pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effects of Ladder Training Versus Plyometric
NCT Number: NCT06462209
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sports Physical Therapy
Interventions: OTHER: ladder training|OTHER: plyometric training
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-05-15
Completion Date: 2024-07
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
To determine the effects of ladder training versus plyometric training program on agility, speed and power in domestic female cricket players. Plyometric training program and ladder training program consider effective training methods for players for development of speed, agility and power.

Primary Outcome Measures: vertical jump test, Reaching up with the hand closest to the wall, the athlete stands side by side with the wall. Mark the point of the fingertips this is the standing reach height. The athlete then takes a step back from the wall and launches himself as high while projecting his body upward . At the top of the jump, try to make contact with the wall. The score is the difference in height between the standing reach height and the jump height., 4 week|30 dash test, 30-yard maximum sprint while timing oneself is part of the exam. Included in the warm-up should be some practice accelerations and starts. The front foot must to land on or behind The tester ought to offer advice on how to run as fast as possible as well as motivation to keep going over the finish line. There can be two trials. If a stopwatch is being used, the time begins at the initial movement., 4 week|T test, T test measured both before and after and Athletes can test their agility by running forward, sideways, and backwards in the T-Test. Arrange four cones. At the sound of the timer, the subject begins at cone A, runs to cone B, and places their right hand on the cone's base. Next, they make a left turn, move sideways to cone C, and touch its base with their left hand once more. After that, shuffle sideways to cone D and use your right hand to contact the base. Then they run backwards to cone A and shuffle back to cone B, touching with their left hand., 4 week
Natural History of Depression, Bipolar Disorder and Suicide Risk
NCT Number: NCT06462196
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Behavioral Symptoms|Suicide|Self-Injurious Behavior|Sensory System Agents|Analgesics|Peripheral Nervous System Agents|Physiological Effects of Drugs|Anesthetics, Dissociative|Anesthetics, General|Anesthetics|Central Nervous System Depressants|Excitatory Amino Acid Antagonists|Excitatory Amino Acid Agents|Neurotransmitter Agents|Molecular Mechanisms of Pharmacological Action|Ketamine|Depression, Unipolar|Depressive Symptoms|Treatment Resistant Depression|Major Depressive Disorder|Depression, Bipolar
Sponsor: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-10
Completion Date: 2030-06-01
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

Summary:
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.

People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.

This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.

Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.

Primary Outcome Measures: Score on Montgomery Asberg Depression Rating Scale, Depression rating scale, Weekly
Secondary Outcome Measures: Score on Scale for Suicide Ideation, Scale for rating suicide ideation, Weekly
Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
NCT Number: NCT06462183
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Adenoid Cystic Carcinoma|Colorectal Cancer
Interventions: DRUG: RGT-61159
Sponsor: Rgenta Therapeutics Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 105
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-06
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Next Oncology VA, Fairfax, Virginia, 22031, United States|Princess Margaret Cancer Center, Toronto, Ontario, M5G 2M9, Canada

Summary:
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC

Primary Outcome Measures: Number and type of dose-limiting toxicities (DLTs) in first cycle of administration, 21 days|Number and type of adverse events, Through study completion, estimated as 30 days after last dose of study drug|Recommended Phase 2 Dose (RP2D), Assessed at the end of Cycle 1 for each subject (each cycle 21 days)
Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study
NCT Number: NCT06462170
Acronym: PIPC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: DIETARY_SUPPLEMENT: Boost Original meal replacement shake
Sponsor: Ottawa Hospital Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2025-09-30
Locations: The Ottawa Hospital, Ottawa, Ontario, K1H7W9, Canada

Summary:
The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months.

In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours.

With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.

Primary Outcome Measures: Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake., Participants will get blood drawn at time 0, 30, 60, 90, and 120 minutes. Blood will be sent for glucose, insulin, and C-peptide measurements. The area under the curve (AUC) will be calculated from these measurements. The AUC for insulin and for C-peptide will be representative of the participant's PIPC., 12 months
Secondary Outcome Measures: The impact of participant's self-reported weight gain in the past year (12 months prior to the single study visit) on participant's PIPC., Linear regression modelling will be used where weight gain is an independent variable, and PIPC is the dependent variable. The p-value for participant's self-reported weight gain will show the significance of impact on PIPC., 12 months
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
NCT Number: NCT06462144
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus (SLE)|ANCA Associated Vasculitis (AAV)|Idiopathic Inflammatory Myopathy (IIM)
Interventions: DRUG: IMPT-514 CART Cell Injection
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2026-10-31
Locations: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, China|The Affiliated Hospital Of Xuzhou Medical University, Xuzhou, Jiangsu, 221004, China

Summary:
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV) infusion, in participants with B cell driven autoimmune diseases, including active, refractory Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM).

Primary Outcome Measures: Incidence of dose limiting toxicities (DLTs), serious adverse events (SAE) and treatment-emergent adverse events (TEAEs)., 28 days from cell infusion
A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects
NCT Number: NCT06462118
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: Astegolimab
Sponsor: Genentech, Inc.
Sex: ALL
Age: ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-17
Completion Date: 2025-04-04
Locations: Covance Research Unit - Daytona, Daytona Beach, Florida, 32117, United States|Covance Research Unit - Dallas, Dallas, Texas, 75247, United States|Covance Clinical Research Unit, Inc, Madison, Wisconsin, 53704, United States

Summary:
The main objective is to study how astegolimab may behave in the body when injected subcutaneously into the abdomen, thigh, or upper arm in healthy participants.

Primary Outcome Measures: Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab, Approximately 85 days|AUC extrapolated to infinity (AUC0-infinity) of astegolimab, Approximately 85 days|Maximum serum concentration (Cmax) of astegolimab, Approximately 85 days
Secondary Outcome Measures: Relative bioavailability (F%) for thigh injection of astegolimab, Approximately 85 days|F% for upper arm injection of astegolimab, Approximately 85 days|Half-life (T1/2) of astegolimab, Approximately 85 days|Apparent systemic clearance (CL/F) of astegolimab, Approximately 85 days|Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab, Approximately 85 days|Time to maximum serum concentration (Tmax) of astegolimab, Approximately 85 days|Incidence of anti-drug antibodies (ADAs), Approximately 85 days
Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
NCT Number: NCT06462092
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Leptomeningeal Metastases
Interventions: DRUG: Sacituzumab Govitecan|DRUG: Pemetrexed
Sponsor: Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2027-06-15

Summary:
Leptomeningeal metastases is a specific pattern of central involvement in which tumor cells invade and proliferate in the subarachnoid space, and is a lethal complication of malignant tumors. Leptomeningeal metastases from Her2-negative breast cancer is still tricky to treat at present, with an overall median survival of only 3-6 months, even after aggressive treatment. This study is an open, uncontrolled phase I/II clinical study to observe the safety, feasibility, and potential efficacy of Sacituzumab Govitecan combined with pemetrexed intrathecal chemotherapy in the treatment of patients with Her2-negative breast cancer leptomeningeal metastases in search of a more effective treatment.

Primary Outcome Measures: Maximal tolerated dose, A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity. If more than two patients experienced a DLT, that level was considered too toxic. The maximal tolerated dose (MTD) was exceeded and an additional three patients should be treated at the next lower dose level. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose., From the beginning of the treatment until two months after the treatment.
Secondary Outcome Measures: Incidence of treatment-related adverse events, The incidence of treatment-related adverse events were measured for determining tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.03). Events of grade 3-5 are defined as moderate and severe adverse events., From the beginning of the treatment until two months after the treatment.|Clinical response rate, The Response Assessment in Neuro-Oncology (RANO) criteria proposal for response criteria of leptomeningeal metastases was used to assess the clinical response in this study., From the beginning of the treatment until two months after the treatment or when patient died.
Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
NCT Number: NCT06462053
Acronym: TORCH-E2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Early Low Rectal Cancer
Interventions: RADIATION: Short-course radiotherapy|DRUG: PD-1 antibody (Toripalimab)|RADIATION: Long-course radiotherapy|DRUG: Oxaliplatin|DRUG: Capecitabine
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 134
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2027-03-01
Locations: Fudan University Shanghai Cancer Center, Shanghai, China

Summary:
TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Primary Outcome Measures: complete response (CR) rate, Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy., 1 month after the surgery or the decision of W&W
Secondary Outcome Measures: Grade 3-4 adverse effects rate, Rate of chemotherapy, radiotherapy and immunotherapy related adverse events, From date of randomization until 3 months after the completion neoadjuvant therapy|Organ preservation rate, Organ preservation rate, from date of receiving neoadjuvant therapy, assessed up to 3 years|3 year disease free survival rate, Rate of 3 year disease free survival, From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.|3 year local recurrence free survival rate, Rate of 3 year local recurrence free survival, From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.|3 year overall survival rate, Rate of 3 year overall survival, From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.|3 year Quality of Life, Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score., From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
NCT Number: NCT06462014
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DRUG: Relugolix
Sponsor: Pfizer
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-19
Completion Date: 2025-12-31
Locations: Pfizer, New York, New York, 10001, United States

Summary:
The purpose of this real-world study is the learn about the demographics and clinical characteristics of patients with prostate cancer who initiated relugolix

Primary Outcome Measures: Characterize patient characteristics initiating relugolix treatment, Descriptive analysis of baseline characteristics such as age will be defined as of the index date (start of relugolix) and retained in the dataset as a continuous variable. Findings will be presented as the mean, standard deviation (SD), median, 25th percentile, 75th percentile, and interquartile range, Up to 1 year prior to initiating relugolix|Characterize clinical characteristics of patients intitiating relugolix treatment, Descriptive analysis of clinical characteristics such as baseline prostate-specific antigen (PSA) value in ng/dL (among available) based on the PSA value on or prior to the index date will be evaluated. Findings will be presented as the mean, standard deviation (SD), median, 25th percentile, 75th percentile, and interquartile range, Up to 1 year prior to initiating relugolix
Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
NCT Number: NCT06461988
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma|Post Stem Cell Transplant
Interventions: DRUG: Talquetamab|DRUG: Talquetamab and Lenalidomide
Sponsor: Stanford University
Collaborators: Janssen, LP
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-06
Locations: Stanford University, Palo Alto, California, 94304, United States|New Mexico Cancer Research Alliance, Albuquerque, New Mexico, 87102, United States

Summary:
Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Primary Outcome Measures: Complete Response (CR) Rate, The primary outcome for this study, for the purposes of Clinical Trials.gov registration and results reporting, is the percentage of patients in complete response at 12 months., 12 months after the start of talquetamab in each participant.
Secondary Outcome Measures: Minimal Residual Disease (MRD) negativity (10-5) (ClonoSeqTM), The percentage (%) of participants with MRD negativity (10-5) (ClonoSeqTM) at 12 months after starting talquetamab., 2 years|Progression free survival (PFS) and overall survival (OS), Percentage (%) of participants with PFS and OS up to 3 years after starting talquetamab., 4 years|Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and hematologic and non-hematologic toxicities per NCI CTCAE v5 criteria, Number of participants who experience a significant toxicity of interest (STI) in the first 3 months., 1 year and 1 months post first patient treatment start|Quality of life - PROMIS® (Patient-Reported Outcomes Measurement Information System and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®), PROMIS and PRO-CTCAE will be assessed monthly during study treatment and at end of treatment., 2 years
Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
NCT Number: NCT06461975
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Retinopathy of Prematurity
Interventions: DRUG: Benoxinate Hydrochloride|DRUG: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.
Sponsor: Alexandria University
Sex: ALL
Age: CHILD
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-01-01
Completion Date: 2023-06-01
Locations: Faculty of Medicine Alexandria University, Alexandria, Egypt

Summary:
Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.

Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

Primary Outcome Measures: PIPP score, The PIPP is a composite measure that includes seven indicators, each of which is rated on a four-point scale (0-3). The indicators include heart rate, oxygen saturation, GA, brow bulge, nasolabial furrow, behavioural state, and eye squeeze. Larger number indicates more stress (worse outcome), 1-3 month after birth
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
NCT Number: NCT06461962
Acronym: PEER-Heart
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Methamphetamine Use|Heart Failure
Interventions: OTHER: Treatment as Usual|OTHER: Telehealth-Cardiology
Sponsor: Oregon Health and Science University
Collaborators: University of Washington|Bay Area First Step
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-07-15
Completion Date: 2029-06-30
Locations: Oregon Health & Science University, Portland, Oregon, 97239, United States

Summary:
The goal of PEER-Heart is to implement and assess feasibility and preliminary effectiveness of a community peer-facilitated screening for methamphetamine-associated heart failure (MAHF) and linkage to evidence-based cardiology care for people who use methamphetamine in rural areas.

Primary Outcome Measures: Linkage to cardiology care, Proportion of participants who are engaged in cardiac care at 2 months after screening., 2 months
Secondary Outcome Measures: Linkage to diagnostic echocardiogram, Proportion of participants who complete a diagnostic echocardiogram within 2 months after randomization., 2 months|Goal Directed Medical Therapy (GDMT) prescribed, Proportion of eligible patients who are on any GDMT at 6 months after randomization, 6 months
Intra-Tumoral Vascular Growth Patterns is a Robust Indicator of Adjuvant Therapy Following Liver Resection in HCC
NCT Number: NCT06461936
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HCC|Adjuvant Therapy|Immunotherapy|Recurrence
Interventions: DRUG: Sintilimab|DRUG: Lenvatinib
Sponsor: Chen Xiaoping
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 620
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2025-04-30
Locations: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China, Wuhan, Hubei, 430000, China

Summary:
Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC positive patients have a higher rate of postoperative recurrence. However, it is not clear how the surgical prognosis of VETC-positive patients can be improved.

Primary Outcome Measures: Disease -free survival, Disease-free survival was defined as the time from surgery to diagnosis of recurrence or death from any cause., From date of surgery to the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
Secondary Outcome Measures: Overall survival, Overall survival was defined as the time from surgery to death from any cause., From date of surgery to the date of death from any cause, assessed up to 60 months.
Combined Effects Of Percussion With Diaphragmatic Breathing Exercises On Airway Clearance In Elderly Pneumonia Patients
NCT Number: NCT06461884
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumonia
Interventions: OTHER: Percussions|OTHER: , Diaphragmatic breathing exercise
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-03-10
Completion Date: 2024-07-15
Locations: Mayo Hospital Lahore, Lahore, Punjab, 54000, Pakistan

Summary:
The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients.

Primary Outcome Measures: BCSS, BCSS: BCSS is a patient-reported three-item questionnaire for cough, breathlessness and sputum rating on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms)., 4 weeks|HRQOL for quality of life, One of the many factors frequently investigated in the realm of medical research and treatment is HRQOL. It covers a broad spectrum of man experience, contains how we operate and how we perceive illness. The World Health Organization defines health as a condition of whole physical, intellectual, and interpersonal well-being and not just the absence of disease, which is the foundation for modern interpretations of HRQOL., 4 weeks|Rated Perceived Exertion (RPE) Scale, Rate of perceived exertion (RPE) is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes. The RPE scale can help you manage exercise intensity and improve cardio training and endurance, 4 weeks
Combined Effects of BT With Moderate Intensity Aerobic Versus RT in Type 2 DM.
NCT Number: NCT06461871
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2
Interventions: OTHER: BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT)|OTHER: Moderate intensity resistance exercises in combination with balance training
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2023-06-10
Completion Date: 2023-11-20
Locations: Social Security Teaching Hospital Shah rah, Lahore., Lahore, Punjab, 54000, Pakistan

Summary:
A randomized control trail will be conducted at Social Security Teaching Hospital, Multan Road, Lahore. Social Security Teaching Hospital Shah rah, Lahore. Non -probability Convenient Random Sampling Technique will be applied on patients who will be allocated through simple random sampling into group A and group B. Group A received moderate intensity aerobic exercises which include walking, cycling, with each session lasting 15 minutes for 3-5 days per week in combination with balance training which include heel raise, standing march with 10 repetitions each for 3-5 days per week. Group B receive moderate intensity resistance exercises which include biceps curls, triceps curls , with each session lasting 10 repetitions for 3-5 days per week in combination with balance training which include heel raise, standing march with 10 repetitions each for 3-5 days per week. The study will be completed with time duration of six months .Primary outcome of research will be glycemic control, cardio respiratory fitness, and quality of life. Data will be analyzed using SPSS software version 21. After assessing normality of Shapiro-will test, it will be decided either parametric or non parametric test will be used within a group or between groups.

Primary Outcome Measures: VO2 MAX, To assess cardiorespiratory fitness , also known as maximal oxygen uptake , measures maximum amount of oxygen a person can utilize oxygen.

VO2 max = 132.853 - (0.0769 x your weight in pounds) - (0.3877 x your age) + (6.315 if you are male or 0 if you are female) - (3.2649 x your walking time) - (0.1565 x your heart rate at the end of the test)., 12 weeks|EQ -5D-5L QUESTIONNAIRE, EQ-5D-5L is a self assessed , health related, quality of life questionnaire. The scale measures quality of life on a 5 component scale including mobility, self care, usual activities, pain/discomfort , anxiety /depression ., 12 weeks|HbA1c, Hemoglobin analyzers (also referred to as HbA1c Analyzer) can report the concentration of hemoglobin in a blood or urine sample in g/L, g/dL, or mol/L. HbA1c Analyzers can run tests with samples as small as 1uL in just a few minutes., 12 weeks
The Impact of the Anaesthetic Technique Employed on the Quality of Recovery in Patients Undergoing Hysterectomy Surgery.
NCT Number: NCT06461832
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia|Analgesia|Acute Pain
Interventions: PROCEDURE: Group 1|PROCEDURE: Group 2
Sponsor: Samsun University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-12-01
Locations: Samsung Training and Research Hospital, Samsun, 55060, Turkey

Summary:
The objective of this study is to evaluate the results of different anesthesia methods (general anesthesia with epidural catheter application and spinal anesthesia with epidural catheter application) applied in elective hysterectomy surgeries performed in our hospital. The aim is to compare the advantages of both methods.

Primary Outcome Measures: The Quality of Recovery (QoR-40) score in the first 24 hours after surgery, The recovery quality of patients will be assessed with the Quality of Recovery Score-15 (QoR-15), which will be administered at the 24th hour postoperatively. The QoR-15 is a questionnaire comprising 15 items, with each item scored on a scale of 0 to 10. The total score on the QoR-15 ranges between 0 and 150., postoperative 24 hours|A comparison of the difference in recovery quality scores between patients at the preoperative and postoperative 24th hour., The difference between the patients' preoperative QoR-15 score and the QoR-15 score measured at the 24th hour postoperatively will be evaluated., postoperative 24 hours
Secondary Outcome Measures: Opioid consumption in the first 24 hours after surgery, Opioid consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥3., postoperative 24 hours|The incidences of post-operative nausea and vomiting (PONV), Post-operative nausea and vomiting (PONV) will be evaluated with a verbal descriptive scale.

(0 = None at all, 1 = Mild nausea, 2 = Moderate nausea, 3 = Vomiting once, 4 = Vomiting more than once), postoperative 24 hours|NRS Score, The Numerical Rating Scale (NRS) is a frequently utilized pain screening instrument for the objective assessment of the current intensity of pain, employing a scale of 0-10. The scale ranges from zero, which represents the absence of pain, to 10, which represents the worst pain imaginable. The postoperative NRS score will be evaluated at the following time points: the first, third, sixth, twelfth, and 24th hours., postoperative 24 hours|Time to first mobilization, The patients first mobilization time after the operation will be recorded., Up to 24 hours after surgery.|Time to discharge, he length of hospital stay will be recorded., Trough hospital stay, an average of 1 week
Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
NCT Number: NCT06461819
Acronym: DESAR-L
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Low-to-intermediate-risk Prostate Carcinoma
Interventions: RADIATION: Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.
Sponsor: Samsung Medical Center
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-11
Completion Date: 2033-12-31
Locations: Samsung Medical Center, Seoul, 06351, Korea, Republic of

Summary:
A single institution with a single group, a phase II study, low- and medium-risk studies performed after biodegradable substance injection prostate cancer dosage increase. The investigator plans to evaluate grade 1 or higher rectal bleeding occurring within 3 years in patients who have received low -fractionation curative radiotherapy.

Primary Outcome Measures: NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years, NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0, 5 years after radiation therapy of each participant
Secondary Outcome Measures: Radiation therapy-related side effects other than rectal bleeding, Radiation therapy-related side effects other than rectal bleeding, 5 years after each participant's end of radiation therapy after SpaceOAR hydrogel injection|Side effects related to biodegradable material injection, Side effects related to biodegradable material injection, 5 years after radiation therapy of each participant|5-year biochemical recurrence-free survival, 5-year biochemical recurrence-free survival, 5 years after radiation therapy of each participant|5-year progression-free survival, 5-year progression-free survival, 5 years after radiation therapy of each participant|5-year overall survival, 5-year overall survival, 5 years after radiation therapy of each participant|quality of life in every aspect of life, quality of life using Questionnare EPIC ( Extended Prostate Cancer Index Composite), 5 years after radiation therapy of each participant
Effect of Protein Source During Ketogenic Weight Loss Intervention
NCT Number: NCT06461806
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Obesity; Endocrine
Interventions: DIETARY_SUPPLEMENT: Protein supplement - Plant protein|DIETARY_SUPPLEMENT: Protein supplement - Animal protein
Sponsor: Concordia University, Montreal
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-10-01
Completion Date: 2024-12
Locations: School of Health, Concordia University, Montréal, Quebec, H4B 1R6, Canada

Summary:
This randomized, controlled, single-blinded study will investigate how the protein source in a high-protein ketogenic diet affects metabolic weight loss outcomes after a 12-week dietary intervention

Primary Outcome Measures: Change in weight, Overall weight loss, kg, Baseline and at 12 weeks|Change in BMI, Height and weight will be combined to report BMI (kg/m\^2), Baseline and at 12 weeks|Change in fat mass, Body composition is measured by dual energy x-ray absorptiometry., Baseline and at 12 weeks|Change in overall body fat percentage, Body composition is measured by dual energy x-ray absorptiometry., Baseline and at 12 weeks|Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment), Changes in various adipose tissue immune cells including M1-like and M2-like macrophages, T helper cells, and cytotoxic T cells will be measured via flow cytometry., Baseline and at 12 weeks|Concentrations of Circulatory cytokines and adipokines, Changes in cytokines and adipokines will be measured via ELISA. We will measure markers including interleukin 6, tumour necrosis factor a, leptin, and adiponectin., Baseline and at 12 weeks|Resting energy expenditure, Resting energy expenditure will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the resting energy expenditure., Baseline and at 12 weeks|Substrate oxidation, Substrate oxidation will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the respiratory exchange ratio., Baseline and at 12 weeks|Lipidomics, Lipidomics will be measured by mass spectrometry., Baseline and at 12 weeks|Adipocyte size, Regional adipocyte characteristics will be measured in vitro including adipocyte size,, Baseline and at 12 weeks|Rate of pre-adipocyte proliferation, Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro, Baseline and at 12 weeks
Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Patients With High - Risk Localized Prostate Cancer (DESAR-H)
NCT Number: NCT06461793
Acronym: DESAR-H
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: High Risk Prostate Carcinoma
Interventions: RADIATION: Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients
Sponsor: Samsung Medical Center
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-12
Completion Date: 2033-12-31
Locations: Samsung Medical Center, Seoul, 06351, Korea, Republic of

Summary:
Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients who underwent low-fractionation curative radiation therapy and hormone therapy

Primary Outcome Measures: NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years, Adverse Event within three years after the radiation therapy, 3 years after radiation therapy of each participant
Secondary Outcome Measures: Radiation therapy-related side effects other than rectal bleeding, Sigmoi doscopy is performed once a year for up to 2 years after the end of radiation therapy,, up to 2 years afte radiation therapy on each participant|Side effects related to biodegradable material injection, each participant finished with radiation therapy and see after 3-6 months for acute adverse events, 1-5 years for chronic adverse events|biochemical recurrence-free survival, Biochemical recurrence is defined as PSA nadir + 2.0ng/ml according to the Phoenix definition, or when hormone therapy is discontinued, when hormone therapy is newly started, or when hormone therapy is in progress, when the treatment is changed., 5 years after radiation therapy of each participant|progression-free survival, check on each participant by CT scan, MRI, Bone scan for any progressive disease, up to 5 years after radiation therapy of each participant|overall survival, overall survival of participants till the end of the study(death), up to 5 years after radiation therapy of each participant|quality of life on high-risk prostate cancer patients by using EPIC questionnaire, EPIC (Extended Prostate Cancer Index Composite), Korean version, up to 5 years after radiation therapy of each participant
Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months
NCT Number: NCT06461767
Acronym: rTMS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Migraine
Interventions: DEVICE: transcranial magnetic stimulation device
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-01-01
Locations: Sohag faculty of medicine, Sohag, 02, Egypt

Summary:
Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine

Primary Outcome Measures: improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test, improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test, one month after treatment
Prediction of Successful Liberation From Invasive Mechanical Ventilation Via Lung and Diaphragmatic Ultrasound in Intensive Care Unit Patients, Prospective, Observational Study
NCT Number: NCT06461754
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Liberation From Mechanical Ventilation in ICU Patients
Interventions: OTHER: Sonographic evaluation of diaphragm and lung
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-21
Completion Date: 2023-12-20
Locations: Sohag University Hospital, Sohag, Egypt

Summary:
Liberation from invasive mechanical ventilation (IMV) remains a challenge for intensive care physicians. Although standard indices such as blood gases and respiratory clinical data are used routinely but they still have some limitations. Diaphragmatic and lung sonographic parameters (pulmonary scores) recently became the hot spot to help in anticipation of liberation from IMV.The aim of this study was to ensure that, sonographic diaphragmatic thickening indices and lung scores are reliable and accurate additional tools to anticipate successful liberation from IMV in intensive care unit (ICU) patients.

Methods: This study was a prospective, observational study conducted at Sohag university hospital on 80 patients admitted to the Intensive Care Unit (ICU) and mechanically ventilated invasively for more than 24 hours and they were ready for weaning by standard methods. At the time of spontaneous breathing trials (SBT), we did diaphragm and lung ultrasound, where we applied diaphragmatic thickening indices (DTI) and a modified lung ultrasound scores (LUSm). Patients classified into two groups; failed group (FG) and (SG) of liberation from IMV. Comparison between (FG) and (SG) in relation to pulmonary scores (DTI and LUSm) were recorded. Cut-off values, sensitivity and specificity for DTI and LUSm were obtained. Also, comparison between (FG) and (SG) in relation to demographic, clinical and respiratory data were assessed and all data were statistically analysed.

Primary Outcome Measures: a cut off values for DTI and LUSm with sensitivity and specificity for anticipation of liberation from invasive mechanical ventilation, we reporte a cut-off value for DTI and LUSm below or above which the risk for failure of weaning can be predicted with a sensitivity persent and a specificity persent., One year
Secondary Outcome Measures: The correlations of DTI and LUSm with demographic, clinical and respiratory data, We recorded the relations of DTI and LUSm with demographic, clinical and respiratory data in prediction of succeeded liberation from IMV, one year