pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of the ViQtor Monitoring Solution on Surgical Wards
NCT Number: NCT06574867
Acronym: REQUEST
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Monitoring|Post-operative Monitoring|Patient Safety|Healthcare Technology Implementation|Contiuous Vital Signs Monitoring
Sponsor: Catharina Ziekenhuis Eindhoven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
The REQUEST study aims to evaluate the use of a new wireless monitoring device, called the viQtor solution, on a surgical ward in Catharina Hospital Eindhoven. This device continuously tracks vital signs, such as heart rate, breathing rate, and blood oxygen levels, in patients after surgery. The goal is to see if the viQtor solution can help detect health problems earlier and reduce the workload for nurses by minimizing the need for manual checks. The study will involve 500 patients and will take place over 7 months.

Primary Outcome Measures: Usability of the viQtor Monitoring Solution, Evaluation of the usability of the viQtor solution based on the System Usability Scale (SUS). The outcome will be measured by the SUS score, with a target score of \>68 indicating acceptable usability., 8 months
Secondary Outcome Measures: Reduction in Nursing Workload, Assessment of the reduction in nursing workload by comparing the time spent on manual spot checks before and after implementing the viQtor solution. Success is defined as a 20% reduction in time spent on manual checks., 8 months|Predictive Accuracy of the viQtor Solution, Evaluation of the viQtor solution's accuracy in predicting patient deterioration by comparing the continuous vital sign measurements (SpO2, PR, RR) with intermittent measurements conducted as part of the MEWS protocol., 8 months|Implementation Success of the viQtor Solution, Determination of the successful implementation of the viQtor solution, measured by the percentage of available and usable data (\>70%) collected from the device during the study period., 8 months
Other Outcome Measures: Nurse and Physician Adoption of the viQtor Solution, Measurement of the level of adoption and acceptance of the viQtor solution among healthcare staff, assessed through the Evidence-Based Practice Attitude Scale (EBPAS)., 8 months
Effect of Blood Flow Restriction on Pain Perception, Grip Strength and Nerve Conductivity in CTS Patients.
NCT Number: NCT06574841
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carpal Tunnel Syndrome
Interventions: OTHER: Blood Flow Restriction training
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-07
Completion Date: 2025-01-27
Locations: Ahmed ElMelhat [aelmelhat], Cairo, Egypt

Summary:
The goal of this clinical trial is to investigate the effect of blood flow restriction (BFR) on pain perception, grip strength and nerve conductivity in patients suffering from carpal tunnel syndrome (CTS). The main question it aims to answer is:

Does performing blood flow restriction training decrease pain, improve grip strength and does not alter nerve conduction velocity in patients with (CTS)? The participants will be divided into two groups to be compared: Patients in the control group will receive the conventional physical therapy program only. In contrast, participants in the experimental group will receive blood flow restriction (BFR) training in addition to a conventional physical therapy program (which includes an orthotic device, tendon, and nerve-gliding exercises).

Primary Outcome Measures: Electromyography to evaluate median nerve abnormalities specifically within the wrist, assessing their severity, and ruling out other conditions that may imitate carpal tunnel syndrome., EMG activity for motor and sensory nerve conduction:

1. Electrode used for motor median nerve conduction positioned over the abductor pollicis brevis.
2. Electrode used for sensory median nerve conduction positioned 2cm distally for the thumb, the index, middle, and ring finger., Baseline and after 6 weeks
Secondary Outcome Measures: Grip Strength, The JAMAR Hydraulic Hand Dynamometer, frequently utilized in research investigations, holds a powerful validation and is esteemed as the gold standard against which the efficacy of other devices is measured., Baseline and after 6 weeks|Numerical pain rating scale, The numeric rating scale (NRS) is a widely utilized pain screening tool for assessing the severity of pain at a given moment, utilizing a scale from 0 to 10. Zero denotes the absence of pain, while 10 signifies the highest imaginable pain intensity., Baseline and after 6 weeks
Er:YAG Laser and Air Polishing Application in Periodontal Treatment
NCT Number: NCT06574802
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis
Interventions: PROCEDURE: ERL + air polishing|PROCEDURE: ERL
Sponsor: Beijing Chao Yang Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-12

Summary:
Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis. The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.

Primary Outcome Measures: Changes in PD, Changes in probing depth (PD) measured using periodontal probing, at 3 months, 6 months, 1 year, and 2 years|Changes in CAL, Changes in clinical attachment level (CAL) measured using periodontal probing, at 3 months, 6 months, 1 year, and 2 years
Secondary Outcome Measures: changes in BI, Changes in bleeding index (BI) measured using periodontal probing, at 3 months, 6 months, 1 year, and 2 years|PLI, Plaque index (PLI) assessed by an examiner using a scale of 0 to 3, at 3 months, 6 months, 1 year, and 2 years
Prevalence and Associated Mortality of Infections by Multidrug-Resistant Organisms in Adults Intensive Care Units
NCT Number: NCT06574776
Acronym: PREV-AR
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Infectious Disease
Interventions: OTHER: Observation and collecting data
Sponsor: Hospital Italiano de Buenos Aires
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1799
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-24
Completion Date: 2024-01-24
Locations: Hospital Austral, Buenos Aires, Argentina|Hospital de San Martin de La Plata, Buenos Aires, Argentina|Hospital Italiano, Buenos Aires, Argentina|Hospital Pirovano, Buenos Aires, Argentina|Hospital Tornu, Buenos Aires, Argentina|Sanatorio Las Lomas, Buenos Aires, Argentina|Hospital de Clínicas Pte Nicolás Avellaneda, Tucuman, Argentina

Summary:
Observational 24-hr point prevalence study with longitudinal follow-up at 164 ICUs in Argentina. All adult patients (aged ≥18 years) at a participating ICU on November 24-28, 2023 with 60- day follow-up, were included. Epidemiological variables, sites of infection, isolated microorganisms, CPE colonisation, and hospital characteristics were collected. Main outcome measure was ICU mortality.

Primary Outcome Measures: prevalence of infection by MDRO, The main outcome measure was the prevalence of infection by MDRO., All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.
Secondary Outcome Measures: ICU mortality, 28 days mortality and its independent determinants, 28 days|prevalence of colonisation by MDRO, prevalence of colonisation by multidrug resistant organisms, All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.|prevalence of infection in general, prevalence of infection in general in the ICU on the study date, All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.
Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer
NCT Number: NCT06574763
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ovarian Cancer
Interventions: DRUG: RC48/Carboplatin
Sponsor: Sun Yat-sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 47
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01

Summary:
The goal of this phase II single arm prospective clinical study is to evaluate the efficacy and toxicity of RC48 plus carboplatin neoadjuvant therapy in HER2 expressed epithelial ovarian cancer patients. The main questions it aims to answer are:

* The improvement of complete resection rate and pathological complete rate of this regimen.
* The delayed effect of treatment regimens on patient's recurrence.

Primary Outcome Measures: Completed Resection Rate, Completed Resection Rate (CRR): Complete tumor resection is defined as the absence of gross residual intra-abdominal and pelvic lesions assessed by the investigator during interval debulking surgery after the patient has received neoadjuvant therapy. The CRR is the percentage of patients achieving complete tumor resection., 3-month
Secondary Outcome Measures: Pathologic complete response, percentage of patients who achieved complete response, 3-month|Objective Response Rate (ORR), Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 3 cycles, ie ORR=CR+PR, 3-month|Progression Free Survival (PFS), Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first, 3-year|Adverse Event Rate, The Adverse Event Rate is defined as the percentage of patients who experience any Adverse Events (AE), Serious Adverse Events (sAE), and Treatment-Related Adverse Events (TEAEs) from the first day of treatment till 2 years after discontinuing the medication, from the first day of treatment till 30 days after discontinuing the medication|Overall survival, OS is defined as the time from the study enrollment to death due to any cause., 5-year
Effect of a New HA Filler in Correcting Nasolabial Fold
NCT Number: NCT06574750
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging Problems
Interventions: DRUG: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)|DRUG: JuvedermⓇ (Q-Med AB, Uppsala, Sweden)
Sponsor: Seoul National University Bundang Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-10-16
Completion Date: 2023-05-08
Locations: Seoul National University Bundang Hospital, Seongnam, 13620, Korea, Republic of

Summary:
The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction

Primary Outcome Measures: WSRS, Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds), at 24 weeks after treatment
Secondary Outcome Measures: GAIS, Global Aesthetic Improvement Scale from 3 (very much improved) to -1 (worse)., at 24 weeks after treatment|Adverse events related to the procedure, Patients were required to report any adverse events up to 24 weeks, up to 24 weeks
Use of Surface Electromyography as a Tools to Predict Upper Extremity Recovery Function After Stroke
NCT Number: NCT06574737
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Upper Extremity Paresis|Muscle Contracture Upper Arm|Stroke
Sponsor: Universitas Padjadjaran
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2025-07-31
Locations: Berthy Al Mungiza, Bandung, West Java, 40161, Indonesia

Summary:
Hypothesis :

Based on the framework and premises above, the hypothesis is formulated as follows: H0 : surface electromyography parameters cannot predicts upper extremity motor function recovery in stroke patients H1: surface electromyography parameters can predicts upper extremity motor function recovery in stroke patients

Primary Outcome Measures: Electrical activity deltoid, biceps, triceps, wrist flexor, wrist extensor muscle, * Contraction (number/minute). The number of contractions was reported for each participant as a count of the number of contractions divided per minute time (the more the better outcome) windows analyzed for that participant.
* Length of contraction (millisecond) (the longer the better outcome)
* Amplitude (mV) (the more the better outcome), 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset
Secondary Outcome Measures: Manual Muscle Testing score, 5: Normal 4: Good 3: Fair 2: Poor

1: Trace 0: Zero

(5 : higher end of strength ability, 0 = low-end ability of strength ability) (the more, the better outcome), 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset|Fugl Mayer Assessment-Upper Extremity score, ≤25 : severe 26-45 : moderate 46-66 : mild

(66 : maximum score for upper extremity score = normal, the more the better outcome), 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset
Transfer of Microorganisms Between Green Areas and Humans
NCT Number: NCT06574724
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Microbial Colonization
Interventions: OTHER: Visiting a green space
Sponsor: Universiteit Antwerpen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-27
Completion Date: 2027-07-07
Locations: Universiteit Antwerpen, Antwerp, 2020, Belgium

Summary:
The goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer. Additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes. Participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.

Primary Outcome Measures: Microbiome changes, Microbiome sequencing will be performed to assess changes in microbial community composition of nasal and skin swabs, focusing on abundances and diversity of different microorganisms and their genes, Two time points directly before and after the intervention (on 1 day)
Secondary Outcome Measures: Specific microorganisms within the skin and nasal microbiomes, Specific microorganisms within the participants' microbiomes will be assessed through culturing of swabs and/or quantification via qPCR, Two time points directly before and after the intervention (on 1 day)|Associations between the human microbiome and environment, Human microbiome composition and diversity (as assessed in outcome "Microbiome changes") will be correlated with the green space environment characteristics, such as the environmental (microbiome) biodiversity, Two time points directly before and after the intervention (on 1 day)
Other Outcome Measures: Self-reported lifestyle, Lifestyle will be assessed using a short questionnaire to understand how it might impact the microbiome (as assessed in outcome "Microbiome changes"), reflecting lifestyle-related parameters such as weekly time spent outdoors (in hours) and frequency of exposure to green environments (e.g., once a year), One time point directly before or after the intervention (on 1 day)|Self-reported health, Self-reported general health will be assessed using a short questionnaire to understand how it might impact the microbiome (as assessed in outcome "Microbiome changes"), reflecting health-related parameters such as a health rating (from very poor to very good), One time point directly before or after the intervention (on 1 day)|Self-reported demographic information, Demographic information will be assessed using a short questionnaire to understand how it might impact the microbiome (as assessed in outcome "Microbiome changes"), reflecting demographic parameters such as age (in years), gender, and parent-child relationship (having one or more children), One time point directly before or after the intervention (on 1 day)
Functional Yogurt Consumption and Its Effects on the Lipid Profile of Healthy Subjects
NCT Number: NCT06574711
Acronym: FYOPO
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Apolipoproteins|Food Preferences|Low-density-lipoprotein-type|HDL|Triglycerides|Functional Food
Interventions: OTHER: Sacha inchi oil yogurt|OTHER: Hybrid palm oil yogurt|OTHER: Control yogurt
Sponsor: Pontificia Universidad Javeriana
Collaborators: Universidad Nacional de Colombia
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-03-22
Completion Date: 2024-05-07
Locations: Pontificia Universidad Javeriana, Bogotá, 110231, Colombia

Summary:
The purpose of this study was to assess the effect of the daily intake of yogurts enhanced with Sacha Inchi oil and hybrid palm tree oil on human plasma lipids related to cardiovascular risk factors

Primary Outcome Measures: Change in plasma levels of total cholesterol, Measure in plasma (mmol/l), Baseline, 1 month, 2 months and 3 months|Change in plasma levels of LDL-cholesterol, Measure in plasma (mmol/l), Baseline, 1 month, 2 months and 3 months|Change in plasma levels of HDL-cholesterol, Measure in plasma (mmol/l), Baseline, 1 month, 2 months and 3 months|Change in plasma levels of triacylglycerols, Measure in plasma (mmol/l), Baseline, 1 month, 2 months and 3 months|Change in plasma levels of Apolipoprotein A1 (ApoA1), Measure in plasma (g/l), Baseline, 1 month, 2 months and 3 months|Change in plasma levels of Apolipoprotein B (ApoB), Measure in plasma (g/l), Baseline, 1 month, 2 months and 3 months|ApoB/ApoA1 ratio, prognostic predictor of a 10 year cardiovascular event, Baseline, 1 month, 2 months and 3 months
Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
NCT Number: NCT06574698
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neuroblastoma|GD2 Antibody (Naxitamab)
Interventions: DRUG: Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Sponsor: Guangzhou Women and Children's Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-06
Completion Date: 2032-12-31
Locations: Guangzhou Women And Children's Medical Center, Guanzhou, Guangdong, 510000, China

Summary:
To explore the efficacy of adding anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy for newly diagnosed high risk neuroblastoma patients. To investigate wether anding Naxitamab in the induction phase will improve the response rate at the end of induction therapy and further improve the overall survival rate.

Primary Outcome Measures: The number of the patients of VGPR or CR at the end of induction therapy, Measured by cross-sectional computed tomography (CT) or magnetic resonance imaging (MRI) imaging and/or by methyl iodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) responses, evaluated according to the 1993 International Neuroblastoma Response Criteria (INRC), and compared with relevant historical control groups., 5 years
Secondary Outcome Measures: Objective Response Rate (ORR), According to the International Neuroblastoma Response Criteria (INRC) of 1993 and 2017, the proportion of complete or partial responses was calculated in newly diagnosed high-risk group patients with neuroblastoma who received standard induction therapy. The disease status was evaluated by CT or MRI and/or MIBG or PET scans and bone marrow aspiration. After two courses of treatment, the proportion of complete or partial responses was calculated in newly diagnosed high-risk group patients with neuroblastoma who received standard induction therapy after two courses of treatment were completed., 5 years|The number of days a patient survives, The overall survival (OS) of patients receiving standard-induced chemotherapy and GD2 antibody combination therapy., 3 years after the last patient was enrolled|The number of days the patient survive without relapse or progression, The event-free survival (EFS) of patients receiving standard-induced chemotherapy and GD2 antibody combination therapy., 3 years after the last patient was enrolled|The objective response rate (ORR) after 6 cycles of treatment., The objective response rate (ORR) after 6 cycles of treatment., 5 years|The number of patients with adverse events related to treatment, The number of patients with adverse events related to treatment, 5 years
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
NCT Number: NCT06574646
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract
Interventions: DEVICE: LAL+|DEVICE: Clareon Vivity Toric IOL
Sponsor: The Eye Associates
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2026-08-01
Locations: The Eye Associates of Manatee, LLP, Bradenton, Florida, 34209, United States

Summary:
Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs

Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.

Primary Outcome Measures: Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm, Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm, at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done.
Effect of MTX Discontinuation on Shingrix Response in RA
NCT Number: NCT06574594
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rheumatoid Arthritis
Interventions: DRUG: Methotrexate|DRUG: Methotrexate
Sponsor: Konkuk University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-22
Completion Date: 2025-12-31
Locations: Konkuk University Medical Center, Seoul, Korea, Republic of

Summary:
The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are:

Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ?

Researchers will compare humoral and cell-mediated immunity against herpes zoster in RA patients who are vaccinated by shingrix, and compare these immunity between RA patients with MTX discontinuation and MTX continuation groups.

Participants will:

Vaccinated with shingrix twice. MTX continuation group will keep taking MTX after shingrix vaccination, whereas MTX discontinuation group will stop MTX for 2 weeks after shingrix vaccination.

Visit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 \& 6 months later from baseline to achieve blood sample.

Primary Outcome Measures: Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster), baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
Secondary Outcome Measures: , Humoral immunity (anti-VZV antibody, anti-gE antibody), baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
ADSCs Therapy in Patients With CTD-ILD
NCT Number: NCT06574581
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Connective Tissue Diseases|Interstitial Lung Disease
Interventions: BIOLOGICAL: ADSC01
Sponsor: China Medical University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2026-05-30
Locations: China Medical University Hospital, Taichung, 404327, Taiwan

Summary:
Connective tissue disease (CTD), an autoimmune and inflammatory disease, usually accompanied by lung interstitial/alveolar inflammation and fibrosis (so called interstitial lung disease, ILD). The prevalence and mortality rate of CTD-ILD increase in recent several years. Although the use of corticosteroids and strong immunosuppressants can improve ILD in some patients with CTD, progressive lung fibrosis which needs lung transplantation and results in respiratory failure, even with mortality is observed. Currently, stem cell therapy is a breakthrough in the treatment of CTD-ILD, and the effective therapy with stem cells for patients with ILD have been reported.

Primary Outcome Measures: Safety profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs), 1. Stable blood pressure: systolic pressure 90-120mmHg and diastolic pressure 60-80mmHg measured after resting for 10 minutes
2. Stable pulse rate: ranges 60-100/minute after resting for 10 minutes
3. Stable respiratory rate: ranges 12-20/minute after resting for 10 minutes
4. Normal body temperature 35.7℃-37.9℃.
5. Resting oxygen saturation≧90% without oxygen use.
6. Absence of AD-MSCs infusion-related serious adverse event., 48 weeks
Secondary Outcome Measures: Efficacy profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs), 1. Change of six-minute walking distance(6MWD): Increase of 6MWD≧5% from baseline at week 12, 8% at week 24, 10% at week 48.
2. St. George's Respiratory Questionnaire: Change of score≧5% from baseline at week 12, 10% at week 24, 15% at week 48.
3. Quality of life (SF-36): Increase of score≧5% from baseline at week 12, 8% at week 24, 10% at week 48.
4. Forced vital capacity (FVC): Decrement of FVC\<5% at week 12, increment ≧5% at week 24, increment ≧10% at week 48.
5. Diffusing capacity for carbon monoxide (DLco): Decrement of DLco \<5% at week 12, increment≧5% at week 24, increment≧10% at week 48
6. The extent of ILD (interstitial lung disease) lesion in HRCT: Decrement of ILD extent≧5% at week 24, and decrement of ILD extent≧10% at week 48., week 48.
NE ED90 Bolus in C-Sec
NCT Number: NCT06574555
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hypotension|Hypertension|Nausea|Pain|Arrhythmia
Sponsor: Pontificia Universidad Catolica de Chile
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2025-03

Summary:
We are aiming to determine what is the effective intravenous dose required of an initial bolus of norepinephrine prior to a maintenance infusion to prevent a 20% decrease in maternal blood pressure from baseline following the administration of spinal anesthesia for elective cesarean section in healthy parturients

Primary Outcome Measures: Hypotension, The primary outcome will be the presence of arterial hypotension within 10 minutes of anesthesia administration. Post-spinal arterial hypotension will be defined as systolic BP decreasing to less than 80% of baseline., First 10 minutes after spinal anesthesia dose.
Secondary Outcome Measures: Maternal side effects, Any manifestations secondary to the use of norepinephrine will be recorded, such as: headache, hypertension, pain on injection site or changes in skin colour. Nausea or vomiting during the study period shall also be recorded., First 10 minutes after spinal injection|Fetal side effects, After fetal delivery and umbilical cord sample will be taken for blood gas and glycemia., Until completion of the surgical procedure
The Role of Push Enteroscopy in Patients With Passing Melena With Nondiagnostic EGD.
NCT Number: NCT06574542
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Melena Due to Gastrointestinal Hemorrhage
Interventions: DIAGNOSTIC_TEST: Push enteroscopy (PE)|DIAGNOSTIC_TEST: Colonoscopy
Sponsor: Mahidol University
Collaborators: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 77
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2019-07-08
Completion Date: 2022-12-30
Locations: Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand

Summary:
Melena is often caused by upper gastrointestinal (GI) bleeding; therefore, esophagogastroduodenoscopy (EGD) is the first preferred diagnostic tool. However, EGD fails to identify the bleeding source in about 25% of cases. Guidelines recommend colonoscopy for the subsequent investigation. However, the diagnostic yield of colonoscopy is reportedly low, varying from 4.76% to 35%. Even when EGD and colonoscopy have been performed, 4% to 15% of bleeding cases remain unexplained, suggesting small bowel origins. While video capsule endoscopy (VCE) is recommended due to its high diagnostic yield and noninvasive nature, its limitations include missing proximal small bowel lesions due to rapid transit and the inability to perform therapeutic interventions. Push enteroscopy (PE) is a straightforward, cost-effective technique with a reported 30% to 50% diagnostic success rate for such obscure GI bleeding. This study aims to evaluate the diagnostic yield of PE compared to colonoscopy in patients presenting with melena, no hematemesis, and negative EGD results.

Primary Outcome Measures: Diagnostic Yield of Push Enteroscopy, This study aimed to evaluate the diagnostic yield of push enteroscopy in patients presenting with melena, without hematemesis, and with a negative EGD., 30 day
Secondary Outcome Measures: Diagnostic Yield of Colonoscopy, This study also aimed to evaluate the diagnostic yield of colonoscopy in the same patient population: those presenting with melena, without hematemesis, and with a negative EGD, 30 day
Video-observed Therapy for Active Tuberculosis: a Feasibility Study
NCT Number: NCT06574529
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tuberculosis Active
Interventions: DIAGNOSTIC_TEST: Video-observed therapy (vDOT)
Sponsor: Ligue Pulmonaire Genevoise
Collaborators: University Hospital, Geneva
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2021-11-26
Completion Date: 2024-05-31
Locations: Geneva University Hospital, Geneva, 1205, Switzerland

Summary:
Tuberculosis (TB) is still present in Switzerland, and concerns mainly foreign-born subjects. Monitoring compliance to treatment by Directly Observed Therapy (DOT) is strongly encouraged by the World Health Organization (WHO). It is however time-consuming, costly and stigmatising. This study aims to examine the feasibility of monitoring compliance through a secured web platform and videos sent via an application on a cellphone, a concept known as vDOT (Video-observed therapy). The study aims to include all patients treated for tuberculosis is on our area during an 18 month period and monitor acceptance, compliance, and technical issues related to vDOT.

Primary Outcome Measures: Acceptance rate, Number of patients accepting to install the application on their cellphone and send videos of their treatment until treatment completion, among all patients initiating a treatment for active tuberculosis in our center, Two weeks after starting TB treatment|Effective implementation rate, Number of patients for whom installing the application, and learning how to use it was possible among all patients with active TB during study period, Two weeks after starting TB treatment
Secondary Outcome Measures: Ratio of number of videos sent to number of videos expected, Number of videos recorded on the secured platform compared with number expected(% x number of weeks of treatment), Duration of treatment (max 12 months)|Quality of videos sent, Proportion of videos with technical problems (sound, lighting, framing) was recorded, Duration of treatment (max 12 months)|Evaluation of video-observed therapy by specialized nurses following the patients, Questionnaire with Likert scales submitted to all nurses at the end of the study, End of study (18 months)
Pain Management Following Dental Treatment Under General Anesthesia
NCT Number: NCT06574516
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain
Interventions: DRUG: Ibuprofen 200 mg|DRUG: paracetamol
Sponsor: King Abdullah University Hospital
Collaborators: Jordan University of Science and Technology
Sex: ALL
Age: CHILD
Enrollment: 118
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-11-04
Completion Date: 2023-04-09
Locations: king Abdulla University Hospital, Irbid, 21166, Jordan

Summary:
The main goal of this study is to test the efficacy of postoperative pain management for cases undergoing extractions of primary teeth under GA using a validated measure.

Children undergoing extraction of at least one primary molar under general anesthesia GA at King Abdullah University Hospital (KAUH) were randomly assigned into three groups: study group (1) were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, study group (2) were given Ibuprofen three times daily for 3 days, study group (3) were given Paracetamol prn for 3 days.

pain was assessed using parent's postoperative pain measure (PPPM) on the first, second and third days.

Primary Outcome Measures: Efficacy of pain control using different medications, Reduction in pain scores using the parental post operative pain measure, by comparing scores immediately post operative with scores on subsequent days. higher scores indicate worse pain, 3 days post operative
Secondary Outcome Measures: Quality of life of treated children, Using Childhood Oral Health Impact Scale (ECOHIS), by comparing pre and postoperative scores, lower scores mean better quality of life, 2 weeks post operative
Myofunctional Therapy in Open Bite - RCT
NCT Number: NCT06574490
Acronym: Myofunctional
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Open Bite
Interventions: PROCEDURE: Myofunctional therapy (+)|PROCEDURE: Myofunctional therapy (-)
Sponsor: Piotr Fudalej
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-10

Summary:
The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective.

Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year.

Participants will exercise according to a pre-established regimen and schedule

Primary Outcome Measures: Overbite, presence positive vertical (i.e. the upper teeth overlap the lower teeth) and horizontal (i.e. the upper teeth are positioned in front of the lower teeth) occlusion, 12months
Secondary Outcome Measures: Swallowing pattern, swallowing pattern (infant, adult or mixed), 12 months|Articulation, articulation of l,n,d,t,s sounds., 12 months
Impacted Canine and Mixed-reality Technology - RCT
NCT Number: NCT06574477
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth, Impacted
Interventions: PROCEDURE: Planning of alignment with HoloLens 2|PROCEDURE: No planning of alignment with HoloLens 2
Sponsor: Piotr Fudalej
Sex: ALL
Age: CHILD, ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-10-01
Completion Date: 2027-10
Locations: Jagiellonian University Medical College, Kraków, 31-008, Poland

Summary:
The goal of this clinical trial is to determine whether the use of HoloLens 2 mixed reality goggles for planning alignment of palatally impacted canine reduces: 1) treatment time and 2) the risk of complications compared to planning alignment of palatally impacted canine without HoloLens 2 goggles.

Participants will have an impacted canine on palatal side.

Researchers will use or will not use HoloLens 2 goggles in planning therapy

Participants will wear fixed orthodontic appliances for the treatment of impacted canine. During treatment, attachment will fixed to an impacted canine and the direction of traction will be established.

Primary Outcome Measures: Alignment duration, total duration of the phase of the alignment of impacted canine (in days), 6 months, 12 months
Secondary Outcome Measures: Resorption, extent of root resorption of adjacent teeth measured on CBCT, 6 months, 12 months
The BIG Score and In-Hospital Trauma Mortality
NCT Number: NCT06574464
Acronym: BIGstd
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiple Trauma|Injury Traumatic
Interventions: OTHER: BIG SCORE|OTHER: Glasgow coma scale|OTHER: Revised Trauma Score|OTHER: Injury Severity Score
Sponsor: Haseki Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 563
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-01-01
Locations: Haseki Training and Research Hospital, Istanbul, Fatih, 34265, Turkey

Summary:
This study investigated the efficacy and reliability of the BIG score, calculated based on the base deficit (BD), International Normalized Ratio (INR), and Glasgow coma scale (GCS), in comparison with the GCS, Revised trauma score (RTS), and Injury Severity Score (ISS) for predicting in-hospital mortality in adults with multiple-trauma presenting to the emergency department (ED).

Primary Outcome Measures: Predictive ability of BIG score for 28-day mortality, The investigators assessed the predictive ability of BIG score in determining 28-day mortality., From admission to 28 days|Predictive ability of Glasgow coma scale for 28-day mortality, The investigators assessed the predictive ability of Glasgow coma scale in determining 28-day mortality., From admission to 28 days|Predictive ability of Revised Trauma Score for 28-day mortality, The investigators assessed the predictive ability of Revised Trauma score in determining 28-day mortality., From admission to 28 days|Predictive ability of Injury Severity Score for 28-day mortality, The investigators assessed the predictive ability of Injury Severity Score in determining 28-day mortality., From admission to 28 days
Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain
NCT Number: NCT06574451
Acronym: VR-TSP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Postoperative Pain|Video-assisted Thoracic Surgery|Virtual Reality
Interventions: DEVICE: VR-assisted postoperative analgesia
Sponsor: Guangdong Provincial People's Hospital
Collaborators: Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China.|Tianjin Medical University General Hospital|Ruijin Hospital|Maoming People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 215
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-22
Completion Date: 2025-04-24
Locations: Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, China|Maoming People's Hospital, Maoming, Guangdong, China|Ruijing Hospital, Shanghai Jiao Tong University, Shanghai, Shanghai, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, China

Summary:
A randomized controlled, prospective, multicenter, open label, superiority trial aims to evaluate the effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain.

Primary Outcome Measures: Numeric Rating Scale (NRS), The NRS score is a commonly used postoperative pain assessment tool. The score uses a numeric scale from 0 to 10, on which patients are asked to mark their level of pain, with 0 being no pain and 10 being the most severe pain., The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.
Secondary Outcome Measures: Incidence of adverse events, Any unfavorable medical occurrence during the course of the study, whether device-related or not, is an adverse event., Assessment of adverse events is completed within 2 days postoperatively|Incidence of serious adverse events, If an event occurs during the clinical study that results in death or serious deterioration of health status, it is judged to be a serious adverse event, Assessment of serious adverse events is completed within 2 days postoperatively
Long-term, High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis
NCT Number: NCT06574425
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Diseases|Hemodialysis
Interventions: OTHER: long-term, high blood flow hemoadsorption therapy
Sponsor: Dongliang Zhang, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2024-12-31
Locations: Nephrology Department of Beijing Jishuitan Hospital, Beijing, Beijing, 100035, China

Summary:
Objective：The purpose of the study is to confirm that extending the duration of hemoadsorption (HA) and increasing blood flow during the HA+hemodialysis (HD) treatment process is safe and feasible, and to verify that extending the HP treatment duration can further increase the clearance of protein-bound uremic toxins.

Methods: The study employs a multicenter, prospective, cohort design with a self-controlled before-and-after comparison. The duration of HA+HD treatment for maintenance hemodialysis (MHD) patients is extended to 4 hours, and the extracorporeal blood flow rate is increased to over 250-350 ml/min. The safety of the treatment is assessed by evaluating the safety of the procedure; the levels of relevant toxins in the patients' blood are measured before and after treatment, and the clearance rate of uremic toxins after a single treatment is calculated and compared with the self-controlled before-and-after data to determine whether the modified protocol can remove more uremic toxins.

Primary Outcome Measures: protein-bound toxins, the clearance of protein-bound toxins will change, 1month
Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia
NCT Number: NCT06574399
Acronym: FEN-AUREUS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Staphylococcus Aureus Bacteremia
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2025-03-31
Locations: Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain

Summary:
The goal of this observational study is to determine retrospectively whether different patient clinical phenotypes (adults and children) develop Staphylococcus aureus bacteremia.The main questions it aims to answer qre:

1. Evaluate its reproducibility and correlation with mortality
2. Derive and validate a simplified probabilistic model for phenotype assignment
3. External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort
4. Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.

Primary Outcome Measures: Determine whether different patient clinical phenotypes develop S. aureus bacteremia, evaluate its reproducibility and correlation with mortality and derive and validate a simplified probabilistic model for phenotype assignment, Analyze the ISAC (International Staphylococcus aureus collaboration) cohort from an international study (11 hospitals in five countries) on Staphylococcus aureus bacteremia (2590 cases), 1 month
Secondary Outcome Measures: External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort, Perform a multicenter prospective cohort study (Standard study): All patients who develop S. aureus bacteremia will be assigned a phenotype and followed up for six months to evaluate the differences in mortality and development of complicated bacteremia between phenotypes., 34 months|Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes, Study the genetic (microorganism and patient), immunological, biochemical and microbiological variables in patients representative of the phenotypes selected in the prospective cohort in two hospitals (Extended Study), 34 months