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NCT ID: NCT05263895 Completed - Bioavailability Clinical Trials

Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation

Start date: March 3, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to estimate the relative bioavailability of PF-07321332 in different formulations in healthy adult participants.

NCT ID: NCT05263752 Completed - Bile Duct Diseases Clinical Trials

Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease

Start date: October 18, 2017
Phase:
Study type: Observational [Patient Registry]

A previous study evaluating the NvisionVLE® Imaging Low Profile System revealed the system to be feasible and safe for use in bile duct. The study also revealed a potential to better define abnormalities, target sampling and therapy when utilizing the NvisionVLE® Imaging Low Profile System. This study will further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct diseases.

NCT ID: NCT05263635 Completed - Anxiety Clinical Trials

Music Therapy in the Treatment of Perioperative Anxiety and Pain

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

A large number of adults who undergo surgery experience perioperative anxiety and pain. The current recommended approach to perioperative pain management is a multimodal approach including opioids. Evidence has demonstrated that the pharmacological management of pain and anxiety is often associated with side effects which limits patient satisfaction and their ability to be discharged from the hospital. Furthermore, it is established that perioperative level of pain is directly correlated to anxiety, depression, and catastrophizing and these are significant predictors for the level of postoperative pain, as well as at the hospital length of stay. Therefore, considerations have been given to the use of non-pharmaceutical complementary approaches to management of anxiety including pre and postoperative use of music. The benefits of music therapy on anxiety has been reported using several surgical models and conditions in adults (cancer, hysterectomy in cancer) and children, prior to surgery and after. The objective of this study is to investigate the effects of music interventions on anxiety and pain in adult populations undergoing diverse types of minor surgery indicate that music therapy significantly reduces both post operative anxiety and pain in adults receiving music interventions before, during, or after surgery.

NCT ID: NCT05262920 Completed - Pain, Acute Clinical Trials

Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study

PROMPT
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal well-being and infant's health, physical growth, and development. The highest rate of BF cessation occurs within 3 weeks after birth, with 30% of women ceasing BF due to acute breast and nipple pain (BNP). BNP is a complex and understudied biobehavioral phenomenon involving nociceptive signalling that stimulates multiple pain pathways. Women who experience BNP beyond BF initiation report lower BF self-efficacy a key predictor of BF at 6 months, increased maternal distress symptoms, and may differ across races contributing to differences in early BF cessation rates. The investigators developed and tested a 6-week nurse-led and participant-informed, Breastfeeding and Breast and Nipple Pain Self-Management (BSM) intervention guided by the Individual and Family Self-Management Theory. Aligned with the needs and preferences elicited from a diverse sample of BF participants, the investigators used a cloud-based platform, to deliver BF knowledge and skills, and provided support through nurse-led text-based communication to decrease BNP, increase BF self-efficacy, decrease burdensome face-to-face visits, and increase adaptive coping behaviors. Participants in the BSM intervention group reported significantly reduced BNP intensity at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks. Based on these promising results, the investigators propose to examine the efficacy of the BSM intervention in an R56 RCT, Promoting Self-Management of Breast and Nipple Pain Using Technology (PROMPT) for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity. The study will reproduce and extend the pilot findings by exploring in a diverse population of BF participants, how participants' pain sensitivity affects BNP. The study will explore the moderating role of BNP, and maternal well-being symptoms of fatigue, depressive symptoms, anxiety, and sleep, pain, pain coping, and maternal self-efficacy, on BF exclusivity. Participants (N = 222) intending to breastfeed will be randomized to the BSM intervention or the attention control group with assessments performed at baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks. Study results will advance knowledge on the BSM intervention, with direct implications for nurse-designed and led self-management interventions in clinical settings or health care systems.

NCT ID: NCT05262738 Completed - Obesity Clinical Trials

Misoprostol Dosing in BMI Greater Than 30

MD30 RCT
Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.

NCT ID: NCT05262725 Completed - Opioid Use Disorder Clinical Trials

Behavioral Activation for Opioid Use Disorder

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

The overall purpose of this pilot study is to evaluate the feasibility and acceptability of values-based behavioral activation (BA) as an adjunct intervention for patients receiving medications for opioid use disorder (OUD) in primary care. Researcher will evaluate the following aims: 1) examine the feasibility of BA for OUD in primary care, 2) examine whether the BA intervention and study requirements are acceptable to participants, and 3) determine the psychometric properties of the outcome measures in people with OUD. Participants will complete 4-6 brief counseling sessions over the course of 12 weeks. During the first session, participants will discuss values and recovery outcomes important to them. Next, they will set 2-3 personal goals to work on before the next BA session. At the follow-up sessions, participants will update the counselor on progress made or challenges experienced. Personal values will be reviewed and participant goals updated. Study measures (surveys and urine drug tests) will be completed at the start, partway through, and at the end of the intervention.

NCT ID: NCT05262075 Completed - Mindfulness Clinical Trials

Online Mindful & Resiliency Program Intimate Partner Violence

Start date: January 26, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women.

NCT ID: NCT05261451 Completed - Trauma Clinical Trials

Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

This study will utilize a pre/post mix method design Quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops. Qualitative data will be obtained through interviews post- workshop and consultations.

NCT ID: NCT05261386 Completed - Clinical trials for Meibomian Gland Dysfunction

Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction

Start date: March 4, 2022
Phase: Phase 2
Study type: Interventional

Study Design Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study Duration: 1 month of TID treatment Treatment Groups, Dosing, and Treatment Regimen Study Treatment: CBT-008 topical ophthalmic solution Control Treatment: CBT-008 vehicle

NCT ID: NCT05261269 Completed - Clinical trials for HER2-negative Metastatic Breast Cancer

A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer

Start date: February 2, 2022
Phase: Phase 1
Study type: Interventional

This was an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib: - Part A is dose escalation of single agent DAN-222 - Part B is dose escalation of DAN-222 in combination with niraparib