pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
NCT Number: NCT06531148
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chemo-Mechanical Caries Removal
Interventions: OTHER: Chemo-mechanical caries removal
Sponsor: Mansoura University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2024-11-11
Locations: Dentistry, Mansoura, El-dahlewa, 35516, Egypt|Dentistry, Mansoura, 35516, Egypt

Summary:
This study will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children.

The assessed parameters will be:

* Efficacy of caries removal.
* Pain reaction and mean time required for the treatment.
* Total bacterial count before and after treatment.

Primary Outcome Measures: Clinical evaluation, A-Efficacy:

B- Child satisfaction and pain experience:

C-Time assessment, 11.2 ± 3.3 min
A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer
NCT Number: NCT06531135
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female
Interventions: BEHAVIORAL: T-CBSM|BEHAVIORAL: Support group
Sponsor: Koo Foundation Sun Yat-Sen Cancer Center
Collaborators: Soochow university taipei
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-11-23
Completion Date: 2026-12-31
Locations: Koo Foundation Sun Yat-Sen Cancer Center, Taipei City, 11259, Taiwan

Summary:
To test the effects of a 10-wk stress management interventions vs. a 5-wk control condition on positive psychosocial adaptation in women being treated for breast cancer. Participants assigned to either of the stress management groups will show better positive psychosocial adaptation compared to those in the control group.

Primary Outcome Measures: posttraumatic growth by the PTGI, the PTGI a 21-item questionnaire each scored on a range of 0-5., Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)|Distress by the HADS, The HADS is a 14-item scale, with seven items relating to anxiety and seven relating to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression., Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Secondary Outcome Measures: Positive and Negative affect, The Affect Balance Scale includes 20 adjectives assessing negative and positive mood. Possible scores range from 1-5., Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)|Perceived Stress Management Abilities, The Measure of Current Status questionnaire and self-designed items were used to measure abilities learned from the group interventions., Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)|Quality of Life by the SF-36, SF-36, Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
NCT Number: NCT06531083
Acronym: PRECISE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Cancer|Trismus
Interventions: BEHAVIORAL: Supportive Care
Sponsor: University of Alberta
Collaborators: Alberta Health services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-11-02
Completion Date: 2026-05-31
Locations: University of Alberta/ Cross Cancer Institute, Edmonton, Alberta, T6G 2G4, Canada

Summary:
Trismus, or restricted jaw movement, can occur in individuals with head and neck cancer (HNC) undergoing surgery or radiation therapy. There is a paucity of research examining interventions for trismus. We aim to assess the feasibility of prospective surveillance and early intervention to mitigate trismus in individuals undergoing HNC treatment.

Method: The investigators will conduct a pilot randomized feasibility trial involving 30 individuals with HNC who will be undergoing radiation therapy. Participants will be identified at the HNC new patient clinic. Those consenting will be randomized to either usual care (UC) or to prospective surveillance (PS). UC participants will receive active exercises, and referral to physical therapy if trismus is detected. Participants in the PS group will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5% or greater reduction in jaw opening compared to pre-treatment.

The investigators will assess recruitment and completion rates, intervention acceptability, and data collection procedures. Descriptive statistics will summarize feasibility metrics and participant demographics. Findings will inform the design of a larger multicentre trial.

Primary Outcome Measures: Feasibility: completion rate, Number of participants completing the study., 2 years
Secondary Outcome Measures: Feasibility: recruitment rate, Number of participants entering the study by the number of participants eligible., 2 years|Feasibility: adherence rate, Percentage of sessions completed over the 6-week intervention period., 6 weeks.|Maximal interincisal opening, The distance from the incisal border of tooth #21 to the middle of incisal border of tooth #31, 3 months|Trismus symptom questionnaire, Revised Gothenburg Trismus Questionnaire (0-100): higher scores indicate higher symptom burden, 3 months|Quality of life related to Head and Neck Cancer, University of Washington Quality of Life scale (scored 0 to 100): higher scores indicate better functioning., 3 months|Cervical range of motion, Quantification of neck range of motion: higher scores reflect better function, 3 months|Neck Disability, Neck Disability Index (0-50): higher scores reflect more disability, 3 months|Intervention effect on health status, Global rating of change scale (VAS -7 to +7), 6 weeks
Nitrate Formulations and Exercise Performance
NCT Number: NCT06531070
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nitrate|Nitrate/Citrulline|Placebo
Interventions: DIETARY_SUPPLEMENT: Nitrate
Sponsor: University of Greenwich
Collaborators: Crown Sport Nutrition
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-05-15
Completion Date: 2024-10-31
Locations: Sparrows Farm, Eltham, London, SE9 2BT, United Kingdom

Summary:
this study compares the acute effects of Nitrate and Nitrate plus citrulline supplementation on physical performance in recreationally trained males and females. This is a cross-over within-participant comparison design concluding three arms (i) 600 mg of Nitrate (N), ii) 600 mg Nitrate and Citrulline (NC) and (iii) Placebo (PL).

Conditions N, NC and PL will be tested one week apart, considering a minimum washout period of 72 hours.

Dependent variables:

* Number of completed repetitions to failure in squat using 75% of 1RM.
* Ventilatory thresholds (VT1) and (VT2) and Vo2 max from a progressive to exhaustion running test (PGT)
* Lactate post (within 1 min of having completed the PGT)
* Rating of perceived exertion (RPE) by the Borg 6-to-20-point scale recorded every 2 min and at the end of the PGT.
* Heart rate associated with VT1, VT2, and Vo2max - Heart rate maximum.
* Maximal aerobic speed (MAS): calculated from the average speed of the last 2 minutes of the PGT.
* time limit test at MAS (conducted after 15 min of having completed the PGT)

Primary Outcome Measures: Strength, Ten maximum repetitions set in back squat using 75% of the previously determined maximal strength determined by the maximum amount of kg lifter in one sigulare repetitions, Day 4, 2.5 hours after ingesting the supplement|Maximum oxygen consumption (Vo2max), The highest level of oxygen determined during a progressive to exhaustion running test on a treadmill (PGT), through study completion up to 3 weeks
Secondary Outcome Measures: Ventilatory thresholds (VT1) and (VT2), ventilatory thresholds using a gas analyser during a progressive to exhaustion running test on a treadmill (PGT), 15 minutes after completing the strength test|lactate, lactate concentration, through study completion up to 3 weeks|Heart Rate, Heart Rate response to endurance PGT test, through study completion up to 3 weeks|Rate of Perceived Exertion, Perception of effort, through study completion up to 3 weeks
Other Outcome Measures: Maximal Aerobic Speed, the speed at which the Vo2 maximum is determined during the PGT test, through study completion up to 3 weeks
Determination Of Factors Affecting Mobility
NCT Number: NCT06531057
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Surgery
Sponsor: Sanko University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-09-01
Completion Date: 2019-12-20
Locations: Ebru Karaaslan, Şehitkamil, Gazi̇antep, Turkey

Summary:
This descriptive study was conducted to determine the factors affecting mobility in patients undergoing abdominal surgery.

Primary Outcome Measures: Patient Mobility Scale, Through the patient mobility scale, the observer assesses the pain and difficulty experienced while exercising four activities in the postoperative period: "turning from one side of the bed to the other", "sitting on the edge of the bed", "standing up on the edge of the bed" and "walking in the patient room". The severity of perceived pain was rated on a five-point Likert-type scale anchored at "no pain(1)", " a little pain (2)", "moderate pain (3)", "a lot of pain (4)", "the worst pain (5)"; and the degree of difficulty was rated on a five-point Likert-type scale anchored at "very easy (1), easy (2), a bit difficult (3), difficult (4), and very difficult (5)" to determine how much pain and difficulty they felt. The pain and difficulty scores for each movement are summed up separately. The minimum and maximum scores for pain and difficulty are 4 and 20, respectively. A higher score means an increase in the degree of pain and difficulty of the movement., at day 1
Secondary Outcome Measures: Observer Mobility Scale, This scale assesses the extent to which patients are dependent/independent during the movements, and the observer measures blood pressure, pulse rate and respiratory rate two minutes before and two minutes after the movement. Patients are assessed on a 1-5-point scale for their dependence while doing the movements. One point on the scale means that the patient can move independently, while five points means that the patient is unable to move despite verbal warnings and physical assistance. The total score of the scale is obtained by summing the scores for the four movements: "turning from one side of the bed to the other", "sitting on the edge of the bed", "standing up on the edge of the bed" and "walking in the patient room". The minimum and maximum scores of the scale are 4 and 20, respectively. The higher the score, the greater the dependency during the movement, at day 1|Questionnaire for Factors Affecting Movement, The form included 17 questions on post-operative nausea-vomiting, sleep duration, presence of visitors, feeling weak, fear of falling, needing someone while moving, presence of someone to support while moving, fear of wounds to dehiscence while moving, suffering from stress due to surgery, use of the medical devices, pain, uncomfortable clothes and lack of information on how to move., at day 1
Relationship Between Gross Motor Coordination and Balance in Children With Spastic Cerebral Palsy
NCT Number: NCT06531044
Acronym: CP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Sponsor: Sinai University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-06
Completion Date: 2024-11-20
Locations: Sinai University, Ismailia, Egypt

Summary:
This study aims to determine if there is a connection between gross motor coordination and balance in children with spastic cerebral palsy. Since these children often struggle with balance and other motor skills, researchers hypothesize that there is no link between the two abilities.

Primary Outcome Measures: balance., Biodex Balance System will be used to assess balance., 1 day - one session|gross motor coordination., - Gross Motor - BOT -2 will be used to assess gross motor coordination., 1 day - one session
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
NCT Number: NCT06531031
Acronym: IID-BSIqPCR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bloodstream Infection|Sepsis|Septic Shock
Interventions: DIAGNOSTIC_TEST: InfectID-BSI (Bloodstream Infection) qPCR Assay
Sponsor: Microbio Co Ltd
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2025-08
Locations: Indiana University Hospital, Indianapolis, Indiana, 46202, United States|University of Maryland, Baltimore, Maryland, 21201, United States|TriCore Reference Laboratories, Albuquerque, New Mexico, 87102, United States|Vanderbilt University Medical Centre, Nashville, Tennessee, 37232, United States|Texas Children's Hospital, Houston, Texas, 77030, United States|The Prince Charles Hospital, Chermside, Queensland, 4032, Australia|The Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia|Southwest Regional Laboratory, UK Health Security Agency, Bristol UK, Bristol, United Kingdom

Summary:
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture.

The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.

Primary Outcome Measures: Determine the sensitivity and specificity of InfectID-BSI versus blood culture., The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture., Through study completion, an average of 1 year|Determine the efficacy of detection and identification of the 26-pathogen panel in the InfectID-BSI assay versus standard of care blood culture. Using qPCR - a new molecular technology to identify the top 20 bacterial and 6 yeast sepsis causing species., The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture. InfectID has it's own reporting software - InfectID-Client which is how the InfectID-BSI results will be reported for the study., Through study completion, an average of 1 year
Assessment of Ventilation Parameters for Extubation Prediction in ICU
NCT Number: NCT06531005
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Respiratory Failure|Invasive Mechanical Ventilation
Sponsor: Ankara University
Collaborators: Gazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2025-02-01
Locations: Ankara University Faculty of Medicine, Altindağ, Ankara, 06230, Turkey

Summary:
The study aims to research the values of mechanical power, driving pressure, and elastic power in predicting the duration of mechanical ventilation in critically ill patients undergoing invasive mechanical ventilation. This will help determine which patients may be considered for early extubation, which patients should wait for extubation, and the patients where extubation is anticipated to be prolonged, attention should be paid to initiating preparations for alternative treatment methods like tracheostomy early.

Primary Outcome Measures: extubation time, time patients will be extubated after intubation, seven days
Secondary Outcome Measures: mortality, 28 day mortality, 28 days|acute renal failure, Number of patients who developed acute kidney injury according to KDIGO guidelines, one month|ICU/ hospital length of stay, ICU/ hospital length of stay, three months
The Effectiveness of a Tailored Nutritional Education Program on Profound Hearing Impairment Adults
NCT Number: NCT06530979
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Profound Hearing Impairment|Nutrition, Healthy
Interventions: DEVICE: Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter
Sponsor: King Saud University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 61
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-06-01
Completion Date: 2025-03-02
Locations: College of Applied Medical Sciences, Riyadh, 11433, Saudi Arabia

Summary:
Literature suggests that profound hearing-impaired people have poor access to health care directly related to communication difficulties. A lack of knowledge regarding health and healthy dietary patterns has been documented. Several associations between chronic diseases such as obesity, CVD, hyperlipidemia etc., and hearing impairments have been established. There is a gap in the literature for studies that use Saudi-sign language-tailored programs in patient health and nutrition education.

This project aims to create a Saudi-sign language general nutritional education program and then test its effectiveness in enhancing the nutritional status and knowledge of Saudis with profound hearing impairments.

Primary Outcome Measures: Nutrition knowledge, General Nutrition Knowlege Questionnaire GNKQ as videos used Saudi Sign language (Multiple-choice questions with a single select multiple choice question)., 3 months|Anthropometric measurements, Anthropometric measurements (e.g., weight and height will be combined to report BMI in kg/m\^2), (Wist and hip circumference will be combined to report Wist/Hip ratio)., 3 months|Body composition measurement, Body composition measurement via Tanita to measure (FM, FFM, Muscle mass in Kg and TBW %)., 3 months|Dietary assessment, A 3-day food record diary (two days weekday and one day weekend)., 3 months
Phase I Study of ICP-332 in Healthy Subjects
NCT Number: NCT06530966
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Subjects
Interventions: DRUG: ICP-332 Tablets|DRUG: ICP-332 Placebo Tablets
Sponsor: InnoCare Pharma Inc.
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-23
Completion Date: 2024-12-25
Locations: Pharmaron CPC Inc., Baltimore, Maryland, 21201, United States

Summary:
A multiple ascending dose phase I study of ICP-332 in healthy subjects

Primary Outcome Measures: Number of participants with Adverse Events (AEs), Up to Day 28|Number of Participants With Clinically Significant Change in Vital Signs, Up to Day 28|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG), Up to Day 28|Number of Participants With Clinically Significant Change in Physical Examination, Up to Day 28|Number of Participants With Clinically Significant Change in Clinical Laboratory Values, Up to Day 28
Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients : A Pilot Comparative Clinical Effectiveness Trial
NCT Number: NCT06530953
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Disease
Interventions: BEHAVIORAL: Patient Navigator Model
Sponsor: University of California, Riverside
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
The goal of this randomized clinical comparative effectiveness trail is to compare the effects of patient navigator models on follow-up care in Latinx and Indigenous Mexican immigrant patient populations. The main question\[s\] it aims to answer \[is/are\]:

* Participants randomized to PN-CHW compared to the PN-CS model will be more likely to follow through with follow-up care referrals
* Trust will be a driving factor as to why PN-CHW will be a more effective intervention for the patient population.

Researchers will compare patients in a patient navigator community health worker (PN-CHW) intervention to those in a patient navigator clinical staff (PN-CS) intervention to see which model of linkage to care is more effective for follow-up care in the patient population.

Participants will be asked to:

* Complete a baseline survey about healthcare access
* Receive calls and text messages from either a CHW or clinical staff
* Complete a follow up survey

Primary Outcome Measures: Follow up care, Follow up care for referred healthcare need, 12 weeks post randomization
Secondary Outcome Measures: Trust in physicians, Trust in physicians measured by 10-item physician trust Scale, 12 weeks post randomization
Diagnostic Interest of the Buccal Schirmer Test in Xerostomia During Sjögren's Syndrome: XERODIAG
NCT Number: NCT06530940
Acronym: XERODIAG
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sjogren's Syndrome|Xerostomia|Diagnosis
Interventions: DIAGNOSTIC_TEST: Buccal Schirmer Test
Sponsor: University Tunis El Manar
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2024-12-31

Summary:
Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Its diagnosis mainly relies on the measurement of salivary flow (SF). Performing this test is unpleasant for the patient, lacks precision, can be influenced by certain conditions, and requires good patient cooperation. Other alternatives such as the buccal Schirmer test can be used. The aim of this study is to demonstrate the non-inferiority of the buccal Schirmer test compared to SF measurement. This is a diagnostic study comparing a group of patients (n=90) with Sjogren's syndrome (SS) and normal SF (≥0.1 ml/minute) to a group of patients with SS and decreased SF (\<0.1 ml/minute).

Primary Outcome Measures: Sensitivity, ratio of the number of patients with SF+ and BST+ by the number of patients with SF+, 30 minutes|Specificity, ratio of the number of patients with BST- and SF- by the number of patients with SF-, 30 minutes|Positive predictive value, ratio of the number of patients with SF+ and BST+ by the number of patients with BST+, 30 minutes|Negative predictive value, ratio of the number of patients with BST- and SF- by the number of patients with BST-, 90 minutes
A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma
NCT Number: NCT06530914
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions: DRUG: MRG003 combined with Pucotenlimab|DRUG: MRG003 combined with Pucotenlimab+Cisplatin
Sponsor: Lei Liu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-12-31

Summary:
A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.

Primary Outcome Measures: pCR, Pathological complete response rate, After surgery (approximately 9-10 weeks after start of study treatment)
Secondary Outcome Measures: EFS EFS, Event free survival, 1 years|ORR, Objective response rate, 9-10 weeks|OS, Overall survival, 2 years|Number of patients with Adverse Events (AEs), 79/5000 The incidence, severity and correlation of adverse events (AE), serious adverse events (SAE), immune-related adverse events (irAE), and laboratory index outliers were determined according to NCI-CTCAE v5.0 standards, Up to approximately 1 years|Incidence of surgery-related AE/SAE (adverse events/serious adverse events), Rate of delayed or canceled surgery, length of surgery, length of hospital stay, method of surgery, and incidence of surgery-related AE/SAE (adverse events/serious adverse events) within 90 days after surgery, 90 days|Proportion of reduction in clinical stage after treatment, The proportion of clinical stage reduction after combination therapy in the target study population, 9-10 weeks
Ultrasound of the Inferior Vena Cava in the Prevention of Hypotension After Induction of General Anesthesia
NCT Number: NCT06530901
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Elderly Patients Undergoing Elective Non-cardiac Surgery
Interventions: DIAGNOSTIC_TEST: Multidimensional ultrasound of the inferior vena cava
Sponsor: Zhuan Zhang
Sex: ALL
Age: OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-03-31
Locations: the Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, Jiangsu, China

Summary:
Based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in respiratory variability of each parameter, we explored the predictive value of IVC ultrasound indicator parameters on hypotension after induction of general anesthesia in elderly patients undergoing elective non-cardiac surgery, screened the sensitive indicators, and calculated the cut-off values.

Primary Outcome Measures: Changes in the level of Mean Arterial Pressure, The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction, Baseline (before induction), 10 min after induction|Changes in the level of Systolic Blood Pressure, The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction, Baseline (before induction), 10 min after induction|Multidimensional ultrasound of the inferior vena cava, The outcome above should be measured at the time before induction, Baseline (before induction)
Secondary Outcome Measures: Changes in the level of Heart Rate, The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction, Baseline (before induction), 10 min after induction|Changes in the level of Diastolic Blood Pressure, The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction, Baseline (before induction), 10 min after induction
Vaccination Hesitation in Expectant Mothers
NCT Number: NCT06530875
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaccine Hesitation
Interventions: BEHAVIORAL: training on hesitations regarding childhood vaccinations
Sponsor: Yuzuncu Yıl University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2024-11-30
Locations: Yuzuncu Yıl University, Van, Turkey

Summary:
The aim of this study is to increase the awareness of vaccination with the training on childhood vaccine hesitancy given to expectant mothers by a nurse during pregnancy. In addition, it is aimed to evaluate the effect of the training given to expectant mothers on vaccine hesitancy and vaccine literacy.

Hypotheses of the study

H0: Training on Childhood Vaccine Hesitancy does not affect vaccine hesitancy and vaccine literacy in expectant mothers.

H1a: Education on Childhood Vaccine Hesitancy affects vaccine hesitancy in expectant mothers.

H1b: Education on Childhood Vaccine Hesitancy affects vaccine literacy in expectant mothers.

Primary Outcome Measures: Vaccine Literacy Scale for Childhood Vaccines, The Vaccine Literacy Scale consists of 3 sub-dimensions and 13 items in total: Functional Health Literacy, Communicative Health Literacy and Critical Health Literacy., 3 weeks
Secondary Outcome Measures: Vaccine Hesitation Scale, The vaccine hesitancy scale consists of 10 items. Items 1, 2, 3, 4, 6, 7 and 8 contain positive statements, while items 5, 9 and 10 contain negative statements. While the level of vaccine hesitancy decreases as the degrees given by the participants to the positive statements increase, the level of vaccine hesitancy increases as the degrees given to the negative statements increase., 3 weeks
Piriformis Syndrome; Extracorporeal Shock Wave Therapy and Dry Needling
NCT Number: NCT06530862
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Piriformis Syndrome|Extracorporeal Shock Wave Therapy
Interventions: OTHER: ESWT+stretching exercises|OTHER: Dry needling+stretching exercises
Sponsor: Istanbul Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-03
Completion Date: 2024-08-23
Locations: Burak Tayyip Dede, Istanbul, Turkey

Summary:
This study is being conducted on patients with piriformis syndrome. Patients are divided into two groups by list randomization method: Extracorporeal shock wave therapy (ESWT) group and Dry neddling (DN) group. Both groups of patients agreed to perform basic stretching exercises. The ESWT group received 3 sessions of radial ESWT, 1 session per week. The DN group received 3 sessions of ultrasound-guided needling, 1 session per week. Clinical evaluations of the participants were performed at the beginning of treatment, 1 month, and 3 months after treatment.

Primary Outcome Measures: Visual analog scale (VAS) score, Pain was evaluated with a Visual analog scale (VAS) score, 7 months|Lower extremity functiunal scale (LEFS), Pain was evaluated with a Lower extremity functiunal scale (LEFS (minimum=0, maximum=80)) The higher the score, the better the result, 7 months|Oswestry disability index (ODI), Pain was evaluated with a Oswestry disability index (ODI (minimum=0, maximum=60))The lower the score the better the result, 7 months
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
NCT Number: NCT06530849
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Systemic Lupus Erythematosus
Interventions: DRUG: GC012F Injection
Sponsor: Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborators: AstraZeneca|Suzhou Gracell Biotechnologies Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 118
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-23
Completion Date: 2027-02-28

Summary:
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).

Primary Outcome Measures: Dose-Limiting Toxicity (DLT) rate, Phase 1 study：Proportions of subjects with DLT within 28 days after infusion., 28 days|SLE Responder Index (SRI)-4 response rate, Phase 2 study：Proportion of subjects achieving SRI-4 response at Week 48., 48 weeks
Secondary Outcome Measures: adverse events (AEs), Proportions of subjects with AEs after the infusion;, 48 weeks|SRI-4 response rate, Proportions of subjects achieving SLE Responder Index (SRI)-4 response by timepoint;, 48 weeks|Definitions of Remission in SLE (DORIS) rate, Proportions of subjects achieving remission according to the DORIS by timepoint;, 48 weeks|lupus low disease activity state (LLDAS) rate, Proportions of subjects achieving LLDAS by timepoint;, 48 weeks|complete remission (CR) rate, Proportions of subjects achieving CR by timepoint;, 48 weeks|SRI-4 response duration, Maintenance time of SRI-4 response;, 48 weeks|DORIS duration, Maintenance time of remission according to the DORIS;, 48 weeks|LLDAS duration, Maintenance time of LLDAS;, 48 weeks|CR duration, Maintenance time of complete remission, 48 weeks
Chronic Diarrhea Owing to Underlying Microscopic Colitis
NCT Number: NCT06530836
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Diarrhea|Microscopic Colitis
Sponsor: Zagazig University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-01-01
Locations: Zagazig University Hospital, Zagazig, Sharkia, 44519, Egypt

Summary:
The goal of this observational study is to search for accurate diagnoses for patients with chronic diarrhea and assess the prevalence of microscopic colitis. The main question\[s\] it aims to answer \[is/are\]:

Does microscopic colitis account for a significant portion of patients with chronic diarrhea?

Participants will subjected to:

* Routine laboratory examination.
* Colonoscopy: A total colonoscopy will be done with visualization of the terminal ileum. Biopsies will be taken from each segment of the colon and any abnormal appearing areas, the right-sided colon (cecum, ascending colon, and transverse colon), the left-sided colon (descending colon and sigmoid colon), and the rectum.

Primary Outcome Measures: Number of Participants with Chronic Diarrhea Diagnosed with Microscopic Colitis, Diagnostic criteria for the diagnosis of microscopic colitis include increased chronic inflammatory infiltration in the lamina propria, increased intraepithelial lymphocytes (IELs), degeneration of surface epithelium, and increased mitosis in crypts., 6 weeks
Secondary Outcome Measures: Rate of Lymphocytic and Collagenous Types of Microscopic Colitis in Individuals Experiencing Chronic Diarrhea, Over 20 IELs per 100 inter-cryptal epithelial cells (normal \<1-5/100) were required for the diagnosis of lymphocytic colitis.

For collagenous colitis, subepithelial collagen band thickness was measured by ocular micrometer in specimens stained with Masson's Trichrome. Specimen thickness over 10 μm was required for the diagnosis., 2 weeks
Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma
NCT Number: NCT06530823
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Biliary Tract Carcinoma|Cholangiocarcinoma
Interventions: DRUG: Pemigatinib and Durvalumab
Sponsor: Eastern Hepatobiliary Surgery Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-08-01

Summary:
This study is a single-arm, multicenter Phase II clinical trial designed to preliminarily assess the safety and efficacy of the combination therapy of pemigatinib and durvalumab in the second-line treatment of patients with advanced malignant biliary tract cancer.

The study anticipates enrolling 38 participants characterized by the following criteria: 1) A confirmed diagnosis of advanced, metastatic, or unresectable biliary tract cancer by histopathological examination; 2) Presence of FGFR2 fusion or rearrangement confirmed by testing; 3) Prior receipt of first-line treatment for biliary tract cancer.

The primary questions the study aims to address are:

1. Can the combination of pemigatinib and durvalumab improve the prognosis of participants with previously treated biliary tract cancer (BTC)?
2. What is the safety profile of the treatment with pemigatinib and durvalumab?

Participants will receive:

1. Oral administration of 13.5 mg pemigatinib once daily, in combination with durvalumab 1500 mg via intravenous infusion.
2. Follow-up visits will be scheduled every 6 weeks.

Investigators will observe and document the objective tumor response rate of the participants, as well as progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and adverse events.

Primary Outcome Measures: Objective Response Rate, Objective response rate is defined as the proportion of subjects who achieved a complete response (CR; disappearance of all target lesions) or a PR (\> 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1. Clinical response will be determined by an independent radiological review committee., From enrollment to the end of treatment at 8 weeks
Secondary Outcome Measures: Progression-free Survival (PFS), PFS=first dose to progression disease \[PD\] or death, From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months|Disease Control Rate (DCR), DCR=CR+PR+satble disease, From enrollment to the end of treatment at 8 weeks|Overall survival (OS), OS=first dose to death of any cause, From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months|Adverse Event (AE), From enrollment to the end of treatment at 8 weeks
A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer
NCT Number: NCT06530797
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Interventions: DRUG: First-line Adebrelimab regiment for advanced stage ES-SCLC|DRUG: Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-09-01

Summary:
The purpose of this observational study is to evaluate the safety and efficacy of Adebrelimab Injection in extensive-stage small cell lung cancer (ES-SCLC) under real-world conditions. Specifically, the study aims to assess the treatment of Adebrelimab Injection across various subgroups of ES-SCLC patients. The goal is to provide information on treatment patterns and effectiveness in real-life settings, explore potential predictive or prognostic biomarkers, and preliminarily evaluate the pharmacoeconomic indicators of Adebrelimab Injection treatment for extensive-stage small cell lung cancer.

Primary Outcome Measures: Safety (The occurrence of ≥3 grade AEs), The occurrence of ≥3 grade AEs, From August 2024, patients will be followed up for 90 days after the last use of Adebrelimab
Secondary Outcome Measures: PFS, Progression free survival from Adebrelimab treatment, Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.|OS, Overall survival from Adebrelimab treatment, Up to 2 years. From date of enrollment until the date of death from any cause, assessed up to 2 years.|DoR, Duration of response of Adebrelimab treatment, Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.|ORR, Objective response rate of Adebrelimab treatment, Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.|DCR, Disease control rate of Adebrelimab treatment, Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma
NCT Number: NCT06530784
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Carcinoma, Hepatocellular
Interventions: PROCEDURE: Cryoablation|DRUG: PD-1 antibody and bevacizumab
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2026-05-31
Locations: Zhongshan Hospital, Fudan University, Shanghai, Shanghai, 200032, China

Summary:
To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody.

Primary Outcome Measures: Progression-free survival, mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit., Up to 2 years
Secondary Outcome Measures: Time to progress, mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit., Up to 2 years|Objective Response Rate, mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit., Up to 2 years|Overall survival, According to medical documents or descriptions of the patient's family, Up to 2 years|Adverse events, CTCAE v5.0 is used to assess adverse events., Up to 2 years
Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Evaluate the Malignancy Risk Value of Thyroid Nodules
NCT Number: NCT06530771
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multimoda Lultasound|Thyroid Cancer|Microvascular Classification
Interventions: DIAGNOSTIC_TEST: ultrasound
Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 720
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-01
Completion Date: 2024-12-30
Locations: The Fifth Affiliated Hospital Sun Yat-Sen University, Zhuhai, Guangdong, 519000, China

Summary:
The goal of this clinical trial is to explore the value of a multimodal ultrasound model based on Angio Planewave Ultrasensitive Imaging, Shear Wave Elastography and grayscale ultrasound in the differential diagnosis of benign and malignant thyroid nodules. The main questions it aims to answer are:

Can an innovative ultra-microvascular classification system based on Angio Planewave Ultrasensitive Imaging distinguish between benign and malignant thyroid nodules? How about the performance of multimodal ultrasound model to Guide the Fine-Needle Aspiration Management of Thyroid Lesions?

Participants will:

Undergo grayscale ultrasound, SWE, and Angio Planewave Ultrasensitive Imaging multimodal thyroid ultrasound examination within one week before surgery Undergo surgery and obtain the postoperative pathological diagnosis

Primary Outcome Measures: Diagnostic efficacy, the area under the receiver operating characteristic (ROC) curve (AUC), one week|Diagnostic efficacy, sensitivity, specificity, accuracy, one week|positive predictive value (PPV), and negative predictive value (NPV), Diagnostic efficacy, one week
Does the Format of the Adult ADHD Self-Report Scale Impact the Results
NCT Number: NCT06530758
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Attention Deficit Hyperactivity Disorder
Interventions: OTHER: Altered ASRS format, without shading and with grouping|OTHER: Altered ASRS format, with shading and without grouping|OTHER: Altered ASRS format, without shading and without grouping
Sponsor: University of Alberta
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-07-29
Completion Date: 2024-12-31
Locations: Hospital Family Medical Clinic, Devon, Alberta, Canada|Shifa Medical Clinic, Edmonton, Alberta, Canada|Hevloc Family Medical Clinic, Red Deer, Alberta, Canada

Summary:
The World Health Organization Adult ADHD Self-Report Scale v1.1 (ASRS) is frequently used in family medicine clinics to screen for ADHD. Numerous studies have found the ASRS has a low positive predictive value. Compounding this concern is the format of the ASRS. Specifically, the answers on the ASRS that lead to screen positive results are shaded in gray and grouped together, which may make it easy for patients to discern which responses should be selected for a positive screen.

Primary Outcome Measures: Screen positive rate, Poisson regression to determine the relative risk of a screen positive among the different versions of the form. We will include the following covariates: shading, grouping, shading x grouping, suspect ADHD without diagnosis, ADHD diagnosis, sex, and age., Through study completion, estimated to be 2 months
PRP vs HA Intra-articular Injections in TMDs
NCT Number: NCT06530745
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Temporomandibular Joint Disorders|Temporomandibular Joint Pain
Interventions: PROCEDURE: Hyaluronic acid (HA) injection|PROCEDURE: Platelet-rich plasma (PRP) injection
Sponsor: Hospital of the Ministry of Interior, Kielce, Poland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2025-06-01
Locations: Department of Maxillofacial Surgery, Kielce, Poland

Summary:
This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA. It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders.

Primary Outcome Measures: Mandibular abduction, Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii), 0 - 6 months|Mandibular protrusion, Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii), 0 - 6 months|Mandibular right movement, Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii), 0 - 6 months|Mandibular left movement, Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii), 0 - 6 months