1,865 Clinical Trials for Various Conditions
This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.
This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.
Adolescents may have limited time to engage in physical activity during the school day prompting investigations of before and after-school times along with time efficient programming. High-resistance circuit training has been used as a time effective protocol, however adolescents have yet to be studied. The primary aim was to assess feasibility (recruitment, sample size, consent rate, retention rate, fidelity, attendance, adverse events, and participant experience) of a high-resistance circuit training or strength training intervention, conducted before or after-school. The second aim was to explore changes in body composition, strength, and aerobic fitness. Researchers compared feasibility outcomes as well as participant experience between time frames and treatment group.
Transgender men (TGM) have a high incidence of sexually transmitted infected (STIs), including HIV, HPV and bacterial N. gonorrhea and C. trachomatis. In addition, TGM who start testosterone therapy (TT) experience significant vaginal morbidity that causes vaginal dryness and pain, due to the estrogen-inhibiting effects of TT on vaginal epithelium. Vaginal dysbiosis is a known contributor of increased STI risk and vaginal symptoms. In a future study, the investigators are planning a randomized trial of a 6-month oral Lactobacillus probiotics intervention in TGM on TT at the Callen-Lorde Community Health Center (CLCHC), New York City to determine whether this intervention can improve vaginal health in TGM on TT. In this study, the investigators will conduct a pilot and feasibility study to precede the main trial. The investigators will randomize 30 TGM on TT to receive either the intervention (consisting of Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001) or placebo (maltodextrin) for 4 weeks, evaluating the intervention's impact on vaginal microbiota and clinical outcomes, as well as its feasibility, acceptability, and adherence. This study will take place at the CLCHC Brooklyn site, aiming to gain pilot data, address feasibility and acceptability, and plan for the main trial accordingly.
The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are: 1. Is the Down Dog prenatal yoga app feasible for AA pregnant women? 2. How does mental and physical health change after using the Down Dog app for 12-weeks? 3. What cultural adaptations to the Down Dog app are needed? The study lasts for 12 weeks and participants are asked to: * do prenatal yoga with the app for at least 20 min/day, three days/week, from home * wear a Garmin Vivosmart 5 watch daily * complete four online surveys * complete an optional virtual interview This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes.
This study will assess the feasibility and efficacy of 3 treatments to increase physical activity during and after inpatient rehabilitation (IPR) for new spinal cord injuries: 1. Program of sprint interval training (SIT) on an arm crank ergometer during IPR 2. SIT + Provision of an arm ergometer (ERGO) for home use 3. SIT + ERGO for home use + Motivational interviewing to increase adherence to exercise during and after IPR. The primary outcome is minutes per week of moderate to vigorous physical activity at 6 months after IPR discharge. Secondary outcomes include peak power on the 6-Minute Arm Test at IPR discharge and self-reported physical activity, depression, fatigue, pain, community participation, and quality of life at 6 months after IPR discharge. The investigators will obtain data on feasibility, acceptability, and perceived benefits of the treatments from stakeholders. The results of this pilot study will inform the design of a larger randomized trial.
The goal of this clinical trial is to test the feasibility of the Individualized Positive Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to deliver the IPPI and track impact through data collected in the electronic medical records. Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over the course of 6 months.
This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). The study had three primary aims to assess overall feasibility; 1) explore the feasibility of delivering eMB to couples by assessing recruitment, retainment, and adherence, 2) examine eMB's preliminary efficacy for reducing PMAD symptoms, and 3) describe participants' satisfaction and perceptions about eMB acceptability. The intervention group received the 8-week eMB and the control group received an informational resources sheet.
This is a research study evaluating the implementation of a clinic workflow to encourage pre-visit laboratory testing, such as blood work. The purpose of this research is to understand provider and patient satisfaction with clinic workflows to support pre-visit laboratory tests (blood work) for annual physical and wellness visits. Providers and staff at participating sites will be approached to fill out an anonymous survey regarding experiences with implementation of the pre-visit laboratory testing workflow. Additional data from NorthShore's Enterprise Data Warehouse (EDW) will be collected to assess the pre-lab test rate before implementation, at 6 months, and 12 months, in addition to provider and staff time efficiencies and patient satisfaction as assessed by surveys.
The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).
The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study of melatonin intervention for poor sleep quality. Participants (N=60) will be sent a Fitbit device and 3 smart pill bottles, with one containing 3 mg of melatonin, one containing 0.5 mg of melatonin, and the final bottle containing a placebo pill. The first two weeks will be a baseline period, where no supplement is assigned, but data are collected, including self-report of sleep quality and duration and accelerometer-derived sleep and activity data. After successful completion of the baseline period, participants will be randomized to six 2-week intervention blocks of a 3 mg dose melatonin, a 0.5 mg dose melatonin, and a placebo. At the end of the trial, participants will be asked to complete the System Usability Scale, a satisfaction survey (electronic or phone/video call if they are non-responders), and participate in a virtual interview (such as over Microsoft Teams or a phone call) to inform feasibility and acceptability of protocol requirements, study materials, and personalized reports.
The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.
The purpose of this research is to determine whether Ripple Health Smart Medicine Bottle Caps can allow for better interface medication administration than traditional pill bottles. A secondary goal of the study is to determine whether the smart medication caps can allow the physician to intervene in the patient's health regimen when necessary. This occurs when the patient does not take medication for reasons such as the painful side effects of the medication, or the high cost of the medication itself. By intervening, a physician can therefore help increase patient adherence, and improve transparency between the patient and the physician The bottle cap is in essence a pill bottle that contains circuitry in the cap of the bottle, which sends data to a physician over a wifi network. Once the patient opens the pill bottle, sensors inside the bottle cap will trigger, and send data to the web server indicating that the patient has taken the medication(we are assuming that the patient takes the medication if he/she opens the pill bottle). The server will then add this data into a database that is available to the physician to view. In this study, the proposed use of this pill bottle is as a simple medication container that gets opened when the patient needs to take his/her medication.
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Behavioral interventions do not have these adverse effects, but they are not as effective. Mindfulness is a candidate intervention for ADHD in elementary school children, but has not been systematically and rigorously studied. This study will evaluate the feasibility and acceptability of Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is designed for children at precisely the age when ADHD-relevant neurocognitive systems are developing and clinical symptoms begin to appear. Forty-five children from the New Haven, CT area, ages 7-13, will be recruited to participate in this randomized-controlled feasibility trial that will compare MBAT-C, medication, and a combined intervention.
This Personalized Trial will test the feasibility and effectiveness of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified fatigue. Participant's initial levels of fatigue and other outcomes will be assessed in a baseline period 2 weeks in length. Participants will spend 12 weeks alternating between bright light therapy, dim light therapy, and usual care methods to treat their fatigue, while answering daily questions and wearing an activity tracker. After 14 weeks, participants will have the ability to share their opinions about the Personalized Trials platform. The investigators believe a Personalized Trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.
This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months prior to the cancer showing up on usual body imaging or other lab tests. Finally, the investigators hypothesize that, for patients undergoing medical treatment for their cancer, trends in the amount of cancer DNA in the blood stream will correlate with the effectiveness of treatment.
In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during weekly hospice visits to prepare caregivers for proper use of hospice support and healthcare services
The objective of this study is to test and disseminate tools that drive successful immediate postpartum Long-Acting Reversible Contraception (LARC) implementation. The long-term goal is to reduce unintended pregnancy soon after childbirth by increasing access to immediate postpartum LARC for women who desire it.
This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.
This is a pilot, multicenter, prospective, randomized controlled study to evaluate the feasibility of an innovative medication adherence intervention utilizing a web-based, mobile medication management application \[MedActionPlan® (MAP)\] to encourage self-management by reinforcing adherence and education about treatment regimens in Participants with cystic fibrosis (CF) (ages 12 years and older). Outcomes of interest for this study are 1) feasibility of MAP in real-world setting which will be evaluated using patient/caregiver and clinician feedback regarding value, ease of use, and challenges with use, 2) effect of MAP on patient/caregiver knowledge and perception of medication use, 3) effect of MAP on adherence to inhaled and oral medications used in chronic management of CF. Preliminary data regarding outcomes on exacerbations, lung function, and health care system utilization (e.g., emergency department visits, hospitalization) will also be examined as part of this study.
This is a feasibility study of a culturally adapted version of Healthy Dads Healthy Kids for Hispanic families. The adapted version called Papás Saludables, Niños Saludables is a father-targeted program for child obesity prevention and weight loss for fathers. The feasibility study will be conducted with 40 Hispanic families. Baseline assessments (T0) will be completed on all participating family members, followed by randomization to start the program immediately (intervention group), or 6-7 months later (wait-list control). Post assessments (T1) will be completed on the full sample once the intervention group has participated in the 10 week Papás Saludables, Niños Saludables program. A process evaluation will be conducted to assess the feasibility outcomes of the study.
This study will assess and evaluate conference attendance feasibility and will gather feedback about preferences and barriers to attendance at the American Society for Nutrition annual conference.
The objective of this pilot study is to assess overall feasibility prior to embarking on a larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation with NS versus LR for pediatric patients with suspected septic shock. Necessary feasibility assessments include ensuring appropriate compliance with study fluid in each of the two arms, effectiveness of study enrollment using a pragmatic study design embedded within routine clinical practice, and acceptability of using Exception from Informed Consent (EFIC).
As part of the development of the Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the feasibility of assessing economic and sexual risk behaviors using text messages. The team will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, and un/under-employed. Participants will complete a text-messaged survey each week for 5 weeks. The study team will collect information about the number of participants who respond to the weekly survey, the number of questions to which they respond in each survey, and the number of hours from sending a survey to participants to receiving their response. As an exploratory aim, participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain qualitative feedback from participants regarding text messages they most and least liked. The survey is not designed to evaluate the effectiveness of the text message intervention.
The purpose of this study is to examine the feasibility of conducting a pilot randomized controlled trial comparing mindfulness-based stress reduction with the health enhancement program on symptoms of urinary urge incontinence in older adult women, and to establish preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.
The purpose of this study is to investigate the feasibility and acceptability of the Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported outcome (PRO) measure to monitor clinical progress in participant-identified goal areas in individuals with hemophilia A.
Test the feasibility of performing worksite screening of Hypertension, Diabetes and Hyperlipidemia for six months
Scant data have been reported on the effects of weight self-monitoring during weight control. The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?
This feasibility study will allow for the determination of the in vivo recovery and time of dialysis to optimize a future thorough microdialysis study. This is a single session, open label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects. Three healthy subjects will be enrolled and complete the study procedures. Subjects will be admitted to the research unit on Day 1 and three microdialysis probes will be placed in the thigh of each subject prior to the start of the microdialysis procedure. After normal saline solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes. Saline perfusion will occur during the washout period. Microdialysis sampling will be done for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection will continue every 30 minutes for 4 hours. The approximate duration of study including follow-up is 4 days.
The purpose of this study is to test whether it is feasible to provide a smoking cessation program together with a yoga program to help women quit smoking. We anticipate that women will be enthusiastic about the program and that we will be able to recruit and treat women for smoking cessation within the designated time frame.