Clinical trials: Pregnancy; Infection
Acute Kidney Injury Due to Sepsis
Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting…
- Trial name
- CLEAR-AKI (NCT05996835)
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 79 sites in United States, Argentina and 15 more
- Volunteers
- 316 people
- Sponsor
- Novartis Pharmaceuticals
Bacterial Vaginosis
Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis
To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria
- Trial name
- NCT02173184
- Testing
- Gynevac
- Where
- 8 sites in Hungary
- Volunteers
- 240 people
- Sponsor
- Amvac Kft.
Cancer, Healthy
Collection and Distribution of Biospecimens for Novel Research
iSpecimen aims to create a clinical partner network of hospitals, laboratories, academic institutions, and other healthcare organizations ("institutions") capable of providing researchers and educators ("researchers") with…
- Conditions
- Cancer, Healthy, Gastrointestinal Complication, Autoimmune Diseases
- Trial name
- NCT05080907
- Testing
- Observational
- Where
- 7 sites in United States
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- iSpecimen Inc
HSV-2 Infection, Herpes Simplex Virus Infection
NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
This study is designed to compare the performance of the NOWDx HSV-2 Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device.
- Trial name
- NCT04294030
- Testing
- Diagnostic Test: NOWDx HSV-2 Test
- Where
- 3 sites in United States
- Sponsor
- NOWDiagnostics, Inc.
Vaginitis, Infectious Vaginosis
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and…
- Trial name
- NCT01867164
- Testing
- Gynoclin V, Vagitrol V
- Where
- 2 sites in Mexico
- Volunteers
- 160 people
- Sponsor
- Janssen-Cilag, S.A.
Bacterial Vaginosis, Candida Vaginitis
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500…
- Trial name
- NCT06975436
- Testing
- cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP
- Where
- 10 sites in United States, Bulgaria and 1 more
- Volunteers
- 738 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Renal Impairment
Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.
This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK…
- Trial name
- NCT04909853
- Testing
- PF-07321332/ritonavir
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Human Papillomavirus Infection
Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening. This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of…
- Trial name
- NCT01694875
- Testing
- APTIMA HPV Assay
- Where
- 3 sites in United States
- Volunteers
- 2,200 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Urinary Tract Infections
A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection
This is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cUTI) including pyelonephritis to characterize the pharmacokinetics of RO7079901 co-administered with…
- Trial name
- NCT03174795
- Testing
- RO7079901, Meropenem
- Where
- 14 sites in United States, Hungary and 3 more
- Volunteers
- 20 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have…
- Trial name
- NCT02922543
- Where
- Japan
- Volunteers
- 361 people
- Sponsor
- Celgene
Hepatitis B Infection, Chronic Infection
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high…
- Conditions
- Hepatitis B Infection, Chronic Infection, Viremia
- Trial name
- NCT01488526
- Testing
- TDF treatment
- Where
- 5 sites in China
- Volunteers
- 200 people
- Sponsor
- New Discovery LLC
Pregnancy, Influenza
Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry
The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and…
- Trial name
- NCT01945424
- Testing
- Quadrivalent Influenza Vaccine (QIV)
- Where
- 5 sites in United States
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Urinary Tract Infections, Prostatitis
Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study
In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology…
- Conditions
- Urinary Tract Infections, Prostatitis, Interstitial Cystitis
- Trial name
- RapIDMixAR (NCT03931538)
- Testing
- Guidance 4.0 PCR test, Urine Culture
- Where
- United States
- Volunteers
- 2,511 people
- Sponsor
- Pathnostics
Herpes Zoster
Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
The purpose of this post-marketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the…
- Trial name
- NCT05811754
- Testing
- Data collection
- Where
- United States
- Volunteers
- 2,844 people
- Sponsor
- GlaxoSmithKline
HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.
- Conditions
- HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions, High-Grade Cervical Intraepithelial Neoplasia, Human Papilloma Virus
- Trial name
- NCT03697226
- Testing
- Topical ABI-1968
- Where
- South Africa
- Volunteers
- 8 people
- Sponsor
- Antiva Biosciences
Recurrent Urinary Tract Infection
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%.
- Trial name
- PROBUTI (NCT05895578)
- Testing
- Probiotic
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- ProbiSearch SL
Down Syndrome, Edwards Syndrome
Whole Blood Specimen Collection From Pregnant Subjects
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome
- Trial name
- NCT02430584
- Testing
- Observational - no intervention
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Progenity, Inc.
Urinary Tract Infection
An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
The purpose of this study is to compare the effectiveness of antibiotic flomoxef with cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.
- Trial name
- FLORUS (NCT02302092)
- Testing
- Flomoxef, Cefepime
- Where
- 5 sites in Russia
- Volunteers
- 13 people
- Sponsor
- Takeda
Respiratory Syncytial Virus Infections
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA).
- Trial name
- NCT05045144
- Testing
- RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA)
- Where
- 36 sites in United States, Canada and 3 more
- Volunteers
- 1,586 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline