Clinical trials: Pregnancy; Infection
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Advanced Solid Tumor, Unresectable Solid Tumor
A Beta-only IL-2 ImmunoTherapY Study
This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a…
- Conditions
- Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer
- Trial name
- ABILITY-1 (NCT05086692)
- Testing
- MDNA11, Pembrolizumab (KEYTRUDA®)
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Medicenna Therapeutics, Inc.
Urinary Tract Infections, Pyelonephritis
NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis
The goal of this clinical study is to test NRX101 in participants with complicated urinary tract infections including pyelonephritis.
- Trial name
- NCT06128213
- Testing
- NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone))
- Volunteers
- 13 people
- Sponsor
- NeuroRx, Inc.
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
Vulvovaginal Candidiasis
The Study Of Fluconazole For Vulvovaginal Candidiasis
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas.
- Trial name
- NCT01806623
- Testing
- Fluconazole
- Where
- 10 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Pfizer
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- Vanish 306 (NCT03987620)
- Testing
- Ibrexafungerp
- Where
- 41 sites in United States, Bulgaria
- Volunteers
- 455 people
- Sponsor
- Scynexis, Inc.
Advanced Solid Tumor, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
- Conditions
- Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma
- Trial name
- NCT04242199
- Testing
- INCB099280
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 182 people
- Sponsor
- Incyte Corporation
Meningococcal Infection
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
- Trial name
- NCT04843111
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Urinary Tract Infections
Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection
This study is a retrospective record review to determine whether a novel multiplex PCR assay can be utilized as a screening method for UTI in patients receiving Botox injection to treat overactive bladder (OAB).
- Trial name
- NCT04817865
- Testing
- Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST), Urine Culture
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pathnostics
Vulvovaginal Candidiasis
Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy for Vulvovaginal Candidiasis
This single-center, randomized, single-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of oral Lactobacillus crispatus Lc-G22 as adjunctive therapy to clotrimazole for preventing recurrence of…
- Trial name
- NCT07727967
- Testing
- Lactobacillus crispatus Lc-G22
- Where
- China
- Volunteers
- 100 people
- Sponsor
- BioGrowing Co., Ltd
HIV-1-infection
Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected…
- Trial name
- NCT03960645
- Testing
- B/F/TAF
- Where
- 8 sites in United States, Dominican Republic and 1 more
- Volunteers
- 62 people
- Sponsor
- Gilead Sciences
Urinary Tract Infection, Bacteriuria
Evaluation of Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters
According to the World Health Organization, hundreds of millions of patients are affected by health-care associated infections worldwide each year, resulting in prolonged hospital stays, long-term disabilities, deaths, and…
- Trial name
- NCT02277171
- Testing
- Nitric Oxide impregnated catheter
- Volunteers
- 15 people
- Sponsor
- Enox Israel Ltd
Bacterial Vaginosis, Vaginal Candidiasis
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis.
- Trial name
- NCT07234786
- Testing
- Multi-Gyn FemiTotal
- Where
- Mauritius
- Volunteers
- 80 people
- Sponsor
- Karo Pharma AB
Hepatitis B, Chronic, Pregnancy Related
Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B
Immunoprophylaxis failure of hepatitis B (HBV) remains a concern and has been reported in approximately 10-30% of infants born to highly viremic mothers with HBeAg-positive.
- Trial name
- NCT04211805
- Testing
- Tenofovir Alafenamide 25 MG for arm (A), Tenofovir Disoproxil Fumarate 300mg for arm (B)
- Where
- 11 sites in China
- Volunteers
- 450 people
- Sponsor
- New Discovery LLC
Papillomavirus Infections
GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa.
- Trial name
- NCT01245764
- Testing
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Tract Infection
Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection
PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract…
- Trial name
- NCT01406587
- Testing
- PP4001
- Where
- 25 sites in United States
- Volunteers
- 261 people
- Sponsor
- Pinnacle Pharmaceuticals, Inc.
GENITAL HERPES
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as…
- Trial name
- NCT01281007
- Testing
- Famciclovir, Aciclovir
- Where
- 9 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- EMS
Bacteriuria
A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria
A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated catheter. Each participant will take part in the trial from the time the participant signs the informed consent…
- Trial name
- CAM-SPC-001 (NCT04658719)
- Testing
- Camstent Coated Catheter, Standard Care
- Volunteers
- 30 people
- Sponsor
- Camstent Ltd.
Vulvovaginal Candidiasis (VVC)
An Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Vulvovaginal Candidiasis Compared With an Untreated Control Group
The goal of this clinical trial is to learn if pHyph works to reduce signs and symptoms of vulvovaginal candidiasis (thrush). It will also learn about the safety of pHyph.
- Trial name
- NCT07405853
- Testing
- pHyph
- Where
- 3 sites in Sweden
- Volunteers
- 48 people
- Sponsor
- Gedea Biotech AB
Herpes Genitalis
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
- Trial name
- HSV-2 (NCT02837575)
- Testing
- VCL-HB01, Phosphate-buffered saline
- Where
- 15 sites in United States
- Volunteers
- 261 people, healthy volunteers welcome
- Sponsor
- Vical