Phase 2 N=100 Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection
Urinary Tract Infection
Primary: Incidence of Urinary Tract Infection — 7; 13 participants
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Phase 3 N=623 Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Vaginitis Trichomonal or Due to Trichomonas
Primary: Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) — 58; 34 Participants
N/A N=705 Women's Improvement of Sexual Health (WISH) Demonstration Project
Sexually Transmitted Disease · Bacterial Vaginosis · Vaginal Candidiasis
Primary: Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) — 396; 378; 399; 216 Participants
N/A N=36 Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract
Women's Health · HIV Infection · Genital Diseases, Female
Primary: CD4+ to CD8+ T Cell Ratio in Cervical Biopsies — 0.46; 0.52 Cervical CD4+:CD8+ T cell ratio — p=0.6
Phase 4 N=242 Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
Urinary Tract Infections
Primary: Urinary Tract Infection — 11; 12 UTI
N/A N=351 Point of Care Diagnosis of Vaginal Infections
Vaginitis · Bacterial Vaginosis · Yeast Vaginitis
Primary: Number of Participants Prescribed Appropriate Treatment — 61; 104; 58; 21 Participants — p=<.001
N/A N=12 Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
Urinary Tract Infections
Primary: Prevalence of Urinary Tract Infections (UTI) — 28.6; 60; 71.4; 40 percentage of subjects — p=0.034
Phase 2 N=234 Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Bacterial Vaginosis · Candidiasis · Trichomoniasis
Primary: Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights…
N/A N=139 Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women
Recurrent Urinary Tract Infection in Adult Women
Primary: To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI. — 1.2; 1.3 Number of…
Phase 2 N=233 The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
Pelvic Inflammatory Disease
Primary: Clearance of Anaerobic Organisms From the Endometrium — 14; 18; 7; 1 participants — p=0.046
N/A N=194 Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
Respiratory Tract Infections · Influenza, Human · Common Cold
Primary: Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED — 20; 33 Participants
Phase 4 N=270 Trichomonas Vaginalis Recurrence Among HIV+ Women
Trichomonas Infections · HIV Infections
Primary: TV Culture Positive Result — 11; 21 participants — p=.045
N/A N=272 Contraceptive Awareness and Reproductive Education
Pregnancy · Sexually Transmitted Infections
Primary: Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. — 39; 29 Participants — p=>.05
Phase 4 N=25 Preventing Recurrent UTI With Vaginal Estrogen
Recurrent Urinary Tract Infection · Urinary Tract Infections · Cystitis Recurrent
Primary: Change in Vaginal Microbiota — 2.75 change in percent relative abundance
N/A N=68 Rwanda Vaginal Microbiota Restoration Study
Bacterial Vaginosis
Primary: Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria — 7.53; 2.04; 3.36; 3.35 Incidence: events per PY at risk
N/A N=19 Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
HIV Infections
Primary: Raltegravir Male Genital Tract Concentration — 485.1 ng/mL
N/A N=687 PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
Infection
Primary: Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided…
N/A N=103,039 Adolescent Sexually Transmitted Infection Screening in the Emergency Department
Gonorrhea · Chlamydia
Primary: GC/CT Detection Rates — 15.2; 12.1; 11 No. of patients with positive GC/CT
N/A N=200 Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
Chlamydia Trachomatis Infection
Primary: Response Rate at Recruitment — 100; 100 Participants
Phase 4 N=35 Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women
Recurrent Urinary Tract Infection
Primary: Occurrence of UTI During Randomization — 8; 10 Participants
N/A N=68 Human Repeated Insult Patch Test
Dermatitis · Allergy · Contact Allergy
Primary: Erythema at the Patch Test Site is Evaluated for Each Participant — 0.00; 0.59; 0.00 erythema score
N/A N=421 Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections
Upper Respiratory Tract Infections
Primary: Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study — 275; 133 participants
N/A N=2,242 Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections
HIV Infections · Sexually Transmitted Infections
Primary: Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC) — 8; 25; 13; 17 Participants — p=0.044
Phase 3 N=1,365 Bacterial Vaginosis Home Screening to Prevent STDs
Bacterial Vaginosis
Primary: One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared…
N/A N=93 Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions
Asherman's Syndrome
Primary: Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group — 12; 22 participants — p=0.009
N/A N=98 Rapid Diagnostic Assay for Gonorrhea and Chlamydia
Urethritis · Cervicitis · Sexually Transmitted Infections
Primary: Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis — 7; 1 Antibiotic days of therapy (DOT) — p=0.053
Phase 3 N=607 Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
Vesicoureteral Reflux · Urinary Tract Infections
Primary: Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up — 39; 72 participants — p=<0.001
N/A N=500 Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
Chlamydia Trachomatis Infection · Neonatal Infection · Preterm Birth
Primary: Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery — 2; 23 Participants
N/A N=519 A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
Bacterial Vaginosis · Urogenital Infection by Trichomonas Vaginalis
Primary: Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women — 92; 91; 100; 100 Percentage…
Phase 2 N=370 Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Postoperative Urinary Tract Infection · Pelvic Organ Prolapse · Stress Urinary Incontinence
Primary: Post-operative Urinary Tract Infection — 19; 20 Participants