cyrilzakka/clinical-trials huggingface dataset:
Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.

The study aims to evaluate radiomic markers in breast tumors to evaluate metastatic risk based on radiomic features following primary therapy. The investigators aim to analyze images at various time intervals before, during and after primary treatments using two advanced imaging techniques (DCE-MRI \& DWI-MRI).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must give appropriate written informed consent prior to participation in the study;
2. Subjects must be able and willing to comply with the safety procedures during the scanning period;
3. Subjects must be men and women age 18+
4. Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-).
5. Stage I-III disease according to the AJCC v7 criteria.
6. Patients with sufficient renal function (creatinine clearance, i.e., \>=30 mL/min/1.73 m2).
7. Primary treatments can include neoadjuvant chemotherapy or surgery

Exclusion Criteria:

* 1. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue.

  2. Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast 3. Subjects with a current or past medical history of connective tissue disease 4. Subjects who are pregnant or lactating 5. Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator 6. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.

  7. Allergies to any contrast agent administered to this study.
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.


Eligibility Criteria:
Key inclusion criteria:

1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading

Key exclusion criteria:

1. Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding
2. Current or past history of CP score ≥7 points
3. Model for End-stage Liver Disease (MELD) score \> 12
4. ALT ≥ 5 X ULN
5. Calculated creatinine clearance \<60mL/min using Cockcroft-Gault method
6. Hemoglobin A1c (HbA1c) ≥ 9.5 %
7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
8. History of liver transplant, or current placement on a liver transplant list
Follow-up of Adolescent Bariatric Surgery

Very little information is available about extremely obese (body mass index \[BMI\] \> 40 kg/m2) adolescents. The purpose of the Follow up of Adolescent Bariatric Surgery (FABS) study is to collect information obtained during the clinical care of obese adolescents from all over the country that can be used by researchers to study obesity, the complications of obesity, and the outcomes of obesity treatment during adolescence. This information will be used to describe the experience of the obese adolescent, including how obesity during adolescence and its treatment impacts health and well-being. The information may also be used to study causes of obesity, to determine the predictors of successful obesity treatment and for other obesity related research. Because of the importance of understanding the outcome of obesity and obesity treatments (surgical and non-surgical) on the patient over time, the data included in the study will be collected before, during and after any treatments rendered. For those who do not undergo a treatment which results in major weight change, it will be critical to determine the natural history of adolescent severe obesity as the adolescent transitions into adulthood. Finally, another important purpose of the FABS research study is to obtain patients' consent to be contacted for possible participation in future research studies.

SPECIFIC AIMS:

1. To describe the natural history of morbid obesity among adolescents who seek treatment for their obesity
2. To describe major outcomes following bariatric surgery in adolescents evaluated at 3, 6, 12, and annually for 10 years post-operatively and compare these to outcomes to patients managed non-surgically
3. To organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies


Eligibility Criteria:
Inclusion Criteria:

* All patients seeking treatment for Obesity at Cincinnati

Exclusion Criteria:

* Currently Enrolled in Teen LABS Study.
THromboprophylaxis in Sickle Cell Disease with Central Venous Catheters (THIS)

Research Question:

In adult SCD patients with CVC, is it feasible and safe to conduct an adequately powered RCT to evaluate the use of rivaroxaban as thromboprophylaxis in this population?

Study Design:

The study is a vanguard pilot double blind multi-centre randomized controlled trial. Participants with SCD and CVC will be randomized to either rivaroxaban 10mg PO daily or placebo for the duration of CVC in situ or for up to one year, whichever is less. After screening (day -7 to day -1), patients will be followed at day 1, months 3 (+/- 15 days), 6 (+/- 15 days), 9 (+/- 15 days), and 12 (+/- 15 days).

Study Objectives:

The primary objective is to estimate the proportion of eligible patients who will enroll into a trial of thromboprophylaxis.

Secondary objectives include (a) document indications for central venous catheter (CVC), (b) summarize duration of CVC insertion prior to enrollment, (c) estimate adherence to the study drug, (d) estimate proportions of participants being compliant with study procedures, and lost to follow up.

Exploratory objectives will assess thrombotic, bleeding, and quality of life outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (age 18 or older)
2. Documented SCD
3. New or pre-existing CVC planned for long term use (at least 6 months)
4. Able to provide written consent

Exclusion Criteria:

1. Contra-indication to prophylactic dose anticoagulation or active bleeding at discretion of treating physician
2. Already on anticoagulation (prophylactic or therapeutic dose) for an indication other than CVC thromboprophylaxis
3. Previous VTE within the past 3 months
4. Pregnant, within 6 weeks post-partum, or active breast feeding
5. Creatinine clearance \<30mL/min (as calculated by Cockcroft-Gault equation\[67\])
6. Acute hepatitis or chronic active hepatitis
7. Cirrhosis with Child-Pugh score B or C
8. Platelet count \< 50 x109/L
9. Weight \<40kg
10. Uncontrolled HTN (systolic blood pressure \> 170mmhg, or diastolic blood pressure\> 100mmhg) despite antihypertensive treatment
11. On palliative care
12. On dual antiplatelet therapy, or high dose single agent aspirin \> 325mg/day
13. On combined P-glycoprotein and strong cytochrome P450 3A4 inhibitors (including but not limited to ketoconazole and protease inhibitors)
14. On combined P-glycoprotein and strong cytochrome P450 3A4 inducers (including but not limited to rifampin, phenytoin, phenobarbital, carbamazepine, and st. john's wort)
15. Active cancer or treatment for cancer excluding basal cell carcinoma
16. Known allergy to study drug
17. Strong indication for thromboprophylaxis at discretion of treating physician
18. Significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data.
Assessments and Interventions for Hand Neuropathy in DM

This study is to investigate the effects of task-based biofeedback training compared with home-based programs on sensorimotor function and quality of life for diabetic patients with neuropathic hands. The investigators hypothesize that the task-based biofeedback training might have significant effectiveness for restoration of sensory function, precision pinch performance, hand dexterity and life quality for patients with diabetic neuropathy.

Hand tendon gliding exercises allow both the flexor digitorum profundus and superficialis tendons of hands to achieve the greatest range of motion. Thus, in conjunction with resistive exercises for diabetic hands, such exercises are considered an appropriate home-based training method that has positive effects on various diabetic hand problems in terms of regaining smooth tendon excursion, preventing joint contracture, and reducing intrinsic muscle tightness. Different from the biomechanical approach to deal with hand problems, a biofeedback system can be used to provide real-time information on improper movements during task-based training intended to enhance either performance quality or accuracy. This study aims to analyze the difference in treatment effects between a computerized evaluation and a re-education biofeedback system that provides interactive sensorimotor information to shape the optimized coordinated pinch pattern of a hand and a home-based tendon gliding exercise program in conjunction with resistive exercise with weekly supervision on sensorimotor function and quality of life for diabetic patients. The investigators hypothesize the task-based biofeedback training using the biofeedback training system could have significant effectiveness for restoration of sensory function, precision pinch performance, hand dexterity and life quality for patients with diabetic neuropathy.

Eligibility Criteria:
Inclusion Criteria:(for training groups)

* with clinically-defined type II DM who were diagnosed based on the 1997 American Diabetes Association criteria
* impaired in terms of force modulation in precision pinch performance as detected using the PHUA test are referred from outpatients from the Department of Family Medicine in a medical center in southern Taiwan

Exclusion Criteria:(for training groups and healthy control group)

* diagnosed neuro-musculoskeletal disorders
* traumatic nerve injuries of the upper limbs
* trauma to the hand or congenital anomalies of the wrist and hand
* skin infections or disease of the hands
* cognitive deficits
* aged less than 20 years old
Predictors of Hospital Readmission for Chronic Obstructive Pulmonary Disease Patients

This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients

This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients and develop early warning model

Eligibility Criteria:
Inclusion Criteria:

* All COPD patients of both genders diagnosed by (GOLD) Guidelines (2024 Revision).
* Cooprative patients who accept to participate in the current study .

Exclusion Criteria:

* patients with cognitive impairment ,and unable to answer needed questions.
* patients with other lung diseases such as active pulmonary tuberculosis ,asthma ,bronchiactesis,and pulmonary embolism .
* patients with incomplete clinical data .
* Refused to participate in the current study .
Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control

Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy and safety of SPT were proved. The positive control of SPT is histamine.

In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some practice they use other concentration (1, 2.5 mg/ml).

This study will find the proper concentration of histamine for positive control use in SPT.

Appropriate concentration of histamine positive control is important in interpretation the result of skin prick test.

Eligibility Criteria:
Inclusion Criteria:

* Parcitipate person who attented allergy clinic, ENT clinic
* Legible in Thai language

Exclusion Criteria:

* Patient cannot withhold antihistamine drug
* Pragnancy and lactation mother
* comorbid disease such as cardiac disease, liver, renal, hypertension and severe asthma
Relationship of Different Electrocardiographic Parameters and Ambulatory Blood Pressure Parameters to Detect Left Ventricular Hypertrophy

To review the accuracy of electrocardiography in screening for left ventricular hypertrophy in patients with hypertension.

Arterial hypertension is a major cause of coronary heart disease, stroke, and heart failure. Several studies have shown that left ventricular hypertrophy is an important risk factor in patients with hypertension, leading to a fivefold to 10-fold increase in cardiovascular risk,1 2 3 4 5 which is similar to the increase seen in patients with a history of myocardial infarction.6 The presence of left ventricular hypertrophy, in addition to hypertension, thus has important implications for assessing risk and managing patients, including decisions on interventions other than antihypertensive treatment, such as lipid lowering treatment and lifestyle modifications.7 8 Accurate and early diagnosis of left ventricular hypertrophy is therefore an important component of the care of patients with hypertension.

Decisions about treatment should be based on assessments of hypertensive target organ damage and overall cardiovascular risk. The appropriate diagnostic work-up of suspected left ventricular hypertrophy in patients with hypertension is less clear, however. There is many electrocardiographic indexes for the diagnosis of left ventricular hypertrophy, based on the standard 12 lead electrocardiogram, have been described. Many of the proposed indexes have remained anecdotal, but others are commonly used, including the Sokolow-Lyon index,9 the Cornell voltage index,10 the Cornell product index,11 the Gubner index,12 and the Romhilt-Estes scores.13 However, debate about their comparative diagnostic value continues.14 15 We did a systematic review to clarify the accuracy of different electrocardiographic indexes, with emphasis on their ability to rule out left ventricular hypertrophy in patients with arterial hypertension.

Eligibility Criteria:
Inclusion Criteria:

Patients ranging from 20t o 80 years attending the hypertension outpatient clinic for ambulatory blood pressure measurement will be consecutively enrolled

Exclusion Criteria:

1. Patients with ischemic heart disease.
2. Patients with advanced respiratory, renal, or hepatic disease
3. Patients with uninterpretable ECG or ABPM recordings
Sitosterolemia Extension Study (0653-003)(COMPLETED)

This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

The duration of treatment is 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elevated sitosterol levels while taking current medication

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Ketamine Pharmacokinetics in Children Having Heart Surgery

What are the pharmacokinetics of ketamine in infants and children requiring ketamine for induction of anesthesia for cardiac surgery that requires CPB? Specific Aim 1: To determine the pharmacokinetic parameters of a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB (cardio-pulmonary bypass).

Specific Aim 2: To describe the disposition of ketamine's primary active metabolite, norketamine,following a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB.

Specific Aim 3: To determine the relationship between ketamine and norketamine pharmacokinetic parameters and age as well as CPB time.

The role of ketamine in pediatric anesthesia is well established. It is one of the most commonly used agents for conscious sedation in pediatrics. Its widespread use stems for its abrupt onset of action and brief duration of sedation. There is limited ketamine pharmacokinetic data in children and none to our knowledge in infants and young children who will be given an intravenous bolus dose before a surgical procedure that includes cardiopulmonary bypass.

Ketamine is marketed as a racemic mixture (50:50 mixture of S- and R-ketamine enantiomers).

Ketamine undergoes N-demethylation (CYP3B6, 2C9, and 3A4) to its primary active metabolite,norketamine, with minor inactive metabolites, dehydroxynorketamine, generated secondary to direct oxidation. Ketamine exhibits a high intrinsic clearance with hepatic clearance dependent on hepatic blood flow under normal circumstances. One inherent disadvantage associated with the use of cardiopulmonary bypass (CPB) is the potential for organ dysfunction post-operatively.

We propose an open-label controlled study describing the disposition of ketamine in 28 infants and children who will be undergoing cardiac surgery with (n=16) and without (n=12) CPB. We anticipate that cardiopulmonary bypass alters the pharmacokinetics of ketamine.

Eligibility Criteria:
Inclusion Criteria:

* ≤ 6 years of age
* cardiac surgical procedure
* Indwelling arterial line or central venous line for blood sampling

Exclusion Criteria:

* patients with known hepatic dysfunction(\>3 times normal AST \& ALT)
* clinically significant alteration (as determined by the investigator) hemoglobin or hematocrit
* patients receiving medications known to be potent inhibitors or inducers of CYP3A4 and CYP2C19
* patients with significant malnutrition (\< 1%tile for age-adjusted weight)
* patients enrolled in other studies that require frequent blood sampling during and after cardiac surgery
* any contraindication for ketamine administration
* ketamine administration within the previous 24 hours
* Patients with known history of pulmonary hypertension
Intelligent Personal Assistant for Managing Depression in Homebound Older Adults

The purpose of this study is to design a companion booklet and pilot test it with a voice-controlled intelligent personal assistants (VIPA), like Google Home or Amazon Alexa, to provide homebound older adult patients with skills and tools to help manage social isolation.

The objective of this pilot study is to design a companion booklet and pilot test it with a voice-controlled intelligent personal assistant (VIPA), Google Home or Amazon Alexa, to provide patients with skills and tools to help manage their social isolation. The companion booklet is a document that will be created using feedback obtained from a panel of geriatric experts, highlighting features of the VIPA that may be most beneficial to socially-isolated older adults. It will be submitted to the IRB for approval once finalized. The specific aims of this project are to:

Aim 1: Design a companion booklet to be used in conjunction with a VIPA (Google Home/Amazon Alexa) for improving social isolation and communication among homebound older adults, defined as someone who is unable to leave the home without assistance of a device or another person, due to a physical or cognitive condition.

Aim 2: Assess the feasibility and implementation of the VIPA (Google Home/Amazon Alexa) and the companion booklet and its impact on clinical and functional outcomes for older adults with social isolation.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 years or older;
* Homebound patients of the Northwestern Medicine Geriatrics Program;
* English-speaking; and
* Able to verbally consent

Exclusion Criteria:

* Condition that limits ability to consent, such as severe cognitive impairment or lack of English proficiency
* Less than 65 years of age
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Randomized, placebo-controlled, double-blinded, parallel group clinical trial to investigate if 6 months of oral lithium tablets (S-lithium 0,5-1,0 mmol/l) will prevent cognitive decline after brain radiotherapy in pediatric brain tumor survivors.

Primary outcome measure is Processing Speed Index (PSI) 2 years after start of study treatment.

Late-appearing cognitive side effects after brain radiotherapy is a potential disabling condition in pediatric brain tumor survivors. It can have profound negative effects on education, career options and quality of life. There is no current interventional drug treatment to prevent this intellectual impairment after brain tumor treatment.

Primary objective:

To assess the efficacy of lithium treatment (up to 7 years) after brain radiotherapy (both whole brain and focal) for central nervous system malignancy in preventing late-appearing cognitive processing speed impairment in children aged 5 or older.

Secondary objectives:

* To assess the efficacy of lithium treatment through evaluation of other neuropsychological/quality of life test scores.
* To assess the efficacy of lithium treatment through evaluation of radiological findings after lithium treatment using Magnetic Resonance Imaging (MRI) of the brain.

Exploratory objectives:

To explore the feasibility, safety and tolerability of lithium treatment in this patient group, using side effect forms/adverse events (AE) reporting and laboratory measures.

Eligibility Criteria:
Inclusion Criteria:

* Age \>5 years.
* Age \<18 years at time of radiotherapy.
* Has received cranial/craniospinal radiation treatment of brain tumor within the last 7 years.
* Adequate contraceptive method to prevent pregnancy\* during the entire lithium treatment period and six months thereafter.
* Negative pregnancy test\* at screening, at start of study treatment, and monthly thereafter.
* Written informed consent from patient and/or caregiver.

Exclusion Criteria:

* Allergy/hypersensitivity to lithium or any of the excipients
* Renal failure (Cystatin C derived Glomerular Filtration Rate \< 60).
* Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).
* Uncontrolled hypothyroidism.
* Pregnancy or breast feeding.
* Severe fluid or electrolyte imbalance.
* Karnofsky-Lansky score \< 60.
* Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, inability to swallow tablets, language difficulties).
* Inclusion in other study protocol precluding inclusion in this study.