pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation
NCT Number: NCT06493656
Acronym: CSvsCSHD
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adhesive Capsulitis|Adhesive Capsulitis of Shoulder
Interventions: PROCEDURE: Ultrasound-guided glenohumeral space isolated corticosteroid injection|PROCEDURE: Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection|DRUG: 1mL of Triamcinolone (40mg/1mL) Injectable Solution|DRUG: 4mL of Lidocaine 1% Solution Injectable Solution|DRUG: 15mL of Normal Saline
Sponsor: Chuncheon Sacred Heart Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-12-05
Completion Date: 2015-11-17
Locations: Chuncheon Sacred Heart Hospital, Chuncheon, Gangwondo, 700-204, Korea, Republic of

Summary:
This clinical trial investigates whether concomitant capsule-preserving hydrodilatation (CSHD) is more effective than isolated glenohumeral corticosteroid injection (CS) in treating shoulder adhesive capsulitis. The main questions it aims to answer are

* Is CSHD inferior to CS in immediate pain relief as the solution is diluted?
* Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated?

Group CS will receive an ultrasound-guided glenohumeral corticosteroid injection only, with a solution of 5 mL.

Group CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation, with a solution of 20 mL.

Clinical scores and range of motion will be compared between the groups up to six months post-injection.

Primary Outcome Measures: Visual analog scale (VAS) for pain, Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain, Change from the baseline to 6 months
Secondary Outcome Measures: Range of motion (ROM), ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90), Change from the baseline to 6 months|American Shoulder and Elbow Surgeons (ASES) shoulder score, Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome., Change from the baseline to 6 months|Constant-Murley score, Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome., Change from the baseline to 6 months
Peripheral Perfusion Index as a Predictor of Successful Supraclavicular Brachial Plexus Block
NCT Number: NCT06493643
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Perfusion Index
Interventions: OTHER: Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limb
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 43
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2024-12

Summary:
Aim of the study is to determine the best cut off value for the PI and PI ratio for predication of successful supraclavicular brachial plexus block in young and middle age patients undergoing hand surgeries .

Primary Outcome Measures: Cut off value for perfusion index ( PI ) for predication of successful supraclavicular brachial plexus block., Perfusion index (PI) was recorded at baseline and at 10, 20, and 30 minutes after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb., Perfusion index (PI) was recorded at baseline and at 10, 20, and 30 minutes after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.|Cut off value for perfusion index (PI) ratio for predication of successful supraclavicular brachial plexus block., Perfusion index (PI) ratio was calculated as the ratio between the PI at 10 minutes after injection and the baseline PI., Perfusion index ( PI ) ratio was recorded at baseline and 10 minutes after local anaesthetic injection
The Effect of Hypnobreastfeeding Education Given to Primiparas
NCT Number: NCT06493630
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breastfeeding|Self Efficacy|Expectations
Interventions: BEHAVIORAL: Hypnobreastfeeding Education
Sponsor: Amasya University
Sex: FEMALE
Age: ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2025-05-31

Summary:
Primiparous pregnant women may need support regarding the breastfeeding process because they have not had breastfeeding experience before. Hypnobreastfeeding is one of the education-based interventions used in this field. According to the results of the power analysis, at least 104 pregnant women, 52 experimental and 52 control, should be included in the study. Data will be collected with the "Pregnant Introduction Form", "Breastfeeding Myths Scale", "Breastfeeding Expectations Scale-A" and "Prenatal Breastfeeding Self-Efficacy Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the primiparous pregnant women in the experimental group.

Primary Outcome Measures: Breastfeeding Myths Scale, The minimum score that can be obtained from the scale is "30", the maximum score is "150", and as the score obtained from the scale decreases, breastfeeding myths levels also decrease., At the end of the 1 months|Breastfeeding Expectations Scale-A, The minimum score that can be obtained from the scale is "12", the maximum score is "60". Lower scores from the scale indicate more positive expectations regarding the breastfeeding experience., At the end of the 1 months|Prenatal Breastfeeding Self-Efficacy Scale, The minimum score that can be obtained from the scale is "20", the maximum score is "100", and as the score obtained from the scale increases, breastfeeding self-efficacy levels also increase., At the end of the 1 months
Does Cervical Mobilization Have an Effect on Hand Function in Patients With Double Crush Syndrome?
NCT Number: NCT06493617
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Double Crush Syndrome
Interventions: OTHER: Cervical Mobilization|OTHER: Traditional physical therapy treatment
Sponsor: Ahmed Alshimy
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-02
Completion Date: 2024-01-08
Locations: Al Ryada University for Science and Technology, Sadat, Menoufia, Egypt

Summary:
All Double Crush Syndrome patients were assessed via VAS, BCTQ \& Nerve conduction study before and after the treatment program.

Primary Outcome Measures: Visual analogue scale, Used to assess degree of pain, 4 weeks|Boston carpal tunnel syndrome questionnaire, Used to assess patients' functional ability and symptoms severity, 4 weeks|Nerve conduction study, Used to assess sensory and motor fibers of median nerve to determine the improvement in nerve capacity and hand function, 4 weeks
A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
NCT Number: NCT06493604
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Dry Eye Disease
Interventions: DRUG: Reproxalap Ophthalmic Solution (0.25%)|DRUG: Vehicle Ophthalmic Solution
Sponsor: Aldeyra Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2024-12-31
Locations: Andover Eye Associates, Andover, Massachusetts, 01810, United States

Summary:
A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Primary Outcome Measures: Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3, Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort", Day -14 to Day 2
Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery, 10 Year Follow up.
NCT Number: NCT06493591
Acronym: AFACT-10
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Sponsor: Amsterdam UMC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-08-01

Summary:
This observational study investigates the long-term outcomes of patients ten years after their participation in a previous study on the surgical treatment of atrial fibrillation (AF). Participants were part of a the AFACT study a decade ago that explored whether damaging nerves around the heart could reduce AF. Participants were randomized to standard thoracoscopic AF ablation (MiniMaze) with or without Ganglion Plexus (GP) ablation. This new study aims to assess and compare the long-term effects of these treatments. We are specifically interested which treatment leads to more freedom from AF.

Key questions include:

How many patients are free from AF ten years after treatment without using antiarrhythmic drugs? What are the complications from both treatments?

Participants will undergo the following assessments:

* Clinical assessment at the outpatient clinic.
* ECG and 24-hour Holter ECG
* Echocarddiogram and laboratory assessment.
* SF-36 Quality of life questionnaire.

Primary Outcome Measures: Freedom of AF, Number of participants with freedom of AF after ten years after the procedure without the use of antiarrhythmic drugs. Freedom of AF is defined as the absence of documentation of episodes of AF, atrial flutter or atrial tachycardia \>30 seconds on all holters and ECG recordings during follow up., 10 years
Secondary Outcome Measures: Time to first AF recurrence., Time to first AF recurrence defined as the first documentation of documentation of AF \>30 seconds during follow up., Within 10 year follow up.|Classification of AF recurrence, Classifications of AF recurrence and change from baseline of AF recurrence classification (paroxysmal, persistent, permanent AF, and atrial tachycardia)., 10 years|Left Atrial Volume and Function, left Atrial (LA) Volume and Function 8 to 10 years post procedure compared between the two arms. And the change in Left Atrial (LA) Volume and Function from baseline to 8 to 10 years post procedure compared., Between 8 and 10 years follow up|Quality of Life improvement, Improvement from baseline of functional status as measured by the RAND 36 quality of life questionnaires at 10 years, 10 years|Pacemaker implants, Number and reasons for pacemaker implants during the ten-year follow-up period., 10 years|Additional ablation, Number and reasons for additional ablation procedures during the ten-year follow-up period., 10 years|Cardioversions, Number and reasons for cardioversions during the ten-year follow up., 10 years|Major cardiovascular adverse events, Occurrence of major adverse events (heart failure, stroke, major bleeding, mortality) during the follow-up period., 10 years
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
NCT Number: NCT06493565
Acronym: REAL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anastomotic Leak Rectum
Interventions: DEVICE: Routine endoscopic anastomosis inspection
Sponsor: Amsterdam UMC, location VUmc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2026-05
Locations: Bordeaux Colorectal Institute Academy, Bordeaux, France|Humanitas Research Hospital, Milan, Italy|Amsterdam UMC, Amsterdam, Netherlands|University Hospital Vall D'Hebron, Barcelona, Spain|Imperial College London, London, United Kingdom

Summary:
The objective of this international prospective observational study is to evaluate the implementation of a point-of-care digital rectoscope (LumenEye) into routine care to detect colorectal anastomotic leakage in the early postoperative period.

The study includes patients undergoing a colorectal resection with colorectal or coloanal anastomosis ≤15 centimeters from the anorectal junction. The participating centers consist of expert colorectal units in various countries.

The primary endpoint for the study is the time to diagnosis of anastomotic leakage.

Primary Outcome Measures: Time to diagnosis of anastomotic leakage, 1 year
Secondary Outcome Measures: Diagnostic accuracy of point-of-care rectoscopy for detection of AL, Determination of the sensitivity, specificity, negative- and positive predictive values for detecting AL with regards to CT-scan, flexible endoscopy and clinical findings, 1 year|Patient reported comfort score for diagnostic endoscopy (Gloucester Comfort Scale),, a score of 1 refers to no discomfort while 5 is associated with severe discomfort, 1 year|Hospital costs of the diagnostic protocol for detection of AL, The direct hospital costs related to the diagnostics aimed at detecting AL, 1 year|Readmission rate, 1 year|Reintervention rate, Amount of reinterventions and specification, 1 year|Mortality, 1 year|(Permanent) stoma rate at one year, 1 year
CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)
NCT Number: NCT06493539
Acronym: CiNPWT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Wound Heal|Wound Dehiscence
Interventions: PROCEDURE: Standard of Care group|DEVICE: CINPWT
Sponsor: University of Southern California
Collaborators: 3M
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2025-06-30

Summary:
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation(LEA) compared with standard of care compression wrapping and wound care post-LEA.

This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).

Primary Outcome Measures: Number of participants with reduction of edema as assessed using Girth measurements and Grading system., Measurement of edema reduction using the +1 to +4 grading system as well as girth measurements of lower extremity of using measuring tape., Up to 8 weeks|Number of participants with Greater acceptability, tolerability and convenience as assessed by Short Form 36 and patient provided feedback., Determine the overall tolerability, acceptability, and convenience of the intervention using Patient surveys and patient provided feedback., Up to 8 weeks|Number of participants with shorter time to ambulation and weight-bearing as measured by a stopwatch., CiNPWT effect on ambulation by measuring time to ambulation, time to weight-bearing as measured by a stopwatch., Up to 8 weeks|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"., CiNPWT on number of needed physical therapy visits, adverse events, surgical site infection, re-amputation/revision rate, dehiscence, dressing failure, unscheduled/emergency encounters, hospital-acquired pressure injuries., Up to 8 weeks
The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium in Children
NCT Number: NCT06493513
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emergence Delirium|Anesthesia|Children
Interventions: DEVICE: 40Hz stimulation
Sponsor: Henan Provincial People's Hospital
Sex: ALL
Age: CHILD
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2025-01-15

Summary:
Emergence delirium is a complex of perceptual deficits and psychomotor agitation most commonly seen in preschool children in the early post-anesthetic period. It increases the risk of bed falls, accidental catheter removal, surgical wound dehiscence, and delayed discharge in children. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to explore the effect of 40Hz stimulation on the incidence of emergence delirium in children undergoing vascular malformation surgery under sevoflurane anesthesia.

Primary Outcome Measures: The incidence of emergence delirium, Emergence delirium was considered to have occurred in the subject child if Pediatric Anesthesia Emergence Delirium (PAED) scale ≥10 or Cornell Assessment of Pediatric Delirium (CAPD) scale ≥10 (PAED range: 0-20 points, CAPD range: 0 \~ 32 points)., From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery.
Secondary Outcome Measures: The incidence of pain, If the Face, Legs, Activity, Cry and Consolability (FLACC) scale ≥ 4 (0 \[no pain\] \~ 10 \[worst pain\]), the child was considered to be in pain., Day 1, day 2, day 3 after surgery.|The incidence of postoperative nausea and vomiting, Follow up patients for nausea and vomiting, Day 1, day 2, day 3 after surgery.|Sleep quality, Assessment of children's daily sleep quality by Self-Rating Scale of Sleep (SRSS), with a score range of 10 \~ 50, with higher scores indicating poorer sleep quality., Day 1, day 2, day 3 after surgery.
Efficacy of Formulated Eggshell Derived Nano-hydroxyapatite Containing Toothpaste With and Without Addition of Fluoride vs. Conventional Desensitizing Fluoride Containing Toothpaste in Management of Dentin Hypersensitivity
NCT Number: NCT06493500
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Dentin Hypersensitivity|Fluoride|Nano-hydroxy Apatite
Interventions: DRUG: Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste|DRUG: Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-03

Summary:
compare the effectiveness of Eggshell derived nano-Hydroxyapatite with and without fluoride and conventional fluoride containing tooth paste versus conventional desensitizing fluoride containing tooth paste on dentinal tubule occlusion and dentin mineral deposition.

Primary Outcome Measures: Pain intensity due to Dentin Hypersensitivity by Visual Analogue Scale (VAS), VAS is used to "quantify" the pain severity in millimeter (mm) in response to such query as "Draw a line on the scale that shows how much pain you have at this time " with "no pain" on the far left end of scale at 0 mm and "pain as bad as it can be" on the far right at 100 mm., T (Time): T0= Baseline (before treatment). T1= 7 days. T2= 3 months. T3= 6 months
Peer Assisted Breastfeeding Education Program
NCT Number: NCT06493474
Acronym: PABEP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Feeding
Interventions: OTHER: Education|OTHER: Routine Care
Sponsor: Akdeniz University
Collaborators: Burdur Mehmet Akif Ersoy University
Sex: FEMALE
Age: CHILD
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-20
Completion Date: 2024-07-20
Locations: Burdur Mehmet Akif Ersoy University, Burdur, Turkey

Summary:
It was aimed to evaluate the effect of the Peer Supported Breastfeeding Education Program given during the antenatal period on the breastfeeding knowledge and attitude levels, breastfeeding self-efficacy and breastfeeding levels of postpartum women. For this purpose, the hypotheses created in our study are as follows.

1. H1: Breastfeeding knowledge and attitudes of mothers in the PABEP group are significantly higher than those in the control group.
2. H1: Breastfeeding proficiency levels of mothers in the PABEP group are significantly higher than those in the control group.
3. H1: Breastfeeding success of mothers in the PABEP group is significantly higher than the control group, according to the breastfeeding evaluation results.

Primary Outcome Measures: Breastfeeding Self-Efficacy, It is a scale consisting of 33 items developed by Dennis (1999). The scale prepared as a five-point Likert type; (1) I never trust myself, (2) I don't trust myself very much, (3) I sometimes trust myself, (4) I trust myself most of the time, (5) I always trust myself. As the total score on the scale increases, breastfeeding self-efficacy also increases. The lowest score is 33 and the highest score is 165., Research data will be collected during training before birth and at 1 and 4 weeks after birth.
Secondary Outcome Measures: breastfeeding success, The scale consists of six questions and scoring is based on mothers' answers to the questions. The first question is about the baby's starting state of feeding (deep sleep, sleepy, calm-awake, crying). This question is not included in the scoring. The next four questions are about searching and the baby's sucking behavior. Each question is evaluated between 0-3 points and the highest score is 12. The score range in effectively fed babies is 10-12 points. Babies who breastfeed quite successfully when encouraged are given 7-9 points and are considered moderately effective. Babies who do not start feeding upon warning, do not seek nutrition, or breastfeed for short periods are given a score of 0-6. In the last question, mothers record their feelings during feeding (very satisfied, satisfied, not very satisfied, not satisfied). This question is not included in the scoring and is evaluated separately., Research data will be collected during training before birth and at 1 and 4 weeks after birth.
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
NCT Number: NCT06493461
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pulmonary Arterial Hypertension (PAH)
Interventions: BIOLOGICAL: HS135
Sponsor: 35Pharma Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-04
Locations: University of Alberta, Edmonton, Alberta, T6G 2G3, Canada

Summary:
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults

Primary Outcome Measures: Adverse Events (AEs), Up to 24 weeks|Change from Baseline in Physical Examination, Physical Examination will include the assessment of body systems., Up to 24 weeks|Change from Baseline in Clinical Laboratory Parameters, Up to 24 weeks|Change from Baseline in Blood Pressure, Up to 24 weeks
Prospective Observational Cohort Study
NCT Number: NCT06493448
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|Liver Metastases
Interventions: OTHER: observation
Sponsor: Lin Chen
Collaborators: Peking University International Hospital|Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1326
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2028-12-31
Locations: Chinese PLA General Hospital, Beijing, Beijing, 100853, China

Summary:
The goal of this observational study is to learn about the overall disease status, diagnostic and therapeutic modalities, and prognosis of patients with gastric cancer liver metastasis(GCLM) in China. The investigators divided the participants into three groups( three types) of gastric cancer liver metastasis based onChinese c-GCLM classification system.The main question it aims to answer is:

1. How long do patients with GCLM live?
2. How different treatment modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) affect patients' prognosis of three type? All participants will be tracked for their physical condition.

Primary Outcome Measures: 2-year OS, The primary study endpoint was two-year survival in patients, 2 years OS from diagnosed time to measured time or death
Secondary Outcome Measures: OS of type I（questionnaires, phone calls, and outpatient follow-up.）, the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis., OS from diagnosed time to measured time or death（up to 5 years）|OS of type II （questionnaires, phone calls, and outpatient follow-up.）, the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis., OS from diagnosed time to measured time or death（2 to 5 years）|OS of type III（questionnaires, phone calls, and outpatient follow-up.）, the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis., OS from diagnosed time to measured time or death（no more than 2 years）|DFS of type I（questionnaires, phone calls, and outpatient follow-up.）, DFS of type I. Disease-free survival time maintained after the participant has been saved by therapeutic measures.Especially in patients underwent radical surgery., Through study completion, an average of 2 year.|R0 resection rate (pathological information from medical record.), Proportion of all operated patients achieving radical resection., Through study completion, an average of 2 year.|successful conversion therapy rate (pathological information and surgery information from medical record.), Proportion of type II patients underwent radical surgery after systemic treatment., Through study completion, an average of 2 year.
Other Outcome Measures: Objective response rate (ORR) of disease by immunological drugs (Imaging information, pathology information from medical record.), Degree of tumour response after treatment in all participants treated with applied immunological drugs., Through study completion, an average of 2 year.
Online Interplay Between Deciding and Acting With Mild Cognitive Impairment
NCT Number: NCT06493422
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mild Cognitive Impairment
Interventions: BEHAVIORAL: Reaching Movements
Sponsor: University of Delaware
Collaborators: National Institutes of Health (NIH)|National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-09

Summary:
The investigators aim to understand the interplay and neural structures involved with decision--making and movement for participants with mild cognitive impairment. Rapidly deciding and acting becomes bottlenecked with mild cognitive impairment and Alzheimer's, leading to detrimental outcomes such as falling and car crashes. The investigators work will have a tangible impact by discovering sensitive biomarkers to detect disease onset and pave the way for informed and effective neurorehabilitation.

Primary Outcome Measures: Reaching Movements, Hand position will be recorded throughout each trial during the behavioral task, through study completion, an average of 1 year|Change in brain mechanical properties, Investigators are assessing change in brain structure through mechanical properties, through study completion, an average of 1 year
Secondary Outcome Measures: Decision Time, Decision time will be calculated on each trial during the behavioral task, through study completion, an average of 1 year
A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
NCT Number: NCT06493409
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: Repotrectinib|DRUG: Voriconazole|DRUG: Quinidine
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-27
Completion Date: 2024-12-07
Locations: Local Institution - 0001, Daytona Beach, Florida, 32117, United States

Summary:
The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential \[INOCBP\]) participants.

Primary Outcome Measures: Maximum observed plasma concentration (Cmax), Up to Day 23|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)), Up to Day 23|Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)), Up to Day 23
Secondary Outcome Measures: Number of participants with Adverse Events (AEs), Up to Day 52|Number of participants with Severe Adverse Events (SAEs), Up to Day 52|Number of participants with physical examination abnormalities, Up to Day 23|Number of participants with vital sign abnormalities, Up to Day 23|Number of participants with electrocardiogram abnormalities, Up to Day 23|Number of participants with clinical safety laboratory test abnormalities, Up to Day 22|Time of maximum observed plasma concentration (Tmax), Up to Day 23|Apparent terminal phase half-life (T-HALF), Up to Day 23|Apparent total body clearance (CLT/F), Up to Day 23|Apparent volume of distribution of terminal phase (Vz/F), Up to Day 23|Cmax, Up to Day 23|Area under the plasma concentration-time curve over one dosing interval (AUC(TAU)), Up to Day 23|Trough observed plasma concentration (Ctrough), Up to Day 23
Lotrafilcon B Plano Cosmetic Contact Lenses Study
NCT Number: NCT06493383
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cosmetic Appearance
Interventions: DEVICE: Lotrafilcon B plano cosmetic contact lenses
Sponsor: Alcon Research
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 650
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2026-04
Locations: Contact Alcon Call Center for Trial Locations, Fort Worth, Texas, 76134, United States

Summary:
The purpose of this study is to gather long-term performance and safety data on AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses in subjects 12 years of age and older. AIR OPTIX™ COLORS plano contact lenses do not contain visual correction and are worn for cosmetic purposes only.

Primary Outcome Measures: Incidence of corneal infiltrative events, A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea., Up to Year 1|Incidence of microbial keratitis, Microbial keratitis is a sight-threatening infection of the cornea., Up to Year 1
Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
NCT Number: NCT06493370
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Bladder Cancer
Interventions: DRUG: Intravenous ascorbic acid/vitamin C
Sponsor: University of Kansas Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2030-12-01
Locations: Holden Comprehensive Cancer Center - The University of Iowa, Iowa City, Iowa, 52242, United States|The University of Kansas Cancer Center, Kansas City, Kansas, 66160, United States

Summary:
This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC.

Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.

Primary Outcome Measures: Post treatment pathological staging, To assess pathologic downstaging rate in MIBC cisplatin-ineligible patients when IVC is added to a gemcitabine/carboplatin NAC regimen. Pre and Post treatment specimen pathology results evaluated per American Joint Committee on Cancer (AJCC) staging guidelines., Approximately 10 to 12 weeks
Secondary Outcome Measures: To assess Quality of life (QOL), Overall change in participant-reported quality of life outcomes. Fact-Bladder (FACT-BI) Quality of life questionnaire as measurement tool., Approximately 10 to 16 weeks|To measure Disease Free Survival (DFS), Disease free survival rate (DFS) among participants, Approximately 2 years|To measure Disease Specific Survival (DSS), Disease specific survival rate among participants, Approximately 2 years
Other Outcome Measures: Cellular outcome markers, IVC uptake, IVC specific mechanism markers, Cell death, Cell proliferation, Tumor samples will be collected at timepoints as listed in the protocol study procedures and schedule of events table for evaluation of generally used cellular outcome markers, as well as markers for IVC specific mechanism, via the IRB approved BCa tumor bank (Taylor PI). Acetylated tubulin levels and transferrin receptor levels in tumor samples will be detected as IVC related markers. SLC23A2 (SVCT2, vitamin C tissue receptor) will be assessed for drug uptake. TUNEL staining will be used as a measure of cell death and Ki67 as a measure of cell proliferation. Circulating tumor DNA (ctDNA) will be assessed in serum as an additional marker of treatment efficacy and recurrence. In addition, single-cell sequencing will be used to define changes in specific tissue populations at TUR and RC to evaluate both biomarkers of response and potential mechanisms associated with IVC treatment. To monitor inflammation, urinary cytokines will be assessed via multiplex ELISA at RC (post-treatment)., During surgery
The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy
NCT Number: NCT06493344
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy|Gait, Spastic|Motor Disorders|Functional Neurological Disorder
Interventions: OTHER: Applying additional weight
Sponsor: University of Thessaly
Sex: ALL
Age: CHILD
Enrollment: 2
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-09-23
Completion Date: 2022-05-23
Locations: Department of Physiotherapy - University of Thessaly, Lamía, Phthiotis, 35132, Greece

Summary:
The purpose of this study was to investigate the effectiveness of applying additional weight in the improvement of the crouch gait pattern in children with spastic cerebral palsy.

Primary Outcome Measures: Kinovea, Kinovea is a 2D video annotation tool designed for kinematic analysis. Assessment of knee angle during stance phase., up to 16 weeks (every 4 weeks)|Gross Motor Function Measure 88 (GMFM-88), An assessment tool designed and evaluated to measure changes in gross motor function over time in children with cerebral palsy. Unit of Measure: Scoring Options (0, 1, 2, 3, or "not tested") // (higher scores - better outcome), up to 16 weeks (every 4 weeks)|Timed Up and Go, The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in disabled children. Unit of measure: seconds of completion (higher scores - worse outcomes), up to 16 weeks (every 4 weeks)|Sit to Stand (STS) test of the NeuroCom® Balance Master®, A cutting-edge technology used at Balance and Mobility Therapy to accurately assess and treat balance disorders., up to 16 weeks (every 4 weeks)
Talking Circle for Pediatric Nursing Students (TC4PN) Activity
NCT Number: NCT06493331
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Therapeutic Alliance|Nursing Caries
Interventions: OTHER: Talking Circle
Sponsor: Sakarya University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-26
Completion Date: 2024-06-30
Locations: sakarya University, Sakarya, Serdivan, 54000, Turkey

Summary:
Nursing students communicate with patients during clinical practice to assess their needs and environmental factors affecting their health. However, nursing students often find therapeutic communication to be one of the most stressful tasks. Specifically, studies report that nursing students face difficulties in communicating to care for pediatric patients.

In this regard, the aim of this research is; To examine the effects of Talking Circle activities based on JOHN LOWE's self-confidence theory on the therapeutic communication skills of pediatric nursing students.

Primary Outcome Measures: Therapeutic Communication Skills Scale, Between-group differences in Therapeutic Communication Skills Scale for Nursing Students scores

Therapeutic Communication Skills Scale for Nursing Students

The scale consists of 16 items and 3 sub-dimensions: "Non-therapeutic Communication Skills", "Therapeutic Communication Skills-1", "Therapeutic Communication Skills-2". The first sub-dimension of the scale consists of 7 items, the second sub-dimension consists of 6 items, and the third sub-dimension consists of 3 items. The scale is a 7-point Likert type ranging from 1 to 7, and there are no reverse coded items in the scale. The highest score that can be obtained from the scale is 16x7=112, and the lowest score is 16x1=16. The increase in scale scores shows that communication skills have increased., Baseline, (1st measurement) -immediately after the intervention (2nd measurement)
Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability
NCT Number: NCT06493318
Acronym: ELIS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Wrist Disease
Interventions: PROCEDURE: Dorsal ligamentoplasty reinforced with an internal brace
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-24
Completion Date: 2031-05-01
Locations: Clinique Monticelli - Vélodrome, Marseille, 13008, France

Summary:
Prospective longitudinal multicenter observational cohort study conducted on a population of patients who underwent ligamentoplasty for scapholunate instability and agreed to be followed for a period of five years from the day of hospital discharge.

Primary Outcome Measures: Ligamentoplasty failure, Failure of the ligamentoplasty is defined by the need for secondary surgery., Year 5
The Effect of NLP on Pain Before Uterine Curettage Due to the Fetal Demise
NCT Number: NCT06493305
Acronym: NLP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries|Pain, Acute|Pregnancy Loss
Interventions: BEHAVIORAL: Neurolinguistic programming
Sponsor: Sanliurfa Education and Research Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-10-01
Locations: Sanliurfa Education and Research Hospital, Şanlıurfa, Turkey

Summary:
Pregnancy termination is a difficult and painful procedure can be done by medically or uterine curettage. Studies have been conducted to reduce the anxiety of women undergoing pregnancy termination, but there are no publications on topics such as anxiety, pain perception, and pain catastrophizing.

Neuro Linguistic Programming (NLP) has been called "the art and science of personal excellence", "the study of subjective experience". NLP helps us understand the difference between our actions that produce mediocre results or failure and those that require success or excellence.

NLP: "How do I do something I do well?", "How can I do it better?", "How can I gain skills that I admire in others? It addresses questions like ". It is important to note that NLP is not limited to observable behavior. Our way of thinking, that is, all experience and it also includes the mental processes that control our actions. By dealing with the entire structure of a person's experience (in fact, their motivation), it tries to shape the thought processes, emotions and beliefs that result in a behavior. It is especially about our communication with ourselves as well as with others.

No study was planned on pain and pain perception during pregnancy termination by uterine curettage by teaching the NLP technique to the patients.

Primary Outcome Measures: VAS score, pain perception scale and pain catastrophizing scales scores, pain scale, 1 hour
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
NCT Number: NCT06493292
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hemodialysis Access Failure
Interventions: PROCEDURE: Endovascular therapy
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2026-12
Locations: First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China|Renji Hospital, Shanghai, Shanghai, China

Summary:
This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.

Primary Outcome Measures: Clinically-driven target lesion re-intervention, Clinically-driven target lesion re-intervention refers to a repeat procedure performed on a previously treated lesion due to the recurrence of symptoms or other clinical indications, rather than being routinely scheduled., 1-month#3-month#6-month#12-month
Secondary Outcome Measures: Target lesion primary patency, Target lesion primary patency refers to the treated lesion site remaining open and unobstructed without the need for any additional revascularization procedure during the follow-up period., 1-month#3-month#6-month#12-month|Target lesion assisted primary patency, Target lesion assisted primary patency refers to the treated lesion site remaining patent (open) during the follow-up period, but requiring an additional revascularization procedure, such as percutaneous transluminal angioplasty, to maintain patency of the target lesion., 1-month#3-month#6-month#12-month
Evaluate the Safety and Efficacy of Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis
NCT Number: NCT06493279
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Amyotrophic Lateral Sclerosis Als
Interventions: DRUG: RJK002 Intrathecal injection
Sponsor: Rejukon Biopharm Inc.
Collaborators: Peking University Third Hospital|Nanfang Hospital, Southern Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2031-05-02

Summary:
The goal of the study aims to evaluate the safety and tolerability of a single intrathecal injection of RJK002 in subjects with amyotrophic lateral sclerosis (ALS), and to determine the recommended Phase II dose (RP2D).

Primary Outcome Measures: incidence of adverse events (AEs)/serious adverse events (SAEs), Each visit within 5 years after administration|Dose limiting toxicities (DLT), Measured as any drug-related serious adverse event that meet DLT standard. If a dose has less than 33% DLTs it will be considered tolerable., 28 days after administration
Secondary Outcome Measures: Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score, The ALSFRSr, a questionnaire-based scale assessing daily living function ranging from 48 (best score) to 0 (worst), was administered to the patient, or to a proxy if the patient could not communicate effectively. Decline was defined as ALSFRSr at baseline minus ALSFRSr at month 9. A positive value indicates worsening., 28 days, 56 days, 84 days, 6 months, 12months, 18 months after administration
Other Outcome Measures: change of concentration of neurofilament light chain (NFL) in blood and CSF, 84 days, 6 months, 12months, 18 months after administration
The Effect of Neurolingualistik Programming (NLP) on Pain Score, Fear of Pain and Pain Catastrophizing Before Colposcopy
NCT Number: NCT06493266
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute
Interventions: BEHAVIORAL: neurolinguistic programmino
Sponsor: Sanliurfa Education and Research Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-02
Completion Date: 2024-10-02
Locations: Sanliurfa Education and Research Hospital, Sanliurfa, Turkey|Sanliurfa Education and Research Hospital, Şanlıurfa, 63250, Turkey

Summary:
Colposcopy, evaluation of cervical cytological abnormalities and It is the gold standard procedure for the early diagnosis of preinvasive and invasive diseases. Despite her Essentially a minimally invasive intervention, even referring the patient to colposcopy can cause significant anxiety and distress in patients. Increased anxiety can also lead to deterioration in health-related quality. Studies have been conducted to reduce the anxiety of women undergoing colposcopy, but there are no publications on topics such as anxiety, pain perception, and pain catastrophizing.

Neuro Linguistic Programming (NLP) has been called "the art and science of personal excellence", "the study of subjective experience". NLP helps us understand the difference between our actions that produce mediocre results or failure and those that require success or excellence.

NLP: "How do I do something I do well?", "How can I do it better?", "How can I gain skills that I admire in others? It addresses questions like ". It is important to note that NLP is not limited to observable behavior. Our way of thinking, that is, all experience and It also includes the mental processes that control our actions. By dealing with the entire structure of a person's experience (in fact, their motivation), it tries to shape the thought processes, emotions and beliefs that result in a behavior. It is especially about our communication with ourselves as well as with others.

No study was planned on pain and pain perception during colposcopy by teaching the NLP technique to the patients.

Primary Outcome Measures: pain evaluation, pain level, 1 hour