cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis

The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare these results to non-amyloid diseased controls.

Patients with pathologically proven amyloidosis involving the peripheral nervous system will undergo 18-F Florbetapir PET/MR on a GE (General Electric Healthcare) SIGNA PET/MR scanner. A control arm comprised of patients with pathologically-confirmed non-amyloid causes of peripheral neuropathy will also undergo 18-F Florbetapir PET/MR scanning. all images will be reviewed for peripheral nerve uptake.

Eligibility Criteria:
Inclusion Criteria:

* Adults: 18-100
* Pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed non-amyloid causes of peripheral neuropathy

Exclusion Criteria:

* Metallic devices that are not MR safe (cardiac pacers, stents, aneurysm coils, etc.)
* Claustrophobia
* BMI over 38
Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project

The purpose of this research study is to test the utility of an ankle robot, when used during treadmill walking, in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.

Many individuals with central nervous system (CNS) injuries (e.g., a stroke) or peripheral nervous system (PNS) injuries (e.g., peroneal nerve injury, neuropathy, radiculopathy, and/or musculoskeletal injury) that affect their ankle movement have residual impairments that affect their walking and balance. These impairments include the disability "foot drop," which increases the risk for falling.

This study will focus on PNS injuries that cause foot drop.

Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses (braces) that help keep the foot from hitting the ground to prevent falling. Also, some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot. Regardless, none of these, or other existing, methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability. Braces improve walking safety only while they are worn, and functional electrical stimulation does not work when it is turned off, or when the nerve has been severely damaged. Thus, the increased fall risk due to foot drop is generally considered life-long and incurable.

The investigators have developed a shoe-interfaced ankle robot with an adaptive control system, to assist an individual with ankle movement only as needed. Data from the investigators' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop, when used during treadmill walking. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 to 88 years
2. Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
3. Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device\[s\] is permitted)

Exclusion Criteria:

1. Cardiac history of (a) unstable angina; (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); and/or (c) hemodynamically significant valvular dysfunction
2. Hypertension that is a contraindication for a bout of walking training (greater than 160/100 mmHg on two assessments)
3. Medical history of (a) recent hospitalization (less than 3 months) for severe medical disease; (b) symptomatic peripheral arterial occlusive disease; (c) orthopedic or chronic pain conditions that significantly alter gait function; (d) pulmonary or renal failure; and/or (e) active cancer
4. Current participation in orthopedic or rehabilitation medical programs
5. Active deep venous thrombosis
6. Distal paretic leg skin lesions, infections, or soft tissue inflammation
Head Stabilization in Whole Brain RT

This is a single-center, single-arm observational study in which the investigators aim to develop an advanced motion control system for head stabilization in patients undergoing whole brain radiation therapy.

Standard of care treatment is to be immobilized with a mask for whole brain radiation therapy. The purpose of this study is to develop a process to track and correct a person's head movements in real time during radiation treatment. To do this, the investigators will use a mask and head holder connected to a robotic support platform which can make small movements of the head holder.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and older undergoing whole brain radiation therapy
* Participants must sign the informed consent form

Exclusion Criteria:

All patients not meeting the above inclusion criteria will not be considered for this study.
Pharmacogenomics of GLP1 Receptor Agonists

Healthy volunteers were recruited from the Old Order Amish population in Lancaster County, Pennsylvania. After providing informed consent, research participants were screened for eligibility. The clinical trial was designed as a randomized crossover study in which participants underwent two frequently sampled intravenous glucose tolerance tests - one after receiving a subcutaneous injection of saline and one after receiving a subcutaneous injection of rapid-acting exenatide (BYETTA). The study sought to determine whether genetic variants are associated with the magnitude of the effect of exenatide. If an association were identified, this would help physicians to predict whether an individual patient is likely to have a large response to the class of diabetes drugs to which exenatide belongs (GLP1 receptor agonists).

Healthy volunteers were recruited from the Old Order Amish population in Lancaster County, Pennsylvania. After providing informed consent, research participants were screened for eligibility. The clinical trial was designed as a randomized crossover study in which participants underwent two frequently sampled intravenous glucose tolerance tests (FSIGT) - one after receiving a subcutaneous injection of saline and one after receiving a subcutaneous injection of rapid-acting exenatide (BYETTA). Based on data obtained from the FSIGT, participants' response to exenatide was assessed -- specifically, the effect of exenatide to enhance insulin secretion and accelerate metabolism of glucose. The study sought to determine whether genetic variants are associated with the magnitude of the effect of exenatide. If an association were identified, this would help physicians to predict whether an individual patient is likely to have a large response to the class of diabetes drugs to which exenatide belongs (GLP1 receptor agonists).

Eligibility Criteria:
Inclusion Criteria:

* Member of the Old Order Amish community in Lancaster County, Pennsylvania
* BMI: 18-40 kg/sq.m.

Exclusion Criteria:

* Known allergy to exenatide
* History of diabetes, random glucose \>200 mg/dL, or HbA1c \> 6.5%
* Significant debilitating chronic cardiac, hepatic, pulmonary, or renal disease or other diseases that the investigator judges will make interpretation of the results difficult or increase the risk of participation
* Seizure disorder
* Pregnant by self-report or known pregnancy within 3 months of the start of study
* Currently breast feeding or breast feeding within 3 months of the start of the study
* Estimated glomerular filtration rate \<60 mL/min/1.73m2
* Hematocrit \<35%
* Liver function tests greater than 2 times the upper limit of normal
* Abnormal TSH
* History of pancreatitis or pancreatic cancer. Personal or family history of medullary carcinoma of the thyroid.
Family Involvement in ICU

The aim of this prospective cohort study was to investigate the effect of the time spent with relatives of patients treated in a tertiary intensive care unit on patient outcomes.

The main question it aimed to answer was:

Does spending more time with relatives of patients in intensive care result in lower sedative agent requirements? Does spending more time with relatives of patients in intensive care result in less delirium, fewer ventilator days, and shorter ICU stays?


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over.
* Patients with at least one family member actively involved in the care process in the ICU.

Exclusion Criteria:

* Patients with pre-existing cognitive impairment or dementia.
* Patients with severe traumatic brain injury.
* Patients with an expected mortality in the ICU of more than 80%.
* Absence of family members for patients admitted to the ICU.
Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients

To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.

Osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age and geriatric population, which poses a huge burden to our in-patient and out-patient orthopaedic services. Conservative treatment like physiotherapy and analgesic provide temporary symptomatic relief. Surgical treatment like high tibial osteotomy and knee arthroplasty are not without major potential surgical risks and implant-related complications.

Orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the symptoms and disease progression. Small scale biomechanical studies have demonstrated such effects with the use of valgus knee brace (2-4). Though prospective clinical outcome studies on Chinese patients in our locality are lacking.

Valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain. Using a three-point leverage the unloader brace is to shift the stress away from the arthritic area to the normal portion of the knee, maintains good alignment and stability and thus provides significant pain relief during daily activities. It has been commonly used as a first line management option in other countries.

Our aim is to perform a prospective randomized study to look at the difference in outcome measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual regime of conservative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40-80
* History of symptomatic medial unicompartmental knee osteoarthritis \> 6 months
* Willingness to wear the knee brace for a minimum of 4 hours per day during daily activities
* Understanding of the Chinese language
* Ethnic Chinese patients

Exclusion Criteria:

* Symptomatic knee osteoarthritis affecting more than one compartment
* Clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint
* Significant knee effusion or soft tissue compromise preventing long-term knee brace use
* Obesity (BMI\>30)
* Previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy
* Peripheral vascular disease of the lower limb
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.

Primary Endpoints:

* Safety: Death or stroke in downstream territory to 180-days post-procedure
* Technical Success: Device placement success and ability to retain coils at the time of the index procedure
* Rate of aneurysm occlusion at Day zero (0) and 180 days

Additional Evaluations to 180-days and at 365-day follow up:

* Rate of aneurysm occlusion at 365 days
* Device movement or migration
* Stenosis
* Rate of incidence of new neurological deficits
* Complication rate (neurological and non-neurological)

Eligibility Criteria:
Inclusion Criteria:

* Patient who presents with an angiographically confirmed, wide neck intracranial aneurysms located at a bifurcation of the basilar artery or carotid terminus artery
* The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5 mm.
* The patient is 18 years or older at the time of consent
* The patient has signed the IRB/EC approved informed consent form
* In the opinion of the physician, placement of the PulseRider is technically feasible and clinically indicated
* Subject has mental capacity and is willing and able to comply with protocol requirements and follow-up

Exclusion Criteria:

* Unstable neurological deficit (condition worsening within the last 90 days)
* Subarachnoid Hemorrhage (SAH) within the last 60 days
* Irreversible bleeding disorder
* mRS score ≥3
* Patient has another aneurysm which, in the Investigator's opinion, will require treatment within the follow up period (365 days)
* Platelet count \< 100 x 103 cells/mm3
* Inability to tolerate, adverse reaction or contraindication to taking aspirin or clopidogrel
* A history of contrast allergy that cannot be medically controlled
* Known allergy to nickel
* Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)
* Woman with child-bearing potential who cannot provide a negative pregnancy test
* Evidence of active infection
* Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events
* Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 365-day follow-up period
* Extracranial stenosis greater than 50% in the parent artery requiring access to the lesion
* Intracranial stenosis greater than 50% in the treated vessel
* Extreme vessel tortuosity that prohibits appropriate control of the micro-guide wire and/or the PulseRider delivery wire
HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

The combination of vinorelbine with weekly trastuzumab has produced high response rate in HER2 overexpressing metastatic breast cancer (MBC). The present phase 2 study was planned to test activity of the same combination, with trastuzumab given every 3 weeks, rather than weekly.

The schedule of treatment includes vinorelbine (30 mg/m2 on days 1 \& 8 every 21 days) and trastuzumab (8 mg/kg on day 1 and then 6 mg/kg every 21 days). Vinorelbine is planned for maximum 9 cycles, while trastuzumab can be continued until progression. This study is a single-stage phase 2 design, and patients eligible for response evaluation are required.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer
* Stage IV
* No prior or not more than one prior chemotherapy for metastatic disease
* Overexpression of HER-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbB2/neu (positive by Fish method)
* Performance status 0-2 (ECOG)

Exclusion Criteria:

* Absence of measurable disease
* Life expectancy \< 3 months
* Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
* Previous treatment with trastuzumab or vinorelbine
* Neutrophils \< 1500/mm3 or platelets \< 100000/mm3 or haemoglobin \< 8 g/dl
* Creatinine \> 1.5 x the value of the upper normal limit
* GOT and/or GPT \> 2.5 x the value of the upper normal limit and/or bilirubin \> 1.5 x the value of the upper normal limit in the absence of liver metastases
* GOT and/or GPT \> 5 x the value of the upper normal limit and/or bilirubin \> 3 x the value of the upper normal limit in the presence of liver metastases
* Left ventricular ejection fraction \< 50% (measured by ultrasound or MUGA angiography)
* Concomitant conditions that contraindicate the use of the drugs in the protocol
* Male gender
* Pregnancy or lactation·
* Incapacity or refusal to provide informed consent
* Inability to comply with followup
Neuroinflammation After Myocardial Infarction - Imaging Substudy

The purpose of the study is to see if positron emission tomography and magnetic resonance imaging (PET/MRI) with an investigational drug called \[18F\]DPA-714 will show inflammation in the brain after a heart attack. This study may help physicians and researchers better understand the role of brain inflammation in heart disease and develop new treatments to protect the brain.

The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in individuals with recent AMI. The basic premise is that AMI leads to systemic inflammation that includes inflammation in the brain. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The estimates of brain TSPO binding in patients with recent AMI will be compared to a matched group of patients who have undergone a recent elective PCI procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in UAB IRB protocol "Neuroinflammation After Acute Myocardial Infarction" (IRB-300002751, PI Lazar).
2. 21 years of age or older
3. . English speaking with at least 8th grade education
4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
5. Admission to UAB Hospital for ST-elevation acute myocardial infarction (AMI) and treatment with percutaneous coronary intervention (PCI) OR Undergoing elective percutaneous coronary intervention (PCI)

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Serious medical co-morbidity that may interfere with participation
5. Prior myocardial infarction
6. Severe anemia
7. Prior coronary artery bypass grafting
8. Prior angioplasty and/or coronary artery stent placement (PCI group only)
9. History of traumatic head injury defined by a loss of consciousness ≥30 minutes or seizure at the time of injury
10. Diagnosis of major depression
11. Diagnosis of dementia
12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.


Eligibility Criteria:
Inclusion Criteria:

1. Having signed informed consent
2. Age≥ 18 years old
3. Histologically confirmed gastric adenocarcinoma
4. Unresectable recurrent or metastatic disease
5. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
6. Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
7. Measurable disease according to the RECIST criteria
8. ECOG performance status ≤2
9. Life expectancy of ≥3 month
10. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
11. ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>90,000/mm3, Hb\>8g/dl

Exclusion Criteria:

1. Brain metastasis (known or suspected)
2. Previous systemic therapy for metastatic gastric cancer
3. Inability to take oral medication
4. Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
5. Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
6. Allergic constitution or allergic history to any investigating agents.
7. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
8. Pregnancy or lactation period
9. Any investigational agent within the past 28 days
10. Other previous malignancy within 5 year
11. Pre-existing neuropathy\>grade 1
12. Legal incapacity
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study

The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to a participating center
* Appendectomy performed for acute appendicitis
* Intraoperative diagnosis of perforated appendicitis

Exclusion Criteria:

* Simple or gangrenous appendicitis
* Interval or incidental appendectomy
* Initial attempt at non-operative management (defined as \>48 hours between the time of diagnosis and surgical intervention)
* History of iodine allergy, thyroid disease or renal dysfunction
* Pregnancy
Does Perineural Dexamethasone Prolong Duration of a Nerve Block?

The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.

The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class 1
* Body Mass Index 18-30

Exclusion Criteria:

* Allergy to study medication
* Earlier trauma or surgery to lower limb
* Diabetes Mellitus
* Alcohol or drug abuse
* Daily intake of opioids or steroids last 4 weeks
* Daily intake of any analgesics last 48 hours