pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
NCT Number: NCT06516978
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Interventions: DRUG: Polatuzumab vedotin|DRUG: Rituximab|DRUG: Cyclophosphamide|DRUG: Doxorubicin|DRUG: Vincristine|DRUG: Prednisone|DRUG: Orelabrutinib|DRUG: Venetoclax|DRUG: Chidamide|DRUG: Penpulimab|DRUG: Lenalidomide
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 528
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-04-01

Summary:
This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.

Primary Outcome Measures: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, At 24 months
Secondary Outcome Measures: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]|Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]|Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma, up to approximately 48 months|Overall Survival (OS), up to approximately 48 months|Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), From enrollment to study completion, a maximum of 48 months
The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin
NCT Number: NCT06516939
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sensitive Skin
Interventions: DRUG: bFGF|DRUG: Bovine Basic Gel
Sponsor: Shanghai Dermatology Hospital
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-07-18
Locations: Shanghai Skin Disease Hospital, Shanghai, China

Summary:
The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin

Primary Outcome Measures: erythema index, The change rate in lesion clearance of face at 1 month after treatment will be measured as the primary outcome, 0、1、2、4 week
SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
NCT Number: NCT06516926
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
Interventions: DRUG: SHR-4602
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
This is an open-label, randomized, multi-center phase II study to evaluate the safety, tolerability, PK, and efficacy of SHR-4602 monotherapy in subjects with HER2-expressing or -mutated unresectable or metastatic solid tumors.

During the study, a safety monitoring committee (SMC), consisting of the principal investigator, sponsor representative, etc., will be established to review data from the study regarding safety, PK, efficacy, etc. The SMC will make decisions on study-related issues.

The study includes a screening period (begins when the informed consent form (ICF) is signed and ends at the first dose), a treatment period (from the first dose to the last dose), and a follow-up period (end-of-treatment safety follow-up).

Primary Outcome Measures: Two years objective response rate (ORR);, Two years
Secondary Outcome Measures: Duration of response (dor), Two years|Progression-free survival (PFS), Two years|Best overall response (BOR), Two years|Disease control rate (DCR), Two years|Incidence and severity of adverse events (aes), Two years|Severe adverse events (saes) (graded as per CTCAE v5.0), Two years|Blood concentrations of conjugated antibodies, Two years|Blood concentrations of total antibodies, Two years|Blood concentrations of free toxin., Two years
A Study of Subcutaneous Injection in Healthy Participants
NCT Number: NCT06516913
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DEVICE: Syringe Pump
Sponsor: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07
Completion Date: 2024-09
Locations: Fortrea CRU, Inc., Dallas, Texas, 75247, United States

Summary:
The goal of this exploratory study is to learn about the effects of subcutaneous injections on healthy participants.

The study aims to explore how different delivery methods containing a solution impacts injection pain, without an active drug to complicate the results.

Pain assessments will be performed visually and at the injection site to determine the level of pain experienced after each injection.

This study will last approximately 40 days, including screening, assessment, and follow-up.

Primary Outcome Measures: Visual analogue scale (VAS) Pain score at Injection Site, Needle insertion to 240 minutes
Reducing Foot Pain and Peak Plantar Pressure in Patients With Foot Pain
NCT Number: NCT06516900
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Foot Pain
Interventions: DEVICE: OrthoFeet HandsFree Therapeutic Shoe
Sponsor: University of Texas Rio Grande Valley
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-05
Completion Date: 2025-12-31
Locations: Hafizur Rahman, Harlingen, Texas, 78550, United States

Summary:
The research project aims to evaluate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain.

Primary Outcome Measures: Foot pain, Foot pain will be assessed using the Foot Function Index (FFI) questionnaire. It has three subsections: pain, disability, and activity limitation. The scores for the pain and disability subsections range from 0 to 90 (0 represents best and 90 represents worst), and the score for activity limitation ranges from 0 to 50 (0 represents best and 50 represents worst)., Baseline, 6 weeks, 12 weeks|In-shoe Peak Plantar pressure, In-shoe peak plantar pressure data will be recorded as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal (kPa)., Baseline, 6 weeks, 12 weeks|Pressure-Time Integral, Pressure-Time integral data for different foot regions will be measured as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal-sec (kPa-s)., Baseline, 6 weeks, 12 weeks
Secondary Outcome Measures: Quality of life, Medical Outcomes Study 36-item Short Form questionnaires (SF-36) will be used to assess the quality of life. The SF-36 form has four subsections: pain, distance, walking speed, and stair climbing. Each subsection score ranges from 0 to 100 (where 0 is the worst, and 100 is the best health status)., Baseline, 6 weeks, 12 weeks|Physical activity, Physical activity will be expressed in terms of average steps per day. Patients will wear Actigraph accelerometers for seven consecutive days, and we will record the average steps per day., Baseline, 6 weeks, 12 weeks
Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma
NCT Number: NCT06516887
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Lung Adenocarcinoma
Interventions: DRUG: bemcentinib|DRUG: pacritinib
Sponsor: The University of Texas Health Science Center at San Antonio
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01
Locations: University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States

Summary:
This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.

Primary Outcome Measures: Progression Free Survival (PFS), PFS will be defined as the time from the date of randomization to the date of disease progression or death (any cause), whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD will be censored in the PFS analysis at the last known date the subject was documented progression free prior to completing follow-up or initiating the new therapy., Up to 48 months|Overall Response Rate, Overall response rate is defined as the proportion of patients who have a partial or complete response to therapy., Up to 48 months
Secondary Outcome Measures: Overall Survival (OS), The time from randomization to death from any cause, Up to 48 months|Clinical Benefit Rate, The percentage of patients with metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention, Up to 48 months
Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels
NCT Number: NCT06516861
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Intubation Complication
Interventions: DRUG: Magnesium Sulfate 20 MG/ML|DRUG: Lidocaine IV|DRUG: saline solution
Sponsor: Arsil Radiansyah
Collaborators: Universitas Sumatera Utara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-01-31
Completion Date: 2024-03-01
Locations: Adam Malik General Hospital, Medan, Sumatera Utara, 20136, Indonesia

Summary:
The sample was randomly divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. These groups will be checked for hemodynamic changes and cortisol values.

Primary Outcome Measures: Systolic Blood Pressure, mmHg, 1 month|Diastolic Blood Pressure, mmHg, 1 month|Mean Arterial Pressure (MAP), Estimated by using a formula in which the lower (diastolic) blood pressure is doubled and added to the higher (systolic) blood pressure and that composite sum then is divided by 3 to estimate MAP, 1 month|Heart Rate, beats per minute, 1 month
Secondary Outcome Measures: Cortisol Levels, Cortisol Levels in nmol/L, 1 month
The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
NCT Number: NCT06516809
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Healthy
Interventions: DEVICE: DormoTech Vlab SpO2 sensor
Sponsor: Dormotech Medical
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2024-05-30
Locations: Vital Signs Research Group, San Francisco, California, 94107, United States

Summary:
The purpose of the study is to determine the accuracy of the Dormotech VLAB (SpO2) Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions \[510(k)s\], in range of arterial HbO2 saturations from 100% down to 70%.

This was a prospective study with healthy volunteers.

The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70%. As the primary endpoint, the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief, steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a multi-wavelength hemoximeter).

Primary Outcome Measures: Measurement of arterial HbO2 saturations from 100% down to 70%, At the start of each testing cycle, one blood sample was taken while breathing room air.

Subjects then breathed through a partial rebreathing circuit with a nose clip, a mixture of nitrogen, air and carbon dioxide to reach six different stable levels (plateaus) of oxyhemoglobin saturation between 70-100%., day 1
Omitting of Lymphadenectomy is Acceptable for Lung Cancer Smaller Than 6 mm in Solid Size
NCT Number: NCT06516796
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer
Interventions: OTHER: No intervention
Sponsor: Liang Chen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2713
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-02-01
Locations: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China

Summary:
Many studies suggested that selective lymph node sampling was acceptable for specific non-small cell lung cancer (NSCLC). This study aimed to evaluate the acceptability of omitting of lymphadenectomy for selected NSCLC.

Patients with small-sized (≤2 cm) NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened.

Primary Outcome Measures: Overall survival (OS), OS was defined from the surgical date to the date of death or the date of the last follow-up. defined from the surgical date to the date of death or the date of the last follow-up., OS was defined from the surgical date to the date of death or the date of the last follow-up, whichever came first, assessed up to 14 years.
A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.
NCT Number: NCT06516757
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginal Health|Bacterial Vaginosis
Interventions: DIETARY_SUPPLEMENT: Boric Acid Suppository
Sponsor: Love Wellness
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-04-05
Completion Date: 2024-07-05
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).

Primary Outcome Measures: Vaginal Health and Balance, Evaluation of vaginal health and balance via participant questionnaires., Baseline, Day 3, Day 7, and Day 8|Vaginal Health and Balance, Vaginal pH testing, Baseline, and Day 8
Secondary Outcome Measures: Participant Perception of Product Convenience, Assessment of participant perception of the convenience of the boric acid suppository compared to other boric acid suppositories via questionnaires., Day 3 and Day 7
A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.
NCT Number: NCT06516744
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Digestive Health|Digestion
Interventions: DIETARY_SUPPLEMENT: Bye Bye Bloat Capsules
Sponsor: Love Wellness
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-08
Completion Date: 2024-04-20
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Measurements and questionnaires will be completed at Baseline, first use, Week 2, and Week 4.

Primary Outcome Measures: Reduction in Bloating, Evaluation of parameters associated with hormonal and food-related bloating through self-reported questionnaires taken at Baseline, first use, Week 2, and Week 4., Baseline, first use, Week 2, and Week 4
Secondary Outcome Measures: Improvement in Digestion and Mental Well-being, Assessment of changes in participant perception of digestion, gas, mental health, and well-being associated with bloating through self-reported questionnaires taken at Baseline, first use, Week 2, and Week 4., Baseline, first use, Week 2, and Week 4
A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
NCT Number: NCT06516731
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginal Health|Vaginal pH
Interventions: DIETARY_SUPPLEMENT: pH Balanced Cleanser
Sponsor: Love Wellness
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-09
Completion Date: 2024-06-03
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.

Primary Outcome Measures: Effect of pH Balanced Cleanser on Vulvar and Vaginal Health, Parameters associated with vulvar and vaginal health, including odor and pH levels, will be evaluated. Participants will complete questionnaires at Baseline, first use, Week 2, Week 4, Week 6, and Week 8., Baseline, first use, Week 2, Week 4, Week 6, Week 8|Effect of pH Balanced Cleanser on Vulvar and Vaginal Health, Vaginal pH testing will be conducted weekly from Baseline to Week 8., Baseline and Week 8
Secondary Outcome Measures: Tolerability of pH Balanced Cleanser, The tolerability of the product will be evaluated via questionnaires at first use, Week 2, Week 4, Week 6, and Week 8. Parameters of interest include reported irritation or itchiness associated with the product, comfort when using the product, negative changes in vaginal pH associated with product use, and participants' overall perceptions of the product., Baseline, first use, Week 2, Week 4, Week 6, Week 8
The Effectiveness of Multimedia Education on Hypoglycemic Management.
NCT Number: NCT06516705
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type2diabetes|Hypoglycemia
Interventions: BEHAVIORAL: Hypoglycemia education
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 83
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2021-11-09
Completion Date: 2023-12-31
Locations: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 807, Taiwan

Summary:
The first phase of the research was to develop tools, including scales and multimedia, and the second phase was to carry out multimedia hypoglycemia education intervention measures. An experimental randomized controlled trial with a repeated measures design was conducted in second phase. Participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education. Structural questionnaires were used for data collection. The study was to investigate the effectiveness of multimedia hypoglycemia education compared to conventional hypoglycemia education on knowledge, self-care behavior, fear of hypoglycemia, social support, quality of life, nursing hours, education satisfaction, and the recurrence rate of hypoglycemic events among patients with type 2 diabetes.

Primary Outcome Measures: The score of hypoglycemia knowledge, Hypoglycemia management knowledge scale to collect the score in Knowledge (0-25 points), Through study completion, an average of 6 months after education.|The score of hypoglycemia self-care behavior, Hypoglycemia self-care behavior scale to collect the score in Behavior ( 26-130 points), Through study completion, an average of 6 months after education.|Nursing hours, Form Recorded for Health Education Time, Through study completion, an average of 6 months after education.|The score of education satisfaction, Education satisfaction scale to collect the score in education satisfaction ( 5-25 points), Through study completion, an average of 6 months after education.|The recurrence rate of hypoglycemic events, Questionnaire to collect the changes in hypoglycemic events ( time and symptoms), Through study completion, an average of 6 months.
Secondary Outcome Measures: The score of fear of hypoglycemia, Hypoglycemia fear scale to collect the score in fear of hypoglycemia (0-52 points), Through study completion, an average of 6 months after education.|The score of social support, Social support scale to collect the score in social support (0-52 points), Through study completion, an average of 6 months after education.|The score of quality of life, Quality of life scale to collect the score in quality of life (16-80 points), Through study completion, an average of 6 months after education.
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
NCT Number: NCT06516679
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Leukemia, Lymphoid
Interventions: DRUG: Consolidation #4(without daunorubicin)|DRUG: Consolidation #4(with daunorubicin)|DRUG: Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)
Sponsor: Yonsei University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2032-12-31
Locations: Severance Hospital, Seoul, Korea, Republic of

Summary:
This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment.

In addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.

Primary Outcome Measures: 3-years Overall survival(OS) rate, The 3-years overall survival rate defined as the percentage of subject in a treatment group who are alive three years after the start of treatm, 3-years
Secondary Outcome Measures: Overall survival (OS), The overall survival rate defined as the percentage of subject in a treatment group who are alive five years after the start of treatment., Up to 5years|Event Free Survial(EFS), EFS is defined as the period from study enrollment until disease progression, including hematological recurrence of ALL, development of secondary malignancy, or death from any causes, whichever occurs earlier., 3-years and 5-years|The rate of hematopoietic stem cell transplant patients by risk group, through study completion, an average of 1 year, Up to 5years|recurred rate, As a the period from enrollment to disease progression/recurrence, Up to 5years|Death rate related to infusion, The time until defined by date of drug-related mortality from the date of 1st infusion, Up to 5years
Psychophysiological Effects of Music
NCT Number: NCT06516666
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sadness
Interventions: BEHAVIORAL: Music
Sponsor: Zhejiang University
Sex: ALL
Age: ADULT
Enrollment: 149
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-04-18
Completion Date: 2023-06-20
Locations: Shulin Chen, Hangzhou, Zhejiang, 310058, China

Summary:
This study employed a repeated measure between-subjects design. Two groups (i.e., depressed group and non-depressed group) of participants were recruited. Each participant experienced four stages: baseline, neutral control, sadness induction, and music intervention. The outcome variables were self-reported emotion and Heart Rate Variability features. Emotions were reported at the end of every stage. Electrocardiogram signals were recorded throughout the experiment.

Primary Outcome Measures: Self-Assessment Manikin (SAM), The SAM scale is a brief and widely used tool for assessing emotional states. The scale is a nonverbal self-report measure of emotion, using a set of cartoon-like manikins. The manikins illustrate nine intensity levels for valence (1 = unpleasant; 9 = pleasant), arousal (1 = calm, 9 = excited), and dominance (1 = controlled; 9 = controlling)., Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.|Revision of Positive Affect and Negative Affect Scale (PANAS-R), The PANAS is another widely used scale to measure mood or emotion. The Chinese version of PANAS is comprised of 18 items, with 9 items measuring positive affect (e.g., joyful, inspired) and 9 items measuring negative affect (e.g., sad, fearful). Because participants were required to report their feelings repeatedly in this study, 18 items would be too long and tiresome. The 18 items plus "calmness" were used as 19 options for participants to choose. They needed to select one of the emotion words to tag their strongest emotion for the stage that they had just experienced. This revision of PANAS allowed us to capture the specific emotion type., Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.|Mean of Normal-to-Normal Intervals (MeanNN), MeanNN refers to the average duration between consecutive normal heartbeats, also named inter-beat interval. A higher MeanNN indicates a lower heart rate., Throughout the whole experiment, an average of 6 minutes for each stage.|Standard Deviation of Normal-to-Normal Intervals (SDNN), SDNN measures the overall variability of heart rate. Higher SDNN values indicate greater variability., Throughout the whole experiment, an average of 6 minutes for each stage.
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
NCT Number: NCT06516653
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End Stage Renal Disease
Interventions: DEVICE: VasQ|PROCEDURE: Arteriovenous fistula creation for dialysis vascular access
Sponsor: Laminate Medical Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-12
Completion Date: 2028-05

Summary:
VasQ is an external support implant for arteriovenous fistulas created for dialysis access.

This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:

* Treatment arm: End to side fistula supported with VasQ
* Control: Standard of care end to side fistula

Primary Outcome Measures: Fistula functional success, The time, in days, to the first day of a 28-day period in which the study fistula was able to be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis, 6 months
Other Outcome Measures: Safety - vascular access related complications, Comparable rate of access related complications (including major reintervention and cannulation related complications), 1 year
Fulminant Severe CAP - an Observational Study
NCT Number: NCT06516601
Acronym: FULMISCAP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Community-acquired Pneumonia|Severe Pneumonia|ARDS, Human|Sepsis
Interventions: OTHER: no intervention
Sponsor: University of Trieste
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1460
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-02
Completion Date: 2024-10-01
Locations: Marco Confalonieri, Trieste, TS, 34149, Italy|SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina, Trieste, 34126, Italy

Summary:
Severe community-acquired pneumonia (CAP) represents a major cause of hospital mortality. Among severe CAP cases, some exhibit a rapidly progressive evolution, leading to severe ARDS/acute respiratory failure and septic shock within hours to a few days. This type of pneumonia, known as "fulminant pneumonia," is characterized by its rapid onset and deterioration, often necessitating immediate medical intervention. Despite its severity, the true incidence and optimal treatment for fulminant pneumonia are not well understood. This knowledge gap is due to the lack of attention towards pneumonia as a potential time-dependent illness and the separation of overlapping clinical topics: severe pneumonia, ARDS, and sepsis.

In clinical practice, pneumonia is the most frequent cause of both ARDS and sepsis. However, these conditions are often considered separately, combining ARDS and sepsis from various extra-pulmonary causes with those originating from pneumonia. The COVID-19 pandemic, with its vast number of severe CAP cases in a short period, has highlighted the existence of fulminant pneumonias, underscoring the need for further investigation. Recent randomized clinical trials (RCTs) and experiences from COVID-19 have suggested that early and prolonged corticosteroid administration can reduce mortality in patients with severe SARS-CoV-2 infection and severe CAP/ARDS of bacterial origin.

The aim of this observational study is to analyze the rate of fulminant pneumonia and assess the impact of early corticosteroid treatment in a multicentric population of hospitalized patients with severe pneumonia.

Primary Outcome Measures: mortality, mortality in hospital, 2days, 7days, 30days, 60days
tDCS for Post-Stroke Cognitive Impairment
NCT Number: NCT06516588
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Stroke|Mild Cognitive Impairment
Interventions: DEVICE: Transcranial Dirrect Current Stimulation
Sponsor: University of Oklahoma
Collaborators: American Heart Association
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-06-30
Locations: University of Oklahoma, Oklahoma City, Oklahoma, 73117, United States

Summary:
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (PSCI).

Primary Outcome Measures: Montreal Cognitive Assessment (MoCA), It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia., Changes from baseline after intervention week (two weeks), one and three months|NIH Toolbox, NIH Toolbox tests is a computarize test that acess fluid abilities (i.e., working memory, processing speed, episodic memory, and two aspects of executive functioning) and crystallized abilities (i.e., dependent upon past learning and experience), resulting in Standard Scores for these superordinate categories, as well as a total Composite score of all tests.These norms were previously reported to align with the age-corrected normative data for the traditional neuropsychological measures., Changes from baseline after one and three months
Secondary Outcome Measures: Neurovascular Coupling - Cerebral blood flow (fNIRS), fNIRS signal will be recorded using the 16-source/16-detector system (NIRSport, NIRx), Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months|Brain Function (EEG), EEG signal will be recorded at 1 kHz using a 16-channel system (HIAMP,g.tec)., Changes on EEG signal from baseline after after intervention week (two weeks), one and three months|Neurovascular Coupling - (DVA), DVA signal ill be recorded as the mean maximal arteriolar dilation and mean maximal venular dilation in response to flicker light stimulation., Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months|Blood markers, Bblood draw via venipuncture and collect up to 40mL of blood for each visit. We will separate set of plasma (for study 4), serum samples, whole blood, and blood cells (including white blood cells) , a set of each will be stored for future analyses., Changes on blood marker levels from baseline after intervention week (two weeks), one and three months
Listening Effort in Cochlear Implant Users
NCT Number: NCT06516575
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Auditory Perception; Abnormal|Hearing Loss, Sensorineural|Hearing Loss
Interventions: BEHAVIORAL: sentence manipulations
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-09-01
Completion Date: 2028-08-31
Locations: University of Minnesota, Minneapolis, Minnesota, 55455, United States

Summary:
People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation. Listening effort can lead to fatigue, mental strain, burnout, medical sick leave, and the need for increased time to recover from regular daily activities. This proposal aims to understand effort changes on a moment-to-moment basis during listening, how long the effort lasts, and how the planning and execution of effort is impacted by the experience of using a cochlear implant.

Primary Outcome Measures: Listening effort, Listening effort is inferred by measuring changes in pupil dilation linked to stimulus landmarks, 60 - 90 minute testing session|Speech intelligibility, Intelligibility is scored by tallying the accuracy of spoken responses to auditory speech stimuli, 60 - 90 minute testing session
Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study
NCT Number: NCT06516562
Acronym: MCR-HF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Heart Failure With Reduced Ejection Fraction|Heart Failure With Mid Range Ejection Fraction
Interventions: DRUG: Optimal treatment
Sponsor: University Medical Center Ho Chi Minh City (UMC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2028-06-01
Locations: University Medical Center Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

Summary:
Describe the clinical characteristics, paraclinical features, and treatment during hospitalization, as well as at 1, 3, and 12 months post-discharge, of heart failure patients at selected cardiovascular centers in Vietnam.

Primary Outcome Measures: All-cause mortality, Death from any cause, 12 months|Heart failure rehospitalization, Patient rehospitalization due to cardiovascular causes, excluding apparent non-cardiac causes., 12 months
Secondary Outcome Measures: Major adverse cardiovascular events, Acute myocardial infarction, stroke or death from any cause, 12 months|Guideline-directed medical therapy detail, Information regarding guideline-directed medical therapy, including medications used and dose titration over time., 12 months
Evaluation of Skipping Rope and Informational Pamphlet Among Adolescents in South Africa
NCT Number: NCT06516549
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Moderate-vigorous Physical Activity (MVPA)
Interventions: OTHER: Skipping rope and informational pamphlet
Sponsor: University of KwaZulu
Collaborators: Harvard School of Public Health (HSPH)|Africa Academy for Public Health|Heidelberg University|Technical University of Munich|USINGA Health and Demographic Surveillance System
Sex: ALL
Age: CHILD
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-05
Completion Date: 2025-08-30
Locations: University of KwaZulu-Natal, Durban, KwaZulu-Natal, 4091, South Africa

Summary:
The purpose of the study is to evaluate the impact of providing a skipping rope and informational pamphlet to adolescents aged 10-14 years on their physical activity intentions and behaviors from baseline to 12-month follow-up when compared with adolescents of the same age who are not provided with any intervention. This study comprises a two-arm randomized controlled trial nested within an adolescent cohort, i.e. a 'randomized trial-within-cohort'. The intervention will include providing each participant with a skipping rope and a pamphlet with general instructions for skipping the rope and messages about the importance of physical activity. The investigators hypothesize that adolescents in a South African community who are provided with a skipping rope and an informational pamphlet on physical activity will engage in more physical activity behaviors and will report greater intentions to be physically active at a 12-month follow-up, compared to a control group of adolescents who do not receive the intervention.

Primary Outcome Measures: Duration of moderate to vigorous physical activity (MVPA) per week, Total minutes of MVPA/week. This will be calculated by multiplying the minutes of MVPA on the most recent day participant did MVPA by the number of days MVPA was done., Baseline and follow up at 12 months after baseline
Secondary Outcome Measures: Proportion of adolescents who meet the MVPA recommendations over the 7 days preceding the interview, Percentage of adolescents who meet the WHO MVPA recommendations of at least 60 minutes/day of MVPA across the week (\>=420 minutes/week), Baseline and follow up at 12 months after baseline|Intention to engage in physical activity compared to the 7 days preceding the interview, Intention to engage in physical activity compared to previous 7 days. This will be evaluated by asking participants if they intend to change the amount of physical activity they do in the 7 days following the interview, compared to the 7 days preceding the interview., Baseline and follow up at 12 months after baseline
Other Outcome Measures: Utilization of rope, process outcome, Utilization modality of skipping rope, that is alone or with friends, among intervention group, At the 12-month follow up assessment after baseline
Impact of Pulsed Electromagnetic Field (PEMF) on Human Peri-implant Tissues
NCT Number: NCT06516523
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis|Dental Plaque
Interventions: PROCEDURE: PEMF and Control/Sham|DEVICE: PEMF and without PEMF
Sponsor: University of Guarulhos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-01
Completion Date: 2024-07-01
Locations: Guarulhos University, Guarulhos, Sao Paulo, 073040, Brazil

Summary:
Pulsed Electromagnetic field (PEMF) has been shown to heighten bone regeneration and wound healing in various clinical areas, including dentistry. In Oral implantology, PEMF stimulation may enhance peri-implant bone formation and secondary stability and modulate the peri-implant microbiome. This randomized controlled study will evaluate:

1. the impact of PEMF around interim additive manufacturing (AM) implants immediately loaded and retrieved from human jaws after 60 days.
2. the effect of PEMF on diseased dental implants using non-surgical therapy.

Primary Outcome Measures: Non-surgical Treatment of peri-implantitis, reduction of probing depth, 12 months|Bone formations under PEMF, BIC% increase, 2 months
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
NCT Number: NCT06516510
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Metastatic Prostate Cancer
Interventions: DRUG: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
Sponsor: Blue Earth Therapeutics Ltd
Collaborators: Medpace, Inc.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-01

Summary:
A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Primary Outcome Measures: To compare the ratio of the kidney and the tumour absorbed doses of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan., 4-12 weeks
Secondary Outcome Measures: To compare the absorbed dose of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan to tumour lesions and additional organs of interest., 4-12 weeks|To compare the tumour and normal organ effective half lives of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan., 4-12 weeks|To further evaluate the safety profile through frequency of treatment related adverse events of lutetium (177Lu) rhPSMA 10.1 injection, 4-12 weeks
Use of Motion Sensors in Correction Procedures of Long Bone Deformities in the Pediatric Age Group
NCT Number: NCT06516497
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Angulation Deformity of Long Bone (Disorder)|Acquired Deformity of Knee Joint (Disorder)
Interventions: OTHER: Group using traditional method in long bone deformity correction|DEVICE: Group using computer-aided sensors in long bone deformity correction
Sponsor: Ataturk University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-05
Completion Date: 2024-10-02
Locations: Ataturk University, Erzurum, 25000, Turkey

Summary:
Motion sensors will be used in long bone deformity surgery in pediatric patients.

In patients whose deformity status is determined before the surgery, 2 wires will be placed in the same plane from the proximal and distal of the determined osteotomy line to the long bones of the patients who are anesthetized during the surgery and motion sensors will be placed on the wires. Osteotomy will be performed on the bone with deformity from the deformity center. While correcting the degree of deformity, fixation with plate and screws will be performed after the amount of correction determined preoperatively is achieved. Thanks to the sensors and application, it will be determined exactly how many degrees of deformity will be corrected in the case. At the same time, multiplanar and difficult-to-detect deformities will be corrected almost ideally with the help of motion and acceleration sensors. Approximately at the 6th week after the case, deformity correction status will be recorded again with gait analysis and physical examination following the removal of the cast, splint and bone healing. The results will be compared after the traditional method and the method using sensors are performed with an equal number of patients. As a result, it is aimed to clearly correct the deformity quantitatively and shorten the surgical time.

Primary Outcome Measures: measuring preoperative deformity angles, A preoperative clinical examination will be performed in pediatric orthopedic deformity patients, especially in patients who lean in, lean out, or cannot fully extend their knees. During the clinical examination, measurements will be made with a goniometer or on a computer by taking photographs. For rotational deformities in the transverse plane, the foot advancement angle, femoral internal and external rotation angles, and transmalleolar axis angle will be measured and noted. In patients with extension limitation, the degree of limitation will be measured by goniometer or conventional radiographs. The amount of deformity will be determined exactly and the surgery will be performed., 2 months|measuring postoperative deformity angles, The amount of deformity corrected after surgery will be measured and noted by clinical examination and conventional x-rays 2 months later, after the child has recovered., 2 months
Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study
NCT Number: NCT06516484
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Aplastic Anemia
Interventions: DRUG: Romiplostim
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-12-31
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
To investigate the efficacy and safety of roprostin in the treatment of refractory AA after radiotherapy.

Primary Outcome Measures: ORR, Overall response rate (ORR) is defined as the ratio of complete response (CR) + partial response (PR).CR is defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients not receiving transfusion.PR is defined as not transfusion dependent (if previously dependent), or at least one cell lineage doubled or normalised or increased at baseline, or initial ANC \< 0.5 x 10\^9/L increased by at least 0.5 x 10\^9/L after treatment, or initial PLT \< 20 x 10\^9/L increased by at least 20 x 10\^9/L after treatment., 3 months, 6 months|CRR, Overall response rate (ORR) is defined as the ratio of complete response (CR) + partial response (PR).CR is defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients not receiving transfusion.PR is defined as not transfusion dependent (if previously dependent), or at least one cell lineage doubled or normalised or increased at baseline, or initial ANC \< 0.5 x 10\^9/L increased by at least 0.5 x 10\^9/L after treatment, or initial PLT \< 20 x 10\^9/L increased by at least 20 x 10\^9/L after treatment., 3 months, 6months
Secondary Outcome Measures: safety events, Proportion and severity of adverse events in patients during the study period, 3 months，6months