Medication

This research aims to evaluate whether taking antipsychotic medication every other day is as effective as the usual daily dosing for people with schizophrenia or related disorders. The study also explores if the alternate day dosing reduces side effects compared to daily treatment. It is a randomized, double-blind trial designed to compare these two dosing schedules over one year. Participants will be randomly assigned to either continue their current daily antipsychotic medication (risperidone, olanzapine, or paliperidone) or switch to an alternate day dosing schedule. To maintain blinding, active medication and placebo capsules are provided in matching blister packs so participants and staff cannot tell which regimen is assigned. Doses range from 1 mg to 16 mg for risperidone, 5 mg to 20 mg for olanzapine, and 3 mg to 12 mg for paliperidone. Treatment is individualized, and other psychotropic medications can continue if stable. Participants will attend 22 visits over 52 weeks, with visits every two weeks for the first six months and monthly visits for the final six months. Researchers will assess symptom severity and side effects using several scales, including the Brief Psychiatric Rating Scale and multiple symptom and wellbeing questionnaires. The main outcome focuses on clinical deterioration at the start and end of the study. Safety and medication adherence will be closely monitored throughout the trial.

Researchers are comparing two pharmacokinetic models, Eleveld and Schnider, for administering propofol sedation in mechanically ventilated patients in the intensive care unit (ICU). This observational study aims to assess which model better controls sedation depth, maintains hemodynamic stability, and supports faster recovery. The study uses sedation scales and monitoring tools like the Bispectral Index (BIS) and Riker Sedation-Agitation Scale to evaluate patient responses and safety. Participants will receive propofol through a target-controlled infusion (TCI) system guided by either the Eleveld or Schnider model. Sedation will be adjusted to maintain a Riker score between 3 and 4 and a BIS value between 60 and 80. Researchers will record hemodynamic variables, total propofol dosage, awakening time, and incidence of delirium after sedation withdrawal. No other sedatives or hypnotics will be used during sedation. During the study, patients will be monitored for sedation accuracy using BIS values for up to 72 hours. Assessments will include the proportion of time patients remain within the target sedation range. Data such as medical history, laboratory tests, and sedation depth will be collected and analyzed. The study will help identify the most reliable model for safe and effective sedation in ICU settings, with continuous monitoring of patient safety and sedation effects throughout the sedation period.

Researchers are evaluating the safety and tolerability of FX-909, given alone or combined with Pembrolizumab, in patients with advanced solid tumors including advanced urothelial carcinoma. This open-label Phase 1 study aims to find the right dose and gather early information on how the drugs behave in the body and their preliminary effects on the cancer. The study is sponsored by Flare Therapeutics Inc. and includes patients who have advanced or metastatic cancer that has progressed after available treatments. Participants will receive FX-909 orally as a daily tablet, either alone or with Pembrolizumab given every three weeks. The study has several parts: an initial dose-escalation phase to determine the recommended dose, a dose-expansion phase focusing on urothelial carcinoma with high PPARG protein expression, and a combination dose-escalation phase with Pembrolizumab. Treatments are administered in cycles lasting 21 or 28 days, depending on the study part. Throughout the study, participants will attend multiple visits for blood tests, collection of tumor and blood samples, and regular CT or MRI scans to monitor their health and cancer status. They will record any side effects or outcomes from the treatment. The main goal is to assess dose-limiting toxicities and adverse events over about three years. Researchers will also monitor drug behavior in the body and preliminary anti-tumor activity to better understand the treatment's effects.

Researchers are studying the effects of Huperzine A Injection on reducing postoperative delirium in elderly patients aged 75 and older who are undergoing non-cardiac surgery. This randomized, double-blinded, placebo-controlled trial aims to observe how this treatment may influence the occurrence of delirium after surgery in this older population. Participants will be randomly assigned to receive either Huperzine A Injection or a placebo of 0.9% Sodium Chloride Injection during their non-cardiac surgical procedure. The study includes patients with an anesthesia grade of III to IV and an estimated operation time of at least 2 hours. The treatments will be administered under controlled conditions to carefully assess their effects on postoperative delirium. During the study, participants will be monitored for delirium incidence within 7 days after surgery, with additional evaluations at 24, 48, and 72 hours post-operation. Researchers will also assess the type, severity, and duration of delirium, length of hospital stay, economic costs, complications, mortality rates, and cognitive function using the Mini-mental State Examination and EuroQol scale. Follow-up assessments will continue up to 2 months after surgery, with some evaluations occurring around 30 days after discharge.

Researchers are evaluating the safety and effectiveness of NT 201, a type of botulinum toxin A, compared with a placebo in adults who have moderate to severe platysma prominence, which refers to noticeable bands in the neck area. This Phase 3 study aims to understand how well NT 201 works and how safe it is for these participants. The study is sponsored by Merz Aesthetics GmbH and will be conducted in Europe. Participants will be randomly assigned to receive either a single injection of NT 201 or a matching placebo injection in the main study period (MP) on Day 1. After this period, those who received NT 201 can enter an open-label extension period (OLEX) where they will receive another injection of NT 201 on Day 1 of that phase. The study involves a double-blind design, meaning neither the participants nor the researchers know who receives the active drug or placebo during the main period. During the study, participants will be assessed using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) to measure improvement in platysma prominence at various time points, including Week 2 and up to Week 17 in the main period. Both investigator and participant assessments will be used to evaluate the degree of improvement. Satisfaction questionnaires and global aesthetic improvement scales will also be used to measure participant satisfaction and aesthetic changes. Safety and efficacy will be closely monitored throughout the study, which lasts through the main and extension periods.

Researchers are studying how the medicine PF-08653944 affects the speed at which the stomach empties food after eating in adults who are overweight or have obesity. This Phase 1 open-label study aims to understand how the medicine moves through the stomach and to monitor its safety. The findings may help guide future research on this medicine. Participants will receive different doses of PF-08653944 through subcutaneous injections and may also receive a single oral dose of acetaminophen during several study periods. The study includes multiple experimental treatment periods where participants receive either PF-08653944 alone or combined with acetaminophen. During the study, researchers will measure acetaminophen levels in the blood to assess how the medicine affects gastric emptying and will monitor for any adverse effects from the treatments. The study safety and pharmacokinetics will be followed for about 11 weeks after the last dose. Participants' health will be checked through medical history, physical exams, lab tests, and ECGs throughout the study.

Researchers are investigating how acute preoperative pain affects the development of chronic postsurgical pain (CPSP) in patients undergoing emergency orthopaedic or abdominal surgery. Unlike scheduled surgeries where preoperative pain lasts weeks or months, emergency surgery involves intense but short-term pain. This study aims to clarify the long-term impact of this acute pain on CPSP occurrence three months after surgery. Participants will be asked to complete a questionnaire 48 to 72 hours after surgery to share their pain experience and preoperative anxiety. Then, three months post-surgery, researchers will conduct a phone interview using a standardized questionnaire to assess the presence of chronic postsurgical pain. This approach allows evaluation of pain progression from acute to chronic phases following emergency surgery. During the study, patients' pain perception and anxiety levels shortly after surgery will be recorded, followed by a longer-term follow-up assessing the frequency of CPSP. The main measure is the occurrence of CPSP at three months. Participation involves questionnaires and phone interviews without additional treatments. The study is sponsored by Centre Hospitalier Universitaire, Amiens and is open to adults aged 18 and older undergoing emergency surgery.

This research aims to evaluate the added effect of Amantadine or Duloxetine when combined with Pregabalin on the development of post mastectomy pain syndrome (PMPS), a common chronic pain condition occurring after breast surgery. PMPS affects 20% to 50% of patients and is a type of chronic post-surgical pain. The study investigates how these medications might influence pain pathways and nerve excitability in patients undergoing modified radical mastectomy for breast cancer. Participants are assigned randomly to one of three groups. Two hours before surgery, one group receives Pregabalin 75 mg with a placebo tablet; another group receives Pregabalin 75 mg plus Amantadine 100 mg; and the third group receives Pregabalin 75 mg plus Duloxetine 30 mg. All treatments are continued twice daily for seven days after surgery. This double-blind study compares the effect of these treatments on pain development following mastectomy. During the study, researchers will monitor the occurrence of post mastectomy pain syndrome 12 weeks after surgery as the primary outcome. Secondary outcomes include patient quality of life, activity level, pain severity at 12 weeks, and opioid use during and after surgery. Side effects related to each medication are tracked for 48 hours post-procedure. Participants are evaluated through clinical assessments and medication monitoring over the course of the treatment and follow-up period.

Researchers are evaluating the effects of adding clonidine to propofol sedation in patients undergoing colonoscopy. The study aims to compare the safety, patient satisfaction, and efficiency of propofol alone versus propofol combined with clonidine. Colonoscopy is a common procedure used for prevention, diagnosis, and treatment of lower digestive tract conditions, and sedation improves patient comfort and procedure quality. The trial explores how clonidine, which acts on alpha2 adrenoceptors to produce sedation and analgesia, may affect sedation outcomes alongside propofol. Participants will be randomly assigned to one of two groups. One group receives propofol sedation maintained by continuous infusion via syringe pump, starting at 25-75 micrograms per kilogram per minute intravenously for 10 to 15 minutes, then adjusted based on clinical response. The other group receives an intravenous dose of clonidine (2 micrograms per kilogram) 30 minutes before starting propofol sedation, administered over 10 minutes. Sedation onset and dosing are carefully regulated to avoid unnecessary sedative exposure. During the study, patients will be monitored for heart rate and blood pressure throughout the colonoscopy procedure. Patient satisfaction and side effects will be assessed 24 hours after surgery. Researchers will track vital signs until the procedure ends and evaluate overall safety and comfort. The study runs from July to September 2024 and includes adults aged 18 to 65 undergoing colonoscopy with specific health criteria.

Hypertension is a major cause of cardiovascular disease and death, and many patients have uncontrolled blood pressure often due to not taking medications as prescribed. This research aims to study if testing urine for antihypertensive drugs can better detect medication non-adherence in patients with hypertension, including those who recently had a stroke. The study will evaluate whether identifying non-adherence and providing targeted counseling can improve medication use and blood pressure control. The study has three parts: first, reviewing urine samples from 200 patients who recently had a stroke to check medication adherence; second, enrolling 100 patients with poorly controlled hypertension to assess adherence prospectively; and third, counseling participants found to be non-adherent and reassessing them at 3 and 6 months. Urine samples of 50ml will be collected during visits for mass spectrometry analysis to detect medication levels. Participants will attend study visits at enrollment, 3 months, and 6 months, providing urine samples each time. Researchers will measure changes in medication adherence rates and blood pressure, including systolic and diastolic values, over 6 months. The study aims to improve adherence and blood pressure control, potentially reducing healthcare visits and serious cardiovascular events.