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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating surgical methods to treat chronic oroantral fistulas COAF, which are abnormal openings between the mouth and maxillary sinus that tend to recur. This study focuses on comparing a hinge flap technique combined with a buccal advancement flap against the traditional palatal flap method to improve closure success in the most posterior maxilla area. The trial aims to reduce recurrence rates and postoperative complications by reinforcing local tissue flaps during surgery. Participants will be randomly assigned to one of two groups the experimental group receiving the hinge flap with buccal advancement flap, and the control group treated with an anteriorly based palatal rotational flap. The hinge flap involves a circular incision around the fistula to close the sinus membrane and reinforce the buccal flap. The palatal flap uses incisions on the palate with ligation of vessels to reposition tissue over the fistula. Both procedures seek to close the oroantral fistula surgically. During the study, participants will undergo surgery followed by monitoring for recurrence, surgical difficulties, and time taken for the procedure. Researchers will assess outcomes like fistula closure success and patient satisfaction four months postoperatively. This triple-blinded trial ensures unbiased evaluation of the two surgical techniques, with a total study duration extending to 2028. Participants can expect follow-up evaluations to track healing and complications after their surgery.

Age: 18Years +All GendersPhase Not Applicable
1 location
O

Actively Recruiting

This research aims to observe the real-world use and effects of pegcetacoplan in adults diagnosed with Paroxysmal Nocturnal Hemoglobinuria PNH. As a new treatment with a unique mechanism of action, pegcetacoplans effectiveness and safety in routine medical practice are being studied to provide valuable information for patients, healthcare providers, and payers. The study will also gather data on blood transfusions and healthcare resource use before and after starting pegcetacoplan. Patients who have started pegcetacoplan treatment within the past 12 months or are prescribed the drug at enrollment will be included. Data collection includes retrospective information from up to 12 months before treatment start and prospective monitoring for approximately 36 months, with the total data period extending up to about 48 months. After stopping pegcetacoplan, patients remain in the study for 8 weeks to record any adverse events. Patients continue regular clinic visits, where data from each visit will be gathered. Participants will have data collected on various health measures such as hemoglobin levels, blood markers, transfusion needs, and patient and physician treatment satisfaction at regular intervals up to 36 months. Safety and adverse events will be monitored throughout. The main outcome measured is the change in hemoglobin level from treatment start to 6 months. This long-term observational study allows for comprehensive tracking of pegcetacoplans use and effects over time in usual care settings.

Age: 18Years +All Genders
87 locations
C

Actively Recruiting

Healthy Volunteer

Researchers are comparing the effectiveness of two different volumes of buccal infiltration of Articaine for extracting mandibular posterior teeth. This trial aims to evaluate whether 1.8 ml or 3.6 ml of 4% Articaine provides better anesthesia and pain control during tooth extraction. The study addresses concerns with the common inferior alveolar nerve block technique, which can cause complications such as pain, facial nerve paralysis, and other side effects. Participants will be randomly assigned to receive either 1.8 ml or 3.6 ml of 4% Articaine via buccal infiltration. This method is considered safer and less painful than the traditional nerve block. The trial compares these two doses to determine their effectiveness in providing adequate anesthesia for painless extraction of mandibular posterior teeth. During the study, participants will be assessed for pain intensity from reflection of the mucoperiosteum until the tooth is removed, the time it takes for anesthesia to begin up to 10 minutes, and the presence or absence of pain throughout the procedure. The research team will monitor these outcomes to understand which volume of Articaine offers better pain control and faster anesthesia onset during dental extraction.

Age: 18Years +All GendersPhase Not Applicable
2 locations
C

Actively Recruiting

This research evaluates the effectiveness and safety of two dosing methods for colistin, an antibiotic used to treat infections caused by multi-drug-resistant and extensively drug-resistant Gram-negative bacteria in critically ill patients. These infections, especially common in intensive care units, pose a significant threat due to increasing antibiotic resistance, particularly in Saudi Arabia. The study focuses on comparing fixed dose and weight-based dose strategies in both obese and non-obese patients. Participants will be randomly assigned to one of two groups. One group receives intravenous colistin using a fixed dose strategy based on creatinine clearance, with a loading dose of 9 MIU equal to 300 mg of colistin base activity followed by maintenance doses every 12 hours. The other group receives colistin dosed based on body weight, with a loading dose calculated as four times the patients weight in kilograms, which may exceed 300 mg. Both dosing strategies will be administered intravenously in the intensive care unit setting. During the study, patients will be monitored for clinical and microbiological success in eliminating infections, assessed 14 days after starting colistin treatment. Safety will also be closely watched, particularly for kidney-related side effects. Researchers will collect data on how well the infection is cleared and observe any toxic effects from the treatment. The trial will last throughout the treatment period and follow-up to assess outcomes and safety in critically ill patients.

Age: 18Years +All GendersPhase 2Phase 3
1 location
E

Actively Recruiting

Retinopathy of prematurity ROP is a serious eye condition affecting premature infants and can lead to childhood blindness. This research evaluates the occurrence and severity of low oxygen levels hypoxia during bedside injections of ranibizumab, a treatment for ROP, in premature infants across multiple hospitals in the Al Qassim region of Saudi Arabia. The study aims to fill a knowledge gap about breathing problems during these injections under topical anesthesia in this vulnerable population. The study looks at infants who received intravitreal ranibizumab injections at the bedside in neonatal intensive care units NICUs from July 2020 through June 2026. The injections use a standard protocol involving a small needle, antiseptic application, and close follow-up for 1 to 2 weeks after treatment. Oxygen levels are continuously monitored with pulse oximetry during and shortly after the procedure to detect hypoxia, which is classified by severity. Data collected includes demographic, maternal, perinatal, and treatment details. Participants oxygen saturation and other vital signs are monitored closely during the procedure to identify any drops in oxygen levels. Researchers analyze these events along with patient and treatment factors to understand risks. The primary outcome measures the occurrence of hypoxia within one year. The study uses retrospective data and includes follow-up information to assess safety and incidence of low oxygen events during and after ranibizumab injections for ROP.

All Genders
1 location
E

Actively Recruiting

Maxillary sinusitis caused by dental or dento-alveolar structural problems, known as odontogenic maxillary sinusitis OMS, requires a distinct treatment approach compared to other types of sinusitis. This condition involves different causes, diagnosis, and treatments, and there is no clear consensus among specialists such as otolaryngologists, maxillofacial surgeons, and dentists on the best treatment method or which specialist should lead the care. This study aims to evaluate the effectiveness of a combined approach using Single-step Functional Sinus Endoscopy and transoral surgery for treating OMS through an integrated departmental therapy. Participants will be treated in one of three groups the combined Single-step Functional Sinus Endoscopy and transoral surgery group, where functional sinus endoscopy is performed by an otolaryngologist and transoral surgery by an oral and maxillofacial surgeon in the same visit a group treated only with functional sinus endoscopy by the otolaryngologist and a group treated only with transoral surgery by the oral and maxillofacial surgeon. The transoral procedures involve tooth extraction, fistula closure, or cyst removal, while the sinus endoscopy involves cleaning and irrigating the sinus under general anesthesia. Throughout the study, participants will be monitored by measuring the thickness of the sinus mucosa at two weeks, one month, and three months after the intervention. Clinical, radiographic, and endoscopic sinus surgery ESS data will be collected to assess outcomes. The research team will use these measurements to evaluate treatment effectiveness and safety. The study is randomized and double-blinded, with an expected completion date in July 2027.

Age: 18Years +All GendersPhase Not Applicable
1 location