pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Urinary G3BP as a Novel Biomarker in Lupus Nephritis
NCT Number: NCT06520670
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lupus Nephritis
Interventions: DIAGNOSTIC_TEST: Urinary galectin-3 binding protein
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-10

Summary:
Estimation of urinary Galectin-3 binding protein (u-Gal-3BP) in patients with systemic lupus erythematosus with and without lupus nephritis and in glomerulonephritis for other kidney diseases, Find the relation of urinary Galectin-3 binding protein (u-Gal-3BP) levels with lupus nephritis, and Correlate urinary Galectin-3 binding protein (u-Gal-3BP) levels with SLE disease activity

Primary Outcome Measures: Level of galectin_3 binding protein in urine samples ., Level of galectin_3binding protein in urine samples by pg/mmol using ELISA in patient with lupus nephritis., baseline
Effect Of Virtual Reality On Strength and Coordination in Cerebral Palsy
NCT Number: NCT06520644
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy (CP)
Interventions: DEVICE: Wii-based interactive training program|OTHER: Traditional physical therapy program
Sponsor: Shimaa Mohamed Reffat
Collaborators: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-11-10
Completion Date: 2022-12-10
Locations: Israa Ahmed Mohamed Shawki, Cairo, Egypt

Summary:
ABSTRACT:

Purpose: To investigate the effect of interactive training on muscle strength and coordination in children with hemiparesis.

Materials and methods: This study involved 30 children of both sexes with unilateral cerebral palsy aged ranged 8 up to 10 years. A designed physical rehabilitation program was given to both groups. furthermore, study group received a wii fit virtual reality-based program. Muscle strength, bilateral coordination, running speed and agility were assessed by using Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2) while hip and knee extensor strength were assessed by lafayette hand-held dynamometer pre and post treatment program.

Primary Outcome Measures: Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2), The BOT-2 is norm-referenced, and it involves individually administered tasks with direct observation and assessment of a child in a structured environment. Evidence supporting the use of the BOT-2 to assess gross and fine motor proficiency of individuals aged 4 through 21\[9\]. The BOT-2 test consists of four composites and eight subtests including 53 items as follows: Fine manual control (fine motor precision, fine motor integration), Manual coordination (manual dexterity, upper limb coordination), Body Coordination (bilateral coordination, balance), Strength and Agility (running speed and agility, and strength, through study completion, an average of 1 year|Lafayette manual muscle testing system, commonly used device that measure isometric lower limb muscle strength. Handheld dynamometer is used to assess lower limb strength. The test-retest interclass correlation coefficient ranged from 0.95 to 0.99, through study completion ,average of 1 year
Response Of Arteriovenous Fistula Puncture-related Pain To Cryotherapy Application In Haemodialysis Patients
NCT Number: NCT06520631
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis Complication
Interventions: OTHER: Ice packs (cryotherapy)
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-04
Completion Date: 2024-08-31
Locations: Cairo university, Cairo, 11432, Egypt

Summary:
Kidney disease occurs when kidney reduces its normal function, less than 30% of normal activity is related to a long-term condition. Therefore, people need to participate in a haemodialysis (HD) programme. In HD, blood is filtered by an external machine, done about three times a week and the access is gained through intermittent vascular cannulation.

The patients experience considerable pain due to the frequent insertion of AVF catheters.

Hemodialysis patients experience anxiety before needle insertion due to repeated punctures, and over 90% of patients experience acute pain during the process.

Puncture-related pain during arteriovenous fistula (AVF) cannulation in particular is a crucial influential factor in quality of life.

Cryotherapy is one of the interventions used in several studies to alleviate the arteriovenous fistula puncture-related pain. It can be conduct by using ice packs and the results of the previous studies have also shown its positive effects on the relief of the fistula puncture-related pain in these patients.

Primary Outcome Measures: Visual analogue scale (VAS):, Scale to measure the intensity of pain The minimum value is 0 which means no pain and the maximum value is 10 which means the maximum pain, Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions
Secondary Outcome Measures: The Arm Motor Ability Test (AMAT), The Arm Motor Ability Test (AMAT): is used to assess and quantify upper extremity functional limitation., The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.|Hospital Anxiety and Depression Scale (HADS):, Hospital Anxiety and Depression Scale (HADS):

it is a reliable and valid tool It's questions are clear and easy to understand, and thought the questionnaire items covered all patients problem areas regarding their hospital anxiety and depression. Each question is scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 means maximum impairment and minimum score of 0 means no impairment for anxiety or depression., Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.
Clinical Study on the Efficacy and Safety of Qingre Heji in the Treatment of Acute Upper Respiratory Tract Infection
NCT Number: NCT06520618
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Acute Upper Respiratory Tract Infection|Traditional Chinese Medicine|Randomised Controlled Trial
Interventions: DRUG: Qing Re He Ji|DRUG: Shuanghuanglian Oral Liquid
Sponsor: Shengjing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 268
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-01
Completion Date: 2024-02-01
Locations: Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110000, China

Summary:
Originating from China, TCM complements conventional approaches by alleviating symptoms, balancing physical conditions, and enhancing immunity. Clinical studies have shown TCM to be safe and effective in treating AURI. In TCM syndrome differentiation, AURI is considered a "Wind-Heat Syndrome", requiring treatment that clears heat and detoxifies the body. Qing Re He Ji (QRHJ; heat-clearing mixture), a TCM compound developed by our hospital, comprises Huang Qin (Radix Scutellariae), Da Qing Ye (Folium Isatidis), Ge Gen (Radix Puerariae), Yin Chen (Herba Artemisiae Scopariae), and Guan Zhong (Cyrtomium Rhizome). Widely used for AURI, QRHJ effectively clears heat, eliminates pathogens, and strengthens healthy qi. Clinical applications have demonstrated its efficacy, complemented by significant advancements in animal experiments and pharmacokinetics research. To further validate these results, systematic clinical research is imperative, especially in the context of limited direct comparisons between QRHJ and other commercially available TCMs like Shuang Huang Lian (SHL) oral liquid, known for its efficacy and safety in AURI treatment.

Therefore, we performed a rigorously designed non-inferiority randomised controlled trial to assess the efficacy and safety of QRHJ in treating AURI in adults, comparing it directly with SHL oral liquid. This study aimed to bridge existing research gaps and provide healthcare professionals with more diversified treatment options, thereby enhancing personalised and comprehensive patient care plans. Furthermore, we hope that our findings will establish a scientific basis for integrating TCM into modern healthcare practices, promoting the synergy of Chinese and Western medicine.

Primary Outcome Measures: Overall Symptom and Sign Score Improvement Rate, We use both traditional Chinese medicine (TCM) and Western medicine scales to assess the condition., At days 0 (baseline) and 6|Onset time, Defined as the duration from medication administration to a 0.5°C decrease in body temperature., At days 0 (baseline) and 6|Antipyretic time, Measured as the time taken for axillary temperature to drop below 37.3°C after the first dose and maintained for at least 24 hours without recurrence, At days 0 (baseline) and 6|Single Symptom and Sign Disappearance Rate, Disappearance rate of individual TCM symptoms and signs, At days 0 (baseline) and 6
Cytomegalovirus Reactivation in ICU Patients Requiring Prolong Mechanical Ventilation
NCT Number: NCT06520605
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mechanical Ventilation
Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2026-03
Locations: Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, 226014, India

Summary:
Cytomegalovirus (CMV) is a latent infection virus that is widespread in the population. CMV may reactivate under certain circumstances, and its hazardous nature has been proven, especially in immunosuppressed patients. However in recent years, some studies have found that CMV reactivation also exists in apparently immunocompetent patients during their critical illness. In these non-immunosuppressed patients, the presence of sepsis and its immunomodulatory effects may lead to reactivation of dormant viral infections. Studies found the incidence of CMV reactivation in up to one-fourth to half of these non-immunosuppressed patients during their critical illness.

These studies also documented significantly higher length of ICU stay and mortality in critically ill patients with CMV reactivation. CMV reactivation has also been studied in specific critically ill cohorts, exhibiting there impact on mortality. David S Y Yong et al studied the effect of CMV reactivation on mortality in immunocompetent acute respiratory distress syndrome (ARDS) patients. In a recent study, it was found that among cohort of non-immunosuppressed patients with acute respiratory distress syndrome (ARDS), CMV reactivation occurred in 27 % of patients which was associated with overall increased ICU mortality. In another study among septic shock cohort (329 patients), herpesvirus reactivations were documented in 68% patients without prior immunodeficiency and concluded that reactivations could be independently associated with mortality.

However currently, no study is available investigating the CMV reactivation and it's kinetics during critical illness in non immunocompetent patients requiring prolonged mechanical ventilation. In this planned observational study, we aim to find out the prevalence of Cytomegalovirus (CMV) reactivation, viral load and it's association with the severity of illness in non immunosuppressed ICU patients requiring prolong mechanical ventilation.

Primary Outcome Measures: The prevalence of cytomegalovirus reactivation in ICU patients requiring prolong mechanical ventilation, Percentage of total included patients (CMV seropositive IgG) who had viral load \>1000/cc will be calculated., Till 4 weeks after the initiation of mechanical ventilation|The correlation of CMV viral load with the severity of illness ., Patients who had cytomegalovirus reactivation, the correlation will be explored between cytomegalovirus viral load with the severity of illness (total SOFA score)., Till 3 weeks after the cytomegalovirus reactivation
The Effectiveness of Augmented Reality to Enhance CPAP Therapy in OSA Patients
NCT Number: NCT06520592
Acronym: CPAP OSA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aherence|Physical Symptoms|Mental Health|Quality of Life
Interventions: BEHAVIORAL: With AR guided CPAP therapy
Sponsor: National Cheng-Kung University Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-31
Completion Date: 2026-07-31
Locations: National Cheng Kung University Hospital, Tainan, 70403, Taiwan

Summary:
The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. The main questions it aims to answer are:

Does AR guided CPAP therapy increase the adherence of CPAP therapy among OSA patients? What barriers do participants have when using AR guided CPAP therapy? Researchers will compare AR guided CPAP therapy to a control (standard of care) to see if AR guided CPAP therapy works to enhance the adherence of CPAP therapy.

Participants will:

1. Take AR guided CPAP therapy or standard of care every day for 6 months
2. Visit the clinic on baseline (t0), receiving CPAP therapy at the 1st month (t1), for checkups and tests, receiving CPAP therapy at the 3rd month (t2), receiving CPAP therapy at the 6th month (t3).
3. Response their symptoms on each following time.

Primary Outcome Measures: The adherence of CPAP therapy, Adherence refers to the patient's adherence to CPAP therapy, which means using CPAP for more than 70% of the total sleep time during the night, with a minimum duration of 4 hours. The calculation method involves dividing the number of days with CPAP use exceeding 4 hours by the total number of days and multiplying by 100 to obtain the average percentage of CPAP usage., From enrollment to the end of treatment at 6 months
Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention
NCT Number: NCT06520579
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dysphagia
Interventions: BEHAVIORAL: Proactive pharyngeal-laryngeal Exercise Program|DIETARY_SUPPLEMENT: Premier Protein Clear ® High Protein|BEHAVIORAL: Hydration Counseling
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
This study will prospectively recruit and enroll patients undergoing primary Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone. Participants will undergo pre-operative and six-week post-operative swallowing assessment using videofluoroscopy (VFSS). Acoustic voice samples and Patient Reported Outcome Measures (PROMs) for swallowing and voice will also be collected. Beginning one-week before surgery participants will begin a behavioral health program that will be continued for six-weeks after surgery. The primary goal of this study will be to determine whether a preventative behavioral health program improves instrumental measures of swallowing and voice six-weeks after ACDF surgery. .

Primary Outcome Measures: Change in pharyngeal constriction, Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention, Baseline, 6 weeks post-op|Change in pharyngeal shortening, Outcome measure will be assessed using 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention, Baseline, 6 weeks post-op|Change in Dysphagia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI), The HSS-DDI consists of 31 patient-reported questions to assess Dysphagia and Dysphonia. Of the 31 questions, 20 ask about swallowing using a 5-point scoring method (1-5). Scores range from 20-100, where lower scores indicate dysphagia., Baseline, 6 weeks post-op
Secondary Outcome Measures: Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Ratings, Complete acoustic sound files will be blindly rated using the Consensus for Auditory Perceptual Evaluation of Voice (CAPE-V), a validated quantitative rating tool used for perceptual analysis of voice. It is intended to describe the severity of various auditory attributes of a voice problem. The CAPE-V is a visual analog scale that numerically rates various vocal qualities along a continuum from 0-100 based on what the experienced listener hears, with higher values indicating worse severity., Baseline, 6 weeks post-op|Change in Dysphonia Score measured by The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI), The HSS-DDI consists of 31 patient-reported questions to assess Dysphagia and Dysphonia. Of the 31 questions, 11 ask about speaking functions using a 5-point scoring method (1-5). Scores range from 11-55, where lower scores indicate dysphonia., Baseline, 6 weeks post-op
Holistic Care Partner Program Feasibility and Acceptability
NCT Number: NCT06520566
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Maternal Care
Sponsor: NYU Langone Health
Collaborators: National Institute of Nursing Research (NINR)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2026-08-18
Locations: NYU Langone Health, New York, New York, 10016, United States

Summary:
The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal nurses, Black women/birthing people, and their care partners enrolled in the Holistic Care Partner Program (HCP) to understand the program's feasibility and acceptability. HCP was developed at NYU Langone Health by Blank women-led perinatal nurses to address the effects of obstetric racism and the associated fear of pregnancy and birth faced by Black women and birthing people. Utilizing a mixed-methods approach, the study will focus on understanding HCP's acceptability and feasibility via surveys and qualitative interviews with Black women and birthing people and their partners/support persons to identify strategies and recommendations for intervention improvement. Exploratory analysis of maternal and infant outcomes will be conducted using a propensity score matched historical control group.

Primary Outcome Measures: Retention rate, Primary feasibility will be measured by a retention rate of ≥75%, End of study participation (up to 1 year)|Theoretical Framework for Acceptability (TFA) questionnaire score, Anticipated and experienced acceptability will be measured using the Theoretical Framework for Acceptability questionnaire. This is a 13-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the 7 component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy).

Total score ranges from 13-65, with higher scores indicating greater acceptability of the intervention., Visit 3 (6-12 weeks postpartum)|Rate of engagement with video visits, Visit 4 (9-12 months postpartum)|Rate of engagement with education, Visit 4 (9-12 months postpartum)|Rate of engagement with support groups, Visit 4 (9-12 months postpartum)
A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
NCT Number: NCT06520553
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: BI 1569912 (C-14)|DRUG: BI 1569912 (C-13)
Sponsor: Boehringer Ingelheim
Sex: MALE
Age: ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-10-03

Summary:
The main objectives of this trial are:

* To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).
* To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

Primary Outcome Measures: Mass balance recovery for [ 14 C]- radioactivity in urine after oral administration of BI 1569912 (C-14): fe urine,0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point), up to Day 14.|Mass balance recovery for [ 14 C]- radioactivity in faeces after administration of BI 1569912 (C-14): fe faeces,0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point), up to Day 14.|Mass balance recovery for [14C]- radioactivity in urine and faeces after oral administration of BI 1569912 (C-14): Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity), up to Day 14.|AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14), up to Day 13.|AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of [ 13 C] BI 1569912 after a single intravenous infusion of BI 1569912 (C-13), up to Day 6.
Secondary Outcome Measures: Cmax (maximum measured concentration in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14), up to Day 13.|AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14), up to Day 13.|Cmax (maximum measured concentration in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14), up to Day 13.|AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14), up to Day 13.|Cmax of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C- 13), up to Day 6.|AUC0-tz of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C-13), up to Day 6.
HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects
NCT Number: NCT06520540
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Glucagon-Like Peptide-1 Receptor Agonists
Interventions: DRUG: HDM1002 100 mg QD 12weeks|DRUG: HDM1002 200 mg QD 12weeks|DRUG: HDM1002 400 mg QD 12weeks，Q 2W for titration|DRUG: HDM1002 400 mg QD 12weeks，Q 3W for titration|DEVICE: Placebo
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-28
Completion Date: 2024-12-30
Locations: HDM1002, Shanghai, Shanghai, China

Summary:
• To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.

Primary Outcome Measures: TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest, TEAEs and SAEs (incidence, severity and causal relationship), AEs leading to withdrawal, and AEs leading to death, AEs of special interest, Baseline, Week 12
Secondary Outcome Measures: change in body weight from baseline at Day 85, Weight during treatment from baseline, Baseline, Week 12|change in BMI from baseline at Day 85, change in body mass index (BMI) from baseline, Baseline, Week 12|change in waist circumference from baseline at Day 85, Change in waist circumference from baseline, Baseline, Week 12|Plasma PK parameters, Cmax, Baseline, Week 12|Plasma PK parameters, Tmax, Baseline, Week 12|Plasma PK parameters, AUC0-last, Baseline, Week 12|Plasma PK parameters, AUCtau, Baseline, Week 12|Plasma PK parameters, AUC0-24h, Baseline, Week 12|Plasma PK parameters, AUC0-∞, Baseline, Week 12|Plasma PK parameters, t1/2z, Baseline, Week 12|Plasma PK parameters, CL/F, Baseline, Week 12|Plasma PK parameters, Vz/F, Baseline, Week 12
Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Pressure of Obese Patients
NCT Number: NCT06520527
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: MeSH
Interventions: DIETARY_SUPPLEMENT: Andrographis paniculata|BEHAVIORAL: Brisk Walking Exercise|OTHER: Combination
Sponsor: Universitas Palangka Raya
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-21
Completion Date: 2024-09
Locations: Sports Facilities, Palangkaraya, Central Kalimantan, 73111, Indonesia

Summary:
Problem Formulation

1. Is there an effect of giving jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
2. Is there an effect of brisk walking exercise on blood pressure in obese people in Jekan Raya District?
3. Is there an effect of brisk walking exercise and combined administration of jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
4. Is there a difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise and the combination on blood pressure in obese people in Jekan Raya District?

Research Objectives

General Objective:

This study aims to determine the difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise on blood pressure in obese people in Jekan Raya District.

Specific Objectives:

This study specifically aims to:

1. Knowing the effect on blood pressure of obese people in Jekan Raya District before and after giving Jamu Sambiloto (Andrographis paniculata).
2. Knowing the effect on blood pressure of obese people in Jekan Raya District before and after doing Brisk Walking Exercise.
3. Knowing the effect before and after giving Jamu Sambiloto (Andrographis paniculata) and Brisk Walking Exercise on Blood Pressure in obese people in Jekan Raya District.

Primary Outcome Measures: Systole and Diastole Differences, Difference in Systole and Diastole before and after treatment, 7 consecutive days
A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
NCT Number: NCT06520514
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Spesolimab
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-01-17
Locations: SGS Life Science Services - Clinical Research, Edegem, 2650, Belgium

Summary:
The main objectives of this trial is to investigate the safety and tolerability of a single dose of spesolimab administered in 2 different ways in healthy subjects.

Primary Outcome Measures: Occurrence of any treatment-emergent adverse event, Up to day 120
Secondary Outcome Measures: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point), Up to day 120|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), Up to day 120|Cmax (maximum measured concentration of the analyte in plasma), Up to day 120
Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Glucose of Obese Patients
NCT Number: NCT06520501
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: MeSH
Interventions: DIETARY_SUPPLEMENT: Herbal Medicine Sambiloto|BEHAVIORAL: Brisk Walking|COMBINATION_PRODUCT: Brisk Walking and Herbal Medicine Sambiloto
Sponsor: Universitas Palangka Raya
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-21
Completion Date: 2024-09

Summary:
Problem Formulation

1. Does herbal medicine sambiloto affect the blood glucose levels of obese sufferers?
2. Does brisk walking affect blood glucose levels in obese sufferers?
3. Does the combination of bitter herbal medicine and brisk walking have an effect on blood glucose levels in obese sufferers?
4. Is there a difference in the effectiveness between herbal bitter and brisk walking and the combination on blood glucose levels in obese sufferers?

Research Objectives

General Objectives :

The general aim of this research is to determine the difference in effectiveness between the herbal medicine Sambiloto and brisk walking as well as the combination on the blood glucose levels of obese sufferers.

Specific Objective :

1. Knowing the effect of herbal medicine Sambiloto on blood glucose in obese sufferers.
2. Knowing the effect of brisk walking on blood glucose in obese sufferers.
3. To determine the effect of the combination of herbal medicine Sambiloto and brisk walking on blood glucose levels in obese sufferers.

Primary Outcome Measures: Blood Glucose Differences, Difference in blood glucose before and after treatment, 7 consecutive day
A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors
NCT Number: NCT06520488
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Solid Tumors
Interventions: DRUG: HRS-4642
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 118
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-07
Locations: Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200127, China

Summary:
To evaluate the safety and preliminary efficacy of HRS-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with KRAS G12D mutations, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).

Primary Outcome Measures: Stage 1: (IB Period):DLTs, Within 28 days of the first dose|Stage 1: (IB Period): adverse events (AEs), Within 28 days of the first dos,About 1 year|Phase II: (Phase II):investigator-assessed ORR, Assessed every 6 weeks,About 1 year
Secondary Outcome Measures: Stage 1: (IB Period):Investigator-assessed objective response rate (ORR), Assessed every 6 weeks,About 1 year|Phase II: (Phase II):DCR, Assessed every 6 weeks,About 1 year|Phase II: (Phase II):DoR, Assessed every 6 weeks,About 1 year|Phase II: (Phase II):OS, Assessed every 6 weeks+ About 1 year|Phase II: (Phase II):PFS, Assessed every 6 weeks,About 1 year|Phase II: (Phase II):OS, Assessed approximately once every 1 month,About 1 year|Phase II: (Phase II):Incidence and severity of AEs, Assessed approximately once every 1 month,About 1 year
Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block
NCT Number: NCT06520475
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Post Operative Pain
Interventions: PROCEDURE: genicular nerve block using bupivacaine and magnesium|PROCEDURE: genicular nerve block using bupivacaine and normal saline
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03

Summary:
It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves .

No previous studies were conducted on magnesium sulfate as an adjuvant to the local anesthetic in genicular nerve block. Hence, this study will be conducted to assess analgesic efficacy of magnesium sulfate when added to bupivacaine in ultrasound guided genicular nerve block

Primary Outcome Measures: Numerical Rating Scale, Pain will be assessed with Numerical Rating Scale. Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible., 24 hours post-operatively
Secondary Outcome Measures: First request for analgesia, 24 hours post-operatively|Total opioid consumption, 24 hours post-operatively|Patient satisfaction, Patient satisfaction will be assessed at 48 h postoperatively (0 = very dissatisfied, 2 = somewhat dissatisfied, 3 = somewhat satisfied, 4 = very satisfied), 24 hours post-operatively
PCT of Pharmacopuncture for Chronic Neck Pain
NCT Number: NCT06520462
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain|Chronic Pain
Interventions: PROCEDURE: Pharmacopuncture|PROCEDURE: Acupuncture
Sponsor: Jaseng Medical Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2025-12-31

Summary:
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain

Primary Outcome Measures: Neck pain Numeric Rating Scale, NRS, Change from baseline to Week 5 on the Numeric Rating Scale of neck pain, Week 5
Secondary Outcome Measures: Neck and arm pain Numeric Rating Scale, The pain intensity of neck and arm over the past week, Week 1,2,3,4,5,8,12|Neck and arm pain Visual Analogue Scale, The pain intensity of neck and arm over the past week, Week 1,2,3,4,5|Northwick Park Questionnaire, A self-reported questionnaire consisting of 9 items related to the impact of neck pain on daily activities, Week 1,5,8,12|Neck disability index, The degree of neck disability in daily life, Week 1,5,8,12|Patient Global Impression of Change, The subject's subjective improvement, Week 5,8,12|Health-related Quality of Life Instrument with 8 Items, A tool developed to measure the health-related quality of life in Koreans, Week 1,5,8,12|5-Level EuroQol-5 Dimension, A tool that evaluates health status from multiple perspectives, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression., Week 1,5,8,12|Adverse events, An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study., Week 1,2,3,4,5,8,12
68Ga-NTA-476 Imaging in Prostate Cancer
NCT Number: NCT06520449
Acronym: NTA-476
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Prostate Cancer
Interventions: DRUG: 68Ga-NTA-476
Sponsor: Melbourne Theranostic Innovation Centre
Collaborators: 3B Pharmaceuticals GmbH
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2024-12

Summary:
This study is investigating a new agent to be used in PET imaging for prostate cancer, called 68Ga-NTA-476. It aims to find out where 68Ga-NTA-476 goes in the body once it is injected into a person and whether there are any side effects or issues with tolerating the compound. This will be compared to an existing imaging compound which is currently used in Australia called 18F-DCFPyl. 68Ga-NTA-476 has been developed and tested in the laboratory; however, this is the first time that it will be tested in humans.

Primary Outcome Measures: Tumour uptake of 68Ga-NTA-476 as compared to 15F-DCFPyl in participants with prostate cancer, Standardised Uptake Value (SUV)max, SUVmean and total tumour volume by PET/CT quantitation, PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration|To characterize the uptake and washout of 68Ga-NTA-476 in normal organs as compared to 18F-DCFPyL in participants with prostate cancer, Time Activity Curves (TACs), describing % of the injected activity vs time will be derived for selected organs and tumours, PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Secondary Outcome Measures: To assess the safety and tolerability of a single dose of 68Ga-NTA-476, Safety is evaluated with the properties, incidence, nature and severity of AEs and SAEs, abnormal laboratory parameters, vital signs, and electrocardiogram (ECG) results per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Safety will be assessed on the Imaging Day in the clinic during observation for up to 6 hours post injection of 68Ga-NTA-476 and followed up for a total of 1 week following administration.|To explore the dosimetry of 68Ga-NTA-476, Absorbed radiation doses of 68Ga-NTA-476 in critical organs (e.g., kidneys, bone marrow), PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
Arthroscopic-Assisted Reduction of Hip Dislocation Via Sub-Adductor and Anterolateral Portals
NCT Number: NCT06520436
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Developmental Dysplasia of the Hip
Interventions: PROCEDURE: Arthroscopic-Assisted Reduction
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 57
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-01
Completion Date: 2021-05-30
Locations: Kasr Alainy, Cairo University, Cairo, 11562, Egypt

Summary:
This study aims to present our arthroscopic-assisted surgical technique's reliability as a successful treatment for DDH, achieving reduction without the potential sequelae associated with open reduction techniques.

Primary Outcome Measures: Acetabular index, 1 year|Severin radiographic grading, 1 year|Modified Severin clinical grading, 1 year|Postoperative complications, 1 year
Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents With Hypospadias
NCT Number: NCT06520423
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypospadias
Interventions: PROCEDURE: Urethral stent tube irrigation|PROCEDURE: Urinary catheter drainage
Sponsor: Xing Liu
Sex: MALE
Age: CHILD, ADULT
Enrollment: 320
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2027-02-01
Locations: Children's Hospital of Chongqing Medical University, Chongqing, Chongqing, 400000, China

Summary:
This prospective, cluster-randomized, crossover, two-arm controlled clinical trial aims to determine whether urethral stent tube irrigation, combined with urinary catheter drainage, prevents postoperative wound infections compared to urinary catheter drainage alone in adolescents with hypospadias.

Primary Outcome Measures: Postoperative complication rate, Probability of complications after urethroplasty in adolescent children with hypospadias, 6 months
Secondary Outcome Measures: Bacterial culture types, Collect urethral washings from each douche, perform bacterial cultures, and document the bacterial species identified., 7 days|Colony number, Collect urethral washings from each douche, perform bacterial cultures, and record the colony count., 7 days|Patient satisfaction scores regarding the treatment process, Patient satisfaction with the treatment process was assessed using a scale from 0 to 3. A score of 0 indicated no discomfort during treatment, 1 indicated occasional discomfort, 2 indicated that the treatment was mildly uncomfortable but tolerable, and 3 indicated that the treatment was uncomfortable and intolerable., 7 days|Patient satisfaction scores regarding the treatment outcomes, Patient satisfaction with treatment outcomes was assessed using a scale from 0 to 3. A score of 0 represented no postoperative complications, 1 indicated symptoms of malaise with subsequent improvement, 2 signified postoperative complications with minimal disruption to daily life, and 3 denoted significant postoperative complications with considerable disruption to daily life., 6 months
Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries
NCT Number: NCT06520410
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Retinopathy of Prematurity Both Eyes|Retinal Disease|Persistent Fetal Vasculature|Coats Disease|Coats Retinopathy|Familial Exudative Vitreoretinopathies|Vitreous Disorder|Vitreous Anomalies|Retinal Vascular Disorder
Interventions: DEVICE: Pars plana vitrectomy with a 18 mm short vitrector
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-03-05
Completion Date: 2028-02-28
Locations: Chang Gung Memorial Hospital, Taoyuan, 333, Taiwan

Summary:
This study aims to study the safety and efficacy of using an 18 mm short vitrectomy probe for pediatric vitreoretinal surgeries and to investigate the surgeon's comfort and reliability of using the shorter probe.

Primary Outcome Measures: SAFETY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery, Incidence of iatrogenic injury as assessed by the percentage of surgery with iatrogenic injury event, Intraoperatively|SAFETY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery, Incidence of intraoperative instrument bending as assessed by the percentage of surgery with instrument bending event, Intraoperatively
Secondary Outcome Measures: EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery, Incidence of retinal detachment as assessed by ophthalmoscopy, 6, 12, and 24 months postoperatively|EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery, Visual acuity as assessed by the Snellen Chart, 6, 12, and 24 months postoperatively|SATISFACTION of surgeon while using 18 mm short vitrectomy probe for pediatric vitreoretinal surgery, The surgeon's satisfaction score as accessed by a satisfaction questionnaire that includes a scale from 0 (least satisfaction) to 5 (max satisfaction), Intraoperatively
Radiofrequency Applications and Alcoholic Neurolysis of Genicular Nerve for the Treatment of Knee Osteoarthritic Pain
NCT Number: NCT06520384
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Radiofrequency|Alcohol|Genicular Nerve|Knee Osteoarthritis|Pain
Interventions: DEVICE: Radiofrequency|DRUG: Alcohol 30%|DRUG: Alcohol 50%|DRUG: Alcohol 70%
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2024-12-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to investigate the efficacy of radiofrequency ablation and alcoholic neurolysis of genicular nerve on alleviating pain and improving the function of advanced knee osteoarthritis patients.

Primary Outcome Measures: Degree of knee pain, The degree of knee pain will be assessed using the visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and 10 means the worst pain). VAS will be assessed preoperative and postoperative 1, and 6 months, 6 months postoperative
Secondary Outcome Measures: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): range from 0 to 96 (0 represents the best health status and 96 the worst possible status). The higher the score, the poorer the function. It will be assessed preoperative and postoperative 1, and 6 months., 6 months postoperative|Patient satisfaction, Degree of patient satisfaction will be assessed on a 5-point Likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied)., 6 months postoperative|Incidence of adverse events, Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded., 6 months postoperative
Percutaneous vs Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain
NCT Number: NCT06520371
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Percutaneous|Conventional|Radiofrequency|Knee Osteoarthritis|Pain
Interventions: DEVICE: Percutaneous radiofrequency|DEVICE: Conventional radiofrequency
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2024-12-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.

Primary Outcome Measures: Degree of pain, Degree of pain will be assessed using visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and ten means the worst pain). VAS will be assessed pre-procedure and post-procedure 2nd, 6th, and 12th week., 12th week post-procedure
Secondary Outcome Measures: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores: range from 0 to 96 (0 represents the best health status and 96 the worst possible status). The higher the score, the poorer the function. It will be assessed pre-procedure and post-procedure 1, 4, and 12th week., 12th week post-procedure|Patient satisfaction, Degree of patient satisfaction will be assessed on a 5-point Likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied). It will be assessed pre-procedure and post-procedure 1, 4, and 12th week., 12th week post-procedure|Incidence of adverse events, Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded., 12th week post-procedure