Treatment Trials

15 Clinical Trials for Various Conditions

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COMPLETED
Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
Description

A blinded randomized control trial in living kidney donors. The study group will receive a liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general anesthesia. The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes.

NOT_YET_RECRUITING
Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
Description

The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. There is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in MS. Physical activity has beneficial effects on many of the consequences of MS, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in MS. The proposed research examines the effect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS. The research proposed, if successful, will provide evidence for the efficacy of physical activity as a translatable approach for managing sexual dysfunction among women with MS.

COMPLETED
Defining Sexual Activity
Description

This will be a descriptive study using patients from the Urogynecology and Urology University of South Florida Clinics and Urology clinic at Tampa General Hospital Healthpark on 30th Street to analyze the impact of demographics on the definition of being sexually active. It is believed one's demographics influence their definition of being sexually active.

COMPLETED
Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
Description

The purpose of this study is to determine the amount of cardiac work as measured by heart rate and blood pressure during physical exertion compared to sexual activity.

UNKNOWN
A Mother's Role in Delaying Onset of Sexual Activity in Her Children
Description

The goal of this study is to enhance the mother's role in promoting avoidance of sexual risks and problem behaviors in 6- to 12-year-old children. Consenting mothers will attend a 10-session program designed to enhance the quality of mother-child communication, identify sexual risks, and increase parental monitoring and self-efficacy.

UNKNOWN
The "Reach For Health" Program: Delaying Sexual Activity in Children
Description

Working with multiple schools in Brooklyn, NY, this study will develop and evaluate school- and community-based strategies designed to reduce early sexual activity and risky sexual behavior in middle school-aged children. These strategies will focus on parent education, classroom health curriculum, and learning through participation in community service.

UNKNOWN
Delaying Sexual Activity in African American Adolescent Girls
Description

This study will evaluate the effectiveness of a program designed to prevent early sexual behavior in middle school-aged African American girls.

COMPLETED
Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood
Description

The investigators will conduct a pilot study to assess the acceptability, feasibility, satisfaction, and participant-level outcomes among girls and their mother/female caregiver participating in a preconception health program. The program was developed through an extensive formative phase and is delivered weekly over \~3 months. The investigators will enroll a total of 60 female caregivers and their 8-11 year old daughters/female children to participate in the program and evaluation. Implementation data including acceptability, feasibility and satisfaction will be collected through REDCap and paper assessments completed after each program session and at the completion of the program. Preliminary impact data will be collected through REDCap up to 3 months post-intervention completion. The aims are as follows: 1. To understand if the preconception health program is feasible and acceptable among young girls and their mothers or female caregivers 2. To explore optimal implementation of the program to inform future research and scale up. 3. To assess preliminary impact of the preconception health program on girls' and caregiver's knowledge, cultural connectedness, caregiver-child relationship, community and school connectedness, coping skills, parenting self-efficacy, depression, quality of life as well as substance use behaviors and intentions and intention about sexual activity.

ACTIVE_NOT_RECRUITING
Vaginal Injection of Platelet Rich Plasma for Sexual Function
Description

The goal of this clinical trial is to learn about an injection of platelet rich plasma into the vaginal wall and around the clitoris. The main questions it aims to answer are: * To see if a PRP injection improves sexual satisfaction * To learn the effect of PRP injections on sexual function Participants will get assigned to getting a one time PRP injection or a placebo injection. They will answer questionnaires about their sexual function at their first visit and their followup visit. The investigators will then compare the two groups.

COMPLETED
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
Description

The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

COMPLETED
Survivors of Sex Trafficking: Occupation-Based Interventions for Executive Functioning
Description

Persons traumatized through sex trafficking can demonstrate similar neurobehavioral and executive function (EF) deficits as persons with cortical injuries. In this pilot study, occupation-based activity (OBA) programming was implemented at a residence for females who had been trafficked. The study hypothesis was that OBA would facilitate development of EF skills in these clients, enabling more successful occupational performance. Method: Eight women engaged in OBA sessions over the course of eight months. Session objectives were to maximize independence in daily life skills and to foster EF component skills such as problem-solving, decision-making, cooperation, direction following and appropriate self-expression. Outcome measures used were the Executive Function Performance Test (EFPT), the Canadian Occupational Performance Measure (COPM) and the Occupational Therapy Task Observation Scale (OTTOS). Results: Gains were seen from baseline to final session in COPM score changes meeting minimally clinical difference, and OTTOS scores showing significant improvement: t(7)= -2.49, p=.04. Preliminary findings suggest that occupation-based programming may facilitate development of EF skills in sex-trafficked women.

COMPLETED
Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma
Description

The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.

COMPLETED
Study of Infant Diets on Estrogen Activity and Development
Description

This study, conducted at the University of Pennsylvania s Newborn Nursery, the Children s Hospital of Philadelphia, and the Exton Specialty Care Center, will examine how different infant diets may affect estrogen activity in babies. During pregnancy, babies are exposed to the female hormone estrogen from their mother. Estrogen plays a key role in the development of breasts and milk production, as well as the development of the uterus. The effects of these hormones can be seen when babies are examined. Between 6 and 12 months of age, the effects are reduced. Breast milk and some infant formulas may contain compounds that can act like female hormones in the body and may prolong the estrogen effects. This study has two parts. Part 1 studies the physical development of babies fed different ways. Part 2 studies how hormone levels in babies differ depending on what they are being fed. Babies may participate in one or both parts. Part 1 includes babies 0 to 6 months of age; part 2 includes babies 0 to 12 months of age. In each part of the study, parents may choose to have their babies evaluated from one to four times. Full-term infants (age 37 to 41 weeks gestational age) from birth to 12 months of age who weigh from 2501 to 4499 grams (about 5.5 to 10 pounds) at birth and who have no chromosomal abnormalities, major malformations, or endocrine problems may be eligible for this study. Male infants must have palpable testes. Infants being fed a diet of breast milk, soy milk, or cow s milk will be included. Study procedures include the following: Part 1 * Feeding history: the parent provides information about the baby s dietary intake since birth. * Length, weight, and head circumference: the baby s measurements are taken. * Physical examination: the baby s physical maturity is assessed by examination of the skin, breasts, and external sex organs. * Breast secretions: the baby s breast buds are gently pressed during the physical examination to look for a milky-white substance that some babies produce during the first year of life. If the substance appears, a specimen will be collected. * Vaginal cells: for baby girls, the opening of the vaginal area is gently swabbed with a sterile Q-tip to assess the maturity of the vaginal lining. Part 2 * Feeding history and length, weight and head circumference measurements as described above. * Urine: a urine sample is collected in a cotton diaper or a urine collection bag. * aliva: a saliva sample is collected by gently swabbing the inside of the baby s mouth 1 hour after a morning feeding to remove any left over milk. * Hair: a lock of hair, 1/2-inch wide and 1 to 2 inches long is taken from 12-month old babies. * Blood: some infants have a small blood sample collected by a heel-stick. This study will serve as a basis for a later study about how infant formulas affect infant growth.

COMPLETED
Effects of Infant Diets on Estrogen Activity and Development
Description

This study, conducted at the Children's Hospital of Boston and the Brigham and Women's Hospital in Boston, will examine the natural history of infant development in the first year of life and how different types of infant feeding may affect that development. During pregnancy, babies are exposed to the female hormone estrogen from their mothers. Estrogen affects development of breasts and milk production, as well as the development of the uterus, ovaries and possibly other hormonally responsive organs in both males and females. Between 6 and 12 months of age, the effects are reduced. Breast milk and some infant formulas may contain compounds that can act like female hormones in the body and may prolong the estrogen effects. This study will examine the natural history of estrogen activity in infants on different feeding regimens, breast milk, cow's milk, and soy milk and will serve as preparation for a larger study of the effects of soy formula on estrogen activity in infants. Full-term female babies (37 to 41 weeks gestational age at birth) from 0 to 12 months of age and male babies from birth to 6 months of age who weigh from 2501 to 4499 grams (about 5.5 to 10 pounds) at birth and who have no chromosomal abnormalities, major malformations, or endocrine problems may be eligible for this study. Males must have palpable testes. Babies being fed a diet of breast milk, soy milk, or cow's milk will be included. Study procedures include the following: * History of the baby's dietary intake since birth, provided by the parent; * Ultrasound measurement of the uterus, ovaries, and breasts in female babies; the testes, prostate, and breasts in males; and the thymus, thyroid, and kidneys in all babies; * Measurements of all babies' weight, length, and head circumference.

Conditions
COMPLETED
Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
Description

The purpose of this study is to find the best tests to use to investigate the differences between older and younger people with HIV disease. Test to be included will measures of memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.

Conditions