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NCT ID: NCT05667688 Completed - Healthy Volunteer Clinical Trials

Pharmacokinetics and Pharmacodynamics Study of LBS-008 in Healthy Volunteers Aged 50-85

Start date: November 28, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Tinlarebant when administered as an oral dose to elderly healthy volunteers. This study will evaluate 2 dose levels in 2 cohorts comprising up to a total of 16 participants (8 per cohort). Dose levels will be evaluated in parallel.

NCT ID: NCT05663853 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

An Observational Biomarker Study in Multiple Sclerosis (MS) Patients

Start date: March 28, 2023
Phase:
Study type: Observational

All males and females between 18-70 years of age regardless of their race and ethnicity with a confirmed diagnosis of Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), and Relapse Remitting Multiple Sclerosis (RRMS) are invited to participate in this Observational study being conducted across four sites in the US. Since this is an observational study no medication/drug or treatment will be given to the participants. The investigator will be collecting information about the participant's MS disease, its progression, current medications, radiographic scans, and blood samples. This will help the investigator evaluate the biomarkers and new treatment options to better understand the MS disease process.

NCT ID: NCT05662943 Completed - Clinical trials for Age-Related Macular Degeneration

Outcomes of Tolerating Subretinal Fluid in Type 1 MNV and PCV

Start date: December 5, 2022
Phase:
Study type: Observational

The purpose of the present study was to evaluate the outcomes of type 1 macular neovascularization (MNV), including polypoidal choroidal vasculopathy in patients treated tolerating subretinal fluid (SRF) using Aflibercept in a clinical setting. Approximately 150 patients are anticipated to be enrolled in this study. SRF is a primary type of fluid compartment prevalent in type 1 aneurysmal MNV. In a recent study, the prevalence of SRF during 24-month follow-up period was 36.7% to 38.8% in type 1 MNV and polypoidal choroidal vasculopathy (PCV), 20.0% in type 2 MNV, and 7.7% in type 3 MNV. In addition, patients with SRF showed better visual prognosis in type 1 MNV/PCV. For this reason, type 1 MNV is an appropriate candidate for evaluating the influence of tolerating SRF.

NCT ID: NCT05659758 Completed - Clinical trials for Anesthesia Intubation Complication

Is Effective Preoxygenation in Elderly Patients Related to Position?

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

The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.

NCT ID: NCT05659004 Completed - Clinical trials for Chronic Limb Threatening Ischemia

Referrals for CLTI: Qualitative Study

Start date: January 10, 2023
Phase:
Study type: Observational

The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to answer are: - What are the perceptions and experiences of patients between first symptom of CLTI and vascular surgery assessment - What is important to patients during this process. Participants will be interviewed and their words analysed using reflexive thematic analysis.

NCT ID: NCT05658406 Completed - Clinical trials for Nausea and Vomiting, Postoperative

Supplemental Perioperative Intravenous Crystalloids for Postoperative Nausea and Vomiting in Children Undergoing Oncological Surgery

Start date: January 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Postoperative nausea and vomiting (PONV) is a common complication in the paediatric population and is a source of significant morbidity. The incidence of PONV in children is alarmingly high, as it is estimated to be between 33.2% to 82% depending on patient risk factors. Even with the administration of prophylactic antiemetic medications, the risk of PONV can still be approximately 30%. Various independent risk factors have been implicated in the development of paediatric PONV. The following risk factors were identified: a duration of surgery 30 minutes or longer, age 3 years or older, strabismus, adenoidectomy, and tonsillectomy surgeries, a history of PONV in the child or immediate relatives (parents or siblings), use of volatile anaesthetic, use of opioids, increased postoperative pain, prolonged preoperative fast, and state of dehydration Significant improvement in patient satisfaction can be achieved if the incidence of PONV is decreased. Although not usually life-threatening, PONV may lead to complications commonly associated with vomiting, including dehydration, electrolyte imbalance, and aspiration of gastric contents. In some surgical cases, PONV has also led to wound complications, oesophageal rupture, subcutaneous emphysema, pneumomediastinum, and bilateral pneumothorax. PONV typically describes nausea, vomiting, or retching that can occur starting in the post-anaesthesia care unit (PACU) and continuing through the 24 hours following surgery. PONV occurs twice as often in children than in adults and can lead to longer PACU stays, delays in hospital discharge and subsequent unplanned readmissions, which ultimately lead to significant financial burden on the patients. A variety of antiemetic regimens are recommended for the prevention and treatment of PONV in children, including pharmacotherapy with dexamethasone, 5HT-3 receptor antagonists, butyrophenones, prokinetics, anticholinergics and antihistamines. Hydration is yet another important factor in the development of PONV in paediatric patients. Administration of intravenous dextrose-containing solutions may also prevent PONV. Investigation of the effect of perioperative intravenous crystalloid administration on PONV was initially motivated by the results of observational studies suggesting that perioperative volume status influenced postoperative complication rates. This work showed that PONV was among the most prevalent events after surgery and motivated subsequent inquiry into the relationship between perioperative volume resuscitation and PONV . Multiple reviews have explained the complex physiology of nausea and vomiting. Briefly, the vomiting centre, located in the lateral reticular formation of the medulla, co-ordinates efferent activity to the respiratory, gastrointestinal, and abdominal musculature to produce vomiting. This centre receives afferent stimuli from a variety of sites: the pharynx, gastrointestinal tract chemo- and stretch receptors, the brain (including vestibular information from cranial nerve VIII), aortic baroreceptors, and the chemoreceptor trigger zone. The chemoreceptor trigger zone is a neural centre physiologically outside of the blood-brain barrier, which provides afferent information to the vomiting centre in response to noxious stimuli in the blood. Patients particularly paediatrics typically present for surgery with a fluid deficit secondary to fasting, bleeding, bowel preparation, and other causes of dehydration. It has been proposed that brainstem, vestibular, and intestinal hypoperfusion, with concomitant ischaemia, may mediate nausea and vomiting. Supplemental intravenous crystalloids could serve to mitigate this effect; however, no proven explanation for the putative role of volume status in this model exists. Hypovolemia has been associated with a rise in postoperative morbidity and mortality ranging from PONV to other complications such as organ dysfunction . Hypovolemia from overnight fasting without adequate fluid replacement can cause adverse effects postoperatively . Intravenous crystalloids are widely administered before, during, and after procedures requiring general anaesthesia. They are inexpensive and have relatively few adverse effects. A prior systematic review has suggested that supplemental intravenous crystalloids may be effective in preventing PONV . However, studies of supplemental perioperative intravenous crystalloids were noted to vary widely on the specific volumes administered. Despite evidence-based, multimodal prophylactic regimens, PONV remains a prevalent clinical problem . The use of pharmacologic agents alone reduces the risk of PONV but increases the risk of side effects. Intravenous crystalloids are an attractive treatment modality. Many different intravenous fluid interventions have been tested in a wide variety of surgical and anaesthetic contexts.

NCT ID: NCT05656937 Completed - Pediatric ALL Clinical Trials

Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients

NCT ID: NCT05655832 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring disease activity and predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD). The cohort of participants with COPD will be followed for 3 months. A calibration cohort with non-COPD participants will be included and followed for 2 weeks.

NCT ID: NCT05651984 Completed - Clinical trials for Mechanical Ventilation Complication

Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units

Start date: February 9, 2019
Phase: N/A
Study type: Interventional

This prospective study consisted of (1) a descriptive cross-sectional part describing communication difficulties related to mechanical ventilation as experienced by intensive care professionals and patients, and (2) an experimental randomized crossover part comparing the use of a conventional low-tech communication board and a high-tech eye tracking technology-based device to improve communication effectiveness of intensive care mechanically ventilated patients.

NCT ID: NCT05651503 Completed - Clinical trials for Orthodontic Appliance Complication

The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients.

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

Brackets, bands, ligatures and wires in patients receiving orthodontic treatment with fixed appliances are areas that trap food and impede oral hygiene. An ecological environment facilitating the growth of microorganisms (Actinobacillus, Bacteroides, Prevotella etc.) emerges in the mouth and may cause caries, enamel white spots, gingival inflammation and halitosis. Despite the use of specialized orthodontic brushes, interdental brushes, mouthwashes and topical fluorides, plaque removal remains inadequate in patients with fixed orthodontic appliances. On the other hand, patients undergoing orthodontic treatment with aligners have been found to have better oral hygiene because of less plaque accumulation in their mouth. Probiotics are defined as non-pathogenic bacteria that can benefit the host's general health when taken in sufficient amounts through nutrition. Nowadays probiotics can be used to enhance oral health as they are found to reduce dental biofilm formation, prevent and decrease halitosis in children, adolescents and adults. To date, there are few randomized controlled trials (RCTs) examining the efficacy of oral probiotics in patients with fixed orthodontic appliances and none reporting the incidence of halitosis and the effect of probiotics in orthodontic patients wearing aligners.