pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Dural Arteriovenous Fistulas Research at China INI
NCT Number: NCT06543472
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fistula
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2001-01
Completion Date: 2024-12
Locations: Xuanwu Hospital, Capital Medical University, Beijing, China

Summary:
Dural arteriovenous fistula (DAVF) refers to abnormal connections between meningeal arteries and dural venous sinuses and/or subarachnoid veins. DAVF accounts for approximately 10% to 15% of intracranial vascular malformations. With advancements in imaging technology, increased awareness among physicians, and an aging population, the incidence of DAVF appears to be on the rise. Some literature even suggests it may surpass the occurrence of arteriovenous malformations. Several large-scale retrospective studies have been conducted internationally, involving over 1,000 cases, but some of their findings differ from what is commonly understood. Currently, there is a lack of large-sample single-center studies on DAVF, highlighting the urgent need for such research.

Primary Outcome Measures: Long term prognosis, Safety endpoints include perioperative and postoperative complications, as well as the clinical status of the patients. This is evaluated using the preoperative modified Rankin Scale (mRS), mRS at discharge, and mRS at 6 to 12 months, along with the most recent clinical (inpatient/outpatient) or telephone follow-up. Efficacy endpoints include the immediate DAVF occlusion status after the last treatment, and the results from imaging follow-ups (DSA/MRA/CTA) at 6 to 12 months and the latest follow-up., assessed at 3, 6, 12 and 24 months after procedure
Secondary Outcome Measures: Long-term cure rate, The recurrence rate of DAVF after confirmed complete cure, as determined by DSA/MRA/CTA, assessed at 3, 6, 12 and 24 months after procedure
To Evaluate the Effect of Single Oral Dose of MY008211A Tablets on QTc Interval in Healthy Subjects
NCT Number: NCT06543459
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Interventions: DRUG: MY008211A tablets|DRUG: Placebo
Sponsor: Wuhan Createrna Science and Technology Co., Ltd
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2024-12-13
Locations: Peking University Third Hospital, Beijing, Beijing, 100089, China

Summary:
A Concentration-QT Interval Correction (C-QTc) study of MY008211A Tablets in Healthy Subjects

Primary Outcome Measures: ΔΔQTcF (Using Fridericia Formula as the Primary Method for QT Interval Correction), Placebo-corrected, baseline-adjusted QTc interval of prodrug and active metabolite (if necessary), up to 2 weeks
Secondary Outcome Measures: Cmax (Maximum plasma concentration), Cmax of prodrug and active metabolite (if necessary), up to 2 weeks|Tmax (Time to maximum plasma concentration), Tmax of prodrug and active metabolite (if necessary), up to 2 weeks|t1/2 (Terminal elimination half-life time), t1/2 of prodrug and active metabolite (if necessary), up to 2 weeks|AUC0-t (Area under the plasma concentration-time curve from time 0 to the collection time t with the last measurable plasma concentration), AUC0-t of prodrug and active metabolite (if necessary), up to 2 weeks|AUC0-∞ (Area under the plasma concentration-time curve extrapolated from time 0 to infinity), AUC0-∞ of prodrug and active metabolite (if necessary), up to 2 weeks|CL/F (Apparent clearance), CL/F of prodrug and active metabolite (if necessary), up to 2 weeks|Vz/F (Apparent volume of distribution), Vz/F of prodrug and active metabolite (if necessary), up to 2 weeks|The incidence and severity of adverse events to assess safety and tolerability, such as laboratory abnormalities, up to 3 weeks|Other Electrocardiogram (ECG) parameters, Such as T-wave morphology or absence, U-wave presence and absence, HR, RR interval, PR interval, QRS wave complex, up to 2 weeks
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
NCT Number: NCT06543446
Acronym: CONTEMP-ICD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Interventions: PROCEDURE: ICD implantation
Sponsor: University of Rochester
Collaborators: Patient-Centered Outcomes Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3290
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2032-02-01

Summary:
The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).

Primary Outcome Measures: All-cause mortality, Death from any cause, through study completion, an average of 3.5 year
Secondary Outcome Measures: Major adverse cardiovascular events, First occurrence of hospitalization for one of the following: stroke, myocardiac infarction, device-related complications, ICD shocks., through study completion, an average of 3.5 years|Healthcare utilization, Total number of the following events during following: all-cause hospital admissions, emergency department visits, planned and unplanned clinic visits. All events will be captured from electronic medical records, through study completion, an average of 3.5 year|Quality of life, using the Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQol-5 Dimension (EQ-5D), Kansas City Cardiomyopathy Questionnaire \[KCCQ\] (the KCCQ ranges from 0 to 100, with 0 representing the worst possible health status and 100) and EuroQol-5 Dimension (EQ-5D) (Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state), One year|Quality of life, using the EuroQol-5 Dimension (EQ-5D), Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state, One year
Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study
NCT Number: NCT06543433
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Preterm|Preterm Birth
Interventions: DEVICE: Skincubator 2
Sponsor: Itamar Nitzan
Collaborators: Monash University|Monash Health|Riverside University Health System Medical Center
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2027-09-01
Locations: Monash Children's hospital, Clayton, Victoria, 3168, Australia

Summary:
The goal of this clinical trial is to test the feasibility of using the Skincubator, a wearable incubator for skin to skin contact of preterm babies and their parents. It will also learn about the safety of skincubator. The main questions it aims to answer are:

* Can the Skincubator keep a stable temperature for the smallest babies and the first days after birth?
* How many hours will the parents (and other family members) will succeed to perform skin to skin every day?

Participants will:

Be offered the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment.

Primary Outcome Measures: hours of SSC per day, primary neonatal outcome will be hours of SSC per day, In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).|Parental Stress Scale (PSS) NICU, Parental Stress Scale (PSS) NICU performed by the mother. Minimum and maximum values for PSS NICU are 0 and 72, higher scoring indicates higher parental stress., 4 to 7 days after birth.
Secondary Outcome Measures: Time outside of temperature range 36.5-37.5, Time outside of temperature range 36.5-37.5 measured axillary, In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).|time in environmental humidity of less than 60%, time in environmental humidity of less than 60% measured by hygrometer and incubator hygrometer, In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery
NCT Number: NCT06543420
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: PROCEDURE: lateral reconstruction|PROCEDURE: posterior reconstruction
Sponsor: Peking University First Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2026-07-21
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
This study is a single center, single blind, prospective randomized controlled trial. Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 1:1:1 groups, using lateral reconstruction, posterior reconstruction, or no reconstruction. Patients were followed up regularly after surgery and clinical data were collected, including daily use of urine pads, ICIQ-SF score, 24-hour urine leakage, I-QoL score, etc., to evaluate the improvement effect of lateral reconstruction on urinary control and the difference in effect between lateral reconstruction and posterior reconstruction, thereby improving the quality of life of prostate cancer patients after surgery.

Primary Outcome Measures: Recovery rate of urinary incontinence, Urinary incontinence recovery is defined as using 0 urinary pads per day, 1,3,6,9,12 months after operation
Secondary Outcome Measures: The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score, ICIQ-SF is a questionnaire used to evaluate urinary incontinence and assess the recovery of postoperative urinary incontinence in patients. The range of scores is from 0 to 21, with higher scores indicating more severe urinary incontinence., 1,3,6,9,12 months after operation|Incontinence Quality of Life Questionnaire(I-QOL) Score, I-QoL is a questionnaire used to evaluate the quality of life of patients with urinary incontinence after surgery. The range of scores is from 0 to 100, with higher scores indicating higher quality of life., 1,3,6,9,12 months after operation|Perioperative and postoperative complications, Collect perioperative and postoperative complications such as bleeding and pain to compare the differences between two reconstruction methods and non reconstruction methods., 1,3,6,9,12 months after operation|Prostate-specific antigen, Biochemical recurrence is defined as two consecutive postoperative PSA levels above 0.2 ng/ml with an upward trend, 1,3,6,9,12 months after operation|Duration of operation, The purpose of collecting surgical duration is to compare whether there are differences between two reconstruction techniques and no reconstruction., immediately after operation
Harm Reduction for Smokers With Mental Illness
NCT Number: NCT06543407
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Dependence
Interventions: BEHAVIORAL: SWITCH IT|OTHER: E-cig Provision Only
Sponsor: Dartmouth-Hitchcock Medical Center
Collaborators: Dartmouth College|Fordham University|Seven Counties Services|Western Michigan University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-03-31
Locations: Seven Counties Services, Louisville, Kentucky, 40203, United States|Homer Stryker MD School of Medicine (WMed), Kalamazoo, Michigan, 49008, United States

Summary:
To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT

Primary Outcome Measures: Reduction in Urine NNAL, urine levels of NNAL, baseline to 8 weeks, 8 weeks to 26 weeeks|Reduction in CO level, carbon monixide level less than 6, baseline to 8 weeks, 8 weeks to 26 weeks|Lower self-reported cigarette use, self-report of combustible cigarette use, baseline to 8 weeks 8 weeks to 16 weeks
Low-Cost Platelet-Rich Plasma for Hemarthropathy
NCT Number: NCT06543368
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemarthrosis|Hemophilia
Interventions: BIOLOGICAL: Intra articular PRP Injection
Sponsor: University of Utah
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2026-07-01
Locations: University of Utah, Salt Lake City, Utah, 84108, United States

Summary:
Orthopedic complications can be injuries or diseases that affect the bones, muscles, and joints. Hemarthropathy is due to bleeding disorders, most commonly hemophilia, and can result in severe issues related to chronic amounts of blood in the body's joints. This causes swelling, pain, and loss of joint function. A serious barrier to treating many patients with bleeding disorders creates higher health risks and costs. Platelet-rich plasma (PRP) injection is a method that can reduce the cost of care while still offering a similar standard of care for patients.

This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders, without the need for expensive equipment, while monitoring patient treatment results. Study participants will receive injections for joint conditions. Being in the study requires attending 1 to 2 in-person visits at the study clinic. Participants will also complete surveys using email, text messages, in person, and/or on the phone. Participation lasts about 6 months.

Primary Outcome Measures: Pain (numeric pain rating system), Prospectively evaluate clinical outcomes in a cohort of patients with bleeding disorders for pain over six months (at baseline, 1, 3, and 6 months), numeric pain rating system (0-10)., 6-months
Secondary Outcome Measures: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC at baseline, 1, 3, and 6 months for participants receiving knee injections. The questionnaire consists of 24 questions, divided into these three categories (pain, stiffness, and physical function). Patients rate their symptoms on a scale from 0 (no pain or difficulty) to 4 (extreme pain or difficulty)., 6-months|Quick Disabilities of Arm Shoulder and Hand (QuickDASH), QuickDASH at baseline, 1, 3, and 6 months for participants receiving elbow injections. The QuickDASH consists of 11 questions, each with five response options ranging from "no difficulty" to "unable". You rate your symptoms and functional abilities based on the past week. A higher score indicates greater disability., 6-months|Foot and Ankle Outcome Score (FAOS), FAOS at baseline, 1, 3, and 6 months for participants receiving ankle injections. The FAOS is a questionnaire with 42 questions, each rated on a 5-point Likert scale (0-4). Higher scores indicate better function and less pain. The total score ranges from 0 to 100, with higher scores representing better outcomes., 6-months
The Acupuncture for Pain, Opioid Use Disorder and Mood
NCT Number: NCT06543355
Acronym: AcuPOM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain|Opioid Use Disorder|Mood Change|Opioid Misuse|Opioid-Related Disorders
Interventions: DEVICE: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol
Sponsor: Albert Einstein College of Medicine
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2025-08
Locations: Montefiore Division of Substance Abuse (DoSA) Wellness Center at Melrose, Bronx, New York, 10451, United States

Summary:
The goal of this study is to determine how patients with chronic pain and opioid use disorder will respond to treatment with acupuncture, including whether there will be any changes in mood. Results from this study have the potential to inform future studies in patients who would consider using acupuncture as an intervention for their conditions.

Primary Outcome Measures: Feasibility - Percentage Consented, The percentage of total participants screened who have been consented will be calculated and reported., During the informed consent process, prior to the intervention|Feasibility - Percentage Retained, The percentage of total participants consented who complete the study will be calculated and reported., Upon completion of the study, up to four weeks|Adherence to acupuncture treatments, Adherence to acupuncture treatments treatments will also be used to assess feasibility. Adherence the intervention will be defined as the percentage of participants who completed all scheduled acupuncture treatments. Adherence will be successful if participants attend at least 50% of acupuncture treatments., At 0, 2, and 4 week study visits, up to four weeks total|Acceptability/Satisfaction, Acceptability of and Satisfaction with the intervention will be assessed using a single outcome measure, the Patient Global Impression of Change Scale. This scale consists of a single question asking the participant to rate acceptability/satisfaction of the intervention on a seven-point scale ranging from 1 (= very much better) to 7 ( = very much worse). Higher scores are associated with less favorable participant perceptions of the intervention. Group mean scores will be summarized., Upon completion of the study, up to four weeks
Bystander Intervention for Hazardous Drinking
NCT Number: NCT06543342
Acronym: DISH
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hazardous Behavior|Alcohol Consequences
Interventions: BEHAVIORAL: Bystander Brief Motivational Intervention
Sponsor: Brown University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 187
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-01-10
Completion Date: 2022-07-15
Locations: Brown University, Providence, Rhode Island, 02912, United States

Summary:
The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. A set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers. This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.

Primary Outcome Measures: Exposure to the Hazardous Drinking of Others, Number of risk signs observed in peers -validated measure, 1 month and 3 months|The Bystanders to Alcohol Risk Scale - Strategies, Number of strategies used to help others - validated measure, 1 month and 3 months|Alcohol Bystander Readiness to Help, Self-perception of readiness to help others in different situations - measure validation underway, 1 month and 3 months
Evaluation of BTV100 in Subjects With Dry Eye Disease
NCT Number: NCT06543303
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Dry Eye
Interventions: DRUG: BTV100 Low dose|DRUG: BTV100 Mid dose|DRUG: BTV100 High dose|DRUG: Placebo
Sponsor: BioTheraVision, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-15
Completion Date: 2026-02-15
Locations: Sydney Eye Hospital, Sydney, Australia|Chang Gung Memorial Hospital-Kaohsiung Branch, Kaohsiung, Taiwan|Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan|Chang Gung Memorial Hospital-LinKou Branch, Taoyuan, Taiwan

Summary:
This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

Primary Outcome Measures: Schirmer test, Change from baseline in unanesthetized Schirmer test of study eye, Day 85
Secondary Outcome Measures: Schirmer test, Proportion of subjects with an increase in unanesthetized Schirmer of 10 mm or more for study eye, Day 15, 29, 57 and 85.
Azithromycin Before Induction
NCT Number: NCT06543290
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Infections
Interventions: DRUG: Azithromycin Pill
Sponsor: Arrowhead Regional Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-08-07
Completion Date: 2025-08-07
Locations: Arrowhead Regional Medical Center, Colton, California, 92324, United States

Summary:
This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection.

Primary Outcome Measures: Reduction in Composite Infection, single oral dose of Azithromycin given prior to the start of induction of labor will decrease rates of composite infection, Delivery and 6 weeks postpartum
Secondary Outcome Measures: Reduction in Infection, single oral dose of azithromycin will also decrease rates of chorioamnionitis, endometritis, wound infection (both perineal and cesarean), neonatal infection and readmission rates, pyelonephritis, endomyometritis, Delivery and 6 weeks postpartum
Efficacy of Cryotherapy in Managing Chemotherapy-Induced Peripheral Neuropathy in Children With Leukemia
NCT Number: NCT06543264
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: DEVICE: Cryotherapy
Sponsor: Delta University for Science and Technology
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-01-01
Locations: South Valley University, Faculty of Physical Therapy, Qina,, 83523, Egypt

Summary:
This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children

Primary Outcome Measures: Nerve conduction studies (NCS), nerve conduction velocity for sensory ulnar nerve, nerve conduction velocity for sensory ulnar nerve at day 0|Nerve conduction studies (NCS), nerve conduction velocity for sensory ulnar nerve, nerve conduction velocity for sensory ulnar nerve at day 90|Nerve conduction studies (NCS), nerve conduction velocity for sensory median nerve, nerve conduction velocity for sensory sensory median nerve at day 0|Nerve conduction studies (NCS), nerve conduction velocity for sensory median nerve, nerve conduction velocity for sensory sensory median nerve at day 90
Breastfeeding Education Using the Card Game Method
NCT Number: NCT06543238
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primiparity
Interventions: OTHER: Breastfeeding card game group
Sponsor: Çankırı Karatekin University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-06
Locations: Sakine Yılmaz, Cankiri, None Selected, 18100, Turkey

Summary:
This study aims to determine the effects of breastfeeding education using the card game method on breastfeeding success and breastfeeding self-efficacy in primiparous breastfeeding mothers.

Primary Outcome Measures: Breastfeeding Self-Efficacy Scale, The scale consists of a total of 14 items that evaluate breastfeeding self-efficacy. The scale is a 5-point Likert-type scale, and the items are evaluated by rating from 1 = "not sure at all" to 5 = "always sure". The lowest score that can be obtained from the scale is 14, the highest score is 70; higher scores indicate higher breastfeeding self-efficacy., 36th week of pregnancy and postpartum
Secondary Outcome Measures: LATCH Breastfeeding Diagnostic and Assessment Scale, LATCH focuses on 5 features to be able to take appropriate action in cases where intervention is necessary for the mother. L (Latch): Baby's latching on to the breast, A (Audible Swallowing): Baby's swallowing sound is heard, T (Type of Nipple): Type of nipple, C (Comfort of Breast/Nipple): Mother's comfort with the breast/nipple H (Hold/Position): Defined as the assistance the mother needs to place her baby in the breastfeeding position. Each of the criteria is evaluated as "0, 1, 2" points. The maximum score that can be obtained is 10, and a high score from the evaluation and diagnosis scale means that breastfeeding success is high., It will be applied to women in the control and experimental groups after birth.|Visual analog satisfaction scale, It is a scale used to evaluate satisfaction with the training provided. The individual indicates his/her satisfaction by marking a score between 0 (not satisfied at all) and 10 (very satisfied)., It will be applied to women in experimental groups after birth.
Awareness Of Gynecologists About Role Of Physical Therapy In Management Of Polycystic Ovarian Syndrome
NCT Number: NCT06543225
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Polycystic Ovary Syndrome
Interventions: OTHER: No intervention
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 399
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-03
Completion Date: 2023-11-09
Locations: Rolan Khaled Kamal El Dein, Tanta, El Gharbia, Egypt

Summary:
This study aimed to measure the extent of knowledge of gynecologists about the role of physical therapy in the management of PCOS.

Primary Outcome Measures: Awareness and knowledge of gynecologists about role of physiotherapists in the treatment of PCOS, A specially designed questionnaire was used to identify the awareness and knowledge of gynecologists about the physiotherapy role in the treatment of PCOS, 8 months
Eye Alignment and Eye Control Changes Through Follow up Period After Application of Eye Exercises Post Strabismus Surgery
NCT Number: NCT06543212
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Strabismus; Intermittent
Interventions: OTHER: physiotherapy exercises
Sponsor: Amany Refaat Mohamed Abdel Wahid
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-15
Completion Date: 2024-12-15
Locations: Cairo University, Giza, 12613, Egypt

Summary:
The aim of this study is to determine the patient status through its follow up period and weather the eye alignment and eye control are as the same as the last physiotherapy treatment session or there is any deterioration of them.

Primary Outcome Measures: Eye deviation by prism-cover test, This test is used to quantify the movement of deviating eye, 3 months|Measurement of eye control by Intermittent Exotropia Control Scale, The level of control will be evaluated in each patient at both distance and near fixation using Intermittent Exotropia Control Scale. The scale ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control)., 3 months
Evaluation of the Effect of Hypericum Perforatum L and Hyaluronic Acid on Excisional Palatal Wound Healing
NCT Number: NCT06543199
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wound Healing Disorder|Palate; Wound
Interventions: PROCEDURE: local application of hyaluronic acid agent to the wound site|PROCEDURE: Local application of hypericum perforatum L to the wound site|PROCEDURE: wound healing monitoring
Sponsor: Ataturk University
Sex: FEMALE
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-02
Completion Date: 2024-09-10
Locations: Tuğba Aydın, Erzurum, Hiçbiri Seçilmedi, 25240, Turkey

Summary:
The free gingival graft (FGG) procedure is one of the surgical approaches used to create a large area of adherent gingiva around the tooth and implant. As part of this procedure, one SDG at a time is harvested from the donor site of the secondary healing palate. The most common postoperative complications are pain, burning sensation and delayed wound healing at the donor site. Many agents have been used for years to reduce these complications, but so far none has been emphasized as the ideal agent. In this thesis, methods to improve the healing of the hard palate, the donor site for SDG surgery, and postoperative patient comfort will be compared.

Primary Outcome Measures: assessment of pain at the donor site, Measuring and recording the pain score at the donor site with a vas, Days 1,2,3,4,4,5,6,7|evaluation of burning in the donor area, Measuring and recording the burning score at the donor site with a vas, Days 1,2,3,4,4,5,6,7|evaluation of chewing discomfort at the donor site, Measuring and recording the chewing discomfort score at the donor site with a vas, Days 1,2,3,4,4,5,6,7
Effectiveness of Metaverse-Based Immersive Technology Intervention for Oral Health Education: A Quasi-Experimental Study
NCT Number: NCT06543186
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knowledge, Attitudes, Practice
Interventions: OTHER: Oral health education lecture|OTHER: Oral health education via mHealth on WhatsaApp|OTHER: Oral health education via Metaverse platform on Meta-OHE
Sponsor: Universiti Teknologi Mara
Sex: ALL
Age: CHILD
Enrollment: 210
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-05-31
Locations: Maktab Rendah Sains MARA Bentong, MRSM Bentong, Bentong, Pahang, 28700, Malaysia|Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh, Selangor, 47000, Malaysia

Summary:
To evaluate the effectiveness of pre- and post-intervention of oral health education using three interventions (conventional methods, mHealth, and the Metaverse platform) on the oral health status, knowledge, practices, and attitudes among secondary school students in Malaysia.

Primary Outcome Measures: Oral health knowledge, Level of oral health knowledge. Descriptive, association and correlation, Pre-intervention (baseline) and immediately after the intervention|Oral health practise, Level of oral health practise. Descriptive, association and correlation, Pre-intervention (baseline) and immediately after the intervention|Oral health attitude, Level of oral health attitude. Descriptive, association and correlation, Pre-intervention (baseline) and immediately after the intervention
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
NCT Number: NCT06543173
Acronym: PREVENT-VT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: PROCEDURE: Prophylactic Catheter-based VT Ablation
Sponsor: University of Rochester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2030-08-01

Summary:
This prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (ICM) patients referred for primary ICD implantation. Participants will be randomized to receive either prophylactic VT ablation within three months of ICD implantation or continued medical management. The primary objective is to assess the efficacy of preventive VT ablation versus medical management in reducing VT arrhythmia burden.

Primary Outcome Measures: Total Number of VT Arrhythmia Events in High-Risk Patients with Ischemic Cardiomyopathy (ICM) After Primary ICD Implantation: Comparison of Preventive Catheter-Based VT Ablation Versus Medical Management., Evaluating the impact of preventive catheter-based VT ablation versus medical management on the total number of VT arrhythmia events in high-risk patients with ischemic cardiomyopathy (ICM) after primary ICD implantation., One year following ICD implantation.
Secondary Outcome Measures: Impact of Preventive VT Ablation on Healthcare Utilization, assessed using the mean rate of events per arm., Assessing whether preventive VT ablation compared to medical management reduces healthcare resource utilization in high-risk patients with ICM after primary ICD implantation. Healthcare resource utilization will be quantified by averaging planned and unplanned in-office visits, urgent care or emergency room visits, hospitalizations, repeat ablations, or mortality per arm. Data on healthcare utilization will be collected at all follow-up visits (months 3, 6, and 9) and at the end-of-study visit. Analysis will be conducted using a t-test for comparison., One year following ICD implantation.
Other Outcome Measures: Impact of Preventive VT Ablation on the Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)., Assessing whether preventive VT ablation compared to medical management enhances quality of life in high-risk patients with ICM after primary ICD implantation, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life. Scores on the KCCQ range from 0 to 100, with higher scores indicating better quality of life. Data collection with the KCCQ will occur at the Baseline and End of Study visits. Differences in quality of life between the study groups will be analyzed using the t-test based on KCCQ responses., One year following ICD implantation.
Effect of Education on Breast Cancer Fear and Health Beliefs
NCT Number: NCT06543147
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Women's Health|Health Education
Interventions: OTHER: breast cancer and breast self- examination education
Sponsor: Kırklareli University
Collaborators: Ordu University Scientific Research Projects Coordination Department
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2018-03-17
Completion Date: 2019-04-30
Locations: Ordu University, Ordu, 52000, Turkey

Summary:
The study was conducted to determine the effect of breast cancer and breast self-examination (BSE) education on breast cancer fear and health beliefs. The main questions it aims to answer are:

H1: Breast cancer and BSE training given to women will affect the health beliefs of women.

H2: Breast cancer and BSE training given to women will affect the fear of breast cancer among women.

H3: Breast cancer and BSE training given to women will affect the information and behaviour in relation to breast cancer screening among women.

Researchers divided participants into experimental and control groups to examine the effects of breast cancer and breast self-examination education on breast cancer fear and health beliefs. The experimental group received education about breast cancer and breast self-examination and was reminded to perform breast self-examination by phone for six months.

Primary Outcome Measures: Champion Health Belief Model Scale, The CHBMS consists of 6 subscales and 42 items; susceptibility perception of the perceived individual risks of catching breast cancer (3 items), seriousness perception about the perceived degree of individual threat from breast cancer (7 items), benefits perception expressing advantages related to BSE (4 items), barriers perception about perceived obstacles related to BSE (11 items), confidence expressing perceived individual competence in the ability to identify an abnormal breast mass during BSE (10 items) and health motivation subscale (7 items). Each subscale is evaluated separately and total points including the whole scale are not calculated. Women receiving low points for the barrier subscale and high points from the other subscales show positive attitudes and beliefs related to breast cancer and BSE, Six mounth|Champion Breast Cancer Fear Scale, Items on the scale investigate emotions like fear, upset, tension, irritation, restlessness, and worry and situations like depression or increased heart rate when breast cancer is considered. The scale contains 8 items and has a five-point Likert response. Responses to the scale are "definitely disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points and "completely disagree" 5 points. The lowest points that can be obtained from the scale is 8 with the highest points of 40. High points show high levels of fear about breast cancer. For definition of fear levels to breast cancer low levels of fear are 8-15 points, moderate levels of fear are 16-23 points and high levels of fear are 24-40 points., Six mounth
Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation
NCT Number: NCT06543134
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypothermia; Anesthesia|Agitation, Emergence|Postoperative Complications|Hypothermia Following Anesthesia
Interventions: PROCEDURE: surgery|PROCEDURE: sedation scale
Sponsor: Kocaeli City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-09-15
Locations: Kocaeli City Hospital, Kocaeli, Izmit, 41100, Turkey

Summary:
The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation.

Primary Outcome Measures: Relationship between hypothermia and emergence agitation, Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients, first postoperative hour
Secondary Outcome Measures: Incidence of perioperative hypothermia, Incidence of hypothermia observed in the operating room and recovery room, Between the first 1 hour preoperatively and the first 1 hour postoperatively
Other Outcome Measures: Comparison of agitation/sedation rates in hypothermic patients, Comparison of agitation/sedation rates in hypothermic patients will be compared by measuring percentages, Between the first 1 hour preoperatively and the first 1 hour postoperatively
Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET/CT and PET/MR in Gastric Cancer
NCT Number: NCT06543108
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Interventions: DIAGNOSTIC_TEST: The clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer
Sponsor: Hunan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2028-12-31
Locations: Hunan Cancer hospital, Changsha, Hunan, 410000, China

Summary:
This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET/CT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy of 18F-FAPI-04 PET/CT and PET/MR multimodal imaging in evaluating SUVmax, PET/CT-PCI, and PET/MR-PCI for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; Exploring the clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer.

Primary Outcome Measures: 18F-FAPI-04 PET imaging diagnosis of gastric cancer detection rate, Exploring the feasibility of using targeted fibroblast activation protein (FAP) PET/CT imaging for gastric cancer; Compare the advantages and disadvantages of 18F-FAPI-04 and 18F-FDG in gastric cancer imaging, explore the clinical application value of 18F-FAPI-04 PET/CT in gastric cancer imaging, and construct a molecular imaging diagnostic model for gastric cancer, 2 years
Secondary Outcome Measures: Detection rate of peritoneal metastasis in gastric cancer, Comparison of the diagnostic value of 18F-FAPI-04 PET/CT and PET/MR for peritoneal metastasis of gastric cancer, and construction of a molecular imaging diagnostic model for peritoneal metastasis of gastric cancer, 2 years
Rib Removal and Pain in Partial Nephrectomy
NCT Number: NCT06543095
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pain|Partial Nephrectomy|Kidney Cancer
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-01
Completion Date: 2024-01-01

Summary:
In this study, the effect of rib removal on postoperative pain in kidney cancer patients undergoing retroperitoneal open partial nephrectomy with flank incision was investigated. For this purpose, VAS score surveys were prepared for patients who underwent partial nephrectomy surgery in the early and late postoperative periods.

Primary Outcome Measures: Pain level, Primary outcome of the study was to compare the pain intensities of the two groups at postoperative days 0, 1, and 3 and week 3 and to evaluate the additional pain burden induced by the rib removal procedure., days 0, 1, and 3 and week 3
Secondary Outcome Measures: Complications, Postoperative 7 days
Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM
NCT Number: NCT06543069
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Malignant Peritoneal Mesothelioma, Advanced
Interventions: DRUG: Sintilimab, Bevacizumab , Pemetrexed , Cisplatin
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-31
Completion Date: 2027-01-31
Locations: Cancer Institute and Hospital,Chinese Academy of Medical Sciences, Beijing, China

Summary:
To explore the efficacy and safety of sintilimab, bevacizumab combined with pemetrexed and cisplatin in the treatment of malignant peritoneal mesothelioma, and to explore the biomarkers related to efficacy or safety.

Primary Outcome Measures: Progression-Free Survival (PFS), The time from the date of first administration of this regimen to the date of first documented disease progression or death due to any cause., 36 months
Secondary Outcome Measures: Overall Survival (OS), The time from the initiation of the first dose of medication in a patient to death from any cause., 36 months|Objective Response Rate (ORR), The proportion of patients with a comfirmed complete response or patial response using RECIST1.1., 36 months|Disease Control Rate (DCR), The percentage of patients who have achieved complete response, partial response, and stable disease to the treatment, as defined by RECIST 1.1 criteria., 36 months
A Study of ES014 in Subjects With Advanced Solid Tumors
NCT Number: NCT06543056
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Solid Tumor
Interventions: DRUG: ES014
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators: Elpiscience (Suzhou) Biopharma, Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2026-09-30
Locations: Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Summary:
OVERALL DESIGN: This study is an open-label, single-center, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, and tolerability of ES014 in adults with advanced solid tumors. Adult patients with unresectable locally advanced or metastatic solid tumors will be enrolled in this study. This study is not blinded.

Subject type and number : The study population will be adults with unresectable locally advanced or metastatic solid tumors, whose disease has progressed despite standard therapy and for whom no further standard therapy exists; or for whom standard therapy has proven to be ineffective or intolerable.

This study is expected to enroll no more than 15 subjects, including malignant pleural mesothelioma and myxofibrosarcoma, 4-5, respectively, 2-3 malignant peripheral nerve sheath tumors, and other solid tumors.

Duration of treatment: Subjects will be treated with ES014 in 28-day cycles. ES014 will be administered at 1400 mg on days 1 and 15 of each cycle. Each subject will be treated with study drug for a maximum of 24 months. Subjects will be treated according to protocol until disease progression per RECIST v1.1, development of unacceptable toxicity, withdrawal of consent, completion of study treatment of 24 months, end of study, or early termination of study by sponsor, or other discontinuation and withdrawal reason, whichever occurs first.

Primary Outcome Measures: Evaluating the Efficacy of ES014 in Adult Subjects with Advanced Solid Tumours, ORR assessed by the investigators according to RECIST v1.1, 1-2 years