Soto Cano Air Base, Honduras
The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing
Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of non-reactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important. Stress ball is one of the nonpharmacological methods in the management of pain, stress and anxiety based on the logic of drawing the attention of the person to a different side and is an application for the sense of touch. In the obstetric field, there have been studies evaluating the effects of stress ball application on labor and vascular pain of pregnant women, but there is no study evaluating anxiety, comfort and NST parameters during NST.
Phase
N/ASpan
22 weeksSponsor
Gaziantep Islam Science and Technology UniversityGaziantep
Recruiting
Healthy Volunteers
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
Phase
N/ASpan
27 weeksSponsor
Lifetech Scientific (Shenzhen) Co., Ltd.Gaziantep
Recruiting
Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of BNT327 plus chemotherapy for the Phase 2 part of each substudy. After the analysis of the Phase 2 data (efficacy, safety, and exposure-response), an internal review committee (IRC) will decide whether participants will be treated with BNT327 at dose level 1 or 2 in the Phase 3 part of the substudies. After dose selection, the selected dose will be used for all participants in the study. For the Phase 3 parts of both substudies, an independent data monitoring committee (IDMC) will be established as needed to provide independent review of the data during the study. The sponsor may decide not to perform or stop recruiting participants in the Phase 2 part of the study depending on data generated in the BNT327-01 (NCT06449209) and BNT327-02 (NCT06449222) studies. The sponsor may also choose not to continue all substudies.
Phase
2/3Span
312 weeksSponsor
BioNTech SEGaziantep
Recruiting
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
Participants will be treated until disease progression, intolerable toxicity, participant withdrawal, death, study termination or up to 2 years (whichever occurs first). The study plans to randomize or assign eligible participants into two cohorts, i.e., Cohort 1 and Cohort 2. In Cohort 1, participants will be randomized to two treatment arms investigating two dose levels of BNT327 in combination with Nab-paclitaxel. Cohort 2 will not begin until the appropriate dose to move forward has been determined from Cohort 1. After this, the arms in Cohort 2 exploring different chemotherapy combinations will begin to enroll. Participants in Cohort 2, Arm 1 will receive the optimal dose of BNT327 in combination with paclitaxel. Participants in Cohort 2, Arms 2 and 3, will receive the equivalent dose of BNT327 administered once every 3 weeks (Q3W) in combination with gemcitabine plus carboplatin (Arm 2), or eribulin (Arm 3).
Phase
2Span
214 weeksSponsor
BioNTech SEGaziantep
Recruiting
The Effect of Self-Compassion Training on Sexual Life Quality and Marital Adjustment in Women With Sexual Dysfunction
The postpartum period is a 6-12-week period that starts with the delivery of the placenta and continues with the disappearance of the physiologic and anatomic changes that occurred during pregnancy . Spousal and family support is very important for a healthy and harmonious passage of this period. With the realization of delivery, the mode of delivery, body image changes, hormonal changes, lactation and breast problems, fatigue, vaginal bleeding, problems related to the baby, sexual reluctance and the relationship between spouses affect the sexual life of women. Although the time to start postpartum sexual intercourse varies from person to person and culture to culture, this period is traditionally 6 weeks. As a result of the studies, it is reported that the time to start postpartum sexual intercourse is between 5-8 weeks. Couples are concerned about starting sexual intercourse when there is bleeding, laceration or episiotomy in the woman in the postpartum period. Physiologic changes that occur during pregnancy and delivery affect sexual intercourse in the postpartum period, and perineal pain and dyspareunia due to episiotomy and laceration are observed in women. However, according to studies, sexual function problems encountered by women in this period include dyspareunia, pelvic floor dysfunction, vaginal dryness, sexual desire / intercourse. satisfaction as a decrease in sexual satisfaction. In a study conducted by Lagaert et al. with 109 women in the postpartum period; women who had spontaneous vaginal delivery and women who had interventional delivery were compared and women who had interventional delivery stated that they experienced more painful sexual intercourse . In the postpartum period, reasons such as episiotomy, perineal pain, vaginal bleeding and discharge, fatigue, pelvic floor dysfunction, feeling less attractive due to physical changes lead to a decrease in sexual desire and consequently to withdrawal from sexuality. During the first year after birth, new parents face many personal and interpersonal changes, including changes in their sexual relationships. In particular, it has been found that most new parents experience sexual concerns specific to the postpartum period, wondering when to restart sexual intercourse after birth, pain during sexual intercourse, and the impact of body image concerns on sexual activity. Lorenz et al. found that couples generally experienced a decrease in the frequency of sexual activity in the postpartum phase . In a study conducted with 1507 women in the postpartum period, 89% of women were reported to have sexual health problems. In the postpartum 3rd month, the most common complaints were loss of sexual desire, pain during sexual intercourse, and vaginal dryness. Although traditional and complementary treatment practices are utilized in the treatment of sexual dysfunctions, the effectiveness of very few of them has been shown in studies with high level of evidence. Traditional and Complementary Medicine practices used in sexual dysfunctions include natural products (plants, vitamins, minerals and probiotics etc.), mind and body practices such as yoga, mindfulness-based intervention, acupuncture and other methods. The use of mindfulness-based therapies has recently become widespread in the treatment methods of women diagnosed with sexual dysfunction. With these therapies, it has been observed that there is a significant improvement in general sexual function level, arousal and sexual problems. Through mindfulness practices, it has been observed that women perceive stimuli better and are able to recognize clues that they did not notice before. Compassionate mindfulness program is one of these practices. CFT (Compassion Focused Therapy) is known to integrate well with existing approaches to psychosexual therapy and offers some useful ways to reduce sexual problems to provide a coherent rationale for treatment strategies .Self-compassion proceeds in parallel with the individual's self-knowledge, acceptance, positive perspective towards life, social activities, consciousness, character structure open to development and subjectivity. There is an inverse relationship with anxiety disorder, mental depression and the negativities provided by negative situations. In order to develop compassionate involvement in therapy, the therapist's non-judgmental, warm and encouraging stance when talking about sexual intercourse, as well as detailed information about sexual difficulties, can be a starting point for the client to cope with the difficulties they experience. The therapist can then use a normalizing and non-shaming CFT (Compassion Focused Therapy) formulation to help the client turn towards the difficulties they are experiencing and look at them with understanding. In this sense, the place of midwives who are in constant one-to-one communication with women in the protection and development of sexual health is very important. Determining the sexual needs of women in any period of women's life, eliminating sexual problems, explaining behaviors and attitudes related to sexual life, providing education and guidance are among the roles of midwifery. Midwives have the responsibilities of taking anamnesis, identifying sexual problems and providing education and counseling for these problems in order to maintain and increase the sexual health of pregnant women during pregnancy. It is important for midwives to communicate as a very good listener, to take into account the concerns of the woman, to ask effective questions, to speak by reassuring and stating that privacy will be ensured, to identify the sexual problems of the woman and to provide effective counseling.
Phase
N/ASpan
73 weeksSponsor
Inonu UniversityGaziantep
Recruiting
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms: - Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks - Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks - Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks
Phase
2Span
111 weeksSponsor
Tectonic TherapeuticGaziantep
Recruiting
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Phase
3Span
148 weeksSponsor
AmgenGaziantep
Recruiting
The Effect of Mindfulness-Based Psychoeducation
In this research, the sample size calculation was performed using the G Power program by conducting a priori power analysis. Previous studies were reviewed and using the Beck Depression Inventory, expected confidence intervals were determined. With a confidence interval of α=0.05 and a test power (1-β) of 0.95, with an effect size of d=0.9632193, a total of 60 patients were calculated, with 30 patients in the experimental group and 30 patients in the control group. Participants included in the study will be assigned to experimental or control groups using block randomization. Inclusion Criteria for Participation in the study: Individuals who are literate.Individuals are willing to participate in the study voluntarily. Individuals without any communication barriers. Individuals aged between 18 and 65 years. Outpatients being followed up with a diagnosis of major depressive disorder according to DSM-5 criteria. Individuals who have not participated in a mindfulness-based psychoeducation program for their illness in the last 5 years. Exclusion Criteria for Participation in the study: Individuals diagnosed with comorbid psychiatric disorders. Patients with intellectual impairment (e.g., intellectual disability) or cognitive conditions that make collaboration impossible, such as dementia. Patients with psychotic symptoms in addition to the depressive picture. Illiterate individuals. Individuals who do not consent to an interview. Individuals receiving inpatient treatment
Phase
N/ASpan
52 weeksSponsor
University of GaziantepGaziantep
Recruiting
Open-Label Extension Study of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis
A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)
Phase
3Span
157 weeksSponsor
Zydus Therapeutics Inc.Gaziantep
Recruiting
Gaziantep
Recruiting