pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System
NCT Number: NCT06500390
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Levonorgestrel Adverse Reaction|Temporomandibular Joint Disorders|Temporomandibular Disorder
Interventions: DIAGNOSTIC_TEST: Examination of temporomandibular joint and masticator muscles
Sponsor: Marmara University
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-01-15
Completion Date: 2024-08-15
Locations: Marmara University, Istanbul, Maltepe, 34854, Turkey

Summary:
The goal of this clinical trial is to investigate the possible role of levonorgestrel intrauterine system use(LIU) in the pathogenesis of temporomandibular joint disorder (TMD). In this clinical trial, levonorgestrel intrauterine system patients (n=30) aged 25-50 and control group patients (n=30) with the same demographics and age range are used. The main questions it aims to answer are:

To compare the frequency of temporomandibular dysfunction in women using the levonorgestrel intrauterine system with the control group of the same demographic and age range.

The levonorgestrel intrauterine system use group consisted of 50 women who had previously a mirena implanted by a gynecologist at least 3 months ago due to menstrual bleeding and pelvic pain.

The control group included 50 randomised healthy women who had regular menstrual cycles and were not taking any medication.

Primary Outcome Measures: Evaluation of temporomandibular joint disorder and masticator muscle pain, To measure whether there is any difference in the incidence of temporomandibular joint disorders and masticator muscle pain between two groups., One Day
Comparing the Impact of Four Types of Meditation Practices for Relaxation in Cancer Survivors
NCT Number: NCT06500377
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm|Malignant Solid Neoplasm
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Meditation Therapy|PROCEDURE: Meditation Therapy|PROCEDURE: Meditation Therapy|PROCEDURE: Meditation Therapy|OTHER: Questionnaire Administration
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-17
Completion Date: 2026-06-17
Locations: City of Hope Medical Center, Duarte, California, 91010, United States|City of Hope at Irvine Lennar, Irvine, California, 92618, United States

Summary:
This clinical trial compares the impact of four types of meditation practices, breathing only, focused attention only, mindfulness only, and breathing, focused attention and mindfulness combined, for relaxation in cancer survivors. Studies show that many patients with cancer experience stress and anxiety. Meditation therapy uses a variety of techniques, such as breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer. The trial is being done to find out how meditation can help cancer survivors feel relaxed and attain a peaceful state of mind.

Primary Outcome Measures: Retention rate, Feasibility will be achieved if 70% of all enrolled participants attend at least 5 full visits within 6 weeks. Descriptive statistics will be generated., Up to 6 weeks|Adherence rate, Feasibility will be achieved if 70% of all enrolled participants complete all assessments of the program within 6 weeks. Descriptive statistics will be generated., Up to 6 weeks
Knotless Implants as An Alternative for Capsular Closure in Primary Hip Arthroscopy: A Prospective, Multi-Center Study
NCT Number: NCT06500364
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Femoro Acetabular Impingement
Interventions: DEVICE: LoopLoc Arm|DEVICE: Control Arm
Sponsor: American Hip Institute
Collaborators: Arthrex, Inc.
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-08

Summary:
The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available.

The hip capsule is the tissue that surrounds your hip joint. It stabilizes and supports your hip joint. During hip arthroscopy, this tissue must be cut through in order to perform the hip arthroscopy. Once the hip arthroscopy is completed, the surgeon might repair the capsule. Current ways of repairing the capsule include knotted suture that might irritate structures around the hip, leading to the possible formation of scar tissue and pain. The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes.

Therefore, researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used, to see if there is a difference in their outcomes following surgery.

Primary Outcome Measures: Modified Harris Hip Score, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome., 2 years
Secondary Outcome Measures: Non-Arthritic Hip Score, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome., 2 years|International Hip Outcome Tool, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome., 2 years|Hip Outcome Score Sports-Specific Subscale, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome., 2 years|Visual Analog Scale, Patient-reported outcome measure. Scale 0-10, 10 indicating most amount of pain possible., 2 years|Patient Satisfaction, Patient-reported outcome measure. Scale 0-10, 10 indicating the highest level of satisfaction., 2 years
Renalase(rs10887800) Genotyping & Leucocytes Telomere Length in Postpartum. Hypertension
NCT Number: NCT06500351
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Renalase(rs10887800) Genotyping & Leucocytes Telomere Length in Patients With Postpartum Hypertension
Sponsor: Sohag University
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2025-09-01
Locations: Sohag university hosoital, Sohag, Egypt

Summary:
This is an observertional study aimed at Study the association between Renalase(rs10887800) Genotyping \& Leucocytes telomere length in patients with postpartum hypertension whether new onset( denovo) or persistent following pregnancy complicated by hypertension.

Primary Outcome Measures: Renalase(rs10887800) Genotyping, The presence of gene polymorphism whether homogenetic or heterogenetic, 1 year
Secondary Outcome Measures: Leucocytes telomere length, Measurement of the relative length of WBCs telomere in patints with postpartum hypertension, 1 year
Determining the Dose Response Profile of the Headward Fluid Shift During Varying Gravity Levels
NCT Number: NCT06500338
Acronym: AG2
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: PROCEDURE: free-fall
Sponsor: National Aeronautics and Space Administration (NASA)
Collaborators: NOVESPACE (Merignac, France)|European Space Agency (ESA)
Sex: ALL
Age: ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-07-21
Completion Date: 2024-04-17
Locations: NASA, Houston, Texas, 77058, United States

Summary:
Parabolic flight provides a unique opportunity to evaluate the acute changes associated with varying levels of gravity and to describe how key venous parameters change at levels less than normal Earth gravity. Characterizing these changes in response to varying G-levels is an important step in determining what G-level may be required to reverse weightlessness-induced fluid shifts and thus serve as a viable countermeasure during long-duration spaceflight. Further, these results will inform National Aeronautics and Space Administration (NASA) whether there might be a lower risk of Spaceflight Associated Neuro-ocular Syndrome (SANS) and Venous Thromboembolism (VTE) during extended stays on the Moon and Mars.

Primary Outcome Measures: Bilateral Internal jugular vein blood flow characterization, ultrasound measures of the bilateral Internal jugular vein with numeric blood flow characterization, 2-3 hours|Bilateral Internal jugular vein pressure, ultrasound measures of the bilateral Internal jugular vein using a pressure measurement device, 2-3 hours|Bilateral Internal jugular vein area, ultrasound measures of the bilateral Internal jugular vein to measure vein area, 2-3 hours
Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.
NCT Number: NCT06500325
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Proximal Third Tibial Shaft Fractures in Children
Interventions: PROCEDURE: retrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in children
Sponsor: Sohag University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2024-10-01
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm, representing 15% of all pediatric fractures. Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group. Treatment of pediatric fractures dramatically changed in 1982. The goals are to stabilize the fracture, control limb length, alignment, rotation, instability, promote bone healing, and minimize the morbidity and complications for the child and his/her family. Titanium elastic nails (TENs) fixation was originally meant as an ideal treatment method for femoral shaft fractures, but was gradually applied to other long bones diaphysial fractures in children, as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications.

Over the past 20 years, pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications. Each method has had its own complications: cast immobilization alone or following traction had resulted in limb-length discrepancy, angulations, rotational deformity, psychological and economic complications. External fixation had resulted in pin-tract infection, loss of knee range of motion, delayed union, non-union, and refracture after fixator removal. TENs work by balancing the forces between the two opposing flexible implants. To achieve this balance, the nail diameter should be 40% of the narrowest canal diameter or more. The nails should assume a double-C construct. They should have similar smooth curve and same level entry points.

Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively, especially for comminuted, spiral, and long oblique fractures.

Primary Outcome Measures: Goniometry of knee and ankle joints range of motion (ROM), Goniometry involves using a goniometer, which is a specialized protractor-like device, to measure the angles of movement at joints such as the knee and ankle., 1 year
Decoding the Association of Imaging and Tumor Microenvironment in Lung Cancer Using Radiogenomic Approach（Radiogenomics-Lung）
NCT Number: NCT06500312
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-02
Completion Date: 2027-07-02
Locations: Union Hospital，Tongji Medical College，Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

Summary:
This is the prospective, observational cohort study (Radiogenomics-Lung), which aims to explore the relationship between the imaging information of lung cancer patients, tumor microenvironment and the prognosis of lung cancer patients.

Primary Outcome Measures: Correlation analysis of sequencing results and body composition, Conducting correlation analysis between body composition and results of multi-omics sequencing, 0.5 year|Correlation analysis of sequencing results and tumor radiomic features, Conducting correlation analysis between radiomic features and results of multi-omics sequencing, 0.5 year
Secondary Outcome Measures: Constructing tumor microenvironment prediction model, Constructing radiomic model to predict tumor microenvironment. The indicator is the area under the curve (AUC) of the prediction model, 2 years|Constructing a multi-dimensional prognostic prediction model, A high-dimensional model was constructed to predict the prognosis of patients through multi-omics sequencing data, body composition, and tumor radiomic features. The indicator is the area under the curve (AUC) of the prediction model., 3 years
Dorsal Nerve Block and Caudal Block in Hypospedius Repair in Children
NCT Number: NCT06500286
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Dorsal Nerve Block in Hypospiudus
Interventions: DRUG: Marciane|DRUG: Marcaine
Sponsor: Assiut University
Sex: MALE
Age: CHILD
Enrollment: 103
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03

Summary:
Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial

Primary Outcome Measures: Efficacy of dorsal penile block, Score of pain visual Analougue Score, 1year
Secondary Outcome Measures: Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block, Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block, 1year
Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.
NCT Number: NCT06500247
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Interventions: DRUG: Dalpicilib|DRUG: Abiraterone Acetate (II)|DRUG: Androgen Deprivation Therapy|DRUG: Prednisone
Sponsor: Qilu Hospital of Shandong University
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2027-03-31
Locations: Qilu hospital, Jinan, Shandong, 250012, China

Summary:
This study is a single-arm, multicenter, phase II exploratory trial. The purpose is to explore the efficacy and safety of Darxicilib in combination with Abiraterone Acetate for the treatment of subjects with metastatic castration-resistant prostate cancer.The main questions it aims to answer are:

·PSA50 response rate at the end of week 12

Participants will:

* Darxicilib: 125mg per tablet, oral administration, once daily for 21 consecutive days followed by a 7-day break.
* Abiraterone Acetate tablets (II): 300mg per dose, oral administration, once daily for a 28-day cycle.
* Prednisone: 5mg per tablet, oral administration, twice daily.

Primary Outcome Measures: 12 Week PSA 50, Response rate of PSA 50 at the end of 12 weeks., 12 weeks
Secondary Outcome Measures: Radiographic Progression-Free Survival, The time from randomization until the occurrence of radiographic progression or death from any cause., 3 years|Adverse event, During the trial, adverse events are assessed based on laboratory and clinical examinations., 3 years|overall survival, The time from the start of the study or the initiation of treatment for the patient, to the time of death from any cause., 3 years|PSA 50, PSA 50 is defined as the percentage of patients experiencing a reduction in prostate-specific antigen (PSA) levels by at least 50% from their baseline values after treatment., 3 years|PSA 90, PSA 90 is defined as the percentage of patients experiencing a reduction in prostate-specific antigen (PSA) levels by at least 90% from their baseline values after treatment., 3 years
Nutrition Impact on Immunotherapy of Cancer
NCT Number: NCT06500234
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Nutrition Disorders|Immunotherapy|Cancer|Survival, Prosthesis
Interventions: DRUG: Megestrol Acetate and olanzapine|DRUG: Starch powder 50 mg
Sponsor: Qingdao Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2027-05-31
Locations: Qingdao Central Hospital, Qingdao, Shandong, 266042, China

Summary:
This study investigates nutritional status and outcomes of immuntherapy in cancer patients.

Primary Outcome Measures: ORR, overall response rate, 12 months
Secondary Outcome Measures: PFS, profression-free survival, 12 months
Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia
NCT Number: NCT06500221
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes|Sarcopenia
Interventions: BEHAVIORAL: incentive spirometry
Sponsor: Yu-Shan Hsieh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2025-02-28

Summary:
In patients with Type 2 diabetes, the risk of developing sarcopenia is three times higher compared to individuals with normal blood sugar levels. Sarcopenia is often accompanied by reduced physical activity, immobility, slow gait, and poor endurance. More importantly, previous studies have shown that sarcopenia leads to a decrease in mobility, which in turn results in reduced cardiopulmonary function, difficulty in breathing, and subsequently even less activity. In diabetic patients, this can cause poor control of blood sugar and lipids, as well as sarcopenic obesity, creating a vicious cycle. Therefore, preventing such a cycle is a crucial issue that needs attention. The incentive spirometer is widely used in physical, speech, and respiratory therapy, as well as in preventing postoperative pulmonary infections and improving sputum clearance. Consequently, this study aims to further confirm the role and effectiveness of incentive spirometry in improving lung function, activity endurance, and long-term blood sugar and lipid indices in patients with Type 2 diabetes combined with sarcopenia.

Primary Outcome Measures: Lung function: FVC, Forced Vital Capacity (FVC), 3 months|Lung function:FEV1, Forced Expiratory Volume in the First Second (FEV1), 3 months|Lung function: FEV1/FVC ratio, FEV1/FVC ratio, 3 months
Secondary Outcome Measures: Long-term Metabolic Indicators: HbA1c, Glycated Hemoglobin (HbA1c), 3 months|Long-term Metabolic Indicators: TG, Serum Triglycerides (TG), 3 months|Long-term Metabolic Indicators: LDL, Serum Low-Density Lipoprotein (LDL), 3 months|Long-term Metabolic Indicators: HDL, Serum High-Density Lipoprotein (HDL), 3 months|Long-term Metabolic Indicators: TC, Serum Total Cholesterol (TC), 3 months
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
NCT Number: NCT06500208
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-12-31

Summary:
Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.

Primary Outcome Measures: pCR rate, pathological complete response rate: No invasive residual disease in surgical specimen of breast and axillary lymph nodes, up to 8 months, after patients complete surgery
Secondary Outcome Measures: ORR, Objective Response Rate: patients achieving partial response and complete response during treatment, up to 8 months, after patients complete surgery|Incidence of adverse events (Safety), adverse events of patients receiving at least one cycle of treatment, up to 8 months, after patients complete surgery|pCR rate in PD-L1 CPS≥1 subgroup, pathological complete response rate in patients with PD-L1 CPS score ≥1, up to 8 months, after patients complete surgery
Hybrid Construct Versus Pedicle Screw-only System for the Treatment Scoliosis
NCT Number: NCT06500195
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Scoliosis Idiopathic|Dysplastic
Interventions: PROCEDURE: implantation of the hybrid instrumentation system
Sponsor: Pomeranian Medical University Szczecin
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-12-01
Completion Date: 2024-01-02
Locations: Pomeranian Medical University, Szczecin, 71-252, Poland

Summary:
The placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used.

Primary Outcome Measures: correction efficacy, defined as the Cobb score baseline to endpoint change (Cobb angle change in the operated spine segment in % at endpoint: X-ray imaging was performed (AP and lateral), at the 3rd day after the surgery procedure
Secondary Outcome Measures: length of surgery procedure, duration of the hospitalization measured in minutes, procedure (from skin incision to skin suture)
The Benefits of Hippotherapy for Patients With Parkinson's Disease of 75 Years
NCT Number: NCT06500182
Acronym: EQUIDIA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: OTHER: hippotherapy sessions
Sponsor: Central Hospital Saint Quentin
Sex: ALL
Age: OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-07-01
Completion Date: 2024-07
Locations: Centre Hospitalier de Saint-Quentin;, Saint-Quentin, Aisne, 02100, France

Summary:
There is no cure for Parkinson's disease, resulting in an interest for research in this domain. Non pharmacological measures remain essential, specifically physical activity. Hippotherapy is a nonconventional method which uses the horse in addition to standard care. The goal being to improve or maintain the gains of the person through cognitive, sensorial and motor stimulation, with the aim of improving quality of life and maintaining independence. With this in mind, the researchers propose to evaluate quality of life as the main criterion, using the PDQ8 scale validated for this disease. The researchers hope results will lead to the coverage of the costs of non-conventional therapies such as hippotherapy by social security services.

Primary Outcome Measures: Assessing quality of life in Parkinson's disease by PDQ8 questionnaires, changes from baseline in PDQ8 scores, which contain 8 items given a score between 0 (never) and 4 (always) maximum control; range, 0 to 32., 06 weeks
Secondary Outcome Measures: Assessing Parkinson's disease Motor disorders, Motor disorders assessed by Mbientlab devices ., 06 weeks|Assessing Parkinson's disease severity of the non-motor symptoms, The severity of the non-motor symptoms of Parkinson's disease assessed by the score on the non-motor symptoms assesment scale for Parkinson's Disease. This is a 30-question questionnaire. For each question, a severity score ranging from 0 (none) to 3 (severe) and a frequency score ranging from 1 (rarely) to 4 (very frequent) are to be indicated., 06 weeks|Assessing Parkinson's disease Postural and walking disorders, Postural and walking disorders assessed by the Gait and Balance Scale (GABS) 33 (maximum control; range, 0 to 95). changes from baseline in severity motor signs of Parkinson's disease,assessed by the motor score of the MDS UPDRS scale., 06 weeks|MRI in diagnosis differential in Parkinson's disease, The usefulness of flow MRI in diagnosis differential in Parkinson's disease, day 0
Metabolic Cluster Analysis in Septic Shock Patients
NCT Number: NCT06500156
Acronym: ACMEcat
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Septic Shock
Interventions: OTHER: Fluid challenge
Sponsor: Corporacion Parc Tauli
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2026-10
Locations: Hospital Universitari Parc Taulí, Sabadell, Barcelona, 08208, Spain

Summary:
Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured.

Primary Outcome Measures: VO2-response, Percentage increase in VO2 as results of the fluid challenge, 30 minutes
Secondary Outcome Measures: Organ failure, Assessment of the SOFA score at day 1, 2 and 4, 4 days|Mortality, Mortality within the first 28 days, 28 days
Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery
NCT Number: NCT06500143
Acronym: RESIDUAL
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Retention
Interventions: DIAGNOSTIC_TEST: Gastric ultrasound
Sponsor: Ciusss de L'Est de l'Île de Montréal
Collaborators: Institut de Cardiologie de Montréal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-03

Summary:
Glucagon-like peptide-1 agonists (GLP-1RA) are a family of medications used for diabetes and weight loss. One of their effect is to slow down stomach emptying. The goal of this study is to evaluate the effect of GLP-1RA on the effectiveness of fasting before a scheduled surgery.

The question it aims to answer is: does this kind of medication increase the risk of having food or too much liquid in the stomach before a scheduled surgery, even if the minimum 6 hour fast is done?

For this project, researchers will use gastric ultrasound to compare participants already taking one of these medications as part of their home treatment to participants who are not taking them. Gastric ultrasound is a simple bedside exam using an echography machine that takes less than 5 minutes to do.

Participants will:

-Have a gastric ultrasound performed on them before their surgery

Primary Outcome Measures: Increased residual gastric content, The primary endpoint will be the prevalence of increased residual gastric content defined by the presence of any of the following:

* Solid or thick fluid content on gastric ultrasound
* Content of more than 1.5 mL/kg of clear fluids on gastric ultrasound using the following formula : Gastric volume (mL) = 27 + \[14.6 × right lateral cross-sectional area (in cm2)\] - \[1.28 × age (in years)\], Preoperative (day of surgery)
Effects of Liraglutide on Body Surface Gastric Mapping
NCT Number: NCT06500130
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastroparesis|Functional Dyspepsia|Chronic Nausea and Vomiting Syndrome|Healthy
Interventions: DEVICE: Body Surface Gastric Mapping
Sponsor: Alimetry
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-02
Completion Date: 2024-10-30
Locations: Alimetry Clinic, Auckland, 1010, New Zealand

Summary:
Aim 1: To investigate, in healthy participants, the effect of liraglutide injection on gastric electrophysiology (as measured by body surface gastric mapping using the Gastric Alimetry device) during an 13-dayramping dose of liraglutide and subsequent washout.

Aim 2: Assessment of effect of liraglutide injection on gastrointestinal symptoms and gut-brain wellbeing (as measured by validated symptom App and Alimetry gut-brain wellness Scale, respectively) during an 13-day ramping dose of liraglutide and subsequent washout.

Primary Outcome Measures: Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline., Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline., 2 weeks
Secondary Outcome Measures: Change in the following symptoms on treatment compared to baseline, GCSI-DD (3 day average, last 3 days on treatment vs 3 days baseline) Alimetry total symptom burden Alimetry individual symptoms, 2 weeks|Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline, Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline, 2 weeks|Change in GA-RI on treatment to washout, Change in GA-RI on treatment to washout, 1 week|Change in BMI-adjusted amplitude on treatment to washout, Change in BMI-adjusted amplitude on treatment to washout, 1 week|Correlation of total symptom burden with change in GA-RI, Correlation of total symptom burden with change in GA-RI, 4 weeks|Correlation of total symptom burden with change in BMI-adjusted amplitude, Correlation of total symptom burden with change in BMI-adjusted amplitude, 4 weeks|Change in gastric emptying half-time on treatment compared to baseline, Change in gastric emptying half-time on treatment compared to baseline, 2 weeks|Correlation of gastric emptying half-time with GA-RI on treatment, Correlation of gastric emptying half-time with GA-RI on treatment, 2 weeks|Correlation of gastric emptying half-time with total symptom burden on treatment, Correlation of gastric emptying half-time with total symptom burden on treatment, 2 weeks
The Effects of Kefir on Pediatric Obesity
NCT Number: NCT06500104
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: DIETARY_SUPPLEMENT: Kefir peptide|DIETARY_SUPPLEMENT: Placebo
Sponsor: China Medical University Hospital
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-06
Completion Date: 2025-06-30

Summary:
Kefir, a traditional fermented dairy product in the North Caucasus region, is produced through the fermentation of milk by lactic acid bacteria and yeast. In murine studies, it has been observed that consumption of kefir by obese mice resulted in significantly reduced body weight compared to non-kefir-consuming obese mice. Furthermore, insulin resistance and fatty liver conditions showed improvement in the kefir-fed obese mice. Kefir was found to have its effects on obesity-related conditions through the inhibition of lipid synthesis, stimulation of fatty acid oxidation, elevation of basal metabolic rate, and modulation of oxidative damage.

Obesity has emerged as a global epidemic, and its prevalence in pediatric population is rapidly increasing. Obesity is defined as having a body mass index (BMI) above the 95th percentile for the age. According to statistics from the Health Promotion Administration in Taiwan, the prevalence of obesity among elementary and junior high school students in 2021 was 27.1% and 31.2%, respectively. This implies that approximately one out of every three to four students is obese. Insulin resistance and fatty liver are two common manifestations of childhood obesity. Insulin resistance is found closely linked to type 2 diabetes. Prolonged and chronic fatty liver can progress to cirrhosis and even hepatocellular carcinoma. Effective management of obesity holds the occurrence of these diseases. The objective of this study is to analyze the potential benefits of incorporating kefir into the diet of obese children regarding the improvement of obesity-related outcomes.

Primary Outcome Measures: BMI, BMI, From enrollment to the end of treatment at 12 weeks
TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors
NCT Number: NCT06500091
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Soft Tissue Sarcoma|Melanoma
Interventions: DRUG: TQB2916 injection + doxorubicin hydrochloride for injection|DRUG: TQB2916 injection+penpulimab injection
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12
Locations: Cancer Hospital Chinese Academy of Medical Science, BeiJing, Beijing, 100021, China|Beijing Cancer Hospital, Beijing, Beijing, 100142, China|Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China|Hunan Cancer Hospital, Changsha, Hunan, 410000, China|Jilin Cancer Hospital, Changchun, Jilin, 130012, China|Cancer Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, 250117, China|Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China|Shanxi Cancer Hospital, Taiyuan, Shanxi, 030000, China|Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, 300060, China|Xinjiang Medical University Affiliated Cancer Hospital, Ürümqi, Xinjiang, 830000, China|Zhe Jiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China

Summary:
This project is a clinical trial on the efficacy and safety of TQB2916 injection combined with chemotherapy or penpulimab injection in solid tumors. This project is divided into two cohorts. Cohort 1 aims to explore the safety and efficacy of specific subtypes of soft tissue sarcoma in subjects; Cohort 2 aims to explore safety and efficacy in subjects with undifferentiated pleomorphic sarcoma and melanoma. A total of 54 subjects are planned to be enrolled in this project.

Primary Outcome Measures: Overall response rate (ORR), Objective response rate refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST 1.1 for immune based therapeutics(guidelines for response criteria for use in trials testing Immunotherapeutics（iRECIST)) (CR and PR) under iRECIST criteria can occur after imaging disease progression)., Up to 48 weeks|Progression-Free Survival (PFS), PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first., Up to 48 weeks
Secondary Outcome Measures: Overall survival (OS), Overall survival defined as the time from enrollment to death from any cause., Up to 2 years|Duration of Response (DOR), DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes., Up to 48 weeks
68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas
NCT Number: NCT06500065
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Soft Tissue Sarcoma
Interventions: PROCEDURE: Computed Tomography|RADIATION: Gallium Ga 68-HA-DOTA-TATE|PROCEDURE: Positron Emission Tomography
Sponsor: Ohio State University Comprehensive Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2025-12-31
Locations: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States

Summary:
This trial studies how well 68Ga-DOTATATE digital PET/CT work in diagnosing soft tissue sarcoma. 68Ga-DOTATATE is a radiotracer that may improve image quality of PET imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-DOTATATE. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. 68Ga-DOTATATE digital PET/CT may work better in imaging patients with soft tissue sarcomas.

Primary Outcome Measures: Regions of pathologically increased tracer uptake, Positron emission tomography (PET) images will be evaluated visually for regions of pathologically increased tracer uptake that could not be attributed to normal physiologic activity. The non-contrast enhanced computed tomography images are used for attenuation correction and for fusion with PET images to allow for anatomical - localization of PET findings., At completion of imaging
Secondary Outcome Measures: Incidence of adverse events, The incidence of adverse events for each patient will be reported using CTCAE v.5.0, Up to 7 days after completion of imaging
Positive Psychological Interventions for Patients With Multiple Sclerosis
NCT Number: NCT06500039
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: OTHER: Positive Psychological Intervention Program|OTHER: Writing Daily Routines
Sponsor: Abant Izzet Baysal University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2025-01-01
Locations: Bolu Abant İzzet Baysal University, Bolu, 14300, Turkey

Summary:
This study aims to determine the effectiveness of positive psychological interventions on the quality of life and well-being levels of patients with multiple sclerosis.Two groups will be selected as intervention and control groups. An intervention method consisting of three good things in life and gratitude activities, each lasting two weeks, was determined for the intervention group. An activity was planned for control group participants to write their daily routines.

Primary Outcome Measures: Multiple Sclerosis Quality of Life Scale (MSQOL)-54, It was developed by Vickrey, Hays, Harooni, Myers, and Ellison (1995). The scale consists of 2 main groups, composite physical health (BFS) and composite mental health (BMS), 12 subgroups and 2 independent items. The reliability coefficients of the scale were found to be between 0.75-0.96, and the test-retest reliability coefficients were found to be between 0.66-0.96. BFS and BMS scores, the two main groups of the MSQOL-54 scale, take a value between 0-100. A high score from the scale indicates a high quality of life., six month|PERMA Measuring Tool, It was developed by Butler and Kern (2016) to measure well-being levels. The scale consists of a total of 23 items, 15 items measuring the components of the well-being model and 8 filler items. Among the filler items in the scale, items 7, 12, 14 and 20 are reverse coded. There are 3 items in each dimension of the scale, which consists of 15 items. Sub-dimension scores are calculated by taking the average of the 3 items in the relevant sub-dimension. The Cronbach Alpha internal consistency coefficient for the total score of the scale is 91., six month
Secondary Outcome Measures: Positive and Negative Mood Scale (PNDS), The Positive and Negative Affect Scale was developed by Watson and colleagues (1988) to assess positive and negative emotion. There are a total of 20 items in the scale, 10 items for each subscale. The scale is a five-point Likert scale ranging from 1 (very little to not at all) to 5 (very much). The score a person gets from the positive or negative emotion subscales varies between 10 and 50. The internal consistency coefficients of the original form of the scale are .88 for positive emotion and .85 for negative emotion., six month
A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer
NCT Number: NCT06500026
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Small Cell Lung Cancer
Interventions: DRUG: BL-B01D1|DRUG: Topotecan
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 652
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2026-07
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Summary:
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent small cell lung cancer after failure of anti-PD-1/PD-L1 Monoclonal Antibodies and platinum-based chemotherapy.

Primary Outcome Measures: Overall survival (OS), Overall survival (OS) is defined as the time between the subject's randomization date and subject's death., Up to approximately 24 months
Secondary Outcome Measures: Progression-free survival (PFS), Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death., Up to approximately 24 months|Objective Response Rate (ORR), Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS)., Up to approximately 24 months|Disease Control Rate (DCR), Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria., Up to approximately 24 months|Duration of Response (DOR), Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death., Up to approximately 24 months|Treatment Emergent Adverse Event (TEAE), TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1., Up to approximately 24 months|Anti-drug antibody (ADA), Frequency of anti-BL-B01D1 antibody (ADA) will be investigated., Up to approximately 24 months
The Plasma Metabolomics Profiling of Primary Aldosteronism
NCT Number: NCT06500000
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Primary Aldosteronism|Essential Hypertension|Idiopathic Aldosteronism|Aldosterone-producing Adenoma
Interventions: DIAGNOSTIC_TEST: liquid chromatography-mass spectrometry (LC/MS)
Sponsor: Third Military Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-15
Completion Date: 2023-05-19
Locations: China Chongqing The third hospital affiliated to the Third Millitary Medical University, Chongqing, Chongqing, 400042, China

Summary:
Primary aldosteronism (PA), characterized by overt renin-independent aldosterone production, is the most common form endocrine hypertension. Compared with blood pressure-matched cases of essential hypertension (EH), PA is associated with a higher risk of cardiovascular morbidity and mortality. It is estimated that PA affects at least 10% of hypertensive patients and up to 25% of treatment-resistant hypertension. The major subtypes of PA are comprised of bilateral idiopathic hyperaldosteronism (IHA) and unilateral aldosterone-producing adenoma (APA). The screening, confirmatory testing, and subtype differentiation of PA for therapeutic management is a multi-step and complex process, resulting in low screening rates and poor clinical recognition.

PA is an independent risk factor for metabolic morbidity. Metabolomic profiling is a relatively new strategy for the diagnosis and prognosis of disease through identification and quantification of various metabolites. In the current study, we aimed to investigate the potential biomakers for discriminating PA from EH, as well as subtype classification for PA, by untargeted metabolomics.

Primary Outcome Measures: The potential biomarkers for primary aldosteronism diagnosis via untargeted metabolomics, The differentially expressed metabolites between primary aldosteronism (PA) and essential hypertension (EH) will be identified by untargeted metabolomics. The differentially expressed metabolites with good discriminative capability for determination of PA from EH can serve as biomarkers for PA diagnosis., 4 months|The potential biomarkers for primary aldosteronism subtype classification via untargeted metabolomics, The differentially expressed metabolites between idiopathic aldosteronism (IHA) and aldosterone-producing adenoma (APA) will be identified by untargeted metabolomics. The differentially expressed metabolites with good discriminative capability for determination of APA from IHA can serve as biomarkers for PA subtype classification., 4 months|The predictive models for PA diagnosis and subtype classification by machine learning, The predictive models will be constructed through the application of machine learning, integrating clinical data with differentially expressed metabolites for the diagnosis and subtype classification of PA, 4 months