pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.
NCT Number: NCT06457867
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Mobility
Interventions: PROCEDURE: microfragmented adipose tissue loaded on bovine graft
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-03-01

Summary:
Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation.

Primary Outcome Measures: Quantity of bone (vertical bone height), By CBCT, Quantity of bone (vertical bone height) by CBCT after 6 months
Secondary Outcome Measures: Quality of bone, Histological analysis (Core biopsy) Percentage of newly formed bone, Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months
Black Adult Resilience Study
NCT Number: NCT06457841
Acronym: BARS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Use|Cannabis Use
Interventions: BEHAVIORAL: Direct Discrimination|BEHAVIORAL: Vicarious Discrimination|BEHAVIORAL: Daily Hassles
Sponsor: University of Washington
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 456
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-09
Completion Date: 2027-07
Locations: Southern Methodist University, Dallas, Texas, 75204, United States|University of Washington, Seattle, Washington, 98195, United States

Summary:
Alcohol and cannabis are the most misused psychoactive substances in the United States, and their misuse among African American young adults has the potential to be especially problematic. The proposed research examines how daily and racial stressors (e.g., racism and discrimination) may lead to alcohol and cannabis use among African American young adults, and what individual and community coping and resources mitigate this causal effect. This research is designed to identify possible targets for culturally responsive prevention and treatment efforts to help prevent and reduce alcohol and cannabis use among African American young adults.

Primary Outcome Measures: Momentary Alcohol and/or Cannabis Craving, Momentary Alcohol and Cannabis Craving Scale will be administered (adapted from the Momentary Cannabis Craving Scale; Davis et al., 2024) immediately after the intervention. Mean scores will range from 1 to 7, with higher scores indicating greater momentary craving., Immediately after the intervention (i.e., within 1 minute)|Duration of Alcohol and Cannabis Intoxication, Self-reported number of hours of intoxication within 48 hours after the intervention, 48 Hours Post-Intervention
Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
NCT Number: NCT06457828
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain|Symptomatic Irreversible Pulpitis
Interventions: PROCEDURE: Non-corticosteroid injection|DRUG: Corticosteroid injection
Sponsor: Suez Canal University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2021-02-01
Completion Date: 2024-09
Locations: Suez Canal University, Ismailia, Egypt

Summary:
The goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. The main question it aims to answer is:

• How effective are using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis? Participants will be asked to fill a visual analogue scale to record their pain, after receiving a root canal treatment while using local corticosteroids or not as well as maintaining apical patency or not.

Researchers will compare the use of corticosteroids and maintaining apical patency in reducing post-operative pain.

Primary Outcome Measures: Post-operative pain, Patients were instructed to record their pain level using the Visual Analog Scale, 6, 12, 24, 48, 72 hour and 7 days postoperative intervals|Inflammatory markers, Gingival crevicular fluid samples were collected by periopaper for testing the level of IL-1β and IL-10, before treatment, after 3 days and after 7 days
Iron Deficiency in Acute Myocardial Infarction: Prevalence Pilot Study
NCT Number: NCT06457815
Acronym: IDAMI Pilot
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myocardial Infarction
Sponsor: South Tees Hospitals NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-29
Completion Date: 2024-08-30
Locations: South Tees Hospitals NHS Foundation Trust, Middlesbrough, Teesside, TS4 3BW, United Kingdom|South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom

Summary:
Acute Myocardial Infarction (heart attacks) affect about 86000 people each year in the UK. Given this large number of people, it is important that health teams look at ways to ensure the best care to improve outcomes after a heart attack.

In related heart conditions, the role of iron is important, but there isn't much information about what effect iron levels have on patients following a heart attack.

We want to plan a large scale study to look at this, but need some early data to understand how many patients have low iron levels. This small study will take part at one NHS Trust and will test for iron levels in all patients who provide consent (we expect up to 70 patients will take part). We will also collect data from medical notes for these patients and use all of this information together to understand more about iron and to plan a larger study.

Primary Outcome Measures: Prevalence of iron deficiency, Prevalence of iron deficiency in a population of patients following acute MI., within 10 days of acute MI
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
NCT Number: NCT06457776
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteonecrosis of the Jaw|Osteonecrosis Due to Drugs, Jaw|Osteonecrosis Due to Drug|Bisphosphonate-Associated Osteonecrosis|Bisphosphonate-Associated Osteonecrosis of the Jaw
Interventions: PROCEDURE: Dental management
Sponsor: Catholic University of the Sacred Heart
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2028-01-01
Locations: Cosimo Rupe, Roma, 00168, Italy

Summary:
The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.

Primary Outcome Measures: Medication Related OsteoNecrosis of the Jaws, Incidence of Medication Related OsteoNecrosis of the Jaws, Five years after the beginning of AR therapy
Left Double Lumen Tube Selection
NCT Number: NCT06457763
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: One-Lung Ventilation|Thoracic Surgery
Sponsor: Marmara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2024-05-29
Locations: Marmara University, Istanbul, Maltepe, 34854, Turkey

Summary:
The aim of this study was to determine the accuracy and practicality of ultrasound in the selection of double lumen tube and whether the complications that may occur intraoperatively and postoperatively can be reduced.

Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube placement for single lung ventilation will be included in this study. Patients with a history of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation, and patients with previously known hoarseness and chronic cough will not be included in the study. Patients who accept the study will be randomly assigned to one of the anaesthesia groups including ultrasound group (Group 1) and classical method (Group 2).

Randomisation will be in a 1:1 ratio and will be done by closed envelope method.

Primary Outcome Measures: postoperative cough and sore throat, Zero: No sore throat; 1: Mild, sore throat only when swallowing; 2: Moderate, persistent sore throat, aggravated when swallowing; 3: Severe, throat pain affecting the patient's eating, and analgesic drugs were needed, postoperative first at 24 hours
Levilactobacillus Brevis Oral Health
NCT Number: NCT06457724
Acronym: LBOH-RCT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Health|Oral Disease
Interventions: DIETARY_SUPPLEMENT: Levilactobacillus brevis CNCM I-5566|DIETARY_SUPPLEMENT: Placebo
Sponsor: University of L'Aquila
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-10-30
Completion Date: 2023-11-30
Locations: University of L'Aquila, L'Aquila, IT, 67100, Italy

Summary:
This RCT investigates the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. Participants will be randomly assigned to either the probiotic supplement group or a placebo group. The primary objective is to assess changes in salivary biomarkers, including salivary pH and buffer capacity; microbial composition using microbiome next-generation sequencing (NGS); and clinical oral inflammatory markers, such as full mouth bleeding score and full mouth plaque score, over a 4-week period. By comparing these indicators between the two groups, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566 in promoting oral health and potentially preventing oral diseases.

Primary Outcome Measures: Salivary pH, Assay used to define dental caries risk, Baseline, 4 and 6 weeks|Full mouth bleeding score, Index used to quantify gingival inflammation (Percentage as Full mouth Bleeding score), Baseline, 4 and 6 weeks|Full mouth plauqe score, Index used to quantify individual capacity to home oral health (Percentage as Full mouth Plaque score), Baseline, 4 and 6 weeks
Blood Pressure and Cardiometabolic Risk (Diet-to-HTN)
NCT Number: NCT06457711
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arterial Hypertension|Menopause|Obesity|Cardiometabolic Syndrome|Cardiovascular Diseases
Interventions: DIETARY_SUPPLEMENT: Free diet Group (FDG)|DIETARY_SUPPLEMENT: Very low Calorie Ketogenic Diet Group (VLCKDG)|DIETARY_SUPPLEMENT: Intermittent Fasting Group (IFG)
Sponsor: University of Roma La Sapienza
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-06-22
Completion Date: 2023-06-22
Locations: Sapienza University of Rome, Rome, RM, 00189, Italy

Summary:
Obesity is a significant health issue that increases the risk of serious cardiovascular problems. In recent years, two dietary methods, the Ketogenic Diet (KD) and Intermittent Fasting (IF), have become popular for their potential to treat obesity and its related issue, hypertension. While both diets are known for their effectiveness in weight loss, their specific impacts on blood pressure (BP) and overall heart health risks are less understood especially in menopausal women.

The main goal of this study was to investigate how the Ketogenic Diet and Intermittent Fasting compare to a regular, unrestricted diet (referred to as Free Diet or FD) in terms of their effects on clinic blood pressure levels in menopausal women.

Additionally, the study looked at changes in Body Mass Index (BMI), the percentage of total body weight loss, body fat percentage, waist and hip measurements, the ratio of waist-to-hip size, and the Phase Angle (PhA), which is a measure of the body's overall health status.

Primary Outcome Measures: Clinic systolic brachial BP levels., The primary aim was to evaluate the effects of Very low calorie Ketogenic Diet or intermittent fasting compared to Free Diet on clinic systolic brachial BP levels (mmHg)., 6 months
Secondary Outcome Measures: Body composition: BMI, Secondary outcomes included changes from baseline of Body Mass Index (BMI) weight and height will be combined to report BMI in kg/m\^2., 6 months|Body composition: Fat mass (%), Secondary outcomes included changes from baseline of Percentage of total body weight loss (TWL %), Body Fat Percentage (BFP %) derived from Bioelectrical impedance analysis (BIA), 6 months|Body composition: circumference, Secondary outcomes included changes from baseline of waist (WC) and hip circumference (cm), combined in waist-hip ratio (WHR), 6 months|Body Composition: Bioelectrical impedance analysis (BIA), Secondary outcomes included changes from baseline of Phase Angle °, 6 months|Clinic diastolic brachial BP levels., Secondary outcomes included modulation of diastolic blood pressure, 6 months
Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial
NCT Number: NCT06457698
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Joint Disorders
Interventions: PROCEDURE: Double-puncture TMJ arthrocentesis under local anaesthesia
Sponsor: Instituto Portugues da Face
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-01
Completion Date: 2024-12-01
Locations: Instituto Português da Face, Lisboa, 1050-227, Portugal

Summary:
Intra-articular injections of hyaluronic acid (HA) or platelet-rich plasma (PRP) have been used with temporomandibular joint (TMJ) arthrocentesis to improve lubricative properties and influence regenerative processes. A randomized, controlled clinical trial investigated the benefits of complementary bioviscosuplementation (HA+PRP) in patients submitted to double-portal TMJ arthrocentesis.

Primary Outcome Measures: TMJ arthralgia (VAS, 0-10), The level of TMJ arthralgia was registered through pain during palpation of the lateral pole or around the lateral pole or pain on maximum unassisted or assisted opening, right or left lateral movements, or protrusive movements, following the DC/TMD guidelines.12, 13 Patient scored for each side using a 10-point VAS, from 0-no pain and 10-severe pain., TMJ arthralgia will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
Secondary Outcome Measures: maximum mouth opening (MMO), MMO was measured using a certified ruler between the incisor's teeth., MMO will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
Assessment of The Accuracy of Complete Crown 3D Superimposition Technique Relative to The Gold Standard Technique for Digital Quantification of Volumetric Soft Tissue Changes in The Esthetic Zone
NCT Number: NCT06457672
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingival Recession
Interventions: DIAGNOSTIC_TEST: Group I|DIAGNOSTIC_TEST: Group II
Sponsor: British University In Egypt
Collaborators: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-15
Completion Date: 2024-12-30
Locations: Ahmed Hassan, Cairo, 112344, Egypt

Summary:
The aim of this study is to assess the precision of the complete crown technique employed for the superimposition of 3D models, specifically in the quantitative volumetric evaluation of gingival tissues. This technique was initially introduced in an in-vitro study by Dritsas et al. (2023) as a means to achieve an accurate, reproducible, and simple method for quantification of gingival recession.

Primary Outcome Measures: Superimposition accuracy, Using Geomagic Software (RMS) in Millimeter(mm), 6 months
Secondary Outcome Measures: Soft tissue volumetric Changes, Digital using intraoral scanner and blenderfordental software in Millimeter(mm), 6 months|Gingival Margin level change, Digital using intraoral scanner and blenderfordental software in Millimeter(mm), 6 months|Intra-Inter Assessor reliability, Intraclass correlation coefficient, 6 months|Operator's satisfaction, Questionnaire, 6 months
Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation
NCT Number: NCT06457659
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amputation Stump
Interventions: BEHAVIORAL: Early Rehab Group|OTHER: Delayed Rehab Group
Sponsor: Superior University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-10-30
Locations: Mobility Rehab care, Islamabad Medical Center, Dera Ismail Khan, Khyber Pakhtunkhwa, Pakistan

Summary:
A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.

Primary Outcome Measures: World Health Organization Quality of life (WHO QOL), Questionnaire was used to measure the impact in both groups on quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality-of-life assessment that would be applicable cross-culturally. The patient's physical, psychological, social, and environmental state of health is assessed separately in WHO_QOL known as the 4 domains of the questionnaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health about the respective domain., 12 Months
mRNA Expression and Genetic Polymorphisms Affecting DRD3 (rs6280) and HTR2A (rs6313) in Bruxism
NCT Number: NCT06457646
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bruxism
Interventions: GENETIC: Genetic polymorphism
Sponsor: University of Monastir
Sex: ALL
Age: ADULT
Enrollment: 169
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-02
Completion Date: 2024-12-17

Summary:
The goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. The main questions it aims to answer are:

* Is there a significant association between the rs6313 polymorphism of the HTR2A gene and bruxism?
* Is there a significant association between the rs6280 polymorphism of the DRD3 gene and bruxism?

Participants will:

Provide DNA samples for genotyping of the DRD3 (rs6280) and HTR2A (rs6313) polymorphisms.

Provide RNA samples to assess changes in the expression of HTR2A and DRD3. Researchers will compare the genetic data and RNA expression levels between individuals with bruxism and those without (controls) to see if there are significant genetic differences and expression changes associated with bruxism.

Primary Outcome Measures: PCR-RFLP Analysis, 1 year
Comparison of Telerehabilitation vs Clinical Setup Rehabilitation in TKR Patients
NCT Number: NCT06457620
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Injuries
Interventions: BEHAVIORAL: Conventional Physiotherapy|OTHER: Traditional Physical Preatment
Sponsor: Superior University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-10-30
Locations: Acti Life Physiotherapy and Rehabilitation Center Horizon Hospital, Lahore, Punjab, Pakistan

Summary:
This study examines the feasibility, attainability, and patient satisfaction of telerehabilitation and clinical consultation rehabilitation.

Primary Outcome Measures: Western Ontario and McMaster Universities Osteoarthritis (WoMAC), The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. ,, 12 Months|Knee Outcome Survey-Activities of Daily Living (KOS-ADLS), The Knee Outcome Survey (KOS) is a patient-completed questionnaire that provides a percentage of disability during every day activities (activities of daily living subscale) or sports (sports activity subscale). The lower the percentage, the higher the disability., 12 months
Evaluating the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting
NCT Number: NCT06457607
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Intensity Focused Ultrasound
Interventions: DEVICE: LinearZ
Sponsor: Jeisys Medical Inc
Collaborators: Asan Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-02-24
Completion Date: 2023-09-27
Locations: Asan Medical Center, Seoul, 05505, Korea, Republic of

Summary:
Prospective, single center, single arm, open label study to evaluate the efficacy and safety of treatment with LinearFirm(ULTRAcel Q+) in temporary eyebrow lifting

Primary Outcome Measures: The avegrage change in AEH (Average Eyebrow Height) and MEH(Maximum Eyebrow Height) compared to the Baseline, - Evaluation of the efficacy

: Average change in AEH (Average Eyebrow Height) and MEH (Maximum Eyebrow Height) from the baseline, after the application of a medical device for clinical trials, as evaluated by an independent evaluator's eyebrow lifting photo evaluation at 4 weeks, 8 weeks, 12 weeks, and 16 weeks.

This result will be displayed as a percentage., Base line and 4, 8, 12, 16weeks|The evaluation of the GLS (Glabellar Line Scale) compared to the Baseline, - Evaluation of the Exploratory

1. The proportion of participants who showed an improvement of 2 points or more in the Glabellar Line Scale (GLS) evaluation of the most frowning state at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the application of a medical device for clinical trials, compared to the baseline.
2. The proportion of participants who showed an improvement of 1 points or more in the Glabellar Line Scale (GLS) evaluation of the most frowning state at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the application of a medical device for clinical trials, compared to the baseline., Base line and 4, 8, 12, 16weeks|The evaluation of the TEAE (Treatment Emergent Adverse Event) and serious AE/ADE, 1. The frequency and percentage of Treatment-Emergent Adverse Events (TEAE), Adverse Device Effects (ADE), and Serious Adverse Events/Adverse Device Effects (Serious AE/ADE) that occurred after the application of the medical device for clinical trials are presented.
2. The frequency and percentage (%) of Treatment-Emergent Adverse Events (TEAE), Adverse Device Effects (ADE), and Serious Adverse Events/Adverse Device Effects (Serious AE/ADE) that occurred after the application of the medical device for clinical trials are presented., after 16weeks
Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers
NCT Number: NCT06457594
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Head and Neck Cancer
Interventions: OTHER: Questionnaire
Sponsor: Hadassah Medical Organization
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-06-08
Locations: Hadassah Medical Organization, Jerusalem, Israel

Summary:
Importance:

Patient reported outcome and experience measures (PROM and PREM) constitute a cornerstone of the collective efforts to improve and personalize healthcare systems. The EORTC quality of life (QOL) group developed instruments evaluating general and disease specific oncology QOL questionnaires, and the quality of information received. Implementation of PREM and relevant PROM is essential for equity, better resources utility, accessibility and patient centered treatment.

Objectives:

We describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed. We investigate which QOL questionnaire better reflects clinical parameters among head and neck cancer (HNC) patients.

Design:

A prospective cohort. Setting Tertiary, referral, head and neck dedicated surgical service.

Participants:

Consecutive head and neck cancer adult patients, surgically treated, recruited between January to December 2022.

Exposures:

We prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general (QLQ-C30) and specific (QLQ - H\&N43) oncology QOL questionnaires.

Main Outcomes and Measures:

Analyzing the quality of information provided and desired in diverse HNC subgroup of patients.

Analyzing which of PROM questionnaire better reflects HNC patients' disease and treatment parameters, which in turn, may predict poorer QOL.

Results:

We recruited 60 patients, consisting of equal female: male ratio, of which 16.66% were native Arabic speaking. Validated INFO 25 scores (median 62.6±17.5) were not associated with patients' age, sex, education status, disease, and treatment parameters. Yet, the Arabic spoken sub-population had significantly lower scores (p\<0.001).

In contrast to QLQ-C30, clinical imperative associations were demonstrated between QLQ - H\&N43 and patients' disease stage (P\<0.001), admission days (p\<0.0001), free flap reconstruction (P\<0.001) and adjuvant radiotherapy (P\<0.001).

Conclusions and relevance:

The final version of the native EORTC INFO25 translation was approved by the EORTC. We demonstrate lower INFO25 scores among the Arabic speaking population, suggesting frail equity and accessibility. In order to improve patients' centered treatment and resource utilization, we reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific, HNC oriented, EORTC QLQ - H\&N43 questionnaire that was not validated on EORTC QLQ-C30, which can be omitted.

Primary Outcome Measures: Questionnaire scores, 1 year
Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors vs TP Injection for Pain Management
NCT Number: NCT06457581
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Fibromyalgia
Interventions: OTHER: Dry Needling|PROCEDURE: Trigger points injections|DRUG: serotonin reuptake inhibitor (SSRI)
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-09-30
Locations: Chaudary Muhammad Akram Teaching Hospital, Lahore, Punjab, Pakistan

Summary:
The principal objective is to contribute valuable insights that hold direct implications for medical practice and patient care, with the potential to influence health policy pertaining to fibromyalgia management.

Primary Outcome Measures: Pittsburgh Sleep Quality Index (PSQI), It includes 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality., 12 Months|Fibromyalgia Impact Questionnaire:, It includes questions related to physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being. Scores on the FIQ range from 0 to 100, with higher scores indicating greater impact and symptom severity, 12 months
Validation Study of CONTEC08C Electronic Sphygmomanometer
NCT Number: NCT06457568
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure
Interventions: DIAGNOSTIC_TEST: Blood pressure measurement
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-25
Completion Date: 2024-08-01
Locations: Chinese Academy of Medical Sciences，Fuwai Hospital, Beijing, Beijing, 100037, China

Summary:
The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

Primary Outcome Measures: Blood pressure measurement data, Systolic Blood Pressure and Diastolic Blood Pressure, 30mintues
Knowledge Levels and Experiences of Intensive Care Nurses on the Prevention of Pressure Sores: Mixed Method
NCT Number: NCT06457555
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Nurses|Pressure Ulcer|Critical Care
Interventions: OTHER: type of parallel data in a convergent parallel hash pattern (near time)
Sponsor: Burdur Mehmet Akif Ersoy University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-31

Summary:
This research aims to determine the knowledge levels and practices of intensive care nurses regarding the prevention of pressure sores.

The main questions it aims to answer are:

1. What is the level of knowledge of intensive care nurses regarding the prevention of pressure sores?
2. What is the impact of sociodemographic characteristics of intensive care nurses on their knowledge level regarding the prevention of pressure sores?
3. What are the experiences of intensive care nurses regarding their practices for the prevention of pressure sores? In this research, a survey and interview technique will be applied to determine the knowledge levels and experiences of nurses working in adult intensive care units regarding the prevention of pressure sores and their practices.

Primary Outcome Measures: Pressure Ulcer Knowledge Level of Intensive Care Nurses, Pressure Ulcer Knowledge Level Assessment Tool 2.0-Updated Version (PUKAT 2.0): The Turkish adaptation of the PUKAT 2.0 measurement tool was made by Dallı et al. (2021). PUKAT 2.0 is a measurement/test tool scored as multiple choice true-false. It consists of a total of 25 questions. It is scored according to the number of correct answers given by the individual. The Cronbach Alpha value of the internal consistency reliability of the measurement tool was found to be 0.72. All results will be coded as binary variables: correct (1) and incorrect (0). If the answer is not known, more than one answer or no answer is selected, the result will be coded as incorrect. The total score for each participant will be calculated as the sum of the correct answers. The minimum score to be obtained from the scale is 0 and the maximum score is 25. As the scores increase, the level of knowledge increases., four months|Intensive Care Nurses' experiences, The qualitative data obtained from the research will be evaluated with inductive content analysis. In order to increase the validity of the data, two researchers will examine the transcripts separately and comprehensive readings will be made. Codes will be created and compared by interpreting them in terms of differences and similarities, categories and sub-themes will be obtained. Main themes and sub-themes will be determined and research objectives will be tried to be given within the framework of the pattern between the interviews., four months
Comparative Effects of ART and STM in Shoulder Impingement Syndrome
NCT Number: NCT06457542
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Impingement Syndrome
Interventions: OTHER: Active Release Technique|OTHER: Soft Tissue Mobilization
Sponsor: University of Faisalabad
Collaborators: Allied Hospital Faisalabad
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-02-17
Completion Date: 2024-06
Locations: Fatima Afzaal, Faisalābad, Punjab, 38000, Pakistan

Summary:
Shoulder impingement syndrome is primary cause of discomfort and restricted range of motion while reaching above in shoulder region. It is third most common illness affecting musculoskeletal system. The aim of this study will be to analyse comparative effects of active release technique and soft tissue mobilization on pain, range of motion and disability in shoulder impingement syndrome. The study will be a randomized clinical trial. A random sample of 40 subjects with shoulder impingement from Allied hospital, Faisalabad will be evaluated. Subjects who will meet selection criteria will be allocation into two groups by computerized generated allocation method. In addition to ultrasound as baseline treatment group a will receive active release technique while in group B soft tissue mobilization will be administrated for 4 weeks. Treatment session will be 12 session (3 sessions in one week). Baseline, at 2nd week and at 4th week of treatment pain, shoulder elevation, external rotation and shoulder disability will be measure by VAS, goniometer and SPADI. For, data analysis, we will use SPSS software version 23. Data was interrupted through independent t test and repeated measurements ANOVA.

Primary Outcome Measures: Shoulder pain, Visual Analogue Scale Minimum Value= 0mm Maximum Value= 10mm, 7 minutes
Secondary Outcome Measures: Shoulder range of motion, Goniometer Minimum Value= 0 Degree Maximum Value=120 Degree, 10 minutes|Shoulder Function, Shoulder Pain and Disability Index Minimum Value= 0 Maximum Value= 100, 15 minutes
The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.
NCT Number: NCT06457529
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Radiculopathy
Interventions: DIAGNOSTIC_TEST: conventional treatment with Prolotherapy|OTHER: Dry Needling and conventional treatment
Sponsor: Superior University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-10-01
Completion Date: 2024-09-30
Locations: Iqbal Mahmooda Hospital, Iffat Anwar Medical Complex and Life line Hospital, Lahore, Punjab, Pakistan

Summary:
Cervical radiculopathy is characterized by neurological dysfunction caused by compression and inflammation of the spinal nerves or nerve roots of the cervical spine. Rolotherapy is a regenerative therapeutic method that consists of injecting irritant solutions into the injured areas.

Primary Outcome Measures: Neck Disability Index, The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score, 12 Months|WHO Quality of Life, The QOLS is a reliable and valid instrument for measuring quality of life from the perspective of the patient. It focuses on domains that come from the qualitative descriptions of a wide range of adults across gender, cultural and language groups.Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale (16, 17). The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep, 12 months
Comparison the Effectiveness of Mirror Therapy VS Music Therapy for Training in Post Stroke Hemiplegic Patients
NCT Number: NCT06457516
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiplegia
Interventions: COMBINATION_PRODUCT: Mirror Therapy|OTHER: Music Therapy
Sponsor: Superior University
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2022-09-01
Completion Date: 2023-02-01
Locations: Chaudhary Muhammad Akram Hospital, Lahore, Punjab, Pakistan

Summary:
A randomized clinical trial was performed on hemiplegic post-stroke patients with a sample size of 50 (25 in each group).

Primary Outcome Measures: BBS (berg balance scale), A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke., 6 Month|FGA (functional gait assessment scale), The normal score on the FGA would be considered \>27/30; for adults from ages 60 to 80 years, the normal score on the FGA would be considered \>24/30; and for adults over the age of 80 years, the normal score would be considered \>19/30, 6 Months
A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
NCT Number: NCT06457503
Acronym: TRANSPARENT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Nasopharyngeal Cancer Recurrent
Interventions: DRUG: Toripalimab|DRUG: Cisplatin|DRUG: Gemcitabine|DRUG: Carboplatin
Sponsor: Coherus Biosciences, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-12

Summary:
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.

Primary Outcome Measures: Objective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, Up to 24 months
Secondary Outcome Measures: Duration of Response (DoR) assessed by BICR according to RECIST v1.1, Up to 24 months|ORR assessed by the investigator according to RECIST v1.1, Up to 24 months|DoR assessed by the investigator according to RECIST v1.1, Up to 24 months|Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1, Up to 24 months|PFS assessed by the investigator according to RECIST v1.1, Up to 24 months|Overall Survival (OS) defined as time from enrollment to death due to any cause, Up to 42 months|Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1, Up to 24 months|DCR assessed by the investigator according to RECIST v1.1, Up to 24 months|Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve, 12 months, 24 months
Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
NCT Number: NCT06457477
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Hepatitis B
Interventions: DRUG: Sintilimab|DRUG: NAs|DRUG: Peg-IFNα-2b
Sponsor: Beijing 302 Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2025-12-15
Locations: the Fifth Medical Center, Chinese PLA General Hospital, Beijing, Beijing, China

Summary:
This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

Primary Outcome Measures: The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks, Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks., 48 weeks|Incidence of treatment-emergent adverse events/serious adverse events, Evaluate the treatment-emergent adverse events/serious adverse events, 48 weeks
Secondary Outcome Measures: The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks, Evaluate the level of serum HBsAg (IU/ml) at 24 weeks and 48 weeks., 48 weeks|The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks., The rate of HBsAb positive (\>10 IU/ml) at 24 weeks and 48 weeks., 48 weeks|The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks, Evaluate the level of serum HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks., 48 weeks|The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks, Evaluate the level of serum pgRNA (\>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks, 48 weeks|The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks, Evaluate the level of serum anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks, 48 weeks|Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks, Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot), 48 weeks
Clinical Outcomes and Prognostic Factors in Multiple Myeloma Patients
NCT Number: NCT06457464
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma
Interventions: DRUG: Chemotherapy
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-10-01

Summary:
1. Description of the demographic, clinical, and laboratory characteristics of patients with MM admitted to the hematology unit of Assuit University Hospitals.
2. Determination of treatment outcomes and prognostic factors associated with survival rates.

Primary Outcome Measures: variety of drugs used and their responses, and pateints, examine the current state of multiple myeloma management, including the variety of drugs used and their effectiveness, as well as the outcomes for patients undergoing autologous stem cell transplantation (ASCT)., baseline
Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors
NCT Number: NCT06457438
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatitis E
Interventions: DIAGNOSTIC_TEST: Elecsys Anti-HEV IgG, IgM
Sponsor: University Hospital Ostrava
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2022-01-01
Completion Date: 2024-12
Locations: University Hospital Ostrava, Ostrava, Moravian-Silesian Region, 708 52, Czechia

Summary:
In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.

Primary Outcome Measures: Prevalence of Hepatitis E in the study groups, The prevalence of Hepatitis E will be observed in both study groups, measured as the number of positive samples from the total number of samples., 2 years
Secondary Outcome Measures: Presence of Hepatitis E (HEV) RNA in the study groups, The presence of HEV RNA will be observed in both study groups, measured as the number of positive samples from the total number of samples., 2 years
Flunotinib Maleate Phase II Intermediate-High Risk Bone Fiber Clinical Trial
NCT Number: NCT06457425
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: MF,PMF,PPV-MF,PET-MF
Interventions: DRUG: Flonoltinib 50mg|DRUG: Flonoltinib 100mg|DRUG: Ruxolitinib
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-06
Completion Date: 2026-07-06
Locations: West China Hospital Sichuan University, Chengdu, Sichuan, 610000, China|Hematology Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, 300052, China

Summary:
This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose fruquintinib maleate tablet group, high-dose fruquintinib maleate tablet group, or the ruxolitinib tablet group. Stratification factors include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)

Primary Outcome Measures: Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by researcher), Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by researcher), Week 24
Secondary Outcome Measures: Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by IRC), Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC), Week 24|Percentage of subjects with ≥35% reduction in spleen volume from baseline Evaluation by researchers, Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researchers), Week 12|Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by IRC), Percentage of subjects with ≥35% reduction in spleen volume from baseline( Evaluation by IRC), Week 12|Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score, Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score, Week 24 and Week 12