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NCT ID: NCT06454747 Recruiting - Melasma Clinical Trials

A Randomized, Observer-Blinded, Placebo-Controlled Study on Safety and Efficacy of SM-030 in Adults With Melasma

Start date: June 6, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2b, observer-blinded, randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 0.64% and SM-030 gel 0.08% compared against placebo gel in healthy adult male and female subjects with Melasma. The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period. Approximately 138 subjects who meet the eligibility criteria, notably with a clinical diagnosis of Melasma will be randomized in a 3:2:1 ratio to one of three treatment arms: SM-030 gel 0.64% (N=69), Placebo gel (N=46), or SM-030 gel 0.08% (N=23). Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites (4 sites in Mexico and 1 in El Salvador). Subjects will be assessed for safety and efficacy at each visit.

NCT ID: NCT06192901 Completed - Senile Cataract Clinical Trials

Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After Bilateral Cataract Surgery

Start date: September 18, 2023
Phase:
Study type: Observational

Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery

NCT ID: NCT05617820 Completed - Dyspareunia Clinical Trials

Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy

Start date: November 15, 2022
Phase: Phase 3
Study type: Interventional

Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.

NCT ID: NCT05566431 Recruiting - Clinical trials for Severe Traumatic Brain Injury

Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics

BELA TRIPP
Start date: March 22, 2023
Phase: N/A
Study type: Interventional

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.

NCT ID: NCT05511948 Completed - Hyperpigmentation Clinical Trials

Randomized and Open Label Study for Safety and Efficacy of DBI-102 vs. Vehicle vs. Hydroquinone on Skin Pigmentation and Lentigos

Start date: August 18, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, observer-blinded, vehicle-controlled multi-dose trial that examines the effect of twice daily application of 0.8% DBI-102 Gel, 4% Hydroquinone cream, and Vehicle Gel for 12 weeks in adults with Fitzpatrick Skin Types IV-V and a colorimeter L* measurement between 57.8 and 46.1.

NCT ID: NCT05477953 Not yet recruiting - Chagas Disease Clinical Trials

An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health

Start date: June 30, 2024
Phase:
Study type: Observational

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: - Birth defects (abnormal and problematic structures or functions, a child is born with) - Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) - Certain health problems of the child up to 12 months of age - Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.

NCT ID: NCT05431699 Recruiting - Clinical trials for Human Papilloma Virus

Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test

SCALE
Start date: February 13, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to validate a new low-cost, self-collected HPV screening test (ScreenFire) and compare it to the standard provider collected careHPV, for the detection of high grade cervical cancer.

NCT ID: NCT05309135 Completed - Corneal Edema Clinical Trials

A Safety and Efficacy Study of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy in Subjects With Corneal Edema Secondary to Endothelial Dysfunction

Escalon
Start date: March 24, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction.

NCT ID: NCT05295641 Active, not recruiting - Heart Failure Clinical Trials

American Registry of Ambulatory or Acute Decompensated Heart Failure

AMERICCAASS
Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to better characterize and understand the population of patients with ambulatory or acutely decompensated heart failure in the American continent, getting to know their sociodemographic, clinical and paraclinical characteristics

NCT ID: NCT05201027 Terminated - Cataract Senile Clinical Trials

Study to Optimize the IOL Constant of a New Multifocal Intraocular Lens

HECATE A
Start date: January 28, 2022
Phase: N/A
Study type: Interventional

Prospective, non-comparative, multicenter study on medical device with 6 months follow-up.