pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve
NCT Number: NCT06572215
Acronym: DYNAMO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Dapagliflozin
Sponsor: King's College Hospital NHS Trust
Collaborators: King's College London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-14
Completion Date: 2025-01-01
Locations: King's College Hospital, London, United Kingdom

Summary:
This is a feasibility study to assess new, more practical ways of measuring renal reserve.

Primary Outcome Measures: Change in eGFR from baseline to 2hours after oral protein load, 2 hours
Clinical Validation Study of the Eximis CS (Contained Segmentation) System
NCT Number: NCT06572163
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Laparoscopic Gynecological Surgical Procedures
Interventions: DEVICE: Eximis CS (Contained Segmentation) System
Sponsor: Eximis Surgical
Collaborators: Proxima Clinical Research
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-08-27
Completion Date: 2025-04-15

Summary:
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.

Primary Outcome Measures: Performance, Percentage of procedures successfully completed with use of the Eximis CS device per the Instructions for Use and without breach of the containment bag., 2 months
Secondary Outcome Measures: Usability, Percentage of procedures where all critical tasks related to the Eximis CS are performed without observed failure or omission.

Percentage of procedures requiring critical troubleshooting steps (i.e., extending an incision, employing alternate tissue removal techniques) per the Instructions for Use Percentage of procedures requiring other troubleshooting steps (i.e., replacing the RF Generator, Segmenter, or Capture Bag; cutting Segmenter wires; responding to an alarm or information signal) per the Instructions for Use, 2 months
Other Outcome Measures: Adverse Events, The incidence of device-related adverse events. The incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs), 2 months
Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation
NCT Number: NCT06572150
Acronym: MIXT-DBS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: PROCEDURE: Deep Brain Stimulation - Minimal Electrophysiology|PROCEDURE: Deep Brain Stimulation - Standard
Sponsor: Nova Scotia Health Authority
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-10
Locations: Queen Elizabeth Health Science Centre, Halifax, Nova Scotia, B3H 3A7, Canada

Summary:
The goal of this study is to learn if Deep Brain Stimulation (DBS) surgery can be streamlined for patients being treated for Parkinson's disease. The main questions it aims to answer are:

* Can a streamlined DBS surgery protocol with minimal electrophysiology and imaging (MiXT) safely replace the current use of intraoperative electrophysiology?
* Are we able to improve the efficiency, lower the invasiveness, and improve the clinical outcomes for patients undergoing DBS surgery?

Researchers will compare patients undergoing DBS surgery with this streamlined protocol to patients who previously underwent DBS surgery with the standard protocol to see if the accuracy, clinical outcomes, and efficiency improve.

Participants will undergo the standard protocol for DBS work-up and follow-up, but with minimal intraoperative electrophysiological testing.

Primary Outcome Measures: Accuracy of implanted electrode position, The distance between the final implanted electrode and the planned electrode, as measured on imaging software., Intraoperative
Secondary Outcome Measures: Change in disease score units on the Unified Parkinson's Disease Rating Scale, Assessment of therapeutic effects using the Unified Parkinson Disease Rating Scale, Baseline, 12 months|Change in disease score units on the Parkinsons Disease Questionnaire, Assessment of therapeutic effects using the Parkinsons Disease Questionnaire, Baseline, 12 months|Efficiency of Surgery, Assessment of operating room times and length of stay in hospital, Intraoperative|Intraoperative intensity of stimulation in milliampere, Intraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior), Intraoperative|Safety of streamlined protocol, Number of adverse events (neurological deficits, infections, hemorrhages), hardware complications (e.g. electrode dislocation and breakage), psychiatric side effects (e.g. depression, hypomania, obsessive behaviour), and unexpected stimulation induced side effects, 4, 16, and 52 weeks post-surgery
Prevalence of Parental Burnout Among Mothers of Children With Cerebral Palsy
NCT Number: NCT06572137
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parents|Burnout|Children, Only|Cerebral Palsy
Sponsor: Cairo University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 380
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-01-01
Locations: out-patient clinic, faculty of physical therapy, Cairo university, Giza, Egypt

Summary:
This study will be done to determine the prevalence of Parental Burnout among mothers of children with cerebral palsy.

Determine the relation between Parental Burnout syndrome and the motor function levels of children with cerebral palsy.

Primary Outcome Measures: assessment of 4 dimensions of burnout, The Lebanese translation of the Parental burnout questionnaire, a 23-item self-report, includes four subscales: Emotional Exhaustion, Contrast, Feelings of Being Fed Up, and Emotional Distancing. The questionnaire has Cronbach's alphas of.93,.93,.90, and.81 for the sub-scales and.96 for the global score., at baseline
Secondary Outcome Measures: assessment of gross motor function, The Gross Motor Function Classification System (GMFCS) categorizes children into Level I, Level II, Level III, Level IV, and Level V. Level I children can walk, climb stairs, and perform gross motor skills, while Level II and III require assistance, while Level IV and V require manual wheelchair use., at baseline
Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions
NCT Number: NCT06572124
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carious Lesion|Cervical Caries
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-04-30

Summary:
Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.

Primary Outcome Measures: Retention (Success rate), Alpha (A) Present Bravo (B) Partial loss but clinically acceptable Charlie (C)Clinically unacceptable partial loss or absent, T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Secondary Outcome Measures: Marginal adaptation, Alpha (A) Restoration adapts closely to the tooth structure; there is no visible crevice.

Bravo (B) There is a visible crevice, the explorer will penetrate, without dentin exposure.

Charlie(C)The explorer penetrates into a crevice in which dentin or the base is exposed., T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.|Marginal discoloration, Alpha (A) No marginal discoloration. Bravo (B) Minor marginal discoloration without staining toward the pulp, only visible using a mirror and operating light.

Charlie(C) Deep discoloration with staining toward the pulp, visible at a speaking distance of 60 to 100 cm., T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.|Secondary caries, Alpha (A) No active caries present Charlie(C) Active caries is present in contact with the restoration, T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
A Study in Healthy Men to Test How BI 1839100 is Taken up and Handled by the Body
NCT Number: NCT06572111
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: BI 1839100 (C-14) formulation 1|DRUG: BI 1839100|DRUG: BI 1839100 (C-14) formulation 2
Sponsor: Boehringer Ingelheim
Sex: MALE
Age: ADULT
Enrollment: 16
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-09
Completion Date: 2024-11-18

Summary:
This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. It also determines the concentrations in blood plasma and investigates the drug's metabolic pathways. Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously.

Primary Outcome Measures: Mass balance and total recovery of [C-14]-radioactivity in urine and feces., Part A, From drug administration up to Day 21.|Area under the concentration-time curve of Carbon-14-labeled BI 1839100 after intravenous administration and BI 1839100 after oral administration, extrapolated to infinity (AUC0-∞)., Part B, From drug administration up to Day 21.
Secondary Outcome Measures: Maximum measured concentration of BI 1839100 and Carbon-14-labeled BI 1839100 in plasma (Cmax)., Part A, Two hours before drug administration up to Day 21.|Area under the concentration-time curve of BI 1839100 and Carbon-14-labeled BI 1839100 from 0 to the last quantifiable time point (AUC0-tz)., Part A, Two hours before drug administration up to Day 21.|Area under the concentration-time curve of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration, from 0 to the last quantifiable time point (AUC0-tz)., Part B, Two hours before drug administration up to 72 hours (Day 4).|Maximum measured concentration of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration (Cmax)., Part B, Two hours before drug administration up to 72 hours (Day 4).
The Effect of Complex decongestıve Therapy on oxıdatıve Stress and antıoxıdants
NCT Number: NCT06572098
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: What Are the Effects of Lymphedema Treatment
Interventions: OTHER: Complex decongestive therapy
Sponsor: Baskent University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-04-03
Completion Date: 2028-04-03
Locations: Baskent University, Adana, Çukurova, 01250, Turkey

Summary:
It is aimed to determine the changes of complex decongestive therapy applications on oxidative stress parameters and antioxidants in patients with lymphedema after breast cancer treatment.

Primary Outcome Measures: PON1, Paraoksonaz, will be assessed before treatment, immediately after treatment and one month after treatment.
Secondary Outcome Measures: OSİ, Oxidative Stress Index, will be assessed before treatment, immediately after treatment and one month after treatment.
Other Outcome Measures: MDA, malonDialdehit, will be assessed before treatment, immediately after treatment and one month after treatment.|GSH, Rdüktegulutatyon, will be assessed before treatment, immediately after treatment and one month after treatment.|LDL, Low danditelilipoprotein, will be assessed before treatment, immediately after treatment and one month after treatment.|HDL, High densitelilipoprotein, will be assessed before treatment, immediately after treatment and one month after treatment.|Trigliserit, level of Trigliserit, will be assessed before treatment, immediately after treatment and one month after treatment.
Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients
NCT Number: NCT06572085
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Butylphthalide|Cardiac Arrest|Neuroprotective Drugs
Interventions: DRUG: Butylphthalide and Sodium Chloride Injection|DRUG: Saline Solution
Sponsor: Tang Ziren
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2024-12-31
Locations: Beijing Chao-Yang Hospital, Beijing, Beijing, 100020, China

Summary:
Cardiac arrest is one of the critical illnesses that is directly life-threatening, and patients who survive cardiac arrest develop severe neurological deficits or even die. The effectiveness of drugs to improve neurological function in resuscitated brain-injured patients has been a focus of research in the field of resuscitation. Butanephthalein has an ameliorating effect on the damage of central nervous function in patients with acute ischemic stroke, and can promote the improvement of patients' neurological deficits. On this basis, the present study was designed as a multicenter, prospective randomized controlled experiment, with internationally accepted methods for assessing near-term and long-term neurological function, to determine the effectiveness of butalbital in improving neurological function after cardiac arrest, with the aim of searching for new methods and ideas to improve neurological function and prognosis after cardiac arrest.

Primary Outcome Measures: The proportion of patients with a Cerebral Performance Category (CPC) Score of 1-2, The primary outcome is the proportion of patients with a Cerebral Performance Category (CPC) score of 1-2 at 6months after randomization in each group., 6 months
Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients
NCT Number: NCT06572072
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Negative Pressure Ventilation|Right Ventricular Dysfunction|Right Ventricular Failure
Interventions: DEVICE: Negative Pressure Ventilation
Sponsor: Karlsburg Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Klinikum Karlsburg, Klinik für Anästhesiologie, Karlsburg, Mecklenburg Vorpommern, 17495, Germany

Summary:
Patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. A cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. During usual positive pressure ventilation a ventilatory, a hemodynamic and a 3D full volume ultrasounddataset of the right and left ventricle is recorded and severity of tricuspidal regurgitation examined. Afterwards negative pressure ventilation is started and positive pressure ventilation reduced as far as possible without reduction of tidal volumes. The same dataset of ventilation, hemodynamics and ultrasound is collected again during negative pressure ventilation. Afterwards the cuirass gets removed, study finished and everything proceeds as during standard procedure.

Primary Outcome Measures: stroke volume index, transesophageal ultrasound measurement, 1 minute
Secondary Outcome Measures: RVEF, transesophageal ultrasound measurement, 1 minute|LVEF, transesophageal ultrasound measurement, 1 minute|volumes of chambers, transesophageal ultrasound measurement, 1 minute|strain, transesophageal ultrasound measurement, 1 minute|VC, transesophageal ultrasound measurement, 1 minute|PISA, transesophageal ultrasound measurement, 1 minute|EROA, transesophageal ultrasound measurement, 1 minute|area of regurgitation of tricuspid valve, transesophageal ultrasound measurement, 1 minute|arterial blood pressures, hemodynamic measurements, 1 minute|venous blood pressures, hemodynamic measurements, 1 minute|pulmonal blood pressures, hemodynamic measurements, 1 minute|heart frequency, hemodynamic measurements, 1 minute|tidal volume, ventilatory measurements, 1 minute|minute volume, ventilatory measurements, 1 minute|breathing rate, ventilatory measurements, 1 minute|etCO2, ventilatory measurements, 1 minute|pO2 in the blood, blood gases, 1 minute|pCO2 in the blood, blood gases, 1 minute|Laktat, blood gases, 1 minute|cerebral oximetry, NIRS, 1 minute
STOP-HSP.Net: a Registry for Hereditary Spastic Paraplegia as an Integration Tool for Future Therapeutic Strategies
NCT Number: NCT06572046
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hereditary Spastic Paraplegia
Sponsor: IRCCS Fondazione Stella Maris
Collaborators: IRCCS Eugenio Medea|Università degli studi di Messina|IRCCS Istituto delle Scienze Neurologiche di Bologna|Catholic University of the Sacred Heart|CINECA|Fondazione Telethon
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-24
Completion Date: 2029-12-31
Locations: IRCCS Fondazione Stella Maris, Pisa, 56128, Italy

Summary:
Our goal is to create a solid and harmonious disease registry of patient affected by hereditary spastic paraplegia (HSP) that facilitates the collection and management of patients' data over time encouraging the research and the development of future clinical trials. In-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales, biomarkers and so-called patient reported outcomes (PROs).

Primary Outcome Measures: Establishment of the STOP-HSP.net disease registry to systematically document the clinical presentation and natural history of patients affected by both pediatric-onset and adult-onset HSP, five years|Definition of genotype-specific disease progression measured by evaluating the scores of the clinical scale "Spastic Paraplegia Rating Scale" (SPRS), Spastic Paraplegia Rating Scale (SPRS) is a 13-item scale designed to rate motor impairment in pure or complex forms of spastic paraplegia. Its score varies from 0 to 52, whereas higher scores indicate greater motor impairment., five years|Identification of new genetic forms of HSP through the use of Whole Genome Sequencing (WGS) in selected familial cases, five years
Transference of Established Simulated Skills (TEST) Trial
NCT Number: NCT06572033
Acronym: TEST
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neonatal Respiratory Distress
Interventions: BEHAVIORAL: Simulation
Sponsor: University of Texas Southwestern Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2025-05-29
Locations: Parkland Memorial Hospital, Dallas, Texas, 75235, United States

Summary:
This study aims to determine if skills learned in the simulation lab, specifically in managing mask leak during positive pressure ventilation (PPV), translate effectively to the delivery room. By comparing the performance of healthcare providers on mannequins in the lab to their performance on newborns in the delivery room, the study seeks to establish a Ventilation Performance Score (VPS) based on data from a respiratory function monitor. The primary hypothesis is that a provider's ability to minimize mask leak on a mannequin correlates with their ability to do so with a newborn. The prospective observational TEST Trial will use the Monivent Neo100 to collect and analyze PPV data, comparing key parameters like mask leak and VQS between the two settings to assess correlations. Secondary analysis will explore individual aspects of PPV, such as PIP, PEEP, and eVT.

Primary Outcome Measures: Correlation of mask leak performance, Correlation between the percentage of mask leak observed during positive pressure ventilation (PPV) on a mannequin in the simulation laboratory and the percentage of mask leak observed during PPV on a newborn infant in the delivery room., 1 year
Secondary Outcome Measures: Correlation of Ventilation Performance Score (VPS), Correlation of Ventilation Performance Score (VPS) between the simulation lab and the delivery room., 1 year|Correlation of submetrics of VPS, Correlation of submetrics of VPS (such as TVe, mask seal, PIP, PEEP, etc.) between the simulation lab and the delivery room., 1 year
Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis
NCT Number: NCT06571981
Acronym: RUTH
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatitis|Teleradiology
Interventions: DEVICE: TUP ultraportable US with teleradiology capacities|DEVICE: CUS conventional ultrasound
Sponsor: Naik Vietti Violi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)

Primary Outcome Measures: Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions, LI RADS categories

No observation OR Only definitely benign observation(s) Observation(s) \< 10 mm in diameter, not definitely benign Observation(s) ≥ 10 mm in diameter, not definitely benign OR New thrombus in vein, At the end of intervention
Secondary Outcome Measures: liver visualization scores, no or minimal limitations; moderate limitations; severe limitations, At the end of intervention|liver surface nodularity, Yes/No, At the end of intervention|focal lesions, Yes/No, At the end of intervention|caudate lobe dimensions, cm, At the end of intervention|portal flow velocity, cm/s, At the end of intervention|biliary tract / gallbladder abnormalities, Yes/No, At the end of intervention|lymph nodes presence, Yes/No, At the end of intervention|free fluid, Yes/No, At the end of intervention|examination time, minutes, At the end of intervention|audio quality, Adequate/Non Adequate, At the end of intervention|video quality, Adequate/Non Adequate, At the end of intervention|patient's satisfaction, Yes/No, At the end of intervention|agreement rates between reports, Category 1: complete agreement/matching with teleradiologists reports; Category 2: minor discrepancy that would not impact patient management which included hedging terminology and ambiguous differences, for example fatty versus moderate fatty liver; Category 3: major discrepancy that would likely have an impact/change on patient management but would not lead to an adverse outcome for the patient; Category 4: major discrepancy that would impact patient management and lead to adverse outcomes for the patient., At the end of intervention
Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible
NCT Number: NCT06571968
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Implant Placement
Interventions: DEVICE: fully guided stent
Sponsor: Mansoura University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-05-14
Completion Date: 2024-02-02
Locations: Marwa Aboelez, Mansoura, Egypt

Summary:
Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants.

Primary Outcome Measures: Radio graphic evaluation (Angular deviation), For both groups, postoperative CBCT scan was performed after implant placement. The same parameters of preoperative CBCT were followed according to the patient's position, image acquisition, and use of the same apparatus. This scan was performed with the same dental prosthesis as that used for the initial preoperative CBCT scanning, equipped with the gutta percha references, for superimposition of the images. The previously fabricated occlusal registration was used to align the prosthesis. Both CBCT scans were superimposed, and the software compared preoperative horizontal (Mesiodistal and buccolingual), vertical and angular virtual measurements of planned implants with real measurements of the placed implants., one year
Secondary Outcome Measures: Radio graphic evaluation (linear deviation), For both groups, postoperative CBCT scan was performed after implant placement. The same parameters of preoperative CBCT were followed according to the patient's position, image acquisition, and use of the same apparatus. This scan was performed with the same dental prosthesis as that used for the initial preoperative CBCT scanning, equipped with the gutta percha references, for superimposition of the images. The previously fabricated occlusal registration was used to align the prosthesis. Both CBCT scans were superimposed, and the software compared preoperative horizontal (Mesiodistal and buccolingual) measurements of planned implants with real measurements of the placed implants., one year
Video-based Learning for Basic Surgical Skills
NCT Number: NCT06571903
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Teaching Basic Surgical Techniques
Interventions: OTHER: Teaching from videos
Sponsor: Universidade do Porto
Collaborators: Centro Hospitalar Universitário de São João, E.P.E.|Rede de Investigação em Saúde|RISE-Heatlh
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-23
Completion Date: 2024-10-10

Summary:
This is a prospective randomized study, intended to evaluate the effectiveness of teaching basic surgical techniques through video, comparing the results with those of traditional teaching

Primary Outcome Measures: Assessment of the qualities of the techniques (Objective Structured Assessment of Technical Skills (OSATS) modified scale), Evaluate the quality of execution of the technical gesture and its retention on each group (teaching basic surgical techniques through video and traditional education (courses face-to-face)). The Objective Structured Assessment of Technical Skills (OSATS) modified scale is scored from 8 (worst performance) to 40 (best performance)., 2 weeks|Time the participants took to complete the procedure, Time in minutes and seconds (mm:ss) that the participants took to complete the procedure on each group (teaching basic surgical techniques through video and traditional education (courses face-to-face))., 2 weeks
Secondary Outcome Measures: Assessment of participants' involvement and interest (time of self-study in hours), Time of self-study in hours and minutes (hh:mm), to check participants' involvement and interest in the teaching method through video., 1 month|Participant satisfaction with teaching method (Likert-like satisfaction questionnaire), Likert-like satisfaction questionnaire scored from 5 (worst outcome) to 25 (best outcome)., 1 day
Emergence Agitation in Paediatric Day Care Surgery
NCT Number: NCT06571890
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Delirium|Postoperative Agitation|Anesthesia|Pain Monitoring|Heart Rate Variability|Narcotrend|Mdoloris|Anesthesia Nociception Index
Interventions: DEVICE: Narcotrend bispectral index anaesthesia monitor|DEVICE: Mdoloris Anaesthesia Nociception Monitor
Sponsor: University of Southern Denmark
Collaborators: Odense Patient Data Explorative Network
Sex: ALL
Age: CHILD
Enrollment: 93
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-03-29
Completion Date: 2020-09-30
Locations: Odense University Hospital, Odense, 5000, Denmark

Summary:
Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age.

In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS).

93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.

Primary Outcome Measures: Richmond Agitation Sedation Scale Score, Scoring system for sedation and agitation from -5 til +4., During postoperative care unit (PACU) stay within 0-8 hours
Secondary Outcome Measures: Time consumption, Time spent with anesthesia, PACU stay and total time., Within 48 hours of hospital admission|Fentanyl consumption, Given during the anesthesia against postoperative pain, Within 48 hours of hospital admission|Nurse-VAS, A Visual-Analogue-Scale score (VAS score) assessed by PACU nurses. A score from 0-10 where 10 represents worst pain., Within the duration of PACU stay of 0-8 hours|PONV, Postoperative nausea and vomiting (PONV). A score from 0-2 where 2 represents worst nausea and vomiting., Within the duration of PACU stay of 0-8 hours|Other medications, Other drugs, such as NSAIDs, given, During the first 24 postoperative hours
AL Amyloidosis and Anti-CD38-Daratunumab
NCT Number: NCT06571864
Acronym: AL38
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amyloidosis
Interventions: DRUG: Anti-CD38 Monoclonal Antibody
Sponsor: University of Turin, Italy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-02
Completion Date: 2024-02-02
Locations: San Giovanni Bosco Hospital, Turin, Piedmont, 10154, Italy

Summary:
AL Amyloidosis and anti-CD38

Primary Outcome Measures: organ responses were defined according to the updated International Society of Amyloidosis criteria, "through study completion, an average of 1 year".
DAISY- Diagnostic AI System for Robotic and Automated Triage and Assessment
NCT Number: NCT06571838
Acronym: DAISY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Emergencies
Interventions: DEVICE: DAISY system
Sponsor: York Teaching Hospitals NHS Foundation Trust
Collaborators: University of York
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-03-31
Locations: York & Scarborough Teaching Hospitals NHS Foundation Trust, York, N. Yorks, YO31 8HE, United Kingdom

Summary:
This study aims to introduce an automated triaging system called DAISY into the Emergency Department (ED) to give patients the opportunity to self-direct their initial consultation. This is a new system in development, with a robot like the image at the top of this sheet, a touchscreen that will ask patients a number of questions about their current health (as a Triage nurse or doctor in the Emergency Department may do) but also with some attached devices (like a blood pressure monitor and thermometer) that patients can use to help DAISY assess patients' current health.

This study aims to demonstrate how patients can interact with the automated system to produce a report that is useful for the doctors and nurses in the ED. The study will examine the duration and timeliness of the automated assessment to see if it frees up staff time and determine how patients find the experience of using the DAISY system.

Primary Outcome Measures: Acceptability, Patient feedback scores, 30 minutes
Secondary Outcome Measures: Duration, Time taken for the consultation process, 30 minutes|Engagement, Patient satisfaction scores with the automated process, 30 minutes|Concordance, Level of concordance between DAISY report and human generated report, 30 minutes
RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
NCT Number: NCT06571825
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: Venetoclax|DRUG: Allogeneic transplant
Sponsor: He Huang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 118
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2028-02-28
Locations: The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310006, China

Summary:
Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).

Primary Outcome Measures: Relapse-free survival, Relapse-free survival (RFS) is measured from the date of achievement of first remission until the date of hematologic relapse or death from any cause., Up to 2 years
Secondary Outcome Measures: Non-Relapsed Mortality, Non-relapsed mortality (NRM) is measured from the date of achievement of first remission until the date of death from any cause other than relapse., Up to 2 years|Overall Survival, OS is measured from the date of reaching CR1 to the date of death from any cause., Up to 2 years|2-years Relapse Rate, Relapse rate is defined as relapse probability at a given time point, Up to 2 years
Other Outcome Measures: Minimal Residual Disease (MRD) Detected by Flow Cytometry, Research on MRD involves using flow cytometry to detect residual cancer cells, with statistical methods including Kaplan-Meier survival analysis, Fine-Gray analysis and Cox regression modeling to evaluate disease remission and predict relapse risk., Up to 2 years|Number of Participants With Treatment-Related Adverse Events (AEs) as Assessed by CTCAE v5.0, Research on AE uses descriptive statistics, Kaplan-Meier survival analysis, χ² or Fisher's exact tests to assess and compare AE incidence and survival outcomes., Up to 2 years
An Observational Study of the TSX Dental Implant System (Xpresso)
NCT Number: NCT06571812
Acronym: Xpresso
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tooth Loss
Interventions: DEVICE: TSX
Sponsor: ZimVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-24
Completion Date: 2027-06
Locations: Ohio State University, Columbus, Ohio, 43210, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
A prospective, observational, multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years.

Primary Outcome Measures: The number of implants that reach integration success/ implant survival at 2 years; the number of implants reaching primary stability during placement, The following assessments will determine if this primary outcome will be reached during study duration of 2 years:

* Declaration of lack of implant mobility (by applying opposing pressure with instruments to implant)
* Declaration of pain by the patient
* Observed radiolucency on radiograph
* Observed neuropathy
* Observed signs of infection
* Primary stability of the implant reached during implant placement as measured by final placement torque values
* Resonance Frequency measures assessed at various time points in the study, 2 years
Secondary Outcome Measures: The change in bone level (crestal bone regression) measured and compared at various study visits for each study implant, Measurement of bone level changes around the implant up to the 2 year final study visit as compared to the initial level at baseline (implant placement), 2 years
SHAPE for ICP Assessment
NCT Number: NCT06571786
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lumbar Puncture
Interventions: DRUG: Perflutren lipid microsphere
Sponsor: Thomas Jefferson University
Collaborators: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-23
Completion Date: 2025-08-31

Summary:
The Subharmonic Aided Pressure Estimation (SHAPE) technique is a noninvasive ultrasound-based imaging technique that can estimate ambient pressure using subharmonic emissions from ultrasound contrast agents. Ultrasound contrast agents are encapsulated microbubbles (mean diameter \< 8 µm) with a lipid, protein, or polymer shell that traverse the entire vasculature. When the contrast microbubbles are insonated with relatively high acoustic pressures (\>100-150 kPa), these microbubbles act as nonlinear oscillators yielding energy components in the received echo signals at frequencies ranging from the subharmonic (half of transmit frequency) to higher harmonics and even ultraharmonics. Based on empirical evidence, the subharmonic signal exhibits a sigmoidal relationship with incident acoustic pressure i.e., subharmonic signal can be divided into occurrence, growth and saturation stages. In the growth stage, the subharmonic signal has shown sensitivity to ambient pressure characterized by an inverse linear relationship between subharmonic signal and ambient pressure changes. This inverse linear relationship forms the basis for the SHAPE technique. Several pre-clinical and clinical studies have been conducted to utilize the SHAPE technique for in vivo pressure estimation e.g., to diagnose portal hypertension, to estimate intra-cardiac pressures and to determine interstitial fluid pressures. The core imaging mode underpinning the SHAPE technology (subharmonic imaging) is now available on some commercial scanners. In the proposed pilot study, the SHAPE technique will be leveraged for monitoring intracranial pressure (ICP). The use of SHAPE technique for the ophthalmic artery could potentially provide an accurate noninvasive method of measuring ICP in patients with idiopathic intracranial hypertension (IIH) and other conditions of raised ICP, which would revolutionize the field.

Primary Outcome Measures: Comparing SHAPE to lumbar puncture pressure measurements, Use of the SHAPE technique for measuring ophthalmic artery pressure in patients undergoing lumbar puncture for suspected idiopathic intracranial hypertension and compare the SHAPE data with pressures obtained using lumbar puncture (reference standard), 1 year
Evaluation of Toric Intraocular Lens(IOL) Combined with Capsular Tension Ring(CTR) in Patients with Cataract Combined with High Myopia
NCT Number: NCT06571773
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cataract|Astigmatism|Intraocular Lens Rotation
Sponsor: Shanghai 10th People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-01-31

Summary:
The objective of this study is to evaluate the postoperative visual quality and IOL stability in patients with cataracts and high myopia who have undergone surgery using astigmatism-correcting IOLs in conjunction with tension rings.It is a non-randomised retroprospective cohort study. Patients with high axial myopia (AL ≥ 26 mm) who underwent cataract phacoemulsification combined with toric IOL(Acrysof SN6ATY IQ toric IOL, Alcon, Alcon Laboratories, Fort Worth, Texas, USA) implantation from October 2020 to September 2023 at the Shanghai Tenth People's Hospital are selected. According to the usage of CTR, all patients will be divided into CTR group and control group, with a minimum follow-up of 3 months.Each patient underwent a comprehensive preoperative examination and ophthalmological examinations at the outpatient clinic 1 day, 1 week, 1 month, and 3 months postoperatively.Statistical analysis will be conducted using SPSS 26.0 statistical software.

Primary Outcome Measures: Postoperative IOL rotation degree, The surgeon, using the same slit lamp microscope and a narrow band of light, measured the IOL axial position after the patients' pupils were fully dilated with compound tropicamide eye drops, 3 months
Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement
NCT Number: NCT06571747
Acronym: KP-VACCINATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Influenza|Behavior, Social
Interventions: BEHAVIORAL: Cardiovascular-Focused Nudge Communication
Sponsor: Kaiser Permanente
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3750000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-05
Completion Date: 2026-03-31
Locations: Kaiser Permanente Northern California, Pleasanton, California, 94588, United States|Kaiser Permanente Mid Atlantic States, Bethesda, Maryland, 20852, United States

Summary:
In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and potentially cardiovascular (CV) events and mortality in select populations. However, the potential population-level benefit of influenza vaccination is limited by its uptake. Novel implementation strategies to improve vaccination uptake are needed.

KP VACCINATE is a multicenter, sequential, individual-level randomized controlled implementation trial examining the effectiveness of a CV-focused nudging communication vs. usual care communication on influenza vaccination uptake among Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Mid Atlantic States (KPMAS) eligible members during the 2024-2025 influenza season.

Primary Outcome Measures: Proportion of participants with documented influenza vaccine receipt, Proportion of participants with documented influenza vaccine receipt after randomization., up to 8 months
Secondary Outcome Measures: Time to influenza vaccine receipt, Time from randomization to influenza vaccine receipt., up to 8 months
XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma
NCT Number: NCT06571734
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Leiomyosarcoma|Unresectable Leiomyosarcoma
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Computed Tomography|PROCEDURE: Echocardiography|PROCEDURE: Multigated Acquisition Scan|DRUG: Zanzalintinib
Sponsor: Northwestern University
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-07-01
Locations: Northwestern University, Chicago, Illinois, 60611, United States

Summary:
This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma.

Primary Outcome Measures: Progression-free survival (PFS), PFS will be defined as progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.other documented clinical or radiographic progression per physician judgment, or death due to disease., Up to 6 months
Secondary Outcome Measures: Median PFS, Median PFS will be calculated as the overall PFS time as the time that elapses between initiation of trial therapy and first documented disease progression or death from any cause, whichever come first., Up to 5 years|Overall survival (OS), OS will be calculated as the time that elapses between the day of patient registration and death from any cause., Up to 5 years|Overall response rate (ORR), ORR will be defined as the proportion of treated patients who experience an objective response (confirmed complete response or confirmed partial response per RECIST v 1.1.)., Up to 5 years|Duration of response (DOR), DOR will be calculated as the time that elapses between the day of first documented response to trial therapy (confirmed CR or confirmed PR, whichever is first recorded) and subsequent disease progression. DOR will be estimated as median and interquartile range or mean and a confidence interval depending on the distribution., Up to 5 years|Incidence of adverse events (AEs), Frequency of AES will be reported by type, severity (grade), timing, and attribution according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported using descriptive statistics., Up to 30 days after last dose of study drug