pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial
NCT Number: NCT06463535
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus|Periodontal Diseases
Interventions: DRUG: Omega 3|PROCEDURE: SRP alone
Sponsor: British University In Egypt
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-15
Completion Date: 2024-06-01
Locations: British University in Egypt, Cairo, Egypt

Summary:
Patient grouping

* Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
* Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL).

  6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.

Primary Outcome Measures: Serum level of chemerin, Serum level of chemerin, 6 months
Secondary Outcome Measures: periodontal clinical parameters, PD in mm, 6 months|hba1c, Glycated Heamoglobin, 6 months|GCF level of chemerin, GCF level of chemerin, 6 months|periodontal clinical parameters, CAL in mm, 6 months
Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
NCT Number: NCT06463522
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: PROCEDURE: Autologous Tumor-infiltrating Lymphocytes
Sponsor: Beijing 302 Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-07-01
Locations: the Fifth Medical Center of PLA, Beijing, China

Summary:
This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability of Autologous Tumor-infiltrating Lymphocytes Therapy, day0, day3, week1, week2, week4, week12, week24
Secondary Outcome Measures: Concentration of Total Bilirubin (TBIL, mg/dL), Total bilirubin refers to the concentration of bilirubin in a patient's blood sample, which is automatically measured by the laboratories in accordance with standard operating procedures., day0, day3, week1, week2, week4, week12, week24|Child-Turcotte-Pugh(CTP) score, CTP score is currently the most commonly used model to evaluate liver reserve function and prognosis in patients with cirrhosis. This model evaluates liver function based on HE grade, degree of abdominal fluid accumulation, bilirubin (TBiL), albumin (Alb) and prothrombin time (PT). The score ranges from 0 to 15, with the higher the score, the worse the prognosis., day0, day3, week1, week2, week4, week12, week24|Quality of life of patients, Quality of life assessed by Functional Assessment of Cancer Therapy - Hepatobiliary Symptom Index， which has a score ranges 0-32, a higher score indicates better quality of life., day0, day3, week1, week2, week4, week12, week24
Balance and Executive Function in Middle-age and Older Patients With Heart Failure in Post-Acute Care Program
NCT Number: NCT06463496
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Sponsor: Kaohsiung Veterans General Hospital.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-17
Completion Date: 2025-12-31

Summary:
This trial is a single-center clinical trial in Taiwan with an expected enrollment of 60 people in Taiwan. The purpose of this trial is to compare the performance of middle-aged and elderly patients with subacute heart failure with that of a healthy control group in terms of balance function and executive function, as well as to investigate whether there is a correlation between balance function and executive function in middle-aged and elderly patients with heart failure and to track the changes in balance and executive function one month and three months after discharge from the hospital. Please think carefully before deciding whether to participate in this trial.

Primary Outcome Measures: Berg Balance Scale, The balance function will be evaluated using the Berg Balance Scale. Berg Balance Scale have 14 subtests, each of which is scored on a scale of 0 to 4, for a total score of 56, with higher scores indicating better balance., T0 : Baseline ； T1: one month after discharge； T2: three months discharge|Timed Up and Go Test, The balance function will be evaluated using the Timed Up and Go Test. Timed Up and Go Test use a chronograph to measure the total time spent (in seconds), with less time representing better ability., T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Secondary Outcome Measures: Color Trails Test, The Working memory will be evaluated using Color Trails Test. Scoring is based on the total number of seconds to complete the test. Lower scores represent greater difficulty inWorking memory ., T0 : Baseline ； T1: one month after discharge； T2: three months discharge|The Stroop Color and Word Test, The Inhibitor Control will be evaluated using the Stroop Color and Word Test. The test consisted of three parts, each spanning 45 s where participants read out as many colour words such as ''red, green, blue and purple'' or coloured items words as possible.

Number of items corrected and wrongly read out were used to compute the predicted colour-word (Pcw) and interference (IF).Lower scores represent greater difficulty in inhibiting incongruence., T0 : Baseline ； T1: one month after discharge； T2: three months discharge|Digit Span Test, The Cognitive flexibility will be evaluated using the Digit Span test. The scores range from 0 to 45. Lower scores represent greater difficulty in Cognitive flexibility ., T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models
NCT Number: NCT06463444
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: HCC|Precision Therapy
Interventions: DRUG: HAIC + Tislelizumab +lenvatinib
Sponsor: Chen Xiaoping
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-06-30
Locations: Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Summary:
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 monoclonal antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%.

Primary Outcome Measures: Objective response rate, Objective response rate(ORR) was defined as the sum of cases with complete response (CR) and partial response (PR) which assessed by the mRESIST criteria., From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 months.
Secondary Outcome Measures: Overall survival, OS is defined as the time from enrollment to death from any cause., From date of enrollment until the date of death from any cause, assessed up to 60 months.|Safety Assessment, Any adverse event during treatment that is incompatible with the therapeutic purpose of the medication.The incidence and severity of adverse events and serious adverse events as assessed by CTCAE v5.0., Baseline up to study termination, assessed up to 12 months.
Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP)
NCT Number: NCT06463418
Acronym: ExSCIP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Traumatic Spinal Cord Injury
Interventions: DEVICE: Ekoskeleton (Intervention)|OTHER: Relaxation (Comparator)
Sponsor: University College Dublin
Collaborators: Royal College of Surgeons, Ireland|University of Aarhus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-11-30

Summary:
The goal of this feasibility trial is to learn if exoskeleton or robotic walking works to reduce nerve (neuropathic) pain after spinal cord injury.

This study asks is:

* Providing walking practice through use of a robotic device (exoskeleton) three times per week for twelve weeks possible to deliver?
* Would people sign up and stick to the programme?
* And will it help to reduce neuropathic pain levels after spinal injury?

Researchers will compare robotic walking and a relaxation program to see if robotic walking works to reduce neuropathic pain levels after spinal injury.

Participants will:

* Complete a number of questionnaires and tests related to their pain before the trial.
* Complete robotic walking or a relaxation program three times per week for twelve weeks.
* Complete the same questionnaires and tests after the trial finishes and 6 months after.
* Complete an interview telling researchers about their experiences of the trial.

Primary Outcome Measures: International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain intensity), This outcome measure will be used to capture average neuropathic pain intensity in participants, This will be measured at baseline, week 13 and at 6-month follow-up.|International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain interference), This outcome measure will be used to capture average neuropathic pain interference in participants. Pain interference entails interference with sleep, daily activities and overall mood., This will be measured at baseline, week 13 and at 6-month follow-up.
Secondary Outcome Measures: Neuropathic Pain Symptom Inventory (NPSI), This questionnaire is used to capture the severity of neuropathic pain symptoms., This will be measured at baseline, week 13 and at 6-month follow-up.|Electroencephelography (EEG), Resting EEG signals (3 minutes eyes open, 3 minutes eyes closed) for alpha, beta and theta band powers will be assessed using the NeuroCONCISE 8., This will be measured at baseline, week 13 and at 6-month follow-up.
Patient Perception and Oral Function of Implant Restorations
NCT Number: NCT06463405
Acronym: REPLACE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Occlusion
Interventions: OTHER: Splinted
Sponsor: University of Copenhagen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2028-01-31
Locations: Faculty of Health and Medical Sciences, Copenhagen, 2200, Denmark

Summary:
The overall aim is to evaluate the patient-reported outcome and efficiency of replacing posterior teeth with implant-supported crowns compared to RDPs and no treatment. Sub-aims are to evaluate a new 3D-methods for registration of occlusion and to test two crown designs.

Thus, the study design has three aims:

* To analyze patient perception including OHRQoL, when missing posterior teeth are replaced with implant-supported crowns compared to removable dental prostheses (RDPs) or no replacement.
* To develop and validate new 3D digital methods for assessing occlusal contacts between upper and lower jaw and to analyze the methods relation to masticatory ability and efficiency.
* To compare the difference in biological technical outcomes between splinted and non-splinted implant-supported crowns over time.

Primary Outcome Measures: Oral Health Related Quality of Life score, Up to 5 years|Oral Function change in percentage, Up to 5 years|Marginal Bone Loss in mm, Up to 5 years
The Efficacy of Intravenous Pulse in Attaining Remission in Refractory Juvenile Idiopathic Arthritis
NCT Number: NCT06463379
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Refractory Juvenile Idiopathic Arthritis (Despite 2 DMARDs Still Active)
Interventions: DRUG: Solumedrol
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 215
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2024-08-31
Locations: Al-Azhar University, Cairo, Egypt

Summary:
Interventional phase 3 study aiming to unravel the value of pulse steroids in achieving remission or low disease activity in refractory active JIA

Primary Outcome Measures: remission or low disease activity, patients will be assessed at baseline and every month for 3 months using Juvenile Arthritis Disease Activity Score (JADAS) for disease activity American College of Rheumatology Pediatric 30, 50, and 70 (ACR Pedi. 30, 50, 70) for disease activity, 3 months
Multi-parametric Magnetic Resonance Imaging for the Precise Diagnosis and Quantitative Study of Liver Steatosis, Inflammation, and Fibrosis in Chronic Liver Disease.
NCT Number: NCT06463366
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Stiffness
Interventions: DEVICE: 3D-MRE,MRI-PDFF
Sponsor: Shengjing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-14
Completion Date: 2025-09-01
Locations: Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China

Summary:
To construct a novel, non-invasive, accurate, and convenient method to achieve the degree of liver damage is an important general problem in the management of patients with chronic liver disease. The investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI) techniques (MR elastography, MRI-PDFF) to assess the degree of liver damage in patients with chronic liver disease. These techniques could reach high diagnostic performance for detection of liver fibrosis, inflammation and liver fat content; and could decrease the number of liver biopsies, which have risks and sample only a small portion of the liver.

Primary Outcome Measures: the changes of liver stiffness assessed by 3D-MRE before and after treatment., Liver stiffness regression is defined as the change of 3D MRE shear stiffness larger than 19%, 12 months
Study of SGR-3515 In Participants With Advanced Solid Tumors.
NCT Number: NCT06463340
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor
Interventions: DRUG: SGR-3515
Sponsor: Schrödinger, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-18
Completion Date: 2026-12-31
Locations: NEXT Virginia, Fairfax, Virginia, 22031, United States

Summary:
The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.

Primary Outcome Measures: Incidence and severity of adverse events (AEs), Incidence and severity of adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs); and dose interruptions, dose reductions, dose delays and study drug discontinuation due to AEs., Day 1 to 28 days after the last dose of SGR-3515.|Incidence of Dose Limiting Toxicities (DLTs), Incidence of Dose Limiting Toxicities (DLTs), Day 1 to Day 28 of the first 28-day dosing cycle.|Incidence of serious adverse events (SAEs), Incidence of serious adverse events (SAEs), Day 1 to 28 days after the last dose of SGR-3515|Recommended phase 2 dose and schedule, Recommended phase 2 dose and schedule, From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.
Secondary Outcome Measures: Pharmacokinetics: Measures Cmax and Cmin of SGR-3515, Pharmacokinetics: Cmax and Cmin of SGR-3515, Day 1 to Day 28 of first 28-day dosing cycle|Pharmacokinetics Measures: t1/2 of SGR-3515, Pharmacokinetics: t1/2 of SGR-3515, Day 1 to Day 28 of first 28-day dosing cycle|Pharmacokinetics Measures: tmax of SGR-3515, Pharmacokinetics: tmax of SGR-3515, Day 1 to Day 28 of first 28-day dosing cycle|Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515, Pharmacokinetics: Area Under the Curve (AUC) of SGR-3515, Day 1 to Day 28 of first 28-day dosing cycle|Efficacy analysis, Efficacy analysis will be performed for each dose level and include but not limited to objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and duration of disease control (DDC), which will be assessed by investigators, Day 1 to end of Phase I study
Multiplex Near Patient Non-HCP Study
NCT Number: NCT06463314
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV Infections|Syphilis Infection
Interventions: DEVICE: INSTI Multiplex HIV/Syphilis Antibody Test
Sponsor: Unity Health Toronto
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 341
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2024-12

Summary:
To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. bioLytical Laboratories Inc. (Richmond, BC, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood sample that was licensed by Health Canada in March 2023 for use by trained health care professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.

Primary Outcome Measures: demonstrate the simplicity and accuracy of the INSTI Multiplex Test, The objective of this study is to demonstrate the simplicity and accuracy of the INSTI Multiplex Test when used by non-registered health care professionals including peer testers ("Operators) in a clinical near-patient setting. Non-Health Care Professional (Non-HCP) will will administer the test to the 341 participants of both known and unknown status by following the IFU and recording the details in the database. The results of the INSTI Multiplex Test performed by these Operators (the result that is interpreted from the test device) will be compared with the result obtained by the licensed blood-based laboratory serological assays for HIV and syphilis. A positive and negative percent agreement will be calculated., 6 months
Secondary Outcome Measures: A secondary objective includes the ability of the study Operators to correctly interpret a variety of mock test results., Non-health care professionals will be asked to read results from a variety of mock test results. These mock tests will be blind coded, provided to the non-HCP in random order followed by review and documentation of the panels of contrived test results to be interpreted by study Operators. The results indicated by the non-HCP will be compared against the code to determine the ability of the non-HCP to correctly interpret a variety of results including, strong positive, weak positive, invalid, weak negative and strong negative. Each Operator will read a total of fifteen (15) mock devices. A minimum of 9 non-HCP operators will be part of this study., 1 month
Effects of Treadmill Training on Motor Function, Balance, and Spasticity Reduction in Children With Cerebral Palsy
NCT Number: NCT06463301
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: Treadmill Training In CP child|OTHER: Conventional Physical Therapy
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-28
Completion Date: 2024-12-31
Locations: Helping Hand Rehabilitation center, Peshawar, KP, 18800, Pakistan

Summary:
This study investigates the impact of treadmill training on motor function, balance, and spasticity reduction in children with cerebral palsy (CP). The study synthesizes existing research to provide insights into the effectiveness of treadmill training as an intervention for improving these key outcomes in children with Cerebral palsy

Primary Outcome Measures: Pediatric Balance scale to Measure balance, The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (the lowest function) to 4 points (the highest function), with a maximum score of 56 points.in his study, we assessed the effect of treadmill training on balance of CP child, 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
Secondary Outcome Measures: Modified Ashworth Scale to measure spasticity, Ashworth Scale measures spasticity in patients with lesions to the central nervous system. AS is an assessment that is used to measure the increase in muscle tone. AS assigns a grade of spasticity from a 0-4 ordinal scale 0 means no spasticity 4 means complete rigidity, 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks|GMFCS (Gross Motor Function Classification System) to measure the motor functions, The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.

total score is 5 5 full dependent

1 is independent of the limitation, 12th weeks study ,1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
Comparison of Jacobson Relaxation Technique and Pranayama Technique in Patients With COPD
NCT Number: NCT06463288
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD|Shortness of Breath|Quality of Life|Cough
Interventions: PROCEDURE: Jacobsons Breathing Technique|PROCEDURE: Pranayama Technique
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-07-20
Completion Date: 2023-12-10
Locations: Gulab Devi Chest Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
Comparison of Jacobson Relaxation Technique and Pranayama Technique in patients with COPD

Primary Outcome Measures: Dyspnea Severity (Borg Scale), The Borg scale measures the severity of dyspnea (shortness of breath).

Scale Details:

Full Title: Borg Rating of Perceived Exertion (RPE) ScaleFull Title: Borg Rating of Perceived Exertion (RPE) Scale Minimum Value: 0 (No breathlessness at all) Maximum Value: 10 (Maximal breathlessness) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of dyspnea., 4 weeks|Cough and Sputum Analysis (CASA-Q), The CASA-Q (Cough and Sputum Assessment Questionnaire) evaluates the severity and impact of cough and sputum production.

Scale Details:

Full Title: Cough and Sputum Assessment Questionnaire (CASA-Q) Minimum Value: 0 (No symptoms) Maximum Value: 100 (Severe symptoms) Interpretation: Higher scores indicate worse outcomes, meaning more severe symptoms of cough and sputum., 4 Weeks|Spirometry (FEV1 and FVC), Spirometry will be used to measure lung function, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC).

Scale Details:

Full Title: Spirometry (FEV1 and FVC) Minimum Value: Variable (dependent on patient's lung function) Maximum Value: Variable (dependent on patient's lung function) Interpretation: Higher values typically indicate better lung function., 4 Weeks
Secondary Outcome Measures: Quality of Life (SF-36 Questionnaire), The SF-36 (Short Form Health Survey) questionnaire assesses the overall quality of life.

Scale Details:

Full Title: SF-36 Health Survey Minimum Value: 0 (Worst possible health state) Maximum Value: 100 (Best possible health state) Interpretation: Higher scores indicate better quality of life., 4 Weeks|Patient Satisfaction (Patient Satisfaction Questionnaire), The Patient Satisfaction Questionnaire measures the satisfaction of patients with the treatment they received.

Full Title: Patient Satisfaction Questionnaire (PSQ) Minimum Value: 1 (Very dissatisfied) Maximum Value: 5 (Very satisfied) Interpretation: Higher scores indicate greater satisfaction., 4 Weeks
SpinChip Hs-cTnI Determination of the 99th Percentile URL
NCT Number: NCT06463275
Acronym: HEAT-3
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myocardial Infarction
Interventions: DIAGNOSTIC_TEST: SpinChip hs-cTnI
Sponsor: SpinChip Diagnostics ASA
Collaborators: Scandinavian Contract Research Organization|CTC Clinical Trial Consultants AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-20
Completion Date: 2025-01-20
Locations: Phase I-IV Research Unit Karolinska, Solna, 171 64, Sweden|CTC Clinical Trial Consultants AB, Uppsala, 752 37, Sweden

Summary:
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. Low levels of troponin are also present in the blood stream of healthy individuals and can be detected by high-sensitive troponin tests. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack.

The purpose of this study is to determine the upper reference limits (URLs) for the SpinChip hs-cTnI test in a healthy population.

Primary Outcome Measures: Overall 99th percentile URL, Determine the overall 99th percentile URL of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood and Li-Heparin plasma samples using the non-parametric method, 1 day
Secondary Outcome Measures: Sex-specific 99th percentile URLs, Calculate the sex-specific 99th percentile URLs of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood and Li-Heparin plasma samples using the non-parametric method., 1 day|Percentage of measurable values above LoD, To assess the sensitivity of the SpinChip hs-cTnI test quantified as the percentage (%) of measurable values (\>limit of detection, LoD) for males, females, and the overall population, for each sample type (Li-Heparin whole blood and Li-Heparin plasma)., 1 day|Incidence of AEs, ADEs, and DDs, Assess safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs)., 1 day
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
NCT Number: NCT06463249
Acronym: Helpline
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Weight Loss
Interventions: BEHAVIORAL: CORE Helpline|BEHAVIORAL: Extended Helpline|BEHAVIORAL: Enhanced Helpline|BEHAVIORAL: Intensive Helpline
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Maryland Cigarette Restitution Fund
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2027-12
Locations: Johns Hopkins ProHealth, Baltimore, Maryland, 21207, United States

Summary:
The objective of the HELPLINE Weight Loss Program is to determine the comparative effectiveness of two active multi-component, augmented interventions for cancer survivors with overweight or obesity who do not achieve early weight loss goal in the initial intervention period (termed, early non-responders). The core study design is randomized controlled trial with adaptive intervention.

1. CORE Helpline in all participants (first 2 months)
2. Extended Helpline in early responders (additional 6 months)
3. Enhanced Helpline in early non-responders (additional 6 months)
4. Intensive Helpline in early non-responders (additional 6 months)

Primary Outcome Measures: Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms, Weight change for Enhanced Helpline and Intensive Helpline in early non-responders, 8 months
Secondary Outcome Measures: Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms, Weight change for Enhanced Helpline and Intensive Helpline in early non-responders, 12 months
Other Outcome Measures: Weight (pounds) change from baseline to 2 months in all participants, Weight change for CORE Helpline over the first 2 months in all participants, 2 months|Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs, Weight change for each program over 12 months, 12 months
Clinical Validation of the Management Process for Renal Anemia in Maintenance Hemodialysis Patients
NCT Number: NCT06463236
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anemia of Chronic Kidney Disease
Interventions: OTHER: Guiding treatment|OTHER: empirical therapy
Sponsor: Hong Daqing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1296
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-14
Completion Date: 2025-08-31
Locations: Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610000, China

Summary:
This test aims to verify that the management process of renal anemia in maintenance hemodialysis patients can improve the hemoglobin compliance rate better than that of anemia management by primary doctors, and promote the system at the grassroots level to guide primary doctors in anemia management and improve the management standard of renal anemia in maintenance hemodialysis patients through prospective randomized controlled trials. To improve the anemia compliance rate of maintenance hemodialysis patients, and to improve the basic doctors' grasp of the anemia management guidelines, consensus and standard operating procedures.

Primary Outcome Measures: Changes in the one-year compliance rate of renal anemia, Changes in renal anemia compliance rates between the experimental group and the control group within one year, one year
HIBOC = Hepatic Imaging Biomarkers in Obese Children
NCT Number: NCT06463223
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Elastography|Shear Wave Elastography|Shear Wave Dispersion|Attenuation Imaging|Child Obesity|Metabolic Disease|Metabolic and Genetic Disorder Affecting the Liver|Fibrosis, Liver|Diagnosis|Inflammation; Liver|Steatosis
Sponsor: Sahlgrenska University Hospital, Sweden
Sex: ALL
Age: CHILD
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2029-12

Summary:
The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.

Primary Outcome Measures: Attenuation imaging, an ultrasound based measure of steatosis in the liver, baseline, 1 year, 2 years and 3 years follow up|Shear wave dispersion, an ultrasound based estimation of increased liver viscosity, seen in for example inflammation, baseline, 1 year, 2 years and 3 years follow up|shear wave dispersion, an ultrasound based measure of liver stiffness as a reflection of liver fibrosis, baseline, 1 year, 2 years and 3 years follow up
Secondary Outcome Measures: Magnetic Resonance Imaging fat fraction, Estimation of fat content in the liver, baseline, 1 year, 2 years and 3 years follow up|Magnetic Resonance Imaging elastography, measurement of liver stiffnes on MRI, Baseline, 1 year,2 years and 3 years follow up|Magnetic Resonance Imaging diffusionbased imaging, Quantitative estimation of viscoelastic tissue properties, baseline, 1 year, 2 years and 3 years follow up|Magnetic Resonance Imaging relaxometry, Detailed tissue characterization with measurement of fibrosis in the liver, Baseline, 1 year,2 years and 3 years follow up
Other Outcome Measures: serology measures, blood work, baseline, 1 year, 2 years and 3 years follow up|BMI, body mass index, baseline, 1 year, 2 years and 3 years follow up
Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy
NCT Number: NCT06463210
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute|Satisfaction, Patient
Interventions: DEVICE: Virtual reality as a distraction technique
Sponsor: Hospital Universitario 12 de Octubre
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2022-06-30
Locations: Hospital Universitario 12 de Octubre, Madrid, Comunidad De Madrid, 28041, Spain

Summary:
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.

The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.

The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH

Primary Outcome Measures: Peak pain, a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure, being 0 no pain and 10 worst pain imaginable, 5-10 minutes after the procedure|Mean pain, a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable, 5-10 minutes after the procedure
Secondary Outcome Measures: Patient satisfaction with the information received, Prior to the OH all patients were interrogated about their perception of the information received about the procedure through the question "How has been the information received about the procedure?" (Not enough/Normal/Very good, 5-10 min before the procedure|Patient overall satisfaction with the procedure (OH), Overall satisfaction with the OH was assessed through a question formulated as follows: "What is your level of satisfaction with the hysteroscopic procedure?", where patients could evaluate their opinion on a 5-point scale (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied, 5-10 min after the procedure|Patient satisfaction with the VR intervention, On the study group, patient satisfaction with the VR intervention was also assessed with the following 5-point scale satisfaction question "What is your level of satisfaction with the VR intervention? (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied, 5-10 min after the procedure|Patient satisfaction with the VR intervention, Patients on the VR group were also asked whether they would like to use the VR if they need to undergo another OH in the future (Yes/No), 5-10 min after the procedure
Study to Assess Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)
NCT Number: NCT06463184
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Recurrent High-grade Glioma
Interventions: DRUG: Xevinapant
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: EMD Serono Research & Development Institute, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2027-06
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States

Summary:
Researchers will investigate the ability of Xevinapant to cross the blood-brain barrier and exert anti-tumor effects on rHGG through activation of apoptosis. Researchers hypothesize that oral administration of Xevinapant has acceptable safety and tolerability in patients with recurrent HGG and demonstrate pharmacokinetic and pharmacodynamic effects in HGG tumors. To that end, Researchers will engage in a phase I "window of opportunity" translational clinical trial in patients undergoing a clinically-indicated craniotomy for resection of recurrent tumors to evaluate the impact of treatment on rHGG.

Primary Outcome Measures: Concentration of Xevinapant, Concentration of unbound Xevinapant in brain tumor tissue in an exploratory manner (within contrast enhancing tumor as well as non-enhancing tumor, wherever possible) at the time of planned salvage resection., Within 48 hours of last dose of Xevinapant.|Concentration max (Cmax), Maximum observed plasma concentration of Xevinapant., Within 48 hours of last dose of Xevinapant.
Secondary Outcome Measures: Occurrence of AE's and SAE's, The number of patients who experience AE's and SAE's., Up to 12 months.
Phase II Trial of Almonertinib Plus Lastet for EGFR+ Non-small Cell Lung Cancer
NCT Number: NCT06463171
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Cancer Non-small Cell Stage IV
Interventions: DRUG: Almonertinib
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Collaborators: Shanghai Zhongshan Hospital|The First Affiliated Hospital of Xiamen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-06
Locations: Zhongshan hospital, Shanghai, 200032, China|The First Affiliated Hospital of Xiamen University, Xiamen, 361003, China

Summary:
The goal of this clinical trial is to test in Locally Advanced or Metastatic Non-small Cell Lung Cancer patients with EGFR Mutations. The main question it aims to answer is:

Evaluation of the Efficacy and Safety of Aumolertinib in Combination with Lastet for the Treatment of EGFR-Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer in First-line Therapy.

Participants will be treated with a combination of Aumolertinib and Lastet.

Primary Outcome Measures: Progression-Free Survival, PFS is defined as the period from the start of treatment until the disease progresses or the patient dies from any cause, whichever came first, assessed up to 24 months, up to 24 months
Secondary Outcome Measures: Disease Control Rate, Disease Control Rate (DCR) is to describe the proportion of patients who have achieved a response to treatment that includes not only complete and partial responses but also stable disease., 24 months|Duration of Response, The Duration of Response (DoR) is a clinical measure to determine the length of time that a tumor continues to respond to treatment without the cancer worsening., 24 months|Objective Response Rate, The Objective Response Rate (ORR) is a key metric used in oncology to assess the proportion of patients in a study or treatment group who achieve an objective response (CR or PR)., 24 months|Overall Survival, OS is measured from the date of the initiation of treatment to the date of death from any cause, whichever came first, assessed up to 24 months, up to 24 months
Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis (KOA)
NCT Number: NCT06463132
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Knee Osteoarthritis
Interventions: COMBINATION_PRODUCT: PEP/Euflexxa|DRUG: PEP
Sponsor: Rion Inc.
Collaborators: Caidya Clinical Research Organization
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2025-11-01
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the treatment of Knee Osteoarthritis

Primary Outcome Measures: Primary Safety Follow up 90 Days post injection occurrence of DLTs, The safety of a single intra-articular injection of PEP, with or without EUFLEXXA, through the initial 90-day treatment period as assessed by the occurrence of DLTs with severity grading based on the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE)., First 90 days|Long Term Safety Follow-Up Occurrence of DLTs From Day 91 to Day 365, The long-term safety after treatment with a single intra-articular injection of PEP, with or without EUFLEXXA as assessed from the incidence of DLTs during the Day 91 through Day 365 follow up period., Day 365
Secondary Outcome Measures: Exploratory Endpoints of Efficacy-Radiographic Response, Radiographic response, evaluated pre- and post-injection by an independent, blinded radiologist's assessment:

Decrease or lack of progression of cartilage damage (thickness, denudation) and/or bone marrow edema on magnetic resonance imaging (MRI) at 6 or 12 months after injection Decrease or lack of progression in joint space narrowing on weight bearing X ray at 12 months after injection, Day 365|Exploratory Endpoints of Efficacy-Participant-Reported responses:, Clinical improvement measured using a 100 point pain visual analogue scale (VAS) and modified Western Ontario and McMasters University Arthritis Index Questionnaire (WOMAC), which utilizes measures of pain and function, and treatment success based on Osteoarthritis Research Society International Outcome Measures in Rheumatology (OARSI OMERACT) responder criteria defined as follows:

Absolute change of 20 points or more on the VAS 100-point scale; or Improvement of 50% of more in the modified WOMAC pain or function score; or Absolute change of 20 points or more in the combined modified WOMAC pain and function score., Day 365
Registry of Vaccine Responses in Immune Compromised Patients
NCT Number: NCT06463119
Acronym: REVAPI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Immunosuppression
Interventions: OTHER: Collection of data in a registry
Sponsor: Laure Pittet, MD-PhD
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2029-04
Locations: University Hospitals of Geneva, Geneva, 1211, Switzerland

Summary:
The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over.

Primary Outcome Measures: Number of dose of vaccine required to reach seroprotection, Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state, 2 months (window allowed: 1 to 3 months) after vaccination
Secondary Outcome Measures: Number of dose of vaccine required to maintain seroprotection, Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state, 5 years follow-up|Immunogenicity of vaccine (vaccine responses) in immune compromised patients, Vaccine-induced seroprotection (defined as vaccine-specific immunoglobulin concentration above seroprotection cut-off) measured in the 1 to 3 months following vaccination. If funding is sufficient, vaccine-induced cellular response and memory cells will be quantified in a subgroup of participants. Correlation with clinical protection will be evaluated as well., 2 months (window allowed: 1 to 3 months) after vaccination|Persistence of vaccine-induced seroprotection in immune compromised patients, Persistence of vaccine-induced seroprotection (defined as vaccine-specific immunoglobulin concentration above seroprotection cut-off) measured more than 9 months after vaccination. There may be multiple measures per patients, as these are monitored regularly in immune compromised patients. If funding is sufficient, vaccine-induced functional antibodies, cellular responses and memory cells will be quantified in a subgroup of participants. Correlation with clinical protection will be evaluated as well., 5 years follow-up|Occurence of adverse event following vaccine administration in immune compromised patients, Occurrence and severity of local and systemic reaction measured from day 0 to day 42 after vaccination, 0 to 42 days after vaccination|Patients' acceptability of the standardized follow-up, Evaluated through satisfaction questionnaire with open questions, qualitative research, 5 years follow-up