Treatment Trials

32 Clinical Trials for Various Conditions

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COMPLETED
Anorectal Microbicide Project(AMP): Rectal Health, Behaviors and Microbicide Acceptability
Description

Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA and Baltimore, MD including a computer-assisted interview focusing on the behavioral repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional assessment of behaviors, anorectal examination, and testing for sexually transmitted infections (STIs).

COMPLETED
The Sexual Health of Rectal Cancer Patients
Description

We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn: * How the treatment affects emotional and social well-being. * How a new sexual health educational program affects you. Cancer patients seek education for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to individuals who have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual health counseling program. It will teach participants skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of sexual health program with the standard care patients receive after treatment for rectal, colorectal or anal cancer.

UNKNOWN
Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients
Description

Biofeedback therapy improves bowel symptoms and anorectal function in patients with dyssynergic defecation, however its mechanism of action is not known. The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering cortical processing of information and improving cortically mediated neuromuscular function of the gut. However, in order to better understand these mechanisms in patients, the investigators need to examine and establish normative data and compare findings with healthy subjects. The investigators specific aims are to examine and evaluate the following 40 normal subjects; (1) To evaluate the afferent cortical evoked potentials in response to the electrical stimulation of the anorectum and (2) To evaluate the corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses following noninvasive lumbosacral and transcranial magnetic stimulation.

COMPLETED
GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects
Description

The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid, rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of an investigational HIV medication known as GSK1349572 (dolutegravir).

Conditions
UNKNOWN
Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer
Description

This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site. The digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.

Conditions
ACTIVE_NOT_RECRUITING
Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy
Description

This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.

RECRUITING
Resilience and Equity in Aging, Cancer, and Health (REACH)
Description

The purpose of this multi-phase research study is to understand how consultation of cancer care with a geriatrician can best improve outcomes for older adults with gastrointestinal malignancies.

COMPLETED
Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
Description

This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.

Conditions
Acute Myeloid LeukemiaBrain GlioblastomaEstrogen Receptor NegativeExtensive Stage Small Cell Lung CarcinomaHead and Neck CarcinomaHER2/Neu NegativeHormone-Resistant Prostate CancerLimited Stage Small Cell Lung CarcinomaMyelodysplastic SyndromeProgesterone Receptor NegativeProgressive DiseaseRecurrent CarcinomaStage II Pancreatic CancerStage II Rectal CancerStage IIA Pancreatic CancerStage IIA Rectal CancerStage IIB Pancreatic CancerStage IIB Rectal CancerStage IIC Rectal CancerStage III Colon CancerStage III Esophageal CancerStage III Gastric CancerStage III Non-Small Cell Lung CancerStage III Ovarian CancerStage III Pancreatic CancerStage III Rectal CancerStage III Skin MelanomaStage IIIA Colon CancerStage IIIA Esophageal CancerStage IIIA Gastric CancerStage IIIA Non-Small Cell Lung CancerStage IIIA Ovarian CancerStage IIIA Rectal CancerStage IIIA Skin MelanomaStage IIIB Colon CancerStage IIIB Esophageal CancerStage IIIB Gastric CancerStage IIIB Non-Small Cell Lung CancerStage IIIB Ovarian CancerStage IIIB Rectal CancerStage IIIB Skin MelanomaStage IIIC Colon CancerStage IIIC Esophageal CancerStage IIIC Gastric CancerStage IIIC Ovarian CancerStage IIIC Rectal CancerStage IIIC Skin MelanomaStage IV Bladder CancerStage IV Bone SarcomaStage IV Breast CancerStage IV Colon CancerStage IV Esophageal CancerStage IV Gastric CancerStage IV Non-Small Cell Lung CancerStage IV Ovarian CancerStage IV Pancreatic CancerStage IV Rectal CancerStage IV Renal Cell CancerStage IV Skin MelanomaStage IV Soft Tissue SarcomaStage IVA Bone SarcomaStage IVA Colon CancerStage IVA Rectal CancerStage IVB Bone SarcomaStage IVB Colon CancerStage IVB Rectal CancerTriple-Negative Breast Carcinoma
COMPLETED
Colorectal Cancer Screening in a Community Health Setting
Description

This randomized controlled pilot study at the Health Annex, Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

COMPLETED
Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
Description

This clinical trial studies adherence to survivorship care guidelines in health care providers for non-small cell lung cancer or colorectal cancer survivor care. The completion of an educational intervention by health care providers may increase compliance and adherence to National Comprehensive Cancer Network guidelines for survivorship care.

UNKNOWN
Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer
Description

RATIONALE: Use of a web-based risk assessment tool may help improve screening rates for colorectal cancer. PURPOSE: This randomized clinical trial is studying personal electronic health records to see how well they work in improving screening rates for colorectal cancer.

COMPLETED
Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer
Description

RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet. PURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.

TERMINATED
Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer
Description

Treatment of rectal cancer often consists of surgical resection of the tumor. Chemotherapy and/or radiotherapy are frequently given before or after surgery. In this study, we wish to learn if there are differences in the treatment effectiveness or in the quality of life of patients based on their type of treatment (e.g. Radiotherapy and chemotherapy before or after surgery). Information from this questionnaire collected from you and other patients may help improve the quality of life of rectal cancer patients in the future. Medical information on your tumor, treatment received, and side effects will be compiled and maintained in a database to learn more about outcomes of treatment for rectal cancer.

COMPLETED
CHOICE: Communicating Health Options Through Information and Cancer Education
Description

The purpose of this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines.

COMPLETED
The United States Healthy Living Study
Description

The purpose of this study is to pilot test the efficacy of a patient-centered, tailored message intervention delivered via virtual human technology for increasing colorectal cancer (CRC) screening within guidelines. Although participation is not limited to these groups, the study team is particularly interested in the feasibility of the intervention for reaching racial/ethnic minority and rural patients.

COMPLETED
Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions
Description

The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal tissues. This will be accomplished by determining the pharmacokinetic disposition and dose proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal tissue.

COMPLETED
Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants
Description

RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer. PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.

Conditions
COMPLETED
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
Description

This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.

COMPLETED
Mesalamine 4 gm/60 mL Rectal Enema
Description

The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.

Conditions
COMPLETED
Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue
Description

This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.

Conditions
UNKNOWN
Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants
Description

RATIONALE: Developing a personalized screening plan may be more effective than usual care in increasing the number of healthy participants who regularly undergo screening for colorectal cancer. PURPOSE: This randomized phase III trial is studying personalized screening plans to see how well they work compared with usual care in increasing colorectal cancer screening in healthy participants.

COMPLETED
Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
Description

RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer. PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.

ACTIVE_NOT_RECRUITING
Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
Description

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer. PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

COMPLETED
Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
Description

RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening. PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer.

RECRUITING
Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study
Description

The investigators will use a mixed methods study i.e. focus groups involving CHC staff as well as quantitative study which involves analyzing data that is available from the EHR and DRVS population management platform.

COMPLETED
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
Description

This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.

Conditions
Healthy SubjectLocalized Transitional Cell Cancer of the Renal Pelvis and UreterMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterPsychosocial Effects of Cancer and Its TreatmentRecurrent Bladder CancerRecurrent Cervical CancerRecurrent Colon CancerRecurrent Gastric CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Pancreatic CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerRecurrent Uterine SarcomaRegional Transitional Cell Cancer of the Renal Pelvis and UreterStage II Bladder CancerStage II Renal Cell CancerStage II Urethral CancerStage IIA Cervical CancerStage IIA Colon CancerStage IIA Gastric CancerStage IIA Ovarian Epithelial CancerStage IIA Ovarian Germ Cell TumorStage IIA Pancreatic CancerStage IIA Rectal CancerStage IIA Uterine SarcomaStage IIB Cervical CancerStage IIB Colon CancerStage IIB Gastric CancerStage IIB Ovarian Epithelial CancerStage IIB Ovarian Germ Cell TumorStage IIB Pancreatic CancerStage IIB Rectal CancerStage IIB Uterine SarcomaStage IIC Colon CancerStage IIC Ovarian Epithelial CancerStage IIC Ovarian Germ Cell TumorStage IIC Rectal CancerStage III Bladder CancerStage III Pancreatic CancerStage III Renal Cell CancerStage III Urethral CancerStage IIIA Cervical CancerStage IIIA Colon CancerStage IIIA Gastric CancerStage IIIA Ovarian Epithelial CancerStage IIIA Ovarian Germ Cell TumorStage IIIA Rectal CancerStage IIIA Uterine SarcomaStage IIIB Cervical CancerStage IIIB Colon CancerStage IIIB Gastric CancerStage IIIB Ovarian Epithelial CancerStage IIIB Ovarian Germ Cell TumorStage IIIB Rectal CancerStage IIIB Uterine SarcomaStage IIIC Colon CancerStage IIIC Gastric CancerStage IIIC Ovarian Epithelial CancerStage IIIC Ovarian Germ Cell TumorStage IIIC Rectal CancerStage IIIC Uterine SarcomaStage IV Bladder CancerStage IV Gastric CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Pancreatic CancerStage IV Renal Cell CancerStage IV Urethral CancerStage IVA Cervical CancerStage IVA Colon CancerStage IVA Rectal CancerStage IVA Uterine SarcomaStage IVB Cervical CancerStage IVB Colon CancerStage IVB Rectal CancerStage IVB Uterine SarcomaUreter CancerStage IIA Lung CarcinomaStage IIB Lung CarcinomaStage IIIA Lung CarcinomaStage IIIB Lung Carcinoma
COMPLETED
Temperature Response to a Head-Neck Cooling System
Description

This study will evaluate the effectiveness of a specially designed head-neck cooling system for way lowering the body's central, or core, temperature and cooling the brain. Brain cooling has an effect on stopping seizure discharges in the brain as well as the seizures themselves. If this system works to cool the brain, a similar study may be tried in patients with epilepsy. Normal volunteers 21 years of age and older who have no medical or neurological condition and do not use any medications may be eligible for this study. Candidates will be screened with an interview. Women will have a pregnancy test. Those enrolled will be hospitalized twice for overnight stays, with the admissions 2 to 3 days apart. Participants will have a medical history, physical and neurological examinations, electroencephalogram (EEG) and electrocardiogram (EKG). Then, electrodes will be attached to their scalp, forearm and calf to measure temperatures in those locations. Intestinal (core) temperature will be measured with a temperature-sensing pill, which will be swallowed earlier), and a hand-held infrared thermometer will be used to measure temperatures from the ear canal, face, head, arms legs, and abdomen. Electrodes on the scalp will also measure changes in blood volume in the brain for a study of brain blood flow. Subjects will be seated in a comfortable chair and fitted with the cooling system, a portable unit with a circulating coolant. Cooling will last 30 minutes for the first session and 60 minutes for the second. Participants will be monitored for at least 30 minutes after each session to track temperature changes and have a post-cooling EEG recording.

Conditions
ACTIVE_NOT_RECRUITING
Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors
Description

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program.

COMPLETED
Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy
Description

Background: Prostate cancer (PCa) is one of the most common cancers in American men; it is a leading cause of death. Men of African ancestry have a higher rate of prostate cancer, and a higher likelihood of death, compared to men of European ancestry. The reasons for these higher rates are not known; they may include genetic and environmental factors. Better screening methods are needed. Objective: To test an imaging technology called multiparametric magnetic resonance imaging (mpMRI) for detecting prostate cancer in men of African ancestry. Eligibility: Men of African ancestry aged 35 years or older with prostate cancer and/or a strong family history of prostate cancer. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Participants will have an mpMRI. They will lie on a narrow bed that slides into a large cylinder. They will lie still for about 45 minutes. They will hear loud noises during the scan; they may wear earplugs or headphones to muffle the sound. Some participants may have a dye injected into a vein. If the scan indicates participants risk of prostate cancer is medium or high, they will have a biopsy: The area will be numbed, and samples of tissue will be removed from the prostate. The biopsy will be done within 6 months. If the scan indicates participants risk of prostate cancer is low, they will not have a biopsy. All participants will be followed for 5 years. They and/or their local doctors will be contacted once a year for follow-up. Additional mpMRIs may be recommended.

COMPLETED
Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II
Description

There is a critical need for physical activity interventions in colorectal cancer (CRC). The investigators have developed a digital health physical activity intervention, Smart Pace, which includes a wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. In this study, the investigators propose to expand and improve Smart Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the feasibility of this novel digital health physical activity intervention among 48 CRC patients on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.