pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Psychological Resilience and Disaster Preparedness
NCT Number: NCT06542081
Acronym: disaster
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Psychological Resilience and Disaster Preparedness
Interventions: BEHAVIORAL: Descriptive information form, psychological resilience scale and disaster preparedness scale were completed by the parents of hearing impaired children.
Sponsor: Yuzuncu Yıl University
Sex: ALL
Age: ADULT
Enrollment: 178
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-07-14
Locations: Van Yuzuncu Yıl University, Van, Turkey

Summary:
Given our geographical location, there is always the possibility of encountering a disaster at any moment. It is a well-known fact that families with children who have special needs face a series of challenges throughout their lives, and these challenges are known to increase during disaster situations. Therefore, it is emphasized that families with children who have special needs should be supported in every aspect. This study aims to examine the relationship between the psychological resilience levels of parents with hearing-impaired children and their disaster preparedness. With this research, the question "How can the relationship between the psychological resilience levels of parents with hearing-impaired children and their disaster preparedness be assessed, and can this relationship provide insights into how more effective support can be provided to families?" seeks an answer.

Primary Outcome Measures: psychological resilience scale, The scale consists of a total of 21 items. It is rated on a five-point Likert scale ranging from "Completely describes me (5)" to "Does not describe me at all (1)." Higher scores indicate higher psychological resilience. The scale comprises four sub-dimensions: Relational Resources, Individual Resources, Cultural and Contextual Resources, and Familial Resources., 6 monts|disaster preparedness scale, The Disaster Preparedness Scale consists of 15 questions and 4 sub-dimensions. The four factors are named as follows: Disaster Physical Protection (DPP), Planning (P), Disaster Aid (DA), and Disaster Warning and Signals (DWS). The DPP factor consists of 7 items with factor loadings ranging from .79 to .40; The P factor consists of 3 items with factor loadings ranging from .84 to .75;. The DA factor consists of 3 items with factor loadings ranging from .78 to .60., 6 monts|Descriptive information form, Based on the literature, a 23-question form has been created to determine socio-demographic characteristics such as age, gender, income status, presence of chronic illness, number of children, and the place where the family lives., 6 monts
Chatbot Effectiveness for Improving Mental Health and Reducing Stress in Nursing Students
NCT Number: NCT06542068
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health|Stress|Nursing Education
Interventions: BEHAVIORAL: Line Bot Assistance
Sponsor: Chang Gung University of Science and Technology
Sex: ALL
Age: ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-26
Completion Date: 2025-07-31

Summary:
This study aims to evaluate the effectiveness of using a chatbot to improve mental health and reduce stress among nursing students during their internships. The study will be conducted through convenient sampling of nursing students from a technology university in southern Taiwan. Students will be divided into experimental and control groups to compare differences in mental health and stress levels after receiving support from the chatbot. Expected outcomes include gaining a better understanding of the fundamental characteristics of nursing students and their mental health and stress levels during internships. The results are expected to demonstrate that the chatbot can aid nursing students in handling typical internship issues, stress, and challenges, as well as in accessing mental health resources.

Primary Outcome Measures: Brief Symptom Rating Scale, Five-point Likert-type scale of 0 to 4, with 0 being not at all and 4 being extremely.A total score on the BSRS-5 above 14, or a score of more than 1 on the additional suicide survey item, may indicate a severe mood disorder. Scores between 10 and 14 may indicate moderate mood disorders, and those between 6 and 9 could indicate mild mood disorders., The students are interning for four weeks. A pre-test was conducted during the first week, and a post-test was administered at the end of the fourth week.|Clinical Internship Stress Survey Form, Total of 24 questions are included in the survey, utilizing a four-point Likert-type scale ranging from 1 to 4. The total score on the scale falls between 24 and 96, with higher scores indicating increased stress levels during the clinical practicum., The students are interning for four weeks. A pre-test was conducted during the first week, and a post-test was administered at the end of the fourth week.
Application of Nanopore Adaptive Sequencing
NCT Number: NCT06542042
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Transplant Infection
Interventions: DIAGNOSTIC_TEST: NAS, NGS and Laboratory tests
Sponsor: Shenzhen Third People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-10-30
Locations: Shenzhen Third People's Hospital, Shenzhen, Guangdong, China

Summary:
Infection post liver transplantation is an important factor in the death in patients. The traditional method of diagnosing infection post liver transplantation is laboratory tests. But the sensitivity and specificity of blood tests is poor. Next-generation sequencing (NGS) has greater detection rate for mycobacterium tuberculosis, anaerobes and fungi and greater sensitivity compare with blood tests. However use of NGS is limited because of the short read-length. Oxford nanopore adaptive sequencing (NAS) method is the Third Revolution in Sequencing Technology. For each 1 Gbp of data, NAS sequencing detected 45 times more microbiome sequences than Nanopore standard sequencing and 2.5 times more than Illumina sequencing. The purpose of this study is to compare NAS with NGS and laboratory tests for the diagnostic rate of infection post liver transplantation.

Primary Outcome Measures: Diagnosed infection post liver transplantation, Any pathogens are detected in alveolar lavage fluid, peritoneal drainage or blood before patients discharge from hospital, an average of 1 months, Post liver transplantation before patients discharge from hospital, an average of 1 months.
An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients
NCT Number: NCT06542016
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Disease Stage 5|Dialysis|Heart Failure
Sponsor: Shenzhen Second People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 136
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-07-01
Locations: First Shenzhen, Guangdong, Guangdong, 518000, China

Summary:
Cardiovascular Disease (CVD) is the main complication and the most important cause of death in CKD patients. As the disease progresses, the incidence of cardiovascular disease in CKD patients gradually increases, especially in End-Stage Renal Disease (ESRD) patients receiving dialysis treatment, where the prevalence of cardiovascular disease reaches its highest level. Currently, there is a lack of a simple and reliable tool to assess the cardiac function status and predict the risk of cardiovascular events in patients on maintenance dialysis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a widely used patient-reported outcomes measurement tool for assessing health-related quality of life in heart failure patients. It has been shown that KCCQ scores not only reflect the underlying undiagnosed symptoms of heart failure in CKD patients, but also have a strong correlation with prognosis. However, there is currently insufficient clinical evidence to confirm the value of the KCCQ in patients on maintenance dialysis.

Investigators will perform a prospective, single-center, observational study to collect the changing trend of KCCQ scores at baseline and during the observation periods in maintenance dialysis patients, to analyze the association between the scores and the occurrence of long-term cardiovascular events and all-cause mortality. The aim is to construct a predictive model of KCCQ scores to provide a reference basis for clinical management of this high-risk group, so as to optimize the diagnosis and treatment of heart failure in dialysis patients and improve their cardiovascular outcomes.

Primary Outcome Measures: All-cause mortality, All-cause mortality is defined as death from any cause during the study period. This primary outcome measure will assess the occurrence of death among study participants, regardless of the specific cause., 12 months|Mortality from cardiovascular causes, Mortality from cardiovascular causes includes deaths resulting from conditions such as myocardial infarction, heart failure, stroke and other cardiovascular event. This primary outcome measure will assess deaths specifically attributed to cardiovascular causes among study participants., 12 months|Incidence of cardiovascular disease-related hospitalizations, Cardiovascular disease-related hospitalizations include admissions for conditions such as acute coronary syndrome, heart failure exacerbation, stroke, arrhythmias and other cardiovascular events requiring inpatient care. The primary outcome measure will assess the occurrence of hospitalizations related to cardiovascular diseases among study participants., 12 months
Psychoeducational Intervention for Patients With Hepatocellular Carcinoma
NCT Number: NCT06541990
Acronym: HARMONY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma|Cirrhosis
Interventions: BEHAVIORAL: HARMONY|OTHER: Enhanced usual care
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2026-09-30

Summary:
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).

Primary Outcome Measures: Feasibility: enrollment rate, ≥50% enrollment among consecutive eligible patients, 12 weeks|Feasibility: retention rate, ≥50% retention over the 12-week study, 12 weeks
Secondary Outcome Measures: Acceptability, ≥75% of patients reporting Client Satisfaction Questionnaire-8 scores above the midpoint score of 20 on a scale from 8-32 (higher scores indicate higher satisfaction), 12 weeks
The Effect of Needle-free Injection System on Dental Injection Pain in Children
NCT Number: NCT06541925
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia, Local|Child Behavior|Pain
Interventions: DEVICE: Injection with the needle-free (NF) system|DEVICE: Injection with the traditional method (TM)
Sponsor: Marmara University
Sex: ALL
Age: CHILD
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-04-10
Completion Date: 2018-04-10
Locations: Marmara University School of Dentistry, Istanbul, 34854, Turkey

Summary:
The aim of this study was to compare paediatric patients' pain perception and behavioural response during dental injection using needle free injection (NF) or traditional injection method (TM) over two consecutive visits.

Primary Outcome Measures: Wong-Baker Faces Pain Rating Scale (WB PRS) (Wong DL, 1988), which measures the unpleasantness or affective dimension of a child's pain experience. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, 'no hurt') to 5 (crying/screaming face, 'hurts worst'). This scale was explained to the children carefully in advance. Immediately after the each injection, the children were asked to rate the level of pain perceived during the administration, using the PRS., 12 Month|Face, Legs, Activity, Cry, Consolability (FLACC) Scale. (Merkel SI, 1997), Pain level also objectively evaluated by the operator using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. (Merkel SI, 1997) This scale includes the following points: face, leg, activity, cry and consolability. Each one of these five categories records either 0, 1, or 2 which result in either a minimum degree of 0 or a maximum degree of 10. According to this scale: 0 = quiet and relaxed (no pain), 1-3 = mild discomfort or pain, 4-6 = moderate pain, and 7-10 = severe pain., 12 Month
Secondary Outcome Measures: Amount of Anesthetic Solution (ml), Total amount of used anesthetic solution, 12 month|Duration of the Analgesia Effect (min), Duration of used anesthetic solution, 12 month
Comparative Evaluation of Implant Stability, Soft & Hard Tissue Healing Around UV Activated vs Conventional Implants
NCT Number: NCT06541912
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: UV Dental Implant
Interventions: PROCEDURE: conventional implant|PROCEDURE: UV implant
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-02-15
Completion Date: 2026-03-25
Locations: Dr. Prabhuji MLV, Bengaluru, Karnataka, 562157, India

Summary:
Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants.

Primary Outcome Measures: Implant stability using Resonance Frequency Analysis, to measure primary and secondary stability, "Immediately after Post-operative", "1 month", "3 months"
Secondary Outcome Measures: Marginal bone loss using RVG with grid, to measure marginal bone level, "Immediately after Post-operative", 3 months|Soft tissue healing, soft tissue healing to be assessed using Landry Turnbull and Howley Healing Index. Soft tissue healing will be scored from 1 to 5, where score 1 is very poor and 5 is excellent., 1 week, 1 month, 3 months.
Safety and Efficacy of Cryolipolysis Clinical Protocols
NCT Number: NCT06541899
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Fat Loss
Interventions: DEVICE: Polarys Cryolipolysis
Sponsor: Indústria Brasileira Equipamentos Médicos - IBRAMED
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 372
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-10-04
Completion Date: 2024-12
Locations: UNDB, São Luís, MA, 65075-441, Brazil|Clinica Franciele Doneda Estetica Integrada, Paranavai, PR, 87709-180, Brazil|UNIFAE, São Paulo, SP, 13870-377, Brazil

Summary:
A single-arm, multicenter interventional clinical study will be conducted. The objective is to evaluate the safety and efficacy of the cryolipolysis technique. Approximately 372 participants will be included. After analyzing the items listed above, the participants in each study will be divided into 3 distinct intervention groups. The individuals included in the study will undergo anamnesis and data collection.

Primary Outcome Measures: Ocurrence of adverse events after de procedure assessed by clinical evaluation, Adverse events such as erythema, pain, edema or any other event that occurs in correlation with the treatment, through monitoring in the reassessments stipulated in the study and also in a questionnaire answered by the patient, After de procedure and 6 and 20 weeks after|% reduction in fat layer assessed by ultrasound, adipometer and photography, Adipometer: to measure the thickest point within the treatment area. For the evaluation in the abdominal region, reference points located 5 cm to the side of the umbilical scar, both on the right and left sides, will be recorded. For the evaluation in the flank region, the measurement will be standardized using the axillary midline, being performed exactly in the central fold of each flank; Ultrasound: subcutaneous tissue between the anatomical planes. The probe will be positioned at the points previously marked in the treatment area, following the same measurement performed for adipometry; Photography: at fixed angles and postures with standardized disposable underwear. Three-dimensional images will be taken of the subjects in sagittal (left and right sides) and coronal (front and back sides) views at baseline and at the stipulated follow-up periods. The abdominal region will be exposed and the subject will be instructed to remain still while the camera captures an image., Immediately after the procedure and 6 and 20 weeks after
Secondary Outcome Measures: Patient"s satisfaction assessed by GAIS scale, Patient satisfaction level will be categorized using the 5-point Global Aesthetic Improvement Scale (GAIS). It is divided into 5: "excellent", 4: "greatly improved", 3: "improved", 2: "no change" and 1: "worsened"., 6 weeks and 20 weeks after the cryolipolysis procedure
DAratumumab and REvlimid REfractory MM
NCT Number: NCT06541860
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-21
Completion Date: 2028-08-21
Locations: Irccs San Matteo Pavia, Pavia, PV, 27100, Italy

Summary:
Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.

Primary Outcome Measures: To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy., Phase I - Retrospective study The primary objective is to estimate 2-year progression-free survival (PFS) of PVd when used in RRMM after anti-CD38 MoAb and IMIDS

Phase II - Prospective study The primary objective is to estimate the 2-year progression-free survival (PFS) of the on-label combinations in patients with relapsed RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS, 2 years
A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1
NCT Number: NCT06541847
Acronym: INSPIRE-NF1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neurofibromatosis Type 1
Interventions: DRUG: HLX-1502
Sponsor: Healx Limited
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-11

Summary:
The trial will be an open label, single arm, phase 2 study in 20 participants. The study will assess the tolerability and efficacy of HLX-1502 in participants with NF1 16 years of age or older with progressive and/or symptomatic PN.

Primary Outcome Measures: PN response rate, Response will be determined by a blinded centralized review of volumetric MRI. A partial response (PR) is defined as ≥ 20% decrease in the volume of target PN., 12 months
Secondary Outcome Measures: Duration of response (DOR) and Time to response (TOR), Response will be determined by a blinded centralized review of volumetric MRI., 12 months|Safety and tolerability of HLX-1502, Adverse events (AEs) will be assessed according to toxicities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., 12 months|PN response rate, Response will be determined by a blinded centralized review of volumetric MRI. A partial response (PR) is defined as ≥ 20% decrease in the volume of target PN., 24 months|Pharmacokinetics of HLX-1502, Measured by plasma concentrations, 12 months
Physical Activity, Kinesiophobia, and Stoma Compliance in Urostomy Patients
NCT Number: NCT06541821
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Bladder Cancer
Interventions: OTHER: survey evaluation
Sponsor: Selcuk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-02
Completion Date: 2024-09-15
Locations: Selcuk University, Konya, Selçuklu, 42130, Turkey

Summary:
In this study, it is aimed to determine the level of physical activity, to investigate kinesiophobia, to determine compliance with the stoma and to compare with healthy controls in patients with bladder cancer who have undergone urostomy surgery and live with a stoma.

Primary Outcome Measures: International Physical Activity Questionnaire Short Form (IPAQ-SF), To assess physical activity levels in METs, 10 minutes|Tampa Kinesiophobia Scale, assess fear of movement in patients, 10 minutes|Ostomy Compliance Scale, Determination of psychosocial adaptation levels of individuals with ostomy to ostomy, 10 minutes
Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses
NCT Number: NCT06541795
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aphakia|Presbyopia|Residual Refractive Cylinder
Interventions: DEVICE: AcrySof IQ Vivity Extended Vision IOL
Sponsor: Alcon Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12
Locations: Contact Alcon Call Center for Trial Locations, Fort Worth, Texas, 76134, United States

Summary:
The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

Primary Outcome Measures: Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1, Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place using letter charts at a distance of 4 meters. BCVA will be recorded in logarithm Minimum Angle of Resolution (logMAR) LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. No hypothesis testing is prespecified for this endpoint., Visit 1, Year 3-5 postoperative|Incidence of adverse events, An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study device. Adverse events reported or observed since the time of initial exposure to the study model IOL will be recorded., Up to Year 3-5 postoperative|Incidence of device deficiencies, A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies reported or observed since the time of initial exposure to the study model IOL will be recorded., Up to Year 3-5 postoperative
CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression
NCT Number: NCT06541769
Acronym: POLAR
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy|Onychodystrophy
Interventions: DEVICE: Limb hypothermia|DEVICE: Limb compression
Sponsor: University Hospital Heidelberg
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 122
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2019-10-15
Completion Date: 2022-07-15
Locations: National Center for Tumor diseases (NCT), Heidelberg, 69120, Germany

Summary:
The POLAR study is a monocentric, prospective, randomized, 2-arm study designed to evaluate the effectiveness of compression or hypothermia in preventing higher-grade chemotherapy-induced peripheral neuropathy (CIPN) (Grade \> 1 according to EORTC) in patients undergoing (neo-)adjuvant chemotherapy with weekly Paclitaxel or Nab-Paclitaxel. In this study, the dominant hand of participants will be either cooled or compressed, while the contralateral hand will serve as a control. The treatment groups will be randomized.

The primary aim of the study is to compare the effectiveness of limb hypothermia versus compression in preventing CIPN. Additionally, the investigators will assess the quality of life and therapy acceptance among the participants in both study arms. Data from the two groups will be collected and compared to determine the most effective intervention for preventing CIPN and to understand the overall impact on patients' well-being and treatment adherence.

Primary Outcome Measures: Incidence of CIPN grade >1 on the interventional hand compared to the non-interventional hand, Comparing rates of CIPN\>grade 1 on the interventional and non-interventional hand by evaluation CTCAE criteria, EORTC QLQ-CIPN-20, the clinical version of the total neuropathy score (TNSc), Magnetic resonance neurography (MRI; n=21) and nerve conduction studies (n=4), 1 year (during taxane therapy and follow up)
Secondary Outcome Measures: Incidence of onycholysis/onychodystrophy grade >1 on the interventional hand compared to the non-interventional hand, Comparing rates of onycholysis/onychodystrophy\>grade 1 on the interventional and non-interventional hand, 1 year (during taxane therapy and follow up)|Magnetic resonance neurography (MRI) as a possible marker of CIPN, To evaluate the role of MRI as a possible marker for CIPN, MRI will be performed in a subset of patient (N=21), 3 month (before and after taxane therapy)|Influence of CIPN on the quality of life, Standardized clinical questionnaires (EORTC QLQ30, QLQ-CIPN-20) are used to determine the quality of life., 1 year (during taxane therapy and follow up)
Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears
NCT Number: NCT06541756
Acronym: FCAR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Meniscus Tear|Meniscus Lesion|Fibrin Blood Clot|Knee Injuries
Interventions: PROCEDURE: Fibrine Clot-augmented Meniscal Repair|PROCEDURE: Conventional Meniscal Repair
Sponsor: Ankara City Hospital Bilkent
Collaborators: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2029-07-31
Locations: Ankara Bilkent City Hospital, Ankara, 06000, Turkey|Ankara Etlik City Hospital, Ankara, 06000, Turkey

Summary:
Longitudinal meniscal tears are a type of meniscal injury characterized by a displaced fragment of the meniscus that flips over into the joint, often resembling a buckle or handle. These tears typically occur in the medial meniscus and are often associated with traumatic knee injuries, particularly in athletes.

The displaced meniscal fragment can cause mechanical symptoms such as locking, clicking, or catching of the knee, as well as pain and swelling. If not properly treated, buckle-handle meniscal tears can lead to further complications, including chronic knee instability, increased risk of osteoarthritis, and persistent joint pain.Repairing a longitudinal meniscal tear offers several advantages over partial meniscectomy, particularly in preserving knee function and preventing long-term complications.

Meniscal repair aims to restore the integrity of the meniscus, which plays a crucial role in load distribution, shock absorption, and joint stability.

Utilizing a fibrin clot during the repair of a buckle-handle meniscal tear can enhance the healing process and improve surgical outcomes. Fibrin clots act as a biological scaffold, promoting tissue regeneration by providing a matrix that facilitates cellular migration and proliferation.

The purpose of this study was to compare longitudinal meniscal tear repair reinforced with fibrin clot with routine end-to-end repair in a prospective randomized controlled trial.

Primary Outcome Measures: Number of patients with a healed meniscus on MRI, Meniscal healing at 1 year follow up as detected on the control MRI (yes / no / partial), Postoperative 1st year
Secondary Outcome Measures: Tegner Activity Scale, minimum value:0, maximum value 10, higher values mean better outcome, Postoperative 1.st year|The Knee injury and Osteoarthritis Outcome Score (KOOS), minimum value:0, maximum value 100, higher values mean better outcome, Postoperative 1.st year|Tegner-Lysholm Score, minimum value:0, maximum value 100, higher values mean better outcome, Postoperative 1.st year
Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children
NCT Number: NCT06541743
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Children, Adult|Plaque
Interventions: DEVICE: Regular Toothbrush|DEVICE: Musical toothbrush|DEVICE: Electric toothbrush
Sponsor: Jouf University
Sex: ALL
Age: CHILD
Enrollment: 111
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2024-03-01
Locations: College of Dentistry, Jouf University, Sakaka, Al-Jouf, 75432, Saudi Arabia

Summary:
Tooth brushing is essential for maintaining oral hygiene, especially in children, who are at a critical stage for developing lifelong oral health habits. Establishing effective tooth brushing behaviors for school-aged children (6-12 years) is vital for long-term dental health. Consistent and effective tooth brushing is crucial for reducing supragingival plaque, which is key to preventing periodontal diseases and ensuring good oral hygiene. Despite the availability of various plaque control methods, tooth brushing remains the most effective and safest approach.

However, young children, particularly those under ten, often struggle with the dexterity and motivation needed for proper tooth brushing, resulting in inadequate plaque removal. Manual tooth brushing, though effective, can become monotonous and fail to engage children, making it difficult to establish regular brushing habits. Studies have shown that regular removal of supragingival plaque can significantly reduce both supra- and subgingival pathogenic species, underscoring the importance of effective plaque control.

Innovative solutions such as electric and musical toothbrushes have been developed to address these challenges.

Primary Outcome Measures: Plaque Index (Quigley and Hein), Plaque assessments was conducted at baseline (day 0) and on days 15, 30, and 45. Participants were refrain from oral hygiene for 24 hours before each recall visit. During each visit, they were supposed to brush under supervision for two minutes with their assigned toothbrush and toothpaste. Plaque disclosure was achieved using a 5 mL disclosing solution for 15 seconds, followed by rinsing with 10 mL water for 10 seconds.

Quigley-Hain plaque index

0

No plaque

1

Isolated flecks of plaque at the gingival margin

2

A continuous band of plaque up to 1mm at the gingival margin

3

Plaque greater than 1mm in width and covering up to one third of the tooth surface

4

Plaque covering from one thirds to two thirds of the tooth surface

5

Plaque covering more than two thirds of the tooth surface, 45 days
A Study Evulating DA-302168S Tablets in Overweight/Obese Subjects
NCT Number: NCT06541730
Acronym: DA168
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight and Obesity
Interventions: DRUG: DA-302168S|DRUG: Placebo of DA-302168S
Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09
Locations: The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230000, China

Summary:
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of continuous oral administration of DA-302168S tablets for 28 days in overweight/obese subjects.

Primary Outcome Measures: Safety and Tolerability, Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0., Through study completion, an average of 49 days.
Secondary Outcome Measures: Cmax, Plasma samples were collected at different points for pharmacokinetic analysis., Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.|Tmax, Plasma samples were collected at different points for pharmacokinetic analysis., Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.|AUC0-t, Plasma samples were collected at different points for pharmacokinetic analysis., Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.|Cmin, Plasma samples were collected at different points for pharmacokinetic analysis., Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.|PTR, Plasma samples were collected at different points for pharmacokinetic analysis., Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.|Swing, Plasma samples were collected at different points for pharmacokinetic analysis., Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.|Body Weight, Percentage change in body weight from baseline., Day 1, 8, 15, 22, 29.|Changes in glycosylated hemoglobin (HbA1c) relative to baseline after 28 days of administration., Blood samples will be assessed for HbA1c (glycated hemoglobin), Day 1, 29.
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
NCT Number: NCT06541704
Acronym: SIENNA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Age-related Macular Degeneration (AMD)|Geographic Atrophy (GA)
Interventions: DRUG: Pozelimab|DRUG: Cemdisiran|DRUG: Placebo
Sponsor: Regeneron Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-28
Completion Date: 2032-01-05

Summary:
This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have geographic atrophy (GA) caused by age-related macular degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).

The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug(s)
* How much study drug(s) are in the blood at different times
* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Primary Outcome Measures: Growth rate (slope) of total GA lesion area (mm2 /year) measured by Fundus autofluorescence (FAF), From baseline to week 52
Secondary Outcome Measures: Loss of Best corrected visual acuity (BCVA) ≥15 Early treatment diabetic retinopathy study (ETDRS) letters at any 2 consecutive study visits, From baseline through week 52 and week 104|Change in Low-contrast quantitative visual acuity (LC-qVA), From baseline to week 52 and week 104|Change in Low-luminance low-contrast quantitative visual acuity (LL-LC-qVA), From baseline to week 52 and week 104|Change in Quantitative contrast sensitivity function (qCSF), From baseline to week 52 and week 104|Growth rate (slope) of total GA lesion area (mm2 /year) measured by FAF, From baseline to week 104|Concentrations of total pozelimab in serum, Through week 52 and week 104|Concentrations of total cemdisiran in plasma, Through week 52 and week 104|Change in concentration of total Complement component 5 (C5), From baseline to week 52 and week 104|Incidence of Antidrug antibody (ADA) to pozelimab, Through week 52 and week 104|Titer of ADA to pozelimab, Through week 52 and week 104|Incidence of ADA to cemdisiran, Through week 52 and week 104|Titer of ADA to cemdisiran, Through week 52 and week 104|Incidence of Neutralizing antibody (NAb) to pozelimab, Through week 52 and week 104|Occurrence of Treatment-emergent adverse events (TEAEs), Through week 52, 104 and week 284|Severity of TEAEs, Through week 52, 104 and week 284
Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy
NCT Number: NCT06541613
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: External Oblique Intercostal Plane Block|Laparoscopic Cholecystectomy
Interventions: DRUG: local anesthetic injection (bupivacaine)|OTHER: normal saline injection
Sponsor: Theodor Bilharz Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-04-25
Completion Date: 2024-07-15
Locations: Theodor Bilharz Research Institute, Giza, 02, Egypt

Summary:
Pain after laparoscopic cholecystectomy (LC) is a common complaint that prolongs hospital stay and thus increases morbidity. There are three primary sources of pain after LC, incision site, local and systemic effects of pneumoperitoneum, and post cholecystectomy wound to the liver. External oblique intercostal plane block (EOIPB) has recently been described as a novel block for upper abdomen surgery. the probable mechanism of the block with the dyeing of both the anterior and lateral branches of the intercostal nerves T7-T10. This block also provides a dermatomal sensory block at the T6-T10 level in the anterior axillary region and the T6-T9 level in the midline.

Primary Outcome Measures: total morphine consumption, the total analgesic (morphine) requirements in the first 24 hours postoperatively will be calculated, the first 24 hours postoperatively
Secondary Outcome Measures: NRS, Numerical rating scale for pain recorded at 15,30, 60 minutes postopetaively., 6 hours postoperatively
Risk Factors for Adverse Outcomes in Sepsis
NCT Number: NCT06541600
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Sepsis
Sponsor: Qin Zhang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10313
Study Design: Observational Model: |Time Perspective: p
Start Date: 2003-01-01
Completion Date: 2023-01-01
Locations: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China

Summary:
This study will adopt a retrospective clinical cohort design and include a certain scale of sepsis patients as research objects to find the risk factors for adverse outcomes in patients with sepsis. Bioinformatics techniques were used to infer potential differential genes corresponding to different risk factors. Finally, through the biobank the investigators established in the past, biological samples of patients with sepsis were extracted and protein expression in the samples was detected to comprehensively analyze biological information at multiple levels.

Primary Outcome Measures: Survival, Survival, 28 days|Cardiac function, Echocardiography (Ejection Fraction (EF)), 24 hours
Impact of Belt Position on the Results of PEEP Titration by EIT During ARDS
NCT Number: NCT06541522
Acronym: REPEIT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ARDS
Interventions: DEVICE: EIT
Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-09

Summary:
ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. The EIT is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ARDS. The positioning of the EIT belt at different chest heights could influence the result of the PEEP titration.

Primary Outcome Measures: Impact of the position of the electrode belt on the results of PEEP titration by EIT., Optimal PEEP determined by PEEP titration using the crossing point method., Day 0
Secondary Outcome Measures: Impact of the existence of intra-tidal recruitment on the discordance between PEPEIT and PEPCRS, Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median, Day 0|Factors associated with a discordance between PEPEIT and PEPCRS, Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median, Day 0|Discrepancy between compliance measured according to impedance and compliance measured according to exhaled volume, Regional ventilation delay (RVD), Day 0
Image-Guided Pleural Needle Biopsy in Pleural Diseases
NCT Number: NCT06541470
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Biopsy|Diagnosis|Pleura; Exudate
Interventions: PROCEDURE: Cutting needle biopsy|PROCEDURE: Abrams needle biopsy
Sponsor: Eskisehir Osmangazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 148
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-02-11
Completion Date: 2024-06-02
Locations: ESOGU Medical Faculty Department of Chest Diseases, Eskisehir, Meselik - Eskisehir, 26040, Turkey|Muzaffer Metintas, Eskisehir, Meselik, 26040, Turkey|Selma Metintas, Eskisehir, Meselik, 26040, Turkey|ESOGU Lung and Pleural Cancers Clinical and Research Center, Eskisehir, Meselik, 26220, Turkey|Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases, Eskisehir, Tepebaşı, 260140, Turkey

Summary:
In recent observational studies show that ultrasound guidance generally increases the success of pleural needle biopsies, it has been shown that the diagnostic success of needle biopsies is compromised and increased when the presence of pleural fluid is associated with a pleural lesion or pleural thickening or pleural nodular lesions. There is no evidence to support a common view on which needle is appropriate in which situation in terms of diagnostic success, reliability of benign diagnoses, and safety of side effects. This study aimed to compare and evaluate the diagnostic yield of the Abrams biopsy needle and the cutting biopsy needle in US-guided pleural needle biopsy to determine which needle is appropriate in which situation. As a result of the study, the diagnostic yield of the cutting needle was found to be higher in cases with pleural thickening of 1 cm or more, and the diagnostic yield of the Abrams needle was found to be higher in patients with pleural thickening of less than 1 cm.

Primary Outcome Measures: Diagnostic yield of pleural needle biopsy, Diagnostic accuracy, sensitiviy and -LR of pleural needle biopsies with cutting or Abrams needle biopsy., 12 months
Secondary Outcome Measures: Safety of pleural needle biopsy, Determining of the complications for pleural needle biopsies with cutting or Abrams needle biopsy., 12 months
A Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7249 Injection in Healthy Subjects
NCT Number: NCT06541457
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hyperlipidemia
Interventions: DRUG: HRS-7249 injection|DRUG: Placebo
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-05-31
Locations: The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China

Summary:
It is a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. The study plans to conduct four to six dose groups of dose 1, dose 2, dose 3, dose4, dose5 (optional), and dose 6(optional). Eight subjects will be enrolled for each dose group, with six administered HRS-7249 injection and two administered placebo. A total of 32 to 48 healthy subjects are planned to be enrolled.

Primary Outcome Measures: Safety and tolerability: Incidence of subjects with adverse events (AEs), Baseline up to Day 169
Secondary Outcome Measures: Pharmacokinetics (PK) parameter: AUC0-t for HRS-7249, AUC0-t: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration, Baseline up to 48 hours after dosing|Pharmacokinetics (PK) parameter: AUC0-∞ for HRS-7249, AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity, Baseline up to 48 hours after dosing|Pharmacokinetics (PK) parameter: Cmax for HRS-7249, Cmax: Maximum plasma concentration, Baseline up to 48 hours after dosing|Pharmacokinetics (PK) parameter: Tmax for HRS-7249, Tmax: Time to reach maximum plasma concentration, Baseline up to 48 hours after dosing|Pharmacokinetics (PK) parameter: t1/2 for HRS-7249, t1/2: Terminal half-life, Baseline up to 48 hours after dosing|Pharmacokinetics (PK) parameter: CL/F of HRS-7249 for administration subcutaneously, CL/F: Apparent clearance, Baseline up to 48 hours after dosing|Pharmacokinetics (PK) parameter: V/F of HRS-7249 for administration subcutaneously, V/F: Apparent volume of distribution, Baseline up to 48 hours after dosing|Pharmacodynamics (PD): TG, Baseline up to Day 169|Pharmacodynamics (PD): HDL-C, Baseline up to Day 169|Pharmacodynamics (PD): LDL-C, Baseline up to Day 169|Pharmacodynamics (PD): non-HDL-C, Baseline up to Day 169|Pharmacodynamics (PD): VLDL-C, Baseline up to Day 169|Pharmacodynamics (PD): TC, Baseline up to Day 169|Pharmacodynamics (PD): Lp(a), Baseline up to Day 169|Pharmacodynamics (PD): ApoB, Baseline up to Day 169|Pharmacodynamics (PD): ApoA1, Baseline up to Day 169|Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects, Baseline up to Day 169