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Placebo - ClinicalTrials.gov

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Last Updated: 26 September 2022

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A Placebo Controlled Study of Colesevelam in Fecal Incontinence

Clonidine reduced the number of days with FI among patients with diarrhea; however, the findings were not statistically significant. According to uncontrolled studies, the bile acid binding resin colesevelam also raised stool consistency in patients with functional diarrhea. Patients with urge or mixed type of FI would suffer bowel symptoms if they were to compare the results of a combination of colesevelam and clonidine to placebo in this research.

Source link: https://clinicaltrials.gov/ct2/show/NCT02628626


Neurobiological Underpinnings of Placebo Response in Depression

If we determine the role of dopamine in placebo reactions and we know how the placebo response mechanistically takes place, we might be able to develop new drugs that may reduce the placebo effect in clinical trial participants and significantly reduce the sample size of studies, increasing the effect size and decreasing the sample size. On a topic of clinical trial research, dopamine does not appear to be a causal correlate. In addition, if we can identify biosignatures of placebo effect and use them to predict response, we may well increase samples with placebo responders, which could lead to increased signal detection in a clinical trial.

Source link: https://clinicaltrials.gov/ct2/show/NCT02562430


Placebo Controlled Double Blind Crossover Trial of Metformin for Brain Repair in Children With Cranial-Spinal Radiation for Medulloblastoma

We conducted a pilot randomized, double-blind, placebo-controlled trial with crossover in pediatric brain tumor survivors with primary endpoints of safety and reliability as well as secondary endpoints of cognitive and magnetic resonance imaging studies. In either a group AB or group BA sequence, twenty-four participants were recruited and randomly assigned to complete 12-week cycles of metformin and placebo. After a 10-week washout period at 22 weeks, and 4, after a 10-week washout period at 22 weeks, 2. after 12 weeks of monitoring, and 4. after a 12-week washout period at 22 weeks, and 4. after a 10-week washout period at 22 weeks ruled out the study.

Source link: https://clinicaltrials.gov/ct2/show/NCT02040376


Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer

As determined by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale in fatigued advanced cancer patients at the end of one week, the effects of open labeled placebo one tablet twice a day could be determined twice a day relative to waitlist control for reducing cancer-related fatigue. At the end of 1st and 4th weeks, the aim is to determine the effects of OLP on fatigue symptom composite score. In the absence of disease progression, patients receive open labeled placebo orally twice a week. In the absence of disease progression, patients receive open labeled placebo BID for three weeks beginning in week 2.

Source link: https://clinicaltrials.gov/ct2/show/NCT03927885


NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

Behavioural addictions [gambling disorder, food addiction, or sexual abuse] may result in devastating consequences. BAs have been shown to be extremely similar to heroin use disorders, as well as heroin use disorders. Hunger is a defining clinical similarity between those disorders and relapse; one of the few common medical characteristics has been traced to decreased control over the behavior and relapse. Both excitement for rewarding behaviors and hunger can be reduced by lowering dopamine neurotransmission in the reward circuitry. Compared to naltrexone, nalmefene has a higher safety rating. No research has been done on nalmefene's efficacy as a pan-addiction drug for BAs to date. Two clinical trials have established its safety for the treatment of GD, but no clinical trial was conducted for FA and SA. In several BAs, the investigators estimated that nalmefene, compared to a placebo, may have a therapeutic effect as an add-on to the usual treatment for reducing craving.

Source link: https://clinicaltrials.gov/ct2/show/NCT05540288


HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study

The use of corticosteroids in patients with severe community pneumonia, a bacterial disease that kills many patients around the world, reduces morbimortality. However, there are no studies involving steroids for patients in intensive care with nosocomial pneumonia, among which are those with ventilator-associated pneumonia, infections that cause a high mortality rate. In the case of critical care patients with nosocomial pneumonia, the aim of this research is to compare hydrocortisone versus placebo, both with standard therapy. Methods: multicenter randomized, open-label controlled trial, with two parallel groups: hydrocortisone or placebo, both related to nosocomial pneumonia's common treatment. Every eight hours, or until the patient's death, an Intravenous 100 mg of hydrocortisone and normal saline will be tested for five days or until intensive care unit discharge or death. Early clinical decline between the patient's enrollment in the study in the third and seventh days will result in early clinical failure. In addition, we will investigate adverse events and there will be a safety interim report after 25% of the entire sample is selected, which may cause the analysis to be delayed in the case of a high incidence of such activities. With p 0. 001, the primary result will be delayed only if there is a statistical significant difference regarding the primary outcome. This will be the first multicenter controlled trial to evaluate hydrocortisone plus standard therapy in critical care patients with nosocomial pneumonia.

Source link: https://clinicaltrials.gov/ct2/show/NCT05354778


The Effects of Hydrocortisone, Melatonin, and Placebo on Symptoms of Jet Lag

Generally, jet lag is characterized as daytime sleepiness, exhaustion, and poor mental performance, but it can also include weakness and irritability. A question that has not been fully answered is what underlies jet lag. Although a time shift does not effect the total daily amount of cortisol that is unknown, the cortisol secretions' temporal system is distorted, and the circadian rhythm does not re-entrain for several days, and the circadian rhythm does not re-entrain for several days. According to this, the first few mornings in a new time zone can be considered cortisol-deficient because the traveler does not experience cortisol's peak at time of awakening. Taking exogenous glucocorticoids at the right time will help entrain the circadian rhythm and result in less jet lag. According to a new meta-analysis, taking melatonin can reduce jet lag symptoms. The aim of the present research is to attenuate jet lag symptoms with hydrocortisone, melatonin, a mixture of both hydrocortisone and placebo, with hydrocortisone, melatonin, or placebo. On wake-up and at bedtime on one day before flying and at the new destination for days 1 - 10, 7, and 10 after arrival, participants will also get salivary samples of cortisol and melatonin on awakening and at bedtime. For three days and four days before and four days onboard, and on days 7, and 10, the passengers will sleep logs and fill out a symptoms questionnaire daily.

Source link: https://clinicaltrials.gov/ct2/show/NCT00097474


The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

Motility disorders are common in childhood and can cause a variety of signs including recurrent vomiting, abdominal pain, and distension. Amoxicillin-clavulanate, a member of the second group, has been shown to improve fasting small intestinal motility in adults and children. AMC is a combination of amoxicillin and clavulanic acid, a u03b2-lactamase inhibitor. Although both AMX and AMC are generally well tolerated, AMX can have fewer adverse effects due to the presence of the CA moiety in AMC, although AMX and AMC are both well tolerated. Patients on AMC have an elevated risk of antibiotic-associated diarrhea in a research of outpatient children. Patients taking AMC are also more likely to suffer from a drug-related liver disease. In light of the emergence of u03b2-lactamase inhibitor-resistant bacterial strains that have grown in excess antibiotic use, it is advisable to use the most narrow spectrum antibiotic with high success in light. Compared to placebo, the aim of this research is to determine whether a single dose of AMX has an appreciable effect on upper gastrointestinal motility. The primary result of the study will be the induction of phase III of the interdigestive migrating motor complex by AMX. MMCs are periodic waves of electrical activity that result in muscular contractions that penetrate the walls of the stomach and intestinal tract during the fasting state. Secondary findings will include characteristics of the MMC, patient demographics in responders and non-responders, and the safety profile of AMX at the intervention dose.

Source link: https://clinicaltrials.gov/ct2/show/NCT01530009


A Double-Blind, Placebo-Controlled Trial of Metformin in Individuals With Fragile X Syndrome

This is a single-center research at the UC Davis MIND Institute for fragile X syndrome patients aged 6 to 25 years old. Metformin has emerged as a potential treatment of FXS based on animal research demonstrating the rescue of multiple phenotypes in the FXS model. Metformin can help to normalize signaling pathways in FXS in the central nervous system, including those of mTOR and PI3K, which have both been pathogenically overactive in FXS. Metformin appears to be a good candidate for targeting several of the intracellular functions of neurons that have been blocked in FXS and, therefore, has the ability to treat several types of FXS-related disorders. Metformin has been used in the clinical care of over 20 people with FXS between the ages of 4 and 58 years, and has found the drug to be well tolerated and to have benefits not only in lowering weight gain and normalizing appetite, but also in terms of language and behavior. This will involve three visits to the UC Davis MIND Institute as well as 5 phone calls. Throughout the study, the researchers will also investigate the study's side effects as well. The following IRB-approved protocol updates were updated on 9/26/2018, including errors regarding "digital" books for the primary outcome measure, as this measure is administered using printouts. The Anxiety Depression and Mood Screen were substituted by the Anxiety Depression and Mood Screen as a secondary outcome indicator.

Source link: https://clinicaltrials.gov/ct2/show/NCT03479476

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions