pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Efficacy of Gemcitabine and Nab-palitaxe Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Patients With Locally Advanced Pancreatic Ductal Adenocarcinoma
NCT Number: NCT06472037
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced Pancreatic Ductal Adenocarcinoma
Interventions: DRUG: Cadonilimab|DRUG: Gemcitabine|DRUG: Nab paclitaxel
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-01
Locations: Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, 300052, China

Summary:
A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.

Primary Outcome Measures: Clinical benefit rate (CBR, CR+PR+SD), Clinical benefit rate ( complete response and partial response and stable disease), 1 year
Secondary Outcome Measures: ORR, overall response rate, 1 yaear|PCR, Complete pathological response rate, 1 year|(EFS)RECIST 1.1, event free survival, 1 year|OS, Overall survival .OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date., 1 year|Surgical conversion rate, Surgical conversion rate, 1 year|(AEs)CTCAE 5.0, Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0, 1 year
Assessing Manual Acupuncture's Impact on Mucositis From Nasopharynx Cancer Radiotherapy: A Visual Analogue Scale (VAS) and Quality of Life Study
NCT Number: NCT06472024
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Nasopharyngeal Carcinoma|Mucositis
Interventions: PROCEDURE: Verum Acupuncture|PROCEDURE: Sham Acupuncture
Sponsor: Indonesia University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-09

Summary:
The goal of this clinical trial is to learn if acupuncture can play a role in reducing pain and improving the quality of life of post-radiotherapy nasopharyngeal cancer mucositis patients. The main questions it aims to answer are:

- Do manual acupuncture and medication therapy affect pain intensity as measured by the visual analogue scale (VAS) in patients with oral mucositis compared with sham manual acupuncture and medication?

Participants will receive acupuncture therapy 2 times a week for 3 weeks

Primary Outcome Measures: Visual Analogue Scale, VAS is used to assess pain complaints on a scale of 1-10. The VAS scale consists of: mild pain scale 1-3, moderate pain scale 4-6 and severe pain scale 7-10, Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention.|European Organization For Research And Treatment Of Cancer Head and Neck Cancer Quality of Life Questionnaire (EORTC QLQ-H&N35), The EORTC QLQ-H\&N35 is a questionnaire designed to assess the health-related quality of life in patients with head and neck cancer. It consists of 35 questions covering various aspects such as pain, swallowing, speech, social eating, and emotional functioning. Each question is scored on a scale from 1 to 4, with 1 representing "not at all" and 4 representing "very much".

To calculate a score for each domain, the individual item scores are averaged. Higher scores indicate more severe symptoms or poorer quality of life in that domain. Additionally, there are specific guidelines provided by the European Organization for Research and Treatment of Cancer (EORTC) for scoring and interpreting the results, with a minimum and maximum scale of 0-33: mild, 34-66: moderate, 67-100: severe., Monitored before and after intervention. After the intervention; Results will be measured at week 3 after intervention and results will be measured at week 4 without intervention.
Effects of Common Meals on Appetite and Satiety
NCT Number: NCT06472011
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: lean steak and potatoes|OTHER: lentil and sweet potato chili|OTHER: macaroni and cheese|OTHER: fish tacos|OTHER: chicken and pea fried rice|OTHER: pita and hummus|OTHER: creamy pork pasta
Sponsor: San Diego State University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-08-30
Locations: San Diego State University, San Diego, California, 92182-7251, United States

Summary:
The objectives of this study are to assess the impacts of meals composed of lean steak and potatoes (with a small portion of broccoli) in comparison to other common entrée/starch food combinations on metabolic and appetite responses.

Primary Outcome Measures: appetite response, Using 100 mm visual analog scales (score from 0 to 100 and higher score means more), baseline (B), 15 minutes from B, 30 minutes from B, 45 minutes from B, 60 minutes from B, 90 minutes from B, 120 minutes from B, 150 minutes from B, 180 minutes from B, 210 minutes from B, 240 minutes from B
Secondary Outcome Measures: blood glucose, measuring blood glucose level, baseline (B), 15 minutes from B, 30 minutes from B, 45 minutes from B, 60 minutes from B, 90 minutes from B, 120 minutes from B, 150 minutes from B, 180 minutes from B, 210 minutes from B, 240 minutes from B
Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
NCT Number: NCT06471998
Acronym: HTL-LOMB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Low-back Pain
Interventions: DRUG: Sodium Chloride injection
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-09
Locations: Hôpital Privé Clairval, Marseille, 13009, France

Summary:
The purpose of this study is to evaluate the benefit of Localized Tissue Hydration associated with standard management of chronic common low back pain, in terms of improvement in the numerical verbal scale score at 6 months.

Primary Outcome Measures: Success rate, Success rate after treatment with Localized Tissue Moisturization combined with standard management, defined by a reduction in the Verbal Numerical Scale score of at least 30%., 6 months
CoPainHell: The Analgesic Effect of Alcohol and Music
NCT Number: NCT06471985
Acronym: CPH
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Pain
Interventions: COMBINATION_PRODUCT: Music and pain
Sponsor: Eske Kvanner Aasvang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-19
Completion Date: 2024-12-31
Locations: Copenhell metal Festival, Copenhagen, 2100, Denmark

Summary:
The study is a 2x2 randomized crossover study. Participants are randomized to listen to one of two music tracks: "Orinoco Flow" by Enya or "Raining Blood" by Slayer. Prior to the intervention, participants' breath alcohol levels are measured through a breathalyzer test. The intervention involves a cold water test, where the participant's dominant hand is submerged in water at 4-5 degrees Celsius. Participants are instructed to keep their hand in the water until the pain becomes too intense, but no longer than 5 minutes.

Two hours after the first test, the same procedure is repeated, but participants listen to the other music track than they did during the first test. Participants receive no instructions on how to behave during the 2-hour interval.

The experiment takes place during the music festival CopenHell (June 19-22, 2024), provided that there is approval from relevant authorities.

Two hours after the first test, the same procedure is repeated, but participants listen to the other music track than in the first test. Participants are given no instructions on how to behave during the 2-hour interval.

Primary Outcome Measures: pain responsiveness, Pain responsiveness will be measured on the VAS, where an investigator will ask the participants to rate their experienced pain from 1-10.

The VAS will be rated at the start of CPT + 30 seconds, 60 seconds, 90, 120, 180, 240 and 300 seconds or when reaching the pain tolerance (up to 5 minutes), where the test will end whichever comes first.

VAS: Visuel Analog Scale. Values 0-10, where 0 is no pain at al and 10 is the worst pain imaginable, 300 seconds
Secondary Outcome Measures: pain threshold and pain tolerance, Pain threshold is measured as the number of seconds passed from the beginning of the pain stimulation till the participant says "pain", when stimulus evolves from being unpleasant to painful.

Pain tolerance is measured as the number of seconds passed from the beginning of pain stimulation till the participant can't bear the pain anymore and says "pain limit"., five minutes
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
NCT Number: NCT06471972
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrest
Sponsor: Region Skane
Collaborators: University of Helsinki|The George Institute|Copenhagen Trial Unit, Center for Clinical Intervention Research|Medical Research Institute of New Zealand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2029-12-31
Locations: Helsinki Hospital, Helsinki, Finland|Helsingborgs Hospital, Helsingborg, Sweden|Skåne university hospital, Lund, Sweden|Skåne University Hospital, Malmö, Sweden

Summary:
A prospective multicenter biomarker study with adult patients treated on

intensive care units after out-of-hospital cardiac arrest. Patients will be recruited from specific sites participating in the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation (STEPCARE) trial. (ClinicalTrials.gov ID NCT05564754).

Blood samples will be collected at 12, 24, 48, and 72 hours after randomization in selected sites, aliquoted and frozen on-site. After trial completion, samples will be stored in a central biobank. Sample analysis will be performed in batch after trial completion. Functional outcome will be assessed at 30 days and 6 months after cardiac arrest.

Primary Outcome Measures: Functional outcome according to the modified Rankin Scale, Poor functional outcome modified Rankin Scale 4-6, 6 months after randomisation
Secondary Outcome Measures: Functional outcome according to the modified Rankin Scale, Poor functional outcome modified Rankin Scale 4-6, 30 days after randomisation|Mortality at 6 months, 6 months after randomisation
Psychedelic-assisted Group Program for First Responders
NCT Number: NCT06471959
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Psilocybin|Psychotherapy, Group
Interventions: DRUG: Psilocybin
Sponsor: Empower Research Inc
Collaborators: Empower Psychedelics|Centre for Neurology Studies, Canada|Mitacs
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2025-09-01
Locations: Centre for Neurology Studies, Surrey, British Columbia, V3V 0C6, Canada

Summary:
This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters. Trained facilitators will help create a trauma-informed space for the group (n = 6-8) to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work.

Group 1 (control): 12-week group-based program, with a breathwork day at week 10

Group 2 (intervention): 12-week group-based program, with a 10mg dose of psilocybin (PEX010) at Week 10

Assessment timepoints:

* Baseline
* Mid-program (Week 6)
* End of program (Week 12)
* 6-month follow up

Primary Outcome Measures: Target recruitment rate, A minimum recruitment rate of 70% of our target of 36 individuals within 6 months, Within 6 months|Retention rate, Retention rate of 90% at study completion, Study Completion (8 months)|Adherence to schedule, Adherence to scheduled study visits at a rate of 90% or higher at study completion., Through Study completion (8 months)
Secondary Outcome Measures: Scores on the GAD-7 Anxiety Scale, Scores on the GAD-7 Anxiety scale will be evaluated using a two-way mixed effects ANOVA with a between factor of GROUP and a within factor of TIME to determine the effect of the psilocybin and control interventions on symptoms of anxiety in firefighters. The scale reports scores with a lowest value of 0 representing "Not at all" experiencing the symptoms of what is asked in the questions. The highest score of 3 represents "Nearly every day" experiencing the symptoms of what is asked in the questions., Study Completion (8 months)
VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS
NCT Number: NCT06471946
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Higher-risk Myelodysplastic Syndromes
Interventions: DRUG: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
Sponsor: Navy General Hospital, Beijing
Sex: ALL
Age: OLDER_ADULT
Enrollment: 54
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2030-09-01
Locations: Navy General Hospital, Beijing, Beijing, 100048, China

Summary:
The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.

Primary Outcome Measures: Overall Survival, OS was defined as time from diagnosis to death from any cause or the last follow-up, 3 year
Secondary Outcome Measures: Progression Free Survival (PFS), 3 year|Incidence of acute GVHD and chronic GVHD, 3 year|Non-relapse mortality (NRM), 3 year|Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), 3 year
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
NCT Number: NCT06471933
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nasolabial Fold
Interventions: DEVICE: Juläine
Sponsor: Nordberg Medical AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 59
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2026-06-30
Locations: Centro Diagnostico Italiano, Milano, Italy|Ribé clinic, Barcelona, Spain|The Faculty, Stockholm, Sweden

Summary:
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.

The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.

Participants will:

Receive 3 rounds of treatment and will be followed up for a total of 2 years.

Primary Outcome Measures: Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade., Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score.

Score 1-5, Higher scores are a worse outcome., 12 months after final injection
Secondary Outcome Measures: Percentage of subjects with improvement of at least 1 grade on the WSRS., Percentage of subjects with an improvement of at least 1 grade on the WSRS of the left and right (mean of the two) NLF at 3, 6 and 24 months after final injection compared to baseline (investigator assessment at all visits, blinded assessment at 12 months)., Up to 24 months after final injection|Change in WSRS score, Change in WSRS score of the NLF at 3, 6, 12 and 24 months after final injection compared to baseline.

Score 1-5, Higher scores are a worse outcome., Up to 24 months after final injection|Mean WSRS of <2 at each follow-up time, Proportion of subjects with a mean WSRS of \<2 at each follow-up time point at 3, 6, 12, and 24 months after final injection., Up to 24 months after final injection|Time to at least one grade improvement in mean WSRS and time to mean WSRS <2., Time to at least one grade improvement in mean WSRS and time to mean WSRS \<2., Up to 24 months after final injection|Change Face-Q score of Nasolabial Fold, Change in FACE-Q score of the NLF at 6, 12, and 24 months after final injection compared to baseline.

Scores 1-4: high scores better outcome, Up to 24 months after final injection|Change in Global Aesthetic in Improvement Scale, Change in Global Aesthetic Improvement Scale (GAIS) scores evaluated by the subject, the investigator and a blinded assessor from 2D facial digital imaging at 6, 12, and 24 months after final injection compared to baseline.

Scale 1-5; High scores worse outcome, Up to 24 months after final injection|Subject Satisfaction Scores, Assessment of Subject Satisfaction Scores at 6, 12, and 24 months after final injection.

Scale 1-5; High scores better outcome, Up to 24 months after final injection
Comparison of Pain Relief and Peripheral Perfusion Index
NCT Number: NCT06471907
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Erector Spinea Plane Block
Interventions: PROCEDURE: erector spinae plane block
Sponsor: Keimyung University Dongsan Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2025-04-30
Locations: Hong ji HEE, Daegu, 42601, Korea, Republic of

Summary:
The primary endpoint of this study is to compare the pain relief and peripheral perfusion index using different volume of local anesthetics in erector spinae plane block.

Primary Outcome Measures: Numerical rating scale changes among 5 times period, minimum (1) and maximum value (10), lower score means better outcome, Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block
Secondary Outcome Measures: back pain functional scale among 3 times period, minimum (0) and maximum value (60), higher score means better outcome, Baseline, 4 weeks, 8 weeks after the completion of erector spine plane block|Perfusion index changes among 4 times period, erfusion index changes after lumbar ESPB among 4 times period, baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB
Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression
NCT Number: NCT06471894
Acronym: NCMOIBDCWD
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Bowel Diseases
Interventions: RADIATION: Magnetic resonance imaging scanning|DRUG: FMT Protocol
Sponsor: LanZhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2027-12-01

Summary:
The goal of this observational study is to understand the effects of gut microbiota dysbiosis treatment in patients with inflammatory bowel disease (IBD) combined with depression. The main question it aims to answer is:

Does fecal microbiota transplantation (FMT) improve depression symptoms in IBD patients by altering GABA levels in the medial prefrontal cortex?

Participants already undergoing fecal microbiota transplantation (FMT) as part of their regular medical care for IBD and comorbid depression will undergo regular assessments of GABA levels, gut microbiota, and depression symptoms for the duration of the study.

Primary Outcome Measures: Magnetic resonance spectroscopy, Changes in GABA content in the prefrontal lobe of the brain, 1 week before and 1 week after FMT|Magnetic resonance spectroscopy, Changes in alpha diversity and differential abundance of gut microbiota, 1 week before and 1 week after FMT
Zirconia Bars for Mandibular Implant Overdentures
NCT Number: NCT06471881
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Edentulous Mouth
Interventions: DEVICE: Two mandibular implants
Sponsor: University of Bern
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-01-24
Completion Date: 2024-07-01
Locations: University of Bern, Bern, 3010, Switzerland

Summary:
Purpose: To assess the clinical and radiographic outcomes of computer-aided designed and manufactured (CAD-CAM) zirconia bars supporting mandibular implant-retained overdentures (IODs) after a 3-year follow-up.

Methods: A prospective observational single-center study involving 30 edentulous patients rehabilitated with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design - computer-assisted manufacturing zirconia bar with distal extensions was performed assessing clinical and radiographic parameters.

Primary Outcome Measures: Implant Survival, Number of patients with continued presence of the implant(s) during the re-examination appointments, 36 months|Implant Success, Number of patients with absence of persisting subjective discomfort such as pain, foreign body perception and or dysesthesia (i.e., painful sensation), absence of a recurrent peri-implant infection with suppuration, absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency, 36 months|Prosthetic Survival, Number of patients with functional presence of the denture and the bar at the follow-up moments, 36 months|Prosthetic Success, Number of patients with absence of any technical/mechanical complications without the need to repair the dentures (including the attachment systems) or the bars, 36 months|Radiological evaluation, Marginal bone loss, 36 months|Radiological examination, Implant bar fit, 36 months
Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases with Dietary Treatment
NCT Number: NCT06471842
Acronym: MEAL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inherited Metabolism Disease
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-21
Completion Date: 2026-08

Summary:
The main objective of this study is to estimate the prevalence of Pediatric Eating Disorders (PED) in Inherited Metabolic Diseases (IMD) with dietary treatment between the age of 12 months and 6 years 11 months.

Primary Outcome Measures: Feeding scale score, MCH (Montreal Children's Hospital) feeding scale score between the age of 12 months and 6 years 11 months., 1 day
Secondary Outcome Measures: Disorders severity level differentiation, Differentiation between severe/moderate/mild paediatric eating disorders (PED) using the MCH scale score. This scale makes it possible to differentiate the disorders severity level: mild PED with a score between 61 and 65, moderate PED with a score between 66 and 70 and severe PED with a score higher than or equal to 71., 1 day|Paediatric eating disorders prevalence for each pathology, Estimate for each pathology the paediatric eating disorders prevalence using the MCH scale score, 1 day|Risk factors identification, Identify the paediatric eating disorders' risk factors which are inherent to the disease, environmental and psycho-affective based on the parental questionnaire created for this purpose and the data collected, 1 day
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
NCT Number: NCT06471829
Acronym: BalanCeD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cushing's Disease
Interventions: DRUG: Lu AG13909
Sponsor: H. Lundbeck A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2026-05-15
Locations: National Institute of Endocrinology, Tbilisi, 0159, Georgia|Tbilisi Central Hospital, Tbilisi, 0159, Georgia|Multiprofile Clinic Consilium Medulla, Tbilisi, 0186, Georgia|Aversi Clinic, Tbilisi, 160, Georgia

Summary:
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). Cushing's disease is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about

1. the effect of Lu AG13909 on cortisol levels.
2. the safety and tolerability of Lu AG13909.
3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).

Primary Outcome Measures: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV Period, Up to Day 156|UFC Partial Response: ≥50% Reduction in mUFC from Baseline and mUFC >ULN at the end of the IV Period, Up to Day 156
Secondary Outcome Measures: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Up to Day 309|Cmax: Maximum Observed Plasma Concentration of Lu AG13909, Predose up to Day 309|Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909, Predose up to Day 309|Ctrough: Minimum Observed Concentration of Lu AG13909, Predose up to Day 309|Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough, Predose up to Day 309|AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State, Predose up to Day 309|CL: Systemic Clearance of Lu AG13909, Predose up to Day 309|t½: Elimination Half-life of Lu AG13909, Predose up to Day 309|Vd: Apparent Volume of Distribution of Lu AG13909, Predose up to Day 309|SC Bioavailability (F) of Lu AG13909, Predose up to Day 309|Number of Participants With Anti-Drug Antibodies (ADAs), Up to Day 309|Percentage Change from Baseline in mUFC, Baseline, Up to Day 156 and Up to Day 211|UFC Complete Response: mUFC ≤ ULN, Up to Day 211|UFC Partial Response: ≥50% Reduction in UFC from Baseline and mUFC >ULN, Up to Day 211|Late Night Salivary Cortisol (LNSC) Complete Response: Mean LNSC (mLNSC)≤ULN, Up to Day 156 and Up to Day 211|LNSC Partial Response: ≥50% Reduction from Baseline in LNSC and mLNSC >ULN, Up to Day 156 and Up to Day 211
Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens
NCT Number: NCT06471816
Acronym: PRO-DIALOG
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Behavior|Child Development
Interventions: OTHER: Dialogue Based Early Detection|OTHER: Traditional parent-teacher meeting
Sponsor: Haukeland University Hospital
Collaborators: University of Bergen|Western Norway University of Applied Sciences
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2029-06-30
Locations: Haukeland University Hospital, Bergen, NO-5021, Norway|Eventus Barnehage AS, Bergen, NO-5237, Norway|Øygarden municipality, Straume, NO-5354, Norway

Summary:
The goal of this clinical trial is to learn if the novel Dialogue Based Early Detection (DBED) method can prevent impaired mental health in kindergarten children. It will also learn about the screening properties of DBED to identify children with impaired mental health, if DBED facilitates early interventions, and if DBED is well accepted and sustainable in an ordinary kindergarten setting.

The main questions it aims to answer are:

* Do children in kindergartens where DBED is implemented develop better mental health scores than children in kindergarten where DBED is not implemented?
* How well identifies DBED kindergarten children with impaired mental health compared to a traditional screening instrument (the Strengths and Difficulties Questionnaire)?
* What is the impact of DBED on activation of interventions for mental health problems?
* What is the social validity of DBED?

Researchers will compare outcomes in kindergartens where DBED is implemented with outcomes in kindergartens where it's not.

* During the last three years of kindergarten attendance participants (parents of kindergarten children) in the intervention kindergartens will take part in the biannual DBED parent-teacher meetings, while participants in the control kindergartens will take part in traditional parent-teacher meetings.
* Twice a year all participants will answer questionnaires of the child's mental health and parental stress during the follow-up period (3 years in kindergarten and 2 first years in school).
* Participants in the intervention kindergartens will answer user satisfaction questionnaires after every parent-teacher meeting.
* The kindergarten teachers will report on type and time of supportive interventions for each participating child during the follow-up period in kindergarten.

Primary Outcome Measures: Total difficulties score of the Strengths and Difficulties Questionnaire (SDQ), The SDQ has five scales (scored 0-10); emotional problems, conduct problems, hyperactivity, peer problems and pro-social scale. The scales are combined (excluding the pro-social scale) into a 'total difficulties' score (0-40)., The SDQ is completed by both kindergarten teacher and each parent twice a year during the three last year of attendance of the child in kindergarten, continued by the parents during the first two years in school
Multi-omics Merge for Ensemble Subtyping for Atherosclerotic Cardiovascular Disease
NCT Number: NCT06471803
Acronym: ASCVD-MOMENT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atherosclerotic Cardiovascular Diseases
Sponsor: Henan Province Clinical Research Center for Cardiovascular Diseases
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-03-01
Locations: Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450018, China

Summary:
The current biological issues driving the evolutionary progression of coronary artery disease are in focus: at this stage, the biological evidence for them is scarce and small in scale, with the exception of metabolomics and microbiomics. Issues such as histologic mapping of coronary atherosclerosis deterioration remain to be corroborated by more clinical and basic evidence! By analyzing the clinical data and multi-omics data of patients with coronary heart disease, investigators will explore the related risk factors and establish molecular subtypes and prognostic prediction models for individualized prediction of coronary heart disease risk, in order to guide the clinical screening of high-risk groups of coronary heart disease and formulate more targeted intervention countermeasures.

Primary Outcome Measures: ACM, All-cause mortality, 1-3 years
Secondary Outcome Measures: MACE, Major cardiovascular events, 1-3 years
Inertial Sensors for Obstetrical Walking Epidural Tracking
NCT Number: NCT06471790
Acronym: MOTION-EASE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy Related|Epidural; Anesthesia, Headache|Labor Complication
Sponsor: Hospices Civils de Lyon
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-04-02
Locations: Hôpital de la Croix Rousse, Lyon, 69004, France

Summary:
Freedom of movement and the ability to walk are crucial during the first stage of labor, potentially reducing labor duration, cesarean section risk, epidural analgesia use, and bladder catheterization. While the clinical effects of ambulation during labor remain controversial, there is a consensus on its positive impact on the birthing experience and satisfaction.

Epidural analgesia remains the gold standard for pain control during labor, with a utilization rate of 82% in France. Recent advancements in obstetric analgesia have allowed for lower doses of analgesics, often administered via patient-controlled analgesia, which maintains the potential for ambulation during labor. However, only a small number of maternity units in France offer this technique. The main barriers include organizational issues such as unsuitable facilities, lack of wireless telemetry, and potential risks such as falls and hypotension.

Significant changes in gait characteristics are observed throughout pregnancy, particularly during the third trimester, and are studied in laboratory settings using video capture and analysis. Gait during labor is influenced by pain, fetal progression, and anatomical changes in the pelvis. The presence of epidural analgesia, where local anesthetics likely affect neural transmission, may impact motor commands and sensory feedback, further altering gait characteristics. These biomechanical aspects of labor remain understudied.

Wearable inertial sensors show promise in maternal health monitoring by providing real-time data for motion and gait studies. However, their application has not been described or validated during labor, particularly in walking conditions. Continuous dynamic study of gait in these conditions could enable non-invasive, non-intrusive monitoring of analgesia effectiveness, fall risk prediction, and labor progression analysis.

The aim of this feasibility study is to validate the use of wearable inertial sensors to quantify movements and characterize gait during the first stage of labor, both with and without low-dose epidural analgesia.

Primary Outcome Measures: triaxial (x, y, z) velocity changes over time unit (dV/dt) = m/s2 (meter over square second), gait patterns derived from accelerometer data measuring acceleration in three axes (x, y, z), during walking starting from the demand of the parturient to have an epidural up to delivery
Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on KRT Trial in UK
NCT Number: NCT06471777
Acronym: PROBE Fluid UK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Renal Failure on Dialysis (Disorder)
Interventions: PROCEDURE: Fluid removal
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Collaborators: Université de Montréal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-01

Summary:
The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy.

Primary Outcome Measures: fluid balance, cumulative fluid balance, day 5 after randomization
Secondary Outcome Measures: enrolment, Proportion of eligible patients who were enrol in the trial, 20 months|mortality, all-cause mortality, 90 days after randomization|ICU stay, Number of ICU free days, 90 days after randomization|vasoactive therapy, Number of vasoactive therapy-free days, 28 days after randomization|mechanical ventilation, Number of mechanical ventilation-free days, 28 days after randomization|KRT duration, hours of KRT support, 5 days
Validation Study of Frontier X Plus (FX+) Device
NCT Number: NCT06471764
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Sponsor: Fourth Frontier Technologies Pvt Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-04-20

Summary:
The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared gold standard 12-lead and a consumer device which stores ECG (FX2 consumer model used to store the ECG for analysis retrospectively).

The results obtained from this clinical investigation will serve as evidence for larger clinical investigation designs for this non-invasive and fully mobile method of continuous AF measurement in the adult population, including those with known or unknown cases of AF. The ultimate goal of this study is to establish the effectiveness of this novel approach in detecting and monitoring AF, which could potentially revolutionize the field of remote cardiac monitoring and improve the quality of care for patients with AF and other cardiac arrhythmias.

Primary Outcome Measures: Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference, 1. Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference by comparing: a. Quantitative review of RR intervals for date and time-matched segments b. Cardiologist naked-eye review and comparison of date and time-matched segments 2. Evaluate the Sensitivity and Specificity of the AF detection by Frontier X Plus (FX+) • Comparative 30-second rhythm analysis for AF detection obtained simultaneously from FX+ along with the 12-lead ECG (30-second recordings, repeated twice, consecutively), 6 months
Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
NCT Number: NCT06471751
Acronym: REMI SAHOS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea
Interventions: OTHER: Inspiratory and Oropharyngeal Muscle Strengthening
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Association aide à la recherche médicale de proximité (AIRE)|Conseil national de l'ordre des masseurs-kinésithérapeutes
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-08-01
Locations: CHU de Grenoble, Grenoble, 38000, France|Centre Hospitalier Universitaire, Saint-Étienne, 42055, France

Summary:
The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.

Primary Outcome Measures: Apnea-Hypopnea Index (AHI), AHI is measured by polygraphy or polysomnography. It is not a score, At 3 months
Secondary Outcome Measures: Maximum inspiratory pressure measurement (cmH2O), Measured by POWERbreathe® K5, At 3 and 9 Months|Neck circumference (cm), The neck circumference is measured by Magnetic Resonance Imagery (RMI), At 3 months|Epworth sleepiness score, Sleep quality assessment using the Epworth sleepiness score. From 0 to 24. If score up to 10 then the patient has signs of excessive daytime sleepiness, At 3 and 9 Months|Pittsburgh Sleep quality index, Sleep quality assessment using the Pittsburgh Sleep quality index. From 0 to 21. Score 0 = very good sleep quality. Score 21 = very poor sleep quality, At 3 and 9 Months|Quality of life scale : Short Form 12 (SF12), Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life, At 3 and 9 Months|PICOT fatigue scale, Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness, At 3 and 9 Months|AHI (Apnea-Hypopnea Index), AHI is measured by polygraphy or polysomnography It is not a score, At 9 months
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
NCT Number: NCT06471738
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ann Arbor Stage II Follicular Lymphoma|Grade 1 Follicular Lymphoma|Ann Arbor Stage III Follicular Lymphoma|Ann Arbor Stage IV Follicular Lymphoma|Grade 2 Follicular Lymphoma|Grade 3a Follicular Lymphoma
Interventions: DRUG: Zanubrutinib|BIOLOGICAL: Rituximab|DRUG: Venetoclax
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2027-06-01
Locations: Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital, Beijing, 100853, China

Summary:
This is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .

Primary Outcome Measures: CR rate, Determined by PET/CT based on Cheson, Lugano classification 2014 as assessed by the investigator. The number and percentage of subjects with a CR will be tabulated., Within 6 months of therapy completion
Secondary Outcome Measures: Overall response rate (ORR), CR + partial response (PR), determined by PET/CT based on Cheson, Lugano classification 2014 as assessed by the investigator. The number and percentage of subjects with an ORR will be tabulated., Within 6 months of therapy completion|Progression-free survival, PFS is defined as the duration from date of treatment initiation to date of disease progression or death from any cause, up to two years|Overall survival, PFS is defined as the duration from date of treatment initiation to date of death from any cause, up to two years|Incidence of Treatment-Emergent Adverse Events, Incidence of subjects occuring treatment related adverse events., Up to 90 days after the last dose of study drugs
Effectiveness of Adding Pilates Exercises to Sports Hernia Rehabilitation:a Comparative Clinical Trial
NCT Number: NCT06471725
Acronym: PESHR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pilates Exercises|Sports Hernia
Interventions: OTHER: combination of pilates exercises, Low-level laser therapy, and low-intensity ultrasound
Sponsor: Cairo University
Sex: MALE
Age: ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2024-09-30
Locations: Faculty of physical therapy, Delta university for science and technology, Mansoura, Dakahlia, 57357, Egypt

Summary:
The study recruited male sports hernias patients referred for physical therapy by an orthopedist or general practitioner from Damietta General Hospital. Participants had to be between 18 and 45 years old, have had sports hernia for two to ten weeks, and be willing and able to attend and stick to the Pilates exercise program for the trial's entire duration

Primary Outcome Measures: Visual Analogue Scale, Typically, it consists of a 10 cm horizontal or vertical line with no pain at one end and the highest pain level at the other end., 12 weeks
Secondary Outcome Measures: Lower Extremity Functional Scale, Consists of 20 items that assess the ability to perform activities related to lower extremity function, such as standing, walking, stair climbing, and balance., 12 weeks|Harris Hip Score, this tool is used to evaluate patients with hip conditions such as femoral neck fracture or OA., 12 weeks
Effects of Drugs on Stress Memories
NCT Number: NCT06471647
Acronym: ETS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Delta-9-tetrahydrocannabinol (THC)|Stress
Interventions: DRUG: delta-9-tetrahydrocannabinol (THC) (5)|DRUG: Placebo|DRUG: delta-9-tetrahydrocannabinol (THC) (10)
Sponsor: University of Chicago
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2026-07
Locations: University of Chicago, Chicago, Illinois, 60637, United States

Summary:
There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.

Primary Outcome Measures: Change in emotional responses after stress memory cues compared to control cues after delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. placebo, Using a visual analog scale participants will rate feelings of 'distress' 'arousal' and 'valence'. Scores range from 0-100 with higher scores indicating greater responses on particular items, baseline (5 minutes before memory task) and 20 seconds after each cue presentation during the task|Change in physiological responses after stress memory cue presentation compared to control cues, Researchers will assess changes in cardiac output (pre-ejection period) after presentation of cues. This will be measured in milliseconds. Lower values indicate greater sympathetic activation., difference between values at baseline (5 minutes pre-task) and during 20 seconds of task cue presentations
Secondary Outcome Measures: Change in emotional responses one week later during non-drug retrieval session, Using a visual analog scale from 0-100 participants will rate feelings of 'distress' 'arousal' and 'valence' in a non-drug state. Scores range from 0-100 with higher scores indicating greater responses on particular items, 1 week after the first exposure they will complete the memory task again. The timeframe for assessing changes in emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation|Change in negative facial emotion expressions during cue presentation after THC (5 and 10 mg) vs placebo, Using facial expression model, researchers will assess changes in the intensity (0-1) of negative facial emotions during presentation of memory cues, comparing control vs. stress memory cues. higher values indicate greater intensity., During 20 seconds cue presentation
Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life
NCT Number: NCT06471608
Acronym: EFFI-PNO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Spontaneous Pneumothorax|Quality of Life|Ambulatory Care|Chest Tube
Interventions: OTHER: Ambulatory management|OTHER: Standard Care
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT
Enrollment: 387
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2029-05

Summary:
Outpatient treatment of Primary Spontaneous Pneumothorax (PSP) compared to usual inpatient management could improve quality of care and represent a more efficient, generalizable and sustainable strategy.

This multicenter, cluster-controlled, randomized interventional study with stepped wedge implementation will evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care.

Primary Outcome Measures: Quality of life at 6 months, Evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care, using the Short Form (36) Health Survey (The lower the score the more disability), 6 months