over idiopathic interstitial pneumonia .

Integrating clinical data on risk factors for heart failure, echocardiography findings and follow-up imaging response to diuretic therapy can help differentiate the two conditions when HRCT is non-specific

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent HRCT imaging of the chest for evaluation of suspected interstitial lung disease
* Initial radiology report included a definitive diagnosis of interstitial lung disease patterns
* Age 18+ years
* No prior history of pulmonary or cardiac

Exclusion Criteria:

* Inconclusive or unclear initial HRCT report
* Underlying diagnosis other than interstitial lung disease or cardiac congestion
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and safety of two different doses of ianalumab compared to placebo in adults with primary ITP (platelets count \<30 G/L) who require first-line standard-of-care corticosteroids.

After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with standard of care corticosteroids).

After the treatment period, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how they respond to the study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* Male or female participants aged 18 years and older on the day of signing informed consent
* Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)
* Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)
* Response (platelet count \>=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.

Key Exclusion Criteria:

* Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible)
* Current life-threatening bleeding
* Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .
* Prior use of B-cell depleting therapy (e.g., rituximab).
* Absolute neutrophil count below 1.0 G/L at randomization
* Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid

Other protocol-defined Inclusion/Exclusion may apply.
Effects of Caloric Restriction on Fetuin-A and Cardiovascular Risk Factors

The aim of this randomized controlled study was to evaluate the effects of CR on circulating fetuin-A levels in obese humans with type 2 diabetes based on monitoring energy intake and energy expenditure by daily activity. Furthermore, the investigators examined the relationship between the changes of fetuin-A levels induced by CR and cardiovascular risk parameters including atherogenic lipid profile, visceral fat area (VFA), brachial artery endothelial function, and carotid IMT.

Rapidly growing aging society augmented the risk of age-associated disorders, such as metabolic syndrome, type 2 diabetes, and cardiovascular disease. Dietary interventions that reduce daily energy intake, also known as caloric restriction (CR), has been shown to be the most robust intervention to extend average and maximal lifespan in various experimental animals (1). In addition, CR diminishes the risk of multiple age-associated diseases, such as diabetes, cardiovascular disease, and some forms of cancer in rodents and primates (rhesus monkeys) (1; 2). Moreover, in obese humans, CR improves insulin sensitivity and reduces fasting glucose as well as the other components of metabolic syndrome (3). However, the exact underlying mechanism of CR has not been fully defined yet.

Recently, it is hypothesized that liver may regulate systemic energy metabolism through production of secretory proteins known as hepatokines. Fetuin-A, a circulating glycoprotein almost exclusively secreted by the liver, has been found to inhibit insulin receptor tyrosine kinase activity in animal studies (4). Fetuin-A knockout (KO) mice have enhanced glucose sensitivity, resistance to weight gain, and lower serum free fatty acid levels (5). In humans, high fetuin-A levels are associated with insulin resistance and fat accumulation in the liver (6). Ix et al. reported that higher human fetuin-A concentrations are strongly associated with metabolic syndrome and atherogenic lipid profile in non-diabetic patients with coronary artery disease (7). In addition, fetuin-A levels were associated with surrogate marker of atherosclerosis such as arterial stiffness and intima-media thickness (IMT) (8). Recent studies reported that elevated fetuin-A levels predict increased risk of myocardial infarction and ischemic stroke (9) as well as type 2 diabetes (10). However, there has been no previous report about the effects of CR on fetuin-A comparing with changes of cardiovascular risk indicators in animals or humans.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* BMI \>= 23 kg/m2
* stable body weight (\<2 kg change in weight in the past 6 months)
* sedentary lifestyle (\<20 min of exercise twice a week)

Exclusion Criteria:

* smoking
* cardiovascular disease
* chronic kidney disease
* chronic liver disease
* pregnant or breast feeding
* any major illness
* taking medications that could affect laboratory test results
Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.


Eligibility Criteria:
Inclusion Criteria:

* Smoking an average of at least 10 cigarette per day
* General good health

Exclusion Criteria:

* unstable medical or psychiatric conditions
* history of severe motion sickness
* women who are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not participate
10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma

Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.

Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.

Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed, previously untreated oral and oropharyngeal squamous cell carcinoma with radical resection;
2. MRI examination was performed two weeks before surgery;
3. All patients with neck dissection and the status of regional lymph nodes was confirmed via pathological examination;
4. All patients had no clinical evidence of nodal involvement.

Exclusion Criteria:

1. Other malignant tumor, such as adenoid cystic carcinoma;
2. a lack of complete MRI imaging or poor MRI imaging quality;
3. patients had undergone neck dissection or treated non-surgically;
4. patients with metastatic disease.
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).

The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.

Eligibility Criteria:
Inclusion Criteria:

* over age 18
* life expectancy of at least 12 weeks
* Zubrod performance status of ≤2.
* biopsy proven hepatocellular carcinoma (HCC)
* liver metastases
* a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor \> 2cm, or (2) single imaging study showing hypervascular tumor \> 2cm with AFP ≥ 400 ng/mL
* a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of \> 1cm in diameter
* adequate organ function
* women and men not interested in pregnancy
* must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE)
* minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy.

Exclusion Criteria:

* cannot be eligible for a curative liver resection
* uncontrolled ascites clinically evident on physical exam
* known allergy to IC-Green
* known allergy to intravenous iodinated contrast agents
* patients with poor venous access
* patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor \< 6 cm in size.
Multiple Sclerosis Self Monitoring Study

This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). RRMS patients will be recruited and screened for study eligibility at four Dutch MS centers. Following inclusion, participants will be randomly allocated to the intervention group (use of MS sherpa® in addition to standard care) or control group (standard care only). The duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form.
2. Able to comply with the study protocol, as judged by the investigator.
3. A minimum age of 18 years.
4. Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria.
5. Have a length of disease duration of ≥12 months, from date of MS diagnosis.
6. Have clinical disease activity (one or more reported relapses) and/or radiological disease activity (new/enlarged T2 lesions or T1 contrast-enhancing lesions) within the past 12 months.
7. Willing and able to install and use MS sherpa® on own smartphone with Android (version 4.4 or higher) or iOS (version 9 or higher) operating system.
8. Willing to stay for treatment with the same hospital during the year of study.
9. Willing to follow the rules of conduct as described in Appendix A during the year of study.

Exclusion Criteria:

1. EDSS of \> 6.5 at baseline screening.
2. Presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of MS sherpa® on the smartphone, as judged by the investigator.
3. Concomitant use of health monitoring apps or devices for MS during the study.
4. Concomitant participation in another intervention trial in MS.