Treatment Trials

18 Clinical Trials for Various Conditions

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TERMINATED
Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability
Description

Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate infections, including prostate infections. It has been suggested that antibiotic treatment influences PSA levels due to the fact that an increase in PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to treat such inflammatory conditions. However, it has not been proven that antibiotics can be used to lower PSA. This research is being done to see if treatment with the antibiotic Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This study may also help doctors in deciding which patients need a prostate biopsy.

COMPLETED
BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
Description

The primary purpose of this clinical trial is to compare in a double-blind randomized trial, the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a multiple-dose regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate (TRNBP).

COMPLETED
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
Description

Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.

Conditions
RECRUITING
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Description

Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.

Conditions
RECRUITING
Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications
Description

This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy. Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach. This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.

COMPLETED
3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization
Description

The purpose of this research study is to learn about how cone-beam Computerized Tomography scans (X-ray images taken from different angles) work together with an embolization guidance software (helps the doctor see the arteries that feed the prostate)to find and see arteries in the prostate.

COMPLETED
At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions
Description

We are the missing link in clinical trials, connecting patients and researchers seamlessly and conveniently using a mobile health platform to advance medical research. We make it easy for patients to contribute to research for medical conditions that matter most to them, regardless of their location or ability to travel.

COMPLETED
Antibiotic Prophylaxis for Transrectal Prostate Biopsy
Description

This study is being conducted in men scheduled to undergo transrectal ultrasound-guided prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic, ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years as ciprofloxacin resistance has increased in the community, more and more men are becoming infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being done to determine if obtaining rectal swab cultures and choosing antibiotics based on these culture results will result in fewer infectious complications than giving all men ciprofloxacin. The investigators will compare 2 groups: men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on their culture results. Our hypothesis is that these 2 groups will have equal numbers of post-biopsy infectious complications and both groups will have fewer infectious complications than a historical group who received empiric ciprofloxacin without the benefit of rectal swab culture results.

Conditions
COMPLETED
Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy
Description

The purpose of this study is to discover how often certain bacteria are found in the rectum at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of importance because they can cause serious infection. Antibiotics that urologists commonly use to prevent these bacteria from causing infection are no longer effective. Many physicians around the world are noting increased infections with antibiotic resistant bacteria. Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics, certain patients are being readmitted to the hospital with a serious infection. In order to study the incidence of these particular bacteria, the best method is to culture the bacteria at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy of the prostate. Once the incidence of these bacteria is known we may take steps to prevent the serious infections that occur as a result of prostate biopsy.

COMPLETED
Determination of HIV-1 Production by the Prostate
Description

Virus present in semen likely contributes substantially to the sexual transmission of HIV. However, the source of HIV in semen is unknown. Some evidence suggests that the prostate may be the source of at least some of the virus in semen. This study is designed to determine whether the prostate may serve as the source of virus in semen by comparing the concentration of HIV-1 RNA in semen donated normally, in semen obtained following prostatic massage, and in expressed prostatic secretions. Finding a source for semen HIV would provide important insights into several aspects of HIV sexual transmission. Since some drugs do not enter the prostate well, the finding that virus is produced in the prostate might suggest the prostate could serve as a reservoir for HIV, leading to the development of resistance to antiviral agents.

Conditions
UNKNOWN
Role of Prophylactic Postoperative Antibiotics in HoLEP
Description

The purpose of this study is to investigate whether prescribing a 3-day course of antibiotics after Holmium laser enucleation of the prostate (HoLEP) reduces the risk of urinary tract infection. The findings of this trial will have a major impact on clinical practice to either justify the prescription of antibiotics after HoLEP or give urologists more confidence in not prescribing antibiotics prophylactically after HoLEP.

ACTIVE_NOT_RECRUITING
Impact of COVID-19 on GU Disease
Description

The purpose of this research study is to identify patients with GU disease with active or past COVID-19 infection. Participants will be asked to: * Complete an Online COVID-19 Questionnaire. * Disclose if the patient has or had Genitourinary cancer or benign urologic condition * Provide urine specimen for research * Provide 4 tablespoons of blood for testing blood for research. * Provide permission to access medical records, such as patient lab results, medical history, imaging reports, etc.

COMPLETED
The Utility of Urinalysis Prior to In-Office Procedures
Description

The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.

TERMINATED
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
Description

The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.

ACTIVE_NOT_RECRUITING
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
Description

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.

Conditions
Advanced Differentiated Thyroid Gland CarcinomaAdvanced Head and Neck CarcinomaAdvanced Hepatocellular CarcinomaAdvanced Kaposi SarcomaAdvanced Lung Non-Small Cell CarcinomaAdvanced Lung Small Cell CarcinomaAdvanced Malignant Solid NeoplasmAdvanced MelanomaAdvanced Ovarian CarcinomaAdvanced Prostate CarcinomaAdvanced Renal Cell CarcinomaAdvanced Thyroid Gland Medullary CarcinomaAdvanced Triple-Negative Breast CarcinomaAdvanced Urothelial CarcinomaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Castration-Resistant Prostate CarcinomaClinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8HIV InfectionMetastatic Differentiated Thyroid Gland CarcinomaMetastatic Head and Neck CarcinomaMetastatic Hepatocellular CarcinomaMetastatic Kaposi SarcomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Lung Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Ovarian CarcinomaMetastatic Prostate CarcinomaMetastatic Renal Cell CarcinomaMetastatic Thyroid Gland Medullary CarcinomaMetastatic Triple-Negative Breast CarcinomaMetastatic Urothelial CarcinomaRecurrent Differentiated Thyroid Gland CarcinomaRecurrent Head and Neck CarcinomaRecurrent Hepatocellular CarcinomaRecurrent Kaposi SarcomaRecurrent Lung Non-Small Cell CarcinomaRecurrent Lung Small Cell CarcinomaRecurrent Malignant Solid NeoplasmRecurrent MelanomaRecurrent Ovarian CarcinomaRecurrent Prostate CarcinomaRecurrent Renal Cell CarcinomaRecurrent Thyroid Gland Medullary CarcinomaRecurrent Triple-Negative Breast CarcinomaRecurrent Urothelial CarcinomaRefractory Differentiated Thyroid Gland CarcinomaStage III Differentiated Thyroid Gland Carcinoma AJCC v8Stage III Hepatocellular Carcinoma AJCC v8Stage III Lung Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage III Thyroid Gland Medullary Carcinoma AJCC v8Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Thyroid Gland Medullary Carcinoma AJCC v8
COMPLETED
Integrating Targeted MedlinePlus Health Prescriptions Into Clinic Practice Workflow
Description

The specific aim of this proposed project is to implement a standard process for integrating MedlinePlus health information prescriptions into the clinic workflow. Hypothesis 1: Individuals in the intervention group who receive tailored email health information with provider selected MedlinePlus links and added commentary for patient specific conditions will be more likely to seek information / use MedlinePlus compared with individuals in the control group. Hypothesis 2: Individuals in the intervention group who receive tailored email health information with provider selected MedlinePlus links and added commentary for patient specific conditions will be more satisfied with the information received compared with individuals in the control group.

COMPLETED
Eligibility Screening for the NIH Intramural Research Program Clinical Protocols
Description

The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes. Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent. ...

TERMINATED
Connected Catheter- Safety and Effectiveness Study
Description

The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.