pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Educatıon in Patıents Who Had Total Knee Prosthesıs
NCT Number: NCT06521073
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prosthesis-Related Infections|Pain, Postoperative|Analgesia
Interventions: BEHAVIORAL: education
Sponsor: Cukurova University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
The main purposes of nursing care and education for patients who will undergo total knee prosthesis are; The aim is to reduce pain, prevent complications that may develop due to orthopedic surgery, increase patient satisfaction, and preserve function and mobilization.

Primary Outcome Measures: Primary Outcome Measure, Patient Information Form (PIF) This form, prepared by scanning the literature, includes the patient's age, gender, marital status, education level, profession, social security, place of residence, presence of caregivers in the family, from whom he/she receives care, chronic diseases, the side on which knee prosthesis is applied, knee prosthesis. It is a form consisting of questions about your training status, who you received your training from, and your satisfaction with the training., 1 week
Secondary Outcome Measures: Secondary Outcome Measures, Barthel Index (BI):

Barthel activities of daily living index is an evaluation scale used to measure an individual's performance in daily living activities. The index is used for activities of daily living in 10 domains. This scale, which questions nutrition, washing, self-care, dressing, bowel control, bladder control, toilet use, the ability to move from a wheelchair to a bed and vice versa, mobility and going up and down stairs, consists of a total of 10 items rated on a 0-15 point scale. In this scale, where the possible score ranges from 0 to 100, the high score means the degree to which the individual can function independently (0-20 points are fully dependent, 21-61 points are highly dependent, 62-90 points are moderately dependent, 91-99 points are mildly dependent). dependent, 100 points completely independent)., 12 weeks
Other Outcome Measures: Third Outcome Measures, Numerical Pain Scale (NRS):

It is used in patients with scale awareness. 0: I have no pain; 10: indicates unbearable pain and is frequently used in pain assessment in conscious patients. Patients indicate the degree of pain they experience on a scale of 0 to 10; 0 represents no pain and 10 represents the worst possible pain. Thanks to this scale, the patient indicates the worst and mildest pain level he has experienced in the last 24 hours (source)., 12 weeks
A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
NCT Number: NCT06521047
Acronym: PERFECT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myocardial Infarction
Sponsor: CellProthera
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2034-03-15
Locations: CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel, Dijon, 21079, France|Institut Jacques Cartier, Massy, France|CHU Montpellier Arnaud-De-Villeneuve, Montpellier, France|GHRMSA, Mulhouse, 68100, France|Hôpital Haut Levèque, Pessac, France|Hôpital de Rangueil, Toulouse, France|Ninewells Hospital & Medical School, Dundee, B15 2GW, United Kingdom|BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,, Edgbaston, B15 2GW, United Kingdom|University of Edinburgh, Edinburgh, United Kingdom|Saint Bartholomew's Hospital W Smithfield,, London, EC1A 7BE, United Kingdom

Summary:
The PERFECT study is an observational study designed to follow patients randomised in the EXCELLENT study (NCT02669810) for 10 years.

The aim is to assess the long-term clinical outcomes for patients randomised to the Standard of Care arm or the ProtheraCytes arm.

Primary Outcome Measures: Comparison of the safety and efficacy of patients included in the Protheracytes arm versus the Standard of care arm, The data collected for the efficacity part are cardiovascular markers : NT-Pro-BNP, LVESVI, LVEDVI, LVEF

The data collected for the safety are : Occurence of Acute Heart failure, Acute MI, transplantation or MACE. All SAE/AE ongoing at or starting from the participant's last visit of the EXCELLENT clinical trial until 10 years after enrolment, Through study completion, an average of 10 year
CHOICE to AVOID or RESIST
NCT Number: NCT06521021
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight and Obesity
Interventions: BEHAVIORAL: AVOID|BEHAVIORAL: RESIST
Sponsor: Cedars-Sinai Medical Center
Collaborators: University of California, Riverside|Northeastern University|WW International Inc|The University of Tennessee, Knoxville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2026-12-01

Summary:
This trials will formally test whether participants' active choice of self-regulatory strategies (AVOID or RESIST) leads to greater adherence to weight management strategies by comparing the CHOICE arms to the randomized arms of the parent intervention, AVOID/RESIST (IRB STUDY00001652: AVOID-RESIST).

Primary Outcome Measures: Follow-up Completion, We will continuously track the rate of 6- and 12-month follow-up completion as followed: actual follow-ups completed / expected follow-ups to be completed., Baseline, 6 Month, 12 Month
Secondary Outcome Measures: Height, Participant baseline height is self-reported in inches., Baseline|Demographics, Demographic questionnaire will be used to capture date of birth, sex and gender identity, race, ethnicity, socioeconomic status (education, household income, marital status, employment status) and household composition (e.g., multigenerational, children)., Baseline|Drivers of preference, retention, and adherence, Our quantitative analytic approach will make it possible to compare CHOICE and RANDOM study follow-up completion, adherence, and weight loss among Non-Hispanic White and among those who identify to an ethnic and/or racial minoritized group. Quantitative analyses, however, do not make it possible to contextualize drivers that may influence relative preference, retention, and adherence. Using semi-structured interviews (Appendix A), we will explore the depth of personal beliefs and experiences, cultural contexts, social dynamics, social support systems, and household factors that may influence affect participants' preferences and sustained engagement. This knowledge will inform personalized behavior change strategies that are sensitive to the diverse needs of participants' social context., Baseline, 6 Month, 12 Month|Weight, Weight is measured using the Bluetooth enabled scales based on standard practices (e.g., empty pockets). Weight loss will be operationalized as the difference between weight at baseline, 6mo, and 12mo., Baseline, 6 Month, 12 Month
Other Outcome Measures: Dietary intake and physical activity, We will leverage data conferred by the WW program to capture dietary intake and physical activity (type, duration and intensity) via the WW mobile app or online website., Baseline, 6 Month, 12 Month
Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women
NCT Number: NCT06521008
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urge Incontinence|Urinary Incontinence|Postmenopausal Disorder
Interventions: DRUG: anti muscarinic drugs|OTHER: Instructions including bladder training|OTHER: pelvic floor muscle training (PFMT)|OTHER: abdominal exercise|OTHER: Diaphragmatic Training
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2024-06-01
Locations: OM El Masreen General Hospital, Giza, Egypt

Summary:
The purpose of this study was to determine the effect of diaphragmatic training on urgency urinary incontinence in postmenopausal women.

Primary Outcome Measures: assessing the change in Urodynamics (first desire to void), The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of volume at first desire to void, for each woman in all groups. The urodynamic method is a reliable and mandatory method for diagnosing and treating UUI symptoms, as relying solely on urinary symptoms may lead to under-diagnosis of detrusor overactivity., up to 12 weeks|assessing the change in Urodynamics (first sensation of bladder filling), The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of first sensation of bladder filling, for each woman in all groups., up to 12 weeks|assessing the change in Urodynamics (maximum bladder capacity), The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of maximum bladder capacity, for each woman in all groups., up to 12 weeks
Secondary Outcome Measures: assessing the change in weight and height, The study utilized a weight-height scale to measure weight and height for women in all groups (A, B \& C) and to calculate BMI before and after treatment., up to 12 weeks|assessing the change in bladder ascending movement, Transvaginal ultrasound assessment of bladder and urethra was conducted in the midsagittal plane, determining posterior urethro vesical angle., up to 12 weeks|assessing the change in Urinary function, The study uses a self-administered questionnaire to assess urinary function in women in different groups (A, B, and C) at the start and end of the study course. The questionnaire consists of 21 items, each with its own Likert rating scale structure. Each woman is instructed and given appropriate time to answer., up to 12 weeks|assessing the change in body mass index, The study utilized a weight-height scale to measure to calculate BMI before and after treatment., up to 12 weeks
Elderly Patients With Type 2 Diabetes and Cognitive Exercises
NCT Number: NCT06520995
Acronym: DIACOG
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Impairment|Diabetes Mellitus, Type 2|Diabetes Complications
Interventions: OTHER: Educational video program|OTHER: A mobile application
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-04-01
Completion Date: 2025-03-30
Locations: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Avcılar, 34320, Turkey

Summary:
The study was planned as a single-center, prospective randomized controlled study. Individuals over 65 years of age with type 2 diabetes without severe cognitive impairment will be included in the study. The primary aim of the study is to improve the cognitive functions of the patients after the interventions. The secondary aim is to strengthen patients' diabetes self-management and increase their quality of life, especially by improving their glycemic control. For these purposes, in our study, patients will be randomized into three groups: "cognitive exercise and diabetes education", "diabetes education only" and "control" group. The control group will be provided with standard outpatient diabetes education. Individuals who will be in the "cognitive exercise and video training" group will watch a total of 12 diabetes education videos prepared by the researcher, in which a different topic will be discussed every week for 3 months, and they will also participate cognitive exercises for 15-20 minutes a day for 3 months via a mobile application. Individuals in the "diabetes education only" group will similarly watch a total of 12 diabetes education videos prepared by the researchers. Patients will be evaluated in terms of cognitive function, psychosocial problems (anxiety, depression, stress), glycemic control (HbA1c), diabetes management and quality of life before the interventions, at 3 months and 6 months.

Primary Outcome Measures: Neurocognitive profile, Neurocognitive Assessment Battery, The moment it is included in the study, 3rd month, 6th month
Secondary Outcome Measures: Hba1c, Laboratory values derived from patients' routine visits, The moment it is included in the study, 3rd month, 6th month|Psychological state, A Scale to assess psychological state, The moment it is included in the study, 3rd month, 6th month|Quality of Life (1), Burden of Diabetes in the Elderly Scale, The moment it is included in the study, 3rd month, 6th month|Quality of Life (2), Type 2 Diabetes Self-Management Scale, The moment it is included in the study, 3rd month, 6th month|Qality of Life (3), SF-12 Quality of Life Scale, The moment it is included in the study, 3rd month, 6th month|Cognitive Function (2), Cognitive Function Instrument-Participant Form, The moment it is included in the study, 3rd month, 6th month
Early Neurovascular Adaptations in Aging Women
NCT Number: NCT06520982
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Women|Sympathetic Nervous System|Aging|Blood Flow
Interventions: DRUG: Norepinephrine|DRUG: Isoproterenol|DRUG: Acetylcholine|DRUG: Nitroprusside|DRUG: Estrogen
Sponsor: University of Missouri-Columbia
Sex: FEMALE
Age: ADULT
Enrollment: 64
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2027-06-30
Locations: University of Missouri-Columbia, Columbia, Missouri, 65211, United States

Summary:
Our goal is to enhance our understanding of early vascular adaptations in aging women with an emphasis on the sympathetic nervous system.

Primary Outcome Measures: Magnitude of forearm blood flow, Change from baseline during infusion
Prevelance of Uterine Vein and Uterine Vein System Variations
NCT Number: NCT06520969
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Vein Injury Left|Uterine Vein Injury Right
Interventions: OTHER: Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)
Sponsor: Istanbul University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-30
Completion Date: 2027-03-30
Locations: Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology, Istanbul, Istanbul / Turkey, 34093, Turkey

Summary:
Contrary to the uterine arterial system, our knowledge about superficial and deep uterine vein prevalence and anatomic variations are limited. The present study aims to deepen and clarify our knowledge on superficial and deep uterine vein anatomy, prevalence and relationship with other neighbouring structures which may be helpful in uterine transplantation and radical hysterectomy operations.

Primary Outcome Measures: To describe the prevalence of uterine vein and uterine vein system variations, To describe the prevalence of uterine vein and uterine vein system variations, 2 years
Comparison of Minimum Flow and Low Flow Desflurane Anesthesia in Robotic Assisted Laparoscopic Abdominal Surgery
NCT Number: NCT06520943
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Minimal Flow Anesthesia|Low Flow Anesthesia|Robotic Assisted Laparoscopic Abdominal Surgery
Interventions: OTHER: blood gas analysis
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-12-31
Locations: Ankara City Hospital, Ankara, Turkey

Summary:
This study aims to compare the use of low fresh gas flow (1 L/min) desflurane anesthesia with minimum fresh gas flow (0.5 L/min) desflurane anesthesia in patients undergoing robotic-assisted abdominal surgery. The comparison will be based on hemodynamic and respiratory parameters. The secondary aim of our study is to compare the two different fresh gas flow methods in terms of inhalation agent consumption and soda lime consumption.

Primary Outcome Measures: inspiratory O2 concentration, inspiratory O2 concentration is measured from anesthesia machine monitor, from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)|partial oxygen pressure, PO2 from blood gas analysis, from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
Secondary Outcome Measures: desflurane consumption, desflurane consumption, 3th hour|changes in liver and kidney function tests from the preoperative values to 48 hours postoperative, to determine the changes in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine from the preoperative values to 48 hours postoperative, postoperative 1st day
Novel Locator-Positioner Device for Temporomandibular Joint Arthroscopy
NCT Number: NCT06520917
Acronym: TMJ-LOPO
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Joint Disc Displacement|Temporomandibular Joint Disorders|Temporomandibular Joint Dysfunction Syndrome
Interventions: DEVICE: Locator-Positioner (LOPO) Guide Device
Sponsor: Sheba Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2018-08-31
Completion Date: 2020-01-18
Locations: Sheba Medical Center, Ramat Gan, 5265601, Israel

Summary:
The goal of this clinical trial is to evaluate a guide device (locator-positioner LOPO guide device) that is intended to aid the surgeon in temporomandibular joint (TMJ) arthroscopy. The aim of the device is to help the surgeon introduce the arthroscope and working cannula into the TMJ space. The trial evaluates the accuracy and safety of the device.

The main questions it aims to answer are:

* Does the LOPO guide device increase the accuracy of inserting the arthroscope and working cannula into the temporomandibular joint?
* Does the number of attempts to correctly place the working cannula relative to the arthroscope decrease?
* Does the overall time of surgery decrease when using the LOPO device?
* Does the device pose new surgical risks to temporomandibular joint arthroscopy?

The LOPO device was tried on anatomical models and proved to be very accurate. The present study recruits up to 10 patients to participate in this experiment. IRB approval and Ministry of Health approval have been given for conducting the clinical trial in 10 patients.

Participants will:

* Have a diagnosis of temporomandibular closed lock based on clinical and imaging findings.
* Undergo temporomandibular joint arthroscopy with the aid of the LOPO device.
* Visit the clinic for routine follow-up visits after roughly 1 week, 3 weeks, 2 months, and 6 months postoperatively, and at each visit be evaluated for maximal mouth opening and severity of pain on a 1-10 VAS.

Primary Outcome Measures: Number of attempts made to successfully insert the working cannula into the joint space, After puncturing the skin and advancing to the joint, any partial or complete withdrawal of the cannula followed by a change of vector or depth was considered an additional attempt. Confirmation of successful insertion was based on visualizing the working cannula by the arthroscope (i.e. observing the working cannula on the monitor)., This outcome is reported during the surgical procedure, as the number of attempts is counted by a resident in the operating room|The duration of time between the arthroscope's insertion into the joint cavity and the initial appearance of the working cannula on the monitor., The time that elapsed from the point when the arthroscope was inserted in the joint space and the point when the working cannula was seen on the monitor., This outcome is reported during the surgical procedure, as the time is measured by a resident in the operating room
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
NCT Number: NCT06520904
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Coronary Artery Disease|Optical Coherence Tomography
Interventions: DRUG: PCSK9 inhibitor|DRUG: Statin
Sponsor: First Affiliated Hospital of Xinjiang Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 396
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 830011, China

Summary:
The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.

Primary Outcome Measures: mFCT, minimum fibrous cap thickness, Immediate and 1 year after PCI|MLA, maximum lipid arc, Immediate and 1 year after PCI|Calcification, calcification, Immediate and 1 year after PCI|Fibrosis, fibrosis, Immediate and 1 year after PCI|Fibrolipid deposition, fibrolipid deposition, Immediate and 1 year after PCI|Necrosis, necrosis, Immediate and 1 year after PCI
"The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"
NCT Number: NCT06520891
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: 2 Drugs Are Statin and SGLT2i
Interventions: DRUG: Statin and SGLT2i
Sponsor: Fayoum University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-11-30
Locations: Asmaa mohamed abdelkader, El-Fayum, El Fayoum, Egypt

Summary:
correlate the serum level of statin and SGLT2i when given as polytherapy with HPLC in ischemic heart failure patients and their laboratory tests (cholesterol, LDL, HDL and TG...)

Primary Outcome Measures: The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease, correlate the serum level of statin and SGLT2i when given as polytherapy with ECG in ischemic heart failure patients and their laboratory tests (cholesterol, LDL, HDL and TG...), Three months of follow up
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
NCT Number: NCT06520878
Acronym: COGMEG5
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Omega 5|NANO-PSO|Cognition
Sponsor: Distribuidora Biolife SA de CV
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2025-09-01

Summary:
The objective of this randomized, triple-blind, placebo-controlled clinical trial is to compare NANO-PSO therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment. The primary questions it aims to answer are:

• Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo?

The researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients.

Participants will be required to:

* Consume two capsules of NANO-PSO or placebo daily in the morning for six months.
* Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment.
* Be evaluated in person at 90 and 180 days of treatment.
* The patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions.
* At the end of the final patient evaluation, a quality questionnaire will be administered.

Primary Outcome Measures: Cognitive status assessment, Cognitive status assessment using the Mini-Mental State Examination (MMSE), which ranges from 0 to 30 points., Assessed at baseline, 3, and 6 months.
Secondary Outcome Measures: Patients' fatigue status, Evaluation using the 9-item Fatigue Severity Scale, which measures the severity of fatigue and its impact on the daily activities and lifestyle of patients. The scale ranges from 9 to 63 points., Assessed at baseline, 3, and 6 months.|Selective attention and processing speed, Selective attention and processing speed will be evaluated using the Trail Making Test (TMT), where the average time for TMT Part A is 29 seconds, with more than 78 seconds being considered deficient. For TMT Part B, the average time is 75 seconds, and more than 273 seconds is considered deficient., Assessed at baseline, 3, and 6 months.|Frailty, Frailty will be assessed using the Fried Frailty Criteria (Phenotype Model), which comprises five criteria. Based on these criteria. 0 criteria = No frailty; 1 to 2 criteria = Pre-frailty; 3 or more criteria = Frailty, Assessed at baseline, 3, and 6 months.
TIDE Project: Biomarker Discovery for Chronic Tinnitus Diagnosis
NCT Number: NCT06520865
Acronym: TIDE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tinnitus
Interventions: OTHER: Acoustic paradigms
Sponsor: University of Regensburg
Collaborators: University of Dublin, Trinity College|Universität Tübingen|University Hospital, Zürich|Eastern Switzerland University of Applied Sciences|University of Texas at Austin|University of Illinois at Urbana-Champaign|Brai3n - Brain Research Center for Advanced, Innovative, Interdisciplinary and International Neuromodulation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 560
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-12-31
Locations: University of Illinois, Champaign, Illinois, 61820, United States|University of Texas, Austin, Texas, 78712, United States|Brai3n - Research center for Advanced, International, Innovative and Interdisciplinary Neuromodulation, Gent, 9000, Belgium|University of Tuebingen, Tuebingen, Baden-Wuerttemberg, 72074, Germany|Center of Neuromodulation - Psychiatry und Psychotherapie der Universität Regensburg am Bezirksklinikum, Regensburg, Bavaria, 93053, Germany|Trinity College Dublin, Dublin, Ireland|OST - Eastern Switzerland University of Applied Sciences, St. Gallen, 9000, Switzerland

Summary:
Research in clinical neuroscience is founded on the conviction that a better understanding of tinnitus related changes of brain function will improve our ability to diagnose and treat tinnitus. Although considerable advances have been made in understanding the mechanisms of tinnitus, the clinical management of tinnitus remains largely based on a 'trial and error' approach. The identification and validation of a biomarker for tinnitus is thought to be the crucial step in the development of a personalized approach to the diagnosis and treatment of tinnitus. The overarching goal of this study is to incorporate advanced technologies to provide an objective, data-driven, personalized approach to the diagnosis of chronic tinnitus. This should lead to a clinically applicable tool that can be widely and easily used.

Primary Outcome Measures: Event-related potentials, Event-related potentials of a 64-channel EEG, 4 hours
The Effect of the Use of Artificial Intelligence in the Preparation of Patient Education Material
NCT Number: NCT06520852
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Education|Artificial Intelligence
Interventions: OTHER: Group using artificial intelligence tools in addition to traditional tools in preparing educational materials
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-02-05
Completion Date: 2024-06-07
Locations: Sevda Korkut, Talas, Kayseri, 0(553) 310 49 51, Turkey

Summary:
This research was conducted to examine the effect of students' use of AI tools while preparing patient education material on the quality, understandability and actionability of the material in terms of content. Students in the control group used auxiliary tools such as books, journals and websites while preparing patient education materials. Students in the intervention group used AI tools in addition to tools such as books, journals, and websites.

Primary Outcome Measures: Understandability of the material, Patient Education Materials Assessment Tool for Printable Materials: The tool consists of a total of 26 items, 19 items evaluating the understandability of the materials and 7 items evaluating their actionability. PEMAT scores materials from 0 to 100 points for understandability and actionability., After the students have completed the materials (5 days later)|Actionability of the material, Patient Education Materials Assessment Tool for Printable Materials: The tool consists of a total of 26 items, 19 items evaluating the understandability of the materials and 7 items evaluating their actionability. PEMAT scores materials from 0 to 100 points for understandability and actionability., After the students have completed the materials (5 days later)|Quality of the material, Global Quality Scale : According to this scale, the quality of the training materials was evaluated on a 5-point scale (1: poor quality, 2: low quality - limited use, 3: somewhat useful, 4: useful, 5: useful-excellent quality)., After the students have completed the materials (5 days later)
Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes
NCT Number: NCT06520839
Acronym: EDGEN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Erectile Dysfunction With Diabetes Mellitus
Interventions: DRUG: Tadalafil 5mg
Sponsor: University Medical Centre Ljubljana
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-17
Completion Date: 2024-12
Locations: University Medical Centre Ljubljana, Ljubljana, 1000, Slovenia

Summary:
The goal of this clinical trial is to examine the genetic markers of erectile dysfunction degree in patients with diabetes and find new predictive models based on genetic factors, with which we will be able to more accurately address the adequacy of treatment in patients with diabetes, and thus have a long-term impact to reduce side effects of treatment. We will look for a predictive model based on genetic analysis to determine in the future patients with a good response to treatment with phosphodiesterase type 5 inhibitors, in our case tadalafil 5 mg daily. The main questions it aims to answer are:

1. Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
2. Genetic alterations in the folate pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
3. Genetic factors of the vascular wall influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
4. Genetic changes in the pathways of tadalafil metabolism and action influence the response to the treatment of erectile dysfunction in patients with diabetes.

Participants will take the drug tadalafil 5 mg every day for three months. The level of erectile dysfunction will be assessed with the IIEF-5 questionnaire at the beginning of the study and after three months of taking the drug.

Primary Outcome Measures: Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes., Genetic polymorphisms, 3 months|Genetic variations in the folate pathway influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes., Genetic polymorphisms, 3 months|Vascular wall genetic factors influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes., Genetic polymorphisms, 3 months|Genetic variations in tadalafil metabolism and action pathways influence response to erectile dysfunction treatment in patients with diabetes., Genetic polymorphisms, 3 months
Vafseo Outcomes In-Center Experience
NCT Number: NCT06520826
Acronym: VOICE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: Vadadustat|DRUG: Erythropoiesis Stimulating Agent
Sponsor: USRC Kidney Research
Collaborators: Akebia Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-06-30
Locations: USRC Kidney Research, Lone Tree, Colorado, 80124, United States

Summary:
This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.

Primary Outcome Measures: All-cause mortality, 18 months
Secondary Outcome Measures: All-cause hospitalization, 18 months
Analysis and Measurement of Nail Morphology
NCT Number: NCT06520813
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Morphology
Sponsor: University of Seville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-15
Completion Date: 2024-12-15
Locations: Clinica Rayo, Sevilla, 41008, Spain

Summary:
It consists of measuring the nail plate in its different areas.

Primary Outcome Measures: Normal length in milimeters of the nail plate, Analyze the normal parameters of length of the nail plate. The measurement will be carried out with an automatic caliper that will be positioned on the nail plate., 1 year follow-up|Normal width in milimeters of the nail plate, Analyze the normal parameters of width of the nail plate. The measurement will be carried out with an automatic caliper that will be positioned on the nail plate., 1 year follow-up|Normal curvature in degrees of the nail plate, Analyze the normal parameters of curvature of the nail plate. The measurement will be carried out with an automatic caliper that will be positioned on the nail plate., 1 year follow-up
Treatment and Handling Severe Obesity-Related Comorbidities in Adolescents Through Exercise
NCT Number: NCT06520800
Acronym: THOR-X
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adolescent Obesity|Hypertension,Essential|Non-Alcoholic Fatty Liver Disease|Dyslipidemias|Metabolic Disease|Metabolic Syndrome
Interventions: BEHAVIORAL: Treatment and handling obesity-related comorbidities in adolescents through exercise
Sponsor: University of Lisbon
Collaborators: Universidade Lusofona, Centro de Lisboa
Sex: ALL
Age: CHILD, ADULT
Enrollment: 24
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2028-12

Summary:
The main objective of this project is to analyze the effect of a tailor-made, one-to-one, exercise program (aiming to treat and handle obesity-related comorbidities in adolescents with severe obesity at high risk of cardiovascular disease development) on BMI z-score, specific comorbidities, and other health-related indicators.

This project will further allow to analyze the long-term impact of the exercise program not only on clinical parameters, but also on the interaction with drug-treatment, health-related behaviors, and quality of life, further contributing to the understanding of the individual characteristics associated with a positive exercise response and frequency.

The secondary objective of the THOR-X project is to build an educational toolkit, based on project results and relevant literature, addressed to health and exercise professionals, in order to improve management of adolescents with obesity, in particular those with severe obesity.

Primary Outcome Measures: Body Mass Index (BMI) z-score, Calculated according to World Health Organization (WHO) data, using the WHO AnthroPlus calculator (version 1.0.4), 6 (end of intervention) and 12 months (end of follow-up)
The Effect of Injectable PRF Vs LLL on Orthodontic Tooth Movement
NCT Number: NCT06520761
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rate of Canine Retraction|Root Resorption
Interventions: PROCEDURE: Injectable platelet rich fibrin|DEVICE: Low Level LASER
Sponsor: Faculty of Dental Medicine for Girls
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2022-11-01
Completion Date: 2024-12-01
Locations: Faculty of Dental Medicine for Girls Al Azhar university, Cairo, Naser City, 02, Egypt

Summary:
The purpose of the present study is to compare the effect of injectable platelet fibrin and Low Level LASER therapy on the rate of upper canine retraction, and on root resorption of the canine

Primary Outcome Measures: Rate of canine retraction, measure the rate of distal movement of the upper canine, 4 month
Secondary Outcome Measures: Root resorption of upper canine, measure root resorption of upper canine, 4 month
IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN STROKE
NCT Number: NCT06520748
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Hand rehabilitation program using the computerized glove|OTHER: Selected hand program
Sponsor: Ahmed Alshimy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-05
Completion Date: 2024-04-03
Locations: Al Ryada University for Science and Technology, Sadat, Menoufia, Egypt

Summary:
Hand impairment post-stroke is a common condition that contributes to disability around the world. An effective intervention is required to optimize functional outcomes in the rehabilitation of hand-in-stroke patients.

Primary Outcome Measures: Quantitive Electro Encephalo Graphy, Used to assess Neuralplasticity (sleep Delta - Delta/Beta ratio ), 6 weeks|Computerized glove software, Used to assess the Kinematic Data (Thumb, Index, Middle, ring, little, and average range of motion), 6 weeks|Action Research Arm Test, Used to assess Fine manual dexterity, 6 weeks
Effect of Transcutaneous Electrical Nerve Stimulation Versus Capsicum Plaster on Emesis Gravidarum
NCT Number: NCT06520735
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emesis Pregnancy
Interventions: DEVICE: Transcutaneous electrical nerve stimulation|OTHER: Capsicum plaster
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2024-11
Locations: Peter Bahgat Milad, Cairo, Egypt

Summary:
This study will be conducted to determine the difference between the effect of transcutaneous electrical nerve stimulation and capsicum plaster on emesis gravidarum.

Primary Outcome Measures: Rhodes index for nausea and vomiting and retching, It will be used to assess the severity of nausea (N), vomiting (V) and retching (R) for both groups before and after treatment.

It is an instrument consisting of eight 5-point self report items measuring the individual's perception of duration of nausea, frequency of nausea, distress from nausea, frequency of vomiting, amount of vomiting, distress from vomiting, frequency of retching, and distress from retching.

Its score ranges from 0 to 32. A score of 0 indicated no nausea, vomiting, or retching (NVR), 1-8 indicated mild NVR, 9-16 indicated moderate NVR, 17-24 indicated severe NVR, and 24-32 indicated the worst levels of NVR., within Five days|Modified pregnancy unique quantification of emesis and nausea (MPUQE), Nausea and vomiting of pregnancy (NVP) were measured and classified into three groups of different severity by using the 24-h Modified Pregnancy Unique Quantification of Emesis Scale (PUQE). MPUQE consists of three items that are used to assess the severity of NVP; the number of hours of nausea, the number of episodes of retching, and the number of episodes of vomiting within the last 24 hours. Each item has five options which are scored from 1 to 5 points. The MPUQE score is calculated by adding the values from each item which adds up to a total score that ranges from 3 to 15 points. The obtained total MPUQE-score was used to classify the severity of NVP into mild ≤6 points; moderate 7-12 points; severe ≥13 points., within five days
A New POP (Pelvic Organ Prolapse) Scoring System: Validity and Reliability
NCT Number: NCT06520722
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pelvic Organ Prolapse|Prolapse|Prolapse, Vaginal|Prolapse Uterus|Prolapse; Cervix
Interventions: DIAGNOSTIC_TEST: Prolapse scoring system
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-08-05
Locations: Doaa Adel, Cairo, Egypt

Summary:
There is a strong need for a better, simplified and informative applicable classification system that should be used to speak a common descriptive language among health care providers that treat POP.

The aim of our study is to test our proposed system, assess its validity and value in comparison to the widely used current system (POP-Q).

Primary Outcome Measures: Inter-observer reliability and validity of the new POP scoring system, Assessing and measuring the full items of validity and efficiency of our proposed scoring system in comparison to POP-Q system, one year
Secondary Outcome Measures: Time required to complete the new classification system, Time required to complete the new classification system, one year
Kinesiophobia in Postmenopausal Osteoporosis
NCT Number: NCT06520709
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Osteoporosis
Interventions: OTHER: No intervention
Sponsor: Beylikduzu State Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-21
Completion Date: 2024-02-21
Locations: Beylikdüzü State Hospital, Istanbul, 34147, Turkey

Summary:
This study aims to evaluate kinesiophobia levels in postmenopausal women with osteoporosis compared to a healthy control group and to explore the relationships between kinesiophobia and various psychosocial factors, including quality of life, fear of falling, and symptoms of depression and anxiety.

Primary Outcome Measures: Tampa Scale for Kinesiophobia (TSK), The Tampa Scale for Kinesiophobia (TSK) is a widely used tool for assessing fear of movement and physical activity, often referred to as kinesiophobia., 0 day
Secondary Outcome Measures: Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41), The Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) is a comprehensive instrument specifically designed to assess the quality of life in individuals with osteoporosis, 0 day|Hospital Anxiety and Depression Scale (HADS), The Hospital Anxiety and Depression Scale (HADS) is a widely used tool for assessing levels of anxiety and depression in patients, particularly in medical settings., 0 day|Tinetti Falls Efficacy Scale (TFES), The Tinetti Falls Efficacy Scale (TFES) is a tool designed to assess an individual's fear of falling and their perceived confidence in their ability to perform various activities without falling., 0 day
Adjuvant PD-1 Blockade for High-risk Stage-II dMMR/MSI-H Colorectal Cancer
NCT Number: NCT06520683
Acronym: SMALLER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Colorectal Cancer|Microsatellite Instability High
Interventions: DRUG: Tislelizumab|DRUG: Adjuvant chemotherapy
Sponsor: Sun Yat-sen University
Collaborators: BeiGene
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2030-09-01

Summary:
This open-label phase III trial investigates the efficacy of two cycles of PD-1 blockade (Tislelizumab) as adjuvant therapy to see how it works compared with standard of care (SOC) in treating patients with stage II dMMR/MSI-H colorectal cancer.

The rational of giving PD-1 blockade as adjuvant therapy is based on the fact that tumor recurrence is extremely low among patients receiving neoadjuvant immunotherapy, which suggests that PD-1 blockade may likely improve patients' long-term survival.

As for the short course (two cycles), we have the following considerations: firstly, the NICHE-2 trial, which adopted a two-cycle regimen, reported no recurrences during follow-up, suggesting that short-course anti-PD-1 therapy may be sufficient to improve the survival of patients with localized dMMR/MSI-H colorectal cancer. Secondly, the potential benefits of PD-1 blockade should be balanced against its toxicities, because patients with stage-II dMMR colorectal cancer generally have a good prognosis. Two cycles of PD-1 blockade have been shown to have a good safety profile, with low incidence of grade 3-4 and immune-related adverse events.

Primary Outcome Measures: Disease-free survival (DFS), DFS (tumor-specific) is defined as time from randomization to tumor relapse or tumor-related death. DFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test., 3 years
Secondary Outcome Measures: Overall survival (OS), OS is defined as time from randomization to death from any cause. Overall survival will be compared between treatment arms using the log-rank test., 5 years|Incidence of adverse events, Assessed by Common Terminology Criteria for Adverse Events version 4.0. The overall adverse event rates will be compared between treatment arms using Chi-square test or Fisher's exact test, as appropriate., up to 30 days after last treatment