pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot
NCT Number: NCT06480214
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lumbar Spinal Stenosis|Lumbar Disc Herniation
Interventions: PROCEDURE: endoscopic spine surgery
Sponsor: Beijing Jishuitan Hospital
Collaborators: Beijing Chao Yang Hospital|Beijing Friendship Hospital|Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital|Beijing Haidian Hospital|Emergency General Hospital|The Seventh Affiliated Hospital of Sun Yat-sen University|Guizhou Orthopedics Hospital|The Affiliated Hospital of Qingdao University|Liaocheng People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-12-01
Locations: Beijing Jishuitan Hospital, Capital Medical University, Beijing, Beijing, 330000, China

Summary:
The aim of the study was to investigate the correlation between the extent of decompression and patient follow-up metrics at 1 year postoperatively by analysing data from a real-world, multicentre cohort of patients, and to clarify the precise extent of decompression for endoscopic spine surgery.

Primary Outcome Measures: Postoperative 1-year incidence of complications, the incidence of complications such as neural injury, postoperative bleeding, dural tear, wound infection etc, 1 year after the operation, 1 year after surgery
Secondary Outcome Measures: Postoperative lumbar spine function score, We would measure the lumbar spine function score, such as SSM (Spinal Stenosis Measure), JOA (Japanese Orthopaedic Association), ODI (Oswestry Disability Index) and VAS (Visual Analog Scale), after surgery. Higher scores of SSM, JOA, ODI and VAS means worse outcome., 1 year|Range of bony decompression of the lumbar spinal canal, The range of decompression of the bone structures during the surgery, 1 year|Surgical level lumbar spinal canal area, The level of lumbar spinal canal in the surgery, 1 year|White-Panjabi score for lumbar spine stability, White-Panjabi score was used to evaluate the lumbar spine stability. Higher scores of Panjabi score means higher levels of spine instability, 1 year|Weishupt score for degeneration of the small joints of the lumbar spine, Weishupt score was used to evaluate the degree of degeneration of the small joints of the lumbar spine. Higher scores of Weishupt score means higher levels of spine degeneration, 1 year|Degree of fatty infiltration of lumbar spine muscles, Degree of fatty infiltration is measured by MRI scanning, 1 year|Lumbar spine mobility and isometric muscle strength, The measurement of muscle mobidity and strength, 1 year|Post-operative recurrence rate, The recurrence rate after surgery, 1 year|Post-operative reoperation rate, the reoperation rate in the 1-year postoperation period, 1 year|Record of postoperative rehabilitation exercises, rehabilitation exercises patients made after surgery, 1 year
Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression
NCT Number: NCT06480201
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy|Major Depressive Disorder|Treatment Resistant Depression
Interventions: DRUG: Ketamine|OTHER: Saline
Sponsor: Baylor College of Medicine
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-01-01
Completion Date: 2025-12-31
Locations: Wells Medicine, Houston, Texas, 77024, United States|Baylor College of Medicine Jamail Specialty Care Center, Houston, Texas, 77030, United States

Summary:
The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion. Our study design captures the clinical variation associated with real-world treatment resistant depression (TRD) patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment. If successful, it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition.

Primary Outcome Measures: Resting State Gamma Power, Gamma power is the resting state electroencephalogram represents the amplitude of oscillations measuring the in the 30+ hertz (Hz) range of the power-spectrum. This is used as a proxy measure of the level of cortical disinhibition occurring at rest., Before infusion, during infusion, 60-90 minutes after infusion|Auditory Steady State Response Gamma Power, Auditory Steady State Response gamma power represents the entrainment of inhibitory interneurons in response to a train of short tones, resembling a high frequency click, that are presented for a 1000ms at a rate of 40 Hz., Before infusion, during infusion, 60-90 minutes after infusion|Montgomery-Asberg Depression Rating Scale (MADRS), The MADRS is a clinician administered rating scale consisting of 10 items to measure depression symptom severity. Each item has a rating scale of 0-6. Greater total scores indicate more severe depression., Study entry, pre-infusion, study exit visit (up to a month after infusion)
Secondary Outcome Measures: Quick Inventory of Depressive Severity Self Report (QIDS-SR), The Quick Inventory of Depressive Severity Self Report is a 16 item measure of core behavioral domains associated with depression. These cover: sleep/wake cycles, affect, appetite, weight, concentration and decision making, self-perception, suicidality, general interest, and energy levels. Each item has a rating scale 0-3. Greater total scores indicate more severe depression, Study entry, pre-infusion, study exit visit (up to a month after infusion)
Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of Cervical Spondylosis Pain
NCT Number: NCT06480175
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain|Cervical Spondylosis
Interventions: PROCEDURE: cervical plexus block
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 53
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2024-12
Locations: Ain Shams University Hospital, Cairo, Egypt

Summary:
The goal of this clinical trial is to compare the effectiveness in the pain relief between doing radiofrequency ablation for the medial branch of the cervical facet pain alone vs using it combined with superficial cervical plexus block.in adults patients with cervical spondylosis pain

The main question it aims to answer is:

does adding superficial cervical plexus block to radiofrequency in patients with chronic neck pain provide better analgesia than radioprequency alone ?

Primary Outcome Measures: pain releif, evaluating degree of pain releif after cervical medial branch radiofrequency ablation Monitoring pain score using numeric pain rating scale (NPRS) it is a 11 point scale scored from 0-10

* 0 represents no pain
* 10 represents the worst pain imaginable . versus radiofrequency plus superficial cervical plexus block by using numeric pain rating scale after 1 month, 1 months
Secondary Outcome Measures: improved life style, Secondary outcomes that will be detected in our study is the degree of pain releif after 6 months Monitoring pain score using numeric pain rating scale (NPRS) it is a 11 point scale scored from 0-10

* 0 represents no pain
* 10 represents the worst pain imaginable .

  * change the need for the use of oral or parentral analgesics, 6 months|global impression of change, measuring patient global impression of change ( PGIC) score: PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." where score 1 indicating " very much improved " and 7 indicating " very much worse"., 6 months
Mechanical Ventilation on Hippocampus
NCT Number: NCT06480162
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mechanical Ventilation Complication|Brain Injuries
Interventions: PROCEDURE: Mechanical ventilation
Sponsor: Beijing Sanbo Brain Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-08
Completion Date: 2025-06-01
Locations: Beijing Sanbo Brain Hospital, Capital Medical University, Beijing, Beijing, 100090, China

Summary:
Ventilator-associated brain injury (VABI) frequently occurs in ICU patients. Although animal studies indicate the hippocampus as a key target of VABI, its relevance in human patients remains uncertain. In this study, the investigators aim to monitor hippocampal EEG activity during the weaning process of patients off mechanical ventilation, and also exploring the coupling between breathing patterns and hippocampal activity.

Primary Outcome Measures: intracranial EEG (iEEG) recording of the hippocampus, The iEEG data from each patient will be analyzed using Python (version 3.12.4). The data will be represented as power spectral density, also known as the power spectrum or spectrum, which measures the frequency distribution of energy or power within a signal. The power spectrum for each channel will be computed using the Fast Fourier Transform (FFT)., During the process of weaning off mechanical ventilation, assessed up to 3 hours.
Shoulder Massage After Cholecystectomy
NCT Number: NCT06480149
Acronym: SMALC
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Massage|Sleep Quality|Laparoscopic Cholecystectomy|Shoulder Pain
Interventions: OTHER: SMALC|OTHER: no application
Sponsor: Maltepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2020-01-01
Completion Date: 2021-03-31
Locations: Maltepe University, Maltepe, İstanbul, 34857, Turkey

Summary:
Purpose The aim of this study is to determine the effect of shoulder massage administered to patients after laparoscopic cholecystectomy on pain and sleep quality.

Design The study was designed as a randomized controlled trial. Methods This study was carried out with 60 patients who underwent surgery at the General Surgery Department of a university's Faculty of Medicine between January 2020 and March 2021. The study was completed with 60 patients (30 in the intervention group and 30 in the control group). The patients in the intervention group received shoulder massage twice at 6-hour intervals. The data for the study were collected using the "Individual Introduction Form", the "Visual Comparison Scale", and the "Richard Campbell Sleep Scale" .

Primary Outcome Measures: Visual analog scale (VAS), In this scale developed to determine the severity of pain, patients are able to quantify their pain using numbers. It starts from the absence of pain (0) and goes up to the level of unbearable pain(10). According to the VAS, pain intensity is typically rated as 'no pain' with a score of 0 and 'the worst imaginable pain' with a score of 10 (on a 10 cm scale), "through study completion, an average of 1 hour".|Richard-Campbell sleep scale, It is a 6-item scale used to assess the depth of nocturnal sleep, the time to fall asleep, the frequency of awakening, the duration of wakefulness upon awakening, the quality of sleep, and the level of ambient noise. Each item is evaluated on a chart ranging from 0 to 100 using the visual analog scale technique. Scores between "0-25" on the scale indicate very poor sleep quality, while scores between "76-100" indicate very good sleep quality., "through study completion, an average of 12 hour".
SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment
NCT Number: NCT06480136
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: NSCLC
Interventions: DRUG: SHR-A1921 injection and adebrelimab injection
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2028-02-15

Summary:
This is a Phase II clinical study to evaluate the efficacy and safety of SHR-A1921 conbined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Subjects in this study were treated with SHR-A1921 in combination with adebrelimab until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication, whichever occurred first. The maximum treatment time of adebrelimab is 35 cycles or 2 years (whichever comes first), and subjects can continue to be treated with SHR-A1921 until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication. Primary objective of this study was to evaluate the efficacy of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Secondary objective of this study was to evaluate the safety of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy; Exploratory objective of this study was to evaluate the biomarker changes during treatment with SHR-A1921 combined with adebrelimab in patients with advanced NSCLC who failed the previous first-line standard therapy.

Primary Outcome Measures: Objective response rate, Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment., Screening up to study completion, an average of 2 year
Secondary Outcome Measures: Progression-free Survival, Progression-free survival measures the length of time during and after treatment that a patient lives with the disease. without it progressing., Screening up to study completion, an average of 2 year|Duration of response, Duration of response refers to the length of time during which a patient's tumor remains in remission or shows a positive response to treatment., Screening up to study completion, an average of 2 year|Overall Survival, Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives., Screening up to study completion, an average of 2 year|Disease control rate, Disease control rate refers to the proportion of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable disease (SD) cases., Screening up to study completion, an average of 2 year
Stem Cell Derived Exome for Treatment of Diabetic Foot
NCT Number: NCT06480123
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Diabetic Foot|Stem Cell
Interventions: DRUG: Skin drug prepared with exome originated from stem cell
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2033-12-30
Locations: The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510260, China

Summary:
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.

Primary Outcome Measures: Safety of the treatment, Safety will be assessed by recording all types of advise effects upon and after the treatment., Six months|Efficacy of the treatment, Efficacy will be defined as objective response rate + steady disease rate., Six months
Secondary Outcome Measures: Duration of remission (DOR), DOR will be defined as the duration of the diabetic foot remission., 5 years
Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer
NCT Number: NCT06480110
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: DRUG: Docetaxel + Ebastine|DRUG: Docetaxel
Sponsor: Rigshospitalet, Denmark
Collaborators: Danish Cancer Society
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2027-12-01
Locations: Department of Oncology 5073, Rigshospitalet, Copenhagen, 2100, Denmark

Summary:
This is an open-label phase I/II study evaluating the addition of ebastine to docetaxel in the treatment for metastatic castration resistant prostate cancer.

Patients will be randomized in a 2:1 fashion to receive ebastine daily during and after treatment with a maximum of 10 courses of docetaxel.

The primary endpoint is change in the profile of urinary and blood lipids to indicate absorption and possible efficacy of ebastine.

Secondary endpoints include PSA response and radiologic progression free survival.

Primary Outcome Measures: Changes in the profile and concentration of urinary lipids and blood lipids, Measurement of lipid species concentration, focusing on Bis(monoacylglycero)phosphate and lysophospholipids in urine and blood, before, during, and after treatment, compared to PSA levels, radiologic response, and control group results., Blood+urine samples are collected at baseline, at evaluation scans (after 4th and 7th cycles), and at the end of treatment (after 10 Docetaxel cycles, upon progression before 10 cycles, or at study discontinuation). Each cycle is 21 days.
Secondary Outcome Measures: radiologic progression-free survival, Radiologic progression-free survival is defined as ≥ two new lesions on an 8-week bone scan plus two additional lesions on a confirmatory scan, ≥ two new confirmed lesions on any scan ≥ 9 weeks after enrolment, and/or progression in nodes or viscera on cross-sectional imaging as defined by RECIST 1.1 (see below), or death., By comparing with a baseline scan, the treatment effect and disease status will be evaluated with a scan after the 4th and 7th cycles, at end of treatment undtil study completion. Each cycle is 21 days. A patient will receive a maximum of 10 cycles.|PSA response, Prostate-Specific Antigen (PSA) Response criteria according to Prostate Cancer Working Group (PCWG3) 3rd edition, PSA response will be monitored during treatment, compared to radiologic response after the 4th and 7th cycles, and at treatment completion (maximum 10 cycles/progression/discontinuation). Each cycle lasts 21 days
The Role of Nasal Breathing for Perfomance in Elite Athletes.
NCT Number: NCT06480071
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breathing, Mouth
Interventions: DRUG: Oxymetazoline, 0.05% Nasal Spray
Sponsor: Sahlgrenska University Hospital, Sweden
Collaborators: Department of Internal Medicine and Clinical Nutrition, Sahlgrenska University Hospital
Sex: MALE
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-01-13
Completion Date: 2022-03-17
Locations: Department of ENT Sahlgrenska University Hospital, Gothenburg, 41345, Sweden

Summary:
This study investigates the contribution of nasal breathing to the performance during aerobic and anaerobic heavy exercise in 12 male elite cyclists. In a ramp test on a mechanically braked cycle ergometer (Monark LT2, Varberg, Sweden) VO2 max, heart rate, respiratory frequency, intranasal geometry and nasal airflow resitance as well as blood lactate and glucose was measured at each step of the ramp test and after a maximum exhaust test. Nasal breathing was randomized to three sepratae tests, normal open nose, decongested nose with oxymetazoline 0.5mg/ml, 2 sprays each nostril and with a nose clip. The study showed that in the test with the nose clip, mean blood lactate was significantly lower.

Primary Outcome Measures: VO2 max, maximum oxygen upptake during exrecise, 7 minutes per cycle|blood lactate, lactic acid, a cmponent produced during anaerobic heavy exercise, 7 minutes per cycle|Effect, Watt effect generated during exercise, 7 minutes per cycle
Secondary Outcome Measures: HR, heart rate per minute, 7 minutes per cycle|nasal air flow resistance, nasal patency, 7 minutes per cycle
Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies
NCT Number: NCT06480045
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Neoplasms
Interventions: PROCEDURE: Performed PECS II block with AI integrated USG|PROCEDURE: Performed PECS II block with conventional USG
Sponsor: Baskent University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2021-11-05
Completion Date: 2023-05-05
Locations: Çağla Yazar, MD, Antalya, 07090, Turkey

Summary:
The investigator's goal in this study is to apply PECS II block, before starting surgery, by either conventional USG or artificial intelligence integrated USG to patients who will undergo mastectomy under general anesthesia to determine the effect of the block on hemodynamics and opioid consumption in the intraoperative period. Besides, the investigatorwanted to investigate the contribution of artificial intelligence integrated USG use in the success of a 4-year anesthesiology resident for imaging the injection site.

Primary Outcome Measures: Pain in the postoperative period was evaluated using the VAS score., The researchers investigate whether postoperative pain increases or decreases, using the VAS score at the postoperative anesthesia care unit, at postoperative 6 hours, 12 hours, and 24 hours., 24 hours
Secondary Outcome Measures: Incorporating the use of AI applications reduces the time required to block., This software finds the image, implements the block quickly, and spends less time., During the procedure.
Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following ACLR Surgery
NCT Number: NCT06480032
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Strength|Range of Motion|Pain-Knee|Skeletal Muscle Hypertrophy|Effusion Joint
Interventions: DEVICE: Blood Flow Restriction band|DEVICE: Non-Blood Flow Restriction band
Sponsor: Abasyn University Peshawar
Collaborators: Rehman Medical Institute
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-04
Completion Date: 2024-10-15
Locations: Rehman Medical Institute, Peshawar, KPK, 24630, Pakistan

Summary:
The main objective/s of the study is to compare the effectiveness of low load blood flow restriction training (LL-BFR) with traditional resistance training exercises (T-RT) at improving skeletal muscle hypertrophy, strength, ROM, pain and effusion in individuals who have undergone anterior cruciate ligament (ACL) reconstruction surgery.

The study will involve 32 participants who meet the inclusion criteria and will be randomly assigned to either the BFR-RT group or the T-RT group. The primary outcomes measured will include skeletal muscle hypertrophy, strength, range of motion, pain, and effusion.

The intervention will last for eight weeks, during which participants will undergo resistance training according to their assigned group. Data will be collected at various time points, including post-surgery, mid-training, and post-training, to assess the effectiveness of the two training methods. The findings from this study may help inform rehabilitation protocols and improve outcomes for individuals recovering from ACL injuries.

Primary Outcome Measures: Range of Motion, Knee range of motion will be assessed weekly for eight consecutive weeks with the patient in a supine position., eight weeks|Quadricep Strength, Strength will be assessed through manual muscle testing (MMT). MMT is a method used by practitioners to evaluate the strength and function of individual muscles and muscle groups. The grading scale ranges from 0 to 5, with Grade 0 indicating no visible or palpable muscle contraction and Grade 5 indicating that the muscle can move the body part against gravity and maximal resistance., eight weeks|Knee Pain, Pain will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain scale. The KOOS pain scale ranges from 0 to 100, where 0 indicates the worst pain and 100 indicates no pain. A higher score reflects less pain and a better condition. Normal scores are closer to 100, suggesting minimal to no pain. Lower scores indicate increased pain severity., eight weeks
Secondary Outcome Measures: Quadricep Size, Size will be assess using measuring tap wrapping around pre-patellar and down to the the and will be compare with other leg, eight weeks
Validity and Reliability of the BETY-Biopsychosocial Scale in Individuals With Coronary Artery Disease
NCT Number: NCT06480006
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Validity|Reliability
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-10
Completion Date: 2025-05-08
Locations: Hacettepe University, Ankara, State, 06100, Turkey

Summary:
Scales for biopsychosocial assessment of coronary artery disease patients are limited. The aim of this study was to evaluate the validity and reliability of the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (bETY-BQ) in patients with CAD.

Primary Outcome Measures: Biopsychosocial Characteristic, BETY- Biopsychosocial Questionnaire, One Year
Secondary Outcome Measures: Quality of Life, Short Form-36 questionnaire., One Year|Kinesiophobia, Turkish version of the Tampa Kinesiophobia Rating for the Heart (KTKD), One Year|Anxiety and Depression, The Hospital Anxiety and Depression Scale (HADS), One Year|Cardiovascular Disease Risk Scoring, SCORE2, One Year|Functional Status, Seattle Angina Questionnaire (SAQ), One Year
The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs
NCT Number: NCT06479967
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Allergy|Anxiety|Pain|Itching|Vital Signs
Interventions: OTHER: The VR glasses group|OTHER: the music group
Sponsor: Uludag University
Sex: ALL
Age: CHILD
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2022-11-12
Completion Date: 2023-12-15
Locations: Uludag Üniversty, Bursa, 19600, Turkey

Summary:
Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.

Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.

Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.

Primary Outcome Measures: Anxiety level, State-Trait Anxiety Inventory for Children (minimum score of 20 and a maximum score of 60), 12 week|Pain Levels, Wong-Baker Faces Pain Rating Scale (a score of "0" to excruciating pain a value of "10"), 12 week|Itching level, Visual Analogue Score ( rate the severity of the itch on a scale of one to ten) maximum 10axsimum 10, 12 week|Heart Rate, Heart Rate ( pulse rate 70-110 ) ( /minute ) In the 9-12 age range, the lower pulse value is 70 and the upper value is 110., 12 weeks|Oxygen Saturation, Oxygen Saturation. ( between % 95-100), 12 week|Respiratory Rate, Respiratory Rate ( one minute ) (/minute). Between 16-22 / minute, 12 weeks
Non Interventional Study to Investigate the Safety and Effectiveness in Patients With Relapsed and Refractory Multiple Myeloma Treated With Elranatamab Under the Actual Use.
NCT Number: NCT06479954
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Relapsed and Refractory Multiple Myeloma (RRMM)
Sponsor: Pfizer
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 430
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2028-04-28

Summary:
To investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.

Primary Outcome Measures: Incidence of CRS events in adverse drug reaction, An adverse drug reaction (ADR) in cytokine release syndrome (CRS) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician., up to 52 weeks|Incidence of ICANS events in adverse drug reaction, An adverse drug reaction (ADR) in immune effector cell-associated neurotoxicity syndrome (ICANS) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician., up to 52 weeks
Secondary Outcome Measures: Proportion of patients with objective response rate (ORR), Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), up to 52 weeks|Incidence of other adverse drug reactions (ADRs), An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician., up to 52 weeks
Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota
NCT Number: NCT06479941
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Antibiotics Affecting Newborn Gut Microbiota
Interventions: OTHER: antibiotic treatment
Sponsor: Peking University People's Hospital
Sex: ALL
Age: CHILD
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-25
Completion Date: 2024-08-30
Locations: The Peking University People's Hospital, Beijing, China

Summary:
Based on a prospective birth cohort, the investigators will collect biological samples from participants including pregnant women and newborns, to measure the gut microbial diversity and metabolites of newborns. These results systematically evaluate the effects of antibiotic exposure on the structure and function of gut microbiota. The project can reveal the effects of antibiotic exposure on the growth and development of gut microbiota in early life.

Primary Outcome Measures: Infant gut microbiome, * Diversity of gut microbiota
* Abundance of antibiotic resistance genes in gut microbiota
* Metabolic pathway of gut microbiota, Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
Secondary Outcome Measures: Antibiotic treatment, * Frequency of antibiotic treatment
* Kind and Dose of antibiotic;
* Duration of antibiotic use;, Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
Interactions Between Environmental Exposures and Gut Microbiota in Early Life
NCT Number: NCT06479928
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infant Development
Interventions: OTHER: delivery mode
Sponsor: Peking University People's Hospital
Sex: ALL
Age: CHILD
Enrollment: 756
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-01
Completion Date: 2026-12-30
Locations: The Peking University People's Hospital, Beijing, China

Summary:
Recruit the mothers and their infants who bron in Peking University People's Hospital from 2023 to 2026, to evaluate the interaction between environmental exposure and gut microbiota.

Primary Outcome Measures: Arsenic levels and Gut microbiota, Arsenic levels in biological samples; gut microbiota and metabolites in stools., Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 months)
Estimate the Relationship Between Oral Microbiota and Stroke
NCT Number: NCT06479915
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke|Microbial Disease
Sponsor: Fujian Medical University
Collaborators: First Affiliated Hospital of Fujian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-06-30
Locations: School and Hospital of stomatology,Fujian Medical University,Fuzhou,Fujian Province,350002,China, Fuzhou, Fujian, 350002, China|The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350002, China

Summary:
Oral bacteria constitute the second largest population of the human microbiome. Recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. Streptococcus Mutans (SM) is considered the primary pathogen responsible for dental caries. Furthermore, in cases of oral inflammatory diseases, SM has been found to invade the bloodstream and disseminate, leading to systemic diseases. Against this backdrop, this study aims to investigate disparities in oral flora between stroke patients and healthy individuals by collecting saliva samples from both groups.

Primary Outcome Measures: Estimate the Relationship Between Oral Microbiota and Stroke, Measure the diversity and abundance of oral bacteria in stroke patients,units:Number of bacterial species, bacterial counts (CFU/ml), 2025.06|Correlation Between Oral Microbiota and Cerebral Microbleeds in Stroke, Number and volume of microbleeds (measured in mm³), 2025.06
Effects of Core Stability Combined With Diaphragmatic Strengthening Exercises Among Asthmatic Patients
NCT Number: NCT06479902
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mild Intermittent Asthma
Interventions: PROCEDURE: Core stability exercise|PROCEDURE: Diaphragmatic Strengthening Exercise
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 41
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-15
Completion Date: 2024-05-24
Locations: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan

Summary:
This is a quasi intervention study evaluating the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio) and quality of life, in individuals with mild intermittent or mild persistent asthma.

Primary Outcome Measures: Thoracic Kyphosis Angle, Measured with Inclinometer, 18 days|Diaphragmatic Excursion, Measured using Tape method, 18 days|Chest Expansion, Measured using Tape method, 18 days|FEV1/FVC ratio, Measured using Spirometer, 18 days|Quality of Life of patient, Asthma Quality of Life Questionnaire with Standardized Activities. It is a 32-item Likert-type scale that measures the impact of asthma on daily activities, with scores ranging from 1 (severe impairment) to 7 (no impairment)., 18 days
Accuracy of Convex Probe EBUS-TBNA Versus FDG-PET/CT Imaging in Diagnosis and Staging of Lung Malignancies
NCT Number: NCT06479798
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Malignancies|Mediastinal Lymphadenopathy
Interventions: DIAGNOSTIC_TEST: Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-12-21
Completion Date: 2023-11-01
Locations: Department of chest diseases , faculty of medicine, Cairo, Egypt

Summary:
Lung cancer is a prevalent cause of cancer-related mortality on a global scale. Appropriate staging of lung cancer is of paramount importance, as it customizes treatment and predicts prognosis. Fludeoxyglucose-18 (FDG) positron emission tomography (PET) combined with low dose contrast computed tomography (CT) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are two diagnostic modalities widely used in the field of staging \& diagnosis of lung malignancies, the former depends on image analysis while the later enables real-time sampling of lymph nodes under sonographic guidance with concurrent cytological examination. The present research aims to compare the diagnostic and staging accuracies of (EBUS-TBNA) versus FDG-PET /CT as two diagnostic modalities in patients with suspected lung malignancies. However as a secondary outcome this study aims at monitoring the possible complications arising post EBUS-TBNA procedure.

Primary Outcome Measures: Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT, Comparing the diagnostic yield of both modalies as they are considered primary main diagnostic and staging modalities for lung malignancies, 2 years|Comparing the staging accuracies of both convex probe EBUS-TBNA versus FDG - PET/CT, Accurate staging of lung malignancies is considered crucial in determining the prognosis and specifying the treatment plan., 2 years
Secondary Outcome Measures: Determine the complications, EBUS TBNA is a minimally invasive procedure having a very low rate of complications compared to mediastinoscopy, this study aims to monitor complications (if present), 2 years
Effects of an Educational Intervention Program on Marble Factory Workers
NCT Number: NCT06479785
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Diseases
Interventions: OTHER: Educational Intervention Program for machine workers|OTHER: Educational Intervention Program for manual workers
Sponsor: Riphah International University
Sex: MALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2024-12
Locations: Marble factories in Peshawar, Islamabad, AL, 44000, Pakistan

Summary:
Marble cutting exposes workers to dust, increasing risk of lung diseases like asthma, COPD, silicosis, and asbestosis. Many marble cutters in rural areas lack awareness of these risks and work without proper protection. Khyber Pakhtunkhwa has over 4000 marble factories employing over a million laborers, mostly unskilled and vulnerable. Workers face health risks from heavy lifting, poor posture, and respirable dust. Ergonomic disorders are also common due to poorly designed workstations, repetitive motions, and straining postures. Musculoskeletal Symptoms (MSS) can progress into Musculoskeletal Disorders (MSDs), affecting worker well-being and productivity. Findings can inform targeted educational programs and interventions to improve respiratory health and reduce ergonomic risks in the marble industry.

Primary Outcome Measures: Peak expiratory flow rate (PEFR), Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings., 4 weeks|Forced vital capacity (FVC), Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal., 4 weeks|Forced expiratory volume in 1sec (FEV1), Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal, 4 weeks
Secondary Outcome Measures: Rapid Upper Limb Assessment (RULA), RULA evaluates the exposure to posture and force/external load as well as repeated and static posture effects., 4 Weeks|Rapid Entire Body Assessment (REBA), REBA evaluates the exposure to posture and force/external load as well as repeated and static posture effects. The REBA has two additional assessment factors of coupling and dynamic loading effects, compared to the RULA, 4 Weeks
Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening.
NCT Number: NCT06479772
Acronym: ELIAS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators: Vivactis M2Research
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 55589
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-10
Completion Date: 2024-03-31
Locations: Hôpital Privé Jean Mermoz, Lyon, 69008, France

Summary:
Based on data from a series of patients who underwent screening mammography with a "normal" or "benign" first-reading result. The main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero, using an AI system (here the MammoScreen™ system).

Primary Outcome Measures: Percentage of real negatives, Percentage of cases negatived by MammoScreen (considered benign by the system), and for which no cancer was detected at the end of the L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10). We distinguish two sub-populations: L2- and L2+ with BDD- (in addition to L2-)., Week 8
Secondary Outcome Measures: Percentage of real positives, Percentage of MammoScreen-positive cases for which cancer was detected in L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10)., Week 8|Percentage of false negatives, Percentage of MammoScreen-positive cases with an L2 ultimately considered negative (L2- or L2 + with DBB-), for which interval cancer is detected (according to the different risk levels of the MammoScreen software - score from 1 to 10)., Week 8
LM-108 Antibody Combination With Sintilimab for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT Number: NCT06479759
Acronym: ACCLAIM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: NSCLC|PD-1
Interventions: DRUG: LM-108 antibody and sintilimab|DRUG: LM-108 antibody and sintilimab and chemotherapy
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-12
Completion Date: 2025-12-12
Locations: Shanghai Pulmonary Hospital, Shanghai, Shanghai, 200000, China

Summary:
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients.

Primary Outcome Measures: Objective response rate, Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment., up to 24 months
Secondary Outcome Measures: Progression-free Survival, Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing., up to 36 months|Duration of response, Duration of response refers to the length of time during which a patient's tumor remains in remission or shows a positive response to treatment., up to 24 months|Overall Survival, Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives., up to 60 months
Emotional Support Given at Birth to Women Effect on Birth Duration, Perception and Fear
NCT Number: NCT06479746
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: First Pregnancy
Interventions: BEHAVIORAL: Emotional support
Sponsor: Cumhuriyet University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2020-07-01
Completion Date: 2020-12-30
Locations: Sukran Ertekin Pinar, Sivas, 58140, Turkey

Summary:
Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.

Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).

Primary Outcome Measures: Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A), The W-DEQ-A is a validated, to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165., Baseline|Women's Perceptions Scale on Supportive Care Provided at Birth, The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132., Baseline
Secondary Outcome Measures: Wijma Birth Expectation/Experience Scale (W-DEQ) Version B, W-DEQ-B was developed to evaluate women's fear of birth during their own birth experiences in the postpartum period. Responses on the scale are numbered from 1 to 6 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 33 and the maximum score is 198., Within 2-4 hours after birth|Women's Perceptions Scale on Supportive Care Provided at Birth, The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132., Within 2-4 hours after birth