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NCT ID: NCT05625724 Recruiting - Pre-Eclampsia Clinical Trials

Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology

APPART
Start date: August 2, 2023
Phase: Phase 3
Study type: Interventional

This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.

NCT ID: NCT05528536 Recruiting - Chronic Pain Clinical Trials

Acceptance and Commitment Therapy and Exercise for Older Adults With Chronic Pain

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

The objective is to investigate on the effectiveness of Acceptance and Commitment Therapy and Exercise in: (Primary outcomes) 1. Increasing psychological flexibility 2. Reducing pain interference 3. Increasing quality of life 4. Increasing physical functioning (Secondary outcomes) 5. Reducing psychological distress - depression & anxiety

NCT ID: NCT05488717 Completed - Mental Health Clinical Trials

The Effect of Art-Based Mandala on Mental Health in Bone Marrow Transplant Patients

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

According to the World Health Organization (WHO), health is not only a state of complete well-being in terms of illness and disability, but also physical mental and social well-being. Mental health, on the other hand, is a state of goodness in which the individual is aware of his own abilities, copes with the normal tensions of life, can work productively and efficiently and contributes to the society in which he lives. It has been shown in many studies that mental health problems negatively affect the existing disease process. For example, research shows an association between depression and anxiety and cardiovascular and cerebrovascular diseases . In the New York Health Survey, 10,000 individuals representing 33 communities were surveyed by phone; it was found that the general health status of people who reported significant emotional distress was three times worse than those who did not report it . Realizing that mental health is more than just a disease will guide individuals and caregivers. Developing a more comprehensive clinical approach by focusing on a person's healthy, strengths, abilities and personal efforts is important in strengthening mental health. Applications for strengthening mental health include improving nutrition and housing conditions, increasing access to education, strengthening social networks, creating support environments. In the acceptance and stability therapy study of Bash and Dirik with cancer, it was determined that the negative psychological symptoms of the patients decreased and their expectations of life and quality of life increased. In another study , it was determined that the spiritual support practices provided to 150 individuals with breast cancer positively affected the state of spiritual, psychological and physical well-being. Cancer is a life-threatening disease that is common all over the world and affects the individual both physically and psychologically. Hematologic cancers are caused by bone marrow, the place of production of blood, and include diseases such as acute-chronic leukemias and multiple myelomas. Chemotherapy, radiotherapy, surgical methods in the treatment of hematologic cancers; hormonal and biological treatment and bone marrow transplantation (CIS) may be preferred. Among the applications aimed at strengthening mental health are art-based applications (music therapy, applications for visual arts-painting, painting, mandala, clay works, etc.), collage, carving, sculpture, poetry therapy, etc.) as subheadings for the creation of supportive environments. we come across it. When the literature is examined, it is stated that the participation of individuals with art-based applications increases the adaptation process, helps them to find the meaning of life, increases their awareness of cancer and their life, is better adapted to disease and treatment, their emotional expression is more effective, and the state of spiritual and psychological well-being improves positively . Art-based applications provide a significant reduction in anxiety levels in adult cancer patients ; health-related quality of life . In other studies with cancer patients, it was found that art therapy practices reduce the feeling of anxiety and depression and cause a significant increase in health-related quality of life, patients feel more valued and strong, self-esteem increases, interpersonal relationships develop and they are more social .

NCT ID: NCT05457530 Withdrawn - Obesity Clinical Trials

Doravirine and Weight Gain in Antiretroviral Naive

DAWN
Start date: August 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.

NCT ID: NCT05438238 Recruiting - Infertility Clinical Trials

Virtual Reality for Acute Pain and Anxiety During Egg Retrieval for in Vitro Fertility Treatment

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction or satisfaction.

NCT ID: NCT05418140 Active, not recruiting - Infertility Clinical Trials

Adenomyosis and Pregnancy Outcomes in Women Undergoing Assisted Reproductive Technology Treatment

AdAPT-ART
Start date: June 14, 2022
Phase:
Study type: Observational

Rationale: A rising number of adenomyosis cases are being diagnosed in women in the age group of 30 to 40 years. This is due to a combination of better diagnostic imaging techniques and a higher number of women delaying the fulfilment of their fertility aspirations. The association between adenomyosis and pregnancy outcomes in women with subfertility has not been adequately explained by existing evidence due to lack of data on the association between the severity of adenomyosis, disease location, presence of symptoms and coexisting gynaecological conditions and pregnancy loss in women undergoing fertility treatment. There is a need to improve our understanding of prognostic features which would be beneficial in counselling women with adenomyosis undergoing fertility treatment and inform future management options. The investigators propose a research body of work aimed at improving our understanding of adenomyosis and its association with pregnancy loss. Objective: The aim of the study is to determine the association between adenomyosis and pregnancy loss in women undergoing assisted reproductive technology (ART) treatment. Study design: Prospective multicentre cohort study. The cohort will comprise of women with adenomyosis undergoing ART treatment and the control group will include women with normal uterus on baseline ultrasound scan undergoing ART treatment during the study duration. Settings: The study will be conducted at all main CARE fertility units, one of the largest providers of fertility treatment in the United Kingdom. Participant population with exposure and sample size: The cohort group will comprise of women diagnosed with adenomyosis on pre-treatment baseline ultrasound scan before ART treatment who satisfy the eligibility criteria and consent to participate in the study. The total sample size for this study will be 750 participants with 375 women in each arm. Recruitment will take place over the course of 18 months. Diagnostic tool for detection of exposure: The diagnosis of adenomyosis will be made using transvaginal ultrasound scan (TVS) (2D and 3D Ultrasound and applying Morphological Uterus Sonographic Assessment (MUSA) criteria. Schematic mapping system of adenomyosis severity proposed by Lazzeri and colleagues will be used to grade the severity of adenomyosis. Eligibility: Inclusion criteria: All women aged >18 years and ≤42 years undergoing IVF/ICSI cycle. Exclusion criteria: Women with coexisting fibroid uterus, endometrioma confirmed on USS or known laparoscopic diagnosis of endometriosis (with histological confirmation), untreated hydrosalpinx, uterine malformation, previous myomectomy, previous surgery for adenomyosis or inconclusive USS. Recruitment: All women undergoing pre-treatment pelvic ultrasound scans before ART treatment will be screened for adenomyosis at the participating centres. Women who meet the eligibility criteria will be provided with an information leaflet about the study. They will be enrolled in the study after informed consent is obtained. The severity of adenomyosis will be subsequently evaluated using stored 2D and 3D ultrasound scan (USS) images. Several demographic, clinical and treatment characteristics will be recorded for each participant. Control: To ensure adequate comparability of the cohort, women with normal uterus on baseline ultrasound scan during the study duration will be used as control and will be matched for the following variables: age, embryo quality, type of ART cycle (donor or self and IVF or ICSI) and number of embryos transferred. The eligibility criteria will be applicable to the controls as well. Outcome measures: Primary outcome: Pregnancy loss up to 24 weeks out of all pregnancies achieved. The pregnancy loss will include biochemical pregnancy loss, miscarriage, pregnancy of unknown location (PUL) and ectopic pregnancy. This will be reported per embryo transfer and per woman. Secondary outcomes:1. Implantation rate per embryo transfer (number of gestational sacs divided by number of embryos transferred) and per woman; 2. Biochemical pregnancy rate per embryo transfer (positive pregnancy test following embryo transfer) and per woman; 3. Clinical pregnancy rate per embryo transfer (presence of at least one intrauterine gestational sac on ultrasound) and per woman; 4. Ongoing pregnancy rate per woman (defined as a live pregnancy at 12 weeks onwards); 5. Live birth rate after 34 weeks per woman. Subgroup analysis: We will carry out subgroup analysis according to specific patient characteristics. These analyses will include, but not necessarily be limited to women with the following characteristics:1. Varying severity of adenomyosis; 2. Presence /absence of symptoms of adenomyosis; 3. Frozen vs. Fresh embryo transfer; 4. Short vs. long vs. ultralong ovarian stimulation protocol; 5. Recurrent miscarriages; 6. Other associations that may become apparent in post-hoc analyses.

NCT ID: NCT05378607 Recruiting - HIV Clinical Trials

Goals for Adherence With Low-cost Incentives

GOALS
Start date: April 18, 2022
Phase: N/A
Study type: Interventional

GOALS is a three-year randomized control trial (RCT) aimed at testing the effectiveness of three incentive designs to improve the ART adherence of those in need of adherence support. Participants in the first treatment group (T1, n=140) will be eligible for a prize drawing every three months if they reach the adherence target set for them by the study team, gradually increasing from their baseline adherence towards 90% by the end of the year. Participants in the second treatment group (T2, n=140) will be eligible if they reach the adherence target they set for themselves (subject to reaching 90% at the end of year 1 and each target being at least as high as the previous one). Participants in the third treatment group will have a fixed adherence target of 90% and will be eligible for a prize drawing every three months if this target is reached. All treatment groups will receive weekly motivational messages and a reminder of the upcoming prize drawing. The control group (T4, n=140) will receive the usual standard of care offered by the hospital and weekly motivational messages. Primary outcomes measured using Wisepill devices are mean ART adherence and the fraction of clients with adherence of 90% or more. Secondary outcomes are viral suppression, the fraction of clients with treatment interruptions of 48hrs or more, and retention in care.

NCT ID: NCT05358678 Recruiting - Cesarean Section Clinical Trials

Cesarean Section Scar Niche: The Impact on ART Outcome

Start date: May 25, 2022
Phase:
Study type: Observational

To evaluate the impact of the presence of cesarean section niche and its characteristics on the outcome of ART cycles.

NCT ID: NCT05283460 Completed - Gynecologic Cancer Clinical Trials

The Effect of Mandala Activity on Life Satisfaction

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.

NCT ID: NCT05199298 Completed - Breastfeeding Clinical Trials

The Effect of Mandala Activity-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Maternal-Infant Attachment of Primiparous Mothers

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This study will be conducted to determine the effect of breastfeeding program integrated with art therapy such as mandala painting on postpartum breastfeeding self-efficacy, breastfeeding rates, and mother-infant attachment of primiparous mothers. Training on breastfeeding and mother-baby bonding and mandala drawings supporting the training will be sent online to primiparous pregnant women who are at 32-36 weeks of gestation and agree to participate in the study. Telephone follow-up and counseling will continue in the postpartum period. In the postpartum period, follow-up and counseling will continue until the second month.