pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu, Kenya
NCT Number: NCT06582966
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: HIV Infections|STI
Sponsor: University of Washington
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-13
Completion Date: 2027-06-30

Summary:
The first study of doxycycline postexposure prophylaxis for cisgender women did not reduce incident STIs likely due to low use of doxycycline. We will conduct a pilot study of once-weekly doxyxycline to prevent bacterial STIs among Kenyan cisgender women using PrEP for HIV prevention.

Primary Outcome Measures: doxyPEP DOT adherence, Confirmation of weekly doxyPEP DOT dosing each week will be recorded on weekly CRFs and quarterly surveys on acceptability will be completed., 6 months
Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
NCT Number: NCT06582940
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: MRI-guided Adaptive Radiotherapy|Non-small Cell Lung Cancer|Brain Metastasis
Interventions: RADIATION: MRI-guided adaptive SRT|RADIATION: Conventional SRT
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-03-01
Locations: Sun yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis.

Primary Outcome Measures: Radiation-related brain necrosis incidence rate, "Radiation-related brain necrosis" refers to brain tissue damage that occurs as a result of radiation therapy. It can be detected by brain MRI imaging., 1 year
Secondary Outcome Measures: intracranial progression-free survival rate, The percentage of patients who, after one year of treatment, have not experienced any progression of their intracranial disease., 1 year|Objective response rate, To evaluate the effectiveness of a treatment for brain tumors based on RECIST 1.1 criteria., 1-year|Overall survival, The percentage of patients who are alive after one year of treatment., 1 year|Radiation-related Neurotoxicity, "Neurotoxicity" refers to the harmful effects that certain substances or conditions can have on the nervous system, which was examined based on RECIST 1.1 criteria., 1 year
Mindfulness Training for First Responders
NCT Number: NCT06582927
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Burnout
Interventions: BEHAVIORAL: Mindfulness-Based Attention Training (MBAT)
Sponsor: University of Miami
Collaborators: Unlikely Collaborators Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-06-01
Completion Date: 2025-12-01
Locations: University of Miami, Coral Gables, Florida, 33146, United States

Summary:
The present study evaluates the efficacy of Mindfulness-Based Attention Training on measures targeting cognitive abilities and emotional well-being in first responders.

Primary Outcome Measures: Change in self-reported cognitive failures, Cognitive failures are assessed with the 15-item Cognitive Failures Questionnaire (CFQ 2.0). CFQ 2.0 has a range of scores from 0 to 60, with higher scores indicating higher levels of cognitive failure., Baseline, up to 11 weeks|Change in decentering, Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering., Baseline, up to 11 weeks|Change in dispositional mindfulness, Dispositional mindfulness is assessed with the 15-item Five Factor Mindfulness Questionnaire (FFMQ). Each item is rated on a 5-point scale with total scores ranging from 15 to 75., Baseline, up to 11 weeks|Change in resilience, Resilience is assessed via the 6-item Brief Resilience Scale (BRS). The scores range from 6 to 30, with a higher score indicating a higher level of resilience., Baseline, up to 11 weeks
Secondary Outcome Measures: Change in positive affect, Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood., Baseline, up to 11 weeks|Change in negative affect, Negative Affect is assessed with the 5-item negative sub-scale from Positive and Negative Affect Schedule (PANAS-10). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood., Baseline, up to 11 weeks|Change in perceived stress, Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress., Baseline, up to 11 weeks|Change in depression and anxiety, Depression and anxiety are assessed with the ultra-brief 4-item Patient Health Questionnaire (PHQ-4). PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher levels of depression and anxiety., Baseline, up to 11 weeks
Lynch Syndrome Integrative Epidemiology and Genetics
NCT Number: NCT06582914
Acronym: LINEAGE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lynch Syndrome
Sponsor: University of Colorado, Denver
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2054-12-31

Summary:
The vision of the "Lynch syndrome INtegrative Epidemiology And GEnetics" (LINEAGE) Consortium is to collaboratively improve the lives and longevity of individuals and families with Lynch syndrome.

The mission of the LINEAGE Consortium is to collaboratively improve Lynch syndrome care through high-quality research. This consortium will provide intellectual and infrastructure support to facilitate development of research questions, collection of standardized data and biospecimens, support of grant applications, and generation of collaborative manuscripts.

Our aims are to:

I. Establish a prospective cohort of individuals with Lynch syndrome II. Collect standardized longitudinal clinical and biosample data to elucidate Lynch Syndrome epidemiology and gene-host interactions III. Promote intervention trials to improve cancer prevention and early detection in Lynch Syndrome

Primary Outcome Measures: Colorectal cancer incidence, cases of adenocarcinoma of the colon or rectum diagnosed over the observation period, 40 years
Secondary Outcome Measures: non-colorectal cancer incidence, new cases of any cancer diagnosed over observation period, 40 years|precancerous colorectal polyps, new diagnoses of any of the following polyps in the colon or rectum

* tubular adenoma
* villous adenoma
* tubulovillous adenoma
* sessile serrated lesion
* traditional serrated adenoma, 40 years
Interventions for Clinical High Risk Youth in Tunisia
NCT Number: NCT06582901
Acronym: CHRTUNISIA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress, Psychological|Depression, Anxiety|Prodromal Period
Interventions: BEHAVIORAL: Psychosocial Intervention|BEHAVIORAL: Enhanced - Treatment as Usual
Sponsor: University of California, Los Angeles
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2025-08-31
Locations: Razi University Hospital, Tunis, Tunisia

Summary:
Study participants will take part in one of the two types of treatments aimed at improving daily functioning as follows: either a Cognitive Training (CT) Program or an Enhanced - Training Group (E-TG). All group treatments will be provided at Razi Hospital and one of the sessions will be conducted at home.

The Cognitive (thinking skills) Training and Neuropsychological Education Approach to Remediation (CT-NEAR) is a form of cognitive (thinking skills) training that consists of computer-game like brain exercises, learning about thinking skills strategies, and a "bridging group" to help participants use what is learned in daily life. Cognitive exercises are generally fun and playful and are done on a computer. The aim is to train thinking skills and ability to function better in daily life such as at school, university, or at work, or with friends and family. The program lasts 12 weeks with two weekly sessions in groups of 3 to 4 participants. Each session is 1½ hours in length and one of the sessions is which lasts 30 minutes is conducted at home using a tablet that will be provided by the study investigators.

Primary Outcome Measures: Change in Cognitive Functioning, Neurocognitive Test Battery. Scored on a composite of various tests will indicate improved, not improved at follow-up, Baseline, 3 months
Secondary Outcome Measures: Global Functioning Scale - Role and Social, Interview-based assessment of work or school functioning and of social functioning. Scores range from 0-100 with higher score indicating better functioning., Baseline, 3 months|Comprehensive Assessment of Clinical High Risk State, Interview based assessment of clinical status assess change in clinical status from baseline to post - intervention, Baseline, 3 months
Advancing VR-based Attentional Bias As a Biomarker for Tobacco Use Disorder
NCT Number: NCT06582888
Acronym: VR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Nicotine Addiction|Craving
Sponsor: University of California, San Diego
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-12-15
Completion Date: 2028-08-15

Summary:
The proposed project will include enrollment of 200 daily tobacco cigarette users, ages 22+, from the San Diego community. Participants will be assessed on the VR Nicotine Cue Exposure paradigm then randomized (stratified on age and sex) to receive varenicline (target dose 1mg twice daily) or placebo (n per group=100; total N=200). Following eight days of titration, participants will be assessed again on the VR Nicotine Cue Exposure paradigm. They will then be followed via mobile assessments for eight days on target dose of varenicline, and 30-days post assessment by phone, to assess short-term nicotine use behaviors.

Primary Outcome Measures: Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment, Eye gaze fixation time to active versus neutral cues from the \&amp;amp;#34;NTP Cue VR Paradigm\&amp;amp;#34;, during each in-person session, at baseline and on average 8 days post baseline assessment|Nicotine craving, Assessed via the Tobacco Craving Questionnaire - Short-Form, during each in-person session, at baseline and on average 8 days post baseline assessment|Nicotine craving, Assessed via visual analogue scales (VR paradigm and mobile surveys), through study completion, an average of 30 days|Nicotine use episodes, Assessed via the Timeline Followback, during each in-person session, at baseline and on average 8 days post baseline assessment|Nicotine use episodes, Assessed via participant fill-in on mobile surveys, through study completion, an average of 30 days
Enhanced Assistance During Radiotherapy for Unmet Essential Needs
NCT Number: NCT06582849
Acronym: EARN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Cancer|Brain Cancer|Colorectal Cancer|Esophagus Cancer|Lymphoma|Salivary Gland Cancer|Head and Neck Cancer|Liver Cancer|Ovarian Cancer|Pancreatic Cancer|Prostate Cancer|Small Intestine Cancer|Stomach Cancer|Urinary Bladder Cancer|Anal Cancer|Blood Cancer|Breast Cancer|Cervical Cancer|Lung Cancer|Kidney Cancer|Penile Cancer|Skin Cancer|Testicular Cancer|Thyroid Cancer|Uterine Cancer|Vaginal Cancer|Vulvar Cancer
Interventions: OTHER: Standard assistance|OTHER: Enhanced assistance
Sponsor: Washington University School of Medicine
Collaborators: American Society of Clinical Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-31
Completion Date: 2025-12-31
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

Summary:
This is a prospective single-arm study of an enhanced assistance intervention for patients with unmet essential needs undergoing \>10 fractions of radiotherapy comparing delay-free completion of radiotherapy in study participants to historic controls.

Primary Outcome Measures: Delay-free completion of radiotherapy, Defined as: (1) completing all fractions of radiotherapy AND (2) delaying fewer than 5 fractions. Patients who do not initiate a recommended course of radiotherapy will be considered as not completing radiotherapy; however, in the rare case where the patient's radiotherapy treatment recommendation changes by their physician(s) to no longer include radiotherapy, such patients will be dropped from the study and excluded from analyses., Through completion of radiotherapy (estimated to be 4 months)
A Comparative Assessment of Post Extraction Pain in Orthodontic Patients to Evaluate the Effects of Early Engagement of Tooth with Orthodontic Wires. a Single Center Randomized Clinical Trial (RCT)
NCT Number: NCT06582836
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthodontic Extraction|Orthodontic Treatment|Orthodontic Treatment Via Premolar Extraction
Sponsor: Universiti Sains Malaysia
Sex: ALL
Age: CHILD, ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2019-06-10
Completion Date: 2021-12-10

Summary:
The goal of this clinical trial is to determine if the timing of tooth extractions (before or after initial orthodontic treatment) affects pain levels in patients who need bilateral extractions of first premolars in the upper jaw. The participants in this study are patients who require these extractions as part of their orthodontic treatment.

The main questions it aims to answer are:

1. Does extracting teeth before starting orthodontic treatment result in different pain levels compared to extracting teeth after alignment?
2. How do pain levels change over time after the extractions in each group?

Researchers will compare Group A (patients who have extractions before orthodontic treatment) to Group B (patients who have extractions after initial alignment) to see if the timing of the extractions affects pain levels.

Participants will:

Undergo tooth extractions either before or after initial alignment based on their group.

Rate their pain on an 11-point numerical rating scale at various times (2, 4, 8, 12, and 24 hours after extraction, and then daily for a week).

Primary Outcome Measures: A comparative assessment of post extraction pain in orthodontic patients to evaluate the effects of early engagement of tooth with orthodontic wires., In this randomized clinical trial, 44 patients were recruited who needed bilateral extractions of first premolars in upper arches. Patients were divided into two groups based on the timing of extractions. Group A needed extractions before alignment while Group B needed extractions for retraction of anterior teeth. Group A was sent for extractions first while Group B went for orthodontic bonding and banding procedures for orthodontic treatment. After series of aligning wires (0.014, 0.016, 17x25, 19x25 Heat activated NiTi and 19x25 SS) patients from group B were sent for extractions. For pain assessment, an 11-point numerical rating scale (NRS) were given to record pain intensity at 2, 4, 8, 12 and then 24 hours after extraction for the next 7 days., 2.6 years
Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches
NCT Number: NCT06582810
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Subarachnoid; Hemorrhage, Nontraumatic|Headache
Sponsor: University of Kansas Medical Center
Collaborators: Ascension Via Christi Hospitals Wichita, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2028-07

Summary:
The goal of this observational study is to evaluate intravenous lidocaine efficacy and safety in treating headache following non-traumatic subarachnoid hemorrhage. Through this prospective analysis, we hope to:

1. show that intravenous lidocaine infusion causes a clinically significant reduction in pain scores in patients with moderate/severe headache pain following non-traumatic subarachnoid hemorrhage;
2. show that intravenous lidocaine infusion is safe in treating headache following non-traumatic subarachnoid hemorrhage;
3. and report vasospasm prevalence in the cohort.

Participants will receive lidocaine infusion as treatment for non-traumatic subarachnoid hemorrhage headache and provide pain scores (on a numeric pain scale) every two hours they are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of their regular medical care.

Primary Outcome Measures: Reduction of pain, Reduction of pain ≥ 2 points in the numeric pain score after lidocaine infusion treatment., Benefit should be seen within first 24 h of infusion
Other Outcome Measures: Prevalence of vasospasm, Observe the prevalence of vasospasm in participants that receive lidocaine infusion, Within the first 7 days participants are receiving treatment
Analytical Treatment Interruption in a Patient With HIV Post Allogeneic Stem Cell Transplantation From a CCR5 delta32 Homozygous Donor
NCT Number: NCT06582797
Acronym: ATI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV-1-infection
Interventions: OTHER: discontinuation of ART
Sponsor: University of Kansas Medical Center
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2034-09

Summary:
Patients who have Human Immunodeficiency Virus-1 (HIV-1) infection, who also had a stem cell transplant may have achieved cure of their HIV infection. Once the patients blood shows no detectable levels of HIV virus in their blood collected from a process called leukapheresis, they will be closely monitored while discontinuing their HIV treatment which is know as antiretroviral therapy or, ART. They will be tested regularly and monitored for up to 52 weeks at which point they may be considered cured of their HIV.

Primary Outcome Measures: Proof of cure, patient will prove cured of HIV infection if no viral load tests result positive over the duration of study, 52 weeks
IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
NCT Number: NCT06582784
Acronym: IMPACT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Depressive Symptoms|Cancer
Interventions: BEHAVIORAL: Behavioral Activation Therapy App|BEHAVIORAL: Treatment as Usual
Sponsor: Medical University of South Carolina
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 279
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2029-08-01

Summary:
The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood.

Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not.

All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today.

Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.

Primary Outcome Measures: Change in Depression, Change in the PHQ-9 score from baseline., 12 weeks
Secondary Outcome Measures: Change in Anxiety Symptoms, Change in the Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A) score from baseline, 12 weeks|Change in Quality of Life, Change in the Functional Assessment of Cancer Therapy-General (FACT-G7) score from baseline, 12 weeks|Clinical Response Rate, The proportion of patients with a clinically meaningful improvement in depressive symptoms (decrease of ≥5 points on the PHQ-9) from baseline to each time point, 12 weeks
A Study of Sotorasib in People With Non-Small Cell Lung Cancer
NCT Number: NCT06582771
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non Small Lung Cancer
Interventions: DRUG: Sotorasib
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-08
Locations: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States

Summary:
The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a "first-line therapy" since their cancer became advanced.)

Primary Outcome Measures: Response to therapy, will be assessed with serial CT chest/abdomen/pelvis every 2 cycles (6 weeks), with response evaluated by RECIST 1.1, within 6 month of therapy
Does Choice Improve the Pain Relief Derived From a Brief Intervention
NCT Number: NCT06582758
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Acute Pain
Interventions: BEHAVIORAL: Pain Psychoeducation|BEHAVIORAL: Mindful Pain Management
Sponsor: Florida State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2024-12
Locations: Tallahassee Orthopedic Clinic (TOC), Tallahassee, Florida, 32308, United States

Summary:
This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.

Primary Outcome Measures: Change in Pain Unpleasantness Numeric Rating Scale, Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness., Immediately before to after 7 to 10-minute audio recording
Secondary Outcome Measures: Change in Pain Intensity Numeric Rating Scale, Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity., Immediately before to after 7 to 10-minute audio recording|Change in Anxiety Numeric Rating Scale, Change in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety., Immediately before to after 7 to 10-minute audio recording
Targeted Approach to Langerhans Cell Histiocytosis (LCH) Using MEK Inhibitor, Trametinib
NCT Number: NCT06582745
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Langerhans Cell Histiocytosis
Interventions: DRUG: Trametinib
Sponsor: Cook Children's Health Care System
Sex: ALL
Age: CHILD, ADULT
Enrollment: 75
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2039-12
Locations: Cook Children's Health Care System, Fort Worth, Texas, 76104, United States

Summary:
The purpose of this Phase II clinical trial is to establish the safety and effectiveness of trametinib, a targeted therapy, for the treatment of newly or recently diagnosed Langerhans Cell Histiocytosis (LCH) among pediatric patients.

Primary Outcome Measures: Time to Progression (TTP), TTP defined for each participant as the period of time from start of treatment to the manifestation of objective progression, but excluding occurrences of death., Up to six years|Progression-free Survival (PFS), PFS defined for each participant as the time from start of treatment to disease progression (recurrence) or death by any cause in the absence of progression., Up to six years|Overall Survival (OS), OS defined for each participant as the time from the date of first administration until the date of death from any cause. Participants not having an event at the time of analysis will be censored at the date they were last known to be alive., Up to six years
Secondary Outcome Measures: Response Rate, The response rate will be defined as the percentage of patients with Complete Response (the disappearance of all signs of LCH in response to treatment), Stable Disease (neither increasing nor decreasing in extent or severity), Partial Response (at least a 30% decrease in the signs of LCH), and Progressive Disease (at least a 20 percent growth in the signs of LCH since the beginning of treatment)., Up to six years|Blood HistioTrak Levels in Participants with BRAF V600E Mutations, The HistioTrak test is a highly sensitive droplet digital PCR (ddPCR)-based molecular assay designed to measure MRD in patients with BRAF V600E-driven histiocytic and other neoplasms., Up to six years
Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
NCT Number: NCT06582719
Acronym: AIM-GDM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gestational Diabetes
Interventions: DEVICE: GPT-based counseling|OTHER: Nutritional Counseling
Sponsor: Montefiore Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-05

Summary:
The purpose of this study is to assess whether an AI based counseling service can be beneficial for patients to assist in management of gestational diabetes.

Primary Outcome Measures: Birth weight at time of Delivery, Newborns will be weighed within 12 hours of the time of delivery. Birth weights will be summarized and reported by study group using basic descriptive statistics. Higher birth weights have been associated with Gestational Diabetes Mellitus (GDM) and increased risk of perinatal complications., Within 12 hours of delivery
Secondary Outcome Measures: Rate of Neonatal Intensive Care Unit (NICU) admissions, Rate of NICU admission will be expressed as the percentage of newborns who were admitted to the NICU within 12 hours of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. Increased admissions to the NICU are associated with less favorable perinatal outcomes., Within 12 hours of delivery|Rate of Cesarean Section, Rate of Cesarean Section will be expressed as the percentage of patients who delivered via Cesarean section. Rates will be summarized and reported by study group using basic descriptive statistics. Patients with GDM are more likely to need Cesarean sections leading to less favorable perinatal outcomes for the newborn., Within 12 hours of delivery|Rate of Progression to medication requirements, The rate of progression to medication requirements for GDM will be assessed as the percentage of patients who are administered either insulin or oral hypoglycemic at the time of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. Higher rates of progression to medications are associated with increased hyperglycemia and less favorable perinatal outcomes in general., At the time of delivery|Rate of Shoulder Dystocia, Rate of Shoulder Dystocia will be expressed as the percentage of patients who have been diagnosed with should dystocia within 12 hours of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. GDM is a risk factor for shoulder dystocia and higher rates of shoulder dystocia are associated with increased perinatal complications., Within 12 hours of delivery
Nicotinic Acid for the Treatment of Alzheimer's Disease: a Phase 1b/2a Study
NCT Number: NCT06582706
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Alzheimer Disease
Sponsor: Indiana University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-08

Summary:
Increased dietary intake of niacin is correlated with reduced risk of Alzheimer's Disease and age-associated cognitive decline. The goal of this study is to collect data on the penetration of commercially available, FDA approved, extended-release niacin into the spinal fluid. One dose of 500 mg nicotinic acid will be used (in addition to placebo) to build a dose response curve for this compound in human cerebrospinal fluid. This objective will demonstrate target engagement of HCAR2 in the central nervous system, after oral treatment with niacin. The primary endpoints are to show increased nicotinic acid levels in blood and cerebrospinal fluid. A secondary endpoint is to collect safety and tolerability data of niacin in this particular population.

Primary Outcome Measures: Increased nicotinic acid levels in blood and CSF, Target engagement of HCAR2 in the CNS after treatment with niacin, Baseline and 60 day visit
Secondary Outcome Measures: Number of participants with treatment related adverse events, Adverse events will be collected throughout the study. Adverse events deemed related to nicotinic acid will be delineated from procedural based adverse events by the PI., Baseline to 60 day visit
Refer2Quit Randomized Controlled Trial
NCT Number: NCT06582693
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking|Smoking Cessation|Second Hand Tobacco Smoke
Interventions: OTHER: Refer2Quit
Sponsor: Children's Hospital of Philadelphia
Collaborators: National Institutes of Health (NIH)|National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2027-03-01
Locations: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19146, United States

Summary:
The goal of this clinical trial is to compare the reach and effectiveness of the Refer2Quit intervention for increasing tobacco use treatment and quit rates among household members who smoke versus a treatment as usual group. This clinical trial also aims to study household member and pediatric patient characteristics that are associated with reach and effectiveness of Refer2Quit.

Primary Outcome Measures: The proportion of adult participants who engage in any evidence-based tobacco use treatments, The proportion of adult participants who engage in any evidence-based tobacco use treatments, between the intervention and control arms, by adult participant self-report., Baseline, 1 and 6 months|Combustible tobacco quit rate at 1 and 6 months, The quit rate, compared between the intervention and control arms, will be assessed by a self-reported 7-day point prevalence smoking abstinence, collected via follow-up survey, and confirmed via breath carbon monoxide (CO) \<5ppm at the time-point, 1 and 6 months
Aging, Beta Blockers, and Thermoregulatory Responses
NCT Number: NCT06582680
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Heat Stress|Aging
Sponsor: University of Texas Southwestern Medical Center
Sex: ALL
Age: OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2026-09-30

Summary:
We will test the hypothesis that the drugs propranolol and metoprolol will result in greater increases in core body temperature during 3 hours of extreme heat exposure in older adults.

Primary Outcome Measures: Internal temperature, The change in internal temperature to the 3-hour heat exposure will be measured., Continuously throughout the 3-hour heat exposure.|Whole body sweat rate, Whole body sweat rate will be measured via changes in pre/post nude body mass., Nude body mass will be measured before and after the 3-hour heat exposure.
Secondary Outcome Measures: Heart rate, Heart rate will be measured via electrocardiogram., Continuously throughout the 3-hour heat exposure.|Arterial blood pressure, Arterial blood pressure will be measured via a brachial blood pressure cuff., Continuously throughout the 3-hour heat exposure.
Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy
NCT Number: NCT06582667
Acronym: PENG Block
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Fracture|Antithrombotic Therapy|PENG Block
Interventions: PROCEDURE: PENG block
Sponsor: Alexandria University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-17
Completion Date: 2025-04-17
Locations: Faculty of Medicine, Alexandria, Egypt

Summary:
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance

Primary Outcome Measures: Incidence of Hematoma Formation, The occurrence and severity of hematomas at the PENG block site. Measurement: Regular clinical examinations and imaging studies to assess for hematoma formation., first 48 hours postintervention|Bloody Tab on the Needle:, Presence of blood on the needle during the performance of the PENG block., immediately during the procedure ( first 10 minutes after PENG block)|Rest and mobilization pain by numerical rating scale, post intervention to be assessed 0-10, 1 hour and 6 hours after surgery, on the same day of surgery (D 0) and first day postoperative(D 1) at 8 a.m., 1 p.m. and 6 p.m.
Secondary Outcome Measures: Incidence of Nerve Injury, Any signs of sensory or motor deficits, paresthesia, or neuropathic pain related to nerve injury or compression due to hematoma formation., after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours|Postoperative quadriceps strength, Quadriceps strength is assessed using the knee extension Test and Oxford muscle strength grading with grouped scores of intact (5/5), reduced (1-4/5) and absent (0/5)., first day postoperative postoperative (12 hours after surgery)|The quality of Postoperative functional recovery and the variations and differences between groups will be assessed using the validated arabic version of the quality-of-recovery 15-items score (QoR-15), 15 values score ranges from 0-150 ,excellent \>135, good \> 122 and \< 135, moderate \>90 and \< 121, poor \< 90, On the same day of surgery ( 12 hours after surgery) and first day postoperative|- Perioperative opiate use, will be calculated over 48 hours in milligrams, from the end of surgery to 48 hours postoperative|length of hospital stay in days, the number of days spent in the hospital will be calculated at the date of discharge the starting day is the date of admission called day 1 and all days spent in the hospital will be counted till the day of going home and this expected to be from 3-10 days after operation, from the date of admission to the date of discharge
Normalizing Antibody Detection in First-void Urine
NCT Number: NCT06582654
Acronym: URINORM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Human Papillomavirus Infection
Sponsor: Universiteit Antwerpen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-07
Completion Date: 2026-01-01

Summary:
The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.

Primary Outcome Measures: Concentration of total and HPV-specific IgG (immunoglobulin G) in first-void urine., To follow-up levels of total and HPV-specific antibodies in first-void urine at repeated measurements and compare levels of total and HPV-specific antibodies in first-void urine between young men, pre-adolescent girls, post-menopausal women, and women on a contraceptive or ovulatory cycle., Within six months after completion of the study
Secondary Outcome Measures: Concentration of total and HPV-specific IgG (immunoglobulin G) in serum., To compare levels of total and HPV-specific antibodies in serum at repeated measurements and look into correlation between total and HPV-specific antibodies in serum and first-void urine., Within six months after completion of the study|HPV DNA status of first-void urine samples., To test for the presence of HPV DNA in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV., Within six months after completion of the study|Other biomarkers/analyses., To test various biomarkers (e.g. total IgG, IgG subclasses, total protein, total human DNA...) in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV and perform other relevant analyses within the scope of the study.

To test various biomarkers (e.g. total IgG, IgG subclasses, total protein, total human DNA...) in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV and perform other relevant analyses within the scope of the study., Within six months after completion of the study
Evaluation of Peer Group Connection - Middle School
NCT Number: NCT06582641
Acronym: PGC-MS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Teen Pregnancy Prevention
Sponsor: The Policy & Research Group
Sex: ALL
Age: CHILD
Enrollment: 1400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2028-09-14

Summary:
The goal of this randomized trial is to learn if the Peer Group Connection - Middle School (PGC-MS) intervention delays initiation of sexual intercourse in middle school-aged youth. The primary research question it aims to answer is:

Sixteen months after being offered the intervention, does PGC-MS impact youth's initiation of sexual intercourse?

Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)).

Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (either 6th or 7th grade). Participants randomized to the control group will be offered class-as-usual.

Primary Outcome Measures: Initiation of sexual intercourse, Participants are asked the following item: 1) Have you ever had sexual intercourse? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never sexual intercourse and 1 indicates a person who has had sexual intercourse., Assessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program)
Food for Thought - a Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
NCT Number: NCT06582615
Acronym: MIND-TNBC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anatomic Stage II Breast Cancer AJCC V8|Anatomic Stage III Breast Cancer AJCC V8|Triple-Negative Breast Carcinoma
Sponsor: Ohio State University Comprehensive Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-12-31

Summary:
The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression.

Researchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions.

Women randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely.

Participants will:

* Be randomized to MIND or GHC interventions
* Complete all study measures remotely (by online questionnaires, virtual visits and mail )
* Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks
* Be sent some of the key foods in the MIND eating plan during the MIND intervention
* Be contacted for follow-up measures 6 months after interventions

Primary Outcome Measures: Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score, Analyses of change in WAIS-IV test scores will be based on a linear or generalized linear mixed effects regression model, as appropriate. Timepoint, treatment assignment, and their interaction will be included as fixed effects, and a subject-level random intercept effect will be included to account for correlation of repeated measurements from the same subject. Pathological complete response and baseline measurements of the outcome variables will also be included as fixed effects to improve precision, as will any demographic variables that are substantially imbalanced at baseline. Will report descriptive statistics, and when applicable, comparisons between randomized groups., Baseline up to 6 months post-intervention
Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants
NCT Number: NCT06582563
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Coagulation Disorder
Sponsor: Perosphere Technologies Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-03-01
Completion Date: 2025-08-30

Summary:
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).

Primary Outcome Measures: Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices, Whole Blood Clotting Time, Immediate
Secondary Outcome Measures: Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay, Drug concentration measurements, Immediate