cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

* The investigators aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI \> 35 with comorbidities or BMI \> 40) in VETERANS.
* The investigators hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.

This is a bariatric surgery Phase 3 prospective trial.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese VETERANS ONLY (BMI\>35 with comorbidities or BMI \> 40)
* Age \> 18 y/o

Exclusion Criteria:

* Pregnancy
* Severe uncontrolled medical or psychiatric conditions
* Previous bariatric surgery
* Multiple previous abdominal surgeries
Risk Assessment of Long-Haul Truck Drivers

International studies have repeatedly documented a substantial prevalence of sexual risk behaviors and high rates of human immunodeficiency virus (HIV) and other sexually transmitted infections (STI) ranging from 5%-56% amongst long-distance truck drivers ("truckers") living in diverse international settings including India, Bangladesh, South Africa, China, Laos and Thailand. The prevalence of sexual risk factors and STI/HIV in US drivers is unknown. This proposal will provide both qualitative and quantitative data on HIV risk behaviors by interviewing and testing truckers working for established long-distance trucking firms, the sector which accounts for most of the jobs in the trucking and warehousing industry in the United States. The data obtained from this study will be used to inform the development of an HIV prevention intervention for long-haul truck drivers.

The study proposed in this R34 application will address the following specific aims:

Specific Aim 1. To perform focus groups and in-depth interviews with long-haul truck drivers to guide development of both a behavioral risk assessment instrument and an acceptable HIV/STI screening protocol for long-haul truckers.

Specific Aim 2. To perform in-depth interviews with trucking industry executives to determine barriers to routine HIV/STI assessment and screening of their employees.

Specific Aim 3. To perform a pilot phase with a subsample of long-haul truck drivers characterized by the following steps: TTM-based "cognitive interviews" (N=5); pilot testing of the survey and biomedical screening protocol (N=15); and a follow-up focus group (N=8)

Specific Aim 4. To assess a sample of (N=300) truck drivers for general health and sexual risk behaviors using the adapted theory-based survey and to determine the prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis

Eligibility Criteria:
Inclusion Criteria:

1. Long-haul truck driver as defined as a driver, part-time or full-time, who drives a truck across state lines (interstate)
2. English speaking
3. Age 21 or greater
4. Willing to participate
5. Able to provide written informed consent

Exclusion Criteria:

1. Does not fit definition of truck driver in inclusion criteria #1
2. Unwilling to participate
3. Unwilling or unable to provide informed consent
4. Unable to understand or speak English
5. Age \< 21 years
MORbidity PRevalence Estimate In StrokE

Information regarding the likely progress of post-stroke symptoms is vitally important to stroke survivors to allow them to plan for the future and to adjust to life after stroke. Moreover, the prevalence of morbidity secondary to stroke is of central importance to Health Professionals to understand the prognosis of the disease in the patients under their care. Additionally, it will also allow commissioners of care, planners and third sector organisations to adapt to and answer the needs of a post-stroke population.

Currently, the data collected by national audit programmes are concentrated on what can be termed 'process or process of care' data. The utility of these data are in the ability to audit the care received by stroke survivors on stroke units against evidenced standards for care, thus ensuring evidence based practice. Nevertheless, process of care is only one form of measuring stroke unit care and the audit programmes collect some limited functional status data, data relating to risk-factor co-morbidities and treatment received data. Therefore, the scope of this study is to build on the minimum data set currently collected and to collect post-stroke data in domains not currently collected.

The International Consortium for Health Outcomes Measurement (ICHOM) takes important steps to collect data outside of process of care data such as a Patient Reported outcome data in their minimum outcome data set for stroke \[currently under review\].. Nevertheless, the ICHOM doesn't currently advocate the specific collection of data relating to cognitive impairment or emotional problems secondary to stroke. It is in these important aspects that this study will augment the data set currently advocated by ICHOM to collect data in the areas of cognitive impairment and emotional problems secondary to stroke.

Therefore, the aim of this study is to quantify the prevalence of morbidity at six months post-stroke.


Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of stroke either;

  * Cerebral Infarct (ICD I63) \[1\]
  * Intracerebral Haemorrhage (ICD I61) \[1\]
  * Stroke, not specified as haemorrhage or infarction (ICD I64) \[1\]
* 18 years of age or older (≥ 18 years old)
* Received a clinically confirmed diagnosis of stroke within the previous 14 days (Stroke diagnosis ≤ 14 days)

Exclusion Criteria:

* Clinically confirmed diagnosis of any of the following

  * Transient Ischaemic Attack (ICD G45) \[1\]
  * Subarachnoid Haemorrhage (ICD I60) \[1\]
  * Any condition defined under ICD G93 e.g. Anoxic brain damage \[1\]
  * Patients receiving or eligible for Palliative Care.
Ceftaroline Pharmacokinetics in Continuous Renal Replacement Therapy

Dosing of ceftaroline in patients with chronic kidney disease is defined, but there is no data on pharmacokinetics and pharmacodynamics of the drug in patients receiving continuous renal replacement therapy (CRRT). The purpose of this study is to determine pharmacokinetics and pharmacodynamics of ceftaroline in a critically ill patient population receiving CRRT, in order to define a dosing recommendation in this population.

Ceftaroline fosamil is a time-dependent, hydrophilic, bactericidal fifth generation cephalosporin that was FDA approved in 2010 for community acquired pneumonia and skin and skin structure infections. Ceftaroline is FDA approved for both Gram-positive and Gram-negative organisms. Gram-positive organisms covered are Staphylococcus aureus (methicillin resistant and methicillin sensitive strains), Streptococcus agalactiae, Streptococcus pneumonia, and Streptococcus pyogenes. Gram-negative coverage includes Escherichia coli, Haemophilus influenza, Klebsiella pneumonia, and Klebsiella oxytoca. In order for ceftaroline to exhibit effective bacterial killing, it requires that a certain percentage of the dosing interval is spent above the MIC.

Dosing of ceftaroline in patients with chronic kidney disease is defined, but there is no data on pharmacokinetics and pharmacodynamics of the drug in patients receiving continuous renal replacement therapy (CRRT). The purpose of this study is to determine pharmacokinetics and pharmacodynamics of ceftaroline in a critically ill patient population receiving CRRT, in order to define a dosing recommendation in this population. CRRT modes that patients may be receiving in this trial include: continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to an intensive care unit
* Receiving CRRT (CVVH, CVVHDF, CVVHD)
* Receiving ceftaroline

Exclusion Criteria:

* Pregnant patients
* Burn patients
* Patients with toxic epidermal necrolysis or Stevens-Johnson syndrome
* Patients prescribed extended infusion ceftaroline
Urinary Biomarkers Characteristic to Interstitial Cystitis

This is a retrospective study of urine samples stored in the Beaumont BioBank for future research. The urine samples will be drawn from the urine back with patients previously diagnosed with severe interstitial cystitis (IC), mild IC and no IC.

Interstitial Cystitis (IC) also known as Painful Bladder Syndrome (PBS) is a chronic inflammatory disease. It has an unknown etiology, symptoms which present to varying degrees, as well as an uncertain natural history. Diagnosis of IC is based on symptoms after excluding more common and dangerous pathologies.

Extensive research has been done to understand the multifactorial etiology as well as to help diagnose IC. Infectious, autoimmune and anatomic causes have been looked at with few usable results. Inflammatory cells and markers have been more productive. Recently we have shown in the rat model, that chemically induced inflammation, yields temporal increases in measurable cytokines and chemokines in the urine. Moreover, this was done by Multiplex analysis, using a multiple antigen bead assay (Luminex).

Cytokines and chemokines, part of an organisms proteome, allow for looking at the function of a cell or organ at the time of the collection United States: Institutional Review Board. Urine is obtained non-invasively and yields significant information about urinary tract organs. The ability to find a biomarker or pattern of biomarker in the urine, diagnostic to a disease, offers significant advantages over serum or tissue diagnosis.

We hope to identify patterns of inflammatory markers using proteomic analysis using the previously mentioned multiple antigen cassettes (Luminex) as well as identify possible new biomarkers using a Protein Chip SELDI--TOF (surface enhanced laser desorption ionisation-time of flight) mass spectrometer. The detection of patterns or new biomarkers has promise to help with diagnosis, treatment, and ultimately revealing the etiology and course of IC.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have previously been contacted and consented to place a sample within the biobank. We will select five representative patients from the severe IC diagnosis, mild IC diagnosis, and no IC diagnosis, and we will match these patients as best as possible within the limited biobank samples.

Exclusion Criteria:

* None
Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

HELP-A study is a single-center, randomized, controlled trial. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 1 month of follow-up period. This study aims to compare diagnostic yield between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms.

HELP-A study is a single-center, randomized, controlled trial designed to compare diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms. Patients who have symptoms of arrhythmia but are not diagnosed on a 12-lead ECG and require additional tests. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 3 month of follow-up period. Patients will be assigned to continuous patch ECG or intermittent handheld ECG and will be examined for one month. If there is no diagnosis after a month, the patient will be crossed over to another device and examined for another month.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have arrhythmia symptoms but are not diagnosed on a 12-lead electrocardiogram and require additional tests.
* Patients who can use a smartphone

Exclusion Criteria:

* Patients who have cardiac implantable electronic devices(CIEDs)
* Patients who can't use handheld ECG
[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer

This clinical trial studies how well 18F-fluoromisonidazole (\[18F\]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. \[18F\]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by \[18F\]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible

PRIMARY OBJECTIVES:

I. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors.

SECONDARY OBJECTIVES:

I. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT.

II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor.

III. Determine any toxicities related to \[18F\]FMISO use for PET/CT.

OUTLINE:

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole intravenously (IV) and undergo PET/CT scans within 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

After completion of treatment, patients are followed up at 2 and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor \>= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LIRADS) 4 or greater
* Total bilirubin \< 3.0
* Child Pugh A or B
* Tumor amenable to transcatheter arterial embolization
* Able to provide informed consent

Exclusion Criteria:

* Uncontrolled large ascites
* Main or segmental portal vein thrombosis
* Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
* Inability or contraindication to undergo transcatheter arterial embolization
* Inability to lay flat for at least 2 consecutive hours
* Severe acute illness
* Uncontrolled chronic illness such as hypertension, diabetes, or heart failure
* Contraindication to CT or MRI contrast
* Pregnancy
Reducing Youthful Dangerous Driving

To examine the effectiveness of four motivational counseling groups and a directed observational experience in the emergency room in comparison to education and community volunteering only, in reducing high risk driving behaviors


Eligibility Criteria:
Inclusion Criteria:

* Age 16-20 years
* Court referred for driving offense
* Speak English

Exclusion Criteria:

* Age over 20 years
* Not court referred
* Not English speaking
The Effect of Group-Based Laughter Yoga on Midwifery Students

This study was planned to determine the effect of laughter yoga on the secondary traumatic stress and depression levels experienced by midwifery students due to the use of social media after the earthquake. The universe of the research will be the third year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department (N:84).

A total of 8 sessions of laughter yoga, 2 sessions per week, will be applied to midwifery students in the intervention group of the research. It will be determined as intervention (n:42) and control (n:42) groups. "Descriptive Information Form", "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be applied to both groups.

It was planned to determine the effect of laughter yoga on the secondary traumatic stress and depression levels experienced by midwifery students due to the use of social media after the earthquake. The study will be implemented according to the CONSORT 2010 guidelines.

The research will be carried out in Health Sciences University, Hamidiye Faculty of Health Sciences, Midwifery department classroom. In pre-research classrooms; An environment with good lighting, sound systems and allowing individuals to move comfortably will be arranged. Hamidiye Faculty of Health Sciences Midwifery Department 3rd year students who volunteered to participate in the study will be determined as the intervention (n:42) and control (n:42) groups with the numbers assigned by the researchers via the https://www.randomizer.org/ site. An introductory information form will be applied to all students. A total of 8 sessions of laughter yoga, 2 sessions per week, will be applied to midwifery students in the intervention group of the research. Laughter yoga will be practiced by researchers with leadership certification. Each session will take an average of 45 minutes. Each session will consist of groups of 7 people. Before starting the laughter yoga session, an information meeting will be held with midwifery students who volunteered to participate in the study and were assigned to the intervention group. Midwifery students will be administered "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" before and 4-6 weeks after the application. No intervention will be applied to the control group midwives, and "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be administered again when they are included in the study and 4-6 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Being an active student in the 3rd year of Health Sciences University, Hamidiye Faculty of Health Sciences, Department of Midwifery
* Volunteering to participate in research

Exclusion Criteria:

* Having a psychiatric diagnosis
TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age

Exclusion Criteria:

* Participation in another clinical study which would confound results
* Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
* Simultaneous bilateral Total Knee Arthroplasty cases
Coronary Interventions Ulm - Coronary Chronic Total Occlusions

The aim of the proposed project is to provide the long-term results after a recanalization attempt of chronically occluded coronary arteries.

To investigate recanalization attempt of chronically occluded coronary arteries at the Ulm University Hospital. As shown, it is known that successful recanalization of a chronic occlusion is associated with a lower event rate (reduced mortality and the need for operative myocardial revascularization) compared to unsuccessful recanalization (drug therapy). The standard in the therapy of successfully recanalized chronic occlusions is the use of drug-releasing vascular supports.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years

Coronary intervention in chronic coronary artery occlusion

Occlusion \> 3 months

Indication for PTCA or recanalization according to guidlines

such as:

Symptoms of the patient

Evidence of myocardial ischemia (stress ECG, scintigraphic

Methods, magnetic resonance imaging, stress echocardiography)

pathological intracoronary flow reserve, prognostic

Exclusion Criteria:

* No chronic occlusion,
* Contraindication to anti-platelet therapy

Acetylsalicylic acid plus clopidogrel for at least 3 months such as e.g.

with florid gastrointestinal ulcer disease,

History of hemorrhagic stroke

or urgent non-postponable surgical intervention.

Basic disease with a life expectancy of less than 12 months (here as a rule

no indication for PTCA or reopening available)
Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)

This study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and macroalbuminuria.

The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and losartan in subjects with type II diabetes (T2DM) with macroalbuminuria. Should the investigators study confirm the hypothesis that the proposed novel regimen is superior to the current practice of renin-angiotensin-aldosterone system blockade, the study would significantly advance the care of subjects with type II diabetes and kidney disease in Qatar and worldwide. In this regard it is worth noting that the prevalence of end stage renal disease in Qatar is 202 subjects per million population. This would translate into fewer subjects requiring dialysis or transplantation, an enormous benefit to individuals and society.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin
2. Macroalbuminuria as defined as the presence of a UACR greater than 300 mg/gm creatinine (30 mg/mmol creatinine) on two occasions in the last six months
3. Estimated eGFR of 30 to 90 mL/min/1.73 m2

Exclusion Criteria:

1. Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)
2. Serum Calcium \> 2.45 mmol/L (9.8 mg/dL)
3. Serum Phosphorus \> 1.78 mmol/L (5.5 mg/dL)
4. Serum Potassium \> 5.5 mmol/L (5 mEq/L)
5. Parathyroid hormone \< 20 pg/mL or \> 500 pg/mL
6. Hemoglobin A1C \> 12%
7. 25-OH Vit D \> 50 ng/mL
8. Poorly controlled hypertension defined as systolic blood pressure \>= 180 mm Hg or diastolic blood pressure \>= 110 mm Hg
9. History of kidney stones
10. History of severe disease like chronic liver disease
11. Active malignancy
12. Active granulomatous diseases like turburculosis and sarcoidosis
13. Recent diagnosis of acute renal failure within 3 months of screening visit
14. Likelihood of renal replacement therapy within 1 year
15. History of parathyroidectomy
16. Currently taking calcitriol or 1,25-dihydroxyvitamin D analog
17. Currently taking calcitonin, bisphosphonates, cinacalcet, teriparatide, glucocorticoids or other drugs that may affect calcium or bone metabolism (subjects may be taking calcium containing phosphate binder or other phosphate binder. Subjects may also be taking stable dose of estrogen/progestin)
18. History of osteoporosis or other bone disorder requiring calcitriol therapy
19. History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs
20. History of allergic reaction to losartan or any other angiotensin receptor blocker therapy
21. Evidence of drug or alcohol abuse