pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults
NCT Number: NCT06469970
Acronym: INDICIA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Burns|Intensive Care|Emergencies
Interventions: DRUG: Glucose 30% Intravenous Solution
Sponsor: Centre Hospitalier Régional Metz-Thionville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-05-01
Locations: CHR Metz-Thionville/Hopital de Mercy, Metz, 57085, France

Summary:
This is a low interventional monocentric trial Phase IV aiming to describe the evolutionary profile of the initial volume of glucose distribution (IDVG) during the first four days of management of severely burned patient.

Primary Outcome Measures: Description of the evolutionary profile of the initial volume of glucose distribution (IDVG), The IDVG is calculated according to the method described by Hitota et al. A reference blood glucose level is measured on an arterial blood sample (arterial catheter) by a blood glucose meter. A bolus of 5 g of glucose is injected into a central venous line over 30 seconds.

A second blood glucose level is measured 3 minutes after the end of the injection.

The difference between the two blood glucose levels is recorded as d\[glu\] in mg/dl.

IDVG = 24.4 x e(-0.0298 \* d\[glu\]) + 2.7 in liters, on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn
Secondary Outcome Measures: Study of correlations between initial distribution volume of glucose (IDVG), intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW)., ITBV (intra-thoracic blood volume) and EVLW (extra-vascular lung water) measured at the same time as IDVG, using the PiCCO device and trans-lung dilution of a thermal indicator (cold saline)., on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn|Study of correlations between IDVG and body surface area (BSA), Body surface area assessed on admission according to Wallace method, at hospital admission|Study of correlations between IDVG and water intake and input/output balance, Water intake and input/output balance (water intake minus diuresis), on admission, at Hours 4, 8, 16, 24, 48, 72 and 96 post-burn|Study of correlations between IDVG at H24 to H48 and mortality, In-hospital mortality, at Hours 24 and 48 post-burn
Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer
NCT Number: NCT06469957
Acronym: IMPACTO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Patients With Bronchopulmonary Cancer
Interventions: OTHER: Questionnaires and data collection sheet
Sponsor: Centre Hospitalier Régional d'Orléans
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2025-12-27
Locations: CHU d'Orléans, Orléans, 45067, France

Summary:
This is a prospective, non-interventional study to evaluate impact of hospital pharmacist on drug management in patients (only questionnaires) with bronchopulmonary cancer treated by Chemotherapy and/or Immunotherapy or Oral targeted therapy. The primary objective of the study is to evaluate the number of unscheduled consultations/hospitalizations during 6 months.

Primary Outcome Measures: Impact of hospital pharmacist (interview) on the number of unscheduled consultations/hospitalizations., Number of unscheduled consultations or hospitalizations during the follow up phase, From enrolment to the end of the follow up phase (6 months)
Secondary Outcome Measures: Impact of hospital pharmacist (interview) on cancelled consultations/hospitalizations rate, Number of cancelled consultations/hospitalizations, From enrolment to the end of the follow up phase (6 months)|Impact of hospital pharmacist (interview) on treatment observance, Number of treatment dispensation, From enrolment to the end of the follow up phase (6 months)|Impact of hospital pharmacist (interview) on treatment observance, Gap between each treatment dispensation, From enrolment to the end of the follow up phase (6 months)|Impact of hospital pharmacist (interview) on adverse effects, Number of adverse effects (follow up phase of 6 months), From enrolment to the end of the follow up phase (6 months)|Impact of hospital pharmacist (interview) on adverse effects leading to interrupted or withdrawn treatment, Number of adverse effects leading to interrupted or withdrawn treatment, From enrolment to the end of the follow up phase (6 months)|Impact of hospital pharmacist on pharmaceutical intervention, Number of pharmaceutical interventions (eg. inappropriate prescription, drug interactions), From enrolment to the end of the follow up phase (6 months)
Ozone Therapy in Patients With Carpal Tunnel Syndrome
NCT Number: NCT06469931
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carpal Tunnel Syndrome
Interventions: OTHER: range of motion exercises|DEVICE: Extracorporeal shock wave therapy|OTHER: ozone therapy
Sponsor: Firat University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2024-09-20
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting.

Primary Outcome Measures: Median nerve cross-sectional area, Patients will be positioned seated facing the assessor, with the volar aspect of the wrist facing the air and at rest on a pillow. In the proximal carpal tunnel (at the level of the pisiform bone), the median nerve hyperechoic inner border line will be continuously traced and the transverse section surface area will be measured., 2 minutes
Secondary Outcome Measures: Pain assesment, On a 10 cm straight line with values 0 and 10 marked, the patient will be asked to place a mark according to the severity of the hand and/or wrist pain being studied, 1 minute
Other Outcome Measures: Hand grip strength assessment, A hand dynamometer will be used to evaluate the grip strength of the hand. Double, triple and lateral grip will be evaluated using a pinchmeter., 5 minutes
The Co-Op @ HeartWorks
NCT Number: NCT06469918
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Congenital Heart Disease
Sponsor: HeartWorks, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-24
Completion Date: 2050-01-01
Locations: HeartWorks, Inc., Rochester, Minnesota, 55901, United States

Summary:
This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD community. Individuals choosing to participate will be referred to as 'members' of the co-op. This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. The knowledge generated from this study will help advance the care of CHD patients through the deliberate action of The Co-Op @ HeartWorks members. Unlike a traditional disease registry, the members of The Co-Op @ HeartWorks will actively inform and contribute to the future studies affecting their health.

Primary Outcome Measures: Registry of individuals with CHD to plan and recruit for future interventional trials in Congenital Heart Defects/Disease, 25 years
Erector Spina Plan Block in Patients With Lumbar Disc Herniation
NCT Number: NCT06469905
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: DEVICE: Erector Spina Plan Block|OTHER: Stabilization exercises
Sponsor: Firat University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2024-09-20
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
Erector Spina Plan Block (ESPB) is a technique used in surgical interventions, acute and chronic pain. The aim of this study was to investigate the effect of ESPB and core stabilization exercises on functionality in patients with Lumbal Disc Herniation. ESPB will be applied to the patients in the study group. Stabilization exercises will be applied together with ESPB treatment. Only stabilization exercises will be applied to the patients in the control group. Patients will be asked to complete a questionnaire inquiring sociodemographic data (age, height, weight, BMI, smoking and alcohol use), VAS and Modified Oswestry Questionnaire at initial presentation and after 8 weeks of exercise (8 weeks 3 days a week).

Primary Outcome Measures: Disability assessment, Functional Disability Measurement; Assessment will be made using the Turkish version of the Modified Oswestry Questionnaire. n the evaluation of the Oswestry scale, the scoring for each question is A=0 B=1 C=2 D=3 E=4 F=5 points., 2 minutes
Secondary Outcome Measures: Pain assessment, Pain intensity will be assessed with a 10 cm Visuel Analog Scale (VAS). Patients are told what the numbers mean on the horizontal line, 0 means no pain, 10 means the most severe pain encountered in life, 5 means moderate pain and they are asked to describe the intensity of their pain on the scale., 1 minute
Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring
NCT Number: NCT06469892
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Oral Leukoplakia|Oral Cancer
Interventions: OTHER: Detect the expression level of miR-185 in salivary and plasma exosomes.
Sponsor: Beijing Stomatological Hospital, Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 225
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-06-13
Completion Date: 2023-07-30
Locations: Beijing Stomatological Hospital, Capital Medical University, Beijing, Beijing, 100010, China

Summary:
The goal of this observational study is to test the expression levels of salivary and plasma exosomal miR-185 in patients with oral leukoplakia and oral squamous cell carcinoma. The main questions it aims to answer are:

* Is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting salivary and plasma exosomal miR-185?
* Is it possible to monitor the cancer risk of oral leukoplakia and the prognosis of oral cancer using salivary exosomal miR-185?

Participants will be asked to:

* Cooperate with the investigators in completing the oral examination.
* Take saliva and plasma before the biopsy surgery.
* Perform the biopsy surgery following the usual diagnostic procedures.
* Attend regular follow-up appointments (every 3 months) for the duration of the study.

Primary Outcome Measures: The expression level of miR-185 in salivary exosomes, Exosomes were isolated from saliva using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR., Baseline, pre-biopsy surgery.|The expression level of miR-185 in plasma exosomes, Exosomes were isolated from plasma using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR., Baseline, pre-biopsy surgery.
Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy
NCT Number: NCT06469866
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuromuscular Blockade|Laparoscopy
Interventions: DEVICE: low-pressure pneumoperitoneum|DEVICE: standard-pressure pneumoperitoneum
Sponsor: Anqing Municipal Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2024-11-25
Locations: Department of Anqing Munucipal Hospital Anesthesiology, Anqing, Anhui, 246000, China

Summary:
BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy

METHODS: seventy-two women with elective laparoscopic hysterectomy were randomly divided into 2 groups: Patients in group A received low-pressure pneumoperitoneum (LPP), which was set at 8-10 mmHg with deep NMB. Patients in group B received standard-pressure pneumoperitoneum (SPP), which was set at 12-14 mmHg with moderate NMB. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery. The secondary outcomes included postoperative pain, surgical condition, incidence of shoulder pain, the incidence of rescue analgesic drug use, cumulative dose of analgesics, time of first flatus, post-operative nausea and vomiting, time of tracheal tube removal.

Primary Outcome Measures: Quality of recovery, Primary outcome measure was the quality of recovery at 1 day after surgery. Quality of recovery-15 scale was used to assess the quality of recovery after operation. A higher score of quality of recovery-15 scale indicates a better quality of recovery after surgery, 1 day after operation
Secondary Outcome Measures: Shoulder pain, Secondary Outcome Measure was the incidence of shoulder pain, The first 24 hours after operation|Postoperative nausea and vomiting, Secondary Outcome Measure was the incidence of postoperative nausea and vomiting. PONV score was evaluated verbally with a descriptive scale (0 = None, 1 = Mild Nausea, 2 = Moderate Nausea, 3 = One Vomiting, 4 = Multiple Vomiting)., The first 24 hours after operation
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of MBF-015 in Huntington's Disease Patients
NCT Number: NCT06469853
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Huntington Disease
Interventions: DRUG: MBF-015 16 mg oral capsules
Sponsor: Medibiofarma S.L.
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2025-04
Locations: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Barcelona, 08025, Spain

Summary:
This is a Phase IIa (proof of concept), single center clinical trial to evaluate the safety and efficacy of daily MBF-015 oral treatment during 28 days in Huntington's Disease patients on top of standard of care.

Primary Outcome Measures: Adverse Events, Evaluate safety and tolerability of MBF-015 in participants with Huntington's Disease (HD) on top of standard of care over 28 days, with follow-up to day 43., 43 days
French Translation/Adaptation of AHEMD-SR (FR-AHEMD)
NCT Number: NCT06469840
Acronym: FR-AHEMD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Motor Disorders
Sponsor: Fondation Ildys
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-21
Completion Date: 2025-01
Locations: Les Capucins Angers, Angers, France|Fondation ILDYS, Brest, 29218, France

Summary:
The aim of this study is to develop a French translation and adaptation of the original English version of the AHEMD-SR.

Primary Outcome Measures: Reliability of the French version of the original English version of the AHEMD-SR, July 2024 - October 2024
Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging
NCT Number: NCT06469827
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Traumatic Brain Injury
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Collaborators: Ankang Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2025-07-31
Locations: The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, China

Summary:
The goal of this observational study is to learn about in Evaluation of consciousness impairment in severe TBI and full-cycle neuroregulation based on multimodal imaging. The main question it aims to answer is:

•For the existing examination means of super early neurological consciousness level recognition and function assessment accuracy of poor technical bottleneck, different period individual target brain space positioning difficulties and single rehabilitation technology of whole cycle rehabilitation system, with severe TBI patients as the research object.

Primary Outcome Measures: Full Outline of Unresponsiveness, FOUR, The FOUR is an questionnaire which has four main assessments: eye opening, exercise, brain stem reflex, and respiratory function. Each item has a full score of 4 and a total score of 16. Brainstem reflex and respiratory function of FOUR are more sensitive than the GCS language score for predicting mortality risk in ICU patients. The total score was 0 to 16, with lower scores indicating a greater probability of death and disability., At 0,2,4,6,8, and 10 days after treatment|Sensory Modality Assessment and Rehabilitation Technique, SMART, Assessment of sensory patterns (Sensory Pattern Assessment) and rehabilitation techniques are commonly used in rehabilitation therapy to assess the sensory function and motor ability of patients to develop personalized rehabilitation programs.

Sensory pattern assessment usually involves the following steps:

1. Assess the patient's sensory function.
2. Evaluation sensory conduction pathways.
3. Evaluation of sensory patterns.

Assessment of rehabilitation techniques usually involves the following steps:

1. Assess the patient's motor function.
2. Evaluation of exercise mode.
3. Develop rehabilitation plan., At 0,2,4,6,8, and 10 days after treatment|Coma Recovery Scale Revised, CRS-R, The CRS-R score is a clinical tool used to assess the level of consciousness in comatose and drowsy patients, fully called the Coma Recovery Scale-Revised. The scoring tool includes 23 items covering different aspects of the patient, such as vision, hearing, motor, response, etc. By scoring these items, medical professionals can assess patient level of awareness and response capacity in order to develop corresponding treatment and rehabilitation plans.

Auditory function scale = for movement to commands. 4-Consistent Movement to Command 3-Reproducible Movement to Command 2-Localization to Sound

1-Auditory Startle 0-None, At 0,2,4,6,8, and 10 days after treatment
Snapshot Study on Patients With Heart Failure
NCT Number: NCT06469814
Acronym: GRASP-HF
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Sponsor: European Society of Cardiology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-06

Summary:
The goal of this observational study is to provide a better understanding of medical practice for heart failure management based on real-world data, collected both across Europe and the rest of the world, using robust methodology and representativeness within each country.

Standard management of patients will be the diagnostic and therapeutic interventions routinely performed in each center for patients presenting with signs and symptoms of chronic/acute heart failure.

Primary Outcome Measures: Adherence to ESC Guidelines in Heart Failure 2021, Full adherence to guidelines for heart failure management, 12 months per site
ECMO ABI Detection With Hyperfine
NCT Number: NCT06469801
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Brain Injury|Extracorporeal Membrane Oxygenation Complication|Hypoxia-Ischemia, Brain|Stroke, Acute
Interventions: DEVICE: Hyperfine
Sponsor: Children's Mercy Hospital Kansas City
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-23
Completion Date: 2026-07-01
Locations: Children's Mercy, Kansas City, Missouri, 64108, United States

Summary:
The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.

Primary Outcome Measures: Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support., Perform bedside MRI in pediatric ECMO patients treated in pediatric, cardiac, and neonatal intensive care units (ICUs) within 24 hours of cannulation. Determine rates of ABI (hypoxic, ischemic, cerebrovascular, and hemorrhagic injury along with assessment of cerebral edema and midline shift) in the pre- and peri-cannulation time periods. Correlate these imaging findings to rates of clinical neurological events (seizures, pupillary changes, focal neurological examination)., Duration of ECMO treatment period, an average of <2 weeks
Secondary Outcome Measures: Describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients., Obtain bedside MRI in pediatric ECMO patients treated in pediatric, cardiac or neonatal ICUs at 72-120 hours post-cannulation and weekly until decannulation. Quantify and compare rates of ABI between bedside MRI and CT or US as read by blinded neuroradiologist., Duration of ECMO treatment period, an average of <2 weeks
Testimonials and Navigation in Rheumatology
NCT Number: NCT06469788
Acronym: TANGO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rheumatologic Disease|Autoimmune Diseases
Interventions: BEHAVIORAL: Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences|BEHAVIORAL: Video on the importance of good oral health for patients with AIRD|BEHAVIORAL: Brochure on COVID-19 vaccination in AIRD patients|BEHAVIORAL: Patient Navigation|BEHAVIORAL: Brochure on the importance of good oral health in AIRD patients
Sponsor: University of Alabama at Birmingham
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-01
Completion Date: 2027-08-31
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|Brigham Women's Hospital, Boston, Massachusetts, 02115, United States|University of Massachusetts Chan Medical School, Worcester, Massachusetts, 01655, United States

Summary:
The overall goal of this study is to determine whether a novel, multi-modal, patient-directed behavioral intervention initiated in rheumatology clinics is an effective approach to improve uptake of updated COVID-19 vaccine.

Primary Outcome Measures: Receipt of updated COVID-19 vaccination., We will measure rates of receipt of updated COVID-19 vaccination., 3 months
LiSWT for Men With Erectile Dysfunction
NCT Number: NCT06469775
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Erectile Dysfunction
Interventions: DEVICE: Low intensity shock wave|COMBINATION_PRODUCT: Control
Sponsor: Rutgers, The State University of New Jersey
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2031-09-01
Locations: Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08901, United States

Summary:
The goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are:

1. Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function?
2. What is the optimal LiSWT protocol (number of shocks, energy delivered, timeline, etc) for initial and maintenance therapy?

Researchers will compare validated questionnaires on erectile function in men treated with LiSWT compared to men who receive standard of care to see if there is an improvement in erectile function with LiSWT.

Participants will be asked to complete questionnaires at each visit. Those who choose to undergo LiSWT will receive 6 sessions, once per week.

Primary Outcome Measures: Sexual Health Inventory for Men (SHIM), The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. It is graded on a scale of 1-25, with higher scores indicating no signs of erectile dysfunction., Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
Secondary Outcome Measures: Erection Hardness Score, The Erection Hardness Score (EHS) is another tool often used to evaluate and monitor the severity of ED. It is a four-point scale (1-4), with a score of 4 indicating a completely hard and fully rigid erection., Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in mPCa Patients
NCT Number: NCT06469710
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer|Circulating Tumor Cell|Leukapheresis
Interventions: DEVICE: leukapheresis
Sponsor: RenJi Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2025-12-30
Locations: Renji Hospital, Shanghai Jiao Tong University, Shanghai, China

Summary:
The goal of this observational study is to compare the number of CTCs enriched by both sampling methods, leukapheresis and collection of peripheral blood in metastatic prostate cancer patients. The main questions it aims to answer are:

1. The advantages and disadvantages of two sampling methods for further diagnosis and treatment;
2. How to obtain further information on the tumour biology of CTC;
3. The mechanisms of prostate cancer invasion and metastasis Participants will have 7.5mL of peripheral blood taken as well as undergo leukapheresis.

Primary Outcome Measures: Number of circulating tumor cells, Measurement of the number of CTCs enriched from different samples, The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.
A Health Education Intervention Tailored for Malay-Muslim Women
NCT Number: NCT06469684
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: BEHAVIORAL: Health education session
Sponsor: National University of Singapore
Collaborators: Islamic Religious Council of Singapore|National University Polyclinics, Singapore
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SCREENING
Start Date: 2023-02-08
Completion Date: 2023-09-02
Locations: National University of Singapore, Singapore, 117549, Singapore

Summary:
The goal of this experimental study is to compare mammogram rate and knowledge in healthy women of Malay ethnicity in Singapore. The main questions it aims to answer are:

* Will health promotion intervention in the mosque on breast cancer and mammogram lead to mammogram uptake?
* Will health promotion intervention in the mosque on breast cancer and mammogram lead to change in knowledge and perception related to mammogram uptake? Participants will attend an education session in the mosque on breast cancer and mammogram by religious teacher and healthcare professional and will be given an opportunity to voluntarily sign up for mammogram on the Mammobus which will be deployed to the mosque.

Researchers will compare with healthy women of Malay ethnicity attending education session in the mosque on healthy lifestyle to see if there is a difference in mammogram uptake, and in knowledge and perception towards breast cancer and mammogram.

Primary Outcome Measures: Incidence Rate Ratio of Mammogram Uptake by Arm, Attending mammogram after health education session, 2-3 months
Secondary Outcome Measures: Incidence Rate Ratio of Knowledge and Perception at Follow-up by Arm, adjusting for baseline, Survey output on knowledge and perception on health behaviour, breast cancer and mammogram, 2-3 months
Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms
NCT Number: NCT06469671
Acronym: ArtInCol
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colonic Neoplasms|Colonic Polyp|Diagnosis
Interventions: DEVICE: The system based on real - time artificial intelligence - assisted for colonoscopy
Sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2024-12
Locations: Airat Mingazov, Moscow, Russian Federation

Summary:
The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.

Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.

Primary Outcome Measures: Adenoma detection rate, In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma, during the procedure
Secondary Outcome Measures: Polyps detection rate, In each group, the number of patients with all type of neoplasms (polyps) was detected as a percentage of the total number of patients., during the procedure|Number of polyps, In each group, the number of detected all type of polyps, during the procedure|Number of adenomas, In each group, the number of detected adenomas, during the procedure
Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation
NCT Number: NCT06469658
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Interventions: OTHER: The standard practice dietary supplements intervention|OTHER: The AI-guided practice dietary supplements group
Sponsor: S.LAB (SOLOWAYS)
Collaborators: Triangel Scientific|Center of New Medical Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-02
Completion Date: 2024-06-03
Locations: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation

Summary:
This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.

Primary Outcome Measures: Change in HbA1c levels, 180 days
Secondary Outcome Measures: Percent change in fasting venous blood glucose levels., 180 days|Percent change in high-sensitivity C-reactive protein, 180 days|Percent change in cholesterol, 180 days|Percent change in HDL-C,, 180 days|Percent change in LDL-C, 180 days|Percent change in triglycerides, 180 days|Percent change in body weight, 180 days|Incidence of any adverse effects related to supplements, 180 days|Percent change in Body mass index (BMI), 180 days|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), 180 days|fasting insulin levels change (mU/mL), 180 days|Waist Circumference (cm) change, 180 days|microalbuminuria (%) difference, 180 days|changes in physical activity levels (hours/week), 180 days|Percentage of participants using antihypertensive medications (%), 180 days|Percentage of participants using antihypertensive medications (%)., 180 days|Percentage of participants using lipid-lowering medications (%)., 180 days
Study on Female Patients' Mammographic Texture Features
NCT Number: NCT06469606
Acronym: COMPRESS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Artificial Intelligence|Mammography
Interventions: DEVICE: AI tool
Sponsor: Tampere University Hospital
Collaborators: Tampere University|Kuopio University Hospital|University of Eastern Finland|University of Turku|University of Oulu
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-17
Completion Date: 2038-12-15

Summary:
Mammography is the most common method for breast imaging, and it provides information for model building and analysis. Radiomics applied to mammography has the potential to revolutionize clinical decision-making by providing valuable insights into risk assessment and disease detection. Despite this, the influence of imaging parameters and clinical and biological factors on radiological texture features remains poorly understood. There is a pressing need to overcome the obstacle of system-inherent effects on mammographic images to facilitate the translation of radiological texture features into routine clinical practice by enabling reliable and robust AI-based or AI-aided decision-making. Furthermore, understanding the relationship between imaging parameters, textural features, and clinical and biological information supports the clinical use of AI. The objective of this study is to evaluate AI methods for clinical practice and to study how it relates to clinical factors and biological features.

Primary Outcome Measures: Mammographic texture features, Aim: to evaluate how imaging parameters affect the mammographic texture features, Through study completion, an average of 5 year
Secondary Outcome Measures: Biological features, Aim: To evaluate whether there is an interplay between mammographic texture feature parameters and pathological and biological features (e.g., breast cancer biomarkers), through study completion, an average of 10 year
Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure
NCT Number: NCT06469580
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neonatal Disease
Interventions: OTHER: NPLUS (neonatologist performed lung ultrasound)
Sponsor: Medical University of Graz
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-01
Completion Date: 2025-05
Locations: Department of Pediatrics, Division of Neonatology, Medical University of Graz, Graz, Styria, 8036, Austria

Summary:
The objective of the study is to evaluate the role of neonatologist-performed lung ultrasound (NPLUS) after weaning from invasive mechanical ventilation and extubation. Our aim is to study the diagnostic accuracy of NPLUS and investigate whether LUS leads to earlier actions before clinical deterioration and hence prevents extubation failure.

Primary Outcome Measures: Reintubation rate (within 72 hours after extubation), within 72 hours after extubation
Secondary Outcome Measures: Mode of respiratory support, NCPAP, DUOPAP or BILEVEL during 72 hours after extubation, within 72 hours after extubation|Respiratory settings- FiO2, FiO2 (fraction of inspired oxygen) during 72 hours after extubation, within 72 hours after extubation|Respiratory settings- PEEP, PEEP (Positive EndExpiratory Pressure) during 72 hours after extubation, within 72 hours after extubation|SpO2/FiO2 ratio, Ratio of arterial oxygen saturation and fraction of inspired oxygen, every hour during 72 hours after extubation|pH from capillary blood gas analysis, pH routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation, within 72 hours after extubation|Carbon dioxide partial pressure (pCO2), pCO2 Routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation, within 72 hours after extubation|Base Excess (BE), BE routinely obtained capillary blood gas analysis at certain time points within 72 hours after extubation, within 72 hours after extubation|Number of lung imaging, Number of chest X-rays and NPLUS within 72 hours after extubation, within 72 hours after extubation|Number of lung imaging based interventions, Number and time points of chest X-ray or NPLUS based interventions, within 72 hours after extubation|Recruitment maneuvers, Number and time points of recruitment maneuvers (PEEP increase, positioning), within 72 hours after extubation|Time to detect consolidations, Time to detect impairment of lung aeration (consolidations), within 72 hours after extubation|Lung ultrasound scores (LUS), LUS at time point T0 (prior to extubation), T1 (2-4 hours post extubation) and time point T2 (16-24 h post extubation), up to 24 hours after extubation
Doctor's Counselling Using Culturally-responsive Pamphlet Increased Mammogram Uptake Among Malay-Muslim Women in Singapore
NCT Number: NCT06469567
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: OTHER: Patient Counselling
Sponsor: National University Polyclinics, Singapore
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 319
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SCREENING
Start Date: 2021-03-15
Completion Date: 2021-07-16
Locations: National University Polyclinics, Singapore, 609788, Singapore

Summary:
Investigators conducted a randomized controlled trial to evaluate effectiveness of doctor's counselling using a culturally-responsive pamphlet in increasing mammogram uptake among Malay-Muslim women attending the clinic. Those in intervention arm received 8-minutes doctor's counselling on mammogram and breast cancer while those in control arm received 8-minutes doctor's counselling on usual care - dietary care. Investigators recruited 319 Malay-Muslim women aged 50-69 years old who have not undergone a mammogram in the past 2 years. Investigators used Poisson regression to determine effectiveness of intervention in increasing mammogram uptake and to determine any change in knowledge, perceptions and faith-based beliefs on breast cancer and mammogram after counselling.

Primary Outcome Measures: Number of participants who did a mammogram after imparting intervention., The mammogram uptake was assessed from patient input and verified by Radiographer, within 6 weeks of enrolment and intervention(both done on the same day
Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector
NCT Number: NCT06469541
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cataract
Sponsor: Medicontur Medical Engineering Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-11
Completion Date: 2023-12-01
Locations: NHS Ayrshire and Arran, Ayr, Scotland, KA7 2SP, United Kingdom

Summary:
The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).

Primary Outcome Measures: Primary objective, To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation, 12 months after IOL implantation
Secondary Outcome Measures: Secondary onjective, To evaluate the spherical equivalent refraction one month postoperatively. To evaluate level of astigmatism one month postoperatively. To evaluate the Uncorrected Distance Visual Acuity (UDVA) monocular at 1 day, 1 month and 6 months after IOL implantation To evaluate the Best Corrected Distance Visual Acuity (CDVA) monocular at 1 month, 6 months and 1 year after IOL implantation To evaluate safety features of the lens To evaluate PCO development, Nd:YAG capsulotomy rate, 12 months after IOL implantation
Comparison of the Effectiveness of Stretching and Strengthening Exercises in Patients With Frozen Shoulder
NCT Number: NCT06469502
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frozen Shoulder
Interventions: PROCEDURE: Stretching Exercises|PROCEDURE: Strengthening Exercises
Sponsor: Istanbul University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-08-15
Locations: Istanbul University, Istanbul, Turkey

Summary:
The aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.

Primary Outcome Measures: Quick DASH, Quick Disabilities of the Arm, Shoulder, and Hand: The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability)., baseline, after 6 weeks and 6 weeks follow up|NPRS, Numeric Pain Rating Scale: The pain was measured using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable), baseline, after 6 weeks and 6 weeks follow up
Secondary Outcome Measures: ASES, The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment: The ASES score ranges from 0-100. Higher scores indicate better functional ability, baseline, after 6 weeks and 6 weeks follow up|Shoulder Range of Motion (ROM), Shoulder ROM measurements of forward flexion, abduction, and scapular plane external -internal rotation were taken using a standard goniometer. Pain-free active ROM and passive ROM were assesment., baseline, after 6 weeks and 6 weeks follow up|BPI-SF, Brief Pain Inventory-Short Form: The BPI is a two-factor instrument that measures pain severity and pain interference. The pain severity factor has four items, all rated on a 0-to-10 Likert scale: 0 corresponds to "no pain" and 10 corresponds to "pain as bad as you can imagine". The pain interference factor has seven items, all rated on a 0-to-10 Likert scale: 0 corresponds to "does not interfere" and 10 corresponds to "interferes completely"., baseline, after 6 weeks and 6 weeks follow up|PCS, Pain Catastrophizing Scale: Each item is scored from 0 (never) to 4 (always), giving a total score ranging from 0 to 52. Higher scores indicate higher levels of pain catastrophizing., baseline, after 6 weeks and 6 weeks follow up
Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study
NCT Number: NCT06469489
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Cirrhosis
Interventions: OTHER: Liver Disease of all etiologies
Sponsor: Institute of Liver and Biliary Sciences, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-21
Completion Date: 2024-09-30
Locations: Institute of Liver & Biliary Sciences, New Delhi, Delhi, 110070, India

Summary:
Liver biopsy is considered the gold standard for the evaluation of acute and chronic liver disorders. Liver biopsy provides information regarding diagnosis, disease progression, and response to therapy in patients with chronic liver diseases. Trans-jugular liver biopsy (TJLB) consists of obtaining liver tissue through a rigid cannula introduced into one of the hepatic veins typically using jugular venous access. This approach reduces the risk of hemorrhage after biopsy because the bleeding resulting from the biopsy needle will drain into the hepatic veins. In the past, the specimens obtained by a transjugular approach were considered suboptimal compared with the samples obtained with percutaneous needles because they were smaller and more fragmented. TJLB was initially indicated for patients who had a contraindication to percutaneous biopsy such as those with a coagulopathy or congenital clotting disorders, ascites, acute liver failure, large amount of adipose tissue, and patients after liver transplantation. The clinical role of TJLB has expanded due to the possibility of performing hemodynamic evaluation of the hepatic and portal venous systems, which provides useful information and may guide therapy in patients with portal hypertension.

Lacuna in literature:

There is no prospective study in India evaluating the safety and efficacy of trans-jugular liver biopsy in patients with liver disease.

Primary Outcome Measures: Number of patients with liver biopsy taken of more than 1.5 cm in length, Day 0|Adverse event, Day 7
Secondary Outcome Measures: Procedural time (in and out of catheter), Day 0|Number of passes, Day 0|Failure rate, Day 0|Day care time, Day 1|VAS: pain (Abdomen and Neck, pre and post procedure), VAS=10 is maximum pain, Day 0|Number of patients with Complications- arrythmia, hematoma, Day 0|Time of Fluro exposure, Day 0