pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients
NCT Number: NCT06530290
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Parkinson Disease|Anxiety
Interventions: DRUG: Mirtazapine 15 MG|DRUG: Placebo
Sponsor: Leila Dargahi. PharmD PhD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-01
Completion Date: 2024-12-20
Locations: Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital, Tehran, Iran, Islamic Republic of

Summary:
This study is a single-center, parallel and double-blind study in Movement Disorders Clinic of Shohadaye Tajrish Hospital. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. After assessing the inclusion and exclusion criteria's, patients who assigned the informed consent form, are randomly divided into control and treatment groups.Patients in treatment or placebo groups respectively receive mirtazapine (15 mg) or placebo, once a day for 12 weeks. Primary (anxiety) and secondary (depression, fatigue, sleep disorders, and quality of life) outcomes are evaluated at baseline, and after 4 and 12 weeks of treatments.

Primary Outcome Measures: Anxiety score, Anxiety score using Hamilton Anxiety Rating Scale (HAM-A), Baseline, and after 4 and 12 weeks of treatment|Anxiety score, Parkinson Anxiety Scale (PAS) questionnaires, Baseline, and after 4 and 12 weeks of treatment
Secondary Outcome Measures: Depression score, Depression score using Hamilton Depression Rating Scale (HAM-D) questionnaire, Baseline, and after 4 and 12 weeks of treatment|Fatigue score, Fatigue score using Parkinson's Disease Fatigue Scale (PDFS) questionnaire, Baseline, and after 4 and 12 weeks of treatment|Sleep disorder score, Sleep disorder score using Parkinson's disease Sleep Scale (PDSS) questionnaire, Baseline, and after 4 and 12 weeks of treatment|Quality of life score, Quality of life score using Parkinson's Disease Quality of Life (PDQL) questionnaire, Baseline, and after 4 and 12 weeks of treatment
Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy
NCT Number: NCT06530264
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acquired Nasolacrimal Duct Obstruction
Interventions: OTHER: DCR
Sponsor: Minia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-10-15
Completion Date: 2024-10-15
Locations: Faculty of medicine ,Minia university, Minya, 61519, Egypt

Summary:
The aim of DCR is to form a new, mucosa-lined pathway between the lacrimal sac and the nasal cavity where tears can bypass a lacrimal obstruction and drain directly in the nose. The original external approach was described in 19046. In 1920s, mucosal flap anastomosis was added to the procedure as a modification7, and since then, many new modifications have been made to improve the original procedure.

Primary Outcome Measures: Management of posterior flap in external DCR, Evaluation of different methods of posterior flaps management in external dacryocystorhinostomy using nasal endoscopy for evaluation of outcomes, patient evaluated at 2 months after surgery then at 4th month then 6th month
Comparative Study Between Russian And Exercise in Subjects With Flexible Flatfoot
NCT Number: NCT06530238
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Flat Feet
Interventions: PROCEDURE: Russian Currents
Sponsor: Deraya University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-10
Completion Date: 2024-10-20
Locations: Deraya university, Minya, 05673, Egypt

Summary:
The prevalence of flexible flat foot was 13.6% in adults a cross-sectional Study (for males-12.8%; for females-14.4%).18-21-year-old Indian adults. This trial aims to compare between the effects of Russian current for tibialis posterior muscle and comprehensive exercise alone in subjects suffering from flexible flat foot on quality of life, ROM, strength of tibialis posterior and foot posture

Primary Outcome Measures: ROM (inversion and eversion)., Universal goniometer to assess the ROM (inversion and eversion) of the subtalar joint for each patient, 4 weeks|Foot Posture Index (FP1-6), The FPI-6 is a novel method of rating foot posture using set criteria and a simple scale and is a quick, reliable diagnostic tool., 4 weeks
Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program
NCT Number: NCT06530225
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HIV Prevention
Interventions: OTHER: Education and Mentoring for Prescribing Pharmacists
Sponsor: Xavier University of Louisiana.
Collaborators: Louisiana Public Health Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-05-01
Completion Date: 2030-04-30
Locations: Xavier University of Louisiana, New Orleans, Louisiana, 70125, United States

Summary:
Though broadening PrEP (Pre-Exposure Prophylaxis) availability to Louisiana pharmacies addresses key access issues for Louisiana's population, there is no current baseline data which explore current pharmacist and pharmacies' capacity to effectively provide PrEP therapy to patients who meet PrEP prescribing criteria. This study aims to explore1) Louisiana pharmacist and pharmacy capacity to provide PrEP under a state-based collaborative practice agreement, 2) a validated pharmacist education system addressing health disparities in PrEP prescribing and 3) the impact of state pharmacy based policies on equitable PrEP prescribing. Our central hypothesis is pharmacist trained in PrEP prescribing focusing on health disparities and implicit bias education and working with mentors in an implementation framework will have an increase in equitable PrEP prescribing

Primary Outcome Measures: PrEP Prescribing, Number of PrEP prescriptions dispensed from pharmacy (Scale PrEP prescription/1,000 total prescriptions in 30 day period), May 1, 2025- April 30, 2029|Pharmacists' Knowledge and Confidence in PrEP prescribing, Pharmacists will complete a pre and post-test on knowledge and confidence in PrEP prescribing to target populations. Knowledge will be scored on a graded scale of 0 (lowest to 100 (highest). Confidence will be scored on a Likert Scale (1 - least confident, 5 most confident), May 1, 2025- April 30, 2026
Sleeve Gastrectomy With Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass
NCT Number: NCT06530212
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity, Morbid
Interventions: PROCEDURE: SGJIB|PROCEDURE: SAS-JB
Sponsor: Minia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2025-11-20
Locations: Faculty of medicine, Minya, 61511, Egypt

Summary:
sleeve gastrectomy with jejunoileal bypass (SGJIB) is a novel technique for the surgical treatment of obesity. The aim of the study is to compare this maneuver with single anastomosis sleeve jejunal bypass (SAS-JB)

Primary Outcome Measures: Stoma complications, any complication due to sleeve jejunal anastomosis, one year
Secondary Outcome Measures: weight loss at one year, the effect of the 2 procedures on weight measured by percentage of excess weight loss, one year|improvement of comorbidities, change in comorbidities, one year
Simplified Papilla Preservation Flap(SPPF) and Enamel Matrix Derivative(EMD) With or Without Connective Tissue(CTG) Wall for the Treatment of Non Contained Infrabony Defects. A Randomized Controlled Clinical Trail
NCT Number: NCT06530199
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intrabony Periodontal Defect
Interventions: PROCEDURE: Enamel matrix derivative
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-07

Summary:
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .

Primary Outcome Measures: clinical attachment gain, change in attachment level for patient with isolated 2 or 3 wall defect treated with enamel matrix derivative and connective tissue wall graft in 1,3 and 6 months follow up, 6 months
Secondary Outcome Measures: pocket probing depth, change in pocket probing depth from baseline to 1,3 and 6 months, 6 months|radiographic bone gain, change in radiographic bone level from baseline to 1,3,6 months, 6 months|recession reduction, change in recession from baseline to 1,3 and 6 months, 6 months|plaque index, change in plaque index from baseline to 1,3 and 6 months, 6 months|gingival index, change in calculus index from baseline to 1,3 and 6 months, 6 months
Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
NCT Number: NCT06530186
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginal Infection|Vaginal Discharge|Vaginosis|Sexual Dysfunction
Interventions: DEVICE: LiviWell Postcoital Vaginal Insert
Sponsor: Atlantic Health System
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-01-31
Locations: Garden State Urology, Mountain Lakes, New Jersey, 07046, United States

Summary:
LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.

Primary Outcome Measures: User Experience Questionnaire, Validation of User Needs Requirements as well as patient experience, 24 hours
Secondary Outcome Measures: change in vaginal pH, change in vaginal pH before and after using Livi, and before and after NOT using Livi, 2-6 hours, and 10-14 hours after use
Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women: a Cross-Sectional Study
NCT Number: NCT06530173
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Low Back Pain
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 234
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12

Summary:
• To improve the quality of pregnant women's lives and provide better control for pregnancy-associated symptoms.

Primary Outcome Measures: Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women, • To assess the association between the presence and severity of striaegravidarum and low back pain among pregnant women, Baseline
Secondary Outcome Measures: • To determine the prevalence of low back pain among pregnant women., • To evaluate the effect of women's socio-demographic characteristics on the presence of striae gravidarum or low back pain., Baseline
Interleukin-8 Level in Packed Red Blood Cells
NCT Number: NCT06530160
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Packed Red Blood Cells
Interventions: OTHER: ELISA
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2029-10-30

Summary:
1. To compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells.
2. To show the effect of filtration of packed red blood cells on the level of inflammatory interleukin-8.

Primary Outcome Measures: Compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells, Show the effect of filteration of packed red blood cells on the level of inflammatory interleukin-8, Baseline
Transversalis Fascia Plane Block vs Transversus Abdominis Plane Block In Pediatric Surgeries
NCT Number: NCT06530147
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Postoperative Analgesia
Interventions: OTHER: Transversalis Fascia Plane Block|OTHER: Transversus Abdominis Plane Block
Sponsor: Kocaeli University
Sex: ALL
Age: CHILD
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-15
Completion Date: 2024-08-06
Locations: Hasibe Irban, Kocaeli, 41000, Turkey

Summary:
In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries

Primary Outcome Measures: Pain scores, Our primary aim to compare the effect of both blocks groups on the FLACC (Face, Legs, Activity, Cry, Consolability) pain scores at the 6th postoperative hour. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level., at the 6th postoperative hou
Secondary Outcome Measures: Pain scores, Secondary objectives will include comparison of patient FLACC (Face, Legs, Activity, Cry, Consolability) pain scores in 24-hour observations of patients. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level., During postoperative 24 hours|Need for analgesic, It should be recorded whether there is a need for analgesics., During postoperative 24 hours|Nause and vomiting, The presence or absence of nausea and vomiting symptoms will be recorded., During postoperative 24 hours|Parents satisfaction, Parental satisfaction was assessed on a scale ranging from 1 to 5 points parents satisfaction with the applied analgesia methods was evaluated on a scale from 1, indicating the lowest satisfaction, to 5, indicating the highest satisfaction., During postoperative 24 hours|Time elapsed until the first analgesic requirement, What type of analgesic is needed. The time elapsed until the first analgesic requirement was recorded., During postoperative 24 hours
The Effect of Toolbox Training on Radiation Protection Practices of Health Professionals in Radioactive Workplaces
NCT Number: NCT06530121
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Physics, Healthcare Professionals, Toolbox Trainings
Interventions: BEHAVIORAL: Toolbox trainings
Sponsor: Istanbul University - Cerrahpasa (IUC)
Collaborators: Hatay Mustafa Kemal Univercity|Turan Şahmaran
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-28
Completion Date: 2024-12-30

Summary:
This study will be conducted in a randomized controlled, pre-test, post-test and experimental group design to determine the effects of on-the-job training on radiation workers (radiation safety, protective clothing, awareness). The universe of the study was radiation workers using dosimeters at Hatay Mustafa Kemal University Health Practice and Research Hospital. The experimental group determined by randomization consisted of a total of 80 workers working in ionizing radiation departments. Data were collected with the Information Form, radiation safety and awareness Application Information Form (Pre-Test-Post-Test), radiation protection checklists and On-the-Job Training Evaluation Form. Descriptive statistical methods will be used in the evaluation of the data, independent sample t-test, dependent sample t-test will be used in the comparison of scores and the results of variance analysis in repeated measures will be used in the comparison of three follow-up scores.

Primary Outcome Measures: pretest-posttest, It consists of 10 multiple choice questions created to measure the knowledge levels of the participants before and after the training., before education and 1st week after training
Secondary Outcome Measures: radiation protection practices checklist, Applications that form the basis of radiation protection applications consisting of 8 items, pre-training and post-training 1st week
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes Towards Sexuality and Sexual Distress in Pregnant Women
NCT Number: NCT06530108
Acronym: Pregnant Women
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy|Pregnancy Related|Stress
Interventions: BEHAVIORAL: PLISSIT model based sexual health education
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: FEMALE
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-18
Completion Date: 2025-08-01
Locations: Istanbul University-Cerrahpaşa, Istanbul, 34320, Turkey

Summary:
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women

Purpose of the study: In the light of these data, the effect of sexual health education based on the PLISSIT model on sexual function, attitude towards sexuality and sexual distress in nulliparous pregnant women will be examined in a randomized controlled experimental study. It is thought that the data to be obtained will shed light on sexual health education and counseling practices for midwives working with pregnant women in their application areas.

Primary Outcome Measures: Sexual Function Level, Women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction., 12 Mounth
Secondary Outcome Measures: Attitude Towards Sexuality During Pregnancy, An increase in the Attitude Towards Sexuality During Pregnancy score indicates that attitudes towards sexuality during pregnancy are positive., 12 mounth|Sexual Distres Level, KCDÖ-R consists of 13 items that evaluate different aspects of sexual distress in women and varies between 0-52 points. The scale is a five-point Likert type and is scored between 0-4 points (always=4, often=3, sometimes=2, rarely=1, never=0), and 11.5 and above is defined as sexual distress., 12 mounth
We Compared the Covid-19 Acute Respiratory Distress Syndrome (ARDS) Patients Who Applied Prone Positioning for16-24 Hours vs 24-48 Hours
NCT Number: NCT06530095
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Morality|Oxygenation Indices|Hypoxia
Interventions: OTHER: prone positioning
Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-03
Completion Date: 2024-02-15
Locations: Bakirkoy Dr Sadi konuk Research and Training hospital, Istanbul, 34450, Turkey

Summary:
The goal of this study is to understand if there is any improvement on oxygenation of patients diagnosed with Covid-19 ARDS patients when we extend the duration of prone positioning.

Second outcome of the study is to investigate mortality of patients when we extend the duration of prone positioning.

Primary Outcome Measures: Oxygen Saturation Index (OSI), OSI is calculated by dividing the product of mean airway pressure (MAP) and FiO2 with SpO2, 48 hours|Oxygenation Index, Oxygenation index is calculated as OI = MAP × Fio2 × 100 / Pao2, where MAP indicates mean airway pressure and Fio2 indicates fraction of inspired oxygen, 48 hours
Secondary Outcome Measures: ICU mortality, mortality rates during patients admission in the ICU, 28 days
A Single Arm Clinical Study of Dendritic Cell Vaccine Loaded With Circular RNA Encoding Cryptic Peptide for Patients With HER2-negative Advanced Breast Cancer
NCT Number: NCT06530082
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Breast Neoplasms
Interventions: BIOLOGICAL: CircFam53B-219aa DC vaccine|DRUG: camrelizumab
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2027-01-01

Summary:
The purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer, as well as to evaluate its efficacy.

Primary Outcome Measures: Incidence of Dose-Limiting Toxicity (DLT), DLT (Dose-Limiting Toxicity) is defined as the following adverse events occurring during the first cycle (21 days) of treatment with the CircFAM53B-219aa DC vaccine, and deemed related to the study vaccine by the investigator.

Any adverse event resulting in death, for which it is unclear if it is due to the study disease, pre-existing conditions, new complications, or unrelated to treatment, is also considered a DLT., From the vaccine up to 21 days post-injection|Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE), Adverse events are reported based upon CTCAE version 5.0 criteria. The incidence of Grade≥3 TEAE occurring within the 21 days immediately after DC vaccine will be summarized with descriptive statistics., From the vaccine up to 21 days post-injection
Secondary Outcome Measures: Objective Response Rate (ORR), Objective response rate is defined as the percentage of participants in the analysis population who have achieved complete response (CR) or partial response (PR) assessed by modified RECIST criteria by breast MRI during the study. The percentage of participants who experienced a CR or PR is presented., Up to approximately two years|Overall Survival (OS), Overall survival is defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up., Up to approximately two years|Progression Free Survival (PFS), Progression Free Survival is defined as the time from enrollment to disease progression or death due to any cause., Up to approximately two years
Exploring the Risk Factors of Otomycosis: A Case-Control Study
NCT Number: NCT06530069
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Otomycosis
Interventions: OTHER: exposures
Sponsor: Zhongshan Hospital Xiamen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-08-15
Locations: Zhongshan Hospital of Xiamen university, Xiamen, Fujian, 361000, China

Summary:
The goal of this observational study is to explore the risk factors of fungal otitis externa in the fungal otitis externa patients The main question it aims to answer is:

What behaviors lead to the occurrence of fungal otitis externa? Participants will complete a detailed questionnaire survey. If there is a comparison group: Researchers will compare the healthy group and the disease group to see if there are any differences.

Primary Outcome Measures: Odds Ratio, The ratio of exposed to non-exposed individuals in the case group divided by the ratio of exposed to non-exposed individuals in the control group., 1month
Costovertebral Mobilization on Kyphotic Posture and Lung Function in Non-Smoker
NCT Number: NCT06530056
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperkypohsis and Impaired Lung Function
Interventions: OTHER: Costovertebral Mobilization+Conventional Therapy|OTHER: Conventional Therapy
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2025-01-10
Locations: Madiha Ali, Islamabad, 44000, Pakistan

Summary:
Aim of this study is to find the effects of Costoverterbral Mobilization on Thoracic kyphosis and Lung function in non-smoker. A randomized control trial that will include total 44 participants.The first group will receive Costovertebral Mobilization along with conventional therapy and 2nd group will receive conventional therapy.Data collected will be analyzed through SPSS 25

Primary Outcome Measures: X-RAY, X-ray is a gold standard method for objective assessment of Thoracic Kyphosis., 3 weeks
Secondary Outcome Measures: Spirometer, For measurement of forced expiratory volume-one second/ Forced vital capacity ratio (Pulmonary Function Tests)., 3 weeks
Comparing Senobi and Jacobsons Exercises in COPD
NCT Number: NCT06530043
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: OTHER: Senobi exercises|OTHER: Jacobsons Muscular relaxation exercises
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2024-10-25
Locations: University of Lahore Teaching Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
The study aims to evaluate the effects of Senobi versus Jacobsons muscular relaxation exercises on pulmonary functions, dyspnea, and sleep quality in chronic obstructive pulmonary disease. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS and AHS. A non-probability convenient sampling technique will be used to recruit the individuals into two groups. Group A had undergone Senobi exercises and Group B engaged in Jacobsons Muscular relaxation exercises along with conventional treatment of COPD.

Primary Outcome Measures: FEV1(Forced Expiratory Volume per second), Pulmonary Function Test using Digital Spirometer, Pre and Post after 6 week|FVC(Forced Vital Capacity), Pulmonary Function Test using Digital Spirometer, Pre and Post after 6 week|Modified Borg dyspnea Scale, To asses dyspnea, Pre and Post after 6 week|6-minutes walk Test, To asses dyspnea, Pre and Post after 6 week|SATED SLEEP questionnaire, To asses sleep, Pre and Post after 6 week
Clinical Trial to Evaluate the Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment
NCT Number: NCT06530017
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Simple Obesity
Interventions: DEVICE: Ingested, Space Occupying hydrogel capsules|DEVICE: placebo
Sponsor: IMEIK Technology Development Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 440
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2026-06-30
Locations: Beijing Friendship Hospital,Capital Medical University, Beijing, Beijing, 100032, China|Peking University Shougang Hospital, Beijing, Beijing, 100043, China|Beijing Shijitan Hospital, Capital Medical University, Beijing, Beijing, 100071, China|The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050023, China|The Third XiangYa Hospital of Central South University, Changsha, Hunan, 410013, China|The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, 110001, China|Shengjing Hospital Of China Medical University, Shenyang, Liaoning, 110004, China|The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, Luoyang, 471003, China|QILU Hospital Of Shandong University, Jinan, Shandong, 250012, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, 300070, China

Summary:
To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment

Primary Outcome Measures: Weight loss percentage from baseline at Week 24, Calculation formula:Weight loss percentage from baseline = (weight at Week 24 after enrollment of subject - baseline weight) / baseline weight×100%, 24 weeks|Response rate of weight loss at week 24 after enrollment, Calculation formula:Weight loss response rate = Number of subjects with ≥5% weight loss percentage from baseline/total number of subjects ×100%., 24 weeks
Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
NCT Number: NCT06530004
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Nephrotic Syndrome|Rituximab|Children|Efficacy
Interventions: DRUG: Rituximab
Sponsor: The First Affiliated Hospital of Xiamen University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-03-01
Completion Date: 2028-03-01
Locations: First affiliated hospital of xiamen university, Xiamen, Fujian, 361003, China

Summary:
This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.

Primary Outcome Measures: The median relapse-free survival, The median relapse-free survival of nephrotic syndrome before and after RTX treatment was compared., 1 year|Different sequential group curative effect evaluation, After comparing the preventive RTX and recurrence RTX maintain annual recurrent treatment。, 1 year
Secondary Outcome Measures: Risk factors for renal disease recurrence after RTX treatment., Multivariate cox analysis was used to analyze the risk factors of relapse after rituximab treatment in children with nephrotic syndrome by including gender, age of onset of nephrotic syndrome, course of disease before rituximab, history of immunosuppressive therapy, age of rituximab treatment, and maintenance immunosuppressive therapy after rituximab., 1 year
Endocardial Mapping With the CoreMap EP Mapping System
NCT Number: NCT06529978
Acronym: INvENI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Persistent Atrial Fibrillation
Interventions: DEVICE: CoreMap EP Mapping System Mapping|DEVICE: CoreMap EP Mapping System Map-Guided Ablation
Sponsor: CoreMap Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2025-03-31
Locations: Na Homolce Hospital, Praha - Klanovice, Czechia

Summary:
This is a global, multi-site, prospective, feasibility study.

Primary Outcome Measures: Primary Endpoint:, Incidence of study device related serious adverse events within seven (7) days of the study procedure., 7 days
Secondary Outcome Measures: Phase 1 Secondary Endpoint:, Successful completion of the intended study mapping procedure with the CoreMap EP Mapping System., perioperatively/periprocedurally|Phase 2 Secondary Endpoints:, AF rhythm change or termination following CoreMap-guided ablation., perioperatively/periprocedurally
Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect
NCT Number: NCT06529952
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cesarean Scar Defect
Interventions: PROCEDURE: hysteroscopic surgery by resection and endocoagulation|PROCEDURE: hysteroscopic surgery by endocoagulation only|DRUG: hormonal treatment
Sponsor: Alexandria University
Sex: FEMALE
Age: ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-02-10
Completion Date: 2023-02-20
Locations: El shatby hospital Alexandria university, Alexandria, Egypt|Tamer, Alexandria, Egypt

Summary:
Up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. Prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. Classification involves the ratio of myometrial thickness at the scar to adjacent myometrium, with severe deficiency defined by a ratio of ≤50%. Dehiscence is defined as at least 80% myometrial thinning.

The aim of this work was to compare between the effectiveness of two different techniques of hysteroscopic ablation of cesarean scar defect and hormonal treatment to improve abnormal uterine bleeding and pelvic pain localized in the suprapubic area associated with isthmocele.

Primary Outcome Measures: presence or absence of intermenstrual spotting,, improvement of intermenstrual spotting in group a and B from 1 st month , and improvment in all groups after 6 months, 6 months|presence or absence of postcoital bleeding, improvement of postcoital bleeding in all groups after 6 months, 6 months|presence or absence of pelvic tenderness or dyspareunia, improvement of postcoital bleeding in all groups after 6 months, 6 months
The Effects of Technological Oral Health Management
NCT Number: NCT06529900
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Health|Malnutrition|Dysphagia|Sarcopenia
Interventions: BEHAVIORAL: oral mastication training|BEHAVIORAL: texture and diet education
Sponsor: Chang Gung University of Science and Technology
Sex: ALL
Age: OLDER_ADULT
Enrollment: 112
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-02
Completion Date: 2025-07-31

Summary:
The goal of interventional study is to for the elderly who have poor chewing and eating ability after installing removable dentures through the intervention of oral mastication training and texture and diet education, the effects on oral health, eating ability, nutrition, and physical function changes are confirmed in Elderly individuals residing in Chiayi County who are 65 years of age or older, capable of self-care, conscious, and able to communicate in Mandarin and Taiwanese. The main question it aims to answer is:

•Are there significant benefits to oral health, eating ability, nutrition, and physical function through the intervention of oral mastication training and texture and diet education? Researchers will compare changes in oral health, eating ability, nutrition, and physical functioning results to see if oral mastication training is effective.

Participants will:

* Experimental group: oral mastication training and texture and diet education.
* Control group: only texture and diet education.
* Cases were tracked in month 1 and will be tracked again in month 6.

Primary Outcome Measures: Oral Frailty Index-8, The total score was 11 points. 0-2 points: low risk, 3 points: medium risk, and 4 points or above: high risk., Baseline, 1 month, 6 months.|Iowa Oral Performance Instrument, It is considered abnormal for values below the 5th percentile., Baseline, 1 month, 6 months.|Food Intake Questionnaire, A subject with four or more 'difficult-to-eat' responses to the 14-food group questionnaire would be classified as abnormal., Baseline, 1 month, 6 months.|Comfort Eating Scale, On a scale of 1 to 10, where 1 represents very good (no impact, no pain) and 10 represents very bad (impact, pain)., Baseline, 1 month, 6 months.|Mini Nutritional Assessment-Short Form, 0 - 7 points: malnourished; 8 - 11 points: at risk of malnutrition; or 12 - 14 points: well-nourished., Baseline, 1 month, 6 months.|Study of Osteoporotic Fracture, One component was considered to be in a pre-frailty state, while two or more components indicated frailty., Baseline, 1 month, 6 months.|Handgrip strength, Weak hand grip strength was defined as \< 26 kg for men and \< 18 kg for women., Baseline, 1 month, 6 months.
What Does the Patient Experience Represent for Patients and Caregivers in Dialysis?
NCT Number: NCT06529887
Acronym: EnquêteXP
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Experience, Life|Dialysis|Patient Engagement|Patient Participation|Patient Relations, Nurse|Patient Satisfaction
Sponsor: Calydial
Collaborators: OZ'IRIS Santé
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-07
Completion Date: 2022-03-10
Locations: CALYDIAL, Irigny, 69540, France|CALYDIAL, Pierre-Bénite, 69310, France|CALYDIAL, Vienne, 38200, France|CALYDIAL, Vénissieux, 69694, France

Summary:
The primary objective of this work is to describe the vision, representations, and beliefs of professionals and patients regarding the role and place of the user during their care journey at the Calydial renal health facility.

Methodology: a mixed qualitative and quantitative research.

* Qualitative research: semi-structured interviews with patients and caregivers. The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers.
* Single-center prospective quantitative study: design of two questionnaires (one for patients and one for caregivers). The objectives of the questionnaires are to:

  * Evaluate the feelings, experiences, and representations/beliefs of the patient experience by caregivers and patients.
  * Assess the understanding of the patient experience by caregivers and patients.
  * Compare the patient experience based on the following parameters: age of patients, gender, treatment duration, treatment location, treatment modality, patient autonomy.
  * Measure the gap between patient and caregiver perspectives to identify/adjust actions.

Primary Outcome Measures: Understanding the experiences, knowledge, and patient experience, Semi-structured interviews with 8 patients (all dialysis modalities) and 8 healthcare professionals to define the objectives of the quantitative survey (patient and caregiver questionnaires)., 2 years (2020 and 2021)|Evaluation of the care pathway experiences and factors influencing patient experience from the perspectives of patients and caregivers., Quantitative questionnaires for patients (all dialysis modalities) and their caregivers (nephrologists and nurses)., 2 months (february and march 2022)
Pressure Pain Tolerance in Relation to Balance and Strength in Children
NCT Number: NCT06529874
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sickle Cell Anemia
Interventions: OTHER: Pressure pain tolerance measurement using Digital Pressure Algometer|OTHER: Balance assessment using HUMAC balance system|OTHER: Lower limb muscular strength using Lafayette hand held dynamometer
Sponsor: Adly A Adam
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-02-01
Completion Date: 2024-08
Locations: El-Tahrir st.- in front of Ben El-Sarayat, Ad Doqi Al Giza, Giza Governate, Giza, 002, Egypt

Summary:
Sickle cell disease (SCD) is the most frequent life-threatening genetic hemoglobinopathy in the world and occurs due to the synthesis of abnormal hemoglobin S (HbS).Cells with sickle cell hemoglobin are stiff and sticky. When they lose their oxygen, they form into the shape of a sickle or crescent. This can cause pain and tissue damage. Significant decrease in exercise capacity was seen in sickle cell anemic children. In the absence of a guidelines that can guide the prescription of exercise in SCD children. This study is a step for determine the forms of prescription of pain on the balance and muscle strength to build up in future studies a safety of physical exercises for children with sickle cell anemia and improve their functional abilities.

Primary Outcome Measures: Pressure pain tolerance, Pressure pain tolerance measured via digital pressure algometer. It determines the pressure amount could be tolerated over quadriceps. This will represented chronic pain among Sickle cell anemia children in order to aid in diagnosis of hyperalgesia thus provide insight into their management strategies. Digital pressure algometer determines enables the rater to quantify the mechanical sensitivity to pain and the recovery of underlying problems or soreness levels in a semi-objective manner., Baseline of the study.|Balance assessment, Balance assessed via HUMAC balance system to define musculoskeletal involvement in sickle cell anemia children. HUMAC balance system is an electronic balance board connected with laptop running HUMAC balance system software., Baseline of the study.|Lower limb muscle strength, Lower limb muscle (Quadriceps) strength evaluated via Lafayette hand held dynamometer to evaluate voluntary isometric contraction. Hand held dynamometer has a good to excellent reliability and validity mainly for proximal musculatures., Baseline of the study.
Mechanisms Behind Microvascular Dysfunction in INOCA
NCT Number: NCT06529861
Acronym: ExINOCA-P1
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Microvascular Dysfunction|Ischaemia With Non Obstructed Coronary Arteries
Interventions: DIAGNOSTIC_TEST: [15O]H2O-PET Imaging
Sponsor: Bispebjerg Hospital
Collaborators: University of Copenhagen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2028-05-15
Locations: Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000, Copenhagen, 2400, Denmark

Summary:
The purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.

Primary Outcome Measures: Vascular function in response to acetylcholine stress, Vascular conductance measured by ultrasound doppler during infusion of acetylcholine, Baseline only
Secondary Outcome Measures: Vascular function in response to acetylcholine adenosine stress, Vascular conductance measured by ultrasound doppler during infusion of Adenosine, Baseline only|Myocardial Blood flow reserve, Determined by the clinical assessment of \[15O\]H2O-PET, Baseline only|Skeletal Muscle Microvascular Function, Evaluated by brachial artery ultrasound Doppler in response to exercise stress to measure blood flow responsiveness in skeletal muscles., Baseline only|Changes in isolated small artery reactivity assessed with myography, Analyzed using myograph to study the tone of smooth muscle cells, Baseline only|Arterial Compliance, Determined by calculations made from intra-arterial pressure and arterial diameter measurements obtained via ultrasound Doppler to assess arterial compliance., Baseline only|Plasma Lipids, Conducted through clinical chemical analysis to measure levels of HDL, and triglycerides in the blood, providing insights into lipid profiles., Baseline only|Plasma HbA1c, Conducted through clinical chemical analysis to measure levels of HbA1c in the blood, providing insights into glucose metabolism., Baseline only|Plasma Levels of Markers Related to Vascular Function, Assessed using Mesoscale/ELISA to quantify biomarkers associated with vascular function, Baseline only|Plasma Levels of Inflammatory Markers, Measured using Mesoscale/ELISA/O-Link platforms to evaluate the presence and levels of inflammatory markers, Baseline only|Arterial Blood Pressure, Monitored with automated blood pressure measurements at rest and during exercise to assess overall cardiovascular health and response to physical activity., Baseline only|Cardiac Function, Changes in stroke volume using echocardiography during rest and exercise stress, Baseline only
Other Outcome Measures: Tone of smooth muscle cells, Changes in isolated small artery reactivity assessed with myography, Baseline only|Proteomic and transcriptomic analyses, Changes in gene and protein expressions patterns in small arteries, Baseline only
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
NCT Number: NCT06529809
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Locally Advanced Cervical Carcinoma
Interventions: RADIATION: Hypofractionated external beam radiation|DRUG: Chemotherapy|RADIATION: Image-guided brachytherapy
Sponsor: Washington University School of Medicine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2031-11-30
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

Summary:
The standard treatment for locally advanced cervical cancer is well established as a combination of chemotherapy and radiation, typically over 25-28 daily fractions with the addition of a brachytherapy boost to the primary tumor. An important component to treatment efficacy is overall treatment time. Prolongation of overall treatment time has been shown to lead to worse local control and overall survival; thus, strategies to effectively deliver radiation efficiently is required.

This is a pragmatic feasibility study to determine the impact of upfront brachytherapy combined with hypofractionated external beam radiation for patients with locally advanced cervical cancer (FIGO 2018 stage IB3-IVA) on late gastrointestinal and genitourinary toxicity, oncologic outcomes including recurrence free survival, and systemic and local immune response.

Primary Outcome Measures: Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant, -Must be at least possibly related to RT., Up to 2 year follow-up (estimated to be 2 years and 6 weeks)|Progression-free survival (PFS), Up to 2 year follow-up (estimated to be 2 years and 6 weeks)
Secondary Outcome Measures: Local control, Up to 2 year follow-up (estimated to be 2 years and 6 weeks)|Regional control, Up to 2 year follow-up (estimated to be 2 years and 6 weeks)
Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment
NCT Number: NCT06529796
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatic Impairment
Interventions: DRUG: IXP
Sponsor: Vertex Pharmaceuticals Incorporated
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-02
Completion Date: 2025-03
Locations: Division of Clinical Pharmacology, University of Miami, Miami, Florida, 33136, United States|GCP Research, Saint Petersburg, Florida, 33705, United States|Texas Liver Institute, San Antonio, Texas, 78215, United States

Summary:
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Inaxaplin (IXP) in participants with mild or moderate hepatic impairment and in matched healthy participants.

Primary Outcome Measures: Maximum Observed Plasma Concentration (Cmax) of IXP, From Day 1 up to Day 10|Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP, From Day 1 up to Day 10
Secondary Outcome Measures: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs), From Day 1 up to Day 20