pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.
NCT Number: NCT06579638
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: IVDA
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-10

Summary:
Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.

Primary Outcome Measures: Patterns and outcomes of IVDA, To describe the patterns, methods of treatment and outcomes of self-injection of addictive drugs such as amputation rate and patency rate., 1 year
Study on the Preventive Effect of Establishing an Integrated Working Group of Doctors and Nurses in Operating Room
NCT Number: NCT06579599
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthopedic Disorder|Incision Infection
Interventions: OTHER: an integrated working group nursing
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2024-12-30
Locations: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu, Zhejiang, 322000, China

Summary:
To explore the preventive effect and clinical enlightenment of establishing an integrated working group of doctors and nurses in operating room on incision infection in orthopedic surgery.

Primary Outcome Measures: Incision infection rate, Incision infection rate = the number of postoperative incision infection / the total number of cases × 100%, One month after surgery
Secondary Outcome Measures: Incision recovery, On the day of discharge, the effect of incision healing was evaluated by the doctor and recorded by the nurse, including excellent: the surgical incision basically healed without adverse reactions; good: poor healing, mild redness, swelling and induration around the incision, but no suppuration; poor: the incision has been infected and suppurate. Excellent and good rate = (excellent + good) cases / total cases × 100%, On the 1 day of discharge|Nursing quality, The nursing quality management questionnaire of operating room made by our hospital was used, and the quality control department staff or head nurse made an unannounced visit to evaluate the nursing quality, On the 1 day of discharge|Adverse nursing risk events, the total adverse nursing risk rate of the two groups, On the 1 day of discharge
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
NCT Number: NCT06579573
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Epilepsy, Generalized
Interventions: DRUG: Cenobamate
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-07-12
Completion Date: 2027-01-31
Locations: Aichi Medical University Hospital, Aichi, Japan|Hospital of the University of Occupational and Environmental Health, Japan, Fukuoka, Japan|Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic, Fukushima, Japan|Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan|Hokkaido University Hospital, Hokkaido, Japan|Itami City Hospital, Hyōgo, Japan|Tsuchiura Kyodo General Hospita, Ibaraki, Japan|University of Tsukuba Hospital, Ibaraki, Japan|Kagoshima University Hospital, Kagoshima, Japan|SHOWA University Fujigaoka Hospital, Kanagawa, Japan|Yokohama City University Hospital, Kanagawa, Japan|National Hospital Organization Nishiniigata Chuo Hospital, Niigata, Japan|Koide Clinic of Epilepsy and Neurological Disorders, Osaka, Japan|TMG Asaka Medical Center, Saitama, Japan|NHO Shizuoka Institute of Epilepsy and Neurological Disorder, Shizuoka, Japan|Jichi Medical University Hospital, Tochigi, Japan|Jikei University Hospital, Tokyo, Japan|Maynds Tower Mental Clinic, Tokyo, Japan|National Center of Neurology and Psychiatry, Tokyo, Japan|Nihonbashi Neuro Clinic, Tokyo, Japan|Shinjuku Neuro Clinic, Tokyo, Japan|Tokyo Women's Medical University, Adachi Medical Center, Tokyo, Japan|Yamaguchi Grand Medical Center, Yamaguchi, Japan|University of Yamanashi Hospital, Yamanashi, Japan|Yamanashi Prefectural Central Hospital, Yamanashi, Japan

Summary:
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Primary Outcome Measures: Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval, Convert the frequency of generalized tonic-clonic seizures (PGTC) in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these., 12 Weeks of the Maintenance Phase
Secondary Outcome Measures: Percentage Change in all generalized seizure frequency per 28-Day, Convert the frequency of all generalized seizures in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these., 12 Weeks of the Maintenance Phase|Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval, The percentage of subjects who have a 50%, 75%, 90%, and 100% reduction in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to the Pre-treatment Phase, 12 Weeks of the Maintenance Phase
Audio Vestibular Assessment in Patients with Fibromyalgia
NCT Number: NCT06579560
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fibromyalgia
Sponsor: Noha Osman
Sex: ALL
Age: CHILD, ADULT
Enrollment: 4
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-16
Completion Date: 2025-04-16

Summary:
Fibromyalgia (FM) is a common rheumatic illness distinguished by chronic pain, fatigue, cognitive problems, and functional disability. However, the differences between men and women have not yet been comprehensively studied, especially after the development of the last 2016 American College of Rheumatology (ACR) criteria. The disease is more common and more severe in female patients according to a study on gender differences among Egyptian patients (A. Moshrif et al., 2023)

Primary Outcome Measures: Hearing Sensitivity, Measurement of hearing sensitivity using pure tone audiometry. The outcome will be expressed as hearing thresholds in decibels (dB) at various frequencies (e.g., 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz).

\[Unit of Measure: Decibels (dB)\], 2 years
Multimedia Education for Frail Patients
NCT Number: NCT06579534
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frailty
Interventions: OTHER: Health education strategy
Sponsor: Asia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2025-07

Summary:
The goal of this clinical trial is to explore the impact of precision health care interventions on inpatients in acute medical institutions regarding their risk of falls, management, and prevention knowledge, as well as the incidence of falls among these patients. The main questions it aims to answer are:

What is the effectiveness of precision health care interventions on inpatients' knowledge of fall risk in acute medical institutions? What is the effectiveness of precision health care interventions on inpatients' knowledge of fall management in acute medical institutions? What is the effectiveness of precision health care interventions on inpatients' knowledge of fall prevention in acute medical institutions?

Primary Outcome Measures: inpatients' knowledge of fall risk in acute medical institutions, Fall Risk Assessment Scale:

Knowledge related to fall risk is a self-compiled questionnaire with a total of 5 questions. The estimated test time is 3 to 5 minutes.

Answer with true or false questions, each question is worth 20 points, and the score ranges from 0 to 100 points.

The higher the score, the better the knowledge level., 5 minutes|inpatients' knowledge of fall management in acute medical institutions, Fall Prevention Self-health Management Scale:

The knowledge related to fall prevention and self-health management is a self-constructed questionnaire with a total of 5 questions. The estimated test time is 3 to 5 minutes.

Answer with true or false questions, each question is worth 20 points, and the score ranges from 0 to 100 points.

The higher the score, the better the knowledge level., 5 minutes|inpatients' knowledge of fall prevention in acute medical institutions, Fall Prevention Scale Knowledge related to fall prevention is a self-constructed questionnaire with a total of 5 questions.

Answer with true or false questions, each question is worth 20 points, and the score ranges from 0 to 100 points.

The higher the score, the better the knowledge level., 5 minutes
Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chronic Venous Insuficiency
NCT Number: NCT06579482
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Chronic Venous Insufficiency
Interventions: DRUG: Aesculus hippocastanum, and associations
Sponsor: Fundação Educacional Serra dos Órgãos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-06
Completion Date: 2025-02-11
Locations: Centro Universitário Serra dos Órgãos - UNIFESO, Teresópolis, RJ, 25964004, Brazil

Summary:
To demonstrate the clinical non-inferiority of efficacy between Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, Rutin and Diosmin 450mg and Hesperidin 50mg tablets in the improvement of lower limb symptoms assessed by means of a 100mm visual scale (VAS) over 3 months among adult patients presenting with chronic venous insufficiency of the lower limbs.

Primary Outcome Measures: visual analogic scale, A 100 mm VAS (visual analogic scale) is marked from 0 (absence of venous symptoms) up to 100 (maximum symptomatic venous manifestations) by the patient (higher scores means a worse outcome). It is fulfilled by the patient him- or herself, under the physician's watch. VAS is meant to globally evaluate lower limbs venous symptomatology (heavy legs, painful legs, fatigued legs, deambulation limitations, swollen sensation and/or lower limbs tension)., 3 months
Secondary Outcome Measures: Oral acceptability by the patient through the use of a visual analogic scale, A 100 mm VAS (visual analogic scale) is marked from 0 (easy swallowing) up to 100 (very difficult to swallow) by the patient (higher scores means a worse outcome). It is fulfilled under by the patient him- or herself under the physician's watch., 3 months|Quality of life as measured by a specific chronic venous insufficiency questionnaire, CIVIQ-10 (chronIc venous insufficiency quality of life questionnaire) is a questionnaire composed of 20 scored items (on a 4 point scale) that inform on the capacity of the patient of coping with daily routine tasks, regarding their lower limbs venous competence. The higher the score, the better the clinical outcome., 3 months|Medical tolerability to tested drugs as measured by the investigator, Tolerability will be a measure of the nature and quantity of adverse clinical and lab reactions related to study drugs., 3 months|Patient's satisfaction to study medications, This endpoint regards to the medication's efficacy as perceived by the patient and graduated as: "insufficient", "acceptable", "good", or "very good"., 3 months|Physician's satisfaction to study medications, This endpoint regards to the medication's efficacy as perceived by the investigating physician and graduated as: "insufficient", "acceptable", "good", or "very good"., 3 months
Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
NCT Number: NCT06579443
Acronym: RIDDLE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Bowel Diseases|Crohn Disease|Ulcerative Colitis
Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-12
Completion Date: 2025-06
Locations: Abhilasha Patel, Coventry, West Midlands, CV2 2DX, United Kingdom

Summary:
To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.

Primary Outcome Measures: To see if robotic surgery is technically feasible for patients with inflammatory bowel disease., Technical feasibility is measured during intra-operative procedure and includes: estimated blood loss, port placement, docking/patient position, operative time, conversion to open procedure, and monitoring adverse outcomes both intra and post operatively.

Outcomes including surgical approach and postoperative recovery will be compared across these 4 categories. This will help to establish if robotic surgery enables minimally invasive approaches for complex disease in patients who would conventionally have open surgery either from the outset or after failed laparoscopic approach with conversion.

We will explore any relationship between pre-, intra- and post-operative outcomes including surgical approach and quadrants groups. Finally, study aims to identify patients who would benefit from robotic surgery and relevant efficacy outcomes to inform a larger study., 12 months
Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment
NCT Number: NCT06579430
Acronym: Pre-CLOVER
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Hypoparathyroidism
Interventions: DRUG: Indocyanine Green near infrared fluorescence imaging
Sponsor: University Medical Center Groningen
Collaborators: Erasmus Medical Center|Leiden University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2020-11-05
Completion Date: 2024-05-02
Locations: University Medical Center Groningen, Groningen, 9700RB, Netherlands|Erasmus Medical Center Rotterdam, Rotterdam, Netherlands

Summary:
Background Near-infrared fluorescence guided surgery with indocyanine green (ICG) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins in the bloodstream, and circulates in the intravascular compartment only. ICG was already approved in 1956 for clinical use of tissue perfusion. However, until now there is still no (parathyroid) universal standard imaging protocol for ICG-guided fluorescent surgery including quantitative evaluation.

Main research question To develop a standardized universal imaging protocol for the assessment of parathyroid perfusion during total thyroidectomy with ICG including quantitative evaluation of the fluorescent signal.

• Design (including population, confounders/outcomes) This will be a proof-of-concept, prospective cohort study of patients undergoing an ICG-guided fluorescent total thyroidectomy to evaluate parathyroid gland perfusion. The main study endpoint is quantification of the fluorescent signal of ICG stratified by the occurrence of hypoparathyroidism. Hypoparathyroidism will be defined as a decrease in PTH of \&gt;70% at the first postoperative day. Furthermore, we will calculate the sensitivity of our model for the prediction of hypoparathyroidism.

Secondary outcomes are data from surgery, pre- and postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.

Expected results We expect that the results of this study will lead to the development of a universal standard imaging protocol for ICG-guided fluorescent total thyroidectomy.

Primary Outcome Measures: Injection speed, The impact of injection speed on a parathyroid perfusion curve (slow vs fast), During surgery|ICG concentration, The impact of ICG concentration on a parathyroid perfusion curve (2.5 mg/mL vs 0.5 mg/mL), During surgery|Camera system, The impact of a camera system on a parathyroid perfusion curve (Quest vs SpyElite), During surgery
Secondary Outcome Measures: Multicenter application, The correlation between postoperative hypoparathyroidism and the perfusion curve in two different centers (UMCG/EMC), From surgery until one day post-surgery
ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
NCT Number: NCT06579417
Acronym: ART-Pro
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DIAGNOSTIC_TEST: RSI MRI
Sponsor: University of California, San Diego
Collaborators: GE Healthcare|University of California, San Francisco|Massachusetts General Hospital|Weill Medical College of Cornell University|Cambridge University Hospitals NHS Foundation Trust
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-15
Completion Date: 2029-07
Locations: University of California San Diego, San Diego, California, 92037, United States

Summary:
This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.

Primary Outcome Measures: Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy, 6 months
Secondary Outcome Measures: Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer, 6 months
Expanded Access Study of UC-MSC in DMD Patients
NCT Number: NCT06579352
Status: AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Duchenne Muscular Dystrophy
Interventions: BIOLOGICAL: Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC)
Sponsor: MED Institute Inc.
Collaborators: Signature Biologics
Sex: MALE
Age: CHILD
Locations: Neurology Rare Disease Center, Denton, Texas, 76208, United States

Summary:
The primary objective of this study is to provide UC-MSC treatment to patients with DMD.

Secondary objectives will be to further evaluate treatment-related adverse events as well as changes in DMD-related functional testing/assessments, blood laboratories, and inflammation related biomarker levels over time.
Effect of Xylitol Gum Chewing on Postoperative Bowel Activity
NCT Number: NCT06579339
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Xylitol Gum Chewing|Non-xylitol Gum Chewing|Control Group
Interventions: OTHER: xylitol chewing gum
Sponsor: Giresun University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-05
Completion Date: 2024-04-01
Locations: Esra Ozkan, Giresun, Piraziz, 28000, Turkey

Summary:
Altogether, 75 patients undergoing elective laparoscopy cholecystectomy were randomly divided into 3 groups (final numbers, xylitol chewing gum: 24 controls, xylitol free chewing gum:25 and control 25 patients). Controls underwent a routine postoperative regimen. Both groups chewed gum 3 times a day except the control group. Other postoperative management was routine. First flatus, first bowel movement, first defecation, first mobilization time, and discharge time from hospital were recorded. Symptoms included nausea, and vomiting.

Primary Outcome Measures: Time to first postsurgical flatus, Time to first bowel sound after surgery, Time to first postsurgical defecation, First Mobilization time, Discharge time from hospital, The onset of time to first postsurgical flatus, time to first bowel sound after surgery, Time to first postsurgical defecation, first mobilization time, discharge time from hospital were evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the feeding at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards., Baseline
Secondary Outcome Measures: Nausea After Surgery, Vomiting After Surgery, Nausea and vomiting were evaluated and all information was recorded., Baseline
Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease
NCT Number: NCT06579326
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lower Extremity|Photoacoustic
Interventions: DIAGNOSTIC_TEST: Photoacoustic imaging
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
Lower extremity artery disease (LEAD) is characterized by low awareness rate and high missed diagnosis rate, leading to low treatment rate and high disabling mortality rate. However, none of the current examination methods can comprehensively and thoroughly evaluate the vascular structure and blood oxygen status of the lower extremity at the same time. This study aims to evaluate the reliability and accuracy of photoacoustic tomography (PACT) in the diagnosis of lower limb arterial disease through a case-control study. It is planned to recruit 30 patients with clinically confirmed LEAD (15 patients with stenosis ≥50% and \< 50% respectively) and 5 patients without LEAD in preliminary clinical screening. The reliability of PACT was assessed by repeated measurements within the observer and different inter-observer measurements of the same subject. Compared with computed tomographic angiography (CTA), the sensitivity and specificity of PACT in diagnosing vascular stenosis were calculated. The ability of PACT to determine tissue blood oxygen was assessed by comparing PACT functional imaging with ischemic grading as determined by ankle-brachial index (ABI) and transcutaneous oxygen pressure (TcpO2) between subgroups.

Primary Outcome Measures: Stenosis degree of calf artery, Stenosis degree of calf artery measured by computed tomography angiography were refered as standard reference., Baseline
Secondary Outcome Measures: Calf tissue blood oxygen, Calf tissue blood oxygen was evaluated by transcutaneous oxygen pressure and ankle brachial index., Baseline
Current Situation of Health Care in Women With HBV or HCV Infection
NCT Number: NCT06579313
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HBV|HCV
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-07-31

Summary:
A multicenter, retrospective study conducted in male and female population infected with HBV or HCV in east China. HCV part, study will enroll 500 HCV antibody positive and HCV RNA positive patients during 2020.7-2023.12 and then observe the characteristics, duration from diagnosis to treatment, treatment rate and sustained virologic response (SVR12) among eligible female and male patients. HBV part, study will enroll 2000 HBsAg positive patients during 2016.7-2019.12 and then observe the clinical characteristics, natural history, duration from diagnosis to treatment, treatment rate and adherence among eligible female and male patients.

Primary Outcome Measures: Treatment Rate in male in HBV cohort, The treatment rate in male populations who meet treatment criteria recommended by China CHB guideline, from July 2020 to December 2023|Treatment Rate in female in HBV cohort, The treatment rate in female populations who meet treatment criteria recommended by China CHB guideline, from July 2020 to December 2023|Treatment Rate in male in HCV cohort, The treatment rate in male populations who meet treatment criteria recommended by China CHC guideline, from July 2016 to December 2019|Treatment Rate in female in HCV cohort, The treatment rate in female populations who meet treatment criteria recommended by China CHC guideline, from July 2016 to December 2019
Secondary Outcome Measures: Distribution of Income levels among male in HBV cohort, categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in male populations infected with HBV, from July 2020 to December 2023|Distribution of Income levels among female in HBV cohort, categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in female populations infected with HBV, from July 2020 to December 2023|Distribution of medical insurance type in male in HCV cohort, categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV, from July 2016 to December 2019|Distribution of medical insurance type in female in HCV cohort, categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV, from July 2016 to December 2019
A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
NCT Number: NCT06579300
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteer
Interventions: DRUG: ABBV-1088|DRUG: Placebo for ABBV-1088|DRUG: Itraconazole (ITZ)
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-04
Completion Date: 2025-11-12
Locations: Acpru /Id# 270552, Grayslake, Illinois, 60030, United States

Summary:
This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.

Primary Outcome Measures: Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088, Cmax of ABBV-1088, Up to approximately 24 days|Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088, Tmax of ABBV-1088, Up to approximately 24 days|Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088, Terminal phase elimination rate constant (beta) of ABBV-1088, Up to approximately 24 days|Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088, Terminal phase elimination half-life of ABBV-1088, Up to approximately 24 days|Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088, AUCt of ABBV-1088, Up to approximately 24 days|Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088, AUCinf of ABBV-1088, Up to approximately 24 days|Number of Participants with Adverse Events (AEs), An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study, Up to approximately 54 days|Part 1: Trough Concentration (Ctrough) of ABBV-1088, Ctrough of of ABBV-1088, Up to approximately 24 days|Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau), The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)., Up to approximately 24 days
A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control
NCT Number: NCT06579287
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Myopia, Progressive
Interventions: DRUG: SHJ002|DRUG: Atropine
Sponsor: Sunhawk Vision Biotech, Inc.
Sex: ALL
Age: CHILD
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-04
Locations: Pacific Center for Advanced Vision Care Tanasbourne Vision Center, Hillsboro, Ohio, 97124, United States

Summary:
The objective of this study is to explore the safety and efficacy of SHJ002 Sterile Ophthalmic Solution relative to atropine in myopia control

SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.

Primary Outcome Measures: Change of the cycloplegic spherical equivalent (SE), from baseline visit to the final visit, up to 52 weeks
Secondary Outcome Measures: Change of axial length, from baseline visit to the final visit, up to 52 weeks
Intraoral Hypothermia Device for Preserving Taste During Radiation
NCT Number: NCT06579248
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Head and Neck Cancer|Taste Dysfunction|Radiation Therapy
Sponsor: Henry Ford Health System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-30
Completion Date: 2025-08-30

Summary:
Radiation therapy to the head and neck region is known to cause taste dysfunction. Preliminary studies showed that cooling normal structures may lower damage caused by radiation. The purpose of this research study is to see if it is feasible to use an intraoral cooling device during radiation treatments to preserve or lower the decline of taste function.

Primary Outcome Measures: Change in Dysgeusia, Taste will be measured objectively using Burghart taste strips in five different concentrations of salty, sweet, sour, bitter, and umami. Taste will be assessed on a yes/no scale to reflect the ability to correctly identify taste category.

Taste will be measured subjectively with a series of previously-validated, patient-reported taste-related questions. The questions comprise of a modified Chemotherapy-induced Taste Alteration Scale (CiTAS), one question from the Head and Neck Quality of Life questionnaire (HNQOL, question 2H) and one question from the University of Washington Head and Neck-specific Quality of Life questionnaire (UWQOL, question 9).

The CiTAS uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste.

The HNQOL uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste.

The UWQOL uses a scale of 1-4, with 1 meaning taste is normal and 4 being unable to taste.

Questionnaires are used together to quantify change in taste., 6 months after RT completion
Explorative Proteomics in Pediatric Neuroborreliosis
NCT Number: NCT06579235
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neuroborreliosis|Facial Palsy|Pediatric Infectious Disease
Interventions: DIAGNOSTIC_TEST: Proteomics
Sponsor: Rigshospitalet, Denmark
Collaborators: Clinical Proteomics, Department of Clinical Biochemistry, Bispebjerg Hospital|NNF Center for Protein Research, University of Copenhagen
Sex: ALL
Age: CHILD
Enrollment: 106
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-10-17
Completion Date: 2024-12-10
Locations: Rigshospitalet, Department of Children and Adolescents, Copenhagen, 2100, Denmark

Summary:
This study aims to use proteomic analysis to diagnose Lyme Neuroborreliosis (LNB) in children. Pediatric patients with suspected LNB will be enrolled, and their blood samples will be collected for proteomic analyses. Mass spectrometry will be used to compare protein profiles of LNB-positive and LNB-negative patients. The data will be analyzed by bioinformaticians. The expected impact is to establish a non-invasive, reliable method for early LNB diagnosis to improve patient outcomes.

Primary Outcome Measures: Protein concentrations, A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis., An average of 2 years from enrollment
NAD+ Oral Supplement Pilot Intervention in Adult Females
NCT Number: NCT06579209
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Change|Inflammation|Neurodegenerative Diseases
Sponsor: University of Rhode Island
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-04-30

Summary:
The goal of this clinical trial is to learn if Nicotinamide adenine dinucleotide (NAD+) can influence cognition and biomarkers in healthy, cognitively intact women who identify as Latina and are between the ages of 40-80. The main questions it aims to answer are:

Will executive function change in response to NAD+? Will inflammatory markers and serum indicators of neurodegeneration change in response to NAD+? Researchers will compare individuals receiving the NAD+ to see if the results differ from those receiving the placebo.

Participants will:

Complete an online questionnaire, Visit the lab for computerized cognitive testing and a blood draw, Take NAD+ or a placebo every day for 4 weeks, Visit the lab for computerized cognitive testing and a blood draw

Primary Outcome Measures: Neurocognition, NIH Toolkit Cognition Battery, Automated Neuropsychological Assessment Metrics, four weeks|Neurodegenerative disease panel, BDNF, Cathespin D, MPO, PAI-1 (total), PDGF-AA, PDGF-AB/BB, RANTES, slCAM-1, sNCAM, sVCAM-1, four weeks|Markers of systemic inflammation, GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A, IL-23, TNFα, four weeks
Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
NCT Number: NCT06579196
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: Trabedersen|DRUG: Pembrolizumab
Sponsor: University of Nebraska
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2029-12
Locations: University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States

Summary:
The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are:

* What medical problems to participants have when taking OT101 together with Pembrolizumab?
* What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy?
* Does the combination therapy delay progression or relapse of the participant\&#39;s Non-Small Cell Lung Cancer?

Participants will:

* Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion.
* Receive intravenous Pembrolizumab once every 6 weeks.

Primary Outcome Measures: Phase I: Dose Finding, Dose Limiting toxicity (DLT) and Maximum Tolerated Dose (MTD), 18 months|Phase II: Progression-Free Survival (PFS), Progression-Free Survival (PFS) defined as first therapy until the first documentation of clinical progression, relapse, or death due to any cause. Participants not experiencing an event of interest will be right-censored at last known disease status, 36 months
Secondary Outcome Measures: Best Overall Response, Best overall response, defined as the best overall response observed during the evaluation period (up to 12 weeks of treatment): CR, PR, SD, or PD,, 36 months|Disease Control, Disease control \[CR + PR + stable disease (SD)\], 36 months|Duration of Response, Duration of response (DOR) defined as first response (CR or PR) until disease progression., 36 months|Drug Toxicity, Toxicity according to Common Terminology Criteria for Adverse Events (CTCAE)., 18 months|Overall Survival (OS), Overall survival (OS) defined as the time from the first therapy until death., 48 months
Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal
NCT Number: NCT06579157
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bronchopulmonary Dysplasia
Interventions: OTHER: Pressure-Sensing Mattresses
Sponsor: Fu Jen Catholic University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-02-28
Locations: Fu Jen Catholic University Hospital, Fu Jen Catholic University, New Taipei City, 24352, Taiwan

Summary:
This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.

Primary Outcome Measures: ballistocardiography waveform, the correlation between using Ballistocardiography (BCG) for monitoring respiration and heart rate, through study completion, an average of 2 weeks
Secondary Outcome Measures: tidal volume, the correlation between using Ballistocardiography (BCG) for tidal volume, through study completion, an average of 2 weeks
Seating Posture and Its Relation to Pain
NCT Number: NCT06579131
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Posture; Myositis|Sitting Position
Interventions: BEHAVIORAL: sitting position
Sponsor: Izmir Bakircay University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-30
Completion Date: 2025-06-30

Summary:
A study has been designed to evaluate pain levels experienced by subjects in relation to different sitting postures. The objective is to investigate how various ergonomic sitting positions affect pain intensity, by systematically assessing pain across a range of sitting postures to identify significant differences and correlations.

Primary Outcome Measures: pain assessment, 1 year
The Impact of Laughter Yoga on Symptom Management and Quality of Life in Postmenopausal Women
NCT Number: NCT06579118
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menopause
Interventions: OTHER: Laughter yoga
Sponsor: Ataturk University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-08-25
Completion Date: 2024-08-28
Locations: Ayşe Aydın, Yakutiye, Erzurum, 25000, Turkey

Summary:
This study aimed to assess the impact of laughter yoga intervention on symptomatology and quality of life among postmenopausal women.The research was conducted in a randomized controlled experimental design.The sample comprised 128 postmenopausal women (64 in the experimental group and 64 in the control group) who attended the Gynecology Polyclinic at Atatürk University Health Research and Application Center.

Primary Outcome Measures: Personal Information Form, It consists of 10 questions (age, gender, education level, marital status, income status, etc.) prepared by the researcher in line with the literature., 5 months|Menopause Rating Scale, The scale, which includes a total of 11 items including menopausal complaints, consists of 3 sub-dimensions. These sub-dimensions are 1-Somatic complaints sub-dimension (items 1,2,3,11), 2-Psychological complaints sub-dimension (items 4,5,6,7), 3-Urogenital complaints sub-dimension (8,9, Article 10). The scale is a 5-point Likert type and each statement is scored as 0: None, 1: Mild, 2: Moderate, 3: Severe and 4: Very severe. The total score of the scale is calculated based on the scores given for each item. The minimum score that can be obtained from the scale is 0, while the maximum score is 44. An increase in the total score obtained from the scale, on the one hand, indicates an increase in the severity of the complaints experienced, and on the other hand, indicates that the quality of life is negatively affected., 5 months|Menopause-Specific Quality of Life Scale, It is a Likert type scale containing 29 questions. It consists of four subdomains: vasomotor domain (questions 1-3), psychosocial domain (questions 4-10), physical domain (questions 11-26) and sexual domain (questions 27-29). The complaints that women have experienced in the last month are questioned and the answers to the questions are "yes" or "no". In MÖYÖS, each subdomain score is ranked from 0 to 6. A score of "0" indicates that there are no problems with the issue. A score of "1" indicates that the problem exists and is experienced, but it is not disturbing at all, and scores between "2-6" indicate the severity and increasing degrees of the existing problem. The lowest score that can be obtained from the total of the scale is "0" and the highest score (29X6) is 154. However, evaluation is not made based on the total score., 5 months
Improving Participation in Universal School Meals (USM)
NCT Number: NCT06579079
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Food Deprivation|Obesity, Childhood
Interventions: OTHER: Implementation Mapping|OTHER: Waitlist Control - Implementation Mapping
Sponsor: Temple University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2028-01-31
Locations: Temple University, Philadelphia, Pennsylvania, 19122, United States

Summary:
The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).

Primary Outcome Measures: School Meal Participation, Counts to calculate number of students who participate in breakfast and lunch each day will be generated and totaled for each school., Through study completion, an average of 1 year|Qualitative Interviews, Focus group interviews with students, parents, teachers, administration, and food service staff., After 1 year; after 2 years of the trial|Implementation Mapping Self-Assessment, Self-assessment to document fidelity to implementation mapping procedures., After 1 year of the trial|Implementation Cost Measure, A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools., After 2 years|Implementation Outcomes Surveys, Implementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders, After 2 years
Secondary Outcome Measures: Height, Student height (feet, inches) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes., Through study completion, an average of 1 year|Food Insecurity, The United States Department of Agriculture (USDA) 6-item food screening questionnaire is administered to parents across the district. These data are a secondary outcome to implementation outcomes., Through study completion, an average of 1 year|Dietary Behaviors, Students complete a survey each year which records their nutrition behaviors such as fruit and vegetable consumption, sugar-sweetened beverages, and other key behaviors. These data are a secondary outcome to implementation outcomes., Through study completion, an average of 1 year|Student Weight, Student weight (pounds) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes., Through study completion, an average of 1 year
The Effect of Probiotics vs Activated Charcoal in the Management of CKD Patients Suffering From Uremic Pruritus.
NCT Number: NCT06579066
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Kidney Disease|Uremic Pruritus
Interventions: DRUG: Probiotic Blend Capsule|DRUG: Activated Charcoal
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 123
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-03

Summary:
This study aims to evaluate the efficacy and safety of probiotics versus activated charcoal in management of chronic kidney disease patients suffering from uremic pruritus.

Patient data collection

Demographic data:The following data will be collected from the patient records; including age, sex, weight, height.

History Taking :Including patient's medical history, past surgical history, family medical history, and medications the patient is taking or may have recently stopped taking.

A patient's medical history may also include information about allergies, etiology of uremic pruritus.

Laboratory examinations:The following laboratory data to be measured at baseline and after the duration of treatment (4 weeks)

1. Serum levels of indoxyl sulfate (IS)
2. Kidney Function tests: BUN, Creatinine
3. Electrolytes test: sodium, potassium, chloride ,ionized calcium, phosphorus

Dermatological examination: Base on

1. measure Visual Analoge Scale Score(VAS).
2. measure Dermatology life quality index (DLQI).

Primary Outcome Measures: Change in serum Indoxyl sulfate (IS) level, IS is one of the most potent protein bound uremic toxins . mesasuring serum indoxyl sulfate level at baseline and after a 4 weeks trial period by using ELISA kits., Four weeks|Change in visual Analog scale (VAS) score., A 10 cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored at baseline and after a 4 weeks trial period ., Four weeks|Change in Dermatology life quality index (DLQI), 10-Item questionnaire aiming to measure how much skin problem has affected on QOL . mesasuring DLQI at baseline and after a 4 weeks trial period ., Four weeks
Secondary Outcome Measures: Evaluation of the safety of probiotics supplementation and activated charcoal in patients with uremic pruritus., by monitor any adverse effects that may occur throughout the study period., Four weeks