112 Clinical Trials for Various Conditions
Floreciendo is a sexual and reproductive health workshop for Latina teens (ages 14-18 years) and their female caregivers (e.g., mothers, sisters, grandmothers). This study involves conducting a pilot optimization trial of Floreciendo using the multiphase optimization strategy (MOST) framework. The feasibility of using a 2 x 2 x 2 factorial trial design and the acceptability of the intervention components of Floreciendo will be examined. Effectiveness and implementation outcomes will be explored. This work will be conducted in partnership with community-based organizations in the Chicagoland area.
Sexual Risk Behavior, Sexually Transmitted Infections, Unplanned Pregnancy
The goal of this survey study is to identify environmental, occupational and reproductive health risk factors for Lewy body dementia, which includes Parkinson's disease dementia and dementia with Lewy bodies. Participants will complete a one-time survey online or over the phone that includes questions on environmental, occupational factors they may have been exposed to and on medical history including reproductive health. Researchers will then compare the responses of people with Lewy body dementia and people without Parkinson's or memory/thinking problems to see which factors play a role in Lewy body dementia. Identifying risk factors can guide future treatment efforts and provide more insight to this dementia.
Lewy Body Dementia, Parkinson Disease Dementia, Dementia With Lewy Bodies
In this study, the researchers are trying to learn more about the relationship between Polycystic Ovary Syndrome and Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is a sleep-related breathing disorder that involves a decrease or complete stop in airflow. The purpose of this study is to find out why some people with obstructive sleep apnea have higher levels of insulin resistance, and the investigators will study the role of hypoxia (low levels of oxygen in the blood at night) in insulin resistance and see if insulin resistance improves during your treatment with CPAP.
Polycystic Ovary Syndrome, Obstructive Sleep Apnea
Many studies show early detection of sexual activity in adolescents can improve their health management and that primary care pediatricians would benefit from supports to address adolescent health, including sexual and reproductive health. The primary objective of this study is to develop and evaluate the feasibility, acceptability, and usability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool within the electronic health record (EHR) among clinicians, adolescent patients, and their parents. Secondary objectives include assessment of the CDS tool's impact on clinical measures. The STI Testing CDS tool will be embedded within clinical practice and evaluated through a single-armed prospective cohort study of primary care clinicians, adolescent patients, and parents. The STI Testing CDS tool that will support pediatric clinicians by providing evidence-based sexual health-related screening, treatment, and referrals, as needed.
Sexual and Reproductive Health
The proposed virtual training prototype will provide Making Proud Choices (MPC) facilitator trainees the opportunity to make decisions, build facilitator skills, practice core concepts and enhance self-efficacy with a virtual audience programmed to display a range of behaviors and emotions, simulating a true-to-life experience with immediate feedback. Seventy-two adults who have experience working with adolescents but not with MPC, STI, or pregnancy prevention education will receive MPC training. Participants will be randomly assigned to either: 1) virtual training in the MPC module on condom use n=36), or 2) dfusion/ETR's traditional in-person training in the same module (n=36). Using mixed methods (survey, focus groups, observations), the project will evaluate the virtual training's impact on STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills and its usability, feasibility, and acceptability.
Teacher Training
This research will assess the effectiveness of a parent- and an adolescent- intervention in lowering risk of STIs, HIV, and unintended pregnancies among Batswana youth.
Reproductive Health
N/E is a community-based participatory research (CBPR) multi-level, multi-component sexual and reproductive health (SRH) intervention, constructed on Ecological Systems Theory. N/E is based on Fort Peck tribal members' desire to implement a holistic SRH intervention for American Indian youth. N/E includes: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors that lead to sexual risk behaviors; 2) a family-level curriculum called Native Voices, tailored to increase communication between adult family members and youth about SRH topics; 3) a cultural mentoring component at the community level that pairs American Indian youth with adults and elders to discuss traditional American Indian beliefs and practices about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth-servicing organizations at the systems level in Fort Peck to coordinate SRH services for American Indian youth. The overarching aim of this proposal is to refine, tailor, and finalize the components of N/E and evaluate its efficacy. We will use a cluster-randomized stepped-wedge design (SWD), in which 5 schools that American Indian youth from Fort Peck attend are the clusters to be randomized into the intervention 1 at a time, with all schools eventually being randomized to the intervention. The 5 schools are located in separate communities, mitigating the potential for cross-contamination. N/E is a 5-year study involving 456 14- to 18-year-old American Indian youth.
Reproductive Behavior, Sexual Behavior
Determine the effectiveness of an electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making and communication during an office visit through a randomized controlled trial (RCT).
Reproductive Behavior
The purpose of this research is to determine whether there are differences in ovarian suppression between women who are feeding at the breast compared with women who are pumping. * In the main study, the aim is to compare reproductive health outcomes, including amenorrhea rates, duration of lactation, and resumption of sexual activity, between mothers who are exclusively breastfeeding (i.e. feeding at the breast) and those who are pumping after a term or preterm delivery. * In the sub-study, the aim is to determine the feasibility and acceptability of using urinary luteinizing hormone (LH) detection kits at home to detect ovulation in exclusively breastmilk feeding women.
Breast Feeding, Milk Expression, Breast, Amenorrhea, Postpartum
Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Through using mixed methods, this study proposes to develop a brief peer-led intervention (based on the Health Belief Model) to prevent unintended pregnancies among women entering opioid medication-assisted treatment; to assess acceptability, feasibility and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses to identify the Health Belief Model constructs that are most influential on use of long-acting reversible contraception methods. Future research would include testing the intervention in a larger scale trial and with other populations.
Contraception
The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life. Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers have limited guidance on how best to manage these reproductive health late effects. The research team has generated a practical, accessible, evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their providers to address this deficit in survivorship care. This clinical trial will test if YBCS who receive the web-based SCP-R are more likely than controls to improve on at least one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and contraception.
Breast Cancer, Hot Flashes, Sexual Dysfunction, Fertility, Contraception
Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.
Breast Cancer, Hot Flashes, Vaginal Dryness, Estrogen Deprivation Symptoms
The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.
Giant Cell Arteritis, Takayasu's Arteritis, Polyarteritis Nodosa, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Behcet's Disease, Kawasaki Disease, Henoch-schoenlein Purpura, Vasculitis, Central Nervous System, Drug-induced Necrotizing Vasculitis
This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients' understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals.
Malignant Neoplasm
The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.
Breast Cancer, Lymphoma, Hodgkin's Lymphoma
This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means the consumer will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach the participants are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.
Polycystic Ovarian Syndrome, Infertility, Obesity, Overweight
This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means you will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach you are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.
Polycystic Ovarian Syndrome, Infertility, Obesity, Overweight
Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other nutrients essential to sperm development and function. This randomized controlled trial sought to determine if a Western style diet supplemented with walnuts would improve sperm quality as a predictor of male fertility.
Infertility, Nutrition Disorders
The purpose of this study is to investigate the relationship of high exposure to dibutyl phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and sncRNAs, and reproductive hormones. Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm concentration and motility, and increased sperm DNA damage. Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum testosterone, altered LH:testosterone ratio, and decreased inhibin-B. Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered transcript profiles of sperm mRNAs and sncRNAs.
Colitis Ulcerative, Crohn Disease
This project seeks to demonstrate that computer kiosks in a clinic waiting room can improve access to hormonal contraception and screening for sexually transmitted infections. The study will be a randomized controlled trial which will evaluate the use of a computer kiosk module to compare the proportion of women of reproductive age who receive a prescription for hormonal contraception when computer-assisted provision of hormonal contraception is offered (intervention) to encounters when the study clinic provides standard contraceptive care (control). Subjects will be contacted approximately 3 months (range 2-4 months) after the clinic visit to complete a follow-up phone interview. The study population will include English and Spanish-speaking women ages 18-45 who seek care at this clinic. Our hypothesis is that computer-assisted provision of hormonal contraception (intervention)will increase the proportion of women of reproductive age who receive a prescription for hormonal contraception versus standard contraceptive care(control).
Contraception, Sexually Transmitted Diseases
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to: 1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG. 2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test. 3. Assess user comprehension of the pregnancy test, especially assessment of the result.
Infertility
The purpose of the study is to investigate the relationship between environmental agents and reproductive health. Environmental agents of interest include exposure to chemicals such as polychlorinated biphenyls (PCBs), flame retardants, dioxins, bisphenol A, phthalates, pesticides, and metals like lead and cadmium. We are also interested in the relationship between reproductive health and lifestyle risk factors, such as exposure to environmental tobacco smoke. Enrollees are asked to participate in this study because they and their partner are patients of the MGH Fertility Center, trying to get pregnant, either naturally or by undergoing Intrauterine Insemination (IUI) and/or In Vitro Fertilization (IVF).
Infertility
Prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates, as well as measures of safety and acceptability.
Contraception
The objective of this study is to ascertain factors shaping medical students' pre-residency intention to provide abortion through an in-depth qualitative investigation into the context and experiences that shape intention to provide.
Focus: Pre-residency Intention to Provide Abortion
This study is a pilot assessment of whether practices that implement the One Key Question® (OKQ) pregnancy intention screening tool will demonstrate differences in patient-reported receipt of preconception and/or contraceptive counseling, compared to practices that provide usual care. In Phase I, the study team surveyed patients at six practices within NorthShore University HealthSystem to establish baseline rates of counseling. Phase II assesses the effects of the OKQ tool on patient care, and half of participating sites are randomly chosen as intervention sites and exposed to the OKQ tool. After the intervention practices implement OKQ, patients will be surveyed at both intervention and control (usual care) practices to measure changes in preconception and contraceptive care.
Reproductive Health
This randomized control trial (RCT) will assess an innovative demonstration project to improve adolescent sexual and reproductive health among highly mobile and marginalized youth in Fresno County, California. The Digital Initiative for Youth intervention combines existing, in-person, group-based, comprehensive sexual health education with wraparound digital technologies. The technological component was designed by Youth+Tech+Health using a "youth-centered" design approach and the intervention is implemented by Fresno Economic Opportunities Commission (Fresno EOC). The University of California, San Francisco is the external evaluator. The RCT will assess health and behavioral outcomes at three time points (baseline, 4 months, 10 months).
Reproductive Health, Contraception, Sexually Transmitted Diseases
Strong evidence supports that preconception care, or care to optimize a woman's health health prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a broad range of topics, including: desire for pregnancy, obstetric history, nutrition, vaccinations, sexual health, chronic disease, substance abuse, mental health and contraception. Despite calls from public health organizations and experts in the field for universal access to preconception care, most US women do not receive any health counseling to prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is critical that routine primary care serve as a venue for the provision of this important service. From a patient's perspective, improving preconception health involves many health behavior changes. As such, patient engagement and education regarding preconception health must be a primary focus. Several preconception health promotion tools have been developed for patients to date; few are truly patient-centered and even fewer have been rigorously evaluated. This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is truly innovative in two key ways: * MyFamilyPlan is a web-based preconception health self-assessment. This will allow for the employment of skip logic to individualize the questionnaire and subsequent health recommendations for each patient. * Recognizing that preconception care is relevant to all women "at risk" of pregnancy, MyFamilyPlan has been designed for utilization in a primary care setting. This preconception health education tool will be tested using a randomized controlled design. This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of preconception health issues in primary care encounters (primary outcome). It will also evaluate whether the intervention affects participant self-efficacy in planning a healthy pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will improve the quality of evidence for preconception health education tools. Should it demonstrate effectiveness, it will also result in a new tool that could be made more widely available to promote preconception health.
Reproductive Health
Mid-life women, aged 35-50, are currently an underserved population in the areas of unintended pregnancy and STI prevention interventions. Common perception is that women in this age range are no longer sexually active, or are past the menopause transition, but in reality, sexual activity remains stable through mid-life and into the post-menopausal years. Additionally, physiological and relationship status changes (e.g. divorce or death of a partner) put these women at increased risk for both unintended pregnancy and STI's. This project developed and evaluated a theoretically-based multimedia intervention designed to assist mid-life women in protecting themselves from sexually transmitted infections and unintended pregnancy.
Reproductive Health
The purpose of this study is to answer the following questions: (a) how do sexual and reproductive health (SRH) delivery method characteristics play a role in user preference for specific SRH methods; (b) can we understand the interplay between salient SRH product characteristics and effective use; (c) does effective use differ by indication (e.g., whether the product is for contraception or lubrication); and (d) can this knowledge help product developers better understand how to design new SRH products and develop behavioral (or point-of-care) interventions to optimize use?
Sexual and Reproductive Health
The purpose of the NURTURE Registry is to enroll those who are pregnant and/or potentially capable of pregnancy. Participants will complete patient-reported surveys at enrollment and periodically prior to conception, during pregnancy, and following the completion of the study pregnancy. The study rheumatologist will provide the patient's diagnosis and record rheumatic disease activity at each clinic visit. Medication use, vital signs, and routine laboratory assessments will be collected throughout this period. Pregnancy, maternal, and infant outcomes will be obtained through the electronic medical record and from patient-reported surveys. This Registry will provide a rich data repository for research to improve pregnancy and birth outcomes for women with rheumatic diseases and will be used in on-going and future research to better understand the risk factors that are associated with poor pregnancy outcomes, including preterm birth, intrauterine growth restriction, and preeclampsia, as well as the effects of medication on disease management in pregnancy. Infant outcomes, medications, provider care, pregnancy planning, and social determinants of health on pregnancy and pregnancy outcomes will also be collected. The majority of the information collected in NURTURE, such as labs, disease activity, and medications, PRO's will originate from the EHR. Upon consent, participants will complete an enrollment survey that will include relevant patient reported measures. No study visits outside of routine care will occur. Participants may also complete a yearly survey about their reproductive health journey. The registry will be ongoing and will include periodic analysis of clinical data within this protocol. Additional analysis will be covered under seperate IRB approved protocols. Enrollment in the registry does not significantly increase the risk for a patient.
Rheumatic Diseases, Pregnancy Related, Pregnancy Interest, Reproductive Health, Autoimmune Diseases