pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma
NCT Number: NCT06564272
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ewing Sarcoma
Interventions: DRUG: KC1036
Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-27
Completion Date: 2028-04-01
Locations: Beijing Children's Hospital Affiliated to Capital Medical University, Beijing, Beijing, 100045, China

Summary:
This open-label, single-arm clinical trial is to evaluate the safety and effectiveness of KC1036 in treating adolescents aged 12 and above with advanced Ewing sarcoma. Participants will take KC1036 once daily, with each treatment cycle lasting 4 weeks.

Primary Outcome Measures: Adverse events (AEs), Incidence of treatment-related AEs, approximately 3 years
Secondary Outcome Measures: Objective Response Rate (ORR), Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1., approximately 3 years|Progression-free survival (PFS), Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause., approximately 3 years|Disease Control Rate (DCR), Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1., approximately 3 years|Duration of Response (DOR), Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1., approximately 3 years
Relationship Between Serum β2-Microglobulin and Infiltration of CD8+ in the Tumor Tissue of Hodgkin's Lymphoma Patients
NCT Number: NCT06564259
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hodgkin Lymphoma
Sponsor: Tishreen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-04
Completion Date: 2024-08-15
Locations: Tishreen University, Latakia, Syrian Arab Republic

Summary:
In newly diagnosed Hodgkin lymphoma patients, pre-treatment Beta-2 Microglobulin (B2M) levels will be measured. A thorough baseline assessment will be performed using CT imaging, and tumor tissue samples will be collected for Immunohistochemical (IHC) analysis to quantify CD8+ cell infiltration. Patients will be closely monitored throughout their treatment, with a follow-up CT scan at the end of therapy to evaluate therapeutic response. This study aims to investigate the correlation between pre-treatment B2M levels and CD8+ immune cell infiltration in tumor tissues, assessing their potential as predictive markers for chemotherapy response.

Primary Outcome Measures: Therapeutic response, Achieving complete remission after chemotherapy, 2-4 months
Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease
NCT Number: NCT06564246
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Gastroesophageal Reflux Disease (GERD)
Interventions: DRUG: Vonoprazan 20 mg (vonseca) versus Pantoprazole 40 mg (Pantoloc)
Sponsor: Tanta University
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-10
Locations: Theodore Billiharz Institute for Researchs, Giza, Egypt

Summary:
This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease.

Primary Outcome Measures: change in the measured biomarker, Measured biomarkers are serum gastrin hormone and E-Cadherin level, Before and after 2 months
Secondary Outcome Measures: Change in gastroesophageal reflux disease symptoms (The Structured Assessment of Gastrointestinal Symptoms Questionnaire)., Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) is a validated measure of the intensity and impact of 22 upper and lower gastrointestinal symptoms. Responses are given on a 5 point Likert scale from no problem, mild (can be ignored when you do not think about it), moderate (cannot be ignored, but does not influence daily activities), severe (influencing your concentration on daily activities) and very severe (markedly influences your daily activities

\&/or requires rest) problem. In addition the SAGIS asks about the presence of selected non gastrointestinal symptoms including headache, chronic fatigue, back pain, sleep disturbances, depression and anxiety. The patient also answers the following questions, "In your own words, what is your most important health concern or problem?" and "In your own words, what is your second most important health concern or problem?, Before and after 2 months
RCT Supportive Care Outpatient RIC HCT
NCT Number: NCT06564233
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic Stem Cell Transplantation|Cancer
Interventions: BEHAVIORAL: care.coach Avatar™
Sponsor: care.coach corporation
Collaborators: Dana-Farber Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-10
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
The overall goal of this study is to assess the efficacy of the care.coach Avatar™ in improving anxiety and quality of life for patients undergoing outpatient transplant. After care.coach Avatar™ content and scheduling ("digital intervention" or "program") has been optimized for outpatient allogeneic hematopoietic stem cell transplantation (HCT), a randomized controlled trial (RCT) will be conducted of the digital versus usual supportive care program for outpatient HCT recipients. Potential improvements in anxiety and quality of life will be evaluated, with the intent of increasing comfortability with outpatient transplant and expanding the population of eligible patients willing to receive their transplants in an outpatient setting.

Primary Outcome Measures: HADS-A, Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, Baseline, Day 20 (D+20) post-transplant
Secondary Outcome Measures: FACT-BMT, Functional Assessment of Cancer Therapy - Bone Marrow Transplantation, Baseline, Day 20 (D+20) post-transplant|HADS-A, Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, Baseline, Day 90 (D+90) post-transplant|FACT-BMT, Functional Assessment of Cancer Therapy - Bone Marrow Transplantation, Baseline, Day 90 (D+90) post-transplant
Other Outcome Measures: Conversions, Conversion from Outpatient to Inpatient Transplant, Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant|HADS-D, Hospital Anxiety and Depression Scale (HADS) - Depression subscale, Baseline, Day 20 (D+20) post-transplant, Day 90 (D+90) post-transplant
Testicular Adrenal Rest Tumor in Congenital Adrenal Hyperplasia Patients Attending Assuit University Children Hospital
NCT Number: NCT06564220
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Testicular Adrenal Rest Tumor|Congenital Adrenal Hyperplasia
Sponsor: Assiut University
Sex: MALE
Age: CHILD, ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-12

Summary:
assessment of the risk factors contributing for TART development in a male child with congenital adrenal hyperplasia.

Primary Outcome Measures: Testicular adrenal rest tumor in congenital adrenal hyperplasia patients attending Assiut University Children Hospital, Assessment of risk factors contributing for TART development in a child with congenital adrenal hyperplasia., Baseline
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
NCT Number: NCT06564207
Acronym: FOSTA-ARDS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Respiratory Distress Syndrome|ARDS
Interventions: DRUG: Placebo|DRUG: Fostamatinib
Sponsor: Inova Health Care Services
Collaborators: Rigel Pharmaceuticals|Biomedical Advanced Research and Development Authority
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-10-31

Summary:
This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).

Primary Outcome Measures: Cumulative Incidence of Serious Adverse Events (SAEs) Through Day 30, The cumulative incidence of serious adverse events (SAEs) occurring through day 30 following the intervention. An SAE is defined by the International Conference on Harmonization (ICH) guidelines as any adverse event fulfilling at least one of the following criteria:

Results in death; Is life threatening; Requires in-subject hospitalization or prolongation of an existing hospitalization; Results in persistent or significant disability/incapacity; Is considered an important medical event (or medically significant), Up to 30 days post-intervention
The Relation Between Serum Zinc and Lupus Nephritis
NCT Number: NCT06564181
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lupus Nephritis
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-10

Summary:
The goal of this observational study is to investigate the relation between serum zinc and lupus nephritis by search Prevalence of hypozincemia in lupus nephritis and Association between serum zinc and urea, serum creatinine, hemoglobin, estimated glomerular filtration rate (eGFR).

Primary Outcome Measures: Prevalence of hypozincemia in lupus nephritis Correlation between hypozincemia and urea , S. Creatinine and eGFR, 1/9/2024 - 1/9/2025
Nutritional Status of Critically Ill Diabetic Patients
NCT Number: NCT06564168
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Nutrition|Critical Illness|Diabetes Mellitus, Type 2
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 430
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-03

Summary:
1. To investigate the nutritional status of patients with type 2 diabetes mellitus in the intensive care unit.
2. To detect the impact of nutritional status on outcome (mortality, length of hospital stay,duration of mechanical ventilation, and need for renal replacement therapy)

Primary Outcome Measures: Correlation between Diabetes Mellitus and malnutrition in critically ill patients, By using non invasive methods to find a correlation between Diabetes mellitus and malnutrition in critically ill patients by history and examination and scores of nutrition, through study completion, an average of 1 year]|Outcome of patients with Diabetes Mellitus admitted in intensive care unit, As Diabetic patiants are more suspectible to face malnutrition in intensive care unit so non invasive methods as history, examination, score to improve outcome and decrease morbidity and mortality., through study completion, an average of 1 year]
Inturlekin L33 in Ankylosing Spondylities Patients and Its Relation to Subclinical Atherosclerosis
NCT Number: NCT06564155
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ankylosing Spondylitis
Interventions: DEVICE: carotid duplex
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-12

Summary:
detect level of Inturlekin 33 in ankylosing spondyilits patient

measure CIMT (carotid intima media thickness ) by carotid duplex to detect subclinical atherosclerosis in ankylosing spondyitis patients

detect the relation between IL33 and subclinical atherosclerosis in Ankylosinig Spondylitis patients

Primary Outcome Measures: detect level of IL33 in AS patients, measure level of IL33 in the serum of AS patients measure caroid intima media thickness CIMT in AS patients, 3 years
Secondary Outcome Measures: detect the reation between IL33 and subclinical atherosclerosis in AS patients, measure caroid intima media thickness CIMT in AS patients, 3 years
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
NCT Number: NCT06564142
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Immunoglobulin A Nephropathy
Interventions: DRUG: Povetacicept|DRUG: Placebo (matched to Povetacicept)
Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 480
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2028-09

Summary:
The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.

Primary Outcome Measures: Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36, From Baseline at Week 36|Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104, From Baseline Through Week 104
Secondary Outcome Measures: Change From Baseline in eGFR at Week 104, From Baseline at Week 104|Time to Kidney Disease Progression Through Week 104, Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or death from kidney failure., From Baseline Through Week 104|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score at Week 104, From Baseline at Week 104
Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG
NCT Number: NCT06564129
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anterior Large Vessel Occlusion Stroke
Interventions: DEVICE: electroencephalography
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1194
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: Xuanwu Hospital, Beijing, Beijing, Beijing, 100053, China

Summary:
This study is designed to evaluate the accuracy of saline electrode EEG in the prehospital diagnosis of LVO-a stroke.

Primary Outcome Measures: Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;, Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of large vessel occlusion

Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of anterior large vessel occlusion stroke, 24 hours
Secondary Outcome Measures: Other EEG features including relative δ, θ, α power, δ/α ratio, δ+θ/α+β ratio, pdBSI, and WPLI diagnostic accuracy for LVO-a;, ROC curves were plotted for each EEG data feature predicting LVO-a, and sensitivity, specificity, PPV, and NPV were calculated at the optimal cutoff value., 24 hours|Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics;, Remove EEG data artifacts and report the percentage of EEG data available for analysis for each patient, 24 hours|Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data, ROC curves for predicted LVO-a based on this algorithm were plotted and sensitivity, specificity, PPV and NPV were calculated at the optimal cutoff value., 24 hours
Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above
NCT Number: NCT06564116
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hepatitis E
Interventions: BIOLOGICAL: Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)|BIOLOGICAL: Recombinant Hepatitis E Vaccine (Escherichia Coli)
Sponsor: Xiamen Innovax Biotech Co., Ltd
Collaborators: Center for Disease Control and Prevention, Fujian
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 612
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-03-22
Completion Date: 2024-03-28
Locations: Youxi County Center for Disease Control and Prevention, Sanming, Fujian, China

Summary:
The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli) when administered in participants ages 16 years and above.

Primary Outcome Measures: Seroconversion rate of anti-HEV IgG at Month 7, The percentage of participants who had ≥4-fold rise in anti-HEV IgG antibody from baseline to Month 7., Month 7|Anti-HEV IgG geometric mean concentration (GMC) at Month 7, Measure anti-HEV IgG antibody GMC at Month 7., Month 7|Adverse events within 0-7 days after each vaccination, Measure percentage of participants reporting adverse events within 0-7 days after each vaccination., Day 7|Adverse events within 8-30 days after each vaccination, Measure percentage of participants reporting adverse events within 8-30 days after each vaccination., Day 30|Serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination, Measure percentage of participants reporting serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination., Month 12
Stratification for F-L Therapy After LT
NCT Number: NCT06564103
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Liver Transplantation|Adjuvant FOLFOX Plus Lenvatinib|Machine Learning
Interventions: COMBINATION_PRODUCT
Sponsor: Xiao Xu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-08-05
Locations: Zhejiang University school of Medicine, Hangzhou, Zhejiang, 310000, China

Summary:
Objective: To stratify recipients who underwent adjuvant FOLFOX plus lenvatinib (F-L) therapy following liver transplantation (LT) for hepatocellular carcinoma and provide guidance for clinical adjuvant therapy.

Methods: Liver recipients in the Shulan (Hangzhou) Hospital from January, 2017 to December, 2021, including 106 in the F-L therapy group and 229 in the non-adjuvant (N-A) therapy group were included in the analysis. A 1:1 propensity score matching (PSM) analysis was performed to minimize group imbalances. Disease-free survival (DFS) and overall survival (OS) were compared among recipients. Radiomics features that demonstrated predictive value for recurrence were employed, either independently or in conjunction with prognostic clinical features, to formulate predictive models. The combined model was used to perform further subgroup analysis for recipients in the F-L therapy group.

Primary Outcome Measures: The disease-free survival rate was evaluated by follow-up investigation and outpatient review, 1-5 years
Secondary Outcome Measures: The overall survival rate was evaluated by follow-up investigation and outpatient review, 1-5 years
Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients
NCT Number: NCT06564090
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Burns|Gait Training|Rehabilitation
Interventions: OTHER: robot assisted gait training|OTHER: conventional gait training
Sponsor: Hangang Sacred Heart Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-15
Completion Date: 2024-12-30
Locations: Hangang sacred heart hodpital, Seoul, 07247, Korea, Republic of

Summary:
This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT). This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.

Primary Outcome Measures: functional ambulatory category, Ambulatory ability was rated by using the functional ambulatory category (FAC) scale., 8 weeks
Secondary Outcome Measures: 6 minute walking test, 6MWT was performed in accordance with the standardised guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min, 8 weeks|gait parameters(cadence), steps/minutes, 8 weeks|gait parameters(gait speed), Measure walking speed, 8 weeks|gait parameters(step length), Measure the distance between steps, 12 weeks
ELDOA's Effect in Upper Cross Syndrome
NCT Number: NCT06564077
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain
Interventions: OTHER: Eldoa technique with conventional therapy|OTHER: conventional therapy
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-01
Locations: DHQ Hospital, Harīpur, KPK, Pakistan

Summary:
The aim of this randomized clinical trial is to find the effects of ELDOA on decreasing pain ,kyphosis , improving range of motion and reducing disability

Primary Outcome Measures: Numeric Pain Rating Scale (NRPS), The NPRS is a self-reported or clinician-administered measurement tool consisting of a numerical point scale with extreme anchors of "no pain" to "extreme pain". The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100 and can be administered in written or verbal form. The test-retest reliability for the NPRS has been demonstrated to be moderate to high, varying from 0.67 to 0.96. the NPRS has 0.79 to 0.95 convergent validity., two weeks|Neck disability index (NDI)., NDI is a patient completed, condition specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation each section of 5 marks. Interpretation of this scale is as 0 score indicates no activity limitation and 5 score indicates complete activity limitation. Score ranges from 0 to 50 in which 0 indicates no disability and 50 means maximum disability. A higher score indicated a greater level of activity limitation, two weeks|Inclinometer., It is used to measure the cervical range of motion. Cervical spine in neutral position place one inclinometer on C7 spinous process and other over the top of head. adjust both inclinometer dial to 0. Patient perform ranges and record reading on both inclinometer. Mathematically difference between the 2 readings is range of motion., two weeks|Flexi curve ruler, A flexi curve ruler, is used for measuring a kyphotic index that is calculated as the width divided by the length of the thoracic curve, multiplied by 100. the evaluator mark the second and twelfth back vertebrae with a marker. All the measurements conduct in a relax standing position, that the subjects ask to put their weight between their legs and look directly to the front. After marking the intended points, the flexible ruler place on the spine in such a way that it takes shape of the selected area and there is no empty space between the ruler and the spine. Then, the marked points on the spine transfer to the ruler. At the end, the ruler carefully separate from the spine and place on the target paper, and the curves draw on the paper with a pencil and the target points specified. The distance between two points L and the depth of curvature H measure by the ruler and then measure through formula, two weeks
The Effect of Abdominal Binders on Patient's Wellbeing After Cesarean Delivery
NCT Number: NCT06564064
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section
Interventions: DEVICE: abdominal binder
Sponsor: Sohag University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-10-15
Locations: Sohag university Hospital, Sohag, Sohag, Egypt

Summary:
The effect of abdominal binders on patient's wellbeing after cesarean delivery

Primary Outcome Measures: The effect of abdominal binders on pain after cesarean section, abdominal binders will be fit on patient abdomin 2 hrs post cs and VAS will be assessed 12 hrs post cesarean section, 6 months
Secondary Outcome Measures: The effect of abdominal binders on patient's wellbeing after cesarean delivery, effect after one week on quality of recovery ( infection, hematoma, seroma) by QOR 40, one week postoperatively
Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C
NCT Number: NCT06564051
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Chronic Viral Hepatitis C|Monoclonal B-Cell Lymphocytosis
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-11-14
Completion Date: 2027-11-30
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study evaluates the incidence of monoclonal B-cell lymphocytosis MBL) in patients with chronic hepatitis C and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis C.

Primary Outcome Measures: Prevalence of monoclonal B-cell lymphocytosis (MBL), Blood samples collected in conjunction with routine clinical blood draws will be tested for MBL and compared with post-therapy samples and with control patients (without hepatitis C)., Baseline; up to one year
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
NCT Number: NCT06563999
Acronym: NUMER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Cancer Stage III|Mutation
Interventions: DRUG: Sunvozertinib|DRUG: Crizotinib|DRUG: Pralsetinib|DRUG: Larotrectinib|DRUG: Savolitinib|DRUG: Pyrotinib|DRUG: Dabrafenib+Trametinib|DRUG: Glecirasib|DRUG: Ensartinib
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-12-01

Summary:
This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

Primary Outcome Measures: Resectability rate, Baseline to 6 months
Secondary Outcome Measures: Adverse Events, Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0., Baseline to 24 months|Two-year disease-free survival, Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause., 2 years after the last patient is randomized|Two-year overall survival, Overall survival was assessed from randomization to death as a result of any cause., 2 years after the last patient is randomized|Number of participants with perioperative complications, Baseline to 12 months
The Effect of Breast Milk Odor on Feeeding in Preterm Infants
NCT Number: NCT06563973
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bottle Feeding|Preterm İnfant
Interventions: OTHER: Milk odor|OTHER: Pacifier
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-04-18
Completion Date: 2023-11-24
Locations: Fenerbahce University, Istanbul, İ̇stanbul, Turkey

Summary:
This study was conducted as a randomized controlled experiment to assess the impact of breast milk odor, applied before the first oral feeding of preterm infants transitioning to oral feeding, on their feeding performance. Infants in the neonatal intensive care unit who were beginning oral feeding were randomly assigned to one of two groups through computer randomization. In the "pacifier" group, infants were given a pacifier for 3 minutes one hour before feeding and again for 2 minutes 10 minutes before feeding to support oral feeding. In contrast, the "breast milk odor and pacifier" group received 2 cc of breast milk, which was dripped onto a sterile sponge and placed about 3 cm from the infant's nose one hour before feeding. At feeding time, all infants in both groups were bottle-fed by the researcher. This marked their first experience with oral feeding. The infants' feeding skills and performance were then evaluated using the Early Feeding Skills (EFS) form during the feeding session.

Primary Outcome Measures: Early Feeding Skills, An observer nurse, who was not part of the research team, evaluated the infant's feeding skills using the Early Feeding Skills (EFS) Evaluation Form., during feeding up to 1 hour|The feeding duration (Feeding performance), The infant's feeding performance was assessed by calculating the feeding duration. To measure feeding time, a stopwatch on a phone was activated at the start of feeding and stopped once feeding concluded., immediately after feeding|Feeding performance, The infant's feeding performance was assessed by calculating the amount of food consumed per minute. The total amount of food the infant consumed (in cc) was then compared to the amount prescribed by the doctor., immediately after feeding
Effect of Carbonated Water on Swallowing
NCT Number: NCT06563960
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dysphagia
Interventions: OTHER: carbonated water
Sponsor: Federal University of Health Science of Porto Alegre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-02
Completion Date: 2025-12-30
Locations: Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS, 90020-090, Brazil|Fabricio Edler Macagnan, Porto Alegre, RS, 90035-070, Brazil

Summary:
Swallowing has an important function in the lives of individuals, it is related to moments of socialization, pleasure, nutrition and also helps protect against the entry of food, saliva or other material towards the lungs (penetration and/or laryngotracheal aspiration). A Difficulty in swallowing is called dysphagia and therapeutic strategies are necessary to help the affected individuals. The use of carbonated water as a therapeutic strategy has been used, however, there are still few studies on the topic. In the search for therapeutic strategies viable and easy to insert into the clinical routine and daily lives of patients, this study aims to verify the effect of carbonated water on swallowing liquids for patients with dysphagia diagnosed by videodeglutogram examination, through comparison with non-water carbonated. The present study aims to generate scientific evidence about the effect of water carbonated drink as a strategy in patients with liquid dysphagia, with the aim of helping professional speech therapist and other professionals involved in the therapeutic process, in order to improve the health and quality of life of dysphagic patients and contribute to the evolution of knowledge in the field of dysphagia. This is a clinical trial, all participants will be included adult patients to carry out the video swallow examination, which present aspiration and/or laryngotracheal penetration of liquids during the performance of the and who agree to participate in the research. The effect of carbonated water on levels of penetration and/or laryngotracheal aspiration in relation to the use of non-carbonated water, and analyzed whether the results obtained with the use of carbonated water have behavior similar between the different patient profiles studied.

Primary Outcome Measures: Number of participants who reduce or eliminate penetration and/or aspiration with carbonated water., Check for how many participants this strategy is effective in reducing penetration and/or aspiration., 12 months
Single Arm Clinical Trial (Gut Microbiota and HCC)
NCT Number: NCT06563947
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Liver Cancer
Interventions: BIOLOGICAL: Oral enterobacterium capsules
Sponsor: Xu Yong, MD
Collaborators: Nanjing Xiershou Biotechnology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-24
Completion Date: 2026-11-20

Summary:
To evaluate the efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced HCC who have progressed after treating with immune checkpoint inhibitors in combination with anti-angiogenesis targeted agents.

Primary Outcome Measures: Objective Progression-Free Survival (PFS), To analyse the Progression-Free Survival (PFS) of patients, Up to approximately 1 years|Objective Secondary Clinical Endpoints - Overall Growth Phase (OS), To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients, Up to approximately 1 years|Objective Objective Response Rate (ORR), To exprole the Objective Response Rate (ORR) of patients, Up to approximately 1 years|ObjectiveDuration of Response (DOR), To analyse the Duration of Response (DOR) of patients, Up to approximately 1 years|Diversity analysis, We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity., Up to approximately 1 years|Species differential analysis, We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition., Up to approximately 1 years|Feces Metabolomics, Changes of metabolites in feces measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database., Up to approximately 1 years|Serum Metabolomics, Changes of metabolites in serum measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database., Up to approximately 1 years
Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)
NCT Number: NCT06563934
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Liver Cancer
Interventions: BIOLOGICAL: Oral enterobacterium capsules|DRUG: Lenvatinib + PD-1 monoclonal antibody|BIOLOGICAL: Oral enterobacterium capsules placebo
Sponsor: Xu Yong, MD
Collaborators: Nanjing Xiershou Biotechnology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-11-20

Summary:
To evaluate the additional efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced liver cancer and treated with tyrosine kinase inhibitors (TKIs) combined with immunotherapy.

Primary Outcome Measures: Objective Progression-Free Survival (PFS), To analyse the Progression-Free Survival (PFS) of patients, Up to approximately 1 years|Objective Secondary Clinical Endpoints - Overall Growth Phase (OS), To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients, Up to approximately 1 years|Objective Objective Response Rate (ORR), To exprole the Objective Response Rate (ORR) of patients, Up to approximately 1 years|ObjectiveDuration of Response (DOR), To analyse the Duration of Response (DOR) of patients, Up to approximately 1 years|Diversity analysis, We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity., Up to approximately 1 years|Species differential analysis, We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition., Up to approximately 1 years|Feces Metabolomics, Changes of metabolites in feces measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database., Up to approximately 1 years|Serum Metabolomics, Changes of metabolites in serum measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database., Up to approximately 1 years
RE and Probiotics in MAFLD/NAFLD
NCT Number: NCT06563921
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NASH|NAFLD|MAFLD
Interventions: BEHAVIORAL: physical exercise programme|DIETARY_SUPPLEMENT: probiotics supplementation|DIETARY_SUPPLEMENT: placebo
Sponsor: Nicolaus Copernicus University
Collaborators: Medical University of Warsaw|University of Oxford
Sex: ALL
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2036-09-10

Summary:
This project aims to evaluate the roles of the autonomic nervous system (ANS) and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease (MAFLD) and non-alcoholic fatty liver disease (NAFLD) in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation. The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLD/NAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses.

Primary Outcome Measures: Change in liver fat measured using MRI, 12 weeks|Changes in liver fibrosis (FIB-4 score), 12 weeks
Secondary Outcome Measures: changes in weight in kilograms using scale, 12 weeks|changes in body fat mass in kilograms measured using bioelectrical impedance method, 12 weeks|changes in free-fat mass in kilograms measured using bioelectrical impedance method, 12 weeks|changes in visceral fat level measured using bioelectrical impedance method, 12 weeks|HDL, 12 weeks|LDL, 12 weeks|AST, 12 weeks|ALT, 12 weeks
Other Outcome Measures: autonomic nervous system function measured using Task Force Monitor, 12 weeks|changes in maximal strength measured in kilograms, 12 weeks|changes in RMR measured using CPET, 12 weeks|changes in the dynamics of glucose in response to standardized breakfast intake using continuous glucose monitoring, 12 weeks|changes in gut microbiota using fecal samples, 12 weeks
Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
NCT Number: NCT06563869
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Interventions: DRUG: PEG-rhG-GSF
Sponsor: The First Affiliated Hospital with Nanjing 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: 2024-02-02
Completion Date: 2026-11-22
Locations: the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China

Summary:
This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients. In the study, all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles (21 days as one cycle) as neoadjuvant treatment according to the study plan. Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy, and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment. Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators. All subjects need to complete the follow-up plan formulated by the study after surgery.

Primary Outcome Measures: pCR, The pathological complete response rate (pCR) after neoadjuvant therapy, Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.
Secondary Outcome Measures: MPR, major pathological response, MPR, Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.|RFS, Recurrence Free Survival, 5 years|R0 resection rate, The R0 resection rate after neoadjuvant therapy and subsequent surgery, Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment.|AEs, New adjuvant therapy-related AEs, 4 years
VRAS (Velys Robot-Assisted Solution) Operational Excellence Study
NCT Number: NCT06563843
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Total Knee Arthroplasty (TKA)
Interventions: PROCEDURE: Robotic-assisted TKA|PROCEDURE: Conventional TKA
Sponsor: DEO NV
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-27
Completion Date: 2026-07
Locations: Circle health group - BMI The Park hospital, Nottingham, Ng5 8rx, United Kingdom

Summary:
The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.

Primary Outcome Measures: Operational efficiency, Efficiency will be assessed using OR time, by comparing the OR days and procedures where TKR is performed conventionally or by using VRAS surgery.

A granular analysis from the timestamps will be conducted using standard descriptive statistics. Additionally, the impaction process will be further analyzed, broken down into parts., 3 months
Secondary Outcome Measures: Ergonomic impaction - weight of trays, Weight of trays will be measured to report ergonomic impaction of the team for the VRAS TKR compared to conventional TKR., 3 months|Ergonomic impaction - posture assessment, Surgeon's posture assessment using RULA and REBA method will be executed to report ergonomic impaction for the VRAS TKR compared to conventional TKR., 3 months|Total procedure cost, The procedure cost differences between VRAS TKR and conventional TKR will be calculated using activity based costing modeling. This model will include fixed direct, fixed indirect, and variable costs, tailored to each country's local cost parameters and healthcare financing models., 3 months
Assessment of the Association Between Visceral Obesity and the Progression of Diabetic Nephropathy
NCT Number: NCT06563791
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Nephropathies
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-10

Summary:
Assessment of the association between visceral obesity and the progression of diabetic nephropathy

Primary Outcome Measures: Assessment of the association between visceral obesity and the progression of diabetic nephropathy, Assessment of visceral obesity new measures as (the visceral adiposity index (VAI) , lipid accumulation product (LAP) , neck circumference (NC), waist-to-hip ratio (WHR) ) as a risk factor for the progression of diabetic nephropathy and poor renal outcome., Baseline
Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.
NCT Number: NCT06563778
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma
Interventions: DRUG: Chidamide; Decitabine; Anti-PD-1 Antibody|DRUG: Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-09-01
Locations: Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital, Beijing, Beijing, 100853, China

Summary:
The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosed R/R cHL. The primary objective of the study is to evaluate progression-free survival.

Primary Outcome Measures: Progression Free Survival (PFS), Time from the date of first administration of the study drug to disease progression or death from any cause (any earliest date)., 2 years
Secondary Outcome Measures: Complete response rate (CRR), CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects, 1 year|Objective response rate (ORR), The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria)., 1 year|Number of Subjects with treatment-related adverse events (AEs), Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0, 1 year
Other Outcome Measures: Biomarkers predictive of efficacy and toxicity, Biomarkers such as PD-1 from tumor tissue and peripheral blood will be assessed for their potential in predicting clinical efficacy and toxicity., 1 year