pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials
NCT Number: NCT06548139
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Rabies Virus Infection
Interventions: DRUG: Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg|DRUG: Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg|DRUG: Rabies Human Immunoglobulin (HRIG)|BIOLOGICAL: Lyophilized rabies vaccine for human use (Vero cells)
Sponsor: Changchun BCHT Biotechnology Co.
Collaborators: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine|Anning City First People's Hospital|Yunnan Central Hospital|Beijing Contreke Statistical Technology Co., LTD|Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-31
Completion Date: 2025-05-31
Locations: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Kunming, Yunnan, 650000, China

Summary:
To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people

Primary Outcome Measures: Rabia for neutralizing antibody activity, Geometric mean RVNA concentration on day 7 after medication; Proportion of volunteers with 0.5 IU / ml of RVNA on day 7 after medication., 7 Days
Secondary Outcome Measures: Rabia for neutralizing antibody activity, RVNA detection rate at days 0.5,1,2,3,5,7,14,28,42,84, and 105 after drug administration.

Geometric mean concentration and relative antibody positive rate at days 0.5,1,2,3,5,105,28,42,84,105 (RVNA 0.5 IU / ml)., 105 Days|Safety evaluation index, Clinical indicators:Physical examination., 105 Days|Safety evaluation index, Vital signs: ear temperature/℃, 105 Days|Safety evaluation index, Vital signs: blood pressure (sitting position)/mmHg, 105 Days|Safety evaluation index, Vital signs: pulse rate/Time / minute., 105 Days|Safety evaluation index, 12-lead ECG all were abnormal and clinically significant by the investigator, 105 Days|Safety evaluation index, local reaction;constitutional reaction., 105 Days|Safety evaluation index, Laboratory indicator all were abnormal and clinically significant by the investigator, 105 Days|Immunogenicity evaluation index, Positive rate of anti-drug antibodies (ADA) on days 14,28,84,105 after administration. If ADA positive, continue to evaluate whether it is rabies mAb CBB 1 neutralizing antibody, 105 Days
Sensory Synchronized Imaging and Neuromodulation
NCT Number: NCT06548113
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder
Interventions: DEVICE: TMS
Sponsor: Stanford University
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10
Completion Date: 2029-10
Locations: Stanford University, Stanford, California, 94305, United States

Summary:
The purpose of this research study is to better understand the relationship between the type of brain stimulation used and how it changes brain activity in adult military Veterans. The goal is to use this understanding to develop new, personalized brain stimulation. The investigators evaluate brain changes from different types of transcranial magnetic brain stimulation (TMS).

Primary Outcome Measures: Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change, Change in the TMS-EEG measure will be assessed before, during, and after each TMS session. Specifically, the difference in size of the evoked response after a single TMS pulse in the frontoparietal region will be quantified in microVolts and compared between standard TMS and sensory-entrained TMS (se-TMS)., 45 minutes
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
NCT Number: NCT06548100
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Generalized Lipodystrophy
Interventions: DRUG: mibavademab
Sponsor: Regeneron Pharmaceuticals
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-30
Completion Date: 2027-07-12

Summary:
This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.

The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin.

The study is looking at several other research questions, including:

* What side effects may happen from taking mibavademab
* How much mibavademab is in the blood at different times
* Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)

Primary Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs), Up to week 68|Severity of TEAEs, Up to week 68
Secondary Outcome Measures: Change in Hemoglobin A1c (HbA1c), Baseline, week 20 and week 52|Occurrence of HbA1c <7%, Week 20 and week 52|Occurrence of HbA1c <6.5%, Week 20 and week 52|Occurrence of requiring therapy with insulin in participants treated with mibavademab, Week 20 and week 52|Change in total insulin dose, Baseline, week 20 and week 52|Change in fasting plasma glucose, Baseline, week 20 and week 52|Percent change in fasting triglycerides, Baseline, week 20 and week 52|Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab, Baseline, week 20 and week 52|Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab, Baseline, week 20 and week 52|Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab, Baseline, week 20 and week 52|Concentrations of total mibavademab in serum, Up to week 68|Incidence of anti-drug antibodies (ADAs) to mibavademab, Up to week 68|Titer of ADAs to mibavademab, Up to week 68|Incidence of neutralizing antibodies (Nabs) to mibavademab, Up to week 68
Use Of Gigstride Device In Patients With Lower Extremity Deficit
NCT Number: NCT06548087
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ambulation Difficulty|Lower Extremity Problem
Interventions: DEVICE: Gigstride Ambulatory Device
Sponsor: Johns Hopkins University
Collaborators: Gigstride Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-09
Completion Date: 2025-09

Summary:
For patients with lower extremity deficits, the investigator(s) would like to assess implementing use of Gigstride ambulatory device to assess the following:

* Patient satisfaction with use of ambulatory device
* Effects of Gigstride device utilization on kinetics, biomechanics
* Effects of Gigstride device utilization on walking speed, stair speed, stability

Primary Outcome Measures: Device Feasibility as assessed by ambulatory device aid score, The investigators will assess the participants comfort and ease of use of the proposed device with a questionnaire that consists of 11 questions in a likert scale. 1 = strongly agree to 5 = strongly disagree. Lowest score of 11 = participant agrees that the device is a feasible option as an ambulatory aid. Highest score of 55 = participants disagree that the proposed device can be used as an ambulatory aid., 1 year
H-PACE Program for the Improvement of Lifestyle Behaviors Among Children
NCT Number: NCT06548074
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Obesity
Interventions: BEHAVIORAL: H-PACE Behavioral Intervention|OTHER: Accelerometer|OTHER: Questionnaire Administration|OTHER: Supportive Care
Sponsor: Fred Hutchinson Cancer Center
Collaborators: National Cancer Institute (NCI)|New Mexico State University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-14
Completion Date: 2026-07-31
Locations: New Mexico State University, Las Cruces, New Mexico, 88003, United States|Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States

Summary:
This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Together, they can decrease the risk of developing obesity as well as related diseases such as diabetes, heart disease, stroke, and several types of cancer. To address the prevalence of obesity and related diseases, programs focusing on increasing opportunities for active living and healthy eating are necessary. Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits; however, most afterschool programs are short term; evidence is needed to confirm long-term effects. Moreover, programs that involve parents have shown to be more successful in helping children choose healthier behaviors. Unfortunately, due to technological advancement, opportunities for children to be active in schools have become more limited in modern society. H-PACE program is based on the national childhood obesity prevention campaign designed to help families, schools, communities, and physicians to raise awareness of nutritional and PA daily guidelines. The H-PACE will encourage daily lifestyle behaviors (five or more servings of fruits and vegetables, two hours or less of recreational screen time, one hour of PA, zero sugary drinks, ten hours of sleep) that impact childhood obesity. This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children.

Primary Outcome Measures: Percentage of children who attended more than 75% of program sessions (Feasibility), Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric., Up to week 14|Percentage of children who completed more than 80% of assessment activities (Feasibility), Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric., Up to week 14
D20054;LITT for Spine Tumors
NCT Number: NCT06548061
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Metastases
Interventions: DEVICE: Visualase Thermal Therapy System
Sponsor: Dartmouth-Hitchcock Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-06-01

Summary:
The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.

Primary Outcome Measures: Local tumor control, Any increase in the epidural spinal cord compression score (ESCC grade 1 (no compression) to 3 (spinal cord compression) compared to the initial post-procedure MRI will be considered local radiographic failure or evidence of tumor recurrence., Local control rate at 12 months
Secondary Outcome Measures: Evaluate neurologic function before and after sLITT., Using Frankel score. Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact), 3, 6, 9, and 12 months post-operatively
Dietary Supplementation on Fat Oxidation
NCT Number: NCT06548048
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight|Obesity
Interventions: DIETARY_SUPPLEMENT: Dietary supplement containing plant derived phenolics|DIETARY_SUPPLEMENT: Microcrystaline cellulose
Sponsor: Brightseed
Sex: FEMALE
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2024-12-31
Locations: Biofortis, Addison, Illinois, 60101, United States

Summary:
The purpose of this pilot study is to evaluate the effects of 4 weeks of daily consumption of encapsulated N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT) at a dose of 120 mg/d on measures of fat oxidation in women with overweight or obesity. The hypothesis is that fat oxidation at rest (measured via indirect calorimetry) and over a 24 h period (measured via d31-palmitic acid stable isotope tracer) will be higher in the group receiving the active study product compared to the control product at the end of the 4-week consumption period.

Primary Outcome Measures: % deuterium (2H) label from oxidation of d31-palmitic acid, Percentage recovery of the deuterium (2H) label from oxidation of d31-palmitic acid to water in urine samples collected, Day 1 and Day 28 (each day measurements are done in multiple timepoints of Hour 0, Hour 3, Hour 4, Hour 8, and Hour 24)
Secondary Outcome Measures: Change in indirect calorimetry measures, Resting metabolic rate (RMR; kcals/d) derived from the Weir equation, day 1 and day 28|Change in indirect calorimetry measures, Substrate utilization associated with RMR derived from the Respiratory Exchange Ratio (RER), day 1 and day 28|Change in cardiometabolic parameters, Fasting free fatty acids, day 1 and day 28|Change in cardiometabolic parameters, Fasting NMR lipoproteins, day 1 and day 28|Change in cardiometabolic parameters, Fasting Glucose, day 1 and day 28|Change in cardiometabolic parameters, Fasting Insuline, day 1 and day 28|Change in body weight, Change in body weight measured in scale, day 1 and day 28
Serum Metabolics-based Method for Diagnosing Bile Acid Diarrhoea
NCT Number: NCT06548009
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bile Acid Malabsorption|Bile Acid Diarrhea
Interventions: DIAGNOSTIC_TEST: Metabolomics and other blood samples
Sponsor: University Hospital, Gentofte, Copenhagen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-31
Completion Date: 2026-12
Locations: Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark|Herlev Gentofte Hospital, Hellerup, Denmark|Hillerød Hospital, Hillerød, Denmark

Summary:
Bile acid diarrhoea (BAD) is a common yet under-diagnosed and under-recognised disease. The primary symptoms are watery diarrhoea with high frequency of unpredictable bowel movements,urgency and faecal incontinence making BAD a debilitating condition. One of the challenges of BAD is the lack of a readily available and accurate diagnostic test.

The aim of this study is to validate a BAD diagnostic score (BDS) based on metabolomics.

Primary Outcome Measures: AUROC curve of the BDS in the validation cohort, AUROC curve of the BDS in the validation cohort, 1 year from now
Secondary Outcome Measures: AUROC curve of BDS in patients with each of the three subtypes of BAD, 1 year from now|AUROC curve of BDS in the discovery cohort (see 8.2 Data analysis), 1 year from now|Correlation of SeHCAT test result with severity of BAD symptoms, 1 year from now|Correlation of BDS test results with number of stools per day, 1 year from now|Biomarkers for BAD: C4 and FGF19, 1 year from now
Effects of tES Combined With Retrieval Practice on Semantic Memory in Patients With Schizophrenia
NCT Number: NCT06547996
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenic Patients
Interventions: DEVICE: tES-tDCS group|DEVICE: tES-tACS group|DEVICE: tES-sham group
Sponsor: Northeast Normal University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2024-09-20
Locations: Northwest Normal University, Lanzhou, Gansu, 730070, China

Summary:
The semantic processing deficit stands as a central feature of cognitive abnormalities in schizophrenia. Both transcranial electrical stimulation (tES) and retrieval practice have been demonstrated as external techniques capable of ameliorating the semantic processing deficit in individuals with schizophrenia. The inquiry examines whether the combined effect of tES and retrieval practice, following tES intervention targeting the left dorsolateral prefrontal cortex (L-DLPFC) in patients with schizophrenia, contributes to the preservation of semantic memory in these individuals.

Investigators plan to recruit 60 patients diagnosed with schizophrenia from hospitals. Treatment is administered by two examiners, each patient receives transcranial electrical stimulation（2mA×20min） with simultaneous learning of word lists. Each participant of each stimulation type was involved in both learning conditions, meaning that all participants completed both retrieval and restudy learning and testing Subsequently, Investigators observed their immediate and delayed memory performance through tests.

Primary Outcome Measures: The correct recall rate of word lists, The correct recall rate of word lists was calculated for each subject by the experimental assistant., Immediate Test: 5minutes; Delayed Test: 24 hours|Adjusted Ratio of Clustering (ARC), Free recall organization was measured by the Adjusted Ratio of Clustering (ARC) scores. ARC scores range from 1 to 1. A 0 score indicates a level of clustering similar to what would be expected by chance, and a score of 1 implies perfect clustering. Negative values of ARC scores mean atypical and uninterpretable recall patterns. For that reason, negative scores were excluded from analyses., Immediate Test: 5minutes; Delayed Test: 24 hours
Effectiviteit en Beleving Van FooDIYou
NCT Number: NCT06547983
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: OTHER: Personalized nutritional advice|OTHER: Personalized nutritional advice and food boxes
Sponsor: TNO
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-25
Completion Date: 2023-12-04
Locations: TNO, Leiden, South-Holland, 2333BE, Netherlands

Summary:
Studies have shown that personalized nutrition advice is more effective compared to generic nutrition advice for weight loss purposes. However, since decentralization of clinical trials is on the rise, it of interest to test whether personalized nutrition advice is as effective when provided fully digitally. In the current study the investigators compare the effects of generic vs. personal nutritional interventions in a fully digital study. Three groups are included, a control group receiving generic nutritional advice, an intervention group receiving personalized nutrition advice and an intervention plus group receiving personalized nutrition advice plus personalized meals. The trial takes six weeks. Anthropometric data are collected every two weeks and data on changes in nutritional diet are collected at the beginning and end of the intervention. In addition, the opinion of the participants on trial participation is asked as well every two weeks during the trial.

Primary Outcome Measures: Body weight in kilograms, 6 weeks
Secondary Outcome Measures: Body height in meters, 6 weeks|BMI as calculated by combining body weight and height (kg/m^2), 6 weeks|Hip circumference in centimeters, 6 weeks|Waist circumference in centimeters, 6 weeks|Neck circumference in centimeters, 6 weeks|Wrist circumference in centimeters, 6 weeks|Dietary habits as measured using the Nutri+ Module, Nutri+ Module is a food frequency questionnaire developed by TNO (TNO, Leiden, The Netherlands). This is used to obtain information on the habitual total food intake by asking food category consumption over the day., 6 weeks|Opinion on digital intervention as measured using an online questionnaire., The online questionnaire contained the following questions and multiple choice answers:

* How easily can the participant implement the nutritional advice? (very easily/easily/moderately/poorly/very poorly)
* How pleasant is it to implement the nutritional advice? (very pleasant, pleasant, moderate, unpleasant, very unpleasant)
* Did participant's diet change compared to before the intervention? (Yes/no)
* Does the participant feel like the participant's diet is healthier compared to before the intervention? (Yes/no)
* How easily can the participant perform the anthropometric measurements by themselves? (very easily/easily/moderately/poorly/very poorly)
* Are the questions in the questionnaire clear? (yes/no), 6 weeks
A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
NCT Number: NCT06547957
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumors
Interventions: DRUG: EOS301984|DRUG: Anti-PD-1 monoclonal antibody
Sponsor: iTeos Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-07
Completion Date: 2027-05
Locations: Institut Jules Bordet, Brussels, 1070, Belgium|Cliniques Universitaires Saint-Luc, Brussels, 1200, Belgium|Universitair Ziekenhuis Gent, Ghent, 9000, Belgium|CHU de Liège, Liège, 4000, Belgium|GZA Ziekenhuizen campus Sint-Augustinus, Wilrijk, 2610, Belgium

Summary:
APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.

Primary Outcome Measures: To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors, From first study treatment administration to last participant last follow-up (Up to 4 years)|Incidence and severity of AEs in patients receiving EEOS301984, From first study treatment administration to last participant last follow-up (Up to 4 years)
Secondary Outcome Measures: Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level, From first dose up to 21 days repeated cycles|Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level, From first dose up to 21 days repeated cycles|Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors., From first study treatment administration to last participant last follow-up (Up to 4 years)|Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, From first study treatment administration to last participant last follow-up (Up to 4 years)
Duffy-null Associated Neutrphil Count (DANC) Pediatric Patients
NCT Number: NCT06547931
Acronym: DANCChildren
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neutropenia Autoimmune
Interventions: OTHER: Data collection and analysis
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2024-11-30
Locations: Fondazione IRCCS Ca' Granda Ospedale Maggioe Policlinico, Milano, 20122, Italy

Summary:
There are currently no clinical and laboratory data that well characterize this neutropenia associated with the Duffy-null phenotype, particularly for pediatric subjects. In particular there are no data on the frequency of immune neutropenia in DANC neutropenic pediatric subjects.

The goal of this study is to :

* define the frequency of immune neutropenia within the cohort of DANC subjects under study
* evaluate the frequency of different degrees of neutropenia (mild-moderate-severe);
* evaluate the possible association between different degrees of neutropenia and the presence of infections.

Primary Outcome Measures: Immune neutropenia and DANC, Frequency of immune neutropenia, expressed as the percentage of DANC subjects testing positive for anti-neutrophil antibodies out of the total DANC subjects included in the study., Through study completion, an average of 1 year
Secondary Outcome Measures: Distribution of mild, moderate and severe neutropenia in DANC children, Frequencies in percentage of mild (1000-1500 neutrophils/ul), moderate (500-1000 neutrophils/ul) and severe (\<500 neutrophils/ul) neutropenia within the DANC cohort under study, Through study completion, an average of 1 year
Other Outcome Measures: Neutropenia severity and infections, Correlation between the severity of neutropenia and the presence of infections., Through study completion, an average of 1 year
Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU
NCT Number: NCT06547892
Acronym: NOVA-AKI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Critical Illness
Interventions: DRUG: Vasopressin|OTHER: 0,9% saline solution
Sponsor: Hospital do Coracao
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-07
Locations: Matheus Liguori Feliciano da Silva, São Paulo, SP, 03115-001, Brazil

Summary:
Renal dysfunction is a frequent complication in patients admitted to intensive care units (ICUs), associated with high morbidity and mortality. Current therapeutic options to prevent this condition are limited and lack robust scientific evidence. This pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the ICU.

Primary Outcome Measures: Feasibility, Defined by the inclusion of 60 patients in 3 or more ICUs over a period of 6 months, 6 months
Secondary Outcome Measures: Creatinine, in mg/dL, Creatinine will be defined by laboratory analysis, 7 days
Other Outcome Measures: Mortality, Mortality will be defined by medical records, 30 days
Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS
NCT Number: NCT06547853
Acronym: POWERSurviv
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female|Exercise
Interventions: BEHAVIORAL: Physical exercise
Sponsor: Federal University of Alagoas
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-31
Locations: Federal University of Alagoas Institute of Physical Education and Sports, Alagoas, Maceio, Brazil

Summary:
This study aims to evaluate the effect of a physical exercise intervention model on breast cancer survivors and their adherence. The sample will consist of 30 women with a primary diagnosis of breast cancer. The intervention will be carried out in a highly complex oncology center in Maceió-AL, Brazil, using the FITT components of the prescription: frequency (4 days a week), intensity (aerobic part through musical beats, subjective perception scale and resistance exercises through the number of maximum repetitions), the total time of each session will be 45 minutes. The intervention arms include combined exercise training and aerobic exercise (i.e., walking). Adherence to each intervention evaluated in the 12-week intervention cycle will be measured in each session.

Primary Outcome Measures: Exercise adherence, Total adherence will be expressed by the percentage of attendance by each participant in the total exercise intervention length. This will be measured by the study staff as the participants presence in each session., 12-weeks intervention
Secondary Outcome Measures: Change in systolic and diastolic blood pressure, Blood pressure is going to be measured after 10 minutes in a seated position. Mean Systolic blood pressure and diastolic blood pressure will be evaluated through a digital wrist monitor., 12-weeks|Change in cardiorespiratory fitness, cardiorespiratory fitness will be evaluated through the 6-minutes walk test, 12-weeks|Change in depression total score, Depression will be evaluated using the 9-Item Patient Health Questionnaire (PHQ-9) total score, 12-weeks|Change in pain total score, Pain will be evaluated using the Brief Pain Inventory (BPI) total score, 12-weeks|Change in Health-related Quality of Life total score, Health-related quality of life will be evaluated through the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), 12-weeks|Change in Sleep quality, Sleep quality will be evaluated using the The Pittsburgh Sleep Quality Index (PSQI), 12-weeks
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
NCT Number: NCT06547788
Acronym: LAMBDA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mitral Regurgitation|Mitral Valve Disease|Heart Failure
Interventions: OTHER: Mitral valve repair with creation of an 8 mm inter-atrial shunt
Sponsor: Ottawa Heart Institute Research Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2030-01-31
Locations: University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada

Summary:
Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers. Our study focuses on patients with primary MR.

The standard treatment for severe symptomatic primary MR is mitral valve surgery, a type of open-heart surgery. The outcomes following this procedure are excellent, however, a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart, more specifically in the left atrium, which is one of the four heart chambers. This is called functional mitral stenosis (FMS).

Previous studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium. We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS. To answer this question, we will study two groups of patients who need mitral valve surgery for primary MR. The first group will undergo mitral valve surgery, along with the creation of the opening between the two atria. The second group will undergo mitral valve surgery alone. We will then compare the outcomes between both groups, namely with regards to their heart failure symptoms after open-heart surgery.

Primary Outcome Measures: Feasibility: recruitment rate, Process, Resources, Management, Scientific, 30 Months|Feasibility: Success rate of intervention, Process, Resources, Management, Scientific, 30 Months|Feasibility: Study follow-up rate and length, Process, Resources, Management, Scientific, 30 Months
A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight
NCT Number: NCT06547775
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight or Obesity
Interventions: DRUG: KN069
Sponsor: Suzhou Alphamab Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2025-06-30
Locations: The Third Xiangya Hospital of Central South University, Changsha, Hunan, China

Summary:
This is a Phase 1, First-in-human, double-blinded, placebo-controlled study which aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the immunogenicity of KN069 in Chinese male participants with Obesity or Overweight.

Primary Outcome Measures: Frequency and severity of adverse events, Up to Day 42
Secondary Outcome Measures: To evaluate the plasma concentration of KN069, Up to Day 42|To evaluate the Area under the plasma concentration versus time curve (AUC) of KN069, Up to Day 42|To evaluate the weight (kg) change from baseline, Up to Day 42|To evaluate the waist circumference (cm) change from baseline, Up to Day 42|To evaluate the BMI (kg/m^2) change from baseline, Up to Day 42|Number of Participants with Anti-KN069 Antibodies, Up to Day 42
Vitamin D Supplementation in Critically Ill Children With Respiratory Disease
NCT Number: NCT06547749
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Vitamin D Supplementation
Sponsor: Assiut University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-12

Summary:
To evaluate the role of vitamin D supplementation in critically ill children with respiratory disease regarding their outcome.

Primary Outcome Measures: Hospital length of stay, How long the patient will stay in Hospital, Baseline|Ventilator free day, How long is the free days, Baseline
Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer
NCT Number: NCT06547736
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Cancer
Interventions: DRUG: SHR-A2102 or/and HRS-4642|DRUG: SHR-A1904 or/and HRS-4642|DRUG: SHR-A1811 or/and HRS-4642
Sponsor: Fudan University
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-06
Locations: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University, Shanghai, Shanghai, 200032, China

Summary:
The study is being conducted to evaluate the safety, tolerability and efficacy of ADC drugs monotherapy or combination therapy with HRS-4642 in subjects with locally advanced or metastatic pancreatic cancer.

Primary Outcome Measures: Recommended phase II dose (RP2D), RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages., Approximately 12 months|Objective Response Rate (ORR), Evaluated by RECIST v1.1., Up to approximately 12 months]
Secondary Outcome Measures: Disease Control Rate (DCR), Evaluated by RECIST v1.1., Up to approximately 12 months|Duration of Response (DOR), Evaluated by RECIST v1.1., Up to approximately 12 months|Progression Free Survival (PFS), Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free., Up to approximately 12 months|Overall survival (OS), Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive., Up to approximately 12 months|Adverse events (AEs), AEs are assessed by NCI-CTCAE v5.0, From the first drug administration to within 90 days for the last ADC durgs dose
Primary Tumor Resection for M1a Stage Lung Cancer
NCT Number: NCT06547710
Acronym: ECTOP-1023
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer Metastatic|Surgical Resection
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2026-06
Locations: Fudan University Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.

Primary Outcome Measures: Median overall survival, Median overall survival for M1a patients underging surgery., About 10months.
Secondary Outcome Measures: 2-year overall survival, 2-year overall survival, 2 years|5-year overall survival, 5-year overall survival, 5 years|FEV1 and FVC, Preoperative lung function test, 0.5 year
DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
NCT Number: NCT06547697
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: OTHER: Dialysate sodium concentration
Sponsor: University Medical Centre Maribor
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-09-01
Completion Date: 2015-03-01

Summary:
While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. However, the ideal dialysate sodium concentration remains a topic for discussion.

Randomised and prospective single dialysis centre study is presented. The participants are randomly divided into 3 groups and will go through 3 periods of 2 months. A "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/L in the first period, continue with 140 mmol/L in the second period and finish with 142 mmol/L. In the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/L to 138 mmol/L over 3 periods). One group will continue with 140 mmol/L throughout the study. Systolic and diastolic BP values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.

Primary Outcome Measures: Peridialytic blood pressure, Pre- and post dialysis blood pressure values, 6 months (3 periods of 2 months)
Secondary Outcome Measures: Interdialytic weight gain, Weight gain between dialysis sessions, 6 months (3 periods of 2 months)|Ultrafiltration, Change of needed ultrafiltration, 6 months (3 periods of 2 months)|Serum sodium concentration, Change of serum sodium due to the change of dialysate sodium, 6 months (3 periods of 2 months)
Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients
NCT Number: NCT06547684
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Equinus Deformity|Spasticity, Muscle
Interventions: DEVICE: fESWT
Sponsor: Teresa Mateu Campos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-08-28
Completion Date: 2024-08-07
Locations: Hospital de la Plana, Vila-real, Castellon, 12540, Spain

Summary:
The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied.

Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.

Primary Outcome Measures: Modified Ashworth Scale (MAS), A manual measurement of the resistance os muscles during passive stretching. Score from 0 to 4, higher scores mean a worse outcome, Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Secondary Outcome Measures: Passive Ankle range of motion (PROM), Measure with goniometer, Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|Visual Analogue Scale (VAS) Pain Score, Pain Score: from 0 (no pain) to 10 (the worst imaginable pain), Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|10 Meters Walk Test, Measure the gait speed, Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|Test Up and Go (TUG), Asses the mobility and balance, Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|Spasm Frequency Scale, Estimate muscle spams. Score 0 (no spams) to 4 (\>10 spams), Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|Test 6 Minutes Walking, Asses walking resistance, Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|Fall Skip Device, Assesment of fall risk, Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|Stroke Quality of Life Scale (ECVI-38), A questionnaire of 38 items: from 1 (no problem) to 190 (the worst situation), Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.|Self Report Spasticity Scale (SRSS), A questionnaire of 8 items: from 0 (nothing) to 24 (cpmpletely), Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
The Effect of Mouth Closure on Airflow in OSA
NCT Number: NCT06547658
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypopnea, Sleep
Interventions: OTHER: Mouth closure
Sponsor: Brigham and Women's Hospital
Collaborators: Massachusetts Eye and Ear Infirmary|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-17
Completion Date: 2022-07-10
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. However, we propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). The present study investigates the role of mouth breathing as an essential route in some OSA patients and its association with upper airway anatomical factors.

Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.

We evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. We also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.

Primary Outcome Measures: Total inspiratory flow, Change in airflow in the transition from mouth relaxed to mouth closed (intervention)., 1 day - the intervention of mouth closure on the outcome is applied acutely on alternating breaths, such that the effect of mouth closure is assessed based on the experiment which occurs in a single day.
Secondary Outcome Measures: Change in total inspiratory airflow with mouth closure, We analyzed the change in total inspiratory flow within three quantiles of roughly equal sample sizes based on oral breathing; quantile 1: oral airflow \<0.05 L/min, quantile 2: oral airflow between 0.05 and 2.2 L/min, and quantile 3: oral airflow \>2.2 L/min.

We also analyzed the effect of velopharyngeal obstruction on the change in total inspiratory airflow., 1 day - the intervention of mouth closure is applied acutely on alternating breaths, such that the effect of mouth closure on the outcome is assessed based on the experiment which occurs in a single day.
Skilled Nursing Facility at Home Trial
NCT Number: NCT06547645
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skilled Nursing Facility|Rehabilitation|Home Based Care
Interventions: OTHER: Sub-Acute Rehab at Home
Sponsor: University of Massachusetts, Worcester
Collaborators: Baystate Health|UMass Memorial Health|Massachusetts Executive Office of Health and Human Services (EOHHS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 650
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2026-06-26

Summary:
Skilled Nursing Facility at Home is a multicenter randomized control trial that aims to evaluate a home-based model of providing post-acute care (PAC). We will enroll 650 hospitalized patients who require rehabilitation and/or skilled-nursing support upon discharge and randomly assign them to an intervention (home-based PAC) or control arm (facility-based PAC). Our design includes two different health systems in Massachusetts: Baystate Health and UMass Memorial Health. We will perform 1:1 randomization between the intervention and control arm using a permuted block design, with stratification by clinical site and payor group. The primary outcome of the trial will be the difference in hospital readmission or mortality rates from the time of enrollment to 30 days after enrollment. Secondary clinical, functional, and cost outcomes include length of stay in PAC, difference in health-related quality of life (HRQoL), and healthcare cost and utilization.

Primary Outcome Measures: 30-Day Readmission, Hospital readmission rates between the intervention and control groups in the first 30 days after enrollment, From time of enrollment to 30 days after enrollment
Secondary Outcome Measures: Days Alive, Starting with the day of randomization, the total number of days alive outside of the hospital during the study period., From time of enrollment, up to 6 months post-enrollment|Activities of Daily Living, Compare the improvement in ability to perform activities of daily living between the intervention and control groups from time of enrollment to 30, 90 and 180-days after enrollment., From time of enrollment, up to 6 months post-enrollment|Healthcare Costs, Compare healthcare cost incurred and healthcare utilization between the intervention and control group during the PAC episode as well as from time of enrollment to the end of the PAC episode., From time of enrollment, up to 6 months post-enrollment|Mortality rate, Compare mortality rates during the study period between the intervention and control groups., From time of enrollment to 6 months post-enrollment|Length of stay, Compare length-of-stay (number of days) that study participants receive post-acute, SNF-level care during the index PAC episode between the intervention and control groups, From time of enrollment, up to 6 months post-enrollment