pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
NCT Number: NCT06479161
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postoperative Pain
Interventions: DRUG: Tranexamic acid
Sponsor: Matthew Grosso, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2025-03-30
Locations: Trinity Health Of New England/CT Joint Replacement Institute, Hartford, Connecticut, 06105, United States

Summary:
The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.

Primary Outcome Measures: Visual Analogue Scale (VAS) Pain scores, Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome., POD 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).
Secondary Outcome Measures: Range of Motion, Clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion, at 2, 6 and 12 week follow up visits|Opioid consumption, Subjects will keep a log recording opioid consumption. Research staff will ask subjects to report opioids during postoperative telephone calls., POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days)|Ambulation Status, Surgeon or physical therapist will record if patient is using a walker, cane or no assistive devices., at 2, 6 and 12 week follow up visits
Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens
NCT Number: NCT06479148
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract
Interventions: DEVICE: enVista® Aspire™|DEVICE: An IOL with a slightly extended depth of focus|DEVICE: MX60E
Sponsor: Bausch & Lomb Incorporated
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-01
Locations: Site 101 Centro Oftalmológico Robles, Santa Rosa De Copán, Copán, 41101, Honduras

Summary:
A Prospective, Single-Center, Randomized Clinical Investigation to evaluate the safety and performance of the enVista® Aspire ™ (EA) intraocular lens (IOL) when compared to the MX60E monofocal IOL (control lens) and an IOL with a slightly extended depth of focus (active comparator lens) for potentially improved optical properties.

Primary Outcome Measures: Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3, Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3, Assessed from Day 90 to Day 150
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
NCT Number: NCT06479135
Acronym: POIESIS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Myelofibrosis|Post-PV MF|Post-ET Myelofibrosis|Primary Myelofibrosis|MF
Interventions: DRUG: Navtemadlin|DRUG: Navtemadlin placebo|DRUG: Ruxolitinib
Sponsor: Kartos Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2028-12-31
Locations: American Oncology Partners of Maryland, PA, Bethesda, Maryland, 20817, United States|Gabrail Cancer Center, Canton, Ohio, 44718, United States

Summary:
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.

Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Primary Outcome Measures: To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2, The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period, 24 weeks|To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2, The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period, 24 weeks
Secondary Outcome Measures: To compare time to progression between Arm 1 and Arm 2, Time to progression or death from any cause in subjects randomized to each arm, Up to 8 years|To compare overall survival (OS) between Arm 1 and Arm 2, Time to death from any cause in subjects randomized to each arm, Up to 8 years
Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section
NCT Number: NCT06479122
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Cesarean Section|Postoperative Pain
Interventions: DRUG: Acetaminophen|DRUG: Acetaminophen/Ibuprofen|DRUG: Acetaminophen|DRUG: Acetaminophen/Ibuprofen
Sponsor: Seoul National University Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2025-08-25

Summary:
The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.

Primary Outcome Measures: Obstetric QoR-11K score 24 hours after end of surgery, Minimum 0, poor recovery; maximum 110, good recovery, 24 hours after end of surgery
Secondary Outcome Measures: Numeric rating scale pain score (0-10) 4 hours after end of surgery, 0, no pain; 10, worst pain imaginable, 4 hours after end of surgery|Numeric rating scale pain score (0-10) 8 hours after end of surgery, 0, no pain; 10, worst pain imaginable, 8 hours after end of surgery|Numeric rating scale pain score (0-10) 12 hours after end of surgery, 0, no pain; 10, worst pain imaginable, 12 hours after end of surgery|Numeric rating scale pain score (0-10) 24 h after end of surgery, 24 h after end of surgery|Numeric rating scale pain score (0-10) 48 hours after end of surgery, 0, no pain; 10, worst pain imaginable, 48 hours after end of surgery|Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery, 24 h after end of surgery|Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery, 48 h after end of surgery|Use of rescue analgesia during the first 24 hours after end of surgery, 24 h after end of surgery|Use of rescue analgesia during the first 48 hours after end of surgery, 48 h after end of surgery|Wound-related complications during hospital stay, up to 5 days, From end of surgery to patient discharge, up to 5 days|Operation time, Duration of operation|Anesthesia time, Duration of anesthesia|Injection level of intrathecal drug, After arrival at the operating room|Dosage of intrathecal drug (mg, bupivacaine), After arrival at the operating room|Sensory blockade level by time point, 0, 5, 10 minutes after intrathecal injection and at the end of operation
Evaluation of a Behavioral Intervention to Optimize Supplement Adherence in Ethiopia
NCT Number: NCT06479109
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adherence, Patient
Interventions: BEHAVIORAL: Motivational materials for pregnant women attending antenatal care visits to improve supplement adherence|OTHER: Providers
Sponsor: Johns Hopkins Bloomberg School of Public Health
Collaborators: Bill and Melinda Gates Foundation
Sex: ALL
Age: CHILD, ADULT
Enrollment: 5096
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-22
Completion Date: 2025-04
Locations: Four regions in Ethiopia: South Ethiopia, Central Ethiopia, South-West Ethiopia, Sidama, Hawassa, Ethiopia

Summary:
This trial aims to learn if a set of behavioral materials designed to be used by providers and pregnant women increases supplement adherence among pregnant women in Ethiopia. The main questions the study aims to answer are:

* Do the behavioral materials increase adherence to iron and folic acid supplements (IFAS) or multiple micronutrient supplements (MMS) among women attending antenatal care visits?
* Are the materials relevant, easy to use, acceptable, and scalable? During the analysis, researchers will compare supplement adherence between women exposed to the behavioral materials and women not exposed to the behavioral materials. Researchers will also compare supplement adherence before and after the behavioral intervention, ensuring a comprehensive evaluation.

Participants will include providers in intervention clinics and pregnant women attending intervention and control clinics for antenatal care (ANC):

* A total of 28 clinics will receive the behavioral intervention, and another 28 will serve as controls providing the standard antenatal care counseling.
* Pregnant women attending intervention clinics for ANC will receive behavioral materials to use at home as a reminder to take ther supplements (IFAS or MMS).
* Pregnant women attending control clinics will receive the standard ANC counseling.

Primary Outcome Measures: Percentage of pregnant women who report consuming five or more [ 80 percent] IFA/MMS tablets in the past week, Baseline, 8 months, 9 months|Percentage of pregnant women who report consuming 24 or more [80 percent] IFA/MMS tablets in the last 30 days [past month], Baseline, 8 months, 9 months|Percentage of pregnant women who report consuming 90 or more IFA/MMS tablets during the entire pregnancy, Baseline, 8 months, 9 months|Total number of pills provided based on the count of IFAS blister/strips or MMS pills in bottles, Baseline, 8 months, 9 months|Total number of pills consumed based on the count of IFAS blister/strips or MMS pills in bottles, Baseline, 8 months, 9 months
Interdisciplinary + Intersectoral Telemedicine Evaluation, Coordination + Treatment in RhineMain+ Parkinson's Network
NCT Number: NCT06479083
Acronym: INSPIRE-PNRM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: OTHER: New Intervention form including|OTHER: Standard treatment
Sponsor: Johannes Gutenberg University Mainz
Collaborators: Hochschule für Wirtschaft und Gesellschaft Ludwigshafen Institut für Management, Ökonomie und Versorgung im Gesundheitsbereich|Katholische Hochschule Mainz Fachbereich Gesundheit und Pflege|Universitätsklinikum Frankfurt Zentrum der Neurologie und Neurochirurgie|Techniker Krankenkasse Landesvertretung Rheinland-Pfalz|DAK-Gesundheit Landesvertretung Rheinland-Pfalz und Saarland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1354
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2027-01-31

Summary:
Project objective: To improve the health care of Parkinson's disease patients in the ParkinsonNetz RheinMain+.

Hypothesis: Through the interdisciplinary and cross- sectoral networking in a tele medical network and the coordinating function of an "advanced practice nurse" (APN) specially trained for Parkinson's disease, the process quality within the network is increased and the individual health status is positively influenced.

Primary Outcome Measures: Are there differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the controll group- operationalized by the PDQ-39, Parkinson´s Disease Quetionnaire -39 - to measure the differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the control group, duration of the intervention: 24 months
Secondary Outcome Measures: Are there differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group measured with the MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS III), MDS-UPDRS III- to measure the differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group, duration of the intervention: 24 months|Are there differences in the change in quality of life across diseases after 12 months of observation between the intervention and the control group measured with the European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-5L), EQ-5D-5L- to measure the differences in the change in quality of life across diseases after 12 months of observation between the intervention group and the control group, duration of the intervention: 24 months
Applying Herrmann's Brain Quadrant Model to Learning Styles in Anesthesiology Residents
NCT Number: NCT06479044
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Learning Problem
Interventions: DIAGNOSTIC_TEST: Herrmann Brain Model
Sponsor: Instituto Mexicano del Seguro Social
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-05-31
Locations: National Western Speciality Hospital, Mexican Social Security Institute, Guadalajara, Jalisco, 44329, Mexico

Summary:
the ability to learn and adapt to clinical demands is essential in the training of residents. The Herrmann Brain Model categorizes thinking styles based on the preference for utilizing brain quadrants, serving as an applied tool for residents to assess their learning preferences.

Primary Outcome Measures: Quadrant dominance, Determine the learning style of each one of them based on the predominant cerebral hemisphere, 12 months
ETERNALS: Remote Monitoring in Lung Cancer Patients
NCT Number: NCT06479005
Acronym: ETERNALS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-small Cell Lung Cancer|Remote Monitoring|Mobile Health|Chemotherapy Effect
Interventions: DEVICE: Oura Ring
Sponsor: Ziekenhuis Oost-Limburg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2025-12-31
Locations: Ziekenhuis Oost-Limburg, Genk, Limburg, 3600, Belgium

Summary:
The primary objective of this project is to determine the feasibility of an integrated remote monitoring system in the routine care of lung cancer patients receiving cytotoxic chemotherapy.

Primary Outcome Measures: Time interval, Determining the time interval between clinical deterioration detected by the integrated remote monitoring system and the first contact with the care team (i.e., in current clinical practice the patient suffering from chemotherapy-associated symptoms self-reports at the ED), 18 months|Compliance, Patient compliance in using the integrated remote monitoring system which will be determined via: number of missed measurements, number of telephonic/physical contact moments related to the technology, 18 months
Secondary Outcome Measures: System Usability scale to assess usability and acceptability of the remote monitoring system, Acceptability and usability of the integrated remote monitoring system by both the patient and the healthcare specialists. This will be assessed using the following questionnaire: System Usability scale (SUS). The scale varies from 1-5, corresponding with 1 being strongly disagree and 5 strongly agree. Depending on the question, the score can be found either positive/negative., 18 months|mobile Health App Usability Questionnaire to assess usability & acceptability of the remote monitoring system, Acceptability and usability of the integrated remote monitoring system by both the Acceptability and usability of the integrated remote monitoring system by both the patient and the healthcare specialists. This will be assessed using the following questionnaire: mobile Health App Usability Questionnaire (MAUQ). The scale varies from 1-7, with 1 corresponding to 'disagree' and 7 corresponding to 'agree'. Depending on the question, the score can be found either positive/negative., 18 months|Number of ED visits, Determine the number of ED visits retrospectively, including the disease- and therapy related/induced complications (retrospective sub-study), 18 months
Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
NCT Number: NCT06478992
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adenomyosis|Hysteroscopy
Interventions: PROCEDURE: A:hysteroscopic suture fixation of Mirena|PROCEDURE: A: simple Mirena placement under hysteroscopy|PROCEDURE: B: hysteroscopic suture fixation of Mirena|PROCEDURE: B：simple Mirena placement under hysteroscopy
Sponsor: First People's Hospital of Hangzhou
Sex: FEMALE
Age: ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2026-06-30

Summary:
The purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.

Primary Outcome Measures: expulsion rate of the Mirena, 1, 3, 6, and 12 months postoperatively
Secondary Outcome Measures: menstrual volume, 1, 3, 6, and 12 months postoperatively|dysmenorrhea, 1, 3, 6, and 12 months postoperatively|uterine size under ultrasound, 1, 3, 6, and 12 months postoperatively
The Effect of Stoma Care Training Using the PechaKucha Method on Stoma Care Skills and Anxiety in Nursing Studen
NCT Number: NCT06478966
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PechaKucha Method
Interventions: BEHAVIORAL: Experimental
Sponsor: Çankırı Karatekin University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-04-30
Completion Date: 2024-05-15
Locations: Figen Erol Ursavaş, Aksu, Çankırı, 18200, Turkey

Summary:
Aim: This study aimed to evaluate the effects of stoma care training delivered using PechaKucha (PK) on the stoma care skills and anxiety of nursing students.

Background: The PK method is a visual and narrative slide-based presentation technique. The presentation format involves 20 slides (usually containing images only) that are shown for 20 seconds each, for a total presentation length of 6 minutes and 40 seconds.

Design:A single-blind randomized controlled study was conducted according to the CONSORT guideline.

Methods: The study sample comprised 96 first-year nursing students (47 in the intervention group and 49 controls). Data were collected during the 2024 spring semester using a student information form, the Stoma Care Skill Rubric, and the State-Trait Anxiety Inventory. Stoma care training was delivered using the PK method for the intervention group and a classic lecture presentation for the control group.

Primary Outcome Measures: stoma care skills, Comparison of mean stoma care skills score of nursing students in the intervention and control groups of two days after the training Stoma Care Skill Rubric: 23-item scale.It is scored between 0 and 2 points. When the skill is performed completely and in the correct order, 2 points are received. If it is incorrect or not done, 0 points are received. total score is between 0 and 46, Nursing students' stoma care skills mean score levels were evaluated two days after the training
Secondary Outcome Measures: anxiety, Comparison of mean anxiety scores of nursing students in the intervention and control groups of two days after training. The anxiety inventory assesses how the person feels in certain circumstances and at a certain moment, while the trait anxiety inventory assesses how the person usually feels. Each item is scored between 1 and 4. A higher total score is interpreted as a higher level of anxiety, Nursing students' anxiety levels were evaluated two days after the training
3Mixtatin and MTA Vital Pulpotomy in Primary Molars
NCT Number: NCT06478940
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pulp Disease, Dental|Deciduous Teeth
Interventions: DRUG: 3 mixtatin pulpotomy|DRUG: MTA pulpotomy
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-09-01

Summary:
The aim of the study is to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars.

Primary Outcome Measures: Clinical success Clinical success clinical success, absence of postoperative pain,Absence of pain on percussion,Absence of Swelling and Absence of Sinus or fistula, 1 week , 3 months , 6 months , 9 months and 12 months
Secondary Outcome Measures: Radiographic success radiographic success, Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones, internal or external root resorption ), 3 months , 6 months , 12 months
Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
NCT Number: NCT06478927
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Palbociclib capsules
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-15
Completion Date: 2027-01-15
Locations: Henan Cancer Hospital, Zhengzhou, Henan, China

Summary:
Currently, it has been demonstrated that CDK4 is highly expressed in hepatocellular carcinoma patients and is significantly associated with poor prognosis in hepatocellular carcinoma patients. Palbociclib is the world's first marketed inhibitor of the cell cycle protein-dependent kinase CDK4/6, which is capable of blocking cell cycle progression and inhibiting tumor cell proliferation. However, current evidence for the use of CDK4/6 inhibitors in patients with advanced hepatocellular carcinoma cells remains lacking. This study used palbociclib backline treatment for patients with advanced hepatocellular carcinoma, aiming to further validate the potential role of CDK4/6 inhibitors in the treatment of patients with advanced hepatocellular carcinoma.

Primary Outcome Measures: Progression-free survival (PFS), PFS is defned as the time from randomization untlthe date of first occurence of investigator assessed radiolbgical disease progression or death due to any cause,whichever came first., up to approximately 2 years.
Secondary Outcome Measures: Objective response rate (ORR), ORR is defied as the percentage of subject with complete response (CR) or partial response (PR) by investigator assessment per REclsT criteria, version 1.1., up to approximately 2 years.|Disease control rate (DCR), DCR was defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)., up to approximately 2 years.|Overall survival (OS), OS is defined as the time from the date of randomization to the date of death due to any cause., up to approximately 2 years.|Adverse Events (AE), AE assessed by NCI-CTCAE V5.0., up to approximately 2 years.
Neuromuscular Electrical Stimulation Versus Low-intensity Laser on Motor Conduction Velocity of the Common Peroneal Nerve Post Burn
NCT Number: NCT06478914
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuropathy, Peroneal|Motor Neuropathy|Neuromuscular Electric Stimulation (NEMS)|Low Intensity Laser
Interventions: DEVICE: Neuromuscular electrical stimulation (NMES)|DEVICE: low-intensity laser therapy (LILT)
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-02-01
Completion Date: 2023-01-01
Locations: out-clinics of Kasr-El-Aini, Cairo, Egypt

Summary:
Purposes of this study were the following:

1. To evaluate the therapeutic efficacy of NMES in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
2. To evaluate the therapeutic efficacy of LIL in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
3. To detect which one of both was the better and most effective than the other in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.

Primary Outcome Measures: motor conduction velocity (MCV), The study involved a common peroneal nerve MCV measurement in an air-conditioned room. The subject was placed in a supine position for 5 minutes to rest and relax. The recording electrodes were placed over the EDB muscle, with the active electrode placed over the main bulk of the muscle. The stimulating electrodes were placed 8 cm proximal to the active electrode for distal latency and distally in the lateral part of the popliteal fossa for proximal latency. The subject was then asked to lie supine for 5 minutes for leg massage, rest, and relaxation. The EMG12 program disk was loaded, and electrodes were connected to the active channels and common electrode. The program was moved to the ready condition after pressing keys on the keyboard. The sensitivity was 1 mv/diameter, the sweep speed was 3 ms, and the stimulus intensity ranged from 0.1 to 99 mA. Segmental distances between stimulation points were measured using a tape measure., at base line and following 8 weeks
Precision of AI-Based Cardiac Ultrasound for LVEF in the Elderly
NCT Number: NCT06478901
Acronym: PRECISE AI
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Heart Failure Systolic|Elderly|Artificial Intelligence
Interventions: DEVICE: Echocardiography
Sponsor: Hôpital Broca APHP
Sex: ALL
Age: OLDER_ADULT
Enrollment: 129
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-14
Completion Date: 2024-02-20
Locations: Hôpital Broca, Paris, 75013, France

Summary:
Heart failure (HF) is common in older adults, especially those over 65. It is a leading cause of hospitalization and has high mortality rates. Diagnosing HF in elderly patients can be challenging due to atypical symptoms and multiple other health issues. Echocardiography, an ultrasound of the heart, is crucial for accurate diagnosis and treatment planning.

One problem in geriatric care is the difficulty of accessing echocardiography due to high demand and limited specialized doctors. Recent advancements show that AI-assisted portable ultrasound devices can reliably measure heart function, producing results comparable to traditional methods.

This study aims to evaluate the accuracy and relevance of AI-assisted echocardiography (AutoEF-AI) in elderly patients. It also assesses whether geriatricians, even without specialized training, can capture quality images for AI analysis.

In simple terms, this study investigates if portable ultrasound devices with AI can provide precise heart function diagnostics, making it easier for older adults with heart failure to get the care they need, even without specialists.

Primary Outcome Measures: evaluate the relevance and accuracy of echocardiography assisted by Artificial intelligence in elderly patients, The correlation between LVEF measurements from standard echocardiography and AutoEF-AI echocardiography was assessed using the intraclass correlation coefficient (ICC) and Bland-Altman analysis. Weighted Kappa coefficient was calculated to determine agreement between measurements in classifying patients into different categories based on LVEF, From enrollment to the end 48 hours
Impact on Cognitive Impairment of Hearing Disorders Associated or Not With Precarious Conditions
NCT Number: NCT06478888
Acronym: CAP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cognitive Dysfunction
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-01
Locations: Service de neurologie, Bobigny, 93000, France

Summary:
Cognitive disorders are extremely common. Alzheimer's disease is the most common cognitive disorder, with an estimated 800,000 to 1 million patients suffering from this neurodegenerative disorder in France. Cognitive disorders can also be observed in other common conditions such as Parkinson's disease and multiple sclerosis.

It has been shown that the presence of hearing impairment associated with cognitive disorders increases the latter. In addition, rare studies have shown that people in precarious situations are at greater risk of developing cognitive disorders early and rapidly, and consequently dementia.

The population of Seine Saint Denis (93) is known to be particularly affected by precariousness, which is why the investigators want to study its impact on patients with cognitive disorders associated with hearing impairment. These people need to be detected and supported in order to offer them a hearing aid that would improve or stabilize their cognitive state, or at least facilitate the rehabilitative management of their cognitive deficit.

Primary Outcome Measures: The primary endpoint is the MMSE score in subjects with unaidided hearing impairment, comparing precarious, to determine the effect of precariousness on cognitive impairment, as defined by MMSE score, in subjects with unaid hearing impairment., through study completion an average of 1 year
Secondary Outcome Measures: impact of unaidable hearing impairment on cognitive impairment in precarious and non-precarious patients., to evaluate and compare: Cognitive impairment established by MMSE score (2 groups with mild and moderate/severe impairment) according to the presence or absence of hearing impairment and according to the presence or absence of precariousness (according to EPICES score \> 30 or ≤ 30, respectively)., through study completion an average of 1 year|impact of precariousness and unaidable hearing impairment on cognitive impairment as determined by other neuropsychological tests (other than the MMSE score), To evaluate and compare:

Other neuropsychological tests, through study completion an average of 1 year|Evaluate the quality of life of these patients., To evaluate and compare : Quality of life assessed by SF-36 questionnaire, through study completion an average of 1 year
Promitil Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After Therapy
NCT Number: NCT06478862
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cancer of Ovary|Pancreatic Ductal Adenocarcinoma
Interventions: DRUG: Promitil
Sponsor: Lipomedix Pharmaceuticals Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2027-01
Locations: Soroka Medical Center, Be'er Sheva, Israel|Rambam Health Care Campus, Haifa, Israel|Wolfson Medica Center, H̱olon, 5822012, Israel|Shaare Zedek Medical Center, Jerusalem, 9103102, Israel|Tel-Aviv Sourasky Medical Center, Tel-Aviv, 64239, Israel|Shamir Medical Center (Asaf Harofeh), Zerifin, 70300, Israel

Summary:
This multicenter Phase 2a study was designed to evaluate the safety, tolerability, and efficacy of Promitil in patients with recurrent ovarian cancer and inoperable, locally advanced or metastatic pancreatic cancer, which bears deleterious germline or somatic mutations in BRCA1, BRCA2, or HRD (homologous recombination deficiency) -related genes.

Based on reported preclinical and clinical efficacy of Mitomycin C in BRCA-mutated tumors, and together with the demonstrated improved safety profile of Promitil in humans, it is expected that this liposomal formulation will have a favorable therapeutic index and significant clinical antitumor activity in patients with tumors bearing BRCA 1/2 and/or PALB2 mutations.

Primary Outcome Measures: Progression-free survival (PFS) rate at Month 6, defined as the proportion of patients who are alive and without radiological or clinical progression, based on RECIST 1.1, 24 weeks
Secondary Outcome Measures: Incidence, severity, and duration of treatment-emergent adverse events (TEAEs), TEAEs assessed by NCI Common Toxicity Criteria Adverse Events (CTCAE v5.0)., 30 weeks|Objective response rate (ORR):, ORR: proportion of patients with partial or complete response (PR or CR, respectively), based on RECIST 1.1 criteria, 24 weeks|Duration of response (DOR), DOR: defined as the time from first evidence of confirmed objective response to the first occurrence of disease progression or death from any cause, 24 weeks|Disease control rate (DCR), DCR :defined as proportion of subjects alive and free of disease progression with either complete response (CR), partial response (PR) or stable disease (SD), 24 weeks|Overall survival (OS):, OS: time from first dose of Promitil to date of death from any cause, 52 weeks|To assess the changes in tumor biomarker levels following treatment with Promitil, Changes from baseline in CA19-9, CA125 and/or CEA blood levels, 24 weeks
Other Outcome Measures: Plasma MLP (mitomycin lipidic pro-drug) level after Promitil infusion, Plasma MLP levels before and after each Promitil dose (1h, 4h, 24h, 7days) as measured in cycles 1 and 3, 12 weeks
Adherence and Understanding of a Therapeutic Education Program for Patients With Central Venous Access (EDUVVC)
NCT Number: NCT06478849
Acronym: EDUVVC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Central Venous Lines|PICCline|Therapeutic Education Program|Prevention
Interventions: OTHER: QUESTIONNAIRES
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-17
Completion Date: 2025-07-29

Summary:
The ever-increasing use of central venous lines, including PICC lines, and the shift in medical practice towards ambulatory care, are making it increasingly complex to prevent the infectious and non-infectious risks associated with their use.

The involvement of numerous healthcare professionals within and outside the hospital, with varying levels of training, exposes patients to numerous complications, the incidence of which, depending on the device, ranges from 6 to 16%, and occur at the time of insertion (hematoma, pneumothorax, necrosis) or during use (infection, thrombosis, extravasation).

The transmission of knowledge and the acquisition of skills by patients wearing this type of invasive device helps to make the patient a player in his or her own care, and could help to reduce the frequency of risks. As part of a therapeutic education program, we aim to validate the communication tools and messages identified by a panel of French experts. These messages, together with the article published by Petit et al, have enabled us to draw up a skills reference framework for patients with a PICC line.

The aim of this non-interventional project (RIPH3) is to evaluate patient adherence to the project and understanding of the messages in a prospective cohort of patients.

This project is part of a collaborative approach that includes the creation of a mobile application for therapeutic education.

Primary Outcome Measures: Assess patients' level of understanding of communication tools., The level of comprehension will be assessed on the acquisition of the main messages and will be expressed as a percentage of correct answers., WEEK 6 POST INCLUSION
Secondary Outcome Measures: Estimating patient adherence to communication tools, Adherence to communication tools will be assessed by the frequency of participation in the various webinars proposed., WEEK 6 POST INCLUSION|Identify individual factors : a- Demographic b- Related to underlying pathology c- Management-related, age, gender, ethnic origin, mother language, lifestyle, place of residence..., week 6 post inclusion
Planter Pressure and Body Mass Index Affect Balance in Normal Children
NCT Number: NCT06478836
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Plantar Pressure
Interventions: OTHER: planter pressure
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-23
Completion Date: 2024-05-02
Locations: Mostafa S Ali, Giza, Married, 12668, Egypt

Summary:
is there relation between planter pressure, body mass index and balance in normal children?

Primary Outcome Measures: Foot pressure will be recorded by a pedograph, Foot pressure will be recorded by a pedograph, 3 months|BMI will be calculated by weight/height^2 (CDC chart)., BMI will be calculated by weight/height\^2 (CDC chart)., 3 months|Balance will be assessed by Biodex, Balance will be assessed by Biodex, 3 months
Ambulatory Surgery After Hepatectomy: Monitoring by Domomedicine Connected Tools and a Dedicated Nurse.
NCT Number: NCT06478810
Acronym: HEPADOM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Tumor|Hepatectomy
Interventions: OTHER: Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-12-04
Locations: Hepato-biliary surgery department, Villejuif, France

Summary:
There are public health expectations for the development of outpatient surgery and increased comfort and quality of care for the patient. In this study, we are interested in evaluating the feasibility of an outpatient hepatectomy with a a close and secure follow-up at home: through a connected platform and a follow-up by a nurse. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management). This single-center study will includes prospectively 20 patients requiring liver resection of up to 2 segments. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management).

Primary Outcome Measures: Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management)., Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization., Day 30
Secondary Outcome Measures: Evaluation of the rate of data collection in patients' homes outside of technical failure., Evaluation of the rate of data collection in patients' homes outside of technical failure. This will permits to appreciate the adherence to the ambulatory mode of care., Day 30|Diagnosis of digestive complications, Digestive complicactions questionnaire, including transit, pain and feeding personnal feeling (internal scale), At Day -3, at Day 0, at Day 1 to Day 7 and at Day 30|Type of complications, Type of complications, From Day 0 to Day 30|Severity of complications (Clavien classification), Severity of complications following the Clavien classification, From Day 0 to Day 30|Mortality rate at Day 30, Mortality rate at Day 30, Day 30|Morbidity rate at Day 30, CCI score (Comprehensive Complication Index) at Day 30, Day 30|Satisfaction of the ambulatory management., Score based on three questionnaires completed by the patient : MDASI questionnaire, Quality of life questionnaire (SF36) and Satisfaction of the ambulatory medical support, MDASI questionnaire : at Day -3, at Day 0 and at Day 1 to Day 7 ; SF 36 questionnaire : Day -3 and at Day 30; Satisfaction of the ambulatory questionnaire at Day 30.
Effects of Resistance Training in Multiple Sclerosis: a Randomized Trial.
NCT Number: NCT06478784
Acronym: ACTIVE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: OTHER: Resistance training|OTHER: Low aerobic training
Sponsor: Hospital Clínico Universitario de Valladolid
Collaborators: European University Miguel de Cervantes
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-01-30
Locations: Hospital Clínico Universitario de Valladolid, Valladolid, 47003, Spain

Summary:
This is a longitudinal study to examine the effects of a short-term training program on neurofilamet and GFAP plasma levels. Participants will be divided in two groups: control group (moderate aerobic training) and active group (resistance training). The change in biomarkers will be analyzed pre and post intervention in both groups. Differences between groups will be also evaluated by investigators.

Primary Outcome Measures: Comparison of plasma light chain neurofilaments (Nfl) level, To evaluate the change of plasma neurofilament concentrations (pg/mL) between the two groups of multiple sclerosis patients, the control group that will perform moderate aerobic exercise vs. the group subjected to the resistance training intervention., 10 Weeks
Secondary Outcome Measures: Comparison of plasma Glial fibrillary acidic protein (GFAP) level, To study the change of plasma Glial fibrillary acidic protein (GFAP)(pg/mL) between the two groups of multiple sclerosis patients, the control group that will perform moderate aerobic exercise vs. the group subjected to the resistance training intervention., 10 weeks
The Effect of Patient Preference on Retention Success
NCT Number: NCT06478771
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malocclusion|Orthodontic Retention
Interventions: DEVICE: Essix retainer|DEVICE: Lingual retainer
Sponsor: Hacettepe University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2021-12-14
Completion Date: 2024-06-12
Locations: Irmak Ocak, Ankara, Turkey

Summary:
Aim of the Study: To determine whether allowing the patient to choose the type of retainer affects the success of retention in terms of stability and patient satisfaction.

Hypothesis: Allowing the patient to choose their retainer can increase the success of retention.

Design: Two-arm parallel group randomized controlled clinical trial

Primary Outcome Measures: Stability, Stability will be assessed using Little's Irregularity Index at baseline and 24 months post-treatment. The index measures the alignment of anterior teeth, with scores ranging from 0 (perfect alignment) to 10 (severe misalignment). Lower scores indicate better outcomes., 2 years
Secondary Outcome Measures: Retainer survival, The survival rate of retainers will be monitored over a 24-month period. This includes the number of participants who retain their original retainer without breakage or loss. Retainer survival will be categorized into "retained," "broken," and "lost.", 2 years|Oral health, Oral health will be assessed at baseline and 24 months post-treatment using clinical examinations for caries presence (will be evaluated by inspection, will be stated as a number), gingival bleeding (measured by the Gingival Bleeding Index), and sulcus depth (measured in millimeters using a periodontal probe). Lower scores for gingival bleeding and sulcus depth indicate better oral health., 2 years|Patient satisfaction, Patient satisfaction will be measured using a questionnaire. 8 questions in the questionnaire are yes or no questions. Other 3 questions are 5-point Likert questions., 2 years
Ibuprofen Use on Post-operative Pain Following Cholecystectomy
NCT Number: NCT06478758
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Post-operative Pain
Interventions: DRUG: Ibuprofen 400 mg|DRUG: Acetaminophen 100 MG/ML
Sponsor: Giresun University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 71
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2024-04-30
Locations: Giresun University, Giresun, Turkey

Summary:
In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.

Primary Outcome Measures: VAS scores in the postoperative period, Primary outcome was to reduce the VAS scores in the postoperative period. For this purpose the investigators recorded VAS scores at the 1, 2, 6, 12 and 24 h postoperatively., 24 hour
Secondary Outcome Measures: Opioid consumption and length of stay, Secondary outcome was any decrease in opioid consumption and hospitalization., 24 hour
The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity
NCT Number: NCT06478667
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Cardiotoxicity
Interventions: DRUG: levosemindan
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-20
Completion Date: 2025-01-20
Locations: Poison Control Center, Cairo, Egypt

Summary:
To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity

Primary Outcome Measures: systolic blood pressure, Maintain systolic blood pressure with adequate organ perfusion, acute phase of myocarditis in 48 hours