pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Oral Frailty, a Prevalent Syndrome in the Senior Population, Manifests as a Decline in Oral Functions, Often Coupled With Diminished Cognitive and Physical Capabilities.
NCT Number: NCT06536985
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frailty
Interventions: BEHAVIORAL: Oral Health Intervention|BEHAVIORAL: SMS intervention
Sponsor: HangTian Zhu
Sex: ALL
Age: OLDER_ADULT
Enrollment: 146
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-08-15

Summary:
Oral frailty, a prevalent syndrome in the senior population, manifests as a decline in oral functions, often coupled with diminished cognitive and physical capabilities. This condition significantly impacts the elderly's quality of life. Our study aims to assess a hybrid oral health promotion program, grounded in the theory of goal achievement, that integrates both face-to-face counseling and digital health interventions. The goal is to determine its efficacy in alleviating oral frailty among residents of nursing homes.This study is structured as a 16-week prospective, cluster-randomized controlled trial. It will engage 92 seniors aged 65 years and older. To uphold the integrity and impartiality of the research, a blinding protocol is employed for all participants, outcome evaluators, and statistical analysts, ensuring they remain unaware of the subjects' group assignments. Drawing from the theory of goal achievement, we have crafted a comprehensive oral health promotion strategy that blends in-person guidance with digital health initiatives over a 16-week period. Following informed consent, participants will be randomly allocated to the control or intervention group at the outset of the study. The primary outcome measure will focus on oral function, encompassing tongue pressure, masticatory function, pronunciation abilities, and subjective experiences of eating and swallowing difficulties. Supplementary assessments will include frailty scales, social support scales, nutritional screening scales, and self-efficacy scales pertinent to oral health in the elderly. These will be conducted at intervals throughout the intervention (every 4 weeks) and at a 1-month post-intervention follow-up.

Primary Outcome Measures: Risk of oral frailty, Oral debility risk assessment was performed using the Chinese version of the Oral Frailty Index-8 (OFI-8 scale) translated by zongmei. \[18\] The scale consists of eight items with a total score ranging from 0 to 11, with higher scores indicating poorer oral health and higher risk of oral frailty. These include healthy (0-2 points), pre oral debilitation (3 points), oral debilitation (4-6 points) and severe oral debilitation (≥7 points)., 16week
VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
NCT Number: NCT06536959
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Relapsed Acute Myeloid Leukemia|Refractory Acute Myeloid Leukemia|Myelodysplastic Syndromes|Minimal Residual Disease
Interventions: DRUG: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
Sponsor: Beijing 302 Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2027-07-31
Locations: Xiao-ning Gao, Beijing, Beijing, 100071, China

Summary:
The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.

Primary Outcome Measures: Complete remission rate, percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi), At the end of Cycle 2 (each cycle is 28 days)|Complete minimal residual disease (MRD) Response Rate, Percentage of subjects with MRD negative or MRD \< 0.01%, At the end of Cycle 2 (each cycle is 28 days)|MRD Response Rate, Percentage of subjects with MRD \< 0.1% detectable by multicolor flow cytometry, At the end of Cycle 2 (each cycle is 28 days)
Secondary Outcome Measures: Relapse-Free Survival, Time interval from leukemia free state to the first recurrence or death, 24 months|Overall Survival, Time interval from start of treatment until death or last follow-up, 24 months|Duration of response, Time interval from morphologic/MRD response to loss of response or death, 24 months|Adverse events, Number of subjects with adverse events, start of treatment to 2 weeks after end of treatment
B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers
NCT Number: NCT06536946
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cutaneous Squamous Cell Carcinoma
Interventions: BIOLOGICAL: Immunohistochemical staining
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-09-30
Locations: Sohag University hospital, Sohag, Egypt

Summary:
Examine the role of B-catenin in differentiation of cutaneous squamous cell carcinoma from other lesions that may be similar to it

Primary Outcome Measures: Detection of B-catenin expression in cutanous squamous cell carcinoma and its mimickers, Detection of expression of B-catenin in cutaneous squamous cell carcinoma and its mimickers by immunohistochemical procedures using antihuman B-catenin monoclonal antibodies, 6 month
Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees
NCT Number: NCT06536933
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Interventions: DIAGNOSTIC_TEST: Abdominal Ultrasound
Sponsor: Sohag University
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-12-31
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
* Metabolic dysfunction-associated steatotic liver disease (MASLD) is the latest term for steatotic liver disease associated with metabolic syndrome. MASLD is a common cause of chronic liver disease and is the leading cause of liver-related morbidity and mortality.
* The high prevalence of this disease has been fueled by the rapid rise in levels of sedentary behavior, low levels of physical activity, excess calorie intake relative to expenditure in nutritionally imbalanced and unhealthy diets. In parallel, the prevalence of poor metabolic health in adults from many countries is high, even in normal weight individuals.
* MASLD has been estimated to affect 30% of the adult population worldwide, with its prevalence increasing from 22% to 37% from 1991 to 2019 . The increasing prevalence of MASLD parallels the increasing prevalence of obesity and obesity-related diseases.

Primary Outcome Measures: waist circumference, by using a flexible non-stretchable measuring tape by identifying measurement point midway between the lower margin of last palpable rib and the top of iliac crest., 4 months
Migraine Among Sohag University Students
NCT Number: NCT06536920
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine
Interventions: DIAGNOSTIC_TEST: Migraine screening questionnaire
Sponsor: Sohag University
Sex: ALL
Age: ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-10-01
Locations: Sohag university hospital, Sohag, Egypt

Summary:
Diagnosis of migraine among students and detect frequency among them and detect how far migraine affect their life

Primary Outcome Measures: Migraine screening questionnaire, Knowing frequency of migarine and impact of migraine on students' normal life, 1 year
Decompression of Odontogenic Cysts
NCT Number: NCT06536907
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Odontogenic Cysts|Keratocysts of the Jaw|Cysts Dental|Pathology
Sponsor: Akdeniz University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Observational Model: |Time Perspective: p
Start Date: 2015-01-01
Completion Date: 2023-09-01
Locations: Akdeniz University, Antalya, 07070, Turkey

Summary:
The aim of this case-control study is to evaluate the effects of decompression of cystic jaw lesions by means of comparing pre- and post-decompression histologic findings.

The main question it aims to answer is:

Does decompression of cystic jaw lesions alter the histologic diagnosis?

A retrospective analysis was performed based on the comparison of initial and final histologic diagnoses of patients with an odontogenic cystic lesion, that was surgically treated with decompression followed by a definitive surgery.

Primary Outcome Measures: Change in histologic diagnosis following decompression (yes/no), A comparison will be made between the initial histologic diagnosis and post-decompression definitive histologic diagnosis of the cystic jaw lesions, A decompression period ranging between 2 and 15 months
Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
NCT Number: NCT06536868
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Extensive-stage Small-cell Lung Cancer
Interventions: DRUG: Tislelizumab|DRUG: Etoposide|DRUG: Carboplatin or Cisplatin|RADIATION: Thoracic radiotherapy
Sponsor: Second Hospital of Shanxi Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: Jincheng General Hospital, Jincheng, Shanxi, 048000, China|Jinzhong third people's hospital, Jinzhong, Shanxi, 032000, China|Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, 030000, China|Shanxi Bethune Hospital, Taiyuan, Shanxi, 030000, China|Shanxi Hospital of Traditional Chinese Medicine, Taiyuan, Shanxi, 030000, China|TISCO General Hospital, Taiyuan, Shanxi, 030000, China

Summary:
This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.

Primary Outcome Measures: Progression-free Survival (PFS), From the date of enrollment to the date of disease progression, Up to 2 years
Secondary Outcome Measures: Objective Response Rate (ORR), ORR as assessed by the Investigator according to RECIST v1.1, Up to 2 years|Disease Control Rate (DCR), DCR as assessed by the Investigator according to RECIST v1.1, Up to 2 years|Overall Survival （OS）, From the date of enrollment until death by any cause or last follow-up, Up to 2 years|Adverse events, Treatment-related adverse events according to CTCAE 5.0., Up to 2 years
Wound Drain After Lumbar Fusion Surgery
NCT Number: NCT06536842
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lumbar Fusion
Interventions: OTHER: Postoperative Drain Placement|OTHER: No Postoperative Drain Placement
Sponsor: Rothman Institute Orthopaedics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-08-01
Locations: Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, 19107, United States

Summary:
Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression.

The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain

Primary Outcome Measures: Incidence of postoperative complications, Incidence of postoperative complications will be measured but recording the number of emergency department visits, 1 year
Effects of Myofacial Release Technique and Sciatic Nerve Slider Technique in Sciatica
NCT Number: NCT06536829
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sciatic Neuropathy|Sciatica|Range of Motion
Interventions: OTHER: Myofacial release technique and sciatic nerve slider technique|OTHER: Myofacial release technique
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-26
Completion Date: 2024-09-26
Locations: Pakistan Sports Board, Lahore, Punjab, Pakistan

Summary:
Sciatica is not a medical condition itself, but is a symptom of whatever condition is affecting your sciatic nerve. Pain in the lower back, hip and legs is the most common symptom. However, tingling, numbness and weakness are also symptoms of a damaged sciatic nerve. Physical therapy is a popular and effective way of treating the pain from sciatica. Myofascial release (MFR) is another useful option for sciatica due to the fact that it focuses the connective tissues of the body, including muscles and the fibrous tissues, often called fascia, encircling the joints.This study will be conducted to compare the Effects of myofacial release technique with and without sciatic nerve slider technique on Pain, Range of Motion and Functional Disability among cricket players with Sciatica. This study will be conducted because, no such evidence found in literature to find out the effects of myofacial release technique with sciatic nerve slider technique for sciatica. Myofacial release technique and sciatic nerve slider technique are useful, because these can reduce patients number of visits for the treatment and are easy to use, feasible and cost effective. The sciatic nerve is the largest nerve in the human body. It is formed at the point where five nerves from the lower back all come together, and stretches all the way from the hips to the bottoms of the feet. When this important nerve becomes compressed, inflamed or irritated, it causes the pain in the lower back and legs known as sciatica. A physical therapist uses a number of proven methods to help relieve sciatic pain. One of the most commonly employed methods is known as myofascial release therapy. Myofascial release is a method that a physical therapist can use to treat many sources of pain that are caused by damage to the nervous system. It involves the therapist using hands-on, manual techniques to release areas of tension and pain in the body. Here are three reasons that myofascial release is an effective tool for treating sciatica.

Primary Outcome Measures: range of motion, will be measured Goniometer, 0 6 WEEKS 12 WEEKS|Functional disability, will be measured LEFS, 0 6 WEEKS 12 WEEKS
Combined Effects of Game Profile-based Training and Small-sided Games Among Football Players
NCT Number: NCT06536816
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physical Endurance|Muscle Strength|Functional Performance
Interventions: OTHER: Game Profile-based training Group|OTHER: Small-sided games Group|OTHER: Combined training Group with both Game Profile-based training and Small-sided Games
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-06-26
Completion Date: 2024-09-26
Locations: Pakistan Sports Board, Lahore, Punjab, 16250, Pakistan

Summary:
Game profile-based training is a methodology in sports, including football, where training sessions are designed to simulate the specific conditions and challenges that players face during actual games. Coaches analyze individual and team performance data to identify patterns, positions, and scenarios commonly encountered in matches. The training is then structured to replicate these situations, helping players develop the skills, tactics, and decision-making abilities required in real-game scenarios.

Primary Outcome Measures: Endurance, The Hoff-test will be used to access endurance among players, 0 week, 6 weeks, 12 weeks|Strength, The 1 RM test will be used to access strength among players, 0 week, 6 weeks, 12 weeks|Performance, The Sprint test will be used to access strength among players, 0 week, 6 weeks, 12 weeks
Effects of High Load Strength Training With and Without Tissue Specific Planter Facia Stretching With Planter Fasciitis
NCT Number: NCT06536803
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plantar Fascitis|Resistance Training|Muscle Stretching Exercises
Interventions: OTHER: high load strength training and Tissue-specific plantar fascia stretching exercise for 12 weeks|OTHER: high-load strength training with routine physiotherapy
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-26
Completion Date: 2024-09-26
Locations: Youth foot ball club,MOTH, Mīrpur, Pakistan

Summary:
The rationale behind examining the synergistic impacts of high load strength training and tissues pecific plantar fascia stretching activities in athletes diagnosed with plantar fasciitis arises from an acknowledged deficiency in the existing body of scholarly research.Study design will be Randomized Control Trial. The study will be completed in 10 months after Synopsis Approval.The study will be carried in sports clubs of MOTH Mirpur AJK. Convenient Sampling will be used. Data Collection Tools will be used named as VAS, Functional foot index (FFI), and Goniometry used for Pain, functional disability and range of motion will be measured respectively before and after the intervention

Primary Outcome Measures: Range of motion, will be measured through goniometer, 0 week,6 weeks ,12 week|functional disability measured through Foot Function Index, will be measured through Foot Function Index, 0 week,6 weeks ,12 week
Comparative Effects of Hang Clean and Half Squat Training Program Among Basketball Players
NCT Number: NCT06536790
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Weight-Bearing Strengthening Program|Muscle Strength|Basketball
Interventions: OTHER: hang clean training|OTHER: half squat training
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-26
Completion Date: 2024-09-14
Locations: Don Bosco Basketball Court, Lahore, Punjab, 54000, Pakistan

Summary:
The goal of this randomized controlled trial is to compare the effects of hang clean and half squat training programs on vertical jump performance and strength in male basketball players aged 18-35 years. The main questions it aims to answer are: Does a hang clean training program improve vertical jump performance in basketball players? Does a half squat training program improve vertical jump performance in basketball players? Researchers will compare the hang clean training group to the half squat training group to see if there is a significant difference in the improvement of vertical jump performance and strength. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelop method by Non-probability Convenient random sampling technique. Subjects in Group A will receive hang clean training. Group B will receive half squat training, attend pre- and post-testing assessments of vertical jump performance and strength

Primary Outcome Measures: vertical jump test, The vertical jump and reach test through wall will be used to assess the maximum vertical jump height of each participant. The test will be performed by having participants stand side on to a wall with their feet shoulder-width apart. They will reach up with one hand and mark the highest point they can reach with their fingers on the wall. Then, they will perform a maximum vertical jump, landing on both feet, and mark the highest point they can reach at the peak of their jump on the wall. The difference between the two marks will be recorded as the vertical jump height in centimeters (cm). This metric will be used to quantify the improvement in vertical jump performance following the 12-week hang clean training program versus the 12-week half squat training program., 0 week, 12week|1-repitition maximum for strength, The 1RM strength metric will be used to quantify the maximum weight an individual can lift in a single repetition of a specific exercise, in this case, the hang clean and half squat exercises. This metric will be used to assess the improvement in maximum strength following the 12-week hang clean training program versus the 12-week half squat training program., 0 week, 12week
Effects of Ballistic Six Exercises With and Without Blood Flow Restriction in Cricket Players
NCT Number: NCT06536777
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plyometric Exercise|Blood Flow Restriction Training
Interventions: OTHER: Plyometric Exercises|OTHER: Blood Flow Restriction Training
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-25
Completion Date: 2024-09-25
Locations: Dring Stadium, Bahawalpur, Punjab, 63100, Pakistan

Summary:
Cricket is not only a widely played team sport, but it also involves intricate skills that are honed over time, especially in bowling. One of the key concerns for bowlers is the risk of developing shoulder injuries due to imbalances between the agonist and antagonist muscle groups. To address this, the Ballistic Six program focuses on functional exercises that replicate the movements and forces involved in the overhead throwing motion, helping to enhance strength, power, proprioception, kinesthesia, and endurance in the rotator cuff muscles. By incorporating plyometric training in a ballistic, high-velocity manner, the program aims to take advantage of the stretch reflex and reduce the amortization phase of the stretch shortening cycle. Additionally, blood flow restriction (BFR) training has shown promising results in promoting muscle growth and strength. By applying a tourniquet to the arm during intra-set rests, BFR induces muscle hypoxia while restricting venous return, leading to increased lean mass, isometric strength, and muscular endurance in the shoulder and arm. These training methods can contribute to the overall performance and injury prevention of medium pace cricket bowlers.

Primary Outcome Measures: Agility, Will be measured by Closed Kinetic Chain Upper Extremity Stability (CKCUES) Test, 0 week, 8 week|Strength, Will be measured by Seated medicine ball throw test, 0 week, 8 week|Functional Ability, Will be measured by Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow Score, 0 week, 8 week
Esophageal Fistula After Anterior Cervical Decompression and Fusion
NCT Number: NCT06536738
Acronym: ACDF
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Esophageal Fistula
Interventions: PROCEDURE: esophageal repair
Sponsor: Taizhou Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-01-01
Completion Date: 2024-01-01

Summary:
This study aims to evaluate the incidence, risk factors, and preventive measures of esophageal fistula following anterior cervical decompression and fusion. By understanding the mechanisms and clinical manifestations of this complication, the study seeks to provide clinicians with better guidelines for treatment and improve postoperative outcomes for patients.

Primary Outcome Measures: The healing rate after the repair of an esophageal fistula, Successful repair of an esophageal fistula can result in a high healing rate, with many patients experiencing complete recovery. However, complications such as infection, poor blood supply to the repaired area, or underlying health conditions can affect the healing process. Close postoperative monitoring and appropriate care are crucial to ensure optimal healing and to address any potential complications promptly., 2 month
Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis
NCT Number: NCT06536725
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer|Organoid
Interventions: OTHER: Building Organoid-on-chips models
Sponsor: Tianjin Medical University Second Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-12-31
Locations: Tianjin Medical Unversity Second Hospital, Tianjin, Tianjin, 300211, China|Tianjin Medical Unversity Second Hospital, Tianjin, Tianjin, China

Summary:
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.

Primary Outcome Measures: ORR(Objective Response Rate), Selecting ORR as the primary endpoint from clinical efficacy evaluation indicators.Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria., 18 months|Clinical Consistency, Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators., 18 months
Secondary Outcome Measures: Changes in tumor markers levels, The main tumor marker monitored is TPSA.The levels of PSA will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of PSA progression, as defined by PCWG3 criteria.The levels of other tumor markers will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of tumor markers progression., 18 months|PFS(Progression-free survival), Progression-free survival (PFS) is defined as the time from the date of the first administration of patients medication plan based on organoids drug sensitivity test to the date of the first documentation of disease progression or death due to any cause, whichever comes first, censored at the last date at which the participant was determined to be progression-free., 18 months
Effects of Exosome Adminstration in Preventing Early Leakage in Rectal Cancer Patients Undergoing Low Anterior Resection
NCT Number: NCT06536712
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Rectal Cancer
Interventions: BIOLOGICAL: Mesenchymal Stem Cells Derived Exosomes|OTHER: Placebo
Sponsor: Tehran University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2024-12
Locations: Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran, Tehran, 1419733141, Iran, Islamic Republic of

Summary:
The goal of this clinical trial is to assess the safety and efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes in preventing early anastomosis leak in patients undergoing low anterior resection for rectal cancer. The main question it aims to answer are

Do Mesenchymal Stem Cell-Derived Exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer?

If there is a comparison group: Researchers will compare Mesenchymal Stem Cells Derived Exosomes to placebo to see if it can prevent early anastomotic leakage.

Participants will receive intraperitoneal Mesenchymal Stem Cells Derived Exosomes at the end of their surgery.

Primary Outcome Measures: Number of patients with early anastomotic leakage, Failed surgical anastomosis after surgery measured with interview and physical examinations in follow-up sessions in clinic, 1 month
Secondary Outcome Measures: Mean serum and peritoneal Interleukin-6 and Tumor necrosis factor-alpha levels in participants, The level of serum and peritoneal inflammatory markers in postoperative days measured with laboratory tests, 1 month|Anastomosis integrity in Colonoscopy exam, A colonoscopy will be conducted one month after surgery to assess the integrity of the colorectal anastomosis, detect early signs of local recurrence, identify polyps, and monitor for any postoperative complications such as strictures or inflammatory changes. Baseline colonoscopies will be compared with post-surgical colonoscopy at one month. This outcome will help determine the efficacy of surgical intervention and guide future surveillance strategies in rectal cancer management., 1 month|Hospitalization length of stay, The number of days that the patient in hospitalized postoperatively, 1 month
The Effect of Oketani Breast Massage on Breastfeeding
NCT Number: NCT06536608
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Feeding|Massage
Interventions: OTHER: Massage
Sponsor: Saglik Bilimleri Universitesi
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-02
Completion Date: 2024-12-20
Locations: Cankiri State Hospital, Çankırı, Turkey

Summary:
This study aims to determine the effects of Oketani breast massage on breastfeeding success, breastfeeding self-efficacy and satisfaction of primiparous mothers.

Primary Outcome Measures: Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form, The first form of the scale developed by Dennis and Faux was designed as 33 items, but after a second study, Dennis revised the scale and created a 14-item short form. The Turkish validity and reliability study of the scale was conducted by Aluş Tokat et al. in 2017. The scale can be administered in prenatal and postnatal periods and measures how competent women feel about breastfeeding. The items of the five-point Likert-type scale are scored as not at all sure

(1), not very sure (2), sometimes sure (3), sure (4), very sure (5). The lowest score that can be obtained from all the evaluation scores of the scale is 14 and the highest score is 70. A low total score on the scale indicates a low perception of breastfeeding self-efficacy. In the original scale, the Cronbach's alpha reliability coefficient of the prenatal form was 0.87 and the Cronbach's alpha reliability coefficient of the postnatal form was 0.86., 1. week, 2. week and after labor 1. day
Secondary Outcome Measures: Visual Assessment Scale - Satisfaction (VAS - S), The VAS is also used to measure other components besides pain, such as satisfaction.In our study, the VAS will also be used to assess mothers' breastfeeding satisfaction levels. The Visual Assessment Scale - Satisfaction (VAS-S) is a 10 cm ruler with the expression "Not satisfied" on one end and "Very satisfied" on the other end. The mother is asked to rate her satisfaction with breastfeeding after the training from 1 to 10. High scores on the scale indicate that the satisfaction of the recipients is also high, After labor 1. day
Comparison of Efficacy Between ILM Forceps
NCT Number: NCT06536569
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Macular Holes|Epiretinal Membrane
Interventions: DEVICE: Internal limiting membrane (ILM) Peeling with Sharkskin Forceps|DEVICE: Internal limiting membrane (ILM) Peeling with Standard Forceps
Sponsor: University of British Columbia
Collaborators: Sengi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2025-08-01
Locations: Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology, Vancouver, British Columbia, V6Z 1Y6, Canada

Summary:
This study is a Single center, prospective, observational, multi surgeon randomized controlled trial. Subjects will be assessed pre-operatively, operatively and at 1 month postoperatively. Clinical evaluations will include measurement of visual acuity and optical coherence tomography (OCT).

Primary Outcome Measures: Number of attempts to initiate peeling, Evaluated by recorded video, Surgery (Operative Visit)
Secondary Outcome Measures: Number of handle-ReSite/widefield viewing system lens touches, Evaluated by recorded video, Surgery (Operative Visit)|Duration of Peel, Start to completion of peel, Surgery (Operative Visit)|Number of deep retinal grasps, Evaluated by recorded video, Surgery (Operative Visit)
Other Outcome Measures: Corrected Distance Visual Acuity, 1 Month Postoperatively
Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: Comparison of Paclitaxel vs Paclitaxel + Trastuzumab vs Paclitaxel + Carboplatine: the PROTECT-06 Bis Study
NCT Number: NCT06536556
Acronym: PROTECT-06-bis
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: OTHER: First Assessment|OTHER: Second Assessment
Sponsor: Institut de cancérologie Strasbourg Europe
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-02
Completion Date: 2025-09-06
Locations: Institut de cancérologie Strasbourg europe, Strasbourg, 67033, France

Summary:
This study aims to investigate the acute effects (i.e. 4 days) of paclitaxel or paclitaxel vs trastuzumab or paclitaxel and carboplatine on skeletal muscle of breast cancer patients. Muscle biopsies will be performed, as well as measurements of body composition strength, muscle architecture and quality of life.

Primary Outcome Measures: To investigate the effects of a chemotherapy session on mitochondrial function of skeletal muscle in breast cancer patients by comparing the first session of TAX to the first session of TAX + TRASTU or +CARBO., difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression., Change at 4 days post-treatment compare to baseline
Secondary Outcome Measures: Compare the effect of the first TAX to the first TAX+TRASTU or +CARBO on muscle fiber cross-sectional area;cellular mechanisms of inflammation,fat infiltration and protein turnover;body composition;strength;muscle architecture and quality of life, difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression., Change at 4 days post-treatment compare to baseline
EIT Assessment of Overdistension in ARDS Patients in Prone Position
NCT Number: NCT06536543
Acronym: DISTIE-DV
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Respiratory Distress Syndrome
Interventions: OTHER: Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)
Sponsor: University Hospital, Bordeaux
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-09
Locations: Hopital Haut-Lévêque, Pessac, 33604, France

Summary:
Mechanical ventilation in ARDS requires protective ventilation with low VT and PEEP. PEEP titration can improve lung recruitment in the dependent lung but with a risk of overdistension in the non-dependant lung. EIT can measure the distribution of tidal ventilation and assess overdistension and collapse during a PEEP titration in any position (prone or not).

This study aims to measure the best PEEP as a compromise between recruitment and overdistension during a PEEP trial with EIT before and just after PP.

Primary Outcome Measures: Level of distension, Assessing the level of distension when titrating the optimal PEEP in the supine position (SP) and in the PP position the first and second day of ARDS in PP. The measure will be obtained thanks to the crossing in EIT of the overdistension curve and the collapse curve when the PEEP is reduced from 20 to 5 cmH2O., 48 hours after inclusion day
Secondary Outcome Measures: Comparison of the % of overdistension and collapse during the EIT-PEEP titration, Thanks to PEEP-EIT titration in PP and SP the % of collapse and global over-distension in EIT will be evaluate., 48 hours after inclusion day|Repartition of regional ventilation in each part of the lungs., Thanks to PV-EIT curve, the measurement of regional Airway Opening Pressure (anterior vs posterior) will be evaluate (lower inflection point of the PV-EIT curve)., 48 hours after inclusion day|Assessment of prone position, Comparison of the data between the first day of prone position and the second day., 48 hours after inclusion day
The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
NCT Number: NCT06536517
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Fibroid Uterus
Interventions: DRUG: Methadone
Sponsor: Johns Hopkins University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12

Summary:
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use.

Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of Methadone, a longer opioid analgesics, intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries. The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption, including new opioid abuse.

Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids (standard).

Primary Outcome Measures: Total post-operative opioid requirements in oral morphine milligram equivalents (MME), Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days., 1 week
Secondary Outcome Measures: Mobility and satisfaction of analgesia, Mobility and satisfaction of analgesia on post-operative day one and seven (binary question Y/N), Post operative day 1, Post operative day 7|Number of unplanned returns to emergency room/clinic or patient initiated phone call regarding pain, 1 week|Overall satisfaction with pain control, 0-10 scale (0- no pain, 10-worst pain), 1 week
A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)
NCT Number: NCT06536504
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Pain
Interventions: OTHER: Steinway Spirio M recording/player piano
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01-31
Completion Date: 2029-03-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
The study plans to enroll a total of 132 patients and 30 distinct providers. The goal of this study is to measure pre-, intra- and post-intervention changes in patients' vital signs (BP, HR, HRV, MAP), serum- and plasma-level biomarkers by proteomics analysis (including but not limited to interleukin-6, cortisol, ACTH, oxytocin, dopamine, epinephrine, norepinephrine, B-endorphin, growth hormone, and IgA.), total amount of pain meds and sedatives, and validated measures or surveys.

Primary Outcome Measures: BMEQ (Brief Music Experience Questionnaire), Approximately 15 minutes to complete each time), Through study completion; an average of 1 year
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
NCT Number: NCT06536491
Acronym: BETTIS-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Diabetic Macular Edema
Interventions: DRUG: EC-104 high dose|DRUG: EC-104 low dose|DRUG: Dexamethasone intravitreal implant
Sponsor: Eclipse Life Sciences, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2025-12-31
Locations: Retina Associates of Florida, LLC, Tampa, Florida, 33609, United States

Summary:
This is a prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide \[FA\] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).

Primary Outcome Measures: Ocular and Systemic Safety, Incidence of Adverse events, Through Week 24
Secondary Outcome Measures: Diabetic macular edema recurrence, Time (days) to recurrence, Through Week 24
The Effect of Exercise Intervention on Posture, Trunk Flexibility and Spine Function in Patients With Parkinson's Disease
NCT Number: NCT06536478
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: OTHER: exercise|OTHER: education
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-28
Completion Date: 2026-07-31
Locations: National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan

Summary:
The primary goal of this clinical trail is to compare the effect of a five-week specific motor interventions on the postural alignment, trunk range of motion and spine function in patients with Parkinson's disease. The secondary goal is to investigate the effect of specific motor interventions on pain, balance, gait, and quality of life.

Participants will:

be randomly allocated to a control group or an exercise group and will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks. Each group will be assessed for posture, trunk range of motion, spine function, pain, balance, gait, and quality of life before and after the intervention.

Primary Outcome Measures: postural alignment of frontal and sagittal plance, The angles of Flexion and Side-bending of the trunk in degrees, before and immediately after the intervention|range of motion of trunk flexion and side-bending, The range of motion of trunk flexion and side-bending will be evaluated in degrees, before and immediately after the intervention|Supine to and from sitting, The time of supine to and from sitting is measured in seconds, before and immediately after the intervention
Secondary Outcome Measures: Visual Analogue Scale of low back pain, It is a scale from 0 to 10. The higher score means the patient has more severe pain., before and immediately after the intervention|The Shortened Version of the Balance Evaluation Systems Tests (Mini-BEST), It is a scale from 0 to 28. The higher score means the patient has no impairment in their balance., before and immediately after the intervention|10 meter gait speed, the speed of gait is measured in meters per second, before and immediately after the intervention|Tinetti Mobility Test (TMT), It is a scale from 0 to 12. The higher score means the patient has a better gait pattern., before and immediately after the intervention|the short version of the Parkinson's Disease Questionnaire (PDQ-8), quality of life will be measured by the PDQ-8. It is a scale from 0-32. The higher scale means the patient has worse quality of life., before and immediately after the intervention|Falls Efficacy Scale International (FES-I), It is a scale from 16 to 64. The higher score means the patient is more afraid of falling down., before and immediately after the intervention