Treatment Trials

15 Clinical Trials for Various Conditions

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UNKNOWN
A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
Description

In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study. Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This study will allow surveillance of disease through cytology and HPV DNA testing via collection of data using Thin Prep® cytology with reflex HPV DNA testing according to established guidelines as described below. Provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. Patients will receive first vaccine in the ED and will have arranged follow up for administration of the 2 month and 6 month series of the HPV vaccination. Through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..

COMPLETED
Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
Description

RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination, and anal endoscopy and biopsy, may help find and diagnose anal and genital human papillomavirus infection and squamous intraepithelial lesions and help doctors plan better treatment. PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS cancer clinical trial.

RECRUITING
Screening Women With Prior HPV for Anal Neoplasia
Description

The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.

COMPLETED
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
Description

The Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate effectiveness of home-based HPV kits for improving cervical cancer screening uptake and its cost-effectiveness. The investigators will compare cervical cancer screening uptake within six months among women randomized to different outreach approaches based on prior screening behavior: A) Adherent and coming due: direct mail HPV kit vs. opt-in HPV kit vs. education; B) Overdue: direct mail HPV kit vs. education; C) Unknown: opt-in HPV kit vs. education.

COMPLETED
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts
Description

This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A \& B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.

COMPLETED
HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3
Description

Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.

RECRUITING
Intralesional HPV Vaccine for Condylomata
Description

This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.

COMPLETED
Efficacy and Tolerability of Topical LFX453 for External Genital Warts
Description

The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%. During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.

COMPLETED
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Description

The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.

Conditions
COMPLETED
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
Description

The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin.

Conditions
COMPLETED
Alternate Dosing Schedules Study for HPV Vaccine (ADS)
Description

The purpose of this study was to determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This was a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. Immune responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended. In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised. Please note: This record refers only to the observational portion of the study. Please refer to NCT00862810 for the results of the randomized portion of the study.

COMPLETED
Alternate Dosing Schedules Study for HPV Vaccine
Description

To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This is a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended. Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised. Please note: This record refers only to the randomized portion of the study where pain following vaccination was assessed. Please refer to NCT02280642 for the observational portion of the study.

COMPLETED
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Description

The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.

Conditions
TERMINATED
Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
Description

The purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" (HRME) for the diagnosis of cervical pre-cancerous lesions and cervical cancer. The investigators want to compare patients' clinical findings using the current equipment used in clinic with the clinical findings using new equipment we are testing on this research project. If the new equipment is proven to give comparable findings with current equipment being used, doctors might be able to offer a diagnosis and treat cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to come back before women would receive the indicated treatment. Study subjects are being asked to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to have a colposcopic examination to determine the reason for abnormal results and receive treatment.

COMPLETED
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
Description

To evaluate the tolerability and safety of axalimogene filolisbac 1 x 10\^10 colony forming units (cfu) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).