Treatment Trials

72 Clinical Trials for Various Conditions

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COMPLETED
Mom Power is an Attachment Based Parenting Program for Families and Their Children
Description

Mom Power is a weekly attachment based parenting program aimed to increase parenting and self-care skills for families.

Conditions
COMPLETED
The Impact of Familiarity and Emotional Attachment on the Visual Processing of Faces
Description

This study uses functional magnetic resonance imaging (fMRI) to look at brain activity while patients view pictures of people's faces that they are familiar with or have emotional attachment to. The functional MRI (fMRI) procedure allows researchers to "see the brain at work." It uses the same powerful magnetic fields and weak electromagnetic radiation (radiowaves) as standard structural MRI. However, functional MRI can also show areas of increased blood flow, which relates to increased activity by brain cells. This research study builds on previous studies that identified specific areas of the brain that are activated by visual stimuli showing faces. However, previous research used anonymous faces as stimuli. This study will use faces of individuals known to the patient. There are three experiments that will be conducted in the study; 1. Experiment 1 will attempt to determine the effects of familiarity of the photographed face on brain activity patterns. Patients will view familiar faces, the faces of close friends and relatives, and the faces of famous people. 2. Experiment 2 will look at how maternal attachment affects the response to visual stimuli. Mothers will view pictures of their first born child, as well as those of familiar children to whom they are not related, unfamiliar children, and unfamiliar adults. 3. Experiment 3 will explore the effects of interpersonal attachment and loss on response to visual stimuli. In this experiment, bereaved spouses will view pictures of their deceased spouse, those of living family members, and those of unfamiliar people.

RECRUITING
Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors
Description

Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. As Invisalign has increased in popularity and demand over the past two decades, clinical trials have shed light on the efficacy of Invisalign treatment. there have been changes in the Invisalign protocol such as introduction of SmartForce features in 2008, such as optimized attachments as well as the implementation of SmartTrack aligner material in 2011. Compared to conventional fixed orthodontic appliances, Invisalign cannot be adjusted on a visit-to visit basis. If ideal tooth movement has not been achieved after completion of the first sequence of aligners, additional trays, known as refinement trays, are required.

RECRUITING
Comprehensive SRS Regenerex Tissue Attachment
Description

The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty.

ENROLLING_BY_INVITATION
Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.
Description

Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.

NOT_YET_RECRUITING
Relationship Between Oxytocin Level, Trust, and Attachment in Individuals With Borderline Personality Disorder
Description

We aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls. Primary Hypothesis (H1): There is a significant difference in trust-related behavior as measured by oxytocin (OXT) levels between borderline personality disorder (BPD) patients and healthy controls. Secondary Hypotheses: H2: The trust-related behavior in BPD patients is significantly influenced by their level of emotional sensitivity. Specifically, higher emotional sensitivity in BPD patients is associated with lower trust-related behavior and vice-versa. H3: There is a significant correlation between trust-related behavior and childhood trauma in BPD patients. BPD patients with higher levels of reported childhood trauma will exhibit lower trust-related behavior compared to those with lower levels of trauma. H4: Trust-related behavior in BPD patients varies depending on their attachment styles. Specifically, BPD patients with insecure attachment styles will exhibit lower trust-related behavior compared to those with secure attachment styles. H5: There is a significant correlation between trust-related behavior and BPD severity. Patients with more severe BPD symptoms will exhibit lower trust-related behavior compared to those with less severe symptoms. H6: The levels of OXT in BPD patients will significantly correlate with their reported levels of emotional sensitivity, childhood trauma, attachment styles, and BPD severity. These hypotheses aim to address the complexities surrounding the modulation of trust-related behavior by oxytocin in BPD patients, taking into account various factors like emotional sensitivity, childhood adversity, attachment styles, and BPD severity. By testing these hypotheses, the study aims to provide a comprehensive understanding of the interplay between these factors in influencing trust-related behavior in BPD patients.

RECRUITING
Partners in Children's Health (CSN): a Randomized Trial of an Attachment Based Intervention
Description

The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group.

TERMINATED
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
Description

In this study, participants will be imaged using two Optical Coherence Tomography (OCT) devices: device N, a standard conventional OCT device with an invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional OCT device with no invention attached. The investigators will assess whether the chin and forehead rest attachment (invention) provides a more comfortable experience for patients.

COMPLETED
The Attachment, Regulation and Competency (ARC) Framework
Description

This study evaluates the effectiveness of the Attachment Regulation and Competency (ARC) treatment framework in comparison to treatment as usual for reducing symptoms of PTSD and Developmental Trauma Disorder among children ages 8 to 16 with a history of exposure to multiple traumatic events.

ACTIVE_NOT_RECRUITING
Attachment and Biobehavioral Catch-up and Depression Treatment
Description

Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both. This project assesses the efficacy of an intervention that treats both mothers and children in an integrated manner. Effects are expected to disrupt the reciprocal relations that perpetuate maternal and child mental health problems over time.

COMPLETED
Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors
Description

The purpose of this research is to test which of four clear aligner attachment types is more efficient in extruding (erupting) maxillary lateral incisors vertically into correct position during orthodontic treatment.

UNKNOWN
Attachment-Based Family Therapy for Adolescents With Binge Eating
Description

The purpose of this study is to examine whether Attachment-Based Family Therapy (ABFT), a well-validated treatment for adolescents with depression and suicidality, is feasible and acceptable for adolescents with binge eating and their families.

COMPLETED
An Attachment Based Approach for Anxiety and Depression
Description

The purpose of the current study is to examine the efficacy of Emotionally Focused Therapy for Individuals (EFIT) as a treatment for depression and anxiety. It is formulated as a trans-diagnostic treatment in line with the call for more transdiagnostic approaches to treat depression and anxiety given the many similarities in the underlying psychological and emotional factors of these disorders, the high levels of co-morbidity, and the preliminary success of transdiagnostic treatment approaches. EFIT has been formulated as an attachment-based alternative to current cognitive transdiagnostic approaches. The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions. EFIT has been formulated for the first time this year in the book that will serve as the therapy manual for this study. The current study aims to examine EFIT outcomes as compared to a control group (a wait-list control followed by online CBT intervention after the wait period). In particular, this research project aims to distinguish differences in initial and follow-up outcomes between EFIT versus control, and demonstrate significant changes in attachment/emotions and mechanisms of change across EFIT sessions. The primary hypotheses are outlined below.

COMPLETED
Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop
Description

Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos. Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

COMPLETED
Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment
Description

In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment. Study participants will interact with a standardized patient educator (SP) wearing the Lactation Simulation Model and using two baby dolls in a randomized order.

COMPLETED
Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
Description

This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.

UNKNOWN
3D Maternal Fetal Attachment and Smoking
Description

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby

TERMINATED
Evaluating Parent Engagement, Attachment, Stress, and Satisfaction With Remote Rounding in the NICU
Description

The admission of a newborn child to the neonatal intensive care unit (NICU) is among the most distressing situations that parents can face. There are many sources of parental stress including loss of control and competing demands outside of the NICU involving work and other children. During a prolonged admission it is often difficult for families to be present at bedside rounds on a daily basis and thus more difficult to discuss and collaborate with families in the care of their child. Healthcare has been slower than many other fields to adapt to the availability of new technology. This study hypothesizes that the use of wireless technology to allow parents to remotely participate on rounds would improve parental stress and satisfaction, in addition to improving engagement and attachment to their infant.

COMPLETED
Attachment and Biobehavioral Catch-up for Depression
Description

The overarching goal is to pilot the Attachment and Biobehavioral Catch-up (ABC) intervention for mothers with heightened depressive symptom and their children with heightened internalizing symptoms.

COMPLETED
Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment
Description

This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.

COMPLETED
Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas
Description

This study evaluates whether the use of a disposable colonoscope attachment, Endocuff Vision, can increase the detection of sessile serrated adenomas. Participating patients will be randomized to receive either standard colonoscopy or colonoscopy with the Endocuff Vision.

COMPLETED
Effect of Locally-Applied Simvastatin on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Description

The purpose of this study is to determine of local application of commericially-available, FDA-approved preparation of simvastatin is effective in increasing clinical attachment levels (primary outcome), as well as alveolar bone (secondary outcome) compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects undergoing PMT at the UNMC College of Dentistry clinics will be recruited to participate in the randomized one-year clinical trial based on the following eligibility criteria: 1) diagnosis of chronic advanced periodontitis (generalized or localized), 2) participating in regular PMT visits (3-6) month intervals), 3) no systemic diseases or medication which significantly impact periodontal inflammation or bone turnover (e.g. steroids, bisphosphonates, \> 325 mg aspirin/day and in good general health, 4) one experimental quadrant of the mouth with an inflamed 6-9 mm interproximal posterior periodontal pocket with history of bleeding on probing (BOP), 5) willingness to sign consent form. Subjects will be divided into two groups for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of the simvastatin-methylcellulose gel or 2) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of methylcellulose gel alone. Samples/measurement will be obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during PMT: 1) digital radiographs (baseline and 12 months only; bone height measurements), 2) presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid (GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month visit, the research-specific intervention and measurements in the experiment quadrant will be removed from routine PMT.

COMPLETED
Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment
Description

The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.

Conditions
COMPLETED
Evaluation of Cutera Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment
Description

Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment

COMPLETED
Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment
Description

Open-label, Prospective, Study to Evaluate the Cutera excel V laser at 532 nm in a low fluence, high repetition rate mode and the Micro-Lens Array attachment used with excel V laser at 1064 nm and 532 nm for the improvement of skin quality.

COMPLETED
Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Description

The purpose of the study is to determine the effect of enamel matrix protein derivative on an inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix derivative protein with increase the clinical attachment level is localized sites of advanced periodontal disease.

COMPLETED
Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment
Description

The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and subsequently submitting a questionnaire and hold an interview with the operator. Of special interest for the study is to confirm whether the illumination level of SL-D301 is enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower than other existing Topcon digital ready slit lamps due to regulations that limit the maximum light intensity on the human eye. The SL-D301 will be compared against the predicate device SL-3G.

Conditions
COMPLETED
Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Description

The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.

WITHDRAWN
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy
Description

The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.

COMPLETED
Slit Lamp and Digital Camera Attachment
Description

The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.