pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Peripheral Neurostimulation for Nerve Block Placement
NCT Number: NCT06566664
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain Syndrome
Interventions: DEVICE: B Braun HNS 12 nerve stimulator|DEVICE: B Braun HNS 12 nerve stimulator sham control
Sponsor: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2025-10
Locations: Stanford University Hospital, Stanford, California, 94305, United States

Summary:
Peripheral nerve blocks are routinely used and highly successful for intra-operative anesthesia and post-operative pain management. Nerve blocks are guided using either neurostimulation as a means to localize the right nerve or by ultrasound guidance or combining the 2 methods. The purpose of this study is to assess whether electrical stimulation improves nerve block quality, beyond its simple purpose of nerve localization.

Primary Outcome Measures: Onset of sensory block, Determining time when patient feels numb, Within 1 hour after the block placement
Secondary Outcome Measures: Onset of motor block, Determining time when patient cannot move, Within 1 hour after the block placement|Duration of sensory/motor block, Time until the patient feels his limb again and can move, 1 day|Time to first analgesic request, Time it takes for patients to request for one supplemental analgesic medication, Up to 1 year|Patient satisfaction, Assessing patient's satisfaction with the nerve block in controlling pain, using the short standard patient satisfaction Likert Scale, investigating pain management, comfort during procedure, explanations and communication level, and overall satisfaction with for each category a 5 point scale ranging from "strongly disagree" to "strongly agree"., Up to 1 year
Emotion Processing Among Patients With ALS
NCT Number: NCT06566651
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Amyotrophic Lateral Sclerosis|Neuromuscular Diseases|ALS|Motor Neuron Disease|MND (Motor Neurone DIsease)
Interventions: OTHER: Emotion Discrimination Task (EDT)
Sponsor: University of Aarhus
Collaborators: Aarhus University Hospital|Aalborg University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-15
Completion Date: 2026-06-30
Locations: Aarhus University Hospital, Aarhus, Region Midtjylland, 8200, Denmark|Aalborg University Hospital, Aalborg, Region Nordjulland, 9000, Denmark

Summary:
The goal of this observational study is to learn about the emotional perception in people with ALS disease compared to people with other neuromuscular disease and healthy controls. The main questions it aims to answer are:

* How people with ALS judge happy and angry faces and what their "insight" into these judgements are like
* How their autonomic responses differ from the other two test group Participants will asked to judge if a face presents a happy emotion or angry emotion.

Researchers will compare the ALS group responses with neuromuscular diseases group and healthy control group responses to see if the ALS group judge more happy faces than angry.

Primary Outcome Measures: The perception of facial emotions measured using an Emotion Discrimination Task (EDT)., The EDT requires subjects to assess the facial emotion of a face stimulus and report whether the facial emotion was angry or happy. This will be the operationalisation of subjects' emotion perception, which we anticipate will reveal a bias towards positive perceptions. There is thus two scores on this scale: "Angry" and "Happy". There is no one of these scores that is "better" than the other. It is an nominal categorical scare., 20 minutes|Metacognitive sensitivity measured using a retrospective confidence rating scale, Metacognitive insight will be operationalized through a metacognitive sensitivity measure. The method employed for this is a confidence rating measure, where subjects assess their own performance on the EDT. Subjects will indicate on a sliding scale, ranging from "very confident" (maximum score) to a "pure guess" (minimum score), how confident they are that their previous answer was correct. Generally higher scores on this scale is considered better. This scales title is: " Confidence Rating Scale"., 20 minutes
Secondary Outcome Measures: Subjects' heart rate is monitored throughout the EDT, Subjects heart rate is measured through a standard 3-lead electrocardiogram montage. Electrodes were place on both collarbones and on the left lower rib., 20 minutes|Subjects' respiration is monitored throughout the EDT, Subjects' respiration is measured using a respiratory belt around the upper torso., 20 minutes
Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA/NETs in Subjects With Pancreatitis
NCT Number: NCT06566638
Acronym: NUC-SAP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Pancreatitis|Organ Failure, Multiple
Interventions: DEVICE: NucleoCapture device
Sponsor: Liverpool University Hospitals NHS Foundation Trust
Collaborators: Santersus AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2027-04-01
Locations: Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom

Summary:
This is a single-centre, randomised-controlled, open-label, feasibility study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in patients with severe acute pancreatitis.

Primary Outcome Measures: The amount of cfDNA/NETs in the plasma of patients with severe acute pancreatitis after each NucleoCapture treatment., The change in the levels of cfDNA/NETs across the NucleoCapture column at the end of each NucleoCapture treatment session., Within 6 hours from the baseline once 4.5 plasma volumes has been treated.
Secondary Outcome Measures: The amount of cfDNA/NETs in the circulating blood in patients after treatment with NucleoCapture compared to standard of care., The change in the levels of circulating cfDNA/NETS at the end of each NucleoCapture treatment session., Within 6 hours from the baseline once 4.5 plasma volumes has been treated.|Change in organ in support, Change in organ support will be assessed by the combined change in Inotrope e.g. norepinephrine dose, lactate, urine output, Horowitz index and oxygenation index compared to standard of care, From date of randomisation to Day 5|28-day survival, Survival up to 28 days, 28 days|ICU length of stay, The length of stay in the ICU, Up to 28 days.|Hospital length of stay, The length of stay in up to hospital discharge, Up to 28 days
Other Outcome Measures: Exploratory evaluation of the correlation between NucleoCapture treatment and levels of routine biomarkers., Routine organ function, haematology, coagulation and inflammation biomarkers will be measured., At baseline, days 1 to 5, 7, 14 and 21.|Exploratory evaluation of the correlation between NucleoCapture treatment and levels of non-routine biomarkers., Non-routine biomarkers of inflammation and coagulation will be measured., At baseline, days 1 to 5, day 7 and day 14.|Device handling and usability., Usability and handling of the device will be assessed in the intervention arm using a questionnaire., Day 1 to day 5.|Patient reported outcome (PROMs) - PAN PROMISE acute pancreatitis symptom scale, Quantify the symptoms of acute pancreatitis via PROM., Baseline, at discharge from the ICU up to day 28, and at 90 days post discharge from the ICU.
Cardiac MRI Prior to Invasive Coronary Angiography in Patients With Suspected Non-ST-Elevation Myocardial Infarction
NCT Number: NCT06566625
Acronym: KaPSICA-CMR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-ST Elevation Myocardial Infarction|Acute Coronary Syndrome
Interventions: DIAGNOSTIC_TEST: Cardiac MRI (CMR) examination
Sponsor: Region Stockholm
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-17
Completion Date: 2025-12
Locations: Karolinska University Hospital, Stockholm, 171 64, Sweden

Summary:
Patients with a suspected myocardial infarction are subdivided into ST-elevation and non-ST-elevation myocardial infarctions (STEMI and NSTEMI, respectively) using an ECG. While patients with STEMI are urgently referred to a cath lab, patients with NSTEMI usually undergo a planned invasive coronary angiography (ICA) anywhere from 24-72 hours after arriving to the hospital. When an invasive coronary angiography can not explain the cause of a myocardial infarction, an MRI of the heart (a CMR) is often done as a follow-up investigation.

A growing body of evidence suggests that performing a CMR before the planned ICA can provide an accurate diagnosis and defer the need for an ICA in many of these patients with NSTEMI.

Primary Outcome Measures: Rate of non-ischemic diagnosis, In cases where CMR establishes a diagnosis which is non-ischemic in nature, such as a myocarditis, an ICA can be deferred since a diagnosis has been made using CMR., Every three months, until study completion|Rate of IRA territory reclassification, One primary outcome measurement will be to what extent a CMR examination can reclassify the IRA (infarct-related artery) territory established on ICA, by designating a new IRA based on the area of infarction on CMR using the 17-segment model of the American Heart Association and magnetic resonance angiography, Every three months, until study completion
Avoidance-driven Decision Making and Learning in Anorexia Nervosa and Bulimia Nervosa
NCT Number: NCT06566612
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bulimia Nervosa|Anorexia Nervosa
Sponsor: University of California, San Diego
Sex: FEMALE
Age: ADULT
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: UCSD Eating Disorders Treatment and Research Program, La Jolla, California, 92121, United States

Summary:
The purpose of this study is to investigate areas of the brain responsible for avoidance learning in adults with eating disorders using brain imaging techniques, computer tasks, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 78 women with an eating disorder (26 with anorexia nervosa \[AN\], 26 with bulimia nervosa \[BN\]) and 26 healthy controls (HC) aged 18-39.

Aim 1: Evaluate behavioral differences in active and passive avoidance learning in eating disorders and associations with symptoms.

Aim 2: Evaluate whether corticostriatal and limbic-prefrontal fMRI BOLD response associated with avoidance learning differs in eating disorders relative to healthy controls and relates to symptoms.

Aim 3: Evaluate whether functional connectivity of avoidance learning neural circuity differs in eating disorders relative to healthy controls.

Primary Outcome Measures: BOLD Response, Brain activity associated with passive and active avoidance learning, During fMRI scan (approximately 1 hour)|Avoidance Learning, Bias toward active vs. passive avoidance learning in fMRI task, During fMRI scan (approximately 1 hour)|Generalized Psychophysiological Interaction Analysis (gPPI), Whole-brain functional connectivity analysis using task-based fMRI data to assess the influence of learning bias on group differences (AN vs. BN vs. control) in functional connectivity, During fMRI scan (approximately 1 hour)
PGT-A in Couples With Non-obstructive Azoospermia
NCT Number: NCT06566599
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-obstructive Azoospermia|Male Infertility
Sponsor: Inception Fertility Research Institute, LLC
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-04

Summary:
Objective: To examine the rate of embryo aneuploidy in patients with NOA (nonobstructive azoospermia) IVF/ICSI and compare live birth rates with the utilization of PGT-A vs non PGT-A.

Primary Outcome Measures: Aneuploidy rate, Frequency of aneuploidy result in embryos, 1 year|Chromosomes associated with aneuploidy, Compare types of embryonic aneuploidy in male factor patients to advanced maternal age patients, 1 year
Secondary Outcome Measures: IVF outcomes, Live birth rate, clinical pregnancy rate, fertilization rate, 1 year
The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs
NCT Number: NCT06566560
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Oncology|Pharmacy|Drug Prescriptions
Interventions: OTHER: redispensing oral anticancer drugs
Sponsor: Radboud University Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-01-10
Completion Date: 2024-12-31
Locations: Radboudumc, Nijmegen, Gelderland, 6525 GA, Netherlands

Summary:
The goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs.

The main questions it aims to answer are:

* What are the cost-savings of redispensing unused oral anticancer drugs?
* What is the environmental impact of redispensing unused oral anticancer drugs?

Researchers will compare redispensing unused oral anticancer drugs to the standard practice of disposal.

Participants will receive their oral anticancer drugs in a sealed bag with a temperature indicator if needed. They will be asked to return any unused oral anticancer drugs to the pharmacy during their next visit to the hospital.

Primary Outcome Measures: The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal., Environmental impact will be measured in CO2-eq, From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months|Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal., Cost savings will be measured in euros, From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.
Secondary Outcome Measures: The proportion of usability of returned medication for redispensing and the reasons for quality disapproval., From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months|The proportion of returned unused oral anticancer drugs and reasons thereof., From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months|Patients' reasons for not wanting to participate in a redispensing program for oral anticancer drugs., From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.
GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
NCT Number: NCT06566547
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma
Interventions: DRUG: GR1803 injection
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2027-08-01
Locations: he First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China

Summary:
All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Primary Outcome Measures: ORR evaluated by IRC, Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR), 2 years
Secondary Outcome Measures: ORR evaluated by investigator, Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR), 2 years|Progression-free survival (PFS) evaluated by IRC, Time from enrollment to tumor progression or death from any cause, 2 years|MRD negative rate, Proportion of subjects with at least 1 negative MRD after treatment, 2 years|AE, adverse event, 2 years
Personalized Nudging to Increase Influenza Vaccinations
NCT Number: NCT06566534
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Influenza, Human
Interventions: BEHAVIORAL: Reminder
Sponsor: Geisinger Clinic
Collaborators: Massachusetts Institute of Technology|University of Michigan|Abdul Latif Jameel Poverty Action Lab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2024-12

Summary:
The purpose of this study is to prospectively test whether personalized, message-based nudges can increase flu vaccination compared with nudges that are not personalized or no nudges.

Primary Outcome Measures: Number of Patients With Flu Shot Receipt Between Enrollment Date and Target Appointment Date, Our field experiment will be conducted with Geisinger Health patients via SMS messages sent prior to their first flu shot-eligible appointment during the study period, referred to as the "target appointment." The key dependent variable is whether patients receive a flu shot at or before their target appointment (as recorded in their electronic health records).

If patients cancel or do not show up for their target appointment after they have been randomized to a treatment and then schedule a new appointment during the study period, their new flu-shot eligible appointment becomes the target appointment and the outcome window extends from three days prior to the original appointment through the date of the appointment.

Patients who miss their target appointment and do not reschedule within the study period will still be included in the analysis. Their outcome window is from three days prior to the original appointment through the date of the original canceled appointment., Between the enrollment date and target appointment date (at least 4 days and up to 4 months)
Other Outcome Measures: Number of Patients With Flu Shot Receipt On or Before December 31, 2024, Received a flu shot on or before December 31, 2024, Up to 4 months after randomization|Number of Patients with Flu Shot Receipt Between Enrollment Date and First Eligible Appointment, Patients received the flu shot at or before their first eligible appointment, 4 Days|Number of Patients with Flu Diagnosis (encounter diagnosis or flu test), Patients received a flu diagnosis via encounter diagnosis or flu test between enrollment and April 30, 2025., Up to 8 months after randomization|Number of Patients with Flu-related Complications, Patients experienced flu-related complications before as defined by relevant diagnosis, hospitalization, or death, between enrollment and July 31, 2025 as recorded in the electronic health record, Up to 11 months after randomization
Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
NCT Number: NCT06566508
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Intracanal Medication
Interventions: DRUG: Calcium Hydroxide Intracanal medication|DRUG: Leddermix Intracanal medication|DRUG: Asiaticoside Intracanal medication
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-20
Completion Date: 2025-03-03
Locations: Mansoura university, Mansoura, Egypt

Summary:
The objective of this study is to investigate \&#34;clinically\&#34; the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Primary Outcome Measures: counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months], counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) \[Time Frame: up to 7 months\], up to 7 months
Secondary Outcome Measures: using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2), using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2), up to 25 weeks
Microorganisms on Reusable Tourniquets
NCT Number: NCT06566495
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Microbial Colonization|Infection, Bacterial|HAI|Nurse's Role|Vascular Access Device Complications|Vascular Access Complication|CRBSI - Catheter Related Bloodstream Infection|Catheter Infection|Device Colonisation
Interventions: DEVICE: collection of microbiological material from reusable tourniquets
Sponsor: Medical University of Gdansk
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 53
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2024-12-31
Locations: Medical Univeristy of Gdańsk, Gdańsk, Dębinki Street, 80-211, Poland

Summary:
The purpose of this study was to compare microbial contamination on the surface of reusable stasis after indefinite use, 2 weeks and 4 weeks. We investigated how the site - the operating theater and the emergency department, as well as the time of use - affects the number of organisms.

Primary Outcome Measures: Standard Deviation and median of colony forming units (CFU/cm2) in the emergency department, After 24h incubation at 37 deg C, we evaluated the number of bacterial colony-forming colonies on leaf and quality plates. The average number of CFU/cm2 in all stages of the study for the emergency department is 19,110, 34 CFU/cm2. For the MCC substrate for the emergency department medium 227.65; standard deviation 102.75 CFU/cm2. For the King B substrate for the emergency department medium 241.71, standard deviation 115.15 18 CFU/cm2. There is no statistically significant difference for OD versus CFU/cm2 during the second and third intake. There were no bacterial growth was obtained on the ECC plate., 24 hours|Standard Deviation and median of colony forming units (CFU/cm2) in the operating theatre, After 24h incubation at 37 deg C, we evaluated the number of bacterial colony-forming colonies on leaf and quality plates. The average number of CFU/cm2 in all stages of the study for the operating theatre was 88.27 CFU/cm2. For the MCC substrate for the operating theatre medium 14.18 standard deviation 24.06 CFU/cm2. For the King B substrate for the operating theatre medium 33.07 standard deviation 65.18 CFU/cm2.There is no statistically significant difference for OD versus CFU/cm2 during the second and third intake. There were no bacterial growth was obtained on the ECC plate., 24 hours
Secondary Outcome Measures: Blood stains and CFU, 23 of 53 examined tourniquets (43%), 12/18 (67%) from the emergency department and 11/35 (31%) from the operating theatre had visible blood stains. Blood stains did not affect the number of colony-forming units (CFUs)., 2 months
Social Media as a Risk Tool for HIV Prevention Needs
NCT Number: NCT06566417
Acronym: SMaaRT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: HIV Prevention|HIV Preexposure Prophylaxis
Sponsor: Massachusetts General Hospital
Collaborators: Kenya Medical Research Institute|KEMRI-Wellcome Trust Collaborative Research Program|North Carolina State University|National Institute of Mental Health (NIMH)
Sex: FEMALE
Age: ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-01
Completion Date: 2025-06-30
Locations: KEMRI, Kisumu, Kenya

Summary:
The impact of effective HIV prevention tools is limited because many people do not know that they are at risk for HIV acquisition, despite the availability of various risk assessment scores and criteria. This proposal aims to use a novel data science approach to assessing HIV prevention needs among 400 young women in Kisumu, Kenya- namely, topic modeling and network analysis of text and/or social media messages (e.g., WhatsApp, Instagram, Twitter). The study will involve in-depth assessment of relevant ethical and logistical factors to ensure appropriate and optimized use of a sentiment analysis tool for implementation in routine clinical care.

Primary Outcome Measures: Association of artificial intelligence measure datasets with the VOICE risk score, Analysts will examine 6 months of SMS/social media message content from each of the 400 study participants using three computational linguistic methods: 1) sentiment, valence, and arousal analysis; 2) topic modeling; 3) simple textual counts. Analysts will also perform network analysis with up to 20 contacts from each participant to understand how often and with which parties the participant communicates most frequently. These networks will be examined temporally to see if any of the connections have grown or weakened over time.

From these analyses, the investigators will generate multiple measure datasets to compare with the VOICE risk score (i.e., a combined assessment of HIV risk based on age, marital status, sexual partner support, sexual partner sexual behavior, and alcohol use), as assessed in the study participants at the time of SMS/social media data collection., 6 months|Association of artificial intelligence measure datasets with the Wand risk score, The investigators will compare the above-noted measure datasets with the Wand risk score (i.e., a combined assessment of HIV risk based on age, marital status, age at sexual debut, number of sexual partners, use of injectable contraception, and history of sexually transmitted infections), as assessed in the study participants at the time of SMS/social media data collection., One day
Secondary Outcome Measures: Association of artificial intelligence measure datasets with HIV test results, The investigators will compare the above-noted measure datasets with the HIV test results obtained from the study participants at the time of data collection., One day
Gene Expression Profiles and ctDNA for Risk Stratification in Patients With Melanoma
NCT Number: NCT06566404
Acronym: CORRESPOND
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Melanoma
Sponsor: European Institute of Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2028-01-01

Summary:
This study aims at assessing the role of MerlinTM and ctDNA in predicting the nodal status in patients with \>pT3b melanoma, therefore candidate for adjuvant therapy regardless of sentinel lymph node status

Primary Outcome Measures: Model Performance, to compare the performance of the clinicopathologic model and the clinicopathologic model including ctDNA and MerlinTM in predicting SLNB-positivity in terms of area under receiver operating characteristic curve (AUC), 36 months
Secondary Outcome Measures: the estimation of the association between ctDNA-positivity and SLNB-positivity, to assess the role of ctDNA-detected mutations in predicting the SLNB status, 36 months|The estimation of the association between MerlinTM/ctDNA-positivity and SLNB-positivity, To assess the role of MerlinTM and ctDNA in predicting micro- or macro- SLNB involvement (micrometastasis \[pN1a or pN2a\] vs. macrometastasis \[pN1b or pN2b\]), 36 months
Other Outcome Measures: The threshold of ctDNA VAF, The threshold of ctDNA VAF corresponding to nodal status with the highest accuracy (ROC analysis), 36 months|The estimation of the association between ctDNA-positivity and SLNB-positivity, The estimation of the association between ctDNA-positivity and SLNB-positivity according to molecular alterations detected from the ctDNA, 36 months|The estimation of the association between features, The estimation of the association between features identified by digital pathology tecniques and SLNB-positivity, 36 months|The prevalence, The prevalence of patients with QoL affected by SLNB and CP-GEP, 36 months
Ipilimumab and Nivolumab Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma
NCT Number: NCT06566391
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Melanoma
Interventions: DRUG: Ipilimumab
Sponsor: European Institute of Oncology
Collaborators: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-03-05
Completion Date: 2024-12-31
Locations: Istituto Europeo di Oncologia, Milano, 20141, Italy

Summary:
This is open label, single arm study for pts with stage IIIB-IV melanoma, accordingly with AJCC staging criteria (8th ed.), with potentially resectable disease. Patients will receive every three weeks, four cycles of Nivolumab 3 mg/kg (over one 30 minutes infusion) and Ipilimumab 1 mg/kg (over 30 minutes infusion) with a 30 minute break between each infusion. Surgery will be performed after 4-6 weeks from the last dose. After 4-6 weeks from surgery, patients will receive Nivolumab 480 mg (over one 60 minutes infusion), every four weeks for six cycles.

The duration of the trial is expected to be 12 months of accrual and approximately 24 months of follow-up after the end of adjuvant therapy.

Primary Outcome Measures: Percentage of pathological complete response (Efficacy), Efficacy assessment is pathological complete remission rate, documented after neoadjuvant therapy., 12-16 weeks after Neoadjuvant therapy
Secondary Outcome Measures: Rates of 3-4 AEs, Rates of grade 3-4 AE rates (immune related or not) of neoadjuvant and adjuvant regimen, 24 months|Overall AE rates, Overall AE rates (immune related or not), up to 24 months after the end of adjuvant therapy|Patients completing treatment schedule., Rates of pts completing treatment schedule., up to 24 months after the end of adjuvant therapy|Overall Response Rate (ORR), Overall Response Rate (ORR), according to RECIST 1.1 criteria., 12-14 weeks|Overall Survival (OS), Overall Survival (OS), according to RECIST 1.1 criteria, 12-14 weeks
Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children
NCT Number: NCT06566378
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Pain, Acute|Vaccination|Children|Cold Application|Vibration
Interventions: DEVICE: Buzzy|DEVICE: Buzzy (Placed in standard)
Sponsor: Burdur Mehmet Akif Ersoy University
Sex: ALL
Age: CHILD
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-04-01
Completion Date: 2024-12-31
Locations: Burdur Bucak, Burdur, Bucak, 15030, Turkey

Summary:
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of using Cold Application and Vibration in reducing pain during routine vaccination in children.

Primary Outcome Measures: Wong-Baker FACES Pain Rating Scale, In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels., Through study completion, an average of 1 year
Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis Plane Block
NCT Number: NCT06566365
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menstrual Cycle|Subcostal Transversus Abdominis Plane Block
Interventions: OTHER: Subcostal Transversus Abdominis Plane Block
Sponsor: Adiyaman University Research Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2024-10-30
Locations: Adıyaman Training and Research Hospital, Adıyaman, 02200, Turkey

Summary:
Fascial plane blocks are traditionally considered regional anesthesia techniques, where a mixture of local anesthetic (LA) is injected into a plane between two fascial layers, with the aim of spreading along this anatomical plane to block the nerves lying within or passing through it . Various pathophysiological processes that alter the structure and characteristics of fasciae can affect the spread of the local anesthetic and the success of the block. Diabetes, hormonal changes, and cannabinoid use are among these factors. This study aims to investigate the effects of hormonal changes during the menstrual cycle on subcostal TAP block.

Primary Outcome Measures: visual analogue scale (VAS), The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.", postoperative 1st,2nd, 6.- 12.-24. hour
Secondary Outcome Measures: Quality of Recovery - 15, The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery, postoperative 24. hour
Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial
NCT Number: NCT06566352
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy
Interventions: PROCEDURE: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine|PROCEDURE: traditional laparoscopic myomectomy|PROCEDURE: laparoscopic myomectomy with temporary bilateral uterine artery occlusion|DRUG: injection of epinephrine 1mg diluted in 200mg of NaCl
Sponsor: Zagazig University
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-05-01
Completion Date: 2025-05-01
Locations: Zagazig University, Zagazig, 7123001, Egypt

Summary:
Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy.

Primary Outcome Measures: blood loss, estimated blood loss, intra-operative
Robotic OCT for ER Anterior Eye Exams
NCT Number: NCT06566339
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Develop and Test Robotically Assisted Imaging System for the Front of the Eye
Interventions: DEVICE: Robotically Aligned Eye Imaging System
Sponsor: Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 93
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-09
Completion Date: 2026-09-30

Summary:
The purpose of this study is to develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department.

Primary Outcome Measures: Sensitivity, Sensitivity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard., Day 1|Specificity, Specificity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard., Day 1
An Open-label Study on the Clinical Efficacy of tDCS Intervention in PD
NCT Number: NCT06566313
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcranial Direct Current Stimulation|Parkinson Disease|Primary Left Motor Cortex
Interventions: BEHAVIORAL: transcranial Direct Current Stimulation
Sponsor: Anhui Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2024-12-31
Locations: Cognitive Neuropsychology Lab Anhui Medical University, Hefei, Anhui, China

Summary:
To demonstrate that intervention targeting the primary motor area (M1) using transcranial Direct Current Stimulation can improve sleep symptoms in patients with Parkinson's disease.

Primary Outcome Measures: RBD Screening Questionnaire, The RBD Screening Questionnaire (RBDSQ) is the most widely used tool over the past decade and includes 13 yes-or-no questions regarding the presence of move- ments and dream-enacting behaviours during sleep., baseline; day 10
Secondary Outcome Measures: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, baseline; day 10|RBD Screening Questionnaire Hong kong, baseline; day 10|Pittsburgh sleep quality index, baseline; day 10|EPworth Sleepiness Scale, baseline; day 10
Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars
NCT Number: NCT06566300
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Scars
Interventions: PROCEDURE: injection of autologous nanofat grafting|PROCEDURE: microneedling with autologus nanofat graft
Sponsor: Alexandria University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-24
Completion Date: 2025-02
Locations: Alexandria University, Alexandria, Egypt

Summary:
This study aims to evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.

Primary Outcome Measures: change in the scar by by the patient and observer scar assessment scale (POSAS)., patient and observer scar assessment scale score will be uesd, 6 months after the proceedure
Immediate and Delayed Implant Placement Using Socket Shield Technique and Autogenous Dentin Graft
NCT Number: NCT06566287
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant|Tooth Loss|Socket Shield
Interventions: OTHER: Immediate implant|OTHER: Delayed implant
Sponsor: Hams Hamed Abdelrahman
Sex: ALL
Age: ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-17
Completion Date: 2023-12-19
Locations: Alexandria Faculty of Dentistry, Alexandria, Egypt

Summary:
One of the techniques that have been proposed to reduce the amount of bone resorption in anterior maxilla is the "socket shield (SS) ". This technique includes preservation of the facial segment of a root to be extracted and immediate implant placement. A technique of socket shield with delayed implantation using autogenous dentin graft for socket preservation, as an alternative to autogenous bone grafts, has shown predictable clinical and histological outcomes.

Primary Outcome Measures: Change in implant stability, The stability of each implant will be measured using the Osstell device. The ISQ value will be measured immediately at the time of surgery and after three months, Baseline and 3 months
Secondary Outcome Measures: change in thickness of the facial cortical plate, patients will be subjected to CBCT scans, Baseline and 3 months|Change in bone density, patients will be subjected to CBCT scans, Baseline and 3 months
ABA-101 in Participants With Progressive Multiple Sclerosis
NCT Number: NCT06566261
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Progressive Multiple Sclerosis
Interventions: BIOLOGICAL: ABA-101
Sponsor: Abata Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-02

Summary:
This study will test the safety and effects of ABA-101 when given as a single dose to participants with progressive multiple sclerosis.

It is the first study of this treatment in humans. After safety is demonstrated with a low dose of ABA-101, a higher dose will be evaluated.

Primary Outcome Measures: Incidence of adverse events (safety and tolerability), Incidence of AEs through Day 29, Day of Treatment to End of DLT Evaluation Period (28 Days)
Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders
NCT Number: NCT06566235
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotional Disorders
Interventions: BEHAVIORAL: Culturally adapted DBT-A-ST group|BEHAVIORAL: Activities-based support group (ASG)
Sponsor: Mackay Memorial Hospital
Sex: ALL
Age: CHILD
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: MacKay Memorial Hospital, Taipei, Taiwan

Summary:
The goal of this study is to learn if Dialectical behavior therapy Skills

Training for Adolescents (DBT-A-ST) works on emotional disorders in adolescents. The main questions it aims to answer are:

Does DBT-A-ST produce faster improvements (i.e., steeper slopes), compared to ASG, on primary and secondary outcome measures during treatment and 3-month follow-up?

Does DBT-A-ST produce greater improvements, compared to ASG, on primary and secondary outcome measures?

Participants will:

Randomly assigned to (a) a culturally adapted DBT-A-ST or (b) activities-based support group (ASG).

Received five assessments before the start of the trial (T1), after 4, 8 sessions (T2, T3), at post-intervention (T4), and 3-month follow-up (T5).

Primary Outcome Measures: Hamilton Depression Scale-17 item (HAMD-17), Hamilton Depression Scale-17 item (HAMD-17) is an outcome measure widely used in clinical.

trials, with high score indicating a high degree of depression, baseline, 5-month and 8-month follow-up|Hamilton Anxiety Scale (HAM-A), Hamilton Anxiety Scale (HAM-A) comprises 14 items with each item being divided into five grades, based on a scale of 0 to 4. A high score indicates a high degree of anxiety., baseline, 5-month and 8-month follow-up|Clinical Global Impressions-Severity (CGI-S), Clinical Global Impressions-Severity (CGI-S) is a standardized assessment tool used by clinicians to rate the severity of illness, change over time, and efficacy of medication., baseline, 5-month and 8-month follow-up|Clinical Global Impressions-Improvement (CGI-I), Clinical Global Impression-Improvement (CGI-I), is also a 7-point scale that assesses how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention., baseline,5-month and 8-month follow-up
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
NCT Number: NCT06566222
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Radiotherapy
Interventions: PROCEDURE: chemoradiotherapy after surgery|OTHER: High-risk Factors
Sponsor: Changhai Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-25
Completion Date: 2024-12-31

Summary:
The purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage II/III low- and medium-level rectal cancer with or without high-risk factors

Primary Outcome Measures: Overall survival, 2024
FDG-PET As an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
NCT Number: NCT06566209
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis|Myocarditis|ICI-Myocarditis|Solid Malignant Tumor|Hematologic Malignancy|Subclinical Myocarditis|Subclinical ICI-myocarditis
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2027-04-30

Summary:
The purpose of this pilot study is to evaluate Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) as an imaging modality to diagnose and risk stratify subclinical, imaging negative ICI-myocarditis, and to determine whether subclinical ICI-induced myocarditis is a distinct and clinically relevant entity with a risk of progression to fulminant myocarditis.

Primary Outcome Measures: Presennce of inflammation or scarring, Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring., Baseline; 6 months
Secondary Outcome Measures: Incidence of hospitalization, Assessed by review of medical record for incidence of hospitalization, Up to 2 years|Cardiovascular Intensive Care Unit (CICU) Level of Care Days, Assessed by reviewing medical record for number of days, if any, of CICU care., Up to 2 years|Incidence of arrhythmias, Assessed by reviewing medical record for incidence of cardiac arrhythmias., Up to 2 years