cyrilzakka/clinical-trials huggingface dataset:
Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

This is a single arm, phase II study without blinding. The purpose is to determine the impact of hepatic artery infusion Floxuridine (FUDR) on liver metastases from pancreatic adenocarcinoma. Patients at Spectrum Health will receive standard of care chemotherapy. They will also receive chemotherapy via surgically placed hepatic artery infusion (HAI) pump.

This study hypothesizes that the combination of Floxuridine (FUDR), a type of chemotherapy, delivered via a hepatic artery infusion (HAI) pump, with standard of care systemic chemotherapy will lead to improved survival in the treatment of pancreatic cancer liver metastases. Patients will receive 6 cycles of FUDR and will be followed for two years.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases
* Elevated Cancer Antigen 19-9 (CA19-9) at diagnosis (\>37 U/mL)
* Ages 18-75 years
* Karnofsky performance status ≥70
* Ability to undergo general anesthesia and HAI pump placement procedure
* CT or MRI scan imaging of the abdomen demonstrating accessibility of the gastroduodenal artery within 2 months of enrollment
* Received a minimum of 2 months of systemic chemotherapy with stable tumor markers and imaging.

Exclusion Criteria:

* Primary tumor resected
* Model for End Stage Liver Disease (MELD) score \>20, using the variables of: Bilirubin, serum Sodium, International Normalized Ratio (INR), serum Creatinine, and Dialysis twice in the past week.
* Greater than 60% liver parenchymal involvement by tumor
* Evidence of peritoneal metastases
* Current alcohol abuse
* Pregnant or lactating women
Sentinel(TM) Post-Market Registry

The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.

Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.

All Sentinel filters will be sent for histopathology at an independent core-lab.


Eligibility Criteria:
Inclusion Criteria:

1. Approved indications for commercially available CE-Marked TAVR devices.
2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\> 70%).
3. The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.

Exclusion Criteria:

1. Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
4. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
5. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
6. Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
7. Currently participating in an investigational drug or investigational (non CE-mark) device study
Local Gentamicin Application to Reduce Postoperative Infection Rate

The majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. Local application of gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (\< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of proximal femoral fracture
* Must be planned operated with a prosthesis of the hip

Exclusion Criteria:

* Known allergy to gentamicin
* Ongoing treatment with aminoglycosides
* Reduced renal function
* Pregnancy
Evaluating Increasing Physical Activity After Acute Coronary Syndrome

This study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. All participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week follow-up period.

Cardiovascular disease is the leading cause of mortality in the United States. Among patients that survive an acute myocardial infarction (AMI), cardiac rehabilitation (CR) has been demonstrated to effectively reduce risk of re-infarction, cardiac mortality, and all-cause mortality. However, despite cardiac rehabilitation being a Class I (standard of care) recommendation in multiple American Heart Association acute myocardial infarction guidelines, more than 80% of eligible patients do not receive appropriate cardiac rehabilitation and much of this is due to challenges in access to these programs. Recent innovations in technology allow us to passively monitor an individual's physical activity using wearable devices. Incentives designed using insights from behavioral economics have been demonstrated to motivate device engagement and behavior change. A remotely-monitored cardiac rehabilitation program could improve access for many individuals and potentially be more cost-effective because it is less resource- and personnel-intensive. The objective of this study is to use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. ability to read and provide informed consent to participate in the study;
3. History of a) acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction); or b) patients having undergone coronary catheterization for suspected coronary artery disease.

Exclusion Criteria:

1. Inability to provide informed consent;
2. does not have daily access to a smartphone compatible with the wearable device;
3. unable or unwilling to complete the baseline 6-minute walk test and return to perform the 6-minute walk test at 10 and 18 weeks;
4. already enrolled in an exercise cardiac rehabilitation program prior to hospital admission;
5. hemodynamic instability or New York Heart Association III-IV heart failure;
6. any other medical conditions that would prohibit participation in an 18-week physical activity program;
7. not being discharged to home if recently admitted.
Nutritional Management of Neurologically Impaired Children Across China

A retrospective study to (1) investigate clinical characteristics, nutritional status, and nutritional management in neurologically impaired children in China, (2) assess whether enteral nutrition (particularly tube feeding) contributes to improving nutritional outcomes in children with neurological impairments, (3) examine the tolerability of enteral nutrition and whether it can effectively reverse or prevent severe malnutrition.

Electronic health records of children with neurological impairments from 11 medical centers across China between 2015 and 2020 were reviewed. Data were analyzed using SPSS 22.0. Normally distributed data were presented as mean±standard deviation (SD), and non-normally distributed data were presented as median and interquartile range (IQR). Categorical data were presented as frequencies and analyzed using the chi-square test. The Wilcoxon test was used to compare data at different time points. Multivariate logistic regressions were used to analyze the factors influencing gastrointestinal symptoms.

Eligibility Criteria:
Inclusion Criteria:

(1) age≤18 years, (2) with primary, progressive or non-progressive neurological impairment, (3) received oral nutrition or tube feeding, (4) for tube-fed patients only: at least 1 month of nutritional intervention and at least 1 follow-up visit (i.e. at least at Visit 1)

Exclusion Criteria:

with acquired causes of neurological damage (e.g., traumatic brain injury) or tube-fed patients who received nutritional intervention for less than a month and without follow-up
LcProt: Proteomics Longitudinal Cohort Study on Lung Cancer

This study will utilize tissue and peripheral blood samples for proteomics analysis and establish a longitudinal proteomics cohort at multiple critical treatment time points to explore the research value of proteomics in the diagnosis and treatment of lung cancer. The study includes key time points such as screening, postoperative efficacy prediction, and efficacy prediction after medication.


Eligibility Criteria:
Inclusion Criteria:

1. Signing of the informed consent form;
2. Male or female, aged 18-75 years;
3. Patients with lung nodules confirmed by CT examination;
4. Good preoperative pulmonary function cooperation and complete reporting;
5. Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
6. The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.

Exclusion Criteria:

1. Poor preoperative pulmonary function cooperation or missing reports;
2. Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
3. The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
4. Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
5. Coexisting with other severe functional impairments;
6. Patients with obstructive lesions such as airway or esophageal stenosis;

(8) Medication use before pulmonary function testing that does not meet the cessation guidelines; (9) Pulmonary function report quality graded D-F.
Integrating Telehealth to Advance Lung Cancer Screening

The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are:

1. Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS?
2. Is the effectiveness of these telehealth strategies similar by race and sex?

The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.

Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.

Eligibility Criteria:
Inclusion criteria:

Participants will be eligible if:

1. are aged 50 to 80
2. have a history of tobacco use indicated by either: Documented 20 pack-year or greater smoking history in their electronic health record (EHR); OR Self-report via structured survey
3. currently smoke or formerly smoked cigarettes
4. have no documented history of lung cancer
5. have no documented history of lung cancer screening in the 24 months prior to study enrollment
6. have completed at least one primary care visit at Penn Medicine in the 3 years prior to study enrollment.

Exclusion criteria:

Participants who do not meet inclusion criteria will not be eligible.
Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy

Rationale: The highest rates of coronavirus disease (i.e., COVID-19) vaccine hesitancy in the US are among young adults (YAs) aged 18-25. Our preliminary studies show that social norms - perceptions of peers' vaccination attitudes/behaviors - are most strongly related to YAs' vaccine intentions/uptake. Most YAs underestimate the perceived importance of vaccination and their peers' intentions to be vaccinated. The proposed research will develop and test an intervention to correct misperceived norms for vaccination hesitancy and uptake.

Methodology: Rapid prototyping with 20 unvaccinated YAs will help refine the content and design of the online intervention. Then, a diverse national sample (N=600) of unvaccinated YAs will be randomized to treatment or an attention-matched control. The treatment condition will receive personalized normative feedback (PNF) designed to correct normative misperceptions for vaccine hesitancy and uptake.

Normative feedback will be derived from the US Census Bureau's Household Pulse Survey. Follow-up surveys will be administered at 1, 2, 3, and 6 months to assess key outcomes including vaccine uptake, intentions, and reasons for vaccine hesitancy.

Aims and Data Analysis:

* Aim 1: Develop and refine a PNF intervention for vaccine hesitancy/uptake with user feedback from YAs. Rapid analysis of qualitative data will involve looking for themes in responses. Changes will be made iteratively to refine intervention content, design, and delivery.
* Aim 2: Evaluate intervention efficacy for increasing vaccine uptake and reducing time to first vaccine dose, relative to control, over the following year.
* Aim 3: Examine mediators (changes in perceived norms) and moderators (intellectual humility, identification with other people and young adults) of intervention efficacy. A longitudinal moderated mediation model will be examined.

Impact: Findings will clarify the causal role of psychological determinants of vaccine hesitancy (social norms, intellectual humility, group identification). If preliminary intervention efficacy is supported, this intervention could be a low-cost, and easily disseminated strategy to promote YAs' vaccine uptake and contribute to public health efforts to address the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* 18-24 years old (at screening)
* Reside in the United States.
* Have not received a COVID-19 vaccine (at screening)
* Pass attention checks.

Exclusion Criteria:

* Not meeting inclusion criteria.
* Not fluent in English.
* Not providing consent.
* Unwilling to participate.
Evaluation of Jejunal Placement of Enteral Feeding Tubes

The purpose of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population. The investigators hypothesized that success rate of the electromagnetic jejunal tube placement will be lower than the success rate of the endoscopic method.

Clinical studies have shown that up to 62,8% of patients receiving EN have gastrointestinal complications like high gastric residuals (≥200ml), vomiting, abdominal distension and regurgitation. These complications lead to interruptions of the EN, which result in a low caloric intake of the patient.

In order to avoid at least some of these complications the ACCP consensus statement recommends small bowel feeding if gastric residual volumes of 150ml or higher occur. The Canadian clinical practice guidelines recommend acceptance of gastric residual volumes up to 250 ml, use of prokinetic agents and jejunal feeding for patients, who are at high risk for intolerance of EN (on inotropes, sedatives, paralytic agents). When gastric enteral nutrition is insufficient despite acceptance of high gastric residual volumes and use of prokinetic agents, small bowel feeding is the best method to nevertheless feed the patient enterally because it is associated with a significant decrease of reflux, a reduced risk of aspiration and an adequate caloric intake.

For small bowel feeding the placement of a jejunal feeding tube is necessary. There are several possibilities to place the tube in the small bowel. An excellent method still is endoscopy, which has a success rate up to 98% and moreover allows an evaluation of the upper GI-tract concerning pathologies. However, it is a rather time consuming procedure, which is of limited availability and requires trained staff. As more simple alternatives unguided tubes and their placement in the small bowel were tested and showed success rates up to 75% only. One of these alternatives is a jejunal feeding tube, which is placed using an electromagnetic sensing technique to visualize the placement process on a bedside monitor (CORTRAK™). The aim of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population.

Eligibility Criteria:
Inclusion Criteria:

* Intolerance of intragastric feeding (high gastric residual volumes (≥250ml)and/or repeated vomiting)
* Clinical indication of jejunal feeding

Exclusion Criteria:

* Patients not fulfilling clinical indication of jejunal feeding or contraindications for jejunal feeding
Reducing Drug Craving Memories

The primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy.


Eligibility Criteria:
Inclusion Criteria:

* 60 psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old);
* Minimum of three days cocaine abstinent on study days;
* Primary use of cocaine is intra-nasal or smoked crack

Exclusion Criteria:

* Medical conditions that might be aggravated by participation in the study:

  * cardiovascular disorders that might be aggravated by participation in the study: hypotension (SBP: \< 100 mmHg), bradycardia (heart rate \< 60 /min), severe atrioventricular block (Type II or III), severe hypertension (SBP: \> 160 mmHg; DBP: \> 100 mmHg), myocardial infarction, history of chest pain and admission to ED for chest pain;
  * respiratory disorders: bronchial asthma and chronic obstructive pulmonary disease;
  * diabetic patients treated with insulin or oral hypoglycemic agents. Propranolol may mask the first signs of a developing hypoglycemia.
* Seropositive pregnancy test
* Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders
* Severe liver disfunction
* Current or recent (\< 5 half lives) use of medications that may interact with Inderal (see above)
* Positive urine tox screen for barbiturates. Positive breath alcohol screen. {Note: all urine tox screen results will be destroyed immediately after collection. The information will not be stored}
A Progressive Resistance Training Program in Patients With Haemophilia

This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia

The training program aims improving muscular strength and endurance in the relevant muscles and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in the patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of haemophilia A or B
* willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations
* approval by their hematologist to participate in the exercise program
* age between 18 and 60 years
* informed consent signed.

Exclusion Criteria:

* the inability to attend exercise sessions at least twice a week for 6 consecutive weeks
* non adherence to instruction on proper exercise technique
* surgical procedures performed 6 weeks prior to or during the exercise program
* participation in any other form of exercise, including rehabilitation, during the study; (5) changes in medication during the study
* a major bleeding episode that posed a risk or prevented exercise
* History of FVIII inhibitor (titer ≥ 0.6 BU \[Bethesda unit\]) or detectable FVIII inhibitors at screening (titer ≥ 0.4 BU)
* Another haemostatic defect
* Need for major surgery
* Withdrawal of informed consent
Vibration Induced Reflex Responses and Estimation of TVR

The aim of this study is to estimate tonic vibration latency and whole body vibration reflex latency

This study was included 17 patients with spastic spinal cord lesions and 23 healthy control.

Soleus T-reflex, soleus H-reflex, soleus tonic vibration reflex (TVR), and reflex muscle response induced by whole body vibration was evaluated this study. To obtain the H-reflex response, the tibial nerve in the popliteal region was stimulated by using a stimulator (FE155 Stimulator HC ADInstrument, Oxford UK) with 1 ms-pulse current. The records was taken with the Ag / AgCl electrodes (Kendall ®Coviden, self-adhesive electrodes) placed on skin according to the SENIAM protocol. To obtain T-reflex response, an electronic reflex hammer (Elcon 100-150 Germany) was used. After H-reflex and T reflex records at rest, to obtain Tonic vibration reflex, local vibration was applied to the Achilles tendon at 50, 85, 140, 185, 235 and 265 Hz. To obtain the reflex response induced by Whole body vibration, vibration was applied at 35, 37, 39, 41, 43 and 45 Hz. Tibial nerve stimulation was performed again to determine Hmax during whole body vibration and local vibration.H-reflex records was taken while the subject is sitting on a chair.

The data was recorded with the PowerLab data acquisition device (ADInstrument Oxford UK). For Whole-body vibration, PowerPlate Pro5 (London UK) was used.

Eligibility Criteria:
Inclusion Criteria spinal cord injury patients:

* Spastic spinal cord lesion
* Patients between the ages of 20 and 45

Exclusion Criteria for spinal cord injury patients

* Accompanying trauma

  1. Lower extremity fracture
  2. Lower extremity peripheral nerve lesions
  3. Head trauma
* Autonomic dysreflexia
* Heterotopic ossification
* Lesions in calf skin
* Excessive spasticity (Ashwort4) / Contracture (knee, hip, footbath)
* Peripheral nerve-vascular diseases / muscle diseases
* Pressure ulcer (\> Grade 2)

Inclusion criteria for Control

* Ages 20 and 45 old years
* Both sex
* Healthy volunteers

Exclusion Criteria for Control

* Pregnant women