pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Two Preventive Exercise Programs for Swimmer's Shoulder on the Torque of Shoulder Rotator Muscles in Competitive Swimmers
NCT Number: NCT06552585
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Pain|Injury;Sports|Sports Physical Therapy
Interventions: OTHER: 12-weeks weight prevention program|OTHER: 12-weeks elastic band prevention program|OTHER: sham intervention
Sponsor: School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
Collaborators: University of Coimbra|Instituto Politécnico de Leiria
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2022-09-01
Completion Date: 2023-04-30
Locations: Instituto Politécnico de Coimbra - RoboCorp, Coimbra, 3045-093, Portugal

Summary:
The purpose of this study was to verify the effectiveness of two 12-week preventive exercise programs for swimmer's shoulder with monitoring and progression over time, on the peak torque and respective conventional concentric ratio and functional ratio. One of these programs was performed with weights and the other with an elastic band. This study hypothesized that the two preventive exercise programs minimize shoulder rotators imbalanced during the swimming season. The study design is a care provider and participants blinded, parallel, randomized controlled trial

Primary Outcome Measures: Peak torque, The concentric and eccentric peak torque of internal and external rotators of the dominant and non-dominant shoulders at 60°/s, 120°/s and 180°/s, evaluated through an isokinetic dynamometer Biodex System 3 (Biodex Medical Systems, New York)., 12 weeks
Secondary Outcome Measures: Conventional concentric external/internal shoulder rotators ratio, The quotient between peak torque values of the concentric external and internal rotators of the shoulder multiplied by 100., 12 weeks|Functional eccentric external/concentric internal shoulder rotators ratio, The quotient between peak torque values of the eccentric external rotators of the shoulder and concentric internal rotators of the shoulder multiplied by 100., 12 weeks|Time to peak torque, The time between the beginning of the torque caption and the peak torque previously described., 12 weeks
Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy
NCT Number: NCT06552572
Acronym: Glory
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Interventions: DRUG: Glofitamab
Sponsor: Samsung Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2028-12-30
Locations: Samsung Medical Center, Seoul, 135-710, Korea, Republic of

Summary:
The objective of this clinical trial is to determine whether the CD20-CD3 bispecific antibody, glofitamab, is effective in treating residual diffuse large B-cell lymphoma (DLBCL) in adults who have responded to CD19 Chimeric antigen receptor (CAR) T-cell therapy for their relapsed or refractory DLBCL. Additionally, the trial will assess the safety of glofitamab in patients undergoing CD19 CAR T-cell therapy. The primary questions to be addressed are:

Does glofitamab reduce the number of participants experiencing disease progression following CD19 CAR T-cell therapy? What are the medical complications in participants already treated with CD19 CAR T-cell therapy when administered glofitamab?

Participants are required to:

Receive glofitamab every 21 days for 12 cycles or until disease progression. Attend the clinic for checkups and tests every three weeks.

Primary Outcome Measures: 1-year progression free survival rate after enrollment, Measurement of progression-free survival after CD19 CAR T-cell therapy, From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Events, Hematological and non-hematological toxicities associated with glofitamab therapy, From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years
Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma
NCT Number: NCT06552559
Acronym: SIENA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: B-cell Lymphoma Recurrent|B-cell Lymphoma Refractory|CNS Metastases
Interventions: DRUG: Selinexor
Sponsor: Samsung Medical Center
Collaborators: Korean Society of Hematology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2027-12-30
Locations: Samsung Cancer Research Institute, Seoul, 135-710, Korea, Republic of|Samsung Medical Center, Seoul, 135-710, Korea, Republic of

Summary:
Secondary involvement of the central nervous system (CNS), such as CNS relapse after treatment or progression during treatment, is a rare but deadly occurrence in patients with B-cell non-Hodgkin lymphoma (NHL), particularly in cases of diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma (FL). Despite the grim prognosis associated with secondary CNS involvement, no definitive treatment strategy exists. Selinexor®, an oral, first-in-class, potent selective inhibitor of nuclear export that binds to XPO1, leads to the nuclear retention of tumor suppressor and growth regulator proteins, as well as topoisomerase II enzymes, thereby restoring their functions. Preclinical studies have also shown that selinexor can sensitize cancer cells to topoisomerase inhibitors, alkylating agents, and steroids. Selinexor has been approved by the Food and Drug Administration for relapsed or refractory DLBCL. We hypothesize that selinexor could work synergistically with ifosfamide (an alkylating agent) and etoposide (a topoisomerase II inhibitor) in the ifosfamide, carboplatin, and etoposide (ICE) regimen. High-dose dexamethasone was added to this regimen to enhance the efficacy of ICE as a salvage regimen for secondary CNS involvement, due to its ability to cross the blood-brain barrier.

This phase I/II study aims to evaluate the efficacy and safety of selinexor in combination with ifosfamide, carboplatin, etoposide (ICE), and dexamethasone in patients with relapsed or refractory B-cell non-Hodgkin lymphoma with secondary CNS involvement.

Primary Outcome Measures: Maximum tolerated dose of elinexor in phase 1, Maximum tolerated dose and recommended phase 2 dose level of Selinexor combined with ifosfamide, carboplatin, etoposide and dexamethasone, Up to 1 year|Objective response rate, Complete and partial response out of participants in phase 2, Up to 2 years
Secondary Outcome Measures: Duration of response, Time between the first determined response and the data of porgression, Uo to 3 years
Pharmacokinetics of Single- and Double-dose Icodextrin
NCT Number: NCT06552546
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peritoneal Dialysis
Interventions: DRUG: Icodextrin
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-03-30
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
The study aims to provide the pharmacokinetics profiles of single- and double-dose icodextrin in patients on peritoneal dialysis (PD). It may expand the available knowledge of the clinical pharmacology of icodextrin following its intraperitoneal administration and fills the gaps in our understanding of the fate of icodextrin and the metabolic consequences of icodextrin and its metabolites.

Primary Outcome Measures: Peak concentration (Cmax), The maximum serum concentration of icodextrin that occurs after administration., SICO: 0, 4, 8, 10, 12,16, 20, 24, 48, 72 hour, and day 7 and 14; DICO: 0, 4, 8, 12,16, 18, 20, 24, 28, 32, 56, 80 hour and day 7 and 14|Peak time (Tmax), Time (hours) to achieve the maximum serum concentration., SICO: 0, 4, 8, 10, 12,16, 20, 24, 48, 72 hour, and day 7 and 14; DICO: 0, 4, 8, 12,16, 18, 20, 24, 28, 32, 56, 80 hour and day 7 and 14|Area under the concentration-time curve（AUC）, AUC based on icodextrin serum concentrations., 14 days|Elimination half life（t1/2）, How long it takes for blood levels to drop by half. This parameter directly reflects the rate at which the drug is eliminated from the body., 14 days|Clearance(CL), Serum icodextrin clearance., 14 days
Secondary Outcome Measures: Adverse Events, Any adverse events throughout entirety of study as assessed by physician investigator, 14 days
Comparison of Resistance Training With and Without Plyometric Exercises on Athletes With Chronic Ankle Instability.
NCT Number: NCT06552533
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Ankle Instability
Interventions: OTHER: Resistance Exercises with Plyometric exercises|OTHER: Resistance Exercises without Plyometric exercises
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2024-09-14
Locations: Sehat Medical Complex, Pakistan sports board complex, Lahore, Punjab, 54000, Pakistan

Summary:
Chronic ankle instability is characterized by a patient's being more than 12 months removed from the initial LAS and exhibiting a propensity for recurrent ankle sprains, frequent episodes or perceptions of the ankle giving way, and persistent symptoms such as pain, swelling, limited motion, weakness, and diminished self-reported function. This study will Compare Resistance Training with and without Plyometric exercises on Athletes with Chronic Ankle instability and changes will be recorded using different methods and tools. Patients will be randomly allocated into two different groups. Group A will be treated with resistance training and Group B will be treated with resistance training along with plyometric exercises . Participants will complete clinician-oriented tests. Participants of both groups will be evaluated before and after the application of respective interventions at the end of 8th week. Data will be analysed.

Primary Outcome Measures: Numeric pain rating scale, NPRS consists of a scale with 0-10 readings. The zero denotes no pain while 1, 2, 3 denotes to mild pain, 4, 5, 6 denotes to moderate pain while 7-10 denotes to severe pain., 8 Weeks|Goniometer, Active Range of Motion of the patient will be assessed using universal standard goniometer for ankle plantar flexion, dorsiflexion, inversion and eversion. All ranges will be assessed in sitting position.The data will be collected at baseline ankle goniometry. Goniometry will be performed using a universal goniometer with a measuring scale marked out at two-degree interval, 8 Weeks|The Star Excursion Balance Test (SEBT), The Star Excursion Balance Test (SEBT) is a widely accepted method of assessing dynamic postural stability. The Y Balance Test (YBT) is a commercially available device for measuring balance that uses 3 (anterior, posteromedial, and posterolateral) of the 8 SEBT directions and has been advocated as a method for assessing dynamic balance., 8 Weeks|1 RM Leg Press test, A training load that corresponds to 60-80% of one repetition maximum to increase muscle strength in leg and ankle of subjects with a loading range of 10-12 repetitions. It will measure the strength in pre treatment and post treatment evaluation, 8 Weeks
A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
NCT Number: NCT06552481
Acronym: NP-PWD2
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Wound|Soft Tissue Injuries
Interventions: DEVICE: NP-PWD|DEVICE: Wound Vac
Sponsor: The Metis Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-16
Completion Date: 2024-04-25
Locations: Northeast Baptist, San Antonio, Texas, 78217, United States

Summary:
This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.

Primary Outcome Measures: Feasibility and usability of device in treatment., The number and type of issues with the device will be documented to determine feasibility and usability. Events such as complications with application, device changes and early removal and rationale for events during the period the patient has the study device applied and throughout the entire enrollment period., Seven to nine days post application.
Secondary Outcome Measures: Wound readiness for closure, The treating physician will use their best medical judgment to assess the wound bed using rate of epithelization, signs of infection, exposed tendon or bone and overall appearance of the wound bed to determine the wounds readiness for closure. It will be documented the number of subjects from both groups that after treatment are ready to be grafted, or are no longer requiring surgery., Seven to nine days post application.|Incidence of colony forming units., Colony forming units are assessed by obtaining wound swabs and analysis of presence of colony forming units., Seven to nine days post application.|Ease of use of device by healthcare providers, At each research visit the staff will be asked if they had any questions, concerns, complaints or comments about the device or dressing. There is not a separate healthcare provider questionnaire, but any information obtained will be placed in the comments section of the source documents and the feedback will be provided to manufacture., Seven to nine days post application.|Tolerability of the device by patient subjects, Tolerability of device by subjects will be assessed by observation of the length of time subjects were able to keep the dressing on. The subject will be asked if they have any concern or complaints about the device or dressing. Their response and if applicable the reason for removal will all be documented., Seven to nine days post application.
Efficacy and Accuracy of EStimation for BurdEn of Atrial Fibrillation by PPG Using a Smart Watch
NCT Number: NCT06552468
Acronym: EASE-AF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: DEVICE: AF monitoring by a smartwatch with PPG
Sponsor: Beijing Anzhen Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-10-30
Locations: Beijing Anzhen Hospital, Beijing, China

Summary:
The study aims to assess the efficacy and accuracy of using an Electrocardiograph (ECG) watch with photoplethysmography (PPG) for monitoring atrial fibrillation (AF) burden. The PPG data will be automatically analyzed using software, and the results will be compared with cardiologist-annotated ECG collected by a single-lead ECG patch.

Primary Outcome Measures: Simultaneous measurement of AF ≥ 30 seconds with detection, Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring., One day
Secondary Outcome Measures: Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms, Simultaneous measurement of AF ≥ 30 seconds on the ECG patch monitor during each of the pulse tachograms that contributed to the first Irregular Heart Rhythm Detection, among those detections confirmed by ECG., One day
Post-extubation Pressures in Preterm Neonates: A CER Study
NCT Number: NCT06552455
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Respiratory Distress Syndrome|Bronchopulmonary Dysplasia|Preterm Birth
Sponsor: McMaster Children's Hospital
Collaborators: McMaster University|Canadian Institutes of Health Research (CIHR)|Canadian Neonatal Network
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1050
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2028-12-31

Summary:
The optimal post-extubation pressure level on non-invasive respiratory support modes - irrespective of the choice of the specific non-invasive mode - that optimizes extubation success and improves clinical outcomes remains unknown.

The investigators aim to determine the optimal initial non-invasive pressure support level post-extubation in preterm neonates, in relation to the pre-extubation measured mean airway pressures (Paw). The hypothesis is that use of higher pressures will lead to fewer re-intubations.

This will be a prospective comparative effectiveness study across participating tertiary NICUs across Canada. Centres will self-select whether to use Higher or Equal/Lower pressure levels as well as the initial post-extubation mode (NIPPV or CPAP) for the study duration. Only the first eligible extubation will be included for analysis. Eligible patients \<28 weeks' gestational age at birth undergoing an eligible extubation (from a mean airway pressure \</= 13 cmH2O) will be included. The primary outcome will be re-intubation within 7 days. Secondary outcomes will include other neonatal morbidities.

Primary Outcome Measures: Re-intubation within 7 days post-extubation, 7 days
Secondary Outcome Measures: Failure of initial NRS (non-invasive respiratory support) mode, 7 days|Presence of any 1 or more predefined intubation criteria, 7 days|Moderate to Severe Bronchopulmonary Dysplasia, until 36 weeks' postmenstrual age (or discharge if sooner)|Mortality, During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)|Composite of Mortality OR moderate to severe bronchopulmonary dysplasia, During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)|Post-extubation days on any form of positive pressure respiratory support, During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)|Post-extubation days on invasive mechanical ventilation, During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)|New pulmonary air leak including pneumothorax, pulmonary interstitial emphysema, and/or pneumo-mediastinum within 7 days of extubation, 7 days|New gastro-intestinal perforation (any cause) within 7 days of extubation, 7 days|Necrotizing enterocolitis diagnosed any time post-extubation, During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)
Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Glucocorticoid Treatment for No-Reflow in STEMI
NCT Number: NCT06552442
Acronym: GCT-NR-STEMI
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ischemia-reperfusion Injury|No-reflow
Interventions: DRUG: Methylprednisolone
Sponsor: Amosov National Institute of Cardiovascular Surgery
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-09-05
Completion Date: 2024-06-01
Locations: Amosov National Institute of cardiovascular surgery, Kyiv, Amosov Street, 6, 03038, Ukraine

Summary:
The goal of this clinical trial is to improve reperfusion therapy in STEMI patients with no-reflow phenomenon. Based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the no-reflow. To restore blood flow, high-dose intracoronary methylprednisolone was applied. The main idea is to stabilize cell membranes and stop the progression of edema. It is local, not systemic, single administration that avoids serious side effects. The primary hypothesis is that hormone administration will improve blood flow to TIMI 2/3 in TIMI 0/1after stenting infarct-related artery.

Primary Outcome Measures: Restoration of coronary blood flow, Degree of restoration of coronary blood flow on the Thrombolysis in myocardial infarction (ТIMI) grade 0-3 (3 is the best result, 0/1 - bad or no-reflow) from TIMI 0 or TIMI 1 to TIMI 2 or TIMI 3, 3 minutes
Safety of MT-401-OTS in Patients With Relapsed AML or MDS
NCT Number: NCT06552416
Acronym: RAPID
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acute Myeloid Leukemia, in Relapse|MDS
Interventions: DRUG: MT-401-OTS
Sponsor: Marker Therapeutics, Inc.
Sex: ALL
Age: OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2029-05

Summary:
This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or \</= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with \</= 10% blasts following treatment with an HMA-based therapy.

Primary Outcome Measures: Safety of MT-401-OTS, Assess:

* Incidence of DLTs to determine the RP2D
* Safety (including but not limited to): TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE, Version 5.0
* Acute GVHD per 2016 MAGIC criteria
* CRS and ICANS per ASTCT criteria, Through study completion. Approximately 5 years|Tolerability of MT-401-OTS, cGVHD per 2014 NIH consensus criteria for cGVHD, Through study completion. Approximately 5 years
Secondary Outcome Measures: To assess the efficacy of MT-401-OTS in participants with high-risk or very-high-risk MDS per IPSS-M who have evidence of disease following at least 4 cycles of a HMA, Per 2023 IWG criteria for higher-risk MDS:

* CR rate
* DOCR
* ORR
* DOR, Following conclusion of the disease assessment of last MDS subject treated. Approximately 2 years|To assess the efficacy of MT-401-OTS in participants with intermediate or high-risk AML per 2022 ELN criteria who have evidence of disease following induction therapy or at least 4 cycles of nonintensive treatment, Per 2022 ELN Criteria for AML:

* Rate of MRD negativity
* CR, DOCR
* ORR, DOR, Following conclusion of the disease assessment of last AML subject treated. Approximately 2 years
Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China
NCT Number: NCT06552403
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight or Obesity
Interventions: DIETARY_SUPPLEMENT: A modified 5:2 intermittent fasting diet
Sponsor: Zhejiang Provincial Tongde Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2023-12-31
Locations: Xiaoli Wang, Hangzhou, China

Summary:
This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.

Primary Outcome Measures: body measurements, weight, BMI, and waistline, 24 weeks after intervention|glycolipid metabolism indicators, fasting plasma glucose (FPG), fasting plasma insulin (FPI), fasting C-peptide (FCP), triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and uric acid., 24 weeks after intervention|adipokines, leptin and lipocalin, 24 weeks after intervention|inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention, high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α), 24 weeks after intervention
Secondary Outcome Measures: Change in metabolic components, Participants' metabolic components were analyzed by serum metabolomics analysis. The ultra-high performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) (Agilent 1290, Agilent Technologies, Inc., USA) was applied to identify metabolites., 24 weeks after intervention
Cardiac Rehabilitation for Inpatient Heart Transplant (HRN4HTx)
NCT Number: NCT06552390
Acronym: HRN4HTx
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Transplantation
Interventions: PROCEDURE: Cardiac Rehabilitation
Sponsor: Instituto Politécnico de Bragança
Collaborators: Unidade Local de Saúde de Coimbra|Universidade do Porto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-01
Completion Date: 2024-01-01
Locations: Unidade Local de Saúde de Coimbra, Coimbra, 3000, Portugal

Summary:
To evaluate the safety and efficacy of the phase 1 cardiac rehabilitation protocol(HRN4HTx) in heart transplant patients, focusing on self-care capacity and functionalrecovery.

Primary Outcome Measures: Functional Capacity - Evaluation of the 6-minute walk test (6MWT), 6-minute walk test (6MWT), higher value means better outcome (no maximum value), At the date of discharge (mean days of hospitalization of 15 until a maximum of days 21)|Self-Care Capacity - Evaluation of the Barthel Index, Barthel Index, from 0 to 100, higher scores means better outcome, At the date of admission and at the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)|Knowledge of Risk Factors - Evaluation of knowledge regarding alarm signs and cardiovascular risk factors, Knowledge regarding alarm signs and cardiovascular risk factors, from 0 to 100%, higher value means better outcome, At the date of discharge (mean days of hospitalization of 15 until a maximum of 21 days)
Ultrasound and Attenuation Imaging
NCT Number: NCT06552377
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Non-Alcoholic Fatty Liver Disease|Non Alcoholic Fatty Liver|Non-alcoholic Steatohepatitis|Steatosis of Liver
Interventions: DEVICE: Ultrasound Attenuation imaging measurement
Sponsor: Hywel Dda Health Board
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 97
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-14
Completion Date: 2024-04-11
Locations: Bronglais Hospital, Aberystwyth, Ceredigion, SY23 1ER, United Kingdom

Summary:
Fatty liver disease affects almost a 3rd of the United Kingdom (UK) population. Currently, this is being investigated using a type of MRI scan that reports how fatty or not a person's liver is, with a liver fat score, but many patients cannot have this type of scan due to time, cost or because they have a condition which makes Magnetic Resonance Imaging (MRI) an unsafe scan for them to have. An ultrasound scan is cheaper, faster and safer for a wider variety of patients. New developments in ultrasound technology mean that instead of a Sonographer, or ultrasound operator, deciding whether your liver is fatty or not based on what they see on the scan, the ultrasound machine gives a liver fat score. This study will look at the relationship between the Sonographers' view on how fatty the liver is, compared with the liver fat score given by the new development in ultrasound technology.

Primary Outcome Measures: Sonographer assessment of the liver, Sonographers grade the liver normal, mild, moderate, severe fatty liver dependent on factors including hepatorenal contrast, visualisation of vessel borders and of diaphragm., all measurements obtained within single 30 minute appointment|Measurement of liver fat using attenuation imaging, Sonographer uses attenuation imaging function to measure liver fd, all measurements obtained within single 30 minute appointment
Secondary Outcome Measures: Age of patient, Age of patient, all measurements obtained within single 30 minute appointment|Height, Height, patients height measured immediately after scan., all measurements obtained within single 30 minute appointment|Weight, Weight, patient weighed immediately after scan, all measurements obtained within single 30 minute appointment|Diagnosis or Relevant history, Diagnosis or relevant history from referral form., all measurements obtained within single 30 minute appointment
Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture
NCT Number: NCT06552351
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia
Interventions: DEVICE: Needle-Free Jet Injection of 1 % lidocaine|OTHER: traditional needle infiltration of 1% lidocaine
Sponsor: University of Oklahoma
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-08-01
Locations: Oklahoma Children's Hospital, Oklahoma City, Oklahoma, 73104, United States

Summary:
We hypothesize that the J-Tip needle-free jet-injection system offers comparable pain control and greater provider satisfaction due to its less invasive nature compared to traditional needle infiltration of 1% lidocaine in infants undergoing lumbar punctures.

Our aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional lidocaine needle infiltration with J-tip.

Primary Outcome Measures: Pain Score, The primary outcome measure will be the pain score of infants undergoing lumbar punctures, assessed using a validated pain scale appropriate for infants., Immediately post-procedure (within 5 minutes after the lumbar puncture)|Procedure Success Rate, The success rate of the lumbar puncture procedure, defined as obtaining an adequate CSF sample on the first attempt without the need for additional anesthesia., During the procedure|Caregiver Satisfaction, Caregiver satisfaction with the anesthesia method used, measured using a standardized survey or questionnaire completed after the procedure., Within 1 hour post-procedure
Wellness of Osteopathic Medical Students Throughout Their Training (Well-COM)
NCT Number: NCT06552338
Acronym: Well-COM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Students, Medical
Interventions: OTHER: Observational
Sponsor: Sam Houston State University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 650
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-07
Completion Date: 2044-12
Locations: Sam Houston State University College of Osteopathic Medicine, Conroe, Texas, 77304, United States

Summary:
The Well-COM Research Project addresses a critical gap in our understanding of the holistic health of medical students, over the entirety of the medical school experience. While the rigorous demands of medical education and its effects on the well-being of medical students are well-documented, there is a lack of long-term study assessing the mental, physical, and metabolic health of medical students from entry into medical school through their training and into residency. By collecting holistic health data from new first-year medical students, and over a minimum period of 10 years, the Well-COM project aims to provide invaluable insights into the changes in health and wellness experienced by medical students, thereby informing future interventions and support systems to promote overall health and resilience in medical school students.

Primary Outcome Measures: Burnout Index, Maslach Burnout Inventory, Change over 10 years|Quality of Life Survey, Short Form 8, Change over 10 years|Physical Fitness VO2 max, Submaximal Step Test, Change over 10 years|Body Fat Percentage, Portion of body mass composed of fat which is measure by bioelectrical impedance, Change over 10 years|Handgrip strength, Maximal grip strength measured by a handgrip dynamometer, Change over 10 years|Total cholesterol, Total cholesterol mg/dL, Change over 10 years|Blood pressure, Systolic and diastolic blood pressure, Change over 10 years|Perceived Stress, Perceived stress scale (PSS) Range 0-40 with higher scores indicating higher stress, Change over 10 years|Physical Activity, The International Physical Activity Questionnaires (IPAQ), Change over 10 years
Walk-in Therapy in Low Barrier Primary Care
NCT Number: NCT06552325
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|Hiv|Substance Use
Interventions: BEHAVIORAL: Single Session Narrative Therapy
Sponsor: University of Washington
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-02-28

Summary:
The goals of the current research are to adapt an effective walk-in psychotherapy clinic intervention for the context of low-barrier primary care; and conduct a pilot implementation study in two low-barrier primary care clinics that are based in a community organization that is a drop-in center for people experiencing homelessness in North Seattle.

Primary Outcome Measures: Reach, Number and representativeness of patients (with respect to gender, race/ethnicity, current substance use) who have ≥1 session with the therapist (compared to full clinic populations)., Up to 4 months
A Modified Delphi for ECPR Post Resuscitation Care
NCT Number: NCT06552312
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrest
Interventions: OTHER: Delphi Questionnaire
Sponsor: Sydney Local Health District
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-30
Completion Date: 2025-06-30
Locations: Sydney Local Health District, Sydney, New South Wales, 2050, Australia

Summary:
The objective of this study is to generate expert consensus statements on the management of out of hospital cardiac arrest patients treated with extracorporeal membrane oxygenation (ECMO) cardiopulmonary resuscitation (ECPR).

Primary Outcome Measures: Degree of consensus, The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 70% of the panel rating a given statement \>7 on a likert scale between 1-9, Six months
Evaluating Length and Depth Estimation Accuracy of Laypersons and Health-Care Providers
NCT Number: NCT06552299
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiopulmonary Resuscitation
Interventions: OTHER: Laypersons|OTHER: Health-Care Providers
Sponsor: Seoul National University Hospital
Collaborators: SMG-SNU Boramae Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2025-03-31
Locations: SMG-SNU Boramae Medical Center, Seoul, 07061, Korea, Republic of

Summary:
The objective of the study is to measure accurateness of length and depth estimation of laypersons and health-care providers.

Primary Outcome Measures: Depth estimation, Depth pressed by participants measured by depth measuring device, Measurement immediately after registration on the day of arrival at the study site (protocol will take less than 5 minutes to complete)
Secondary Outcome Measures: Length estimation, Length of line drawn by participants, Measurement immediately after registration on the day of arrival at the study site (protocol will take less than 5 minutes to complete)|Depth estimation with assistance, Depth pressed by participants measured by depth measuring device with assistance, Measurement immediately after registration on the day of arrival at the study site (protocol will take less than 5 minutes to complete)
STRW-T Intervention for Autistic Adolescents in 11th and 12th Grade
NCT Number: NCT06552286
Acronym: STRW-T
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: BEHAVIORAL: STRW-T|BEHAVIORAL: PEERS-T
Sponsor: Children's Hospital Medical Center, Cincinnati
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2029-12-31
Locations: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States

Summary:
The current study seeks to compare outcomes of a telehealth intervention targeting daily living skills (Surviving and Thriving in the Real World - Telehealth, or STRW-T) intervention to a control group telehealth intervention targeting social skills (Program for the Education and Enrichment of Relational Skills- Telehealth, or PEERS-T). The key endpoint will be change in daily living skills on primary and secondary outcome measures at the end of treatment.

Primary Outcome Measures: Vineland Adaptive Behavior Scales, 3rd Edition, The VABS-3 is a well-established standardized measure of adaptive behavior that assesses skills in the Communication, Daily Living Skills, and Socialization domains. The DLS domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention.

Subdomain v-scale scores: 1 to 24. Domain and Adaptive Behavior Composite Standard Scores: 20 to 140. The higher the score, the better the adaptive level. V-scale scores have a mean of 15 and standard deviation (SD) of 3. Standard scores have a mean of 100 and SD of 15., 4 months
Secondary Outcome Measures: Adaptive Behavior Assessment System, Third Edition, The ABAS-3 Adult Other measure is a respondent report measure that assesses adaptive behavior in the conceptual, practical, and social domains. The Practical domain standard score summarizes performance across the Community Use, School Living, Health and Safety, and Self-Care skill areas. The standard score is calculated based on the sum of scaled scores for each of the skill areas. Scaled scores range from 1 to 19, with the average score being between 8-12. The standard scores typically range from 40 to 120, with a mean of 100 and a standard deviation of 15. Higher scores equate to better adaptive skills., 4 months
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
NCT Number: NCT06552260
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Glioblastoma|Recurrent Glioblastoma|Brain Tumor
Interventions: DRUG: Troriluzole
Sponsor: Eudocia Quant Lee, MD
Collaborators: National Institutes of Health (NIH)|Biohaven Pharmaceuticals, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02
Completion Date: 2027-08-01
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02215, United States

Summary:
This research study is studying troriluzole as a possible treatment for recurrent glioblastoma.

The name of the study drug involved in this research study is:

-Troriluzole (a tripeptide prodrug of riluzole)

Primary Outcome Measures: The effect of troriluzole on high-gamma band power (a measure of neuronal activity) via electrocorticography during surgical resection, Data will be summarized using descriptive statistics to compare between participants who received presurgical troriluzole and who did not, At time of surgery
Secondary Outcome Measures: Concentrations of Extracellular Glutamate in Resected Tissue by MALDI-MSI, Data will be summarized using descriptive statistics to compare between participants who received presurgical troriluzole and who did not. For MALDI-MSI, raw mass spectrometry data will be analyzed by a combination of Protein Discoverer (Thermo) and in-house software (Computer Assisted Manual Validation, CAMV) to provide accurate identification and quantification of protein phosphorylation sites for each participant sample., From tumor tissue resected at surgery|Grade 3-5 Treatment Related Adverse Event, The percentage of participants who experienced a maximum grade 3-5 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms., From tumor tissue resected at surgery|Proliferation Rate (Ki-67) in Resected Tissue, Western blot analysis for proliferation (Ki-67) will be summarized using descriptive statistics, From tumor tissue resected at surgery|Protein Levels of NLGN3 in Resected Tissue, Western blot analysis for NLGN3 will be summarized using descriptive statistics, From tumor tissue resected at surgery|Protein Levels of Phosphorylated AMPA Receptor Subunits (e.g. GluA2) in Resected Tissue, Western blot analysis for phosphorylated GluA2 will be summarized using descriptive statistics., From tumor tissue resected at surgery|Tumor Tissue Concentration of Troriluzole by MALDI-MSI, MALD-MSI analysis for concentration of troriluzole in resected tumor tissue of participants who received presurgical troriluzole, From tumor tissue resected at surgery
Glaucoma Algorithm Validation Study in African Population - the MAGIC Study
NCT Number: NCT06552247
Acronym: MAGIC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glaucoma|Diabetic Retinopathy
Interventions: DIAGNOSTIC_TEST: Fundus Picture AI testing
Sponsor: Centro Hospitalar Universitário Lisboa Norte
Collaborators: Dr. Agarwal's Eye Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-14
Completion Date: 2024-08-31

Summary:
Artificial Intelligence (AI) algorithms require validation in a variety of populations to ensure widespread clinical applicability. In Ophthalmology, AI algorithms are reaching maturity in diagnosis such as diabetic retinopathy and glaucoma. Higher-at-risk subjects of African descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity.

A small scale validation study in consecutive patients in a large Eyesore unit in Mozambique will be performed to determine the diagnostic ability of these AI softwares in this population

Primary Outcome Measures: Diagnostic agreement between referring decision and reading center decision, Level of agreement will be done between referring decision and the ground truth as assessed by the reading center (normal, glaucoma suspect; definitive glaucoma). All subjects from both centers (referred and non-referred) will be reviewed.

For a primary outcome analysis, the middle category (glaucoma suspect) will be pooled together with the normal diagnosis, Duration of the study - 3 weeks
Secondary Outcome Measures: Level of agreement (in %) between AI-risk score and human-based assessment of disease severity, Reading center risk score of disease severity (ranked from 0 to 100) will be compared to the AI-based disease score. This will be done separately in each of the 3 categories (normal; glaucoma suspect; glaucoma). Analysis of this score would help refine clinical risk (high risk vs low risk patients) of each category. Exploratory analysis will be made to determine the added value of including this risk score in refining AI-based referral, After the study - 6 months
Finistere Myeloma Observatory (OMYFIN)
NCT Number: NCT06552221
Acronym: OMYFIN
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2012-01-01
Completion Date: 2023-06-30
Locations: CHRU de Brest, Brest, 29200, France

Summary:
Current molecular risk stratification of multiple myeloma (MM), based on the presence of t(4 ;14) and 17p deletion, cannot fully explain treatment outcome heterogeneity, as other features also predict prognosis. About 30% of genetic events map to chromosome 1 : most upregulated genes to 1q and most downregulated ones to 1p. CKS1B gains on 1q21 and CDKN2C loss on 1p32, both favoring cell cycle progression, portended impaired outcome in many but not all studies. Based on their recurrence and considering their functional convergence, we hypothesized CKS1B/CDKN2C copy number ratio to be a risk factor fitter than each aberration alone.

Primary Outcome Measures: Response rate, The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on response rate, 10 years
Secondary Outcome Measures: Progression-free survival (PFS), The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on PFS, 10 years
Other Outcome Measures: Overall survival (OS), The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on OS, 10 years
Biliary Obstruction of Neoplastic Origin Treated With Drainage. A Prognostic Study.
NCT Number: NCT06552208
Acronym: PROBILI
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Malignant Biliary Obstruction
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 372
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-07-15
Completion Date: 2021-10-15
Locations: CHRU de Brest, Brest, 29609, France

Summary:
Inclusion of patients with biliary drainage for inoperable malignant biliary obstruction and analysis of clinico-biological parameters

Primary Outcome Measures: Short-term survival after biliary drainage, 30-day survival after biliary drainage, 4 years and fifth months
Secondary Outcome Measures: Prognostic score, To establish a prognostic score, 4 years and fifth months
Phase 1 Study in Diabetes Mellitus(Fasting)
NCT Number: NCT06552182
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes|Diabetes Mellitus
Interventions: DRUG: HUC2-344|DRUG: HUC2-344-R1, HUC2-344-R2
Sponsor: Huons Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-17
Completion Date: 2024-03-18
Locations: Huons, Seoul, Korea, Republic of

Summary:
An open-label, randomized, fasting, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.

Primary Outcome Measures: Cmax, Maximum concentration of HUC2-344, 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours|Tmax, Time of concentration, 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours|AUCt, Area under the drug concentration-time curve, 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours