pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Pilates Versus Eccentric Exercises on Multiple Sclerosis
NCT Number: NCT06524089
Acronym: MS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: OTHER: Pilate training|OTHER: eccentric training
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-03-30

Summary:
This study aims to determine whether Pilates-based stability or eccentric training is more effective for patients with multiple sclerosis(MS) with chronic non-specific low back pain(NSLBP).

Primary Outcome Measures: pain intensity, VAS for measuring pain severity, At baseline and after 6 week|Function, The Trunk impairment scale (TIS) The static subscale investigates: (1) the ability of the subject to maintain a sitting position with feet supported; (2) the ability to maintain a sitting position while the legs are passively crossed, and (3) the ability to maintain a sitting position when the subject crosses the legs actively. The dynamic subscale contains items on lateral flexion of the trunk and unilateral lifting of the hip. To assess the coordination of the trunk, the subject is asked to rotate the upper or lower part of his or her trunk 6 times, initiating the movements either from the shoulder girdle or from the pelvic girdle, respectively. For each item, a 2-, 3- or 4- point ordinal scale is used. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. Therefore, TIS ranges between 0 for a minimal performance to 23 for a perfect performance., At baseline and after 6 week
Secondary Outcome Measures: back muscle strength, Handheld dynamometer measuring isometric trunk muscle strength, At baseline and after 6 week
Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA
NCT Number: NCT06524076
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulp Disease, Dental
Interventions: PROCEDURE: Partial Pulpotomy|PROCEDURE: Complete pulpotomy
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-22
Completion Date: 2025-12-22

Summary:
Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).

Primary Outcome Measures: Postoperative pain, Postoperative pain assessment through Visual Analog Scale (the lower the value the better)., one week postoperative|Swelling/ Fistula, Assessment of swelling and fistula through visual examination., 3, 6, 9, 12 months|Mobility, Assesment of pathological mobility using mobility test., 3, 6, 9, 12 months
Secondary Outcome Measures: Radiographic success, Radiographic evaluation (Radiolucency at furcation or periapical, internal or external root resorption) through visual interpretation of digital radiograph at 0, 6 and 12 months postoperatively., 0, 6, 12 months
Puppet Show and Storytelling Effect Among Children With Cancer
NCT Number: NCT06524050
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Children With Cancer
Interventions: BEHAVIORAL: standard care
Sponsor: Abeer Abd Elwahed Almowafy
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2023-06-01
Completion Date: 2023-12-13
Locations: Abeer, Cairo, Egypt

Summary:
Objective The objective of this study was to evaluate the effectiveness of puppet show and storytelling effect on oral medication adherence and negative emotions among children with cancer.

Methods A non-equivalent control group pre-test and post-test, between subjects design was conducted in the Maternity \& Children Hospital Bisha, Al-Namas General Hospital, Kingdom of Saudi Arabia and Suez Canal University Hospital at Egypt. A total of 100 children (ages 3-12) admitted for treatments in this hospital were invited to participate in the study. Of the 100 paediatric patients; 50 received puppet show and storytelling interventions and 50 received usual care.

Primary Outcome Measures: Measurment tool: Questionnaire Evaluate the effectiveness of puppet shows and storytelling effect on oral medication adherence and negative emotions among children with cancer, Puppet Show and Storytelling Effect on Oral Medication Adherence and Negative Emotions among Children with Cancer, 12 weeks
Relationship Between Metabolic Profiles and Chronic Diseases and Neoplasms
NCT Number: NCT06524037
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metabolic Diseases
Sponsor: First Affiliated Hospital of Chongqing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2032-12-31
Locations: The First Branch of the Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400010, China

Summary:
Metabolic disorders are involved in the occurrence and development of a variety of chronic diseases and tumors. There are many common risk factors between chronic diseases and tumors. However, the mechanisms of chronic diseases and tumors caused by metabolic disorders are not completely clear. By observing the relationship between metabolic indexes and chronic diseases and tumors, the investigators intend to explore the possible mechanisms of metabolic status participating in the occurrence and development of chronic diseases and tumors.

Primary Outcome Measures: metabolic disorder, The degree of metabolic disorder liking the levels of glycolipids, through study completion, an average of 1 year|Chronic disease, The occurrence of chronic disease, through study completion, an average of 1 year|Tumor, The occurrence of tumor, through study completion, an average of 1 year
Clinical Study of Tumor Polypeptide DC-CTL in the Treatment of Solid Tumors
NCT Number: NCT06524024
Acronym: DC-CTL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Solid Tumor
Interventions: BIOLOGICAL: Tumor polypeptide pool induced DC-CTL cell injection
Sponsor: Zhengzhou Revo-Gene Technology Co., LTD
Collaborators: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-04-01

Summary:
This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors.

Primary Outcome Measures: PFS, progression free survival time, From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment
Secondary Outcome Measures: OS, over all survival time, From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment
Stromal Vascular Fraction Enriched PRP in Treatment of Post-acne Scars
NCT Number: NCT06524011
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acne Scars - Atrophic
Interventions: BIOLOGICAL: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone
Sponsor: Zagazig University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-02
Locations: Zagazig University Hospitals, Zagazig, Egypt

Summary:
in a split face fashion, 30 patients will be randomized into 3 groups: Group A: rt side treated with SVF enriched PRP, lt side treated with prp Group B: rt side treated with SVF enriched PRP, lt side treated with SVF Group C: rt side treated with PRP, lt side treated with SVF

Primary Outcome Measures: change in severity of acne scars using Goodman scoring system, at baseline, acne scars will be assessed clinically using the 4 point grading system proposed by Goodman \&colleagues in 2006, patients' complaints and expectations will be addressed as well and the impact of acne scars on patients' quality of life will be investigated using the dermatology life quality index (DLQI). Goodman scoring system will be used at the last session and at the follow up visit to measure the change pre and post treatment., 3 monthly sessions and follow up for 3 months after the last visit
A Study on Rare Dermatological Infections Conducted at Three Major Reference Hospitals in Costa Rica.
NCT Number: NCT06523998
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Sporotrichosis|Chromomycosis|Actinomycosis|Nocardiosis|Mycetoma|Mycobacterial Cutaneous Infection|Coccidioidomycosis|Blastomycosis|Paracoccidioidomycosis|Phaeomycosis
Sponsor: Caja Costarricense de Seguro Social
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-11
Completion Date: 2024-05-24
Locations: Hospital Rafael Ángel Calderón Guardia, San José, 10101, Costa Rica|Hospital San Juan de Dios, San José, 10103, Costa Rica|Hospital México, San José, 10107, Costa Rica

Summary:
In Costa Rica there are some descriptive studies of some of these rare infectious diseases (sporotrichosis, chromomycosis and mycetomas); however, there are no recent published reports. Most of the publications on the subject date back to the previous century; from 2000 to the present year there are only publications of small series of cases, so the current behavior of these skin infections is unknown. The primary objective is to analyze the epidemiological, clinical, and therapeutic profile and determine the risk factors in patients with a diagnosis of rare infections of dermatological interest treated at Hospital México, Hospital Rafael Calderón Guardia, and Hospital San Juan de Dios during the period 2019-2023.

Primary Outcome Measures: Analyze epidemiological, clinical, and therapeutic profile, Analyze the epidemiological, clinical, and therapeutic profile and determine the risk factors in patients with a diagnosis of rare infections of dermatological interest treated at Hospital México, Hospital Rafael Calderón Guardia, and Hospital San Juan de Dios during the period 2019-2023., 5 year|Determine the risk factors, Analyze the epidemiological, clinical, and therapeutic profile and determine the risk factors in patients with a diagnosis of rare infections of dermatological interest treated at Hospital México, Hospital Rafael Calderón Guardia, and Hospital San Juan de Dios during the period 2019-2023., 5 year|Determine the diagnostic methods, Determine the diagnostic methods utilized for each case, including culture, histological techniques, and molecular testing., 5 year
The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution
NCT Number: NCT06523985
Acronym: PP-OD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carrying Naloxone/Narcan on Their Person or in Their Vehicle|Being Trained to Respond to an Opioid Overdose
Interventions: BEHAVIORAL: Push messages (standard)|BEHAVIORAL: Push messages (customized)
Sponsor: Indiana University
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2026-08

Summary:
We will conduct a feasibility trial to assess whether, in a random sample of 180 agencies where PulsePoint is already active, revised procedures (hereinafter PulsePoint-OD) to facilitate opioid overdose and naloxone distribution (OEND) can successfully recruit first responder agencies and layperson responders. For this study, agency refers to a single implementation site where PulsePoint is active and that is bound by the service area or jurisdiction of the first responder agency collaborating with PulsePoint.

We will test the following hypotheses:

H1: more first responder agencies will be successfully recruited by arm 2 than by arm 1.

H2: more layperson responders will report engaging with OEND programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 \[only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research\].

Primary Outcome Measures: Certification of receiving OEND programming and naloxone carrying, At baseline, we will calculate the ratio of persons certifying that they are trained (numeric count of N) compared to the total number of push message recipients (T), the ratio of persons certifying that they carry naloxone (numeric count of C) compared to the total number of push message recipients (T), and the ratio of individuals who clicked on the link (O) compared to the total number of push message recipients (T). Separately at 6- and 12-month follow-ups, the numbers of certifications of training and carrying naloxone (N and C, respectively) that were submitted compared to the numbers of push recipients (T) in each period (tracked by D) and the ratio of individuals who clicked on the link (O) each month compared to the number of total push message recipients (T). Our outcome variables are ratios: X = (N / T) for each value of D (0, 1, or 2) and Y = (C / T) for each value of D. The ratio Z = (O / T) is a covariate representing engagement with push messages at each value of D., 12 months
A Study of Cardiovascular Disease Awareness and Cardiovascular Health
NCT Number: NCT06523972
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Diseases|Cardiovascular Health
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 525
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2024-12
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
The objective is to increase awareness of various cardiovascular diseases (CVDs) through an interactive, educational experience to promote cardiovascular health (CVH) via an inflatable heart model exhibit and assess community CVD knowledge and whether this experience is an acceptable tool to promote and provide education on CVH.

Primary Outcome Measures: Cardiovascular Health (CVH), CVH will be measured by LE8 composite score (scale 0-100 points). A higher composite score is associated with ideal cardiovascular health., Baseline
Secondary Outcome Measures: Social Determinants of Health (SDoH), SDoH will be measured by education level, insurance status, and neighborhood zip code, Baseline|Individual LE8 component scores (Life's Essential 8), LE8 component scores will be measured from eight health behavior and clinical factors including diet, physical activity, nicotine exposure, sleep health, body mass index (BMI), blood lipids, blood pressure (BP), and blood glucose., Baseline
Pacific Islander Physical Activity Project
NCT Number: NCT06523946
Acronym: PiPA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Physical Inactivity
Interventions: BEHAVIORAL: Diabetes Prevention Program (DPP) (shortened)
Sponsor: University of Utah
Collaborators: Ohio State University|National Tongan American Society
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-09
Completion Date: 2028-06-30

Summary:
This proposed longitudinal study will examine the influences of neighborhood factors and momentary contextual and psychosocial factors, which the investigators call acute precipitants, on physical activity (PA) adoption and maintenance among Pacific Islanders (PcIs). Specifically, the investigators will enroll 150 sedentary PcI adults and examine their PA adoption and maintenance based on measurements at five separate weeks during a 20-month period. The investigators will use MotionSense, an innovative and proven mHealth kit developed by team members, Global Positioning System (GPS), and ecological momentary assessment to measure PA and its key determinants. Our central hypotheses are that individual and neighborhood factors are associated with PA adoption and maintenance among previously sedentary PcIs, and that psychosocial precipitants mediate these associations.

Primary Outcome Measures: Physical activity adoption measure 1, Physical activity adoption will be defined in terms of change of weekly moderate-to-vigorous physical activity (MVPA) minutes during the 5 measurement weeks., 5 separate weeks' data in 20 months for each participant|Physical activity maintenance measure 1, Physical activity maintenance will be defined in terms of change of weekly moderate-to-vigorous physical activity (MVPA) minutes during the 5 measurement weeks., 5 separate weeks' data in 20 months for each participant|Physical activity adoption measure 2, Physical activity adoption will also be measured by a binary variable-i.e., whether the participant meets the weekly PA threshold or not., 5 separate weeks' data in 20 months for each participant|Physical activity maintenance measure 2, A secondary type of physical activity maintenance would be a binary variable-i.e., whether the participant meets the weekly PA threshold or not, 5 separate weeks' data in 20 months for each participant
Distribution of Bacteria in OME After Radiotherapy For NPC.
NCT Number: NCT06523933
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Otitis Media Effusion|Nasopharyngeal Carcinoma
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 234
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-12
Completion Date: 2025-05-12
Locations: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China

Summary:
To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.

Primary Outcome Measures: Positive Bacterial Culture Rate in Middle Ear Effusion, Up to 24 weeks
Secondary Outcome Measures: Changes in Air Pressure (Tympanogram), Tympanogram changed from type B to type A or type C., Collected at 6, 12, 24 Weeks after Tympanocentesis|Eustachian Tube Dysfunction Questionnaire (ETDQ-7), The ETDQ-7 tool is used to assess the symptoms of Otitis Media With Effusion (OME), which consists of seven items with a scale of graduated responses ranging from 1 (No Problem) to 7 (Severe Problem), and 4 would correspond to a Moderate Problem. If the total score is more than 14, it is considered that there is eustachian tube dysfunction. The average post-operative ETDQ-7 score is less than 2.1 or decrease \> 0.5 (minimal clinically important difference=0.5), it is considered that the eustachian tube function is improved., Collected at 6, 12, 24 Weeks after Tympanocentesis
Protecting Autologous Free Flaps From Ischemia/Reperfusion Damage With Cold Storage.
NCT Number: NCT06523920
Acronym: PAFFIRD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ischemia Reperfusion Injury
Interventions: DEVICE: University of Wisconsin solution + cold storage|OTHER: Unperfused free flap under warm ischemia
Sponsor: University of Cagliari
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-06-30

Summary:
Reconstructive microsurgery allows autologous transplantation of flaps. The procedure causes temporary ischemia. The absence of perfusion and the post-anastomosis reperfusion causes ischemia/reperfusion (I/R) damage and an increased percentage of flap complications associated with the longer duration of the ischemia time. In reconstructive surgery the utilization of preservation solution is very limited. The research hypothesis is that cold storage of free flaps might offer benefits. The present study is a RCT to evaluate the feasibility and safety of a cold preservation (using the UW solution) of the free flaps from I/R damage in oncological microsurgical reconstructions. Blood perfusion will be intraoperatively evaluated through indocyanine green and SPY-DHI.

Moreover, patients' outcomes will be evaluated postoperatively through clinical and radiological examinations, particularly focusing on somatosensory recovery and dental rehabilitation after mandibular reconstruction.

Primary Outcome Measures: Rate of total flap loss, Frequency of flaps that suffer from complete loss and are removed evaluated through fluorescence after the injection of indocyanine green by means of SPY PHI (Portable Handheld Imager) by Stryker (Kalamazoo, USA),, 1 month|Rate of partial flap loss, Frequency of flaps that suffer from partial loss and are debrided, 1 month
Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery
NCT Number: NCT06523881
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Disturbance|Anesthesia; Adverse Effect
Interventions: PROCEDURE: Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey)|PROCEDURE: Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)
Sponsor: Uludag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-20
Completion Date: 2024-03-01
Locations: Uludag University, Bursa, Nilufer, 16059, Turkey

Summary:
Investigators aimed to evaluate the impact of the anesthesia method and surgical procedure on the sleep patterns and sleep quality of patients undergoing posterior spinal instrumentation using the Pittsburgh Insomnia Rating Scale-20 (PIRS-20).

Primary Outcome Measures: Pittsburgh Insomnia Rating Scale-20, Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome., Preoperative one month|Pittsburgh Insomnia Rating Scale-20, Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome., Postoperative seventh day|Visual Analogue Scale, Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome., Preoperative one day|Visual Analogue Scale, Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome., Postoperative first hour|State-Trait Anxiety Inventory, Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome., Preoperative one day|State-Trait Anxiety Inventory, Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome., Postoperative seventh day
Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique
NCT Number: NCT06523855
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alveolar Cleft
Interventions: PROCEDURE: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2025-07-01
Locations: Faculty of Dentistry, Cairo university, Cairo, 12311, Egypt

Summary:
The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.

Primary Outcome Measures: Bone density immediate versus 6 months postoperatively., bone density changes are measured using CBCT after 6 months via HU, 6 months
Secondary Outcome Measures: Bone width and height immediate versus 6 months postoperatively, bone height and width changes are measured using CBCT after 6 months in mm, 6 months
Cross Culture Adaptation Validity and Reliability of Arabic Version of Cornell Muscloskeletal Discomfort Questionnaire
NCT Number: NCT06523842
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Translation of Cornell Muscloskeletal Questionnair Into Arabic Language
Interventions: OTHER: questionnaire
Sponsor: Sara Mortada Mohamed
Sex: ALL
Age: ADULT
Enrollment: 540
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-02-28
Locations: Faculty of Physical Therapy, Dokki, Giza, 023, Egypt

Summary:
The purpose of this study is to translate and test face validity,content validity, Feasibility, internal consistency reliability and Test retest reliability of adapted Arabic-language version of Cornell musculoskeletal discomfort questionnaires in patients with musculoskeletal

Primary Outcome Measures: cronell muscloskeletal discomfort questionnaire, questionnaire for assessment muscloskeletal discomfort in sedentary and standing workers in previous weeks How can I classify the severity of discomfort into mild, moderate, or more. The discomfort score is a severity of discomfort. Originally we had it as 'mild', 'moderate' and 'severe discomfort', but we found that people more easily understood the categories 'slightly', 'moderately' and 'very uncomfortable' . if you like you can replace the scale point titles with 'mild', 'moderate' and 'severe discomfort, 15 minutes
Dermoscopy and Histopathology in Non-melanocytic Skin Tumors
NCT Number: NCT06523816
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-melanoma Skin Cancer
Interventions: DIAGNOSTIC_TEST: dermoscopy
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-10-01

Summary:
The main aim of the study is to investigate the relation between dermoscopic findings in pre-operative diagnosis of non-melanocytic skin tumors and post-operative histopathology findings .

Primary Outcome Measures: sensitivity of dermoscopy to detect NMSTs, investigate the relation between dermoscopic findings in pre-operative diagnosis of non-melanocytic skin tumors and post-operative histopathology findings, 2 years
The Impact of Exercise Methods on Human Body Functions and Metabolism
NCT Number: NCT06523790
Acronym: EXMET-BW&Y
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome
Interventions: BEHAVIORAL: Yoga|BEHAVIORAL: Brisk walking
Sponsor: Zhoukou Normal University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-03
Completion Date: 2025-12-31
Locations: Zhou Kou Normal University, Zhoukou, Henan, China

Summary:
The objective of this study is to compare the effects of 8 months of yoga and walking exercise training on weight-related body fat and metabolic biomarkers in women. Participants will be randomly assigned to either a yoga group or a walking group. The yoga group will undergo 90-minute sessions, 3 times per week, while the walking group will engage in one-hour sessions, 6 times per week. Physical and metabolic markers will be measured at baseline and after 8 months of intervention.

Primary Outcome Measures: Change in Body Weight, Measurement of body weight changes in kilograms from baseline to 8 months., Baseline, 8 months|Change in Body Mass Index (BMI), Measurement of BMI changes calculated as weight in kilograms divided by height in meters squared from baseline to 8 months., Baseline, 8 months
Secondary Outcome Measures: Change in Serum Leptin Levels, Measurement of serum leptin levels in ng/mL from baseline to 8 months., Baseline, 8 months|Change in Fasting Blood Glucose Levels, Measurement of fasting blood glucose levels in mg/dL from baseline to 8 months., Baseline, 8 months|Change in Total Cholesterol (TC) Levels, Measurement of total cholesterol levels in mg/dL from baseline to 8 months., Baseline, 8 months
Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment
NCT Number: NCT06523764
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Helicobacter Pylori Infection Chronic Gastrit
Interventions: DRUG: tegoprazan|DRUG: Minocycline|DRUG: bismuth potassium citrate|DRUG: Esomeprazole 40mg|DRUG: Amoxicillin|DRUG: clarithromycin
Sponsor: Xijing Hospital of Digestive Diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-01

Summary:
The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Primary Outcome Measures: Helicobacter pylori eradication rate, The primary end point of this study is H.pylori eradication,established by negative urea breath test#rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treament, 28 days after treatment
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Events (Safety), Newly occurring drug-related symptoms during the treatment process, 14 days of treatment|Rate of participants with good medication compliance (Compliance), Taking more than 80% of medication is defined as good compliance, 14 days of treatment
Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy
NCT Number: NCT06523751
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Open Angle Glaucoma|Pseudoexfoliation Glaucoma
Interventions: DIAGNOSTIC_TEST: Trabeculopuncture
Sponsor: Wuerzburg University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-06-13
Completion Date: 2025-03-31
Locations: Uniklinikum Würzburg, Würzburg, Bavaria, 97080, Germany

Summary:
The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.

Primary Outcome Measures: IOP, Intraocular pressure measured by Goldmann applanation tonometry, before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively|Outflow facility, Outflow facility is measured by the use of a pneumatonometer, before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively|Surgical success, surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops, at month three
Left Atrial Volume Changes Who Underwent Cardioversion and Recurrence of AF After RF Ablation in Persistent AF (SAFE-AF)
NCT Number: NCT06523738
Acronym: SAFE-AF-ABL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Persisent Atrial Fibrillation|Reversal of Atrial Enlargement|Recurrence of Atrial Fibrillation
Interventions: DIAGNOSTIC_TEST: 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolation
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-07-01
Completion Date: 2025-12-31
Locations: The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400072, China

Summary:
Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesize that persistent atrial fibrillation (AF) patients with more significant left atrial size reduction after cardioversion have lower AF recurrence rates following radiofrequency ablation. The aim is to evaluate the relationship between changes in left atrial size 3 to 6 months after cardioversion and the recurrence rate of atrial fibrillation following radiofrequency ablation.

Primary Outcome Measures: Recurrence of atrial fibrillation, Recurrence of atrial fibrillation after radiofrequency ablation, 1, 3, 5 years
Effectiveness of Interactive Oral Care Lessons on Children Dental Health Practices
NCT Number: NCT06523712
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Plaque
Interventions: BEHAVIORAL: Smile Smarts
Sponsor: Universiti Putra Malaysia
Collaborators: University of Lahore
Sex: ALL
Age: CHILD
Enrollment: 1800
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-25
Completion Date: 2025-07-15

Summary:
It presents a randomized clinical trial to assess the effectiveness of interactive oral care lessons for children. It highlights the importance of oral health education during childhood and proposes using engaging teaching methods. The study involves baseline and post-intervention assessments, with participants randomly assigned to receive oral health education or serve as a control group. Data collected through questionnaires and plaque assessments will be analyzed to determine the impact of the intervention on oral hygiene habits.

Primary Outcome Measures: DENTAL HEALTH PRACTICES AND BEHAVIOUR, The primary outcome is dental health practices and behaviour will be assessed using a pre-validated questionnaire derived from a reference study with a reliability score of 0.719. The questionnaire comprises 12 questions, where questions 1-6 pertain to awareness and questions 7-12 assess practices. The scoring range is from 0 to 12, with higher scores indicating better dental health practices and behavior., 6 MONTHS
Secondary Outcome Measures: PLAQUE SCORE, The secondary outcome is Plaque score will be measured using the Silness and Löe plaque index. This index scores the thickness of dental plaque at the gingival margin. The scoring range is from 0 to 3, with 0 indicating no plaque and 3 indicating a high amount of plaque accumulation., 6 MONTHS|GINGIVAL SCORE, The other secondary outcome is gingival score will be measured using the Silness and Löe gingival index. This index assesses the severity of gingivitis based on color, consistency, and bleeding on probing. The scoring range is from 0 to 3, with 0 indicating healthy gums and 3 indicating severe inflammation.

Scoring Criteria: Assess gingival inflammation at four sites around each tooth (mesial, distal, buccal, and lingual), 6 MONTHS|ORAL HEALTH RELATED QUALITY OF LIFE, Oral Health-Related Quality of Life is a vital measure that reflects the broader implications of oral health on an individual's life. By understanding and improving OHRQoL, healthcare providers and policymakers can enhance the overall health and well-being of individuals and communities., 6 months
Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant
NCT Number: NCT06523699
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Multiple Myeloma
Interventions: DRUG: Recombinant glycosylated human interleukin-7|DRUG: Melphalan|PROCEDURE: Autologous hematopoietic cell transplant
Sponsor: Washington University School of Medicine
Collaborators: Revimmune
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-31
Completion Date: 2028-10-31
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

Summary:
This is a two-arm, open-label, randomized, single-site, pilot study testing the addition of CYT107 following autologous hematopoietic cell transplant (AHCT) in patients with multiple myeloma (MM). The hypothesis of this study is that recombinant human CYT107 can be safely administered after AHCT and will promote quantitative and qualitative T cell reconstitution, which will be associated with enhanced tumor cell clearance and reduced infectious complications. Patients will be randomized to either the intervention arm that will receive CYT107 + standard of care melphalan and AHCT or to the control arm that will receive standard of care melphalan and AHCT only.

Primary Outcome Measures: Rate of non-hematologic grade ≥3 treatment-related AEs (excluding expected transplant-related AEs) according to CTCAE v5, Treatment-related AEs will be defined as AEs occurring that are at least possibly related to the CYT107 treatment, or the combination of melphalan, AHCT, and CYT107., Through day 365
Secondary Outcome Measures: Rate of minimal residual disease (MRD), For the purposes of this study, a patient will be considered as having minimal residual diseases if a positive result (per 10-5 threshold) is obtained using the Adaptive Clonoseq MRD testing., At Day 100|Rate of response by IMWG of ≥ complete response (CR), * Stringent complete response (sCR):

  * CR as defined below
  * Normal free light chain ratio (0.26-1.65)
  * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
* Complete response (CR):

  * Negative immunofixation on the serum and urine
  * \<5% plasma cells in the bone marrow aspirate
  * Disappearance of any soft tissue plasmacytomas, At Day 100|Rate of ≥ grade 3 infections, Through day 365|Days from transplant until absolute neutrophil count (ANC) engraftment, Neutrophil engraftment is defined as the first day of 3 consecutive days of ANC ≥ 500 following the post-transplant nadir., Through Day 30|Feasibility of treatment schedule, The study will be feasible if 20% of patients are able to receive all 5 doses of CYT107 within the first month post-transplant., 1 month post-transplant (transplant is on Day 0)|Absolute lymphocyte count (ALC) recovery from pre-AHCT, Through Day 30
Lateral Ridge Augmentation Using Two Graft Combination and a Cross-linked Collagen Membrane
NCT Number: NCT06523686
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Alveolar Bone Resorption
Interventions: PROCEDURE: Guided bone regeneration
Sponsor: Saint-Joseph University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-09
Completion Date: 2024-07-10
Locations: Saint Joseph university, Beirut, 00000, Lebanon

Summary:
To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.

Primary Outcome Measures: Linear bone width changes, Linear bone width changes assessed clinically and radiographically in mm, 6 months|Volumetric bone changes, Volumetric bone changes assessed radiographically in cubic mm, 6 months
Secondary Outcome Measures: Clinical Ridge Height gain, Clinical Ridge Height gain in mm, 6 months|Probe penetration, Probe penetration at the occlusion-buccal angle, 6 months
Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer
NCT Number: NCT06523673
Acronym: OPPRESS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Metastatic Non-Small Cell Lung Cancer|NSCLC Stage IV|OligoProgressive Metastatic Disease
Interventions: RADIATION: Stereotactic Body Radiotherapy|DRUG: second-line systemic therapy
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-09
Locations: Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

Summary:
The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:

Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?

Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.

Participants will:

Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.

Primary Outcome Measures: progression-free survival (PFS), Progression-free survival, PFS: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first., Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first, assessed up to 18 months.
Secondary Outcome Measures: Overall Survival (OS), Overall Survival，OS: Time from date of randomization to death (from any cause)., Time from date of randomization to death (from any cause), assessed up to 36 months.|Quality of Life (QoL), Patient quality of life will be assessed using the patient-reported European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - Core 30 (EORTC QLQ-C-30) scale. Patient-reported EORTC-QLQ-C30 scale results will be scaled and scored according to the procedures recommended by the EORTC Quality of Life Panel, and scale scores for each visit period of the trial will be analyzed, as well as change values relative to baseline., From enrollment to the end of survival follow-up at 36 months.|Safety of SBRT, the safety of SBRT, From enrollment to the end of treatment at 4 weeks
Clinical Efficacy of Ustekinumab in Crohn's Disease
NCT Number: NCT06523647
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn's Disease
Sponsor: Kazakhstan Scientific Society for Study of intestine diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-27
Completion Date: 2025-12
Locations: NJSC "West Kazakhstan Marat Ospanov Medical University", Aktobe, Kazakhstan|Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov", Almaty, 055990, Kazakhstan|State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana, Astana, Kazakhstan|State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region, Shymkent, Kazakhstan

Summary:
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.

Primary Outcome Measures: The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index, at week 24 of therapy
Secondary Outcome Measures: Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index, at 12 and 52 weeks of therapy|Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease, at 24 and 52 weeks|Dynamics of fecal calprotectin levels, at 24 and 52 weeks|Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity, at 12 and 52 weeks|Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire, at 12, 24 and 52 weeks|Dynamics of antibody synthesis to the drug Ustekinumab, at 0/1, 24 and 52 weeks|List of medications indicated in the general scheme with Odeston, through study completion, an average of 1 year|Dynamics of assessing patient adherence to treatment using the Morisky-Green scale, at 0/1, 12, 24 and 52 weeks|Collection of information on adverse reactions and/or registration of pregnancy cases, through study completion, an average of 1 year|Dynamics of red blood cell parameters, at 24 and 52 weeks|Dynamics of hemoglobin parameters, at 24 and 52 weeks|Dynamics of platelet parameters, at 24 and 52 weeks|Dynamics of leukocyte parameters with leukocyte formula, at 24 and 52 weeks|Dynamics of erythrocyte sedimentation rate parameters, at 24 and 52 weeks|Dynamics of potassium parameters, at 24 and 52 weeks|Dynamics of sodium parameters, at 24 and 52 weeks|Dynamics of C-reactive protein parameters, at 24 and 52 weeks|Dynamics of albumin parameters, at 24 and 52 weeks|Dynamics of total protein parameters, at 24 and 52 weeks|Dynamics of serum iron parameters, at 24 and 52 weeks|Dynamics of serum iron-binding capacity parameters, at 24 and 52 weeks|Dynamics of vitamin B9 parameters, at 24 and 52 weeks|Dynamics of Nutritional Risk Index indicators, at 24 and 52 weeks