cyrilzakka/clinical-trials huggingface dataset:
Comparison of Percutaneous Image-guided Gastrostomies

Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating gastroenteric access through the anterior abdominal wall for nutrition and/ or compression. Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop catheters via the push technique are both used at Interventional Radiology for PIG at our institution. To date, there is no guideline for PIG and no direct comparison of two PIG techniques. The proposed pilot study is to compare the two different types of PIG techniques in head and neck cancer patients who require prophylactic enteral feeding by PIG. The purpose of the study is to assess the feasibility of a large randomized clinical trial to compare these two PIG techniques.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years;
2. Life expectancy \> 6 months;
3. Diagnosed with head and neck cancer; and
4. Scheduled to have prophylactic enteral feeding by percutaneous image-guided gastrostomy performed in the interventional radiology suite.

Exclusion Criteria:

1. Pregnancy; or
2. Established pharyngeal obstruction and/or presence of an enteral feeding device.
Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients

This Phase 1 trial will assess the dose-related safety and PK profile of different doses of NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.

The Part I (Phase 1a) assessments of the dose-related safety and PK of NVR 3-778 in volunteers will be conducted an established Phase 1 unit, which will facilitate the overnight confinements and frequent safety assessments and blood sampling required for the Part I evaluations. The Part II (Phase 1b) assessments of the dose-related safety, PK, and initial antiviral efficacy of NVR 3-778 in hepatitis B patients will also be conducted at approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis B patients.

To promote objective safety and tolerance assessments during this trial, study subjects, and site personnel administering the study drug and performing the clinical assessments on the subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or placebo doses), for all treatment cohorts in the study. Study advancement to subsequent volunteer cohorts in Part I and subsequent patient cohorts in Part II will require satisfactory interim reviews of available cumulative safety data by the Part I and Part II Safety Review Committees (SRCs), using the safety criteria and review procedures described in the protocol. Also, there will be two interim reviews of safety data by an independent Safety Monitoring Board (SMB), as described in the protocol.

Eligibility Criteria:
Healthy volunteers may be male or female between 18 and 65 years old with a BMI of 18-32kg/m2. They must be in good health not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study.

Patients enrolling in Part II of the study, may be male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2. Patients must have HBeAg positive, chronic hepatitis B with no history of clinical decompensation, and must not have been treated for hepatitis B before.
Ultrasound-based Intima-Media Thickness Measurements

Develop a standard technique and demonstrate adequate precision for measurement of intima-media thickness (IMT) for routine clinical use.

IMT is measured using software to analyze ECG-gated US image sequences acquired using a standard protocol. Two sonographers acquire images and measure IMT for 100 vessels. IMT technique standard deviation (SD) is determined by assuming normally distributed measurements, and dividing the SD of the 100 (paired) IMT differences by sqrt(2). This SD will be taken as measures of precision of the IMT technique.

Eligibility Criteria:
Inclusion Criteria:

* Must have an appointment at either the Cardiovascular Health Clinic or scheduled for a carotid ultrasound.

Exclusion Criteria:

* Carotid endarterectomy,carotid stenting, carotid repair, less than 45 degree range of motion in the neck, and/or cannot lie flat on back.
* Participants Enrolled who are found after imaging not to exhibit a \~1cm long common carotid far wall region free of focal plaque in which to measure IMT will not have their data analyzed further.
Radiofrequency Ablation for the Treatment of Gastric Dysplasia

The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.

Gastric cancer is the fourth most common cancer and the second leading cause of cancer related death worldwide. The 10-year survival of patients with this malignancy is 20% due to advanced disease at the time of diagnosis. Screening programs in countries with a high incidence of gastric neoplasia aim to detect early stage cancer, suitable for curative treatment. Well-differentiated dysplastic gastric lesions limited to the mucosa (when non-ulcerated or ulcerated and less than 3 cm) or limited to the superficial submucosa (when less than 3 cm and with no lymphatic or vascular invasion) have a negligible risk of lymph node metastasis and are suitable for endoscopic curative treatment.

Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) have been increasingly used in this setting with promising results. However, even with these advanced techniques, en bloc and R0 resection is not possible in up to 13-15% and 16-26% of the cases, respectively. The presence of dysplasia after endoscopic resection (DAER) in the post-resection scar presents a challenging dilemma due to the technical difficulty, and associated complications, of performing subsequent EMR/ESD in fibrotic tissue. Another issue of concern is the presence of gastric dysplasia not associated with macroscopic lesions (DNAML). In such cases, a targeted endoscopic treatment is difficult and clinical management is not standardized.

Radiofrequency ablation (RFA) has been increasingly advocated for the treatment of dysplastic Barrett's esophagus (BE) and early esophageal squamous cell carcinoma (ESCC), but its use in gastric dysplasia has not yet been tested. The investigators aim to study the role of gastric RFA in the treatment of DNAML and DAER.

Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmation of gastric dysplasia.
2. The lesion is no larger than 5 cm in diameter.
3. Age ≥ 18 years.
4. Subject is able to tolerate endoscopy and sedation.
5. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.

Exclusion Criteria:

1. Prior gastric irradiation or surgery.
2. Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA.
3. Gastric ulcers, fistulae, varices and malignancy.
4. History of alcohol and/or controlled substance dependency.
5. Pregnancy.
HOPE At Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.

The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death.

The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.

The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

This is a prospective, single-arm, multi-national, multicentre, proof-of-concept study to evaluate post-transplant outcomes after the use of direct procurement followed by a period of hypothermic oxygenated perfusion of the donor heart in DCD using the XVIVO Heart Assist Transport system.

The investigation will be conducted at 4 heart transplant centres, one in Belgium and three in The Netherlands.The study will include 20 DCD heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications, patient survival and graft function for a period of 6 months post-transplant.

The study will not include a control group as this is a proof-of-concept study, investigating an alternative method of procurement of DCD hearts by providing additional safety and performance data.

The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.

The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Signed informed consent form
3. Accepted and/or listed for heart transplantation

Exclusion Criteria:

1. Not able to understand the information provided during the informed consent procedure
2. Previous solid organ transplantation
3. Grown-up congenital heart disease
4. Dialysis
5. Incompatible blood group
6. Combined organ transplantation candidates
7. Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
8. Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)
The Core Body Temperature Rhythms: Distinguishing MCS From UWS

In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h .

Living beings have multicomponent biological rhythms. There was a research recorded 24-h virations in electroencephalographic patterns. In normal subjects, the circadian rhythms of core body temperature is close to 24 h. When the interference of environmental and mental elements were eliminated, circadian rhythm shows the endogenous circadian rhythm of body acquiescently (\>24h ), which is also called free-running period.

Measuring the continuous external auditory canal temperature of 4 unresponsive wakefulness syndrome (UWS) and 3 minimally conscious state(MCS) on the fluorescent lamp surrounding every 2 hours for 168 hours starting at 00:00 on the first day to address circadian capabilities.

Researchers expected to see the difference between MCS and UWS.

Eligibility Criteria:
Inclusion Criteria:

* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma or vegetative state
* patients \< 1 months after the acute brain injury
Investigating the Morbidity of Glucocorticoid Use in Patients With Autoimmune Bullous Diseases (AIBDs)

This project utilised the validated glucocorticoid toxicity index (GTI) tool to assess the morbidity of glucocorticoid-use in patients with autoimmune bullous disease. In particular, the study investigated the nature and prevalence of glucocorticoid-induced myopathy.

This study is an multi-centre observational trial. Patients with AIBDs are recruited based on the criteria: an age of eighteen years or above; a new or established diagnosis of autoimmune bullous disease confirmed by clinical assessment, histopathology, immunofluorescence, and enzyme-linked immunoassay (ELISA) or biochip testing; new or current use of oral glucocorticoids for the treatment of autoimmune bullous disease (Group 1, active treatment group), patients with receipt of previous oral glucocorticoid use with no current use (Group 2, steroid-sparing control group) or patients who had ceased glucocorticoids during the study (Group 3, ceased steroid group) ; attendance of at least one baseline visit (V1) and one follow-up visit during the study period; and, the provision of capacitated and informed consent.

Patients are considered for enrolment based on inclusion criteria after attendance at a bullous disease clinic at a participating study site. At the baseline visit (V1), patients are comprehensively interviewed for demographic factors (age, gender), pre-existing medical conditions, and past and current medications. Patients attend regular follow-up visits at three-month intervals, to a maximum follow-up period of 15 months (V6). Treatment plans, including glucocorticoid dose, are determined by accredited medical professionals based on the clinical condition of the patient.

The Glucocorticoid Toxicity Index (GTI) tool (Figure 1) is used to evaluate glucocorticoid toxicity at all visits, including in dermatologic, neuropsychiatric, musculoskeletal, endocrine and metabolic domains.

Myopathy was measured and graded in accordance to the GTI.

Patients were divided into three groups: Group 1 (control) comprised of patients was comprised of who were not exposed to glucocorticoids during the study period, Group 2 comprised of patients whose glucocorticoid dose was ceased during the study period. Patients who continued on glucocorticoid treatment for the duration of the study period formed the third group.

Eligibility Criteria:
Inclusion Criteria:

* An age of eighteen years or above.
* A new or established diagnosis of autoimmune bullous disease confirmed by clinical assessment, histopathology, immunofluorescence, and enzyme-linked immunoassay (ELISA) or biochip testing
* New or current use of oral glucocorticoids for the treatment of autoimmune bullous disease (Group 1, active treatment group), or patients with receipt of previous oral glucocorticoid use with no current use (Group 2, steroid-sparing control group)
* Attendance of at least one baseline visit (V1) and one follow-up visit during the study period; and, the provision of capacitated and informed consent.

Exclusion Criteria:

* Inability to consent.
* Under 18 years of age.
Plantar Pressure and Electroencephalographic Signals During Pedal and Vision-deprived Walking in Stroke Patients.

Complex task training may be more effective than simple task training in promoting functional recovery and brain restructuring in stroke participants. The researchers intend to investigate the real-time changes in plantar pressure and electroencephalographic signals in stroke participants during two complex tasks: pedal walking and visual-deprivation walking. The research hypothesis is that pedal walking and visual-deprivation walking can improve the difference of plantar pressure between the affected and unaffected lower limbs of stroke participants, and cause corresponding electroencephalographic changes.

Stroke participants perform the following tasks after wearing a plantar pressure device and a 32-lead electroencephalographic cap. First, stroke participants walk on the pedal on the lower limbs of the affected side. Then the researchers cover the participants' eyes with an eye mask, the participants perform the task of visual-deprivation walking. Finally, the participants walk on a flat surface. Each walking task lasts for 60 seconds. The participants can rest for 3-5 minutes between tasks.

Eligibility Criteria:
Inclusion Criteria:

* MRI or CT diagnosis of the first stroke onset；
* The onset of the stroke occurred more than 30 days;
* Safely walk 50 meters without assistance.

Exclusion Criteria:

* Cerebellar injury；
* Brain stem injury；
* Visual impairment.
The Change Club Study: Evaluation of Civic Engagement for Built Environment Change and Health Improvement

This is a community randomized controlled trial to evaluate a civic engagement curriculum through which residents will identify barriers and facilitators to healthy eating and physical activity and then implement a project in their communities.

The purpose of this research is to better understand how resident-led activities to change the community environment affect health. The Change Club is a small group of residents who will try to change their community environment relative to food (for example, foods in restaurants or schools) or physical activity opportunities (for example, parks or walking trails) by following a step-wise process facilitated by an extension educator. The purpose of this research is to better understand if and how these activities affect individual behaviors (for example physical activity) and health outcomes (for example BMI) of adults in rural communities.

This study will take place in designated rural communities in Texas and New York. It is planned that about 2,260 people will participate in this study. Some will participate as Change Club members; some will participate as family and friends of Change Club members; and others will participate as community residents.

Eligibility Criteria:
Inclusion Criteria:

We will be recruiting Change Club members (CCM), friend and family members (FFM) of CCM, and community residents (CR).

Common inclusion criteria include:

* Age 18-99
* English-speaking

CCM also must:

* Provide consent electronically
* Be willing to be randomized to either group
* Score "poor" or "intermediate" on at least one of the Simple 7 composite score items (e.g. not meeting Physical Activity Guidelines for Americans)
* Live in one of the designated towns in NY and TX

FFM also must:

* Provide consent electronically
* Be family members or friends identified by a CCM

CR also must:

* Provide consent electronically
* Live in one of the designated towns in NY and TX

Exclusion Criteria:

* Cognitive impairment (if it precludes completion of assessments and/or intervention)
* Inability to communicate due to severe, uncorrectable hearing loss or speech disorder (if it precludes completion of assessments and/or intervention)
* Severe visual impairment (if it precludes completion of assessments and/or intervention)
* Inability to read (as it precludes completion of assessments and/or intervention)
* Already included in another study sample (e.g. CR cannot also be CCM)
Aspiration in Acute Respiratory Failure Survivors 2

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.

Eligibility Criteria:
Inclusion Criteria:

1. Admission to an ICU.
2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.

Exclusion Criteria:

1. Likely persistent contraindications to enteral/oral nutrition administration.
2. Pre-existing history of dysphagia or aspiration.
3. Pre-existing or acute primary central or peripheral neuromuscular disorder.
4. Presence of a chronic tracheostomy (present prior to ICU admission).
5. Pre-existing head and neck cancer or surgery.
6. Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
7. Delirium for more than 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).
8. Extubated for greater than 96 hours.
9. Inability to obtain informed consent from patient or an appropriate surrogate.
10. Age \< 18 years.
Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)

Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Using a stepped-wedge design, the investigators plan to utilize tools from implementation science to improve uptake, acceptability, and sustainability of FH diagnostic programs in primary care settings. If successful, this study will provide tools generalizable to other health care systems to improve FH diagnosis rates.

Familial hypercholesterolemia (FH) is a common genetic disorder (prevalence 1 in 250) that requires lifelong sustained medical care. Evidence-based guidelines for screening and treatment for FH exist. These include universal screening of children ages 9-11, of adolescents ages 18-20, and of adults ages 40 and above; approved diagnostic tools including lipid panels and genetic testing; and recommendations for initiation of lipid lowering medication. FH diagnosis is currently made too late in life, often after a premature heart attack has occurred creating a care gap that results in excess cardiovascular morbidity and mortality. Diagnosing FH in the primary care setting would optimize treatment for individuals with FH and close this care gap. Utilizing tools from implementation science and human centered design, and by considering uptake, acceptability, and sustainability of programs related to FH care should improve earlier diagnosis. Implementation strategies that include insights from patients, clinicians, and healthcare systems are necessary. The long-term goal is to create an effective FH diagnosis program that is practical and sustainable in the real-world setting. The main objective of this project is to determine the uptake of an FH diagnosis program integrated into primary care practices to promote early identification of adult and pediatric patients that is generalizable to other healthcare settings. The research question is, does using a multi-level implementation strategy package, designed to address the specific needs of patients, clinicians, and healthcare systems, improve the diagnosis and activation of care management for individuals with FH. The specific aims are to: 1) to design a clinical trial to assess multi-level implementation strategies for improving FH diagnosis in an integrated health system, 2) compare FH diagnosis rates among primary care clinicians who receive the implementation strategy package versus those who do not, 3) to measure implementation success of an organized FH diagnosis program, and 4) to explore patient-related service and health outcomes related to an FH diagnosis program.

Eligibility Criteria:
Inclusion Criteria:

* Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System

Exclusion Criteria:

* None