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NCT ID: NCT05654467 Not yet recruiting - Poliomyelitis Clinical Trials

Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama

Start date: May 29, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).

NCT ID: NCT05595538 Completed - COVID-19 Clinical Trials

Use of Multiple Doses of Convalescent Plasma in Mechanically Intubated Patients With COVID-19

Start date: June 6, 2020
Phase: Early Phase 1
Study type: Interventional

This study will assess the feasibility and safety of administering multiple doses of convalescent plasma to Covid-19 positive patients admitted to the Intensive Care Unit (ICU) receiving mechanical ventilation. Donor plasma will be obtained from Covid-19 recovered patients. All plasma used in this protocol will be collected following the guidelines issued by the Food and Drug Administration (FDA) and the Ministry of Health in Panama. Every patient recruited will receive one or two plasma units infused on days 0, 2, 4, 6, and 8. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma more than once. The investigators will evaluate the safety and feasibility of this study by accounting for any related adverse event. The secondary study endpoints are overall survival at days 14, 28, and 60 after the first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow-up until day nine and on days 14, 28, and 60.

NCT ID: NCT05594056 Not yet recruiting - Preeclampsia Severe Clinical Trials

Transorbital Ultrasound of Optic Nerve Sheath Diameter Between Healthy Pregnant Women and Those With Severe Preeclampsia.

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

The neurological alterations associated with preeclampsia depend on cerebral autoregulation, a theory that outlines the mechanisms by which the nervous system controls cerebral perfusion. However, with the loss of autoregulation, increased blood flow, edema and eventually increased intracranial pressure are triggered and may be translated into neurological manifestations such as symptoms of vasospasm, one of the criteria for severity in preeclampsia. Nervous system manifestations frequently found in preeclampsia are headache, blurred vision, scotomas and hyperreflexia. Although uncommon, temporary blindness (lasting a few hours to a week) may also accompany severe preeclampsia and eclampsia. The optic nerve, as part of the central nervous system, is surrounded by cerebrospinal fluid and dura mater, which forms the optic nerve sheath. Due to the connection with the intracranial subarachnoid space, the diameter of the optic nerve sheath is influenced by variations in cerebrospinal fluid pressure. Increased intracranial pressure is transmitted to the subarachnoid space surrounding the optic nerve, causing its expansion. Recent studies suggest that an optic nerve sheath diameter greater than 5 mm correlates 100% with ICP (intracerebral pressure) greater than 20 mm Hg. Due to the simple nature of the test and the limited time required to perform it, it is an ideal non-invasive test to assess changes in mental status, severe headache, and to take the necessary measures aimed at reducing intracranial pressure. The diagnosis of elevated intracranial pressure is challenging and critical, because early recognition and treatment are essential to prevent brain damage or death since preeclampsia with severe data remains one of the most frequent complications in our institution. These values are not taken from the obstetric population, so this study proposes the description of a standard value for the pregnant population. There are few studies that describe a value to help us define cases of this pathology and correlate it with the signs and symptoms of severity in patients with preeclampsia.

NCT ID: NCT05567757 Recruiting - Clinical trials for End Stage Renal Disease

Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)

Start date: October 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.

NCT ID: NCT05542082 Recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA

ARCTIC-2
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to: - Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease. - Evaluate the chronic performance of the CHILLS system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

NCT ID: NCT05447988 Recruiting - Breast Cancer Clinical Trials

Motiva Flora Tissue Expander PMCF

Start date: December 14, 2020
Phase: N/A
Study type: Interventional

The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of Motiva Flora® TE in breast reconstruction surgery. The study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.

NCT ID: NCT05415462 Active, not recruiting - Seasonal Influenza Clinical Trials

A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

Start date: June 6, 2022
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains at Day 29, and to evaluate the safety and reactogenicity of mRNA-1010.

NCT ID: NCT05404490 Recruiting - Pain, Postoperative Clinical Trials

Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.

NCT ID: NCT05317728 Not yet recruiting - Cataract Clinical Trials

Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design

Start date: March 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

NCT ID: NCT05295641 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