cyrilzakka/clinical-trials huggingface dataset:
Spinal Cord Compression. ICORG 05-03, V6

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression.

PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.

OBJECTIVES:

Primary

* To compare the response in patients with malignant spinal cord compression treated with single fraction (10 Gy) radiotherapy vs standard multiple fraction (20 Gy) radiotherapy.
* To compare the toxicity of these treatment regimens in these patients.

Secondary

* Examine the safety, practicability, and efficacy of treatment with a single 10 Gy fraction of radiotherapy in these patients.
* Analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients.
* Perform an economic impact analysis comparing the two treatment arms.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I (control): Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
* Arm II: Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).

Patients complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter.

After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignancy, excluding the following:

  * Leukemia
  * Myeloma
  * Germ cell tumor
  * Primary tumor of the spine or vertebral column
* Diagnosis of malignant spinal cord compression confirmed by MRI of the entire spine
* Deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment
* No single bone metastasis with controlled primary site

PATIENT CHARACTERISTICS:

* Karnofsky performance status 30-100%
* No medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance
Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure

This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.

Standard intraprocedural guidance for transcatheter left atrial appendage closure (LAAC) employs a multi-modality integrated approach combining fluoroscopy for guiding the delivery system, and transesophageal echocardiography (TEE) for intracardiac characterization to guide device selection and monitor procedural complications. Successful implantation of the device is confirmed with contrast-enhanced fluoroscopy and color doppler flow imaging on TEE. TEE is the current gold standard for procedural guidance but requires general anesthesia (GA) to avoid patient motion and discomfort during the procedure. General anesthesia, however, is associated with pulmonary complications and patient discomfort due to endotracheal intubation. Intraprocedural LAAC guidance under local anesthesia or conscious sedation might help mitigate these GA-related disadvantages and has motivated multiple clinical studies, establishing intracardiac echocardiography (ICE) as a safe and feasible alternative to TEE.

The new generation of NuVision ICE catheter offers a larger imaging volume of 90° x 90° with multiplanar reformatted (MPR) echo views for better visualization of anatomical landmarks and procedural guidance and aid in sizing of the device. This has a potential to improve outcomes and reduce procedure times while lowering healthcare costs.

In this study, Role of NuVision Intracardiac Echocardiographic (ICE) catheter with Tranesopheal echocardiography (TEE) in predicting intra-procedural outcomes and success of implantation in patients undergoing left atrial appendage occlusion will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male/Females
* Age:18-80 years
* History of Atrial Fibrillation/Atrial flutter
* Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device

Exclusion Criteria:

* Inability or unwillingness of an individual to give written informed consent
* Patient not following with our practice after the procedure
* Complex anatomy for endocardial LAAC
* Thrombus in LAA
* Patients with pericardial effusion in pre-op TEE/CCTA
* Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)
Consortium of Early Arthritis Cohorts USA

Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease. Fortunately in the last few years, a shift in strategy toward the earlier institution of disease modifying drugs and the availability of new classes of medications have greatly improved the outcomes that can be expected by most patients.

The goal of treatment now aims toward achieving the lowest possible level of arthritis disease activity and even remission, if possible as early on as possible. Research has shown that this translates into minimized joint damage and enhanced physical function and quality of life for the RA patient. This also requires that a diagnosis of RA be made as early on as possible, and herein lies the challenge, i.e. identifying the RA patient early on in the course of their disease.

This is a study of usual care, a prospective cohort of all eligible and consenting patients referred to the Inflammatory Arthritis Center of Excellence and the Division of Rheumatology, Department of Medicine at HSS as well as 3 consortium sites across the U.S.

In order to study the effectiveness of recommended treatments in usual practice in different patients for short-term and long-term outcomes, and to determine factors that may predict how a patient's disease might progress over time, investigators will need to analyze and describe the strategies used to manage these patients and will need to understand:

i. The frequency of single time-point and sustained (two or more time points) remission or low disease activity over time ii. Factors that influence remission iii. Which patients can achieve persistent sustained remission, and iv. Who can undergo drug withdrawal and still sustain remission of low disease activity v. Factors associated with treatment optimization or barriers to achieving this

Eligibility Criteria:
Inclusion Criteria:

* Patient was 18 years of age or over at time of referral
* Joint symptoms for \< 12 months
* 2+ swollen joints OR 1 swollen joint with one of the following: Rheumatoid Factor \> 20 IU, (+) anti-CCP antibody, morning stiffness \> 45 minutes, responded to NSAIDs, (+) MTP squeeze test
Postoperative INTELLiVENT-ASV Ventilation

The aim of this study is to investigate whether postoperative ventilation with INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation.

Recently, Hamilton Medical has introduced the new mechanical ventilation mode "INTELLiVENT-ASV". This is a fully closed ventilation mode that can automatically adjust the ventilation settings based on the measured End tidal CO2 (ETCO2) and the measured saturation (SpO2) in both passive and active ventilated patients. Current literature has shown that this mode is safe to use in patients admitted on the intensive care unit. A pilot study in the Catharina Hospital Eindhoven confirmed that in postoperative low risk patients on the intensive care unit INTELLiVENT-ASV is safe. Compared to continuous mandatory or pressure controlled ventilation with pressure support (conventional mechanical ventilation), INTELLiVENT-ASV is even as effective as conventional mechanical ventilation, with a significantly reduced number of interactions with the ventilator. However, available research about the effectiveness of INTELLiVENT-ASV in postoperative high risk patients is lacking. Also the knowledge about the user-friendliness of the above modes of mechanical ventilation for the users is lacking.

This is a prospective randomized study with a control group and a intervention group of postoperative high risk patients. Through randomization will be determined whether the participant, after surgery, will be mechanically ventilated with INTELLiVENT-ASV and Quickwean or with conventional mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years of age.
* Informed consent.
* Body mass index of \<35 kg/m2.
* Mechanical ventilation after elective cardiothoracic surgery.
* Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.

Exclusion Criteria:

* Withdrawal of consent
* Medical history of a pneumonectomy or lobectomy.
* The patient wit acute respiratory distress syndrome after surgery.
* The patient with a medical history of COPD Gold 3 or 4.
* The patient is participating in another postoperative study performed on the intensive care.
* The patient is, preoperatively determined, eligible for a fast-track postoperative treatment program on the Post Anesthesia Care Unit.
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

IRIS-CKD Management Program: will compare prescriptions for guideline-directed medical therapies (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* (CKD Management)

  * Adults with type 2 diabetes (T2D)
  * Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)
  * Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):

    * UACR \>300 mg/g or
    * eGFR \<45 ml/min/1.73 m2 or
    * UACR ≥30 mg/g with eGFR \<60 ml/min/1.73 m2
  * Receiving \<100% GDMT at baseline. For patients with UACR \<30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).

Exclusion Criteria:

* (CKD Management)

  * Type 1 diabetes
  * Most recent eGFR \<20 ml/min/1.73 m2
  * Prior kidney transplant
  * Autosomal dominant polycystic kidney disease (ADPKD)
  * Active pregnancy or plans for conception within 1 year
FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment

For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.

The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a larger study based on the results of our successful pilot study using the same protocol. The 48 week, phase IV trial addresses the issues of the high cost of HIV treatment, adherence problems associated with daily treatment, and cumulative toxicities. Virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will be measured. Subjects will have to be seen at CRI for 6 visits after randomization. Subjects randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load remains undetectable.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* CD4 count \> or = 200
* Viral load \< 50
* Treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening

Exclusion Criteria:

* Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening
* Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues
* Hepatitis B infection
Buccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone in Esthetic Zone

To achieve esthetic immediate implants a minimum of adequate buccal bone thickness must be present. It was postulated that 2 mm of buccal bone thickness was needed to prevent recession of the buccal plate. However, this was reduced to 1 mm with more ongoing research. In a recent study postulated that a buccal bone thickness less than 1 mm could be sufficient.

Scarce literature was found that monitored the ridge alterations following implant placement.

In regards to the controversies regarding the minimal initial buccal bone thickness required to perform immediate implant placement, our study aims to monitor the buccal bone thickness and soft tissue changes over a year from implant and prosthetic placement.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have at least one unrestorable tooth in the esthetic zone that needs to be extracted.
* Subjects with healthy systemic condition.
* Availability of bone apical and palatal to the socket to provide primary stability.

Exclusion Criteria:

* Patients with signs of acute infection related to the area of interest.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.
* Smokers
Early Exposure to Lead and Adult Antisocial Outcomes

Prior research indicates a link between early lead exposure and risk for delinquent behavior. In this study, we follow a large birth cohort from the Cincinnati Lead Study into early adulthood to determine whether this increased risk persists. Outcome measures include official arrest records, diagnoses of Substance Abuse Disorder and Antisocial Personality Disorder, self-report of delinquent behavior, and a psychopathy scale. Predictors include pre-natal and post-natal blood lead levels. Multivariate statistical methods will control for potential confounders/covariates.


Eligibility Criteria:
Inclusion Criteria: (1) Part of original CLS birth cohort -

Exclusion Criteria: (1) Moved out of geographic area

-
V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds

This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.


Eligibility Criteria:
Inclusion Criteria:

* The patient is of 18 years or older.
* Males and females - provided they are not pregnant and if of reproductive age are using contraception.
* Patient with ulcers that:

  1. Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing
  2. Have been present for at least 4 weeks
  3. Are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu
  4. Are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone.
  5. The patient has an ABI of greater or equal to 0.8 and lower than 1.3 or has a suitable Peripheral Vascular Resistance (PVR) and Doppler assessment which confirms venous disease \& therefore treatment with Profore is deemed acceptable by the clinician.
  6. The patient has one or more clinical signs of infection (edema, malodor, local/periwound erythema, spontaneous pain between dressing changes, increased exudate, discoloration of granulation tissue, increased temperature at wound, non progression of wound, purulent exudate and friable granulation tissue)
  7. The patient is able to understand the evaluation and is willing to consent to the evaluation.
  8. Patients with a suitable wound on a different limb to any other wounds previously eligible.

Exclusion Criteria:

1. Patients undergoing chemotherapy
2. Patients being treated with immunosuppressive drugs or corticosteroids
3. Patients with an autoimmune disease
4. Patients who have participated in an experimental drug or device study within the last 15 days
5. Patients that have been entered in this evaluation previously as an evaluable patient.
MR Based Prediction of Molecular Pathology in Glioma Using Artificial Intelligence

This registry aims to collect clinical, molecular and radiologic data including detailed clinical parameters, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and conventional/advanced/new MR sequences (T1, T1c, T2, FLAIR, ADC, DTI, PWI, etc) of patients with primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine algorithms that able to predict molecular pathology or subgroups of gliomas.

Non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations is challenging. With the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced MR imaging (T1 weighted imaging, T2 weighted imaging, FLAIR, contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, and perfusion imaging) could be excavated to aid prediction of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed molecular pathology, radiological data and with sufficient sample size for deep learning (\>1000) provide considerable opportunities for personalized prediction of molecular pathology with non-invasiveness and precision.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic devices
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfunctions
Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients

The aim of the study is to evaluate whether distal gastrectomy without post-operative nasogastric decompression tube is better in terms of quality of life.

Nasogastric decompression tube is an intra-operative routine in most of the time to facilitate exposure of operative field during elective distal gastrectomy, however, whether it should be retained post-operatively is controversial. Nasogastric decompression tube helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. However, nasogastric intubation could cause patients discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with pulmonary complication.

Eligibility Criteria:
Inclusion Criteria:

* on the basis of whether distal gastrectomy was anticipated at WMUH for gastric cancer.

Exclusion Criteria:

* patients who were diagnosed inadequacy for this study by a physician.
* patients without an informed consent.
Preventing Pain After Heart Surgery

The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* First time sternotomy for all cardiac surgery
* Patient aged 18 - 80 years

Exclusion Criteria:

* Emergency surgery (decision to operate taken on the day of surgery)
* Previous sternotomy
* Preoperative renal failure (eGFR \<60 ml/min)
* History of chronic non-anginal pain
* Chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs
* Concurrent use of oxycodone, lorazepam, or ethanol.
* Concurrent use of any drugs for neuropathic pain e.g. antiepileptics, antidepressants
* Allergy to pregabalin, gabapentin or ketamine
* Pregnancy
* Limited understanding of numerical scoring scales
* Previous participation in other trials investigating analgesic agents or any IMP in previous three months
Mitigating the Pro-inflammatory Phenotype of Obesity

The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6).

Our study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo.

1. Using a randomized, double-blinded, parallel-design approach, we hypothesize that 4 weeks of SNA blockade (oral clonidine) will cause a significant reduction in expression of inflammatory markers in blood, endothelial cells, and central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment.
2. Determine the extent to which inflammation in the body is caused by elevated sympathetic nerve activity

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, age 18-79
* Obese: BMI \> 30 m/kg2
* Hypertensive: blood pressure \>130/80
* Elevated insulin resistance (HOMA-IR \> 2.5)
* Waist circ: \>102 cm (men) and \>88 cm (women)
* Fasting glucose \< 126 mg/dL
* Fasting triglycerides \< 250 mg/dL
* HbA1c \< 6.5%
* Willing to visit research lab (Fairway CTSU)
* Willing to undergo a blood draw
* Able to provide written informed consent

Exclusion Criteria:

* Current use of clonidine or beta-blockers
* Current smoker or History of smoking in the past 3 months.
* Hyperlipidemia: Fasting triglycerides \> 250 mg/dL
* Currently taking hypertension medication
* History of heart disease (e.g., myocardial infarction, stent, byass, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)
* History of neurological disorders
* History of transplant
* Actively participating in other studies, except for a registry study.