pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparison of Online and Paper-Based Exercise Efficacy in Forward Head Posture
NCT Number: NCT06571253
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Pain
Interventions: BEHAVIORAL: Digital Exercise Intervention|BEHAVIORAL: Paper-Based Exercise Intervention
Sponsor: Medipol University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2023-03-01
Completion Date: 2023-06-01
Locations: Istanbul Medipol University, İstanbul, Kavacık, 34815, Turkey

Summary:
Proper posture is a musculoskeletal balance that minimizes stress on the body and is a key component of orthopedic physical examination. Poor posture, including forward head posture (FHP) and round shoulders, can develop as early as puberty and is exacerbated by prolonged use of smartphones and visual display terminals (VDT), leading to neck and shoulder fatigue and degenerative spine changes. FHP, a common postural issue in the sagittal plane, is associated with thoracic hyperkyphosis and can negatively impact respiratory function by reducing thoracic expansion and lung capacity. FHP also contributes to various musculoskeletal issues, such as temporomandibular disorders, myofascial pain syndrome, and cervicogenic headaches, by increasing biomechanical strain on the posterior neck muscles. Kendall and colleagues describe FHP as a forward positioning of the head, with shortened neck extensors and weakened anterior vertebral neck flexors, leading to muscle fiber damage over time. FHP can be measured using methods like craniovertebral angle (CVA), which is a reliable indicator of FHP severity. Exercise therapy, including strengthening, stretching, and proprioceptive exercises, is recommended to correct FHP and improve postural alignment, potentially enhanced by scapular stabilization exercises. The rise of telehealth presents a promising avenue for treating FHP through accessible and effective telerehabilitation methods. This study aimed to compare the effects of a 6-week home exercise program implemented via the Fiziu digital exercise platform and a traditional paper-based program on FHP and to compare the results between the two groups.

Primary Outcome Measures: Cervical Joint Range of Motion (ROM), The range of motion of the cervical spine will be measured in flexion, extension, lateral flexion (both right and left), and rotation (both right and left) using a goniometer. These measurements assess improvements in the mobility of the neck, which is directly affected by forward head posture (FHP)., 6 weeks|Craniocervical Angle (CVA), The craniocervical angle, defined as the angle between the horizontal line through the external auditory meatus and the line through the 7th cervical vertebra (C7), will be measured using a goniometer. This angle provides an indicator of the severity of FHP., 6 weeks
Validity and Reliability of the Turkish Version of the Tegner Activity Score
NCT Number: NCT06571240
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Knee Injuries
Interventions: PROCEDURE: Anterior cruciate ligament reconstruction
Sponsor: Kırklareli University
Collaborators: Gazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-04

Summary:
The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:

* Is the Turkish version of the Tegner Activity Score a valid scale?
* Is the Turkish version of the Tegner Activity Score a reliable scale?
* What is the minimal clinically important difference value of the Turkish version of the Tegner Activity Score?
* What is the substantial clinical benefit value of the Turkish version of the Tegner Activity Score?

Primary Outcome Measures: Functional level, Tegner Activity Score (total score between 0-10) (higher values indicate higher functional level), before the surgery, after 1 week from the surgery and after 3 months from the surgery
Secondary Outcome Measures: Functional level, Lysholm Knee Score (total score between 0-100) (higher values indicate higher functional level), before the surgery|Functional level, International Knee Documentation Committee-Subjective Knee Evaluation Form (total score between 0-100) (higher values indicate higher functional level), before the surgery
Establishing the Clinical Significance Values of the Lysholm Knee Score
NCT Number: NCT06571227
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Knee Injuries
Interventions: PROCEDURE: Anterior cruciate ligament reconstruction
Sponsor: Kırklareli University
Collaborators: Gazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-04

Summary:
The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:

* What is the minimal clinically important difference value of the Lysholm Knee Score?
* What is the substantial clinical benefit value of the Lysholm Knee Score?
* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the minimal clinically important difference value?
* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the substantial clinical benefit value?

Primary Outcome Measures: Functional level, Lysholm Knee Score (total score between 0-100) (higher values indicate higher functional level), before the surgery and after 3 months from the surgery
Patient-reported Outcomes and Esthetics With Single Dental Implants
NCT Number: NCT06571201
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Patient Reported Outcome Measures|Patient Satisfaction|Implant Complication
Sponsor: Kristianstad University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2006-08-15
Completion Date: 2007-06-07
Locations: Kristianstad University, Kristianstad, Sweden

Summary:
The goal of this observational study is to investigate patient-reported long-term outcomes of single dental implants. Therefore, the aim of the study is to describe patient-reported functional and esthetic outcomes of single dental implants. A secondary aim is to evaluate the objective esthetics of single dental implants.

The primary outcomes are patient-reported experiences regarding the function, cleaning ability, and esthetics of the single dental implant. The esthetics of the single dental implant will also be assessed using the Pink Esthetic/White Esthetic Score Index (Belser et al., 2009) and considered secondary outcome.

Primary Outcome Measures: Patient- reported outcomes concerning function and cleaning of dental single implants, Visual Analogue Scale 0=yes absolutely 10= absolutely not. Maximum=100 scores Minimum=0 scores, At the dental examination|Patient- reported outcomes concerning esthetics of dental single implants, Visual Analogue Scale 0=not satisfied at all. 10=completely satisfied Maximum=40 scores Minimum=0 scores, At the dental examination
Secondary Outcome Measures: Pink and white esthetic scores for single dental implants, PES/WES index Belser et al. 2009 0=worst outcome and 2=best outcome reported by a dentist from intraoral photographs, 15 years later
Comparison Of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia
NCT Number: NCT06571188
Acronym: TEAVSESPB
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: OTHER: THORACIC EPIDURAL BLOCK|OTHER: ERECTOER SPINE BLOCK
Sponsor: Menoufia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2024-12-10
Locations: Menoufia university, Cairo, Shibin Elkom, 23535, Egypt

Summary:
There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose

Primary Outcome Measures: MORPHINE CONSUMPTION, cumulative 24 h opioid (morphine) consumption, 24 hours|Numeric rating scale, is an 11-point scale scored from 0-10:

1. "0" = no pain
2. "10" = the most intense pain imaginable Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours., 24 hours
Secondary Outcome Measures: Time for first rescue analgesia, Time for first rescue analgesia will be measured and recorded, 24 hours|The number of rescue analgesics, the number of rescue analgesics within 24hrs after surgery will be recorded, 24 hours|Time to ambulation, Time to ambulation WILL BE RECOREDED, 24 hours|Complications, Complications like bradycardia or hypotension, itching, nausea and vomiting will be recorded., 24 hours
Quantification of Myocardial Fibrosis in Aortis Stenosis
NCT Number: NCT06571175
Acronym: SAS-F-5
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Valve Stenosis|Myocardial Fibrosis
Interventions: DIAGNOSTIC_TEST: High frame rate echocardiography|DIAGNOSTIC_TEST: MRI|DIAGNOSTIC_TEST: Blood test|DIAGNOSTIC_TEST: ECG and Holter-ECG|DIAGNOSTIC_TEST: 6 min walking test
Sponsor: Norwegian University of Science and Technology
Collaborators: St. Olavs Hospital|Oslo University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12
Locations: St. Olavs Hosptial, Trondheim, Trøndelag, 7030, Norway

Summary:
This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis.

Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.

Primary Outcome Measures: Cardiovascular morbidity, Admissions with heart failure, 5 year|Cardiovascular mortality, Death caused by cardiac disease, 5 year
Secondary Outcome Measures: All cause mortality, Mortality in general, 5 years|Time of first re-hospitalization, Time of first re-hospitalization after inclusion, 5 years|Cardiac systolic function, Systolic function based on left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS).

Unit of measure for LVEF and for GLS is % for both (a positive number for LVEF, and a negative number for GLS), 5 years|Cardiac diastolic function (1 of 5), Echocardiographic diastolic function based on i) left atrial volume index {ml/m\^2)., 5 years|Cardiac diastolic function (2 of 5), Echocardiographic diastolic function based on ii) mitral annular velocities {cm/sec}, 5 years|Cardiac diastolic function (3 of 5), Echocardiographic diastolic function based on iii) mitral inflow velocities {cm/sec}, 5 years|Cardiac diastolic function (4 of 5), Echocardiographic diastolic function based on iv) ricuspid regurgitation velocity {cm/sec}, 5 years|Cardiac diastolic function (5 of 5), Echocardiographic diastolic function based on v) E/è-ratio, 5 years|Velocity of natural mechanical waves propagating through the myocardium, Investigate for prognotisc value and if it can be a marker of diastolic dysfunction. Unit of velocity measurement is m/sec., 5 years
A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients
NCT Number: NCT06571162
Acronym: INCLUDE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atherosclerotic Cardiovascular Disease
Interventions: OTHER: Clinical Pharmacy Team|OTHER: Usual Care
Sponsor: Intermountain Health Care, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2028-09
Locations: Intermountain Healthcare Hospitals and Clinics, Salt Lake City, Utah, 84107, United States

Summary:
Patients who had an ASCVD event at an Intermountain hospital will be screened for eligibility to be randomized. Subjects who meet eligibility criteria will be randomized 1:1 to receive targeted care of their LDL-C through a pharmacist-driven management program or not. Patients may opt-out of receiving LDL-C management by the pharmacy team at any time. The purpose of this program is to increase the proportion of patients who achieve guideline-based recommendations of LDL-C levels of \<70 mg/dL by increasing statin and/or LLT adherence and LDL-C testing. Data collection as part of the study will continue until the last person randomized has had 1-year of follow-up.

Primary Outcome Measures: Proportion of patients who achieve an LDL-C <70 mg/dL by 1-year., 1 year
The Measurement of Chemicals in Exhaled Breath Can Identify if a Person is Infected With COVID-19
NCT Number: NCT06571136
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: COVID-19
Sponsor: N5 Sensors
Collaborators: Providence Health & Services|U.S. Department of Homeland Security
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2024-10
Locations: Providence Regional Medical Center Everett, Everett, Washington, 98201, United States

Summary:
The type and number of chemicals in exhaled breath are different in people with infection as compared to those without infection. In this study, the breath of people with and without COVID infection will be measured. Changes in the amount and type of chemicals in breath will be used to determine if an individual does or does not have COVID infection. If the measurements of breath are a reliable measure of COVID infection, this device may be used to rapidly screen people who are attending large public events (for example, music concert or baseball game) to minimize the spread of COVID at the event.

Primary Outcome Measures: Exhaled chemicals in breath will be compared with COVID status, Between subjects with and without COVID, changes in the chemical composition of exhaled breath are correlated with markers of COVID infection: 1) antigen testing of nasal mucous sample and 2) RT-PCR testing of nasal mucous sample., On the day of enrollment, all measurement will be made over the course of 2 hours.|Measurement of chemical composition in exhaled breath, Each subject will provide two breath samples. Each sample will be analyzed by the RISE device., On the day of enrollment, all measurement will be made over the course of 2 hours.|Assessment of COVID status using nasal swab., Two nasal swabs will be collected for each subject. One nasal swab will be evaluated by antigen testing and the other sample will be analyzed using RT-PCR., On the day of enrollment, all measurement will be made over the course of 2 hours.
Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
NCT Number: NCT06571110
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: PROCEDURE: Traditional/Sham Acupuncture
Sponsor: University of California, Irvine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2026-12-01
Locations: UCI Health Susan Samueli Integrative Health Institute, Irvine, California, 92617, United States

Summary:
This study aims to see whether acupuncture can help fibromyalgia patients by giving them acupuncture treatment and seeing whether acupuncture helps enhance the effects of an opioid.

Primary Outcome Measures: Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA, We hypothesize that patients randomized to TA treatment will have a statistically greater change in pain after the final opioid challenge compared to the initial opioid challenge, as compared to patients randomized to SA treatment(p-value set at 0.05)., Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).
Secondary Outcome Measures: Change in FIQ, patients' response to pain interference over the past 7 days as assessed by the Fibromyalgia Impact Questionnaire in both patient groups to ensure a similar response to TA and SA as reflected in prior studies. The minimum value is: 0 and the maximum value is: 100. A Higher score on the FIQ indicates a worse outcome, meaning greater impact of fibromyalgia on the individual's daily life and overall functioning., Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).
New Screening and Diagnostic Cut-off Points of PA Patients
NCT Number: NCT06571084
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Aldosteronism
Sponsor: China National Center for Cardiovascular Diseases
Collaborators: Beijing Anzhen Hospital|First Affiliated Hospital of Chongqing Medical University|Fuwai Central China Cardiovascular Hospital|Wuhan Asia Heart Hospital|Fuwai shenzhen hospital，chinese academy of medical sciences|Fuwai yunnan hospital，chinese academy of medical sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 770
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-04
Completion Date: 2025-12-31
Locations: Kai-juan Wang, Beijing, 100037, China

Summary:
This study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule "sandwich method" aldosterone and renin chemiluminescent immunoassay.

Primary Outcome Measures: Preliminary confirmation positive for primary aldosteronism, Aldosterone ≥ 85pg/ml after sitting saline test, 1 month
B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking
NCT Number: NCT06571058
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urinary System Disorder
Interventions: OTHER: Assistance|OTHER: Educational Intervention|DEVICE: Medical Device Usage and Evaluation|OTHER: Medical Device Usage and Evaluation|OTHER: Questionnaire Administration|PROCEDURE: Remove|OTHER: Walking
Sponsor: Ohio State University Comprehensive Cancer Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-07-27
Completion Date: 2024-12-31
Locations: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States

Summary:
This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking. Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. Despite the use of modern urinary drainage bags for over 60 years, workarounds, including hooking the bag into pants pockets, are being used to secure the bags while walking. The B3 Buddy may help keep the urinary drainage bag at the proper level for drainage while walking.

Primary Outcome Measures: Acceptability of device, The proportion of patients who find the device acceptable will be determined with the Acceptability of Implementation Measure tool. The device will be considered acceptable if at least 70% of patient participants find the device acceptable, which will be calculated by survey responses., Up to 17 minutes|Usability of device, Clinicians perception of usability will be determined with the System Usability Scale. The device will be considered usable if the overall mean score is 68 or greater, which will be calculated by survey responses., Up to 20 minutes
A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
NCT Number: NCT06571045
Acronym: BRUNELLO
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Diabetic Macular Edema (DME)
Interventions: DRUG: Ranibizumab|DRUG: EYE103
Sponsor: EyeBiotech Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 960
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-14
Completion Date: 2027-12-31
Locations: Scottsdale, Scottsdale, Arizona, 85255, United States|Mountain View, CA, Mountain View, California, 94040, United States|Sacramento, CA, Sacramento, California, 95825, United States|Santa Ana, Santa Ana, California, 92705, United States|Hagerstown, MD, Hagerstown, Maryland, 21740, United States|Germantown, TN, Germantown, Tennessee, 38138, United States|Knoxville, TN, Knoxville, Tennessee, 37922, United States|Nashville, TN, Nashville, Tennessee, 37203, United States|Amarillo, TX, Amarillo, Texas, 79109, United States|Austin, TX, Austin, Texas, 78705, United States|Bellaire, TX, Bellaire, Texas, 77401, United States|Plano, TX, Plano, Texas, 75075, United States|Round Rock, TX, Round Rock, Texas, 78681, United States|The Woodlands, TX, The Woodlands, Texas, 77384, United States|Arecibo, PR, Arecibo, 00612, Puerto Rico

Summary:
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)

In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.

Approximately 960 participants will be entered in the study.

Primary Outcome Measures: Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart, Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart, 52 Weeks
Secondary Outcome Measures: Changes in structural and visual outcomes, Changes in structural and visual outcomes, Duration of the study, through Week 104
Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries
NCT Number: NCT06571032
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Injuries
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-12-31
Locations: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, 201114, China

Summary:
The goal of this observational retrospective study is to evaluate the electroencephalography (EEG)'s poficiency in the treatment of neuroelectric stimulation in patients with severe traumatic brain injuries (TBI).

The main questions it aims to answer are:

1. Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?
2. How can EEG be used to evaluate the condition of patients with severe TBI?

Primary Outcome Measures: CRS-R scores 6 months after the patient's discharge, Using the COMA RECOVERY SCALE-REVISED (CRS-R) to evaluate the condition of the patient 6 months after discharge and the effectiveness of neuroelectrial stimulation.., 6 months
Secondary Outcome Measures: CRS-R scores during hospitalization, Using the COMA RECOVERY SCALE-REVISED (CRS-R) to evaluate the condition of the patient during hospitalization and the effectiveness of neuroelectrial stimulation., 3 months
Comparative Analysis of Cost-effectiveness Between Sulfonylureas and DPP4 Inhibitors in Combination With Metformin in Treatment of Type 2 Diabetic Patients : A Retrospective, Observational Study.
NCT Number: NCT06570980
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes Mellitus (T2DM), Cost-effectiveness, Sulfonylureas, DPP4 Inhibitors, Metformin
Interventions: DRUG: sulfonylurease with metformin, DPP4 inhibitors with Metformin
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-25
Completion Date: 2024-08-30
Locations: BSMMU, Dhaka, 1000, Bangladesh

Summary:
The aim of this study is to compare the cost effectiveness of Sulfonylureas and DPP4-inhibitors in combination with Metformin among type2 diabetic patients diagnosed for 2-5 years. Glycemic status and other clinical outcome are compared in between two groups and ICER are compared.

Primary Outcome Measures: HbA1c%, achievment of target HbA1 less than 7%, 2-5years
Secondary Outcome Measures: Insulin therapy, requirement of insulin therapy, 2-5years|hospitalization, requirement of hospitalization, 2-5years|3rd line therapy, addition of any 3rd drug, 2-5years|nephropathy, development of nephropathy, 2-5years
A Clinical Study of Hyperthyroidism in Children
NCT Number: NCT06570967
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hyperthyroidism
Interventions: DRUG: Methimazole(MMI)
Sponsor: Shengjing Hospital
Sex: ALL
Age: CHILD
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-18
Completion Date: 2027-12
Locations: Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China

Summary:
This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.

Primary Outcome Measures: Remission of hyperthyroidism in children treated with methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months., To analyze the therapeutic effect of methimazole and the predictors of remission of hyperthyroidism after methimazole treatment., 10 years|Adverse effects of methimazole in the treatment of hyperthyroidism in children. Adverse effects are defined as having neutropenia (absolute neutrophil count< 1500/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al., Analyze the adverse reaction of methimazole treatment in hyperthyroidism children. Explore the risk factors related to the occurrence of methimazole related adverse reactions., 1 year
Secondary Outcome Measures: Relapse of hyperthyroidism in children treated with methimazole. Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole., The risk factors of relapse in children with hyperthyroidism treated with MMI were analyzed, 10 years
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
NCT Number: NCT06570941
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Restless Legs Syndrome
Interventions: DRUG: Chylobinoid Topical Cream
Sponsor: Synthonics Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-10-31
Locations: Synthonics, Sarasota, Florida, 34238, United States

Summary:
The goal of this open label clinical trial is to reduce the effects of restless leg syndrome. The main it questions it aims to answer are:

1. Reduce or eliminate the symptoms of restless leg syndrome.
2. Improve the quality of life of participants with restless leg syndrome.

Participants will be asked to apply the topical cream to the affected area 30 to 45 minutes before bedtime for 14 consecutive days.

Primary Outcome Measures: Change of Restless Leg Syndrome, Severity of restless leg syndrome will be measured using the international restless leg syndrome questionnaire. It is a 10 question scale that is scored from 0 to 5 with 4 representing the most severe symptoms and 0 representing the least., 14 days
Secondary Outcome Measures: Patient Quality of Life in response to treatment, Change measured by Patients' Global Impression of Change scale (PGIC). The scale is 3 to -2 with 3 being much improved and -2 being much worse., 14 days
Prosective WCD Post CABG Registry (CABG Registry)
NCT Number: NCT06570902
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiomyopathy Ischemic|Cardiomyopathies|Cardiovascular Diseases|Heart Disease, Ischemic
Interventions: DEVICE: WCD
Sponsor: Zoll Medical Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 910
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2030-05
Locations: Kerckhoff Klinik, Bad Nauheim, Hessen, 61231, Germany|Medizinische Hochschule Hannover, Hannover, Niedersachsen, 30625, Germany

Summary:
The primary objective is to observe the rate of recovery of ventricular function (EF\>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care.

Primary Outcome Measures: EF recovery, EF recovery at end of WCD use, usually after 90days of wear. End of WCD use will be determined by the prescribing physician. For this study, EF\>35% will be considered as EF recovery., Enrollment till WCD End of Use
Secondary Outcome Measures: Quality of Life (KCCQ, Quality of Life (QoL) information will be collected using the following questionnaires:

- Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12), Enrollment till WCD End of Use, usually up to three month|Quality of Life EQ, Quality of Life (QoL) information will be collected using the following questionnaires:

- EQ-5D-5L, Enrollment till WCD End of Use, usually up to three month|Medication Adherence, Medications and self-reported adherence to taking those medications as prescribed will be recorded from chart review and patient interview, if necessary, every month (30 days). Medications will also be recorded at the start and end of WCD use, Enrollment till WCD End of Use, usually up to three month|Healthcare utilization, Information (days, reasons) on any hospitalizations, emergency room visits, observation stays, urgent care visits, other physician office visits, and stays at skilled nursing facilities., Enrollment till WCD End of Use, usually up to three month
Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre
NCT Number: NCT06570876
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Liver; Cyst, Hydatid, Granulosus (Etiology)
Interventions: PROCEDURE: Surgery
Sponsor: Hospital Universitari de Bellvitge
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Observational Model: |Time Perspective: p
Start Date: 1996-01-01
Completion Date: 2021-12-31
Locations: Marina Vila Tura, Hospitalet de Llobregat, Barcelona, 08907, Spain

Summary:
The goal of this observational study is to compare the results in terms of morbidity and disease-free survival between groups of patients with liver cystic echinococcosis (LCE) managed with radical surgery (RS) or conservative surgery (CS), and to evaluate potential risk factors of clinically relevant biliary fistula and liver recurrence.

Primary Outcome Measures: To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors, Hepatic recurrence was defined as the appearance of a new growing cyst, non-detected by radiologic exploration before the first surgery, in the first location of the hydatid cyst in the liver or in another liver's segment., Diagnosis during the first 6 months was considered as persistence of the disease.|To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors., The type of fistula was classified according to the International Study Group of Liver Surgery classification. A complex biliary fistula was defined as external bile leakage for ≥28 days and/or the need for percutaneous drainage or reoperation., 90 days postoperative
Secondary Outcome Measures: To estimate the incidence of overall morbidity related to surgery., 90 days postoperative|To estimate the incidence of specific morbidity related to surgery., Biliary fistula, intra-abdominal abscess, residual cavity abscess, hemoperitoneum, incisional infection, liver failure, respiratory infection, others)., 90 days postoperative|To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors., 90 days postoperative|To estimate the incidence of mortality related to surgery., 90 days postoperative|To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months), From 6 months postoperative
To Evaluate the Effects of Systemic Probiotics & Antibiotics and Local Application of Antibiotics as an Adjuvant to NSPT
NCT Number: NCT06570863
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis|Adult
Interventions: OTHER: Antibiotics(doxycycline)|OTHER: Probiotics|OTHER: Metronidazole gel 25%
Sponsor: Dr fizza khalid
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-07-01
Completion Date: 2024-12
Locations: Baqai Medical University, Karachi, Sindh, 78530, Pakistan

Summary:
Background:

Periodontitis is defined as "an inflammatory disease of the supporting tissues of the teeth caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with pocket formation, recession or both. It has been shown that systemic administration of antibiotics results in changes in plaque flora, reduction in gingivitis and decrease in the rate of bone resorption. In systemic administration, however, the drug must be given in high doses in order to maintain effective concentration of the drug in the gingival crevicular fluid. Whereas recent literature supports use of Local antibiotic therapy which involves the direct placement of an antimicrobial agent into sub gingival sites. The primary goal in using an intra-pocket device for the delivery of an antibacterial agent is the achievement and maintenance of therapeutic levels of the drug for the required period of time. More over use of probiotics is increasing in dentistry, Probiotics are bacterial strains usually isolated from human commensal microbiota and adequately characterized for strain identity, content, stability, and proven health effects. They come in food supplements (cheese, yoghurt, milk, lozenges) with microbial elements.

The purpose of this study is to test the clinical effects of systemic antibiotics, local delivery of 25% of metronidazole gel and probiotics after scaling and root planning in periodontitis.

Objective:

To evaluate the effects of Probiotics (Lactobacillus), antibiotics (Doxycycline 100mg) and metronidazole gel (25%) as an adjuvant to non-surgical periodontal therapy on pocket depth, clinical attachment loss and bleeding on probing after one month of intervention among patients with periodontitis.

Methods:

All study participants meeting the inclusion criteria of the study will be allocated to one of the three groups (Group 1= SRP + Antibiotics, Group 2 = SRP + probiotics and Group 3 = SRP+ LDD) through randomization. After the baseline recording of clinical periodontal parameters, non-surgical periodontal therapy will be done and Group A will be given antibiotic therapy for 14 days, group B will be given probiotics for 1 month and group C will be given LDD after NSPT. After 1-month follow-up and recording of all the clinical parameters will be done.

Primary Outcome Measures: CAL, clinical attachment loss, 1 month|PD, pocket deapth, 1 month|BOP, bleeding on probing, 1 month
Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
NCT Number: NCT06570850
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Infection Due to Carbapenem Resistant Acinetobacter
Interventions: DRUG: Colistin Sodium Methanesulfonate|DRUG: Colistin Sodium Methanesulfonate plus Fosfomycin
Sponsor: Chiang Mai University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 188
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-01
Completion Date: 2025-07
Locations: Faculty of medicine, Chiang Mai university, Chiang Mai, 50200, Thailand

Summary:
The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:

1. Which group has better clinical response at end of treatment
2. Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment

Primary Outcome Measures: Number of participants with clinical response after completion of therapy, Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment., Baseline, day 10-14 (end of therapy)
Secondary Outcome Measures: Number of participants with clinical response at 72 hours of therapy, Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment., Baseline, day 3|Number of participants with microbiological cure at 72 hours of therapy, Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours, Baseline, day 3|Number of participants with microbiological cure after completion of therapy, Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours, Baseline, day 3
Iron Deficincy Among Children With type1 DM in Assiut University Hospital
NCT Number: NCT06570837
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Iron Deficiency, Anaemia in Children Type1DM
Interventions: DIETARY_SUPPLEMENT: Iron
Sponsor: Assiut University
Sex: ALL
Age: CHILD
Enrollment: 141
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2026-02

Summary:
detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes.assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition

Primary Outcome Measures: detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes., detect the prevelance of anemic and non anemic iron deficiency in children with type 1 diabetes., baseline
Secondary Outcome Measures: assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition, assess the impact of anemic and non anemic iron deficiency in children with type 1 diabetes on their general condition, baseline
Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients
NCT Number: NCT06570811
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer|Chemotherapeutic Toxicity
Interventions: DRUG: Placebo|DRUG: Coenzyme Q10 200mg twice daily
Sponsor: Damanhour University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-03
Locations: Damanhour Oncology Center, Damanhūr, 22511, Egypt

Summary:
investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients

Primary Outcome Measures: Clinical assessment of the possible effect of COQ10 on some of the expected paclitaxel adverse events using grading system provided by Common Terminology Criteria for Adverse Events (CTCAE) version 5 (V5), The primary endpoint is assessing the effect of coenzyme Q10 on the severity grades of the following adverse events : fatigue, sleep disturbance, peripheral neuropathy, nausea , vomiting , mucositis, Anemia , febrile neutropenia and pruritis.using the severity grades of common terminology criteria for adverse event (NCI-CTCAE) versión 5.The grades as follow

* Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
* Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate Instrumental activities of daily living (IADL)
* Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
* Grade 4 Life-threatening consequences; urgent intervention indicated.
* Grade 5 Death

grades are documented at baseline and weekly over 3 months., 3 months|The possible impact of COQ10 on peripheral neuropathy affecting patients' quality of life using Neurotoxicity-12 item questionnaire score (Ntx-12) from Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG-Ntx-12), The questionnaire is comprised of statements intended to measure the possible impact of COQ10 on peripheral sensory neuropathy symptoms interfering with patients' lives, which includes numbness or tingling in hands or feet, discomfort in hands or feet, joint pain, general weakness, trouble hearing, ringing or buzzing in ears, trouble with buttons, trouble feeling shape of objects in hands, trouble with walking, and pain in hands or feet when exposed to cold temperatures. At each cycle, each patient is instructed to choose severity of discomfort he feels with (0) indicating not at all; (1), a little bit; (2), somewhat; (3), quite a bit; and (4), very much. The sum of the score is obtained, This sum ranges from 0 to 48. The higher the score, the more severe is the neuropathy and a worse QOL, 3 months
A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
NCT Number: NCT06570798
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Systemic Lupus Erythematosus
Interventions: DRUG: Inebilizumab|DRUG: Blinatumomab
Sponsor: Amgen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-12-14

Summary:
The main objective is to assess the safety and tolerability of inebilizumab (Subprotocol A) and subcutaneous (SC) blinatumomab (Subprotocol B) in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis.

Primary Outcome Measures: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE), Day 1 to Week 52|Number of Participants Who Experience a Serious TEAE, Day 1 to Week 52
Secondary Outcome Measures: Number of Participants With a 24-hour Urine Protein-creatinine Ratio (UPCR) ≤ 0.5 mg/mg, Week 12 and Week 24|Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS), Week 12 and Week 24|Number of Participants With a Lupus Low Disease Activity State (LLDAS), Week 12 and Week 24|Change From Baseline in SLE Activity Index-2000 (SLEDAI-2K) Score, Baseline, Week 12 and Week 24|Percent Change From Baseline in SLEDAI-2K Score, Baseline, Week 12 and Week 24|Change From Baseline in UPCR, Baseline, Week 12 and Week 24|Percent Change From Baseline in UPCR, Baseline, Week 12 and Week 24|Subprotocol A: Maximum Concentration (Cmax) of Inebilizumab, Day 1 to Week 52|Subprotocol A: Time to Cmax (tmax) of Inebilizumab, Day 1 to Week 52|Subprotocol A: Area Under the Concentration-time Curve (AUC) of Inebilizumab, Day 1 to Week 52|Subprotocol B: Cmax of Blinatumomab, Day 1 to Week 12|Subprotocol B: tmax of Blinatumomab, Day 1 to Week 12|Subprotocol B: AUC of Blinatumomab, Day 1 to Week 12|Subprotocol A: Number of Participants With Anti-inebilizumab Antibody Formation, Day 1 to Week 52|Subprotocol B: Number of Participants With Anti-blinatumomab Antibody Formation, Day 1 to Week 52
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
NCT Number: NCT06570772
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Ulcerative Colitis
Interventions: BIOLOGICAL: AVT16|BIOLOGICAL: Vedolizumab
Sponsor: Alvotech Swiss AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 748
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-08-31
Locations: Batumi Referral Hospital/JSC Evex Clinics, Batumi, 6010, Georgia

Summary:
The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis.

Primary Outcome Measures: Clinical Response at week 6, Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome, Week 6
Secondary Outcome Measures: Clinical Response at week 52, Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome, Week 52