pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Effect of Salt Water Nebulization on Cough, Sputum and Quality of Life in Chronic Obstructive Pulmonary Patients
NCT Number: NCT06519188
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Copd
Interventions: OTHER: Nebulization application with 5 ml isotonic sodium chloride
Sponsor: Ministry of Health, Turkey
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 81
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-02-28
Completion Date: 2022-12-30
Locations: Yedikule Chest Surgeory and Chest Disease Hospital, Istanbul, Zeytinburnu, 34020, Turkey

Summary:
The aim of this clinical trial is to evaluate the effects of salt-water nebulization on individuals with chronic obstructive pulmonary disease. The main questions it aims to answer are:

Does salt-water application have an effect on cough and sputum management in individuals with COPD diagnosis? Does salt-water application have an effect on dyspnea management in individuals with COPD diagnosis? Does salt-water application have an effect on the quality of life in individuals with COPD diagnosis? The work was continued with two groups that did and did not practice. The group who made the application made the application twice a day every day for 2 months. The results of both groups were compared.

Primary Outcome Measures: The effect of salt water application on cough in individuals diagnosed with COPD after a 8 weeks period., COPD Assesment Test's 1st question is belong to cough. The cough assessment of the patients was evaluated from "0" (no cough) to "5" (a lot of coughing). As the score obtained from the scale increases, the rate of being affected by COPD also increases., Base week and measurement interval is 8 weeks.|The effect of salt water application on sputum management in individuals diagnosed with COPD after a 8 weeks period., COPD Assesment Test's 2nd question is belong to sputum. The sputum assessment of the patients was evaluated from "0" (no sputum) to "5" (a lot of sputum). As the score obtained from the scale increases, the rate of being affected by COPD also increases., Base week and measurement interval is 8 weeks.
Secondary Outcome Measures: The effect of salt water application on dyspnea management in individuals diagnosed with COPD after a 8 weeks period., The Modified Medical Research Council Scale dyspnea scale is a five-item scale based on various physical activities that create a feeling of dyspnea.

In this scale, "0" (NO DYSPNEA) and "4" (WORST DYSPNEA). As the score obtained from the scale increases, the rate of being affected by COPD also increases., Base week and measurement interval is 8 weeks.|The effect of salt water application on quality of life in individuals diagnosed with COPD after a 8 weeks period., St. George's Respiratory Questionnaire with Quality of life were monitored in patients every 14 days and for the following 8 weeks.

A score of zero (0) Good state of health, and (100) indicates the most severe disease., Base week and measurement interval is 8 weeks.
Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome
NCT Number: NCT06519162
Acronym: LGAS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Autoimmune Hepatitis|Primary Sclerosing Cholangitis|Non-Alcoholic Fatty Liver Disease|Liver Abscess|Primary Biliary Cirrhosis
Sponsor: Chungnam National University Hospital
Collaborators: Chungnam National University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-08
Completion Date: 2029-07-08
Locations: Chungnam National University Hospita, Daejeon, Jung-gu, 35015, Korea, Republic of

Summary:
In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.

Primary Outcome Measures: Chi-square test, Using the Galaxy platform, perform taxonomic profiling followed by LDA(Linear Discriminant Analysis ) analysis. Group by primary diagnosis and derive the LDA(Linear Discriminant Analysis) Effect Size, or utilize MaAsLin2(Microbiome Multivariable Association with Linear Models 2) to identify genera/species showing significant compositional changes between diseases., Before treatment, 3~12months after treatment|t-test, Using the Galaxy platform, perform taxonomic profiling followed by LDA(Linear Discriminant Analysis) analysis. Group by primary diagnosis and derive the LDA(Linear Discriminant Analysis) Effect Size, or utilize MaAsLin2(Microbiome Multivariable Association with Linear Models 2) to identify genera/species showing significant compositional changes between diseases., Before treatment, 3~12months after treatment|Pearson's coefficient, Using the Galaxy platform, perform taxonomic profiling followed by LDA(Linear Discriminant Analysis) analysis. Group by primary diagnosis and derive the LDA(Linear Discriminant Analysis) Effect Size, or utilize MaAsLin2(Microbiome Multivariable Association with Linear Models 2) to identify genera/species showing significant compositional changes between diseases., Before treatment, 3~12months after treatment
Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
NCT Number: NCT06519149
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea
Interventions: DEVICE: Slow Wave UASD
Sponsor: Slow Wave, Inc.
Collaborators: St. David's HealthCare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-03

Summary:
This is a safety and efficacy trial for a Slow Wave, Inc. UASD oral appliance for the treatment of Obstructive Sleep Apnea. This trial will recruit 60-80 participants through our IRB partner. Each participant will take pre-trial and post trail sleep studies and be measured before, throughout and after the trial for Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), pulse rate to determine level of sleep improvement while wearing the device. Safety will also be measured through survey, dental exams and adverse events monitoring. Patients will wear an O2 monitoring ring throughout the study and upload results daily. Primary Objectives will evaluate AHI and ODI between sleep studies. Secondary outcomes will compare the daily ring data to these two sleep studies to evaluate changes over time. Patients will have the opportunity to complete daily diaries on their sleep experiences.

Primary Outcome Measures: AHI Events per hour, A 50% or greater reduction in apnea-hypopnea index (AHI) events from the baseline reading while wearing the device, 90 days|Oxygen Desaturation events during sleep, a 25% or greater decrease in events where oxygen desaturation is greater than or equal to 4% during sleep while wearing the device, 90 days|Device safety and comfort, All reported adverse events and patient input of side effects, dental exams and surveys, 90 days
Secondary Outcome Measures: Efficacy Ring Comparison, comparing baseline and ending HSAT sleep study results to collected patient ring data, 90 days|Pulse rate, effect on pulse rate while wearing the appliance, 90 days|Device safety and comfort, development of adverse events and development of any side effects over time., 120 days
Ambient Digital Scribes Populating Clinical Notes
NCT Number: NCT06519123
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Satisfaction|Clinician Satisfaction
Interventions: OTHER: Ambient Digital Scribes
Sponsor: Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-01
Completion Date: 2024-12-31
Locations: Duke University Health System, Durham, North Carolina, 27710, United States

Summary:
The purpose of this study is to assess the impact of Ambient Digital Scribes that will automatically record clinical encounters and use AI technology to populate clinical notes. The investigators expect that when clinicians do not need to either write notes during the clinical encounter and can instead face patients when talking, several effects could result, including 1) patients report higher satisfaction with the visit 2) clinicians report less burnout, and 3) clinician-patient communication includes more evidence-based tools that indicate high quality communication.

Primary Outcome Measures: Patient-perceived clinician empathy, Patient perceived empathy will be assessed via post doctor appointment administered survey., through study completion, an average of 2 months|Patient Satisfaction, Patient satisfaction will be assessed via post doctor appointment administered survey., through study completion, an average of 2 months
Secondary Outcome Measures: Clinician Satisfaction as measured by level of burnout, Assessed by clinician-reported levels of burnout via survey., through study completion, an average of 2 months|Clinician Communication, Communication will be coded for reflective statements (showing active listening), empathic responses to empathic opportunities, patient question-asking, and length of encounter., through study completion, an average of 2 months
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
NCT Number: NCT06519110
Acronym: CVL009-C2001
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Solid Tumor
Interventions: DRUG: Neratinib tablets
Sponsor: Convalife (Shanghai) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2026-04-15

Summary:
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.

Primary Outcome Measures: Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1, Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1, Throughout the study for approximately 3.5 years
Secondary Outcome Measures: Duration of Response (DoR), DoR as assessed by the investigator, Throughout the study for approximately 3.5 years|Progression-Free Survival (PFS), PFS as assessed by the investigator, Throughout the study for approximately 3.5 years|Disease Control Rate (DCR), DCR as assessed by the investigator, Throughout the study for approximately 3.5 years
Home Based Program Physical Training in Congenital Heart Disease
NCT Number: NCT06519084
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Congenital Heart Disease|Functional Capacity|Body Composition|Quality of Life
Interventions: OTHER: Home based exercise training
Sponsor: University of Sao Paulo General Hospital
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Sex: ALL
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-03-01
Completion Date: 2023-12-01
Locations: Heart Intitute, São Paulo, 05403-900, Brazil

Summary:
Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic Diseases Such as Cardiovascular Disease. Another Highly Prevalent Risk Factor in These Patients is Sedentary Behavior; These Patients Are Not Encouraged to Engage in Sports and Exercise During Childhood Due to Their Cardiac Condition, Leading to a Progressive Decrease in Physical Capacity. Studies Have Shown That Congenital Heart Disease Patients Are Not Active Enough and That a Substantial Amount of Patients is Overweight.This Study is a Randomized Controlled Trial That Investigates the Effects of the Home Based Program Physical Training, in the Exercise Capacity, Quality of Life and Body Composition.

Primary Outcome Measures: Improvement exercise tolerance and functional capacity (peak VO2), Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 and Predicted Peak VO2 (%). After the training program, an increase in the peak VO2(mL/kg/min) value between 10 to 15% is expected in relation to the baseline value., Baseline to 3 months
Secondary Outcome Measures: Change in quality of life measurement, Changes in quality of life will be measure by Short Form 36 questionnaire by 8 domains: Physical functioning, Physical role functioning, body pain, general health, vitality, social functioning, emotional role functioning, mental health.

The quality of life rating for each domain is typically measured on a scale of 0 to 100, where a score close to 100 indicates a higher or higher quality of life, while a score close to 0 suggests a lower or poorer quality of life., Baseline to 3 months|Change in body composition measurement, The body composition were assessment by the bioimpedance analyses in the baseline and After the home based training program with duration 12 weeks ou usual routine., Baseline to 3 months|Improvement in peripheral blood flow post exercise training program, Increase forearm blood flow in mL/min/100mL, Baseline to 3 months
Tryptophan Requirements During Pregnancy
NCT Number: NCT06519071
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy
Interventions: OTHER: Tryptophan Intake
Sponsor: University of British Columbia
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-07-20
Completion Date: 2025-05
Locations: BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, V5Z4H4, Canada

Summary:
Pregnancy is an important period of life where there is an increased need for nutrients including protein and amino acids from food. The current protein and amino acids dietary recommendations were all established using older methods done in adult men. Then protein and amino acids requirements for all stages of pregnancy were calculated without accounting for changing demands in each trimester. Therefore, another more precise method is needed to better understand how much amino acids (in this study tryptophan) women need during pregnancy.

In the current study, the investigators are going to apply the Indicator Amino Acid Oxidation (IAAO) method to measure the dietary tryptophan needs in a healthy pregnancy. This method is a noninvasive, quick, and reliable technique that uses a stable isotope-labeled amino acid. The stable isotope tracer is a labeled amino acid, which is colorless, odorless, tasteless, and completely safe; they are present in the air, water and food. Amino acids are mostly made of Carbon-12 (12C), whereas the isotope tracer contains Carbon-13 (13C). The tracer can be detected in breath and urine samples with special equipment because it looks different than the rest of the amino acids in the body. In Elango lab, the investigators have done similar studies, using the same technique in children, nonpregnant women and pregnant women. This will allow us to measure tryptophan needs in pregnancy.

Primary Outcome Measures: Carbon 13 Oxidation, Urine and breath will be collected to measure the rate of oxidation of L-\[1-13C\]phenylalanine oxidation., 8 hours
Effectiveness of Self-Myofascial Stretching on Carpal Tunnel Syndrome
NCT Number: NCT06519058
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patients With Stage I and II Carpal Tunnel Syndrome
Interventions: OTHER: self-myofascial stretching|OTHER: conventional physical therapy
Sponsor: Imam Abdulrahman Bin Faisal University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-05-29
Locations: Awh special college, Calicut, India

Summary:
Background and aim: Carpal tunnel syndrome (CTS) also known as median mononeuropathy occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS.

Methodology: Thirty-six subjects with stage I and II CTS who fulfilled the inclusion criteria were randomly assigned to experimental group and control group with 18 patients in each group. Experimental Group received carpal ligament self-myofascial stretching along with conventional physical therapy while the Control Group received conventional physical therapy alone. The duration of the treatment was 6 weeks. The outcome measures used were Boston Carpal Tunnel Questionnaire and Visual Analogue Scale.

Primary Outcome Measures: Boston Carpal Tunnel Questionnaire, Used to assess the function of carpals, 6 weeks|Visual Analogue Scale, Involves asking participants to rate their current level of pain on a scale from 0= No pain to 10= maximum pain is felt., 6 weeks
PK of Codeine and Metabolites in Human Fingerprint Sweat, Oral Fluid, Blood and Urine
NCT Number: NCT06519045
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pharmacokinetics
Interventions: DEVICE: Intelligent Fingerprinting Drug Screening System
Sponsor: Intelligent Bio Solutions Inc.
Collaborators: Cliantha Research
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-11
Completion Date: 2024-09-30
Locations: Cliantha Research, Mississauga, Ontario, L4W1N2, Canada

Summary:
This study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting Drug Screening Cartridge, versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, versus blood, oral fluid and urine sample concentrations of opiates identified within codeine phosphate dosed healthy males and non-pregnant females.

Primary Outcome Measures: Maximum concentration (Cmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine, Peak concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens, From -1 hr to 24 hrs relative to codeine sulfate dose|Time to reach maximum concentration (Tmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine, Time after drug administration at which peak plasma concentration occurs in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens, From -1 hr to 24 hrs relative to codeine sulfate dose|Area under the curve (AUC) of codeine in fingerprint sweat, oral fluid, plasma, and urine, Efficiency of physiological processes that characterize the drug elimination in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens, From -1 hr to 24 hrs relative to codeine sulfate dose|Terminal half-life (T1/2) of codeine in fingerprint sweat, oral fluid, plasma, and urine, The period of time that it takes for the concentration of codeine and codeine-6-glucuronide to decrease by 50% in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens, From -1 hr to 24 hrs relative to codeine sulfate dose|Clearance of codeine in fingerprint sweat, oral fluid, plasma, and urine, Amount of codeine eliminated per unit of time/ drug concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens, From -1 hr to 24 hrs relative to codeine sulfate dose
Secondary Outcome Measures: Sensitivity of fingerprint sweat screening system for codeine, Comparison of results of fingerprint sweat screening system to LC-MS/MS analysis of fingerprint sweat specimens for codeine, From -1 hr to 24 hrs relative to codeine sulfate dose
Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI
NCT Number: NCT06519032
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bacterial Infections
Sponsor: GramEye
Collaborators: Osaka University|Keio University|Fukujuji Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-20
Completion Date: 2027-03
Locations: Osaka University Hospital, Suita, Osaka, 5650871, Japan

Summary:
The goal of this observational study is to develop AI that detects and classifies Acid-Fast Bacilli from microscope images using anonymized and fixed glass slides.

Primary Outcome Measures: Rate of concordance between AI-estimated results with actual culture results regarding the presence or absence of acid-fast bacteria, Evaluate the difference between actual medical record reports(such as culture results) and AI-estimated results regarding the presence or absence of acid-fast bacteria, Day1
Evaluation of Soft and Hard Tissue Healing and Implant Stability Of Hydrophilic Versus Conventional Titanium Dental Implants.
NCT Number: NCT06519019
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implants
Interventions: PROCEDURE: Dental Implant Surgery - Hydrophilic group|PROCEDURE: Dental Implant Surgery - Conventional group
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-08

Summary:
Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. Researchers always tried to improve design, mechanical and chemical properties of implant. Major benefit of surface modification are to improve hydrophilicity, cell to implant adhesion and cell proliferation. These modification improve osseointegration and reduce treatment duration. In this study investigators are evaluating healing capacity of hydrophilic implant compared to conventional implant.

Primary Outcome Measures: Implant Stability Using Resonance Frequency Analysis, Implant stability is measured, "Baseline", "2 weeks", "1 month", "3 months"|Marginal Bone Loss Using RVG and Grid., Marginal Bone Loss Measured, "3 months"|Soft tissue healing, Soft tissue healing will be assessed using Landry Turnbull and Howley Healing Index. Where soft tissue healing will be scored from 1 to 5, where score "1" indicate worse score and score "5" indicate Best score, "1 Week", "2 weeks", "1 month", "3 months"
Observational Study to Collect Safety Data and PROMs on Primary THA
NCT Number: NCT06518993
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hip Arthritis|Osteoarthritis, Hip|Coxitis|Femoral Head Necrosis|Femoral Neck Fractures
Interventions: DEVICE: Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
Sponsor: Corin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-19
Completion Date: 2026-09-01
Locations: CH Valenciennes, Valenciennes, 59300, France

Summary:
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system

Primary Outcome Measures: Evaluation of hip functional performance, Improvement of Oxford Hip Score (OHS), 2 years
Secondary Outcome Measures: Confirmation of safety of the study devices, Number, severity and causal relationship procedure of implant-related adverse events, 2 years|Evaluation of outcome after hip arthroplasty, Number, severity and causal relationship procedure of implant-related adverse events, 2 years|Evaluation of clinical outcomes, Improvement of Harris Hip Score (HHS), 2 years|Assessment of health-related quality of life, Change of EQ-5D-5L, 2 years|Assessment of patient's satisfaction, Improvement of patient's satisfaction following surgery using Self-Administered Patient Satisfaction Scale, 2 years
Performance Study With the SiMoT System for in Vitro Diagnostic Tests
NCT Number: NCT06518967
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-interventional Analytical Performance Study on Left-over Samples
Interventions: DIAGNOSTIC_TEST: analytical performance study
Sponsor: Centro di Innovazione Regionale in Single Molecule Digital Assay
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-16
Completion Date: 2025-05-31
Locations: IRCCS Istituto Tumori Giovanni Paolo II, Gynecological Oncologic Clinic, Bari, 70124, Italy

Summary:
Advanced and performing technologies able to analyze specific biomarkers for the diagnosis, prognosis and prediction as well as for the monitoring, the personalized care and the evaluation of the therapeutic response to pathologies, is currently considered extremely relevant. Such technologies work only if molecular markers specific for a given pathology have been already validated. This approach is considered of strategic importance for the health and well-being of citizens as well as for the sustainability of public spending. Often, however, the analysis of the markers is carried out on tissues or fluids of the organs involved, being hence quite invasive procedures. In this scenario, it is strategic to develop devices and platforms that allow the analysis of markers in a minimally invasive or non-invasive way, through the analysis of peripheral biological fluids, such as blood or urine. The goal is to provide clinicians with the attacker's advantage against a plethora of progressive diseases by mass-screening individuals who are affected by a disease long before symptoms appear or to allow the identification of those patients who have a high probability of recurring or responding to target-oriented pharmacological approaches. This study pertains to the definition of the analytical performance of the Single-Sensor Single-Molecule with a large Transistor (SiMoT) device. In the context of the present performance study, the IVD SiMoT system will be equipped with an accessory-cartridge developed and produced without any diagnostic purpose but only to verify the analytical performance of the SiMoT system, in the detection of exogenous biochemical molecules suitably selected to act as markers of interest.

Primary Outcome Measures: To evaluate the analytical performance in plasma, serum, and urine samples supplemented with non-endogenous molecules (three proteins and two nucleotide sequences) of the SiMoT handheld device, Qualitative detection of specific marker at single molecule level, December 2024
Secondary Outcome Measures: Duration of analytical analysis performance, To define the time to obtain the test result (time-to-result) for a complete analysis., December 2024
Triggers of Eating Disorders in Athletes
NCT Number: NCT06518954
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Eating Disorders
Interventions: OTHER: Interview
Sponsor: Ostfold University College
Collaborators: Norwegian School of Sport Sciences
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-01-31
Locations: Østfold University College, Fredrikstad, Kobberslagerstredet 5, 1671, Norway|Norwegian School of Sport Sciences, Oslo, 0806, Norway

Summary:
Over the past 30 years, a high prevalence of eating disorders in sports has been repeatedly documented, yet few preventive measures have been implemented. While most studies explore risk factors through quantitative means, few have investigated how athletes themselves experience the triggering elements in sports and how they perceive these triggers could be better managed. Another persistent question is why some athletes from a given sport and environment develop eating disorders while others do not. This study explore the experienced triggers reported by athletes who have struggled with eating disorders and compare them to the perspectives of athletes without eating disorders from the same environment. The study also aim to gather perceptions from both groups on how eating disorders and body dissatisfaction could be better addressed and prevented in sports.

Primary Outcome Measures: Timing of eating disorder symptoms, Question asking about when the eating disorder first started (age, performance period and level), August-December 2024|Cause to development of eating disorders, Question asking about what the athlete think triggered the eating disorder. comparing responses from the athlete WITH an eating disorder to the thoughts of the athlete without an eating disorder., August-December 2024|Knowledge on the eating disorder, Did the others in the team know about the eating disorder experienced by one of the athletes What did they observe, how did they respond or think about it, how did it affect the suffering athlete if she/he knew the others knew/did not knew., August-December 2024|Preventive measures, Question on what can be done to prevent eating disorders in sport. How can we better prevent eating disorders in sport; what needs to be done, what must be changed., August-December 2024
Secondary Outcome Measures: Background variable, current symptoms of eating disorder, Eating disorder Examination Questionnaire (EDE-Q) by Prof. Fairburn. A validated questionnaire to measure symptom severity of eating disorders., August-December 2024|Background variable, family history, Have others in the family been diagnosed with an eating disorder (genetics), have others in the family competed in sport (environmental factors), August-December 2024|Background variable, other interests and identity, Have you had interests that you have invested time in, other than sport?, August-December 2024
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
NCT Number: NCT06518941
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Anorexia Nervosa
Interventions: DRUG: Donepezil
Sponsor: New York State Psychiatric Institute
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-12
Completion Date: 2025-12
Locations: New York State Psychiatric Institute, New York, New York, 10032, United States

Summary:
The purpose of this study is to test the feasibility and tolerability of donepezil in a small group of patients with anorexia nervosa (AN). Study participants will be receiving care at the New York State Psychiatric Institute Eating Disorders Unit. Study medication will be increased from 1 mg per day to a maximum of 5 mg per day for up to 8 weeks. Participants will be closely monitored for side effects by a research psychiatrist every week, in addition to the regular clinical monitoring they receive during inpatient treatment. The study will also include assessments of habit strength to measure any changes in maladaptive eating habits over the course of the treatment.

Primary Outcome Measures: Side Effects Form, The study psychiatrist will assess the tolerability of donepezil during weekly meetings with participants. The presence of side effects will be assessed using the Side Effects Form. Higher scores indicate more severe side effects (each side effect is scored separately). The Clinical Global Impressions (CGI) scale will evaluate overall functioning and psychopathology., From enrollment to the end of treatment at 8 weeks|Clinical Global Impressions Scale, The Clinical Global Impressions Scale (CGI) is a seven-point scale. A score of 1 indicates the most positive change in the treatment course and the least severity of psychopathology, while a score of 7 indicates the most negative change in the treatment course and the highest severity of psychopathology., From enrollment to the end of treatment at 8 weeks
Secondary Outcome Measures: Self-Report Habit Index, The Self-Report Habit Index (SRHI) is a 12-item scale that measures habit strength. Higher scores indicate greater habit strength., From enrollment to the end of treatment at 8 weeks|Food Choice Task, The Food Choice task is a computer based assessment of preferences for different foods. Higher scores indicate greater preferences. ., From enrollment to the end of treatment at 8 weeks
SprmPik AI Sperm Selection Study SiD, an Assistant for Sperm Selection During Intracytoplasmic Sperm Injection in Medically Assisted Reproduction: Effect on Fertilization, Blastocyst Formation, Early Pregnancy Loss, and Consistent Practice. A Prospective Pilot Study.
NCT Number: NCT06518928
Acronym: SprmPik
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infertility
Interventions: OTHER: Artificial Intelligence assisted sperm selection
Sponsor: Ovation Fertility
Collaborators: IVF 2.0 Limited
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 155
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2026-10-01
Locations: Ovation Fertility Las Vegas, Las Vegas, Nevada, 89113, United States|Ovation Fertility - Austin, Austin, Texas, 78731, United States

Summary:
SprmPik AI Assisted Sperm Selection Study SiD, an assistant for sperm selection during intracytoplasmic sperm injection in medically assisted reproduction: effect on fertilization, blastocyst formation, early pregnancy loss, and consistent practice. A prospective pilot study.

Primary Outcome Measures: Oocyte Fertilization, Does SiD assist in ICSI Fertilization, 1 day
Secondary Outcome Measures: Blastocyst Formation, Do embryos develop better from SiD oocytes, 7 days
Baroloop Multicenter Trial (Baroloop MCT)
NCT Number: NCT06518915
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension, Resistant to Conventional Therapy
Interventions: DEVICE: baroloop system
Sponsor: neuroloop GmbH
Collaborators: Avania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-22
Completion Date: 2031-12
Locations: Clemenshospital Münster, Münster, Northrhine-Westphalia, 48153, Germany

Summary:
The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication. The main questions it aims to answer are:

* Is the baroloop device associated with any major medical problems including death?
* Does the baroloop lower the blood pressure of study participants?

Participants will be implanted with the baroloop device. Afterwards they will visit the clinic after 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months for adjustment of the device settings and/or other study related assessments. Participants will also be asked to answer questions regarding their quality of life.

Primary Outcome Measures: Safety of the baroloop device, Composite Major Adverse Event (MAE) Rate including all-causes of death and all device or procedure-related serious adverse event, 6 months after initial stimulation|Performance, Change in mean 24-hour Systolic Ambulatory Blood Pressure (ABP) by ambulatory blood pressure monitoring, 6 months after initial stimulation
Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating Acute Ischemic Stroke
NCT Number: NCT06518902
Acronym: UMERIS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acute Ischemic Stroke
Interventions: DRUG: mesenchymal stem cells (umbilical cord) injection
Sponsor: National Engineering Center of Cell Products
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12

Summary:
The goal of this clinical trial is to learn if drug mesenchymal stem cells (umbilical cord) injection works to treat acute ischemic stroke in adults. It will also learn about the safety and efficacy of drug mesenchymal stem cells (umbilical cord) injection . The main questions it aims to answer are:

Identify the dose-limiting toxicity (DLT) of drug mesenchymal stem cells (umbilical cord) injection in acute ischemic stroke patients.

Dose the drug mesenchymal stem cells (umbilical cord) injection improves the mRS score, NIHSS score, Fugl-Meyer score and and Barthel index of acute ischemic stroke patients? What is the pharmacokinetic characteristics and immunogenic response of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.

What is the the possible molecular mechanisms of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.

Participants will:

Take drug drug mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks.

After receiving the corresponding dose of mesenchymal stem cells (umbilical cord) injection, the subjects entered a 6-month safety, efficacy observation and further safety evaluation period. Long term efficacy and survival follow-up up to 2 years.

Primary Outcome Measures: Dose-limiting toxicity, Dose-limiting toxicity and Maximum tolerated dose, 6 months
Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension
NCT Number: NCT06518850
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Small Intestine Bacterial Overgrowth
Interventions: DRUG: Rifaximin
Sponsor: Peking Union Medical College Hospital
Collaborators: Navy General Hospital, Beijing|Air Force Military Medical University, China|Beijing Tongren Hospital|Beijing Friendship Hospital|Beijing Chao Yang Hospital|Beijing Tiantan Hospital|The Luhe Teaching Hospital of the Capital Medical University|China-Japan Friendship Hospital|Beijing Aerospace General Hospital|Beijing Jishuitan Hospital|Peking University Third Hospital
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2025-12-31

Summary:
Most studies of bloating have focused on functional factors, while data on organic abdominal distention are rare, and studies that combine small intestine bacterial overgrowth and/or oral cecum transit time abnormalities are more urgent to explore. On this basis, patients with functional abdominal distension complicated with small intestine bacterial overgrowth were divided according to whether there was abnormal oral cecum transit time, and given the same treatment plan. The relief effect of abdominal distension, small intestine bacterial overgrowth turning negative and oral cecum transit time recovery were observed, so as to further clarify the cause of abdominal distension patients.

Primary Outcome Measures: Part 1 Positive rate of small intestinal bacterial overgrowth, Positive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension, 1 day|Part 1 Abnormal rate of oral cecum transit time, Abnormal rate of oral cecum transit time in organic and functional abdominal distension, 1 day|Part 2 Effective rate of abdominal distension, Total effective rate (%) = Obvious effective rate (%) + Effective rate (%)

1. Obvious effect: the degree and frequency of abdominal distension score improved, or even completely disappeared, small intestinal bacterial overgrowth negative
2. Effective: the degree and frequency of abdominal distension score improved, small intestinal bacterial overgrowth positive
3. Ineffective: the degree and frequency of abdominal distension score did not improve, 2 weeks|Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time, 1. Negative conversion rate of small intestinal bacterial overgrowth (%) =Number of small intestinal bacterial overgrowth negative after treatment/ Number of functional abdominal distention in Part 2\*100%
2. Negative conversion rate of oral cecum transit time (%) =Number of oral cecum transit time normal after treatment/ Number of experimental in Part 2\*100%, 2 weeks
Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
NCT Number: NCT06518785
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Use Disorder
Interventions: DEVICE: Low Intensity Focused Ultrasound
Sponsor: University of California, San Francisco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2027-09
Locations: University of California, San Francisco, San Francisco, California, 94143, United States

Summary:
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.

Primary Outcome Measures: Incidence of LIFU-related adverse events., This will be assessed through monitoring for adverse events (AE) throughout the study., Through study completion, an average of 5 weeks|Reward network activity in response to alcohol cues., Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI., 3 visits over 3 weeks
Orthodontic Treatment Impact on Life Experience of Adolescents With Fixed Orthodontic Appliances
NCT Number: NCT06518733
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Orthodontic Appliance Complication
Interventions: OTHER: appliance type
Sponsor: Cairo University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 364
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2023-12-30
Locations: Cairo University, Cairo, 1234, Egypt

Summary:
This cross-sectional study aimed to investigate the impact of different fixed orthodontic appliances on the day-to-day life experience of adolescent patients at any stage of their orthodontic treatment. A validated questionnaire was translated and used in the assessment, 364 patients (242 female and 122 male) were recruited, impact on the social and emotional well-being status of the participants was assessed as well as oral health, pain, and discomfort.

Primary Outcome Measures: Impact on the social and emotional well-being status of the patient., impact social and emotional well-being status of the patient is assessed using a questionnaire, during the intervention
Secondary Outcome Measures: Impact on the oral health, pain, and discomfort of the respondent, Impact on the oral health, pain, and discomfort of the respondent is assessed using a questionnaire, during the intervention
Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)
NCT Number: NCT06518720
Acronym: TRANSCEND
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Treatment Resistant Depression|Chronic Pain
Interventions: DRUG: Psilocybin 25 mg
Sponsor: Centre for Addiction and Mental Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, M6J1H4, Canada

Summary:
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.

The purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.

Primary Outcome Measures: Percentage of participants recruited, enrolled and retained (feasibility) and the number of serious adverse events and serious adverse drug reactions associated with administration of 25 mg of psilocybin (safety)., Percentage of participants recruited, enrolled and retained over 24 months. Number of serious adverse events and serious adverse drug reactions associated with psilocybin 25 mg., 24 Months
Secondary Outcome Measures: Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline to 1-week post-treatment., The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale that measures depression severity. This measure has 10 items rated from 0-6. The lowest possible score is 0 and highest possible score is 60. Higher composite scores represent a more severe condition/ worse outcomes., Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).
Other Outcome Measures: Change in Patient Reported Outcomes Measurement Information System-Pain Intensity Scale (PROMIS-PI) from Baseline to 1-week post-treatment., The Patient Reported Outcomes Measurement Information System-Pain Intensity Scale (PROMIS-PI) is a participant-rated scale that measures intensity of pain experienced by the participant in the past seven days. Presented on a visual analogue scale of 0-10, scores range from 0= no pain to 10=worst imaginable pain. A score of 5 or greater indicates moderate to severe pain intensity., Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).|Change in Patient Reported Outcomes Measurement Information System- Pain Interference Scale (PROMIS-Interference) from Baseline to 1-week post-treatment., The Patient Reported Outcomes Measurement Information System- Pain Interference Scale (PROMIS-Interference) is a participant rated scale that aims to identify how much an individual's physical pain has interfered with emotional, social and cognitive domains of living. A T-Score greater than 50 indicates higher pain interference than the general population., Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).