Clinical trials: Neonatal Infections
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
Cytomegalovirus Retinitis, HIV Infections
A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy.
- Trial name
- NCT00002247
- Testing
- Ganciclovir
- Where
- 20 sites in United States, Canada
- Volunteers
- 225 people
- Sponsor
- Hoffmann-La Roche
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
Respiratory Tract Infections
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
- Trial name
- DAISY (NCT04583280)
- Testing
- Rilematovir, Rilematovir X mg/kg
- Where
- 142 sites in United States, Argentina and 24 more
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Alpha-Thalassemia, Beta-Thalassemia
FLOWER: Following Longitudinal Outcomes With Epidemiology for Rare Diseases
FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases.
- Conditions
- Alpha-Thalassemia, Beta-Thalassemia, Amyloidosis, Amyotrophic Lateral Sclerosis
- Trial name
- NCT06539169
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- xCures
Hepatitis B Infection, Congenital Malformation
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection.
- Conditions
- Hepatitis B Infection, Congenital Malformation, Birth Defect, Viremia
- Trial name
- NCT03476083
- Testing
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Where
- 7 sites in China
- Volunteers
- 280 people
- Sponsor
- New Discovery LLC
Healthy Volunteer, Hidradenitis Suppurativa
A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
LT-002-158 is an oral IRAK4 protein degrader being developed for the treatment of autoimmune disease and inflammation including Hidradenitis Suppurativa and Atopic Dermatitis.
- Conditions
- Healthy Volunteer, Hidradenitis Suppurativa, Atopic Dermatitis
- Trial name
- NCT06082323
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and…
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Trial name
- NCT02822495
- Testing
- tabelecleucel
- Sponsor
- Atara Biotherapeutics
Staphylococcus Aureus
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed…
- Trial name
- NCT00198289
- Testing
- Aurexis® (tefibazumab)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Bristol-Myers Squibb
Acute Uncomplicated Falciparum Malaria
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
- Trial name
- NCT01619878
- Testing
- Artemether-lumefantrine (COA566)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
- Trial name
- EDIT (NCT00918957)
- Testing
- Tobramycin Inhalation Powder
- Where
- 24 sites in Bulgaria, Egypt and 7 more
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Diphtheria-Tetanus-acellular Pertussis Vaccines
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
The purpose of this Phase 3, non-randomized, single-arm, open-label study is to evaluate the immune response, reactogenicity and safety of GSKs dTpa vaccine in Japanese pregnant women between 27 weeks and less than 37 weeks of…
- Trial name
- NCT07596199
- Testing
- dTpa
- Where
- 21 sites in Japan
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Cytomegalovirus Retinitis, HIV Infections
The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS.
- Trial name
- NCT00002299
- Testing
- Interferon beta-1b, Ganciclovir
- Where
- 6 sites in United States
- Sponsor
- Hoffmann-La Roche
Hepatitis, Hepatitis B
Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates
The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.
- Conditions
- Hepatitis, Hepatitis B, Liver Diseases, Digestive System Diseases
- Trial name
- NCT02764671
- Testing
- 10μg/0.5ml recombinant hepatitis B vaccine
- Where
- 2 sites in China
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Shenzhen Kangtai Biological Products Co., LTD
Cystic Fibrosis
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be…
- Trial name
- CT03Ext (NCT01111383)
- Testing
- tobramycin
- Where
- 20 sites in France, Poland and 1 more
- Volunteers
- 209 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
IgE-Mediated Hypersensitivity, IgE Mediated Food Allergy
A Phase 1 Study of Cizutamig in IgE Mediated Diseases
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
- Conditions
- IgE-Mediated Hypersensitivity, IgE Mediated Food Allergy, IgE-Mediated Cow Milk Allergy
- Trial name
- NCT07408869
- Testing
- Cizutamig
- Where
- Australia
- Sponsor
- Candid Therapeutics
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
HIV Infections, Hemophilia A
Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia
The purpose of this study is to see if indinavir plus two other anti-HIV drugs affect blood clotting in HIV-positive patients with hemophilia.
- Trial name
- NCT00002386
- Testing
- Indinavir sulfate, Lamivudine, Stavudine
- Where
- 8 sites in United States, Canada
- Volunteers
- 55 people
- Sponsor
- Merck Sharp & Dohme LLC
Vitiligo, Atopic Dermatitis
An Observational Study of Patients With Dermatologic Disease
TARGET-DERM+ is an observational research study to conduct a comprehensive review of outcomes for patients with dermatologic disease (DD) and providers who treat these patients.
- Conditions
- Vitiligo, Atopic Dermatitis, Alopecia Areata, Hidradenitis Suppurativa (HS)
- Trial name
- TARGET-DERM+ (NCT07748169)
- Where
- United States
- Volunteers
- 2,000,000 people
- Sponsor
- Target PharmaSolutions, Inc.