pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluate the Effect of Synbiotics on MAFLD
NCT Number: NCT06537882
Acronym: MAFLD-RCT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Dysfunction-Associated Fatty Liver Disease
Interventions: DIETARY_SUPPLEMENT: G-NiiB synbiotics formula (SLP07)|DIETARY_SUPPLEMENT: Active placebo
Sponsor: GenieBiome Limited
Collaborators: Microbiota I-Centre (MagIC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-05-17
Completion Date: 2026-06-30
Locations: GenieBiome Limited, Hong Kong, Hong Kong

Summary:
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omega 3 are safe and effective at treating NAFLD patients. In this study, investigators aim to investigate if the enhanced synbiotic preparation of SLP07 is efficacious in liver function improvement in subjects with MAFLD.

Primary Outcome Measures: Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 3 months, The change of CAP score measured by fibroscan. CAP score is a measurement of fat accumulation in the liver to further determine the steatosis grade. The CAP score ranges from 100 to 400 decibels per meter (dB/m). The higher the score, the more the steatosis is., 3 months
Secondary Outcome Measures: Percentage of participants with improvement in steatohepatitis across the study period., The percentage of improvement in steatohepatitis compared to the baseline, 3 months|Change in lipid profile across the study period., The change in the level of lipid profiles, 3 months|Change of body mass index (BMI) across the study period., The change of body weight and body height, 3 months|Change of body waist circumference across the study period., The change of waist circumference, 3 months|Adverse events reported during the study period., The adverse events reported throughout the study, 3 months|Changes in faecal microbial profiling across 16 weeks, The change of microbial profile in stool compared to baseline, 3 months
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
NCT Number: NCT06537843
Acronym: VenCM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: Venetoclax|DRUG: Cytarabine Injection|DRUG: Metformin
Sponsor: Hospital Municipal São José
Collaborators: Hospital de Clínicas da UFPR. Curitiba, PR, Brazil|Hospital Ophir Loyola. Belem, PA, Brazil|Hospital Universitario Polydoro Ernani de São Thiago. Florianopolis, SC, Brazil|Hospital Amaral Carvalho. Jau, SP, Brazil
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2028-07-01
Locations: Hospital Ophir Loyola, Belem, Brazil|Hospital de Clínicas da UFPR, Curitiba, Brazil|Hospital Universitario Polydoro Ernani de Sao Thiago, Florianopolis, Brazil|Hospital Amaral Carvalho, Jaú, Brazil|Hospital Municipal Sao Jose, Joinville, Brazil

Summary:
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.

Primary Outcome Measures: Overall Survival (OS), Overall survival is defined as the time from patient inclusion to the date of death, using Kaplan-Meier methodology., 12 months and 24 months
Secondary Outcome Measures: Composite Complete Response Rate (CCR), Percentage of participants with complete remission (CR) or complete remission with partial (CRh) or incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the 2022 European LeukemiaNet AML Diagnosis and Treatment Recommendations., 12 months and 24 months|Negative Measurable Residual Disease (MRD) Rate, Percentage of participants with CR, CRh or CRi with negative measurable residual disease (MRD) as assessed by the investigator, in accordance with ELN recommendations, defined as having less than 10-³ residual blasts per leukocyte measured in the bone marrow., 12 months and 24 months
Study to Evaluate HT-4253 in Healthy Subjects
NCT Number: NCT06537817
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Normal Healthy Subjects
Interventions: DRUG: HT-4253|DRUG: Placebo
Sponsor: Halia Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-04

Summary:
The primary objectives of this study are to evaluate the safety and tolerability of HT-4253 when administered as single oral doses and multiple oral doses at escalating dose levels in healthy volunteer subjects.

The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-4253.

Primary Outcome Measures: To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults, Incidence of adverse events (AEs), up to 6 weeks|To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults, Serious adverse events (SAEs), up to 6 weeks|To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults, Treatment-related adverse events (TRAEs), up to 6 weeks|To evaluate the safety and tolerability of single and multiple ascending, Incidence of withdrawals due to AE, up to 6 weeks
Secondary Outcome Measures: To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults, Maximum plasma concentration (Cmax), up to 6 weeks|To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults, Area under the concentration-time curve (AUC), up to 6 weeks|To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults, Elimination half-life (t1/2) plasma concentration of HT-4253, up to 6 weeks|To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults, Trough plasma concentration of HT-4253, up to 6 weeks
Impact of Home-Based Rehabilitation on Motor Function and Mood in Individuals With Disabilities
NCT Number: NCT06537791
Acronym: HB-Rehab
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Musculoskeletal Diseases|Neurological Diseases
Interventions: BEHAVIORAL: Home-Based Rehabilitation Program
Sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2023-12-08
Locations: Corporación de Rehabilitación Club de Leones Cruz del Sur, Punta Arenas, XII Región, 6211525, Chile

Summary:
This study aims to evaluate the impact of a multidisciplinary home-based rehabilitation program on motor function and mood in individuals with moderate neuromusculoskeletal disabilities. Participants will receive personalized treatment plans over four months, including sessions in physical therapy, occupational therapy, nutrition, psychology, nursing, and podiatry. The study will measure motor function using the Berg Balance Scale and mood using the Beck Depression Inventory. This program will be conducted in the Magallanes region of Chile, involving participants recruited from the National Disability Registry.

Primary Outcome Measures: Improvement in Motor Function, Assessment of the improvement in motor function of the participants, measured using the Berg Balance Scale. This scale assesses balance through 14 common tasks performed in daily life. Scores range from 0 to 56 points, where 0 indicates a low level of balance and 56 indicates an excellent level of balance. A higher score on this scale represents a better outcome in terms of balance and motor function., From study start to the end of the intervention (4 months).
Secondary Outcome Measures: Changes in Depression Levels, Assessment of changes in the participants' depression levels, measured using the Beck Depression Inventory. This inventory is a 21-item questionnaire that assesses the severity of depression. Scores can range from 0 to 63 points, with higher scores indicating a greater level of depression. Therefore, a higher score on this scale reflects a worse outcome in terms of emotional well-being., From study start to the end of the intervention (4 months).
Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
NCT Number: NCT06537778
Acronym: sPTB
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Cerclage|Premature Birth
Interventions: DRUG: Atosiban|DRUG: Normal saline
Sponsor: Children's Hospital of Chongqing Medical University
Collaborators: First Affiliated Hospital of Chongqing Medical University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 334
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2018-01-03
Completion Date: 2024-04-12
Locations: Women and Children's Hospital of Chongqing Medical University, Chongqing, Chognqing, 400016, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400000, China

Summary:
After ultrasound-indicated cerclage, some pregnant women still experience sPTB, and there is controversy regarding the use of tocolytic agents during the perioperative period to reduce the incidence of sPTB. In this study, the investigators employed a randomized double-blind method to investigate whether the use of atosiban during the perioperative period can reduce the incidence of sPTB before 34 weeks.

Primary Outcome Measures: Rate of sPTB, Rate of sPTB before 34 weeks of gestation, up to 34 weeks
Secondary Outcome Measures: Rate of preterm delivery <28 or <32 weeks gestation, Rate of preterm delivery \<28 or \<32 weeks gestation, up to 32 weeks|Gestational latency after cerclage placement (days), Gestational latency after cerclage placement (days), through study completion, an average of 1 year|Rate of preterm premature rupture of membranes, Rate of preterm premature rupture of membranes, through study completion, an average of 1 year|Gestational age at delivery (weeks), Delivery weeks, through study completion, an average of 1 year
A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients
NCT Number: NCT06537752
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Sponsor: Boryung Pharmaceutical Co., Ltd
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1052
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2026-10
Locations: Chung-Ang University Hospital, Seoul, 06973, Korea, Republic of|Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu, 11759, Korea, Republic of

Summary:
The purpose of this study is to evaluate ethanol-induced symptoms and safety in breast cancer patients with neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery

Primary Outcome Measures: Incidence of ethanol-induced symptoms in the initial cycle, This outcome's definition is an increase from baseline in the number of ethanol-induced symptoms during or within 30 minutes after the treatment. The initial cycle of non-ethanol formulation docetaxel is collected as 1 cycle., From the time of treatment started until the end of follow-up(30 minutes after the treatment)
Breath Analysis for the Detection of Invasive Fungal Infections
NCT Number: NCT06537726
Acronym: REDEFINE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Leukemia|Leukemia, Myeloid|Leukemia, Lymphoblastic|Neutropenia|Chemotherapy-induced Neutropenia|Invasive Fungal Infections|Invasive Pulmonary Aspergillosis
Interventions: DIAGNOSTIC_TEST: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Sponsor: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2027-02-28

Summary:
Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.

With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).

Primary Outcome Measures: Novel biomarker (m/z value) for IFI by SESI-HRMS, through study completion, on average after 3 weeks
Secondary Outcome Measures: Specificity and sensitivity of this novel biomarker, through study completion, on average after 3 weeks|Timepoint of first detection in relation to first clinical symptoms of IFI, through study completion, on average after 3 weeks
Diagnostic Role of Serum Testican and Ubiquitin Levels in Patients With Head Trauma
NCT Number: NCT06537713
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Moderate Traumatic Brain Injury|Testican-1|Ubiquitin
Interventions: DIAGNOSTIC_TEST: Testican-1
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 89
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-10-01
Completion Date: 2021-04-30
Locations: Kanuni SUltan Suleyman Training and Research Hospital, İstanbul, Küçükçekmece, 34303, Turkey

Summary:
We aimed to determine if testican-1 and ubiquitin can serve as early indicators for diagnosing worsening clinical course (presence of intraparenchymal pathology) and mortality in patients with moderate traumatic brain injury.

Primary Outcome Measures: Comparison of testican-1 and ubiquitin levels in patients with moderate traumatic brain injuries and a control group, We compared the plasma blood levels of biomarkers in both groups, The study was conducted with blood samples taken at the time of admission.
Secondary Outcome Measures: ROC curve analysis for the prediction of intraparenchymal pathology (+), We investigated the diagnostic value of biomarkers in detecting pathology on brain CT in patients with moderate traumatic brain injury., The study was conducted with blood samples taken at the time of admission.
Relational Agents in Cervical Cancer Education (RACE)
NCT Number: NCT06537687
Acronym: RACE
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervix Cancer|Human Papilloma Virus|Vaginal Cancer|Vulvar Cancer
Interventions: OTHER: Control|OTHER: Intervention
Sponsor: Radhika Gogoi
Collaborators: University of Oklahoma
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 91
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2020-11-18
Completion Date: 2023-07-31
Locations: Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States

Summary:
The goal of this clinical trial is to assess the feasibility of using interactive teaching to educate cervical cancer patients about Human papillomavirus (HPV) and HPV vaccinations.

Primary Outcome Measures: Participation Rate, The Ratio of the number of participants to the number of patients asked to join the clinical trial, Up to 6 weeks|Survey Completion Rate, The Ratio of the number of participants who complete the survey to the number of participants overall., Up to 6 Weeks
Secondary Outcome Measures: Change in intention to discuss HPV vaccination, Changes from pre to post/follow up on intervention survey, Up to 6 weeks|Change in Health Literacy, Changes in knowledge of HPV virus and prevention from pre to post/follow up survey, Up to 6 weeks|Change in social norms and behaviors, Changes in social norms and behavioral control measures from pre and post/follow-up survey, Up to 6 weeks|Change in Stigma, Changes in stigma measures in pre and post/follow up surveys, Up to 6 weeks
Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer
NCT Number: NCT06537674
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HER2+ Breast Cancer
Interventions: DRUG: Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection
Sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2026-12-30

Summary:
This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer

Primary Outcome Measures: EORTC QLQ-C30 scale score, PRO scale scores between two groups collected at different time points, through study completion, an average of 1 year
Secondary Outcome Measures: tpCR, total pathological complete response, 1-2 weeks after surgery
Effect of Virtual Reality on TMD Following Maxillofacial Surgery
NCT Number: NCT06537661
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Disorder
Interventions: OTHER: Virtual reality|OTHER: Traditional exercises
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 2
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-10
Completion Date: 2024-09-10
Locations: Nehal mohamed, Giza, 20, Egypt|Nehal mohamed, Giza, Egypt

Summary:
Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).

Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.

The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.

Primary Outcome Measures: Measure pain, Measure by visual analog scale (VAS) 0: low in pain 10:high in pain, 6weeks
Secondary Outcome Measures: Maximum mouth opnening (MMO ), Measure by milemeter, 6weeks
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
NCT Number: NCT06537648
Acronym: DANCE-DS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Down Syndrome|Physical Inactivity
Interventions: BEHAVIORAL: Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program
Sponsor: University of Kansas Medical Center
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-02
Completion Date: 2025-06-01
Locations: University Of Kansas Medical Center, Kansas City, Kansas, 66160, United States

Summary:
The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Participants will take part in a 12-week exercise program with two 35-minute session per week delivered in a group setting. The aims of the project are to:

* Assess the feasibility of a 12 week remotely delivered group dance intervention.
* Assess changes in aerobic fitness and cognitive function in response to a 12 week remotely delivered group dance intervention.
* Assess the intensity and total energy expenditure of remotely delivered group dance sessions.

Primary Outcome Measures: Attendance, Attendance at each 35-minute online exercise classes will be collected. Attendance will be assessed as the number of sessions attended out of the total number of sessions available (24 sessions available)., 12 weeks|Retention, Participant retention will be collected based on the number of participants who complete the 12 week intervention. A total of up to 20 participants will be enrolled into the study. Participants that complete the 12-week intervention will be considered retained. Any participant that discontinues participation prior to the end of the 12-week intervention will not be considered retained., 12 weeks|Adverse Events, Adverse events will be collected on a weekly basis., 12 weeks
Secondary Outcome Measures: 6-minute walk test, This test measures the distance that a participant can walk on a flat, hard surface in a period of 6 minutes. The research team will instruct them on how to prepare and conduct this test., 12 weeks|Episodic Memory, Episodic memory will be assessed before and after the intervention using the modified Cued Recall Test., 12 weeks|Energy Expenditure, Energy expenditure during a dance session (kilocalories per minute; Metabolic equivalents (METs) will be assessed by portable indirect calorimetry., 1 session|Exercise intensity, Exercise intensity will be assessed as an average of the percent of age-estimated maximal heart rate achieved during dance sessions assessed by a Fitbit®, 12 weeks
Cubii Vital Sign and Range of Motion Study
NCT Number: NCT06537635
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Effects of; Exertion
Interventions: DEVICE: Cubii seated compact elliptical trainer
Sponsor: Sport and Spine Rehab Clinical Research Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2019-11-18
Completion Date: 2021-03-25
Locations: Sport and Spine Rehab, Rockville, Maryland, 20852, United States

Summary:
The purpose of this study is to evaluate the effect of a seated compact elliptical on vital signs and range of motion (of knees and ankles) following thirty minutes of activity.

Primary Outcome Measures: Overall Satisfaction, The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied., After the 30-minute treatment (T4)|Ease of Use, The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied., After the 30-minute treatment (T4)|Refer a friend, The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied., After the 30-minute treatment (T4)|Knee Flexion Baseline, Knee flexion range of motion was evaluated using the EasyAngle, a digital goniometer., This information was collected after the 30-minute treatment (T4).
89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
NCT Number: NCT06537596
Acronym: ZOLAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Soft Tissue Sarcoma
Interventions: DRUG: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2026-06
Locations: Melbourne Theranostic Innovation Centre, Melbourne, Victoria, 3051, Australia

Summary:
Soft Tissue Sarcoma (STS) is a type of cancer that develops in soft tissues such as muscles, tendons, fat, blood vessels, and nerves. STSs generally express a protein called Platelet-Derived Growth Factor Receptor (PDGFR)α, which makes them a target for the development of STS therapies, such as olaratumab.

Olaratumab has been identified as a promising candidate to which radioactive substances can be attached for imaging or therapeutic purposes. Thus, this first in human imaging trial aims to study olaratumab combined with a radioactive metal called zirconium-89 (89Zr-TLX300-CDx) as a potential new product that may be used for STS imaging and identification of patients that may benefit from future treatments targeting PDGFRα.

Primary Outcome Measures: Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx, Number of Adverse events (AEs), 30 days|Biodistribution and radiation dosimetry of 89Zr-TLX300-CDx, Measurement of absorbed radiation doses to organs (Gy/MBq), tumour(s) and whole body (Sv/MBq)., 6 days|Pharmacokinetics (PK), Measure the antibody concentration at each timepoint to determine a PK curve., 6 days
Secondary Outcome Measures: Determine a suitable antibody mass for administration, SUV (max, mean) values of tumour lesions and tumour to background organ (e.g. blood/liver/muscle) ratios., 6 days
Other Outcome Measures: Evaluate the correlation between tumour uptake of 89Zr-TLX300-CDx and PDGFRα expression, Immunohistochemistry expression of PDGFRα in tumour tissue AND SUV (max, mean) tumour values and tumour to background ratios., 30 days|Compare the tumour uptake and detection of lesions between 89Zr-TLX300-CDx and standard of care imaging, 89Zr-TLX300-CDx uptake within tumours and organs and Localisation of tumour deposits on conventional imaging (CT, MRI and/or FDGPET), 30 days
The Efficacy and Safety of Low-Level Tragus Stimulation on Heart Rate Variability, Neutrophil-Lymphocyte Ratio, and Major Adverse Cardiovascular Events in Patients With ST-Segment Elevation Myocardial Infarction (TESLA-STEMI)
NCT Number: NCT06537583
Acronym: TESLA-STEMI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ST Elevation Myocardial Infarction
Interventions: DEVICE: Parasym Neuromodulation Device (Treatment Group)|DEVICE: Parasym Neuromodulation Device (Sham Group)
Sponsor: Universitas Diponegoro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2024-09-30
Locations: Dr. Kariadi Central General Hospital, Semarang, Central Of Java, Indonesia

Summary:
The goal of this clinical trial is to learn the effect of low level tragus stimulation (LLTS) on heart rate variability (HRV), neutrophil-lymphocyte ratio, and major adverse cardiovascular events in patient with ST-segment Elevation Myocardial Infarction (STEMI). It will also learn about the safety of LLTS in such setting. The main questions, it aims to answer are compared with sham control:

1. Does LLTS could alter low frequency/high frequency ratio in patients with STEMI?
2. Does LLTS could alter neutrophil-lymphocyte ratio in patients with STEMI?
3. Does LLTS could decrease mortality in patients with STEMI?
4. Does LLTS could decrease reinfarction event in patients with STEMI?
5. Does LLTS could decrease stroke event in patients with STEMI?
6. Does LLTS could decrease lethal arrhythmia event in patients with STEMI?
7. Does LLTS could decrease acute lung oedema event in patients with STEMI?
8. Does LLTS could decrease cardiogenic shock event in patients with STEMI?

Researchers will compare LLTS to sham LLTS control to see if LLTS have benefit in participants with STEMI participants will divided into two group i.e. treatment group vs control (sham/placebo) group, then both of them:

1. Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI)
2. Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI)
3. Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI
4. Undergo PPCI
5. Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI)
6. Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (PPCI)

Primary Outcome Measures: Major Adverse Cardiovascular Events, Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock, During hospitalization around up to 1 weeks
Secondary Outcome Measures: Heart Rate Variability, Heart Rate Variability measurement by using WeCardio device, Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)|Neutrophil-Lymphocyte Ratio, Neutrophil-Lymphocyte Ratio from laboratory findings, Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
The Effect of Guided Imagery Practice on Psychosocial Health and Fear of Childbirth in Primiparous Pregnant Women
NCT Number: NCT06537570
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Related
Interventions: BEHAVIORAL: Guided Imagery Practice
Sponsor: University of Gaziantep
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-07-20
Completion Date: 2024-01-01
Locations: Gaziantep Univeristy, Gaziantep, 0027, Turkey

Summary:
Physical changes that occur during pregnancy, transition to parenthood and taking on new responsibilities cause burden, anxiety and stress in women and negatively affect psychosocial health. One of the conditions that negatively affect psychosocial health during pregnancy is the fear of childbirth. One of the current methods used in the management of the pregnancy process is guided imagery.It is known that guided imagery practice reduces stress and anxiety in pregnant women, increases well-being and is beneficial to their daily lives, contributes positively to mother-baby attachment, and reduces pain in childbirth.

Primary Outcome Measures: Psychosocial Health Assessment Scale in Pregnancy, Psychosocial Health Assessment Scale in Pregnancy. The minimum score that can be obtained from the scale is 46 and the maximum score is 230., 12 weeks|Wijma Birth Expectation/ Experience Scale-A Version, 0 is expressed as "completely" and 5 is expressed as "none". While the minimum score on the scale is 0, the maximum score is 165., 12 weeks
Secondary Outcome Measures: Psychosocial Health Assessment Scale in Pregnancy sub-dimensions, In the scale, the first sub-dimension evaluates "Characteristics of pregnancy and spousal relationship", the second sub-dimension evaluates "Characteristics of anxiety and stress", the third sub-dimension evaluates "Characteristics of domestic violence", the fourth sub-dimension evaluates "Characteristics of psychosocial support need", the fifth sub-dimension evaluates "Family characteristics" and the items in the sixth sub-dimension evaluates "Characteristics of physical-psychosocial changes related to pregnancy". scale, it is stated that each item should be scored between 1-5 (1= Not at all, 2= A little, 3= Moderately, 4= A lot, 5= Very much). The minimum score that can be obtained from the scale is 46 and the maximum score is 230., 12 weeks
Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients
NCT Number: NCT06537557
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heat Stroke
Interventions: OTHER: the early in-hospital temperature management protocol for heat stroke patients
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Jinhua Municipal Central Hospital|Dongyang People's Hospital|Lanxi People's Hospital|Yiwu Central Hospital|Jinhua People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 188
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-30
Locations: Dongyang People's Hospital, Dongyang, China|The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, China|Jinhua Municipal Central Hospital, Jinhua, China|Jinhua People's Hospital, Jinhua, China|Lanxi People's Hospital, Lanxi, China|Yiwu Central Hospital, Yiwu, China

Summary:
Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. It is defined by an elevated core temperature exceeding 40°C and central nervous system abnormalities, accompanied by multi-organ dysfunction. The severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. Rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. Therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. However, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. To address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. This study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.

Primary Outcome Measures: Body temperature at 0.5 hours, Body temperature at 0.5 hour refers to a reading obtained 25 to 35 minutes after admission., 0.5 hours
Secondary Outcome Measures: Body temperature at 2 hours, Body temperature at 2 hours refers to a reading taken 100 to 140 minutes after admission, 2 hours|cooling rate at 0.5 hours, The cooling rate at 0.5 hours was calculated in reference to initial body temperature and body temperature at 0.5 hours, 0.5 hours|in-hospital mortality, Mortality from any cause during hospitalization, 30 days|3-month mortality rate, death within 3 months after emergency visit, 3 months|Number of participants with other complications, including heart failure, renal failure, coagulation disorders, respiratory failure, neurological sequelae, etc., 3 months
Comparison of Comprehensive Rehab Program and Pelvic Floor Training in Women With Stress Urinary Incontinence
NCT Number: NCT06537544
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress Urinary Incontinence
Interventions: OTHER: Comprehensive Rehabilitation Program|OTHER: Conventional Pelvic Floor Training
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2024-12
Locations: King Abdullah Teaching Hospital, Mansehra, KPK, 21300, Pakistan

Summary:
The goal of this clinical trial is to compare a comprehensive rehabilitation program and a conventional pelvic floor training program in women with stress urinary incontinence,to compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of SUI, on the strength of pelvic floor muscle and on quality of life in women with SUI. Following the randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.

Primary Outcome Measures: Severity of stress urinary incontinence, To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of stress urinary incontinence, Changes from Baseline to 8 weeks
Secondary Outcome Measures: Strength of pelvic floor muscle, To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the strength of pelvic floor muscle, Changes from Baseline to 8 weeks|Quality of life in women with stress urinary incontinence, To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on quality of life in women with stress urinary incontinence, Changes from Baseline to 8 weeks
Video Classification of Intubation in Spain (VCI)
NCT Number: NCT06537531
Acronym: VCI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Difficult Intubation
Interventions: OTHER: Compare VCI scale
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-26
Completion Date: 2025-12-01
Locations: Clinica Universidad de Navarra, Madrid, 28027, Spain|Miguel Angel Fernandez-Vaquero, Madrid, 28027, Spain

Summary:
Use of VCI in Spain

Primary Outcome Measures: VCI scale from intubator, VCI scale from intubator, minute 2|VCI scale from observer, VCI scale from observer, minute 2
The Difference Between Using Local and General Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair
NCT Number: NCT06537518
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ACL Injury
Interventions: DRUG: Dexamethasone injection|DRUG: Bupivacaine 0.375% Injectable Solution|DRUG: Bupivacaine 0.5% Injectable Solution
Sponsor: Benha University
Sex: ALL
Age: ADULT
Enrollment: 123
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-05-01
Completion Date: 2022-12-25
Locations: Benha faculty of Medicine, Banhā, El Qalyoubia, 13511, Egypt

Summary:
Arthroscopic knee injuries, such as the anterior cruciate ligament (ACL) injury, are common and often result in postoperative pain. Regional anesthetic techniques, such as femoral nerve block (FNB) and adductor canal block (ACB), can help alleviate pain and reduce opioid consumption. ACB, which blocks the saphenous nerve and obturator nerve branches, is preferred over FNB due to its potential to decrease mobility and increase falls risk. Dexamethasone, a potent glucocorticoid, is used as an adjuvant for ACB, but its perineural administration may carry neurotoxicity risks. Some pain physicians prefer intravenous administration to prolong the action of local anesthetics used in peripheral nerve blocks.

Primary Outcome Measures: Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-arthroscopic ACL management., Value of administration of dexamethasone enhancing the analgesic action of bupivacaine used in ACB after arthroscopic management of the ACL., 6 months
A Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Solid Tumors
NCT Number: NCT06537505
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Solid Tumor
Interventions: DRUG: Adebrelimab|DRUG: Apatinib|PROCEDURE: microwave ablation
Sponsor: Beidahuang Industry Group General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2027-08-31

Summary:
This is a multi-center, phase Il trial to evaluate the efficacy and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs in the treatment of advanced second-line and above solid tumors.

Primary Outcome Measures: Objective Response Rate, Determined using RECIST V1.1 criteria, defined as best overall response (CR or PR), up to 24 months
Secondary Outcome Measures: Disease control rate, Disease Control Rate determined usina RECIST V1.1 criteria., up to 24 months|Progression-free Survival, Defined as the time from randomization to the first occurrence of disease progression, up to 36 months|Overall Survival, Defined as the time from randomization to death from any cause., up to 36 months|incidence rate of AE, Incidence, nature, and severity of adverse events graded according to the NCI CCAE, up to 36 months
Other Outcome Measures: explore immune resistance mechanisms, to explore immune resistance mechanisms, up to 36 months
Combined Effects of Buteyko Breathing Technique and Chest Wall Mobilization on Pulmonary Functions and Quality of Life
NCT Number: NCT06537479
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Smokers
Interventions: OTHER: Buteyko breathing technique|OTHER: Chest Wall Mobilization
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2024-09-10
Locations: University of Lahore Teaching Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
The study aims to evaluate the effects of Buteyko breathing techniques with and without chest wall mobilization on pulmonary functions, and quality of life in chronic smokers. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS \& AHS. A non-probability convenient sampling technique will be used to recruit the individuals. Group 1-Buteyko breathing technique + Chest Wall Mobilization and Group 2-Buteyko Breathing Technique + Without Chest Wall Mobilization

Primary Outcome Measures: FEV1(Forced Expiratory Volume per second), Pulmonary Function Test using Digital Spirometer. • Forced Vital Capacity (FVC): the amount of air that can be forcefully exhaled after taking a complete breath., Pre and Post after 1 week|FVC(Forced Vital Capacity), Pulmonary Function Test using Digital Spirometer. the amount of air expelled during the first second of the forced ventilation test (FVC), which measures how rapidly the lungs can empty., Pre and Post after 1 week|St George Questionnaire, To assess the Quality of Life. The total questionnaire score is 100 (highest impairment) while the subscale values range from zero (no impairment), Pre and Post after 1 week
Ketogenic Diet in MASLD-related cACLD
NCT Number: NCT06537466
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Steatohepatitis, Nonalcoholic|Steatosis of Liver|Cirrhosis, Liver
Interventions: DIETARY_SUPPLEMENT: Mediterranean diet|DIETARY_SUPPLEMENT: Very Low Ketogenic Diet
Sponsor: University of Palermo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2026-11
Locations: Section of Gastroenterology, PROMISE, University of Palermo, Palermo, Italy

Summary:
The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.

Primary Outcome Measures: weight loss≥10% compared to the initial weight in individuals with cACLD secondary to MASLD, Weight in Kg, 48 weeks
Secondary Outcome Measures: ▪ changes in liver stiffness by Magnetic Resonance Elastography (MRE), MRE in KPa, 48 weeks|▪ changes in liver fat by Magnetic Resonance Imaging-proton density fat fraction (MRI-PDFF), MRI-PDFF in %, 48 weeks|▪ changes in liver stiffness by transient elastography, Liver Stiffness in KPa, 48 weeks|▪ changes in liver fat by controlled attenuation parameter (CAP), CAP in dB/m, 48 weeks|▪ changes in Spleen stiffness by Magnetic Resonance Elastography (MRE), Spleen Stiffness in KPa, 48 weeks|▪ changes in Spleen stiffness by Transient Elastography, Spleen stiffness in KPa, 48 weeks|▪ changes in AST serum levels, AST in IU, 48 weeks|▪ changes in ALT serum levels, ALT in IU, 48 weeks|▪ changes in GGT serum levels, GGT in IU, 48 weeks|▪ changes in alcaline phosphatase serum levels, alcaline phosphatase in IU, 48 weeks|▪ changes in albumin serum levels, albumin in g/L, 48 weeks|▪ changes in INR serum levels, INR in IU, 48 weeks|▪ changes in bilirubin serum levels, bilirubin in mg/dl, 48 weeks|▪ changes in total, HDL and LDL cholesterol serum levels, total, HDL and LDL cholesterol in mg/dl, 48 weeks|▪ changes in glucose serum levels, gluceos in mg/dl, 48 weeks
Effect of Acupuncture on Opioid-associated Constipation in Cancer Patients
NCT Number: NCT06537440
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid-associated Constipation in Cancer Patients
Interventions: OTHER: electro-acupuncture
Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-05-22
Locations: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin, 300193, China

Summary:
To evaluate the efficacy and safety of acupuncture for opioid-associated constipation in cancer patients.

Primary Outcome Measures: Respondent ratio, Patients will have at least three spontaneous bowel movements (SBM) per week during the treatment period and an increase of at least one SBM from baseline during the treatment period.A bowel movement can only be described as SBM if it has occurred without any intervention to assist in defecation in the past 24 hours., 1-2 week